Cyclimorph 10 Injection Solution for Injection *

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 28 May 2021

File name

Cyclimorph 10 & 15 Solution for Injection_PIL_IE_1622218788.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 May 2021

File name

Cyclimorph 10 Solution for Injection_SPC_IE_1622199857.pdf

Reasons for updating

  • Other
  • Updated inline with QRD template and/or excipient guideline

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

Free text change information supplied by the pharmaceutical company

Type IB, category C.I.z. variation application according to Article 5 of Commission Regulation (EC) No. 1234/2008 to update SmPC and PIL in line with CMDh recommendation.
MAH took an opportunity to update sections of SmPC, Carton, Label and PIL for few editorial changes; in line with QRD template and excipient guideline based on CMDh guidance in this variation.

Updated on 28 August 2019

File name

1.3.1 SPC-Ireland-English (003)_1566995311.pdf

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 31 March 2015

Reasons for updating

  • New SPC for new product

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

Updated on 31 March 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.8 of the SPC is updated

Updated on 31 March 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.8 of the SPC is updated

Updated on 27 January 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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

Sections 1,2,4.1-4.9,5.1-5.3,6.1,6.3,6.6,9 & 10 are updated in the SmPC

Updated on 27 January 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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

Free text change information supplied by the pharmaceutical company

Sections 1,2,4.1-4.9,5.1-5.3,6.1,6.3,6.6,9 & 10 are updated in the SmPC

Updated on 25 June 2012

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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

List of changes to previous Cyclimorph 10 SPC.

 
·         In section 1 (Trade name of the medicinal product), the trade name has been updated to read:

Cyclimorph 10 Solution for Injection.

 

 
·         In section 2 (Qualitative and quantitative composition), the following statements have been added:

Excipients: Each 1 ml contains 1 mg sodium metabisulphite (E223).

For a full list of excipients, see section 6.1.

 

 
·         In section 3 (Pharmaceutical form), the pH of the solution has been added to read:

A clear very slightly coloured solution.  pH 4.3 to 5.0

 

 
·         In section 6.1 (Excipients) the list has been updated to read:

Tartaric acid
Sodium metabisulphite (E223)

Water for injections

 

 
·         In section 6.2 (Incompatibilities) the word ‘none’ has been removed and following statement has been added:

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

 


 
·         In section 6.3 (Shelf life) the following statements have been added:

Unopened: 3 years.

Once Opened: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

 


 
·         In section 6.4 (Special precautions for storage) the following statement has been added:

 Do not freeze.

 


 
·         In section 6.6 (Instructions for use/handling) the statement ‘no special instructions are required’ has been removed and the following statements have been added:

No special requirements.

For single use only.  Discard any remaining solution.

 


 
·         In section 10 (date of (partial) revision of text) the date has been updated to read:

August 2009

Updated on 25 June 2012

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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

List of changes to previous Cyclimorph 10 SPC.

 
·         In section 1 (Trade name of the medicinal product), the trade name has been updated to read:

Cyclimorph 10 Solution for Injection.

 

 
·         In section 2 (Qualitative and quantitative composition), the following statements have been added:

Excipients: Each 1 ml contains 1 mg sodium metabisulphite (E223).

For a full list of excipients, see section 6.1.

 

 
·         In section 3 (Pharmaceutical form), the pH of the solution has been added to read:

A clear very slightly coloured solution.  pH 4.3 to 5.0

 

 
·         In section 6.1 (Excipients) the list has been updated to read:

Tartaric acid
Sodium metabisulphite (E223)

Water for injections

 

 
·         In section 6.2 (Incompatibilities) the word ‘none’ has been removed and following statement has been added:

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

 


 
·         In section 6.3 (Shelf life) the following statements have been added:

Unopened: 3 years.

Once Opened: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

 


 
·         In section 6.4 (Special precautions for storage) the following statement has been added:

 Do not freeze.

 


 
·         In section 6.6 (Instructions for use/handling) the statement ‘no special instructions are required’ has been removed and the following statements have been added:

No special requirements.

For single use only.  Discard any remaining solution.

 


 
·         In section 10 (date of (partial) revision of text) the date has been updated to read:

August 2009

Updated on 27 August 2008

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 27 August 2008

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 June 2005

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 10 June 2005

Reasons for updating

  • New SPC for medicines.ie