GlucaGen HypoKit 1 mg powder and solvent for solution for injection

  • Name:

    GlucaGen HypoKit 1 mg powder and solvent for solution for injection

  • Company:
    info
  • Active Ingredients:

    Glucagon hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/06/20

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Summary of Product Characteristics last updated on medicines.ie: 16/6/2020

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Novo Nordisk Limited

Novo Nordisk Limited

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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 16 June 2020 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 2: statement regarding latex removed

Section 4: HPRA contact details shortened

Updated on 16 June 2020

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.4: 

Latex warning removed: "The tip cap of the syringe included in the GlucaGen HypoKit contains natural rubber latex which may cause allergic reactions in latex sensitive individuals."

 

Section 4.8:

HPRA contact details shortened

Updated on 15 December 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 December 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works

Updated on 3 November 2015 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 7 - Marketing authorisation holder
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

3.            PHARMACEUTICAL FORM

 

Powder and solvent for solution for injection.

 

Before reconstitution the compacted powder should be a white or nearly white powder. The solvent should be clear and colourless without particles.

 

 

4.            CLINICAL PARTICULARS

 

4.1          Indications

 

Therapeutic indication

 

TreatmentGlucaGen is indicated for treatment of severe hypoglycaemic reactions, which may occur in the management of insulin treated personschildren and adults with diabetes mellitus.

 

Diagnostic indication

 

MotilityGlucaGen is indicated for motility inhibition in examinations of the gastrointestinal tract in adults.

 

4.2          Posology and method of administration

 

Dissolve the freeze-dried product in the accompanying solvent, as described under item 6.6.

 

Posology

 

•          Therapeutic indication (Severe hypoglycaemia)

 

Dosage for adult patients:

 Administer 1 mg by subcutaneous or intramuscular injection.

 

Special populations

 

Paediatric population (<18 years old): GlucaGen can be used for the treatment of severe hypoglycaemia in children and adolescents.

 

Dosage for paediatric patients:

 Administer 0.51 mg (children abovebelow 25 kg or olderyounger than 6-8 years) or 0.51 mg (children belowabove 25 kg or youngerolder than 6-8 years).

 

Elderly (≥ 65 years old): GlucaGen can be used in elderly patients.

 

Renal and hepatic impairment: GlucaGen can be used in patients with renal and hepatic impairment.

 

•          Diagnostic indication (Inhibition of gastrointestinal motility)

 

Dosage for adult patients: The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum and small bowel is 0.2–0.5 mg given as intravenous injection or 1 mg given intramuscularly; the usual dose to relax the colon is 0.5–0.75 mg intravenously or 1–2 mg intramuscularly.

Special populations

Paediatric population (<18 years old): The safety and efficacy of GlucaGen for inhibition of gastrointestinal motility in children and adolescents have not been established. No data are available.

Elderly (≥ 65 years old): GlucaGen can be used in elderly patients.

Renal and hepatic impairment: GlucaGen can be used in patients with renal and hepatic impairment.

 

Method of administration

 

Dissolve the compacted powder in the accompanying solvent, as described in section 6.6.

 

Therapeutic indication (Severe hypoglycaemia):

 

Administer by subcutaneous or intramuscular injection. The patient will normally respond within 10 minutes. When the patient has responded to the treatment, give oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia. If the patient does not respond within 10 minutes, intravenous glucose should be given.

 

Medical consultation is required for all patients with severe hypoglycaemia.

 

Diagnostic indication (Inhibition of gastrointestinal motility)):

 

 

 

GlucaGen must be administered by medical personnel. Onset of action after an intravenous injection of 0.202–0.5 mg occurs within one minute and the duration of effect is between 5 and 20 minutes depending on the organ under examination. The onset of action after an intramuscular injection of 121–2 mg occurs after 5155–15 minutes and lasts approximately 104010–40 minutes depending on the organ.

 

After end of the diagnostic procedure oral carbohydrate should be given, if this is compatible with the diagnostic procedure applied.

Dose range from 0.2-2 mg depending on the diagnostic technique used and the route of administration. The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum and small bowel is 0.2-0.5 mg given intravenously or 1 mg given intramuscularly; the usual dose to relax the colon is 0.5-0.75 mg intravenously or 1-2 mg intramuscularly.

