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Endogen hp insert pi0205 (d)

For the use of a Registered Medical Practitioner, Hospital or Laboratory Clinical Pharmacology
Endogen-HP administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with Endogen- Endogen HP
HP in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG (Pubergen JO 7500 IU)must be given to induce ovulation. Urofollitropin for Injection
Pharmacokinetics
For Subcutaneous / Intramuscular Injection only
Published clinical data reveals that there is a variation in AUC & Cmax depending on the route of administration. Pharmacokinetic data obtained by Presentation :
SC & IM routes are not bioequivalent. Each ampoule of sterile freeze-dried product contains: Absorption
The maximum plasma concentration of FSH was attained at 20.5 and 17.4 (As Highly Purified Human Follicle Stimulating Hormone) hours following SC and IM single dose administration, respectively. Mannitol I.P. 12 mgPotassium Dihydrogen orthophosphate B.P. However, following multiple dosing, it was attained at approximately 10 hours Dipotassium Hydrogen orthophosphate B.P. following both routes of administration. Reconstitute with 1 ml of Sodium Chloride injection(0.9% w/v) I.P. provided with this pack.
Distribution
Each ampoule of sterile freeze-dried product contains: Human tissue or organ distribution of FSH has not been studied Metabolism
(As Highly Purified Human Follicle Stimulating Hormone)Mannitol I.P. Metabolism of FSH has not been studied for in humans.
Potassium Dihydrogen orthophosphate B.P.
Dipotassium Hydrogen orthophosphate B.P. Elimination
Reconstitute with 1 ml of Sodium Chloride injection(0.9% w/v) I.P. provided with this pack.
Published clinical studies have demonstrated the mean elimination half-lives of FSH for SC and IM single dosing are 31.8 and 37 hours, respectively. Drug Description
However, following multiple dosing (X 7 days) they are 20.6 and 15.2 hours for SC and IM, respectively. Endogen-HP is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of Pediatric Populations
postmenopausal women. Human FSH consists of two non-covalently linked Endogen-HP is not indicated in pediatric populations. amino acids of which two are modified by attachment of carbohydrates. The Geriatric Populations
subunit has 111 amino acids of which two are modified by attachment of Endogen-HP is not indicated in geriatric populations. Endogen-HP is a sterile, lyophilized powder intended for subcutaneous (SC) Special Populations
or intramuscular (IM) injection after reconstitution with Sodium Chloride 0.9% w/v Injection.
The safety and efficacy of Endogen-HP in renal and hepatic insufficiency have not been studied. Indications & Usage
Drug Interactions
Ovulation Induction
No drug / drug interaction studies have been conducted for Endogen-HP in Endogen-HP administered SC or IM in conjunction with hCG, (Pubergen JO 7500 IU) is indicated for ovulation induction in patients who have previously received pituitary suppression.
Storage Conditions
Multifollicular Development during ART
Store between 2 C - 8O C. Do not freeze.
Endogen-HP administered SC in conjunction with hCG is indicated for Use Immediately after reconstitution.
multiple follicular development (controlled ovarian stimulation) during ART After reconstitution of Endogen-HP, if the reconstituted solution is not used, cycles in patients who have previously received pituitary suppression.
Selection of Patients
How Supplied
1.Before treatment with Endogen-HP is instituted, a thorough gynecologic Box containing 1 Ampoule of sterile freeze-dried Highly Purified Urofollitropin and endocrine evaluation must be performed. Except for those patients 75 IU + 1 Ampoule of Sodium chloride injection I.P.(0.9 %w/v).
enrolled in an in vitro fertilization program, this should include a hysterosalp in angiography (to rule out uterine and tubal pathology) and documentation of Box containing 1 Ampoule of sterile freeze-dried Highly Purified anovulation by means of basal body temperature, serial vaginal smears, Urofollitropin 150 IU + 1 Ampoule of Sodium chloride injection I.P. (0.9 %w/v).
examination of cervical mucus, determination of serum (or urine) progesterone, urinary pregnanediol and endometrial biopsy.
2.Primary ovarian failure should be excluded by the determination of 3.Careful examination should be made to rule out the presence of an early pregnancy.
4.Patients in late reproductive life have a greater predilection to endometrial Gaganpahad, R.R. Dist. - 501 323, A.P., India carcinoma as well as a higher incidence of anovulatory disorders. Cervical dilation and curettage should always be done for Careful monitoring of ovarian response can further minimize the risk of over diagnosis before starting Endogen-HP therapy in such patients who stimulation. If the ovaries are abnormally enlarged on the last day of Endogen demonstrate abnormal uterine bleeding or other signs of endometrial HP therapy, hCG should not be administered in the course of therapy; this will reduce the chances of development of the Ovarian Hyperstimulation Syndrome. If severe OHSS occurs, treatment must be stopped and the 5.Evaluation of the husband's fertility potential should be included in the Multiple Pregnancies
Multiple pregnancies have occurred following treatment with Endogen-HP Infertile patients with oligo-anovulation: The dose of Endogen-HP to SC and IM. The patient and her partner should be advised of the potential risk stimulate development of ovarian follicles must be individualized for each of multiple births before starting treatment.
patient. The lowest dose consistent with achieving good results based on clinical experience and reported clinical data should be used. The Hypersensitivity/Anaphylactic Reactions
recommended initial dose of Endogen-HP for patients who have received Hypersensitivity/anaphylactic reactions associated with follitropins for GnRH agonist or antagonist pituitary suppression is 150 IU daily injection, have been reported in some patients.
administered SC or IM for the first 5 days of treatment.
