Humulin S (soluble), 100IU/ml solution for injection in cartridge

  • Name:

    Humulin S (soluble), 100IU/ml solution for injection in cartridge

  • Company:
    info
  • Active Ingredients:

    Insulin human

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/09/18

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 27/3/2019

Click on this link to Download PDF directly

Eli Lilly and Company (Ireland) Limited

Eli Lilly and Company (Ireland) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name ABASAGLAR 100 units/mL solution for injection in cartridge Active Ingredients Insulin glargine
Medicine Name ABASAGLAR 100 units/mL solution for injection in pre-filled pen Active Ingredients Insulin glargine
Medicine Name Adcirca Active Ingredients Tadalafil
Medicine Name Alimta Active Ingredients Pemetrexed disodium
Medicine Name Cialis 10mg Tablets Active Ingredients Tadalafil
Medicine Name Cialis 2.5mg Tablets Active Ingredients Tadalafil
Medicine Name Cialis 20mg Tablets Active Ingredients Tadalafil
Medicine Name Cialis 5mg Tablets Active Ingredients Tadalafil
Medicine Name Cymbalta Active Ingredients duloxetine hydrochloride
Medicine Name Cyramza 10 mg/ml concentrate for solution for infusion Active Ingredients Ramucirumab
Medicine Name Forsteo Active Ingredients Teriparatide
Medicine Name Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen Active Ingredients Insulin lispro
Medicine Name Humalog 100 units/ml Kwikpen soluton for injection Active Ingredients Insulin lispro
Medicine Name Humalog 100 units/ml, solution for injection in cartridge (3ml) (insulin lispro) Active Ingredients Insulin lispro
Medicine Name Humalog 100 units/ml, solution for injection in vial Active Ingredients Insulin lispro
Medicine Name Humalog 200 Units/ml KwikPen, solution for injection in pre-filled pen Active Ingredients Insulin lispro
Medicine Name Humalog Mix25 100 units/ml Kwikpen suspension for injection Active Ingredients Insulin lispro
Medicine Name Humalog Mix25 100 units/ml suspension for injection in cartridge Active Ingredients Insulin lispro
Medicine Name Humalog Mix50 100 units/ml Kwikpen suspension for injection Active Ingredients Insulin lispro
Medicine Name Humalog Mix50 100 units/ml suspension for injection in cartridge Active Ingredients Insulin lispro
Medicine Name Humulin I (Isophane), 100IU/ml suspension for injection in cartridge Active Ingredients Insulin human
Medicine Name Humulin I (Isophane), 100IU/ml suspension for injection in vial Active Ingredients Human Insulin
Medicine Name Humulin I KwikPen 100 IU/ml suspension for injection Active Ingredients Human Insulin
Medicine Name Humulin M3 (Mixture 3), 100IU/ml suspension for injection in cartridge Active Ingredients Insulin human
Medicine Name Humulin M3 (Mixture 3), 100IU/ml suspension for injection in vial Active Ingredients Insulin human
1 - 0 of 41 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 27 March 2019 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13 March 2015

Date of last renewal: 11 March 2019

10. DATE OF REVISION OF THE TEXT

11 March 201917 August 2018

Updated on 3 September 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 30 August 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Added (underline) deleted (strikethrough)

 

7.         MARKETING AUTHORISATION HOLDER

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

 

 

 

8.         MARKETING AUTHORISATION NUMBER(S)

PA0047/058/007PA2276/001/004

 

 

 

10. DATE OF REVISION OF THE TEXT

17 August 2018

Updated on 18 July 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 18 July 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

Changes

Added (underline) deleted (strikethrough)

4. CLINICAL PARTICULARS

4.2 Posology and method of administration

Cartridges (S)

Humulin S in cartridges is only suitable for subcutaneous injections from a reusable pen. should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. It may also be administered intravenously.

If administration by syringe or intravenous injection is necessary, a vial should be used.

 

10. DATE OF REVISION OF THE TEXT

10 July 2018

 

Updated on 18 July 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

4. CLINICAL PARTICULARS

4.2 Posology and method of administration

Cartridges (S)

Humulin S in cartridges is only suitable for subcutaneous injections from a reusable pen. should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. It may also be administered intravenously.

If administration by syringe or intravenous injection is necessary, a vial should be used.

 

10. DATE OF REVISION OF THE TEXT

10 July 2018

 

Updated on 4 July 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to other sources of information section

Updated on 26 June 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes

Added (underline) deleted (strikethrough)

 

4. CLINICAL PARTICULARS

4.4 Special warnings and precautions for use

  

Pens to be used with Humulin S cartridges

The cartridges should only be used in conjunction with a Lilly reusable insulin pen and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.

Excipients

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially

“sodium-free”.


4.8 Undesirable effects

…..

Local allergy in patients is common (1/100 to < 1/10). Redness, swelling, and itching can

occur at the site of insulin injection. This condition usually resolves in a few days to a few

weeks. In some instances, local reactions may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.

Lipodystrophy at the injection site is uncommon (1/1,000 to < 1/100).

(Introduction of a greater & equals symbol)

 

 5. PHARMACOLOGICAL PROPERTIES

 5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Insulins and analogues for injection, fast-acting.  Humulin S

ATC code: A10A B01.                           (Humulin S cartrdige)

 

6.6     Special precautions for disposal and other handling 

…..

The cartridges should only be used in conjunction with a Lilly reusable insulin pen and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.

A  suspension  for  injection  in  a  3  ml  cartridge  to  be  used  with  a  CE  marked  pen  as recommended in the information provided by the device manufacturer.

…..

10. DATE OF REVISION OF THE TEXT
29 September 2016

19 June 2018

Updated on 5 June 2018 SmPC

Reasons for updating

  • New individual SmPC (was previously included in combined SmPC)

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC re-formatted from a combined Humulin SmPC (featuring all presentations) to individual Humulin SmPCs (presentation specific). 

Updated on 10 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 14 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 February 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 22 March 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

Previous

Changes

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 

human insulin

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 

insulin human

4.2 Posology and method of administration

 

The dosage should be determined by the physician, according to the requirement of the patient.

 

HUMULIN S should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection.  It may also be administered intravenously.

 

 

 

4.2 Posology and method of administration

 

Posology

 

The dosage should be determined by the physician, according to the requirement of the patient.

 

Paediatric population

 

No data are available

 

Method of administration

 

HUMULIN S should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection.  It may also be administered intravenously.

 

4.3 Contraindications

 

Hypersensitivity to HUMULIN or to the formulation excipients, unless used as part of a desensitisation programme.

4.3 Contraindications

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, unless used as part of a desensitisation programme.

4.4 Special warnings and precautions for use

 

 

4.4 Special warnings and precautions for use

 

Instructions for use and handling

 

Cartridges

To prevent the possible transmission of disease, each cartridge must be used by one patient only, even if the needle on the delivery device is changed.

 

Pre-filled Pens

To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.

6.6 Special precautions for disposal and other handling

 

Do not reuse needles.  Dispose of the needle in a responsible manner.  Needles and pens must not be shared.  Vials, cartridges and HUMULIN I- and M3 KwikPen can be used until empty, then properly discard.  Any unused product or waste material should be disposed of in accordance with local requirements.

 

Instructions for use and handling

 

B             Cartridges

 

A solution or suspension for injection in a 3ml cartridge to be used with a CE marked pen as recommended in the information provided by the device manufacturer.

 

C             Pre-filled pens

 

A suspension for injection in a pre-filled /disposable pen injector containing a 3ml cartridge.  HUMULIN I- and M3 KwikPen delivers up to 60 units per dose in single unit increments.

 

6.6 Special precautions for disposal and other handling

 

Do not reuse needles.  Dispose of the needle in a responsible manner.  Needles and pens must not be shared.  Vials, cartridges and HUMULIN I- and M3 KwikPen can be used until empty, then properly discard.  Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

Instructions for use and handling

 

B             Cartridges

 

To prevent the possible transmission of disease, each cartridge must be used by one patient only, even if the needle on the delivery device is changed.

 

A solution or suspension for injection in a 3ml cartridge to be used with a CE marked pen as recommended in the information provided by the device manufacturer.

 

C             Pre-filled pens

 

To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.

 

A suspension for injection in a pre-filled /disposable pen injector containing a 3ml cartridge.  HUMULIN I- and M3 KwikPen delivers up to 60 units per dose in single unit increments.

 

8. MARKETING AUTHORISATION NUMBER(S)

 

HUMULIN S vial: PA 0047/058/003

HUMULIN I vial: PA 0047/059/003

HUMULIN M3 vial: PA 0047/069/002

 

HUMULIN S cartridge: PA 0047/058/005

HUMULIN I cartridge: PA 0047/059/006

HUMULIN M3 cartridge: PA 0047/069/004

 

HUMULIN I KwikPen: PA 0047/088/001

HUMULIN M3 KwikPen: PA 0047/092/001

 

8. MARKETING AUTHORISATION NUMBER(S)

 

HUMULIN S vial: PA 0047/058/006

HUMULIN I vial: PA 0047/059/007

HUMULIN M3 vial: PA 0047/069/005

 

HUMULIN S cartridge: PA 0047/058/007

HUMULIN I cartridge: PA 0047/059/008

HUMULIN M3 cartridge: PA 0047/069/006

 

HUMULIN I KwikPen: PA 0047/088/002

HUMULIN M3 KwikPen: PA 0047/092/002

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

HUMULIN S vial:

Date of first authorisation: 22 June 1983

Date of last renewal:           24 April 2006

 

HUMULIN I vial:              

Date of first authorisation: 22 June 1983

Date of last renewal:           24 April 2006

 

HUMULIN M3 vial:          

Date of first authorisation: 23 February 1993

Date of last renewal:           24 April 2006

 

HUMULIN S cartridge:    

Date of first authorisation: 30 April 1996

Date of last renewal:           24 April 2006

 

HUMULIN I cartridge:     

Date of first authorisation: 30 April 1996

Date of last renewal:           24 April 2006

 

HUMULIN M3 cartridge: 

Date of first authorisation: 30 April 1996

Date of last renewal:           24 April 2006

 

HUMULIN I KwikPen:     

Date of first authorisation: 18 September 1998

Date of last renewal:           24 April 2006

 

HUMULIN M3 KwikPen:

Date of first authorisation: 18 September 1998

Date of last renewal:           24 April 2006

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

HUMULIN S vial:

Date of first authorisation: 13 March 2015

Date of last renewal:          

 

HUMULIN I vial:              

Date of first authorisation: 13 March 2015

Date of last renewal:

 

HUMULIN M3 vial:          

Date of first authorisation: 13 March 2015

Date of last renewal:          

 

HUMULIN S cartridge:    

Date of first authorisation: 13 March 2015

Date of last renewal:          

 

HUMULIN I cartridge:     

Date of first authorisation: 13 March 2015

Date of last renewal:          

 

HUMULIN M3 cartridge: 

Date of first authorisation: 13 March 2015

Date of last renewal:          

 

HUMULIN I KwikPen:     

Date of first authorisation: 13 March 2015

Date of last renewal:          

 

HUMULIN M3 KwikPen:

Date of first authorisation: 13 March 2015

Date of last renewal:          

10. DATE OF REVISION OF THE TEXT

 

31.3.2015

10. DATE OF REVISION OF THE TEXT

 

29 September 2016

HUMULIN* (human insulin [prb]) is a trademark of Eli Lilly and Company.                               HU36M

 

HUMULIN* (insulin human [prb]) is a trademark of Eli Lilly and Company.                               HU38M

 

 

Updated on 22 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 21 March 2017 PIL

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 15 May 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company


4.          CLINICAL PARTICULARS

4.8        Undesirable effects
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer.  Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death.  No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e.g., a patient’s level of diet and exercise.

Local allergy in patients is common (1/100 to <1/10).  Redness, swelling, and itching can occur at the site of insulin injection.  This condition usually resolves in a few days to a few weeks.  In some instances, local reactions may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.

Systemic allergy, which is very rare (<1/10,000) but potentially more serious, is a generalised allergy to insulin.  It may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating.  Severe cases of generalised allergy may be life-threatening.  In the rare event of a severe allergy to HUMULIN, treatment is required immediately.  A change of insulin or desensitisation may be required.

Lipodystrophy at the injection site is uncommon (1/1,000 to <1/100).

Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.