 

4.3          Contraindications

 

Hypersensitivity to glucagonthe active substance or lactoseto any of the excipients listed in section 6.1.

 

Phaeocromocytoma.

 

4.4          Special warnings and precautions for use

 

Due to the instability of GlucaGen in solution, the product should be given immediately after reconstitution and must not be given as an intravenous infusion.

 

The tip cap of the syringe included in the GlucaGen HypoKit contains natural rubber latex which may cause allergic reactions in latex sensitive individuals.

 

Therapeutic indication

 

To prevent relapse of the hypoglycaemia, oral carbohydrates should be given to restore the liver glycogen, when the patient has responded to the treatment.

 

Glucagon will not be effective in patients whose liver glycogen is depleted. For that reason, glucagon has little or no effect when the patient has been fasting for a prolonged period, or is suffering from adrenal insufficiency, chronic hypoglycaemia or alcohol induced hypoglycaemia.

 

Glucagon, unlike adrenaline, has no effect upon muscle phosphorylase and therefore cannot assist in the transference of carbohydrate from the much larger stores of glycogen that are present in the skeletal muscle.

 

The tip cap of the syringe included in the GlucaGen HypoKit contains natural rubber latex which may cause allergic reactions in latex sensitive individuals.

 

Diagnostic indication

 

Persons who have been given glucagon in connection with diagnostic procedures may experience discomfort, in particular if they have been fasting. Nausea, hypoglycaemia, and blood pressure changes have been reported in these situations. After the end of a diagnostic procedure, oral carbohydrates should be given to patients, who have been fasting, if this is compatible with the diagnostic procedure applied. If fasting is needed post-examination or in case of severe hypoglycaemia, glucose given intravenously given glucose may be required.

 

Glucagon reacts antagonistically towards insulin and caution should be observed if GlucaGen is used in patients with insulinoma. Caution should also be observed in patients with glucagonoma.

 

Caution should also be observed when GlucaGen is used as an adjunct in endoscopic or radiographic procedures in diabetic patients or in elderly patients with known cardiac disease.

 

Glucagon stimulates the release of catecholamines. In the presence of phaeocromocytoma, glucagon can cause the tumour to release large amounts of catecholamines, which will cause an acute hypertensive reaction. Glucagon is contraindicated in patients with phaeochromocytoma (see section 4.3).

 

GlucaGen should not be given via intravenous infusion.

 

4.5          Interaction with other medicinal products and other forms of interaction

 

Insulin: Reacts antagonistically towards glucagon.

 

Indomethacin: Glucagon may lose its ability to raise blood glucose or paradoxically may even produce hypoglycaemia.

 

Warfarin: Glucagon may increase the anticoagulant effect of warfarin.

 

Beta-blockers: Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be temporary because of glucagon’s short half-life. The increase in blood pressure and pulse rate may require therapy in patients with coronary artery disease.

 

Interactions between GlucaGen and other drugs are not known when GlucaGen is used in the approved indications.

 

4.6          Fertility, pregnancy Pregnancy and lactation

 

Pregnancy

 

Glucagon does not cross the human placenta barrier.  The use of glucagon has been reported in pregnant women with diabetes and no harmful effects are known with respect to the course of pregnancy and the health of the unborn and the neonate. GlucaGen can be used during pregnancy.

 

Breast-feeding

 

Glucagon is cleared from the bloodstream very fast (mainly by the liver) (t1/2= 363–6 min.); thus the amount excreted in the milk of nursing mothers following treatment of severe hypoglycaemic reactions willis expected to be extremely small. As glucagon is degraded in the digestive tract and cannot be absorbed in its intact form, it will not exert any metabolic effect in the child. GlucaGen can be used during breast-feeding.

 

 

Fertility

 

Animal reproduction studies have not been conducted with GlucaGen. Studies in rats have shown that glucagon does not cause impaired fertility.

 

4.7          Effects on ability to drive and use machines

 

No studies onAfter a severe hypoglycaemic event, the effects on thepatient’s ability to concentrate and react may be impaired. Therefore the patient should not drive and use machines have been performed.or operate machinery after a severe hypoglycaemic event until the patient has stabilised.

