PUREGON SOLUTION FOR INJECTION 150 iu/0.5 ml
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
21-01-2014
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Active ingredient:
FOLLITROPIN BETA
Available from:
MSD PHARMA (SINGAPORE) PTE. LTD.
ATC code:
G03GA06
Dosage:
150 iu/0.5 ml
Pharmaceutical form:
INJECTION
Administration route:
SUBCUTANEOUS, INTRAMUSCULAR
Prescription type:
Prescription Only
Manufactured by:
ORGANON (IRELAND) LTD
Authorization date:
2003-02-06
Patient Information leaflet
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
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