 

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie

 

 

 

6.          PHARMACEUTICAL PARTICULARS
6.1
        List of excipients 

 . . . . . . . . . . . .
For HUMULIN I and HUMULIN M3 preparations:

m-cresol
Glycerol
Phenol
Protamine sul
phfate
Dibasic sodium phosphate 7H2O
Zinc oxide
Water for injections

The following may be used to adjust pH:
Hydrochloric acid and/or Sodium hydroxide

 

10.        DATE OF REVISION OF THE TEXT
Revision date changed to
31.3.2015

 

 

 

 

 

 

 

 

 

Updated on 12 May 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 28 June 2013 PIL

Reasons for updating

  • Change of manufacturer

Updated on 9 October 2012 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

6.             PHARMACEUTICAL PARTICULARS
6.3          Shelf life

 

Vials

Unopened vials:   2  3 years.    

 

After first use: 28 days.

 

 

10.          DATE OF REVISION OF THE TEXT

 

Revision date changed to:

 

 

18 September 2012

Updated on 21 June 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

 

PLEASE NOTE:  Following the discontinuation of Humulin Pen, the SPC has been updated throughout in order to reflect the removal of Humulin I Pen information.

 

4.             CLINICAL PARTICULARS

 

4.4          Special warnings and precautions for use

 

Added (new) text:

 

Combination of human insulin with pioglitazone

Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind, if treatment with the combination of pioglitazone and human insulin is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs.

 

 

4.5          Interaction with other medicinal products and other forms of interaction

 

Amended text (new text underlined, strikethrough for previous text):

 

A number of medicinal products are known to interact with glucose metabolism and therefore the physician should be consulted when using other medications in addition to human insulin (see section 4.4). The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.

 

Some medicinal products are known to interact with glucose metabolism.  The physician should take possible interactions into account and ask patients about their other medications in addition to human insulin.

 

 

4.8          Undesirable effects

 

Added (new) text:

 

Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.

 

 

6.             PHARMACEUTICAL PARTICULARS

 

6.3          Shelf life

 

Re-format of information/text (strikethrough for previous text only):

 

Vials

Unopened vials: 2 years.    

After first use: 28 days.

 

Cartridges

Unused cartridge: 2 years (HUMULIN  S).    3 years (HUMULIN I and HUMULIN M3).    

After cartridge insertion: 28 days.

 

 

Pre-filled pens

Unused pre-filled pens: 3 years.    

After first use: 28 days.

 

Vials: The shelf-life for HUMULIN S, HUMULIN I and HUMULIN M3 presentations is two years.

 

Once in use the vials may be used for up to 28 days.  Do not use beyond this period.  When in use the vials should not be stored above 30°C.

 

Cartridges: The shelf-life for the HUMULIN S presentation is two years.  The shelf-life for HUMULIN I and HUMULIN M3 presentations is 3 years.

 

After insertion of the cartridge in the pen, the solution or suspension should be used in 28 days.  Do not use beyond this period.  When in use the cartridges should not be stored above 30°C.

 

Pre-filled pens: The shelf-life for HUMULIN I- and M3 KwikPen presentations is 3 years.

Once in use HUMULIN I- and M3 KwikPen may be used for up to 28 days.  Do not use beyond this period.  When in use HUMULIN I- and M3 KwikPen should not be stored above 30°C.

 

 

6.4          Special precautions for storage

 

Re-format of information/text (strikethrough for previous text only):

 

Vials

 

Do not freeze.  Do not expose to excessive heat or direct sunlight.

Unopened vials: Store in a refrigerator (2°C- 8°C).  

After first use: Store below 30°C.

 

Cartridges

 

Unused cartridge: Store in a refrigerator (2 °C – 8 °C). Do not freeze. Do not expose to excessive heat or direct sunlight.

After cartridge insertion: Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the needle attached.

 

Pre-filled pens

 

Unused pre-filled pens: Store in a refrigerator (2 °C – 8 °C). Do not freeze. Do not expose to excessive heat or direct sunlight.

After first use: Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.

 

 

Store in a refrigerator (2°C-8°C).

 

Do not freeze.  Do not expose to excessive heat or direct sunlight.

 

Keep the container in the outer carton.

 

 

6.5          Nature and contents of container

 

Amended text to reflect Irish (opposed to EU) registered pack sizes only ((strikethrough for previous text only):

 

Pre-filled pens -    HUMULIN I- and M3 KwikPen:  Pack size of 5, or 2 x 5 x 3ml.

