karma-FSH

Urofollitrophin

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path-6-dimention

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory. UROFOLLITROPHIN FOR INJECTION B.P. (FSH)
karma-FSH®
For Intramuscular or Subcutaneous injection

PROPERTIES:

karma-FSH® contains a purified hormone obtained from Human Menopausal urine having 75 I.U. / 150 I.U. FSH activity and less than 1 I.U. / 2 I.U. Luteinizing Hormone activity per vial. Human menopausal gonadotrophins (HMG) exerts both FSH and LH activities. For this reason, HMG is indicated in Hypogonadotrophic hypopituitarism (WHO Group I patients), where both gonadotrophin stimulations are needed. In patients showing normal or high LH levels (WHO Group II), require preparations without LH activity, this character belongs to FSH. FSH stimulates both the growth and maturation of follicles, it induces secretion of oestrogens and proliferation of the endometrium.

INDICATIONS:

karma-FSH® and Human Chorionic Gonadotrophin (HCG) given in a sequential manner are indicated for induction of ovulation in patients with Polycystic Ovarian Disease (PCOD) who have an elevated LH / FSH ratio and who have failed to respond to adequate clomiphene citrate therapy. karma-FSH® and HCG may also be used to stimulate the development of multiple oocytes in ovulatory patients participating in an in vivo fertility program.

CONTRA-INDICATIONS:

karma-FSH® is
contra-indicated in
women who exhibit:

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High levels of FSH indicating primary ovarian failure

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Uncontrolled thyroid or adrenal dysfunction

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An organic intracranial lesion such as pituitary tumor

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Ovarian cysts or enlargement not due tovarian
Polycystic Ovarian Disease

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The presence of any cause of infertility other than
anovulation as stated in indications unless they
are candidates for in vitro fertilization

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Prior hypersensitivity to Urofolltrophin

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karma-FSH® is contra-indicated in women who are
pregnant. There are limited human data on the
effects of karma-FSH® when administered
during pregnancy.

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WARNING:

karma-FSH® is a drug that should be used by physicians who are thoroughly familiar with infertility problems.

1. karma-FSH® should be used only with appropriate monitoring facilities.

2. Lowest dose consistent with expectation of good result should be used.

Ovarian response should be carefully monitored to minimize the risk of overstimulation.

If the ovaries are abnormally enlarged on last day of karma-FSH® therapy, HCG should not be administered in this course therapy. This reduces development of OHSS (Ovarian Hyperstimulation Syndrome).

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DOSAGE & ADMINISTRATION:

Dosage:

The dose of karma-FSH® to produce maturation of the Follicle must be individualized for each patient.

It is recommended that initial dose to any patient should be 75 I.U. of karma-FSH® per day administered intramuscularly for 12-7 days followed by HCG 5000 I.U. to 10000 I.U. one day after the last dose of karma-FSH®. Administration of karma-FSH® may exceed 12 days if inadequate Follicle development is indicated by estrogen and/or ultrasound measurements. If there is evidence of ovulation but no pregnancy repeat this dosage regimen for at least 2 or more courses before increasing the dose to 150 I.U. FSH per day for 12-7 days. As before this dose should be followed by 5000 I.U. to 10000 I.U. of HCG one day after last dose of karma-FSH®. If evidence of ovulation is present but pregnancy dose not ensure repeat the same dose for 2 more courses. Doses larger than this are not routinely recommended.

In-vitro Fertilization:

In-vitro Fertilization therapy with karma-FSH® should be initiated in the early follicular phase (cycle day 2 or 3) at a dose of (150 I.U. per day) until sufficient Follicular development is attained. In most cases therapy should not exceed beyond 10 days.

Administration:

Dissolve the contents of one vial of karma-FSH® in 1 ml of Sodium Chloride Injection and administer immediately. Any unused reconstituted material should be discarded.

STORAGE:

Vials of karma-FSH® Injection should be stored between °2C–°8C and protected from light. Do not freeze. Solution of karma-FSH® reconstituted in Sodium Chloride Injection should be used immediately after preparation. Discard any unused portion. Keep out of reach of children.

PRESENTATION:

karma-FSH® is supplied in a sterile lyophilized form as a white to off-white powder in vials containing 75 I.U. FSH activity / 150 I.U. FSH activity, accompanied by a solvent ampoule containing 1 ml of Sodium Chloride Injection B.P.

Marketing Authorization Holder: Homa Pharmed Co.

Under License: karma Pharmatech - Germany