Section 2: Qualitative and Quantitative Composition: Text amended to include: Excipients: 27.3 mg mannitol, 0.05 mg poloxamer 188, 0.1 mg L-methionine
For a full list of excipients, see section 6.1.
Section 3: Pharmaceutical Form: pH and osmolarity added.
Section 4.4: Special warning and special precautions for use: the following warnings and precautions have been added.
Severe ovarian hyperstimulation syndrome could be complicated in rare cases by haemoperitoneum, acute pulmonary distress, ovarian torsion, and thromboembolism.
Section 4.6 Pregnancy and Lactation: Typographical change.
Section 4.8 Undesirable Effects: The listing of adverse events reported is updated presented by revised body systems. Adverse events added include
very rare
Immune system disorders: allergic reactions
Skin and subcutaneous tissue disorders: Mild reversible skin reactions manifesting as rash.
Section 5.3 Preclinical safety data: Revised to read: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Studies on carcinogenic potential were not performed. This is justified, given the proteinous nature of the drug substance and the negative outcome of the genotoxicity testing. Studies on reproduction were not performed in animals.
Section 6.4 Special precautions for storage: Change in word order of phrase ‘Store at 2ºC - 8ºC (in a refrigerator) to Store in a refrigerator (2oC – 8oC).
Section 6.5 Nature and contents of container: Reference to inclusion of plunger rods has been removed. Statement added ‘The vials and cartridges are closed by rubber stoppers’.
Section 9 Date of First Authorisation / Renewal of Authorisation: Date of renewal amended to 2 February 2001/ 31 January 2006’.
Section 10 Date of Revision of the Text: Amended to January 2006
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