 

 

10.          DATE OF REVISION OF THE TEXT

 

Revision date changed to:      11 June 2012

 

 

 

 

 

 

 

 

Updated on 21 June 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 4 August 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition/Introduction of Humulin I and M3 Kwikpen to the SPC.

Change to Date of Revision of text:

02 July 2010

Updated on 1 April 2010 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision
  • Change due to harmonisation of patient information leaflet

Updated on 3 February 2010 SmPC

Reasons for updating

  • Change to section 6 - Pharmaceutical particulars
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Changes

 

 

 

6.             PHARMACEUTICAL PARTICULARS

 

 

6.3          Shelf life

 

               

Vials: The shelf life for HUMULIN S, HUMULIN I and HUMULIN M3 presentations is two years.

 

Once in use the vials may be used for up to 28 days.  Do not use beyond this period.  When in use the vials should not be stored above 30°C.

 

Cartridges: The shelf life for the HUMULIN S presentation is two years.  The shelf life for HUMULIN I and HUMULIN M3 presentations is 3 years.

 

After insertion of the cartridge in the pen, the solution or suspension should be used in 28 days.  Do not use beyond this period.  When in use the cartridges should not be stored above 30°C.

 

Pre-filled pen: The shelf life for HUMULIN I Pen is 3 years.

 

Once in use HUMULIN I Pen may be used for up to 28 days.  Do not use beyond this period.  When in use HUMULIN I Pen should not be stored above 30°C.

 

 

The shelf-life for HUMULIN S, HUMULIN I, and HUMULIN M3 presentations is two years.

 

Vials and pre-filled pens: Once in use the vials or HUMULIN I- and M3 Pen may be used for up to 28 days.  Do not use beyond this period.  When in use the vials or HUMULIN I- and M3 Pen should not be stored above 30°C.

 

Cartridges: After insertion of the cartridge in the pen, the solution or suspension should be used in 28 days.  Do not use beyond this period.  When in use the cartridges should not be stored above 30°C.

 

 

6.6          Special precautions for disposal and other handling

 

                Change to the 6.6 sub-heading title

 

6.6          Special precautions for disposal and other handling of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

                Also inclusion of sub-heading   Instructions for use and handling

 

                The phase ‘…diabetic nurse.’ amended to ‘…diabetes specialist nurse’.

 

 

8.             MARKETING AUTHORISATION NUMBER(S)

 

Minor change of format of PA numbers, i.e.- from PA 47/58/3 to PA 0047/058/003

 

HUMULIN S vial:               PA 0047/058/003

HUMULIN I vial:                PA 0047/059/003

HUMULIN M3 vial:           PA 0047/069/002

HUMULIN S cartridge:      PA 0047/058/005

HUMULIN I cartridge:       PA 0047/059/006

HUMULIN M3 cartridge:  PA 0047/069/004

HUMULIN I Pen:                PA 0047/088/001

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date

 

16 December 2009

 

 

               

Updated on 29 January 2009 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

3.             PHARMACEUTICAL FORM

 

Deleted (strikethrough):

 

Humulin I is a sterile suspension of a white, crystalline precipitate of isophane human insulin in an isotonic phosphate buffer. adjusted to a pH range of 6.9 to 7.5.

 

 

 

4.             CLINICAL PARTICULARS

 

4.1          Therapeutic indications

 

Deleted:

 

Humulin is also indicated for the initial control of diabetes mellitus and diabetes mellitus in pregnancy.

 

4.2                Posology and method of administration

 

Deleted:

 

Instructions for use and handling

 

A             Vials

 

A solution or suspension for injection in a 10ml vial to be used in conjunction with an appropriate syringe (100IU/ml markings).

 

 

B             Cartridges

 

A solution or suspension for injection in a 3ml cartridge to be used with a CE marked pen as recommended in the information provided by the device manufacturer.

 

C             Pre-filled pens

 

A suspension for injection in a pre-filled/disposable pen injector containing a 3ml cartridge.  HUMULIN I Pen delivers up to 60 units per dose in single unit increments.

 

a)             Preparing a dose

 

Vials or cartridges containing HUMULIN S formulation do not require resuspension and should only be used if it is clear, colourless, with no solid particles visible and if it is of water-like appearance.