.

 

After diagnostic procedures hypoglycaemia has been reported infrequently. Therefore driving a carvehicle and operating machinery  should be avoided until the patient has had a meal with oral carbohydrates.

 

4.8          Undesirable effects

 

Summary of the safety profile

 

Severe

 

adverse reactions are very rare, although nausea, vomiting and abdominal pain may occur occasionally. Hypersensitivity reactions, including anaphylactic reactions, have been reported as ‘very rare’ (less than 1 case per 10,000 patients). When used in the diagnostic indication, hypoglycaemia/hypoglycaemic coma have been reported, especially in patients who have fasted. Cardiovascular adverse events, such as tachycardia and blood pressure changes have only been reported when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.

 

Tabulated summary of adverse reactions

 

Frequencies of undesirable effects considered related to GlucaGen treatment with GlucaGen during clinical trials and/or post -marketing surveillance isare presented below. Undesirable effects which have not been observed in clinical trials, but have been reported spontaneously, are presented as "very rare".rare’. During marketed use reporting of adverse drug reactions is very rare (<  1/10,000). However, post-marketing experience is subject to under-reporting and this reporting rate should be interpreted in that light. The estimated number of treatment episodes is 46.9 millions over a 16 year period.

 

Therapeutic indication

 

System Organ Class

Subject incidence

Adverse drug reaction

Immune system disorders

Very rare < 1/10,000

Hypersensitivity reactions including anaphylactic reaction/shock

Gastrointestinal disorders

Common > 1/100 andto < 1/10

Uncommon > 1/1,000 and ≤to < 1/100

Rare > 1/10,000 and ≤to < 1/1,000

Nausea

Vomiting

Abdominal pain

 

Paediatric population

 

Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in children are expected to be the same as in adults.

 

Other special populations

 

Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment are expected to be the same as in the general population.

 

Diagnostic indication

 

System Organ Class

Subject incidence

Adverse drug reaction

Immune system disorders

Very rare < 1/10,000

Hypersensitivity reactions including anaphylactic reaction/shock

Metabolism and nutrition disorders

Uncommon > 1/1,000 and ≤to < 1/100

Very rare < 1/10,000

Hypoglycaemia*1

Hypoglycaemic coma

Cardiac disorders

Very rare ≤ 1/10,000

Very rare ≤< 1/10,000

Bradycardia*2

Tachycardia*2

Vascular disorders

Very rare < 1/10,000

Very rare < 1/10,000

Hypotension*2

Hypertension*2

Gastrointestinal disorders

Common > 1/100 andto < 1/10

Uncommon >1/1,000 and ≤to < 1/100

Rare > 1/10,000 and ≤to < 1/1,000

Nausea

Vomiting

Abdominal pain

*1 After a diagnostic procedure it canthis could be more pronounced in patients havingthat have fasted, (see section 4.4 Special warnings and precautions for use).

 

*2 Cardio-vascularCardiovascular adverse events have only been reported, when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.

 

Paediatric population

 

There are no data available on the diagnostic use of GlucaGen in children.

 

Other special populations

 

Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment are expected to be the same as in the general population.

 

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

 

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

 

 

4.9          Overdose

 

Adverse effects of overdose have not been reported. See section 4.8

 

In the case of overdose, the patient may experience nausea and vomiting. Due to the short half life of glucagon, these symptoms will be transient.

 

In case of dosages substantially above the approved range, the serum potassium may decrease and should be monitored and corrected, if needed.

 

 

5.            PHARMACOLOGICAL PROPERTIES

 

5.1          Pharmacodynamic properties

 

Pharmacotherapeutic group: H 04 AA 01Pancreatic hormones, Glycogenolytic hormones: H04AA01.

 

Mechanism of action

 

Glucagon is a hyperglycaemic agent that mobilizesmobilises hepatic glycogen, which is released into the blood as glucose.Glucagon will not be effective in patients whose liver glycogen is depleted. For that reason, glucagon has little or no effect when the patient has been fasting for a prolonged period, or is suffering from adrenal insufficiency, chronic hypoglycaemia or alcohol induced hypoglycaemia.Glucagon, unlike adrenaline, has no effect upon muscle phosphorylase and therefore cannot assist in the transference of carbohydrate from the much larger stores of glycogen that are present in the skeletal muscle.

 

Glucagon stimulates the release of catecholamines. In the presence of phaeocromocytoma, glucagon can cause the tumour to release large amounts of catecholamines, which will cause an acute hypertensive reaction.

 

 Glucagon inhibits the tone and motility of the smooth muscle in the gastrointestinal tract.

 

Pharmacodynamic effects

 

When used in treatment of severe hypoglycaemia, an effect on blood glucose is usually seen within 10 minutes.

 

 

 

The onset of inhibitory effect on gastrointestinal motility occurs within 1 minute after an intravenous injection. Duration of action is in the range 5–20 minutes depending on the dose and on the organ under examination. The onset of effect occurs within 5–15 minutes after an intramuscular injection, with a duration of 10–40 minutes depending on dose and organ.

 

5.2          PhamacokineticPharmacokinetic properties

 

Metabolic clearance rate of glucagon in humans is approximately 10 ml/kg/min. ItMetabolism

 

Glucagon is degraded enzymatically in the blood plasma and in the organs to which it is distributed. The liver and kidney are major sites of glucagon clearance, each organ contributing about 30% to the overall metabolic clearance rate.

 

Elimination

 

Glucagon has a short half-life in the blood of about 363–6 minutes.

 

Onset Metabolic clearance rate of effect occurs within 1 minute after an intravenous injection. Duration of actionglucagon in humans is in the range 5-20 minutes depending on dose and on the organ under examination. The onset of effect occurs within 5-15 minutes after an intramuscular injection, with a duration ofapproximately 10-40 minutes depending on dose and organ ml/kg/min.

 

When used in treatment of severe hypoglycaemia, an effect on blood glucose is usually seen within 10 minutes.

 

 

6.3          Shelf life

 


Prior to reconstitution, the shelf life of the product is 36 months.

 

 

The reconstituted GlucaGen should be used immediately after preparation.

 

6.4          Special precautions for storage

 

The sealed container should be protected from light and stored in a refrigerator (+2°C to 8°C).

 

The user can store GlucaGen HypoKit at room temperature (25°C) for up to 18 months within the shelf life period.

 

Freezing should be avoided.

 

Do not freeze.

 

If, in rare cases, the reconstituted product shows any signs of fibril formation (viscous appearance) or insoluble matter, it should be discarded.


GlucaGen HypoKit should be stored at a temperature of 2-8°C (in a refrigerator). The user can store GlucaGen HypoKit at a temperature not exceeding 25ºC for 18 months provided that the expiry date is not exceeded. Store in the original package in order to protect from light.

 

6.5          Nature and contents of container

 

Container for GlucaGen:

 

Vial made of glass type I, Ph. Eur., closed with a bromobutyl stopper and covered with an aluminium cap.

 

Containers for solvent:

 

Vial made of glass type I, Ph. Eur., closed with a bromobutyl disc with teflon and covered with an aluminium cap

or

pre-filled syringe made of glass type I, Ph. Eur., with plunger (bromobutyl rubber) and needle.

 

The vials are provided with a tamperproof plastic cap which must be removed before use.

 

Not all presentations of GlucaGen are necessarilymay be marketed.

 

6.6          Special precautions for disposal and other handling

 

Reconstitution:

 

GlucaGen 1mg:

Draw up the water for injections (1.1ml) in a disposable syringe. Inject the water for injections into the vial containing the gucagon compacted powder.

Shake the vial gently until the glucagon is completely dissolved and the solution is clear. Withdraw the solution back into the syringe.

 

GlucaGen HypoKit 1 mg:

Inject the water for injections (1.1 ml) into the vial containing the freeze-dried glucagon compacted powder. Shake the vial gently until the glucagon is completely dissolved and the solution is clear. Withdraw the solution back into the syringe.

Note that a syringe with a thinner needle and a finer graduation may be more suitable for use in diagnostic procedures.

