BRAVELLE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 75 IU

Product Information

Registration Status: Active

BRAVELLE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 75 IU is approved to be sold in Singapore with effective from 2013-10-28. It is marketed by FERRING PHARMACEUTICALS PTE LTD, with the registration number of SIN14420P.

This product contains Urofollitropin 75 IU in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for SUBCUTANEOUS use.

This product is manufactured by Ferring GmbH (Powder) in CZECH REPUBLIC, andHaupt Pharma Wulfing GmbH (Solvent) in GERMANY.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Urofollitropin

Description

Urofollitropin is a purified form of follicle-stimulating hormone (FSH) that is manufactured by extraction from human urine and then purified. It consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Urofollitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Urofollitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

Indication

For treatment of female infertility

Mechanism of Action

FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.

Pharmacokinetics

Absorption
74%
Distribution
Time to peak in plasma: IM: 17 hours (single dose), 11 hours (multiple doses) SubQ: 21 hours (single dose), 10 hours (multiple doses)
Metabolism
Elimination

Active Ingredient/Synonyms

Follitropin human | Urofollitrophin | Urofollitropin |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank