GONAPURE 75IU VIAL; follitropin alpha, hormonal agents .
ACTIVE-INGREDIENT OF GONAPURE 75IU VIAL
r – Hfsh 75 i.u.
INDICATION OF GONAPURE 75IU VIAL
follicle -stimulating hormone is secreted by the anterior lobe of the pituitary gland , with another gonadotropin ; luteinising hormone . These gonadotropins stimulate the normal functioning of the gonads and the secretion of sex hormones in both men and women . in women , follicle -stimulates the development and maturation of the follicles and ova ; in men it has a role in spermatogenesis . recombinant human follicle -stimulating hormones are used in the treatment of female infertility due to anovulation , in women who have not responded to clomiphene therapy . FSH is also used for the stimulation of spermatogenesis in the management of male infertility caused by hypogonadotrophic hypogonadism .
DOSAGE OF GONAPURE 75IU VIAL
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
the dosage and schedule of treatment for female infertility must be determined according to the needs of each patient ; it is usual to monitor response by studing the patient’s urinary oestrogen excretion or by ultrasonic visualization of the follocles or both . in menstruating patients treatment should be started within the first 7 days of the menstrual cycle . treatment is usually begun with 75 to 150 units daily by subcutaneous or intramuscular injection for 7 or 14 days ; if there is no response , dosage is increased at 7 – or 14-day intervals until an adequate but not excessive response is achieved . treatment is then stopped and followed after 1 or 2 days by a single dose of chorionic gonadotrophin 5000 to 10000 units to induce ovulation . a daily dose of 225 units is the usual maximum , and that if a patients fails to respond adequately after 4 weeks of treatment that cycle should be abandoned and the patient should subsequently begin the next cycle at a higher starting dose . FSH is also used as part of IVF or other assisted reproductive technologies . for this purpose doses of 150 to 225 units daily are generally given , for at least 4 days commencing on the second or third day of the menstrual cycle . therafter the dose may be adjusted individually based on ovarian response to a usual maximum of about 450 units ; adequate follocular development generally occurs within about 5 to 10 days of treatment . pituitary downregulation with a gonadorelin may be used with FSH therapy , in which case the gonadorelin analogue is generally begun about 2 weeks before FSH , and the 2 are the 2 are then continued together until follicular development is adequate . a single dose of up to 10 000 units of chorionic gonadotrophin is then given to induce final follicular maturation gonadotrophin is then given to induce final follicular matruration and oocyte retrieval performed about 35 hours later . FSH is used stimulation of spermatogenesis in management of male infertility caused by hypogonadotrophic hypogonadism . before starting FSH therapy , chorionic gonadotrophin is given to raise serum testosterone concentrations to the normal range , which may take 3 to 6 months . a dose of 150 units subcutaneously three times weekly is then used , with continued chorionic gonadotrophin ; doses of FSH up to 300 units three times weekly may be required . treatment is continued fo at least 4 months , and more than 18 months of treatment may be needed .
OVER-DOSAGE OF GONAPURE 75IU VIAL
CONTRA-INDICATION OF GONAPURE 75IU VIAL
FSH is contraindicated in women and men who exhibit : prior hypersensitivity to reconbinant FSH preparations or one of their excipients . High levels of FSH indicating primary gonadal failure . Uncontrolled thyroid or adrenal dysfunction . Sex hormone dependent tumors of the reproductive tract and accessory organs . an organic intracranial lesion such as pitutary tumor . and in women who exhibit : abnormal uterine bleeding of undetermined origin . ovarian cyst or enlargement of undetermined origin . pregnancy .
STORAGE OF GONAPURE 75IU VIAL
stored refrigerated at temperature 2-8 c . Protected from light .
PACK OF GONAPURE 75IU VIAL
is supplied in a sterile , lyophilized form in single dose vials containing 75 or 150 iu FSH activity with diluent (sterile water for injection
GONAPURE 75IU VIAL MANUFACTURED BY