 

Vials containing HUMULIN I or the HUMULIN M3 formulations should be rotated several times in the palms of the hands before use to completely resuspend the insulin, until it appears uniformly cloudy or milky.  Cartridges and pre-filled pens containing HUMULIN I and cartridges containing HUMULIN M3 formulations should be rolled in the palms of the hands ten times and inverted 180 ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.  If not, repeat the above procedure until contents are mixed.  Cartridges contain a small glass bead to assist mixing.  Do not shake vigorously as this may cause frothing, which may interfere with the correct measurement of the dose.

 

The vials and cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the vial or cartridge, giving a frosted appearance.

 

HUMULIN S and I Vials: Mixing of insulins - The shorter acting insulin should be drawn into the syringe first, to prevent contamination of the vial by the longer acting preparation.  It is advisable to inject directly after mixing.  However, if a delay is necessary, a consistent routine must be followed.

 

Alternatively, a separate syringe or, separate cartridges of HUMULIN S and I, can be used for administration of the correct amount of each formulation.

 

Vials:

 

Prepare your syringe prior to injection, as directed by your doctor or diabetic nurse.

 

Use an insulin syringe marked for the strength of insulin being administered.

 

Cartridges and pre-filled pens:

 

The cartridges are not designed to allow any other insulin to be mixed in the cartridge.  Cartridges are not designed to be refilled.

 

The manufacturer's instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.

 

Follow the instructions with HUMULIN I Pen for attaching the needle and administering the insulin injection.

 

For HUMULIN I Pen, a needle must always be attached before priming, dialling, and injecting an insulin dose.  HUMULIN I Pen should always be primed before each injection.  Failure to prime HUMULIN I Pen may result in an inaccurate dose.

 

b)             Injecting a dose

 

Inject the correct dose of insulin, as directed by your doctor or diabetic nurse.

 

Use of the injection sites should be rotated so that the same site is not used more than approximately once a month.

 

4.5           Interaction with other medicinal products and other forms of interaction

 

Added (bold):

 

Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics (OHA), salicylates (for example, acetylsalicylic acid), certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme (ACE) inhibitors (captopril, enalapril), angiotensin II receptor blockers, non-selective beta-blocking agents and alcohol.

 

Deleted (strikethrough) Added (bold):

 

Somatostatin analogues (octreotide, lanreotide) may both decrease and or increase insulin dose requirements.

 

 


 

 

6.             PHARMACEUTICAL PARTICULARS

 

6.1          List of excipients

 

Deleted (strikethrough) Added (bold):

 

disodium phosphate anhydrous dibasic sodium phosphate 7H20      

 

6.6          Special precautions for disposal and other handling

 

Instructions for use and handling

 

A             Vials

 

A solution or suspension for injection in a 10ml vial to be used in conjunction with an appropriate syringe (100IU/ml markings).

 

 

B             Cartridges

 

A solution or suspension for injection in a 3ml cartridge to be used with a CE marked pen as recommended in the information provided by the device manufacturer.

 

C             Pre-filled pens

 

A suspension for injection in a pre-filled/disposable pen injector containing a 3ml cartridge.  HUMULIN I Pen delivers up to 60 units per dose in single unit increments.

 

a)             Preparing a dose

 

Vials or cartridges containing HUMULIN S formulation do not require resuspension and should only be used if it is clear, colourless, with no solid particles visible and if it is of water-like appearance.

 

Vials containing HUMULIN I or the HUMULIN M3 formulations should be rotated several times in the palms of the hands before use to completely resuspend the insulin, until it appears uniformly cloudy or milky.  Cartridges and pre-filled pens containing HUMULIN I and cartridges containing HUMULIN M3 formulations should be rolled in the palms of the hands ten times and inverted 180 ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.  If not, repeat the above procedure until contents are mixed.  Cartridges contain a small glass bead to assist mixing.  Do not shake vigorously as this may cause frothing, which may interfere with the correct measurement of the dose.

 

The vials and cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the vial or cartridge, giving a frosted appearance.

 

HUMULIN S and I Vials: Mixing of insulins - The shorter acting insulin should be drawn into the syringe first, to prevent contamination of the vial by the longer acting preparation.  It is advisable to inject directly after mixing.  However, if a delay is necessary, a consistent routine must be followed.

