HUCOG 5000IU is widely known as Novarel, Ovidrel, Pregnyl, Human chorionic gonadotropin, hCGOther alternative names for3 x 5000IU (hCG): Bharat Serums, hCG, Human Chorionic Gonadotropin, hCG, Human Chorionic Gonadotropin, Novarel , HUCOG 3 x 5000IUAll of these are different brands of the same active substance – hCGHighly Purified Chorionic Gonadotrophin Injection HUCOG®For Subcutaneous / Intramuscular Injection onlyComposition :Each ml contains :Chorionic Gonadotrophin highly purified I.H2000 I.U. / 5000 I.U. / 10000 I.U.Water for Injection I.Pq.s.Excipients & Stabilizers :Disodium Hydrogen Phosphate Dihydrate I.P., Benzyl Alcohol I.P., Sucrose I.P., Poloxamer188U.S.P./NF, Methionine B.P., Phosphoric acid I.P.One IU of Chorionic Gonadotrophin is defined as the activity contained in 1.279 mg of the 2nd InternationalStandard Preparation.Properties :Chorionic Gonadotrophin (HCG) is a hormonal substance obtained from urine of pregnant women. Itsaction is predominantly luteinizing.Indications :Anovulatory infertility :In the female, HUCOG HP is used in the treatment of anovulatory infertility. where its administration wouldform part of recognized treatment regimen involving prior stimulation of follicular maturation andendometrial proliferation e.q. with Menotropin Injection (HUMOG HP).Hypogonadotrophin hypogonadism and cryptorchidism :In the male, HUCOG HP stimulates the interstitial cells of the testes and consequently the secretion ofandrogens and the development of secondary sexual characteristics. With concomitant MenotropinInjection therapy, HUCOG HP stimulates the induction and maintenance of spermatogenesis.Dosage and Administration :HUCOG HP is given by subcutaneous / intramuscular injection only.Anovulatory infertility :HUCOG HP 10000 I.U. is administered in mid-cycle, following treatment with Menotropin Inj. (HUMOG HP)according to a recognised scheme. Details of Menotropin Inj. (HUMOG HP) dosage and monitoring areavailable on request.Hypogonadotrophic hypogonadism :HUCOG HP 2000 I.U. twice weekly concomitant with Menotropin Inj. (HUMOG HP) (1 vial three times aweek) if necessary for a minimum period of four months.Cryptorchidism :Equivalent to 1000 I.U. of HUCOG HP on alternate days for several weeks.Contra-Indication and Warnings :Stimulation of ovulation with HUCOG HP may lead to superovulation and the hyperstimulation syndrome.Oestrogen assays will detect the excessive response so that HUCOG HP (HCG) may be withheld in thatparticular treatment cycle. In the male, high dosages of HUCOG HP may lead to oedema and in suchcases dosages should be considerably reduced.If signs of sexual precocity are observed a reduced dosage regimen should be instituted.Side Effects :Headache, irritability, restlessness, depression, fatigue, edema, gynecomastia, sexual precocity, pain atthe site of injection.Adverse Events :The adverse reactions for use in infertility are: (1) Ovarian hyperstimulation (OHSS), a syndrome ofsudden ovarian enlargement, ascites with or without pain, and/or pleural effusion, (2) Rupture of ovariancysts with resultant hemoperitoneum, (3) Multiple births, and (4) Arterial thrombo-embolism.PRECAUTION :HCG should be used in conjunction with human menopausal gonadotropins only by physiciansexperienced with infertility problems who are familiar with the criteria for patient selection,contraindications, warnings, precautions, and adverse reactions described in the package insert formenotropins.Interaction with other medicinal products and other forms of interaction :Concomitant use of HuCoG Injection with other agents used to stimulate ovulation(e.g. HMG,clomiphene citrate) may potentiate the follicular response. (See Warnings Precaution & Overdosage.)Overdose :The effects of an overdose of HuCoG Injection are unknown, nevertheless one could expect ovarianhyperstimulation syndrome (OHSS) to occur, which is further described as below:Ovarian Hyperstimulation Syndrome (OHSS) : (See Warnings) :OHSS is a medical event distinct from uncomplicated ovarian enlargement. OHSS is a syndrome that canmanifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serumsex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in theperitoneal, pleural and, rarely, in the pericardial cavities.The following symptomatology may be observed in severe cases of OHSS : abdominal pain,abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinalsymptoms including nausea, vomiting and diarrhoea.Adherence to recommended HuCoG Injection dosage, regimen of administration and careful monitoringof therapy will minimize the incidence of ovarian hyper stimulation and multiple gestations. In ART,aspiration of all follicles prior to ovulation may reduce the occurrence of hyper stimulation. OHSS may bemore severe and more protracted if pregnancy occurs. Most often, OHSS occurs after hormonal treatmenthas been discontinued and reaches its maximum at about seven to ten days following treatment. Usually,OHSS resolves spontaneously with the onset of menses. If severe OHSS occurs, gonadotrophin treatmentshould be stopped if still ongoing, the patient hospitalized and specific therapy for OHSS started. Thissyndrome occurs with higher incidence in patients with polycystic ovarian disease.Ovarian response should be carefully monitored to minimize the risk of overstimulation. If the ovaries areabnormally enlarged on last day of gonadotrophin therapy, HCG should not to be administered in thiscourse therapy. This reduces development of OHSS (Ovarian Hyperstimulation Syndrome). Use ofultrasound monitoring of ovarian response and/or measurement of serum estradiol levels can furtherminimize the risk of overstimulation.Storage :Vials of HUCOG HP should be stored between 20C – 80C. Do not freeze. Protect from light. Any unusedportion should be discarded.Presentation :HUCOG HP is supplied in vials containing sterile having activity of 2000 I.U. / 5000 I.U. / 10000 I.U.Manufactured in India by :BHARAT SERUMS AND VACCINES LIMITED..