Precautions
Based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results) subsequent dosing should be adjusted according to Laboratory Tests
individual patient response. Adjustments in dose should not be made more frequently than once every 2 days and should not exceed more than 75 to The combination of both estradiol levels and ultrasonography are useful for 150 IU per adjustment. The maximum daily dose of Endogen-HP should not monitoring the growth and development of follicles, timing hCG exceed 450 IU and in most cases dosing beyond 12 days is not administration, as well as minimizing the risk of the Ovarian Hyperstimulation Syndrome and multiple gestations.
The clinical confirmation of ovulation, is determined by: If patient response to Endogen-HP is appropriate, hCG 7500 IU units, Pubergen JO should be given 1 day following the last dose of Endogen-HP .or the follicle attains a size greater than 18 mm. hCG should be withheld if the serum estradiol is greater than 2000 pg/mL, if the ovaries are abnormally c. Menstruation following the shift in basal body temperature.
enlarged or if abdominal pain occurs, and the patient should be advised to When used in conjunction with indices of progesterone production, refrain from intercourse. These precautions may reduce the risk of Ovarian sonographic visualization of the ovaries will assist in determining if ovulation Hyperstimulation Syndrome and multiple gestations. Patients should be has occurred. Sonographic evidence of ovulation may include the following: followed closely for at least 2 weeks after hCG administration. If there is inadequate follicle development or ovulation without subsequent pregnancy, the course of treatment with Endogen-HP may be repeated. b. Ovarian stigmata, andc. Collapsed follicle.
Assisted Reproductive Technologies:
Because of the subjectivity of the various tests for the determination of The recommended initial dose of Endogen-HP for patients undergoing IVF follicular maturation and ovulation, it cannot be overemphasized that the and donor egg patients who have received GnRH agonist or antagonist physician should choose tests with which he/she is thoroughly familiar.
pituitary suppression is 225 IU daily administered SC for the first 5 days of treatment. Based on clinical monitoring (including serum estradiol levels and Carcinogenesis and Mutagenesis
vaginal ultrasound results) subsequent dosing should be adjusted according to individual patient response. Adjustments in dose should not be made more Long-term toxicity studies in animals and in vitro mutagenicity tests have not frequently than once every 2 days and should not exceed more than 75 to been performed to evaluate the carcinogenic potential of urofollitropin for 150 IU per adjustment. The maximum daily dose of Endogen-HP given should not exceed 450 IU and in most cases dosing beyond 12 days is not Pregnancy & Lactation
Endogen-HP should not be administered during pregnancy. It is not known Once adequate follicular development is evident, highly purified hCG 7500 whether the drug is excreted in breast milk.
IU(Pubergen JO) should be administered to induce final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be Geriatric Patients
withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS.
Safety and effectiveness in geriatric patients have not been established. Side-Effects
Overdose
Gastrointestinal Nausea, Vomitting, Abdominal Pain Aside from possible ovarian hyperstimulation and multiple gestations, little is known concerning the consequences of acute overdosage with Endogen- In susceptible individuals Ovarian Hyperstimulation Syndrome (OHSS) Warnings
Contraindications
Endogen-HP drug that should only be used by physicians who are thoroughly Endogen-HP is contraindicated in women who have:
Ahigh FSH level indicating primary ovarian failure.
Overstimulation of the Ovary During Endogen-HP Therapy
Uncontrolled thyroid and adrenal dysfunction.
Ovarian Enlargement: Mild to moderate uncomplicated ovarian enlargement An organic intracranial lesion such as pituitary tumor.
which may be accompanied by abdominal distension and/or abdominal pain The presence of any cause of infertility other than anovulation.
occurs in susceptible individuals treated with follitropin and hCG, and Abnormal bleeding of undetermined origin.
generally regresses without treatment within two or three weeks. In order to Ovarian cysts or enlargement not due to polycystic ovary syndrome.
Prior hypersensitivity to urofollitropins, purified.
minimize the hazard associated with the occasional abnormal ovarian 1 Endogen-HP is contraindicated in women who are pregnant and may enlargement, which may occur withFSH - hCG therapy, the lowest dose (D5 cause fetal harm when administered to a pregnant woman. There are consistent with expectation of good results should be used. limited human data on the effects of Endogen-HP when administered

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