Summary of Product Characteristics
last updated on the eMC:
03/11/2010
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 03/11/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 22-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Various section changes.
Words in bold have been added in the new version.
Section 1:
Pabrinex Intramuscular High Potency, Solution for injection
Section 2:
Each presentation (carton) contains either 5ml or 2ml ampoules. Each pair of ampoules to be used in treatment is labelled Pabrinex No 1 and Pabrinex No 2.
The following lost of components has also been put in a table form.
Section 3:
The long sentence there has been replaced by: Solution for injection.
Section 4.4
Has been replaced with: Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Pabrinex Intramuscular, such rare occurrence of serious allergic reactions should not preclude the use of Pabrinex Intramuscular in patients who need treatment by this route of administration. Initial warning signs of a reaction to Pabrinex Intramuscular are sneezing or mild asthma, and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Pabrinex Intramuscular High Potency is administered.
This medicine is for injection into a muscle only and should not be given by any other route
Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended – reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions.
Section 4.6
"...clinically indicated. However animal studies are insufficient with respect to effects on pregnancy/ and-or/ embryonal/foetal development/ and-or/ parturition/ and-or/ postnatal development (see section 5.3). The potential risk for humans is unknown.
Caution should be exercised when prescribing to pregnant women. "
Section 6.4
Keep the container in the outer carton.
Section 6.6
Replace "None stated." with: In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.
Section 10:
Change of date of revision of the text.
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Updated on 10/03/2008 and displayed until 03/11/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change of Marketing Authorisation Holder from Link Pharmaceuticals to Archimedes Pharma UK Ltd
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Updated on 06/11/2003 and displayed until 10/03/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 20/08/2001 and displayed until 06/11/2003
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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