 

The reconstituted solution appears clear and colourless and forms an injection of 1 mg (1 IU) per ml to be administered subcutaneously, intramuscularly or intravenously. (injection).

 

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

 

7.            MARKETING AUTHORISATION HOLDER

 

Novo Nordisk A/S

Novo Allē

DK-2880 Bagsvaerd

DenmarkVaries from country to country.

 

 

8.            MARKETING AUTHORISATION NUMBER(S)NUMBERS

 

PA 0218/031/002Varies from country to country.

 

 

9.            DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

Date of first authorisation: 17 December 199129 July 1991

 

Date of last renewal: 15 October 2006

10.          DATE OF REVISION OF THE TEXT

 

02/2008

08/201404/2015 

Updated on 3 November 2015

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 15 July 2010 SPC

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 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company



1.  Name of the Medicinal Product

 

        GlucaGen® HypoKit 1 mg powder and solvent for solution for injection in pre-filled syringe.

2        Qualitative and Quantitative Composition

Active substance:  Glucagon, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae cells by recombinant DNA technology).  

            Biosynthetic gGlucagon rDNA

3        Pharmaceutical Form

 

Powder and solvent for solution for injection in pre-filled syringe.

4.1       Indications

Diagnostic indications

 

Inhibition of motility: a.         As a motility inhibitor in examinations of the gastrointestinal tract, e.g. double contrast radiography and endoscopy.

b.    As a motility inhibitor in computerised tomography (CT), nuclear magnetic resonance scanning (NMR) and digital subtraction angiography (DSA).

Motility inhibition in examinations of the gastrointestinal tract

 

4.2       Posology and method of administration

Severe hypoglycaemiTherapeutic indication (Severe hypoglycaemia)a

 

            Dosage for adult patients

Administer 1 mg by subcutaneous or intramuscular injection. Post treatment: as described below.  mg.

 

by subcutaneous or intramuscular injection. Post treatment: as described below.
a       Administration by medical personnel
b.      Administration to the patient by a relative

 

  Inject GlucaGen as indicated below.

 

Administer by subcutaneous or intramuscular injection.  The patient will normally respond within 10 minutes.  When the patient has responded to the treatment, give oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia.

 

Medical assistance consultation
Diagnostic indication (Inhibition of motility)

b. In CT-scanning, NMR and DSA intravenous doses of up to 1mg are used.

 

 


4.4       Special warnings and special precautions for use


Glucagon reacts antagonistically towards insulin and caution should be observed with regard to relapse of the hypoglycaemia,

4.6       Pregnancy and lactation

(t ½ T/2 = 3-6 min.);
4.8 Undesirable effects
The estimated number of treatment episodes is 26.246.9 millions over a 163-year period.

The estimated number of treatment episodes is 26.246.9 millions over a 163-year period.

4.9       Overdose

 In case of suspected overdosing (i.e. above therapeutic dosages) dosages substantially above the approved range, the serum potassium may decrease and should be monitored and corrected if needed.

6.1       List of excipients

 Sterile Water for injections

 

6.4       Special precautions for storage

 GlucaGen HypoKit The user can, within the shelf life period, be stored GlycaGen HypoKit at room temperature (up to 25oC) for 18 months within the shelf life period.

6.6  Special precautions for disposal and other handling
Note that a syringe with a thinner needle and a finer graduation may be more suitable for use in diagnostic procedures.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of first authorisation 17 December 1991
Date of last renewal 15 October 2006

10. DATE OF THIS
September 2009

 

Updated on 13 April 2010 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 9 February 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 27 January 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 August 2008 SPC

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 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1. Name of the medicinal product

The second presentation of GlucaGen is now included: GlucaGen 1 mg Powder and solvent for injection.

Section 2. Qualitative and Quantitative composition

The non-proprietary name has been changed from 'Glucagon, biosynthetic (rys)' to 'Glucagon rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae)'.

Section 3. Pharmaceutical form

A description of the product before and after reconstitution has been added.

Section 4.1. Indications

In the therapeutic indication 'diabetic patients receiving insulin' has been changed to 'insulin treated persons with diabetes'.

Under diagnostic indications the division into examinations with radiography/endoscopy and CT/NMR/DSA has been deleted. The indication is not general 'Motility inhibitor in examinations of the gastrointestinal tract', with no mention of type of procedure.

Section 4.2. Posology and method of administration

An important change here is that intravenous injection is no longer recommended for the therapeutic indication, treatment of severe hypoglycaemia. The section dealing with dosage and administration for severe hypoglycaemia is no longer divided into administration by medical personnel or by relatives since it is now equally applicable to both. The dosage for children has not been changed, but the wording has been clarified as the previous wording was ambiguous.

For the diagnostic indication it is now stated that administration should only be by medical personnel. A new statement has been added that oral carbohydrate should be given at the end of the diagnostic procedure if compatible with the diagnostic procedure applied. To be consistent with the more general diagnostic indication (Section 4.1) mention of dosages specific procedures (CT/NMR/DSA) has been deleted.

Section 4.3 Contraindications

Hypersensitivity to 'any of the excipients' has been changed to specifically mention lactose. This is the only excipient in GlucaGen which has the potential for causing hypersensitivity reactions.

 Section 4.4 Special warnings and precautions for use

The warnings have been divided into those relevant for the therapeutic indication and those relevant for the diagnostic indication.

 A new paragraph has been included under the diagnostic indication. This concerns patients experiencing discomfort especially if they have been fasting, and the need for oral carbohydrate at the end of the procedure. The possibility of patients needing intravenous glucose under certain circumstances is also mentioned.

 A new warning that GlucaGen should not be given via intravenous infusion has been included.

 Section 4.7 Effect on ability to drive and use machines

This has been amended to state that no studies have been performed and to include a warning concerning the possibility of hypoglycaemia following use of GlucaGen in diagnostic procedures.

 Section 4.8 Undesirable effects

This section has been amended so that adverse events are separated into those occurring with the therapeutic indication and those occurring with the diagnostic indication.

 Section 6.5 Nature and contents of container

This section now includes details of the second type of container for the diluent (glass vial).

Section 6.6. Special precautions for disposal
 
Instructions of reuse of the presentation containing two vials is included.

Updated on 25 July 2008 SPC

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 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1. Name of the medicinal product

The second presentation of GlucaGen is now included: GlucaGen 1 mg Powder and solvent for injection.

Section 2. Qualitative and Quantitative composition

The non-proprietary name has been changed from 'Glucagon, biosynthetic (rys)' to 'Glucagon rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae)'.

Section 3. Pharmaceutical form

A description of the product before and after reconstitution has been added.

Section 4.1. Indications

In the therapeutic indication 'diabetic patients receiving insulin' has been changed to 'insulin treated persons with diabetes'.

Under diagnostic indications the division into examinations with radiography/endoscopy and CT/NMR/DSA has been deleted. The indication is not general 'Motility inhibitor in examinations of the gastrointestinal tract', with no mention of type of procedure.

Section 4.2. Posology and method of administration

An important change here is that intravenous injection is no longer recommended for the therapeutic indication, treatment of severe hypoglycaemia. The section dealing with dosage and administration for severe hypoglycaemia is no longer divided into administration by medical personnel or by relatives since it is now equally applicable to both. The dosage for children has not been changed, but the wording has been clarified as the previous wording was ambiguous.

For the diagnostic indication it is now stated that administration should only be by medical personnel. A new statement has been added that oral carbohydrate should be given at the end of the diagnostic procedure if compatible with the diagnostic procedure applied. To be consistent with the more general diagnostic indication (Section 4.1) mention of dosages specific procedures (CT/NMR/DSA) has been deleted.

Section 4.3 Contraindications

Hypersensitivity to 'any of the excipients' has been changed to specifically mention lactose. This is the only excipient in GlucaGen which has the potential for causing hypersensitivity reactions.

Section 4.4 Special warnings and precautions for use

The warnings have been divided into those relevant for the therapeutic indication and those relevant for the diagnostic indication.

A new paragraph has been included under the diagnostic indication. This concerns patients experiencing discomfort especially if they have been fasting, and the need for oral carbohydrate at the end of the procedure. The possibility of patients needing intravenous glucose under certain circumstances is also mentioned.

A new warning that GlucaGen should not be given via intravenous infusion has been included.

Section 4.7 Effect on ability to drive and use machines

This has been amended to state that no studies have been performed and to include a warning concerning the possibility of hypoglycaemia following use of GlucaGen in diagnostic procedures.

Section 4.8 Undesirable effects

This section has been amended so that adverse events are separated into those occurring with the therapeutic indication and those occurring with the diagnostic indication.

Section 6.5 Nature and contents of container

This section now includes details of the second type of container for the diluent (glass vial); this is not available in the UK and a comment has been added as such.

Section 6.6. Special precautions for disposal

Instructions of ruse of the presentation containing tow vials is included (not relevant for UK)

The revised SmPC is version 3 with a revision date of July 2008, and should be used with immediate effect.

Updated on 22 February 2007 SPC

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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The principal changes are as follows:

 

1. Name of the medicinal product

 

The name of the product has been harmonised throughout the EU. In Ireland this has meant a minor name change from 'GlucaGen 1 mg HypoKit' to 'GlucaGen HypoKit 1 mg'.

 

2. Qualitative and quantitative composition

 

Reference included to glucagon being produced in Saccharomyces cerivisiae cells by recombinant DNA technology.

 

3. Pharmaceutical form

 

A description of the glucagon powder and the solvent has been included.

 

4.2. Posology and method of administration

 

The general statement that reconstituted GlucaGen is given by subcutaneous, intramuscular or intravenous injection which was given at the beginning of this section has been deleted. Instead the recommended routes of administration are given as appropriate for each indication. It should be noted that intravenous administration is no longer recommended for treatment of severe hypoglycaemia, even when administered by medical personnel.  

 

For treatment of severe hypoglycaemia the recommended dosage for children has been reworded and separated from the dosage for adults as the previous wording was considered ambiguous.

 

For the diagnostic indications two additional statements have been included:

'GlucaGen must be administered by medical personnel'

and

'After end of the diagnostic procedure oral carbohydrate can be given, if this is compatible with the diagnostic procedure applied.'

 

4.3. Contraindications

 

Hypersensitivity to lactose has been included.

 

4.4. Special warnings and special precautions for use

 

The statement concerning the need for caution if glucagon is used in patients with insulinoma has been expanded to state that caution is required with regard to relapse of hypoglycaemia.

 

A new paragraph has been added concerning possible effects of use of glucagon in diagnostic procedures and precautions to take after the procedure:

'Persons who have been given glucagon in connection with diagnostic procedures amy experience discomfort, in particular if they have been fasting. Nausea, hypoglycaemia and blood pressure changes have been reported in these situations. After the end of a diagnostic procedure oral carbohydrate can be given to patients who have been fasting, if this is compatible with the diagnostic procedure applied. In case of severe hypoglycaemia, intravenously given glucose may be required.'

 

A warning that 'GlucaGen should not be given by intravenous infusion' has been included.

 

4.7 Effect on ability to drive and use machines

 

A new statement has been included:

'No studies on the effects on the ability to drive and use machines have been performed. After diagnostic procedures hypoglycaemia has been reported infrequently. Therefore driving a car should be avoided until the patient has had a meal with carbohydrate.'

 

4.8 Undesirable effects

 

The whole section has been revised according to new requirements for describing adverse reactions; this includes tabulation of adverse reactions to include frequency, and separation of adverse reactions which may occur in connection with treatment of hypoglycaemia from adverse reactions which may occur in connection with diagnostic use.

 

Hypertension is a new adverse reaction listing. It is noted that cardiovascular adverse events have only been reported when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.

 

A note that nausea and vomiting sometimes seen on injection of glucagon may also be seen 2-3 hours after injection.  

 

6. Pharmaceutical particulars

 

There have been a number of editorial changes to sections 6.1, 6.3, 6.4, 6.5 and 6.6. No additional information has been included other than statements in section 6.6 describing the appearance of the reconstituted solution and that unused product should be disposed of in accordance with local requirements.

 

 

10. Date of revision of the text

 
06/2006.

Updated on 29 March 2006 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 not be renewed (A)

Updated on 30 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)