Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
FOLLITROPIN BETA
MSD PHARMA (SINGAPORE) PTE. LTD.
G03GA06
50 iu/0.5 ml
INJECTION
FOLLITROPIN BETA 50 iu/0.5 ml
SUBCUTANEOUS, INTRAMUSCULAR
Prescription Only
N.V. ORGANON
ACTIVE
2003-02-06
S-CCDS-MK8328-SOi-082013 1. NAME OF THE MEDICINAL PRODUCT Puregon 50, 100 or 150 IU/0.5 mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 50, 100, 150 IU recombinant follicle-stimulating hormone (FSH) activity in 0.5 mL aqueous solution. This corresponds to strengths of 100, 200, 300 IU/mL. One vial contains 5, 10, 15 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH/mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications In the female Puregon is indicated for the treatment of female infertility in the following clinical situations • Anovulation (including polycystic ovarian syndrome PCOS) in women who have been unresponsive to treatment with clomifene citrate. • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilization/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. In the male • Deficient spermatogenesis due to hypogonadotrophic hypogonadism. 4.2 Posology and method of administration Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems. The first injection of Puregon should be performed under direct medical supervision. Posology Dosage in the female There are great inter- and intra-individual variations in the response of the ovaries to ex Read the complete document
S-CCDS-MK8328-SOi-062019 1. NAME OF THE MEDICINAL PRODUCT PuregonⓇ 50, 100 or 150 IU/0.5 mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 50, 100, 150 IU recombinant follicle-stimulating hormone (FSH) activity in 0.5 mL aqueous solution. This corresponds to strengths of 100, 200, 300 IU/mL. One vial contains 5, 10, 15 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH/mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colorless solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications In the female PuregonⓇ is indicated for the treatment of female infertility in the following clinical situations Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate. Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilization/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. In the male Deficient spermatogenesis due to hypogonadotrophic hypogonadism. 4.2 Posology and method of administration Treatment with PuregonⓇ should be initiated under the supervision of a physician experienced in the treatment of fertility problems. The first injection of PuregonⓇ should be performed under direct medical supervision. Posology Dosage in the female There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. This requires ultrasound assessment of follicular development. The concurrent determination of ser Read the complete document