1 Name of Medicine
Follitropin beta. [Recombinant human follicle-stimulating hormone (recFSH)].
2 Qualitative and Quantitative Composition
One cartridge contains either 0.480 mL equal to a net dose of 300 IU follitropin beta (rch), 0.840 mL equal to a net dose of 600 IU follitropin beta (rch) or 1.230 mL equal to a net dose of 900 IU follitropin beta (rch).
Follitropin beta (rch) is produced by recombinant-DNA technology in a Chinese hamster ovary cell line transfected with the human FSH subunit genes.
For the full list of excipients, see Section 6.1 List of Excipients.
3 Pharmaceutical Form
Solution for injection.
Clear, colourless solution.
4 Clinical Particulars
4.9 Overdose
No data on acute toxicity of Recagon in humans is available, but the acute toxicity of Recagon and of urinary gonadotrophin preparations in animal studies has been shown to be very low. Too high a dosage for more than one day may lead to hyperstimulation of the ovaries (see Section 4.4 Special Warnings and Precautions for Use).
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
5 Pharmacological Properties
5.3 Preclinical Safety Data
Genotoxicity. Follitropin beta showed no genotoxic activity in a series of assays performed to evaluate its potential to cause gene mutations (Salmonella typhimurium and E. coli) and chromosomal damage (human lymphocytes in vitro).
Carcinogenicity. Long-term studies in animals have not been performed to evaluate the carcinogenic potential of follitropin beta.
6 Pharmaceutical Particulars
6.7 Physicochemical Properties
Chemical structure. No data available.
CAS number. 146479-72-3.
7 Medicine Schedule (Poisons Standard)
Prescription Only Medicine (S4).
Summary Table of Changes
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