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EVENTIN / EVENTIN HP (HIGHLY PURIFIED):

 
 
 
   
   
   
 
 



 
   
 
     
     
 
  Composition
   
  Each ampoule of EVENTIN 75 / 150 contains:
Menotropins
Equivalent to the activity of Follicle Stimulating Hormone (FSH). . .75 / 150 IU
Luteinizing Hormone (LH). . .75 / 150 IU
Mannitol. . .12 mg
Potassium Dihydrogen Orthophosphate. . .0.46 mg
Dipotassium Hydrogen Orthophosphate. . .0.36 mg
Reconstitute with 1ml of sodium c
   
   
  Therapeutic Indications & Usage
   
  EOGENTIN is indicated in conjunction with human chorionic gonadotropin (hCG) for multiple follicular development (controlled ovarian stimulation) and ovulation induction in those who have received previous pituitary suppression.
   
   
  Contraindications
   
  EVENTIN is contraindicated in women who have:
   
 
  • A high FSH level indicating primary ovarian failure.
  • Uncontrolled thyroid and adrenal dysfunction.
  • Presence of any causes of infertility other than anovulation unless the patient is to potentially undergo in-vitro fertilization.
  • Ovarian cysts or enlargement not due to polycystic ovary syndrome.
  • Prior hypersensitivity to menotropins.
  • Presence of pregnancy.
   
  Precautions
   
  EVENTIN must be advocated in late reproductive life period since there is a greater predilection for endometrial carcinoma, as well as a higher incidence of anovulatory disorders.
   
   
  Warnings
   
  EVENTIN must be advocated in the lowest possible dose so as to minimize the chances of producing abnormal ovarian enlargement. If the ovaries are enlarged on the last day of EVENTIN therapy, hCG should not be administered in this course of therapy so as to reduce chances of development of Ovarian Hyperstimulation Syndrome (OHSS). Occurrence of OHSS is an Indication for stopping treatment with EVENTIN and hospitalizing the patient.

Multiple pregnancies have been reported following usage of menotropins (EVENTIN). Before instituting therapy with EVENTIN, evaluation of the spouse's fertility potential must be evaluated.

The combination of estradiol levels estimation and ultrasonography is useful for monitoring the growth and development of follicles, timing of hCG administration as well as minimizing the risk of precipitating OHSS, and multiple pregnancies.

Safety and efficacy of menotropins (EVENTIN) during lactation and in children have not been established.
   
   
  Adverse Reactions
   
  Menotropins (EVENTIN) administration can cause hypersensitivity reactions including flu-like symptoms, pulmonary and vascular complications, OHSS, hemoperitoneum, adnexal torsion, mild-to-moderate ovarian enlargement, ovarian cysts, abdominal pain and other gastrointestinal complaints, dizziness, tachycardia, dyspnea, tachypnea as well as local reaction at injection site (pain, rash, swelling, irritation).

Subsequent to pregnancy resulting from EVENTIN, menotropins usage has been associated with ectopic pregnancy and congenital abnormalities; however, the incidence of the latter does not exceed that found in general population.
   
 
  Recommended Dosage & Administration
   
  INFERTILITY WITH OLIGO-ANOVULATION
   
  Patients having received gonadotropin releasing hormone (GnRH) agonist or antagonist pituitary suppression: 150 IU EVENTIN (dissolving 1-6 vials in 1-2 ml sterile saline) subcutaneous (SC) (lower abdomen alternating sites) or intramuