Section 2. Qualitative and quantitative composition: This section has been amended to include “Excipients: 164.40 mg mannitol. For a full list of excipients, see section 6.1.”
Section 3. Pharmaceutical form: The following sentence has been added to the end of this section: “The pH of the reconstituted solution is 4.0 – 6.0”.
Section 4.2. Posology and method of administration. The last sentence of this section has been amended as follows: “For instructions on preparation for use and handling, see section 6.6.”
Section 4.3. Contraindications. The first bullet point of this section has been amended to: “Hypersensitivity to the active substance or any structural analogue of GnRH, extrinsic peptide hormones or to any of the excipients.”
Section 4.8. Undesirable effects. This section has been tabulated by system organ class and frequency. No new adverse events added. The following paragraph has been added ‘Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.’
Section 5.3. Preclinical safety data. The following paragraph has been added to the beginning of this section: “Non-clinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.”
Section 6.1. List of Excipients. This section has been amended to “Powder: Mannitol Solvent: Water for injections”
Section 6.2. Incompatibilities. This section has been amended to: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.”
Section 6.4. Special precautions for storage. This section has been amended to:
“Do not store above 25°C. Keep the vial in the outer carton in order to protect from light.”
Section 10. Date of revision of the text. The data of revision of the text has been amended to October 2006.
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