Foliculin Injection 75IU (Urofollitropin for injection BP-Freeze Dried)

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

UROFOLLITROPIN

Dostupné z:

BSV BIOSCIENCE MALAYSIA SDN. BHD.

INN (Medzinárodný Name):

UROFOLLITROPIN

Počet v balení:

1Units Units; 1ml mL

Výrobca:

BHARAT SERUMS AND VACCINES LTD.

Príbalový leták

Not applicable

Súhrn charakteristických

ROUTE OF ADMINISTRATION:
Intramuscular (IM) + Subcutaneous (SC).
CONTRAINDICATION:
_FOLICULIN_
is contraindicated in women who exhibit:
1. High levels of FSH, indicating primary ovarian failure.
2. Uncontrolled thyroid or adrenal dysfunction.
3. An organic intracranial lesion such as pituitary tumor.
4. The presence of any cause of infertility other than anovulation
unless they are candidates for in vitro fertilization.
5. Ovarian cysts or enlargement not due to ovarian polycystic ovarian
disease.
6. Prior hypersensitivity to Urofollitropin.
7. Foliculin is contraindicated in women who are pregnant. There are
limited human data on the effects of Foliculin when administered
during
pregnancy.
Contraindicated for safety reasons in gynecological hemorrhages of
unknown aetiology.
WARNINGS AND PRECAUTIONS:
Before starting treatment, the couple's infertility should be assessed
as appropriate and putative contra-indications for pregnancy
evaluated.
Adherence to the recommended dosage and monitoring schedules will
minimize the possibility of ovarian hyperstimulation syndrome.
Excessive ovarian response to
_FOLICULIN_
treatment does generally not induce significant adverse effects except
if hCG is administered
for ovulation induction or if pregnancy occurs; ovarian hyper
stimulation syndrome occurs usually 1 to 2 weeks following hCG
administration and
ovulation.
In case of symptoms such as pelvic pain, abdominal distension or
ovarian enlargement or if oestrogen assays or ultrasound examinations
suggest an excessive oestrogenic response, Foliculin administration
should be discontinued and hCG should not be administered and
intercourse avoided in order to prevent ovarian hyperstimulation.
Ascites, pericardial effusion, hydrothorax, hemo-concentration,
secondary hyperaldosteronism or hypercoagulability might appear. These
symptoms should be controlled through appropriate medical measure,
including avoidance of unnecessary pelvic examination. In the absence
of pregnancy, they usually resolve spontaneously with the onset of the