 

Alternatively, a separate syringe or, separate cartridges of HUMULIN S and I, can be used for administration of the correct amount of each formulation.

 

Vials:

 

Prepare your syringe prior to injection, as directed by your doctor or diabetic nurse.

 

Use an insulin syringe marked for the strength of insulin being administered.

 

Cartridges and pre-filled pens:

 

The cartridges are not designed to allow any other insulin to be mixed in the cartridge.  Cartridges are not designed to be refilled.

 

The manufacturer's instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.

 

Follow the instructions with HUMULIN I Pen for attaching the needle and administering the insulin injection.

 

For HUMULIN I Pen, a needle must always be attached before priming, dialling, and injecting an insulin dose.  HUMULIN I Pen should always be primed before each injection.  Failure to prime HUMULIN I Pen may result in an inaccurate dose.

 

b)             Injecting a dose

 

Inject the correct dose of insulin, as directed by your doctor or diabetic nurse.

 

Use of the injection sites should be rotated so that the same site is not used more than approximately once a month.

 

Each pack contains a patient information leaflet with instructions on how to inject insulin.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

17 December 2008

Updated on 1 February 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 25 January 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

7.             MARKETING AUTHORISATION HOLDER

 

Changed:

 

Eli Lilly and Company Limited

Lilly House

Priestley Road

Basingstoke

Hampshire, RG24 9NL

England.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date:

 

Humulin S vial:                    28 November 2007

Humulin I vial:                    28 November 2007

Humulin M3 vial:                28 November 2007

Humulin S cartridge:           28 November 2007

Humulin I cartridge:           28 November 2007

Humulin M3 cartridge:       28 November 2007

Humulin I Pen:                    28 November 2007

Updated on 25 June 2007 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to improve clarity and readability
  • Change to date of revision

Updated on 24 April 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

1.             NAME OF THE MEDICINAL PRODUCT

 

Deletions in strikethrough text

 

Humulin* S (Soluble)

(Soluble insulin injection)

100IU/ml solution for injection in vial.

100IU/ml solution for injection in cartridge.

 

 

Humulin I (Isophane)

(Isophane insulin injection)

100IU/ml suspension for injection in vial.

100IU/ml suspension for injection in cartridge.

 

 

Humulin I Pen (Isophane)

(Isophane insulin injection)

100IU/ml suspension for injection.

 

 

Humulin M3 (Mixture 3)

(Biphasic isophane insulin injection -

30% soluble insulin/70% isophane insulin)

100IU/ml suspension for injection in vial.

100IU/ml suspension for injection in cartridge.

 

 

 

 

2.             QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Changes shown in bold text

 

1ml contains 100IU human insulin (produced in E. coli by recombinant DNA technology).

 

Humulin S:           One vial contains 10ml equivalent to 1000IU of soluble insulin.

One cartridge contains 3ml equivalent to 300IU of soluble insulin.

 

Humulin I:            One vial contains 10ml equivalent to 1000IU of isophane insulin.

One cartridge contains 3ml equivalent to 300IU of isophane insulin

 

Humulin I Pen:    One pre-filled pen contains 3ml equivalent to 300IU of isophane insulin.

 

Humulin M3:       One vial contains 10ml equivalent to 1000IU of biphasic isophane insulin - 30% soluble insulin/70% isophane insulin.

One cartridge contains 3ml equivalent to 300IU of biphasic isophane insulin in - 30% soluble insulin/70% isophane insulin

 

For a full list of excipients, see section 6.1.

 

 

3.             PHARMACEUTICAL FORM

 

                Reformatted section and moved the following statements to section 5.1.

 

Humulin S is a rapidly acting insulin preparation.

 

Humulin I is an intermediate acting insulin preparation

 

Humulin M3 is an intermediate acting insulin preparation.

 

 


 

4.             CLINICAL PARTICULARS

 

4.2          Posology and method of administration

 

Deletions in strikethrough text and additions in bold

 

Humulin I and Humulin M3 in vials, and Humulin I and Humulin M3 in cartridge presentations should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection.  These formulations should not be administered intravenously.

 

Humulin I (Isophane) may be administered in combination with Humulin S (Soluble).  (See section 6.6 ‘Instructions for use and handling’ for ‘Mixing of insulins’.)

 

The Humulin Mixture formulation is a ready-made defined mixture of Humulin S soluble and Humulin I isophane insulin designed to avoid the need for the patient to mix insulin preparations.  A patient’s treatment regimen should be based on their individual metabolic requirements.

 

                The entire section on ‘Instructions for use and handling’ brought forward from section 6.6 to section 4.2 with reformatting and slight rewording.

 

4.8          Undesirable effects

 

Added:

 

No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors eg, a patient’s level of diet and exercise.

 

Frequency categories added for the AEs; local allergy, systemic allergy and lipodystrophy.

 

4.9          Overdose

 

Added:

 

Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may occur after apparent clinical recovery.

 

 

 

5.             PHARMACOLOGICAL PROPERTIES

 

5.1          Pharmacodynamic properties

 

The following statements moved from section 3 to this section.

 

Humulin S is a rapidly acting insulin preparation.

 

Humulin I is an intermediate acting insulin preparation.

 

Humulin M3 (Mixture 3) is an intermediate acting insulin preparation

 

 

 

6.             PHARMACEUTICAL PARTICULARS

 

6.1          List of excipients

 

Deleted the following statements:

 

Each vial or cartridge will contain human insulin (recombinant DNA origin) and the following excipients.

 

Each vial, cartridge, or pre-filled pen will contain human insulin (recombinant DNA origin) and the following excipients:

 

The name of the excipient ‘dibasic sodium phosphate’ changed to ‘disodium phosphate anhydrous’ for the Humulin I and M3 preparations.

 

6.3          Shelf-life

 

Deletions in strikethrough text and additions in bold.

 

The in-use shelf-life for all Humulin vials and all Humulin 3ml cartridges (including the Humulin I Pen) is 28 days.

 

Vials and pre-filled pens: Once in use the vials or Humulin I Pen may be used for up to 28 days.  Do not use beyond this period.  When in use the vials or Humulin I Pen should not be stored above 30 C.

 

Cartridges: After insertion of the cartridge in the pen, the solution or suspension should be used in 28 days.  Do not use beyond this period.  When in use the cartridges should not be stored above 30°C.

 

6.4          Special precautions for storage

 

Changed ‘Store at 2°C-8°C (in a refrigerator).’ to ‘Store in a refrigerator (2°C-8°C).’

 

Deleted following statements:

 

Once in use, the vials, cartridges, and pre-filled pens may be used for up to 28 days.  Do not use beyond this period.

 

When in use, the vials, cartridges, and pre-filled pens should not be stored above 30°C.

 

6.5          Nature and contents of container

 

Deletions in strikethrough text and additions in bold.

 

Humulin vials: The product is filled in vials that comply with the requirements of the PhEur for Type I flint glass, stoppered with rubber closures, and sealed with aluminium seals combined with a plastic 'flip top'.

 

1 x 10ml vial

 

Vials: 10ml of solution or suspension in a vial (Type I glass) with a stopper (rubber) sealed with a seal (aluminium) combined with a flip top (plastic).

 

Pack size 1 or 2.

 

Humulin cartridges and prefilled pens: The product is filled in cartridges that comply with the requirements of the PhEur for Type I flint glass, and sealed with rubber closures consisting of a plunger head at the bottom and a disk seal at the top of the cartridge.

 

5 x 3ml cartridges

5 x 3ml pens

 

Cartridges: 3ml solution or suspension in a cartridge (Type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber).

 

Pack size of 5.

 

Pre-filled pens: 3ml suspension in a cartridge (Type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber) in a pre-filled pen.

 

Pack size of 5


 

6.6          Instructions for use and handling Special precautions for disposal and other handling

 

The entire section on ‘Instructions for use and handling’ moved from this section to section 4.2.

 

Subheading, ‘c) Disposal of used containers and needles’ deleted.

 

Changes to the following paragraph shown in bolded text below:

 

Do not reuse needles.  Dispose of the needle in a responsible manner.  Needles and pens must not be shared.  Vials, cartridges and Humulin I Pen can be used until empty, then properly discard. Any unused product or waste material should be disposed of in accordance with local requirements.

 

 

 

9.             DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of last renewal for all presentations changed to 24 April 2006.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date

 

20 November 2006

Updated on 21 June 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 August 2005 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 14 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)