Sifasi Injection from Fast Escrow Refills

Chorionic Gonadotropin Injection I.P. SIFASI

For Intramuscular or Subcutaneous Use

DESCRIPTION

Human chorionic gonadotrophin (hCG) is a hormone produced by human placenta. lt is composed of an alpha and a beta sub-unit. The alpha sub-unit has structure identical to the alpha sub-unit of other hormones like human pituitary gonadotrophins, luteinlzing hormone (LH) and follicle-stimulating hormone (FSH), and human thyroid-stimulating hormone (TSH). The beta sub-units of HCG differs from these hormones.

COMPOSITION - SIFASI 2000 IU

Each vial of sterile freeze-dried product contains:

Chorionic Gonadotrophin IP.............................................2000 IU

Disodium Hydrogen Orthophosphate IP as buffer..................q.s.

Sodium dihydrogen Orthophosphate IP as buffer..................q.s.

Mannitol IP...................................................................q.s. 

Each ampoule contains:

Sodium Chloride Injection IP.............................................0.9% w/v

Water for Injection IP.....................................................q.s.

SIFASI 5000 IU

Each vial of sterile freeze-dried product contains:

Chorionic Gonadotrophin IP.............................................5000 IU

Disodium Hydrogen Orthophosphate IP as buffer..................q.s.

Sodium dihydrogen Orthophosphate IP as buffer..................q.s.

Mannitol IP...................................................................q.s. 

Each ampoule contains:

Sodium Chloride Injection IP.............................................0.9% w/v

Water for Injection IP.....................................................q.s.

SIFASI 10000 IU

Each vial of sterile freeze-dried product contains:

Chorionic Gonadotrophin IP..............................................10000 IU

Disodium Hydrogen Orthophosphate IP as buffer..................q.s.

Sodium dihydrogen Orthophosphate IP as buffer..................q.s.

Mannitol IP...................................................................q.s. 

Each ampoule contains:

Sodium Chloride Injection IP.............................................0.9% w/v

Water for Injection IP.....................................................q.s.

CLINICAL PHARMACOLOGY

Action of HCG is identical to that of pituitary LH, although hCG has a small degree of FSH activity also. hCG can be used to substitute LH for its participation with FSH in the development and maturation of the normal ovarain follicle, and the midcycle triggering of ovulation. hCG also stimulates production of gonadal steroid hormones by stimulating interstitial cells (Leydig cells) of testes to produce androgens and corpus luteum of ovary to produce progesterone. During a normal pregnancy, hCG secreted by placenta maintains the corpus Iuteum after LH secretion decreases, supporting continued secretion of estrogen and progesterone and preventing menstruation.

Androgen stimulation by hCG in male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present.

INDICATIONS AND DOSAGE

SIFASI is for intramuscular or subcutaneous use. The dosage regimen will depend upon the indication for use, age and weight of the patient. However, the following regimens can be used as reference guidelines.

IN FEMALES

1. ANOVULATORY INFERTILITY:

Usually one injection of SIFASI 5000 - 10000 IU is given after completion of a recommended course of PERSINAL or SIPHENE (clomiphene citrate) (given to create prior stimulation of follicular maturation and endometrial proliferation).

Up to 3 repeat injections of SIFASI 5000 IU may be given within 9 days following the first injection to prevent insufficiency of the corpus luteum.

2.THREATENED AND HABITUAL ABORTION

Once pregnancy is confirmed, SIFASI 5000 IU - 10000 IU to be given followed by SIFASI 2000 IU - 5000 IU twice a week till the 14th week of pregnancy.

IN MALES

1. HYPOGONADOTROPHIC HYPOGONADISM

SIFASI 2000 IU 2-3 times a week

2. STERILITY DUE TO DEFICIENT SPERMATOGENESIS:

SIFASI 2000 IU 2-3 times a week in combination with PERSINAL (HMG). PERSINAL (HMG) may be given daily or 2-3 times a week. The combined therapy should continue for at |east 4 months.

3. CRYPTORCHIDISM

(not due to anatomical obstruction) SIFASI 500-1000 IU on alternate days for several weeks.

DIRECTIONS FOR USE

SIFASI comes in a pack of 1 vial & 1 ampoule.

One vial contains lyophilized SIFASI powder and the other ampoule contains diluent solvent.

Use the diluent solvent to dissolve the SIFASI powder, just prior to use. 

Agitate the vial gently until the powder is completely dissolved into the solution.

The solution should be completely used after reconstitution.

SIDE EFFECTS

Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection may sometimes be present. Localized and systemic hypersensitivity reactions.

WARNINGS

Physicians experienced with infertility problems and who are familiar with the criteria for patient selection only should use SIFASI in conjunction with human menopausal gonadotrophins. The principal serious adverse reactions during this use are: (1) Ovarian hyper stimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion, (2) Rupture of ovarian cysts with resultant hemoperitoneum, (3) Multiple births, and (4) Arterial thromboembolism. ln case of excessive ovarian response to PERSINAL (HMG), its is of primary importance that SIFASI should be with held in such cycles. Anaphylaxis and other Hypersensitivity reaction have been reported with urinary derived HCG product.

PRECAUTIONS

Since androgens may cause fluid retention, hCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.

Hormone levels in anovulatory infertility patients should be monitored.

PEDIATRIC USE

Induction of androgen secretion by hCG may induce precocious puberty in pediatric patients treated for cryptorchidism. Therapy should be discontinued if signs of precocious puberty occur.

CONTRAINDICATIONS

Precocious puberty, prostatic carcinoma or other androgendependent neoplasm, prior allergic reaction to hCG.

PRESENTATION

Box containing 1 vial of lyophilized product either (2000 IU or 5000 IU or 10000 IU of hCG) + 1 ampoule diluent solvent

STORAGE

Store below 20°C. Do not freeze. Protect from light.

Dosage : As directed by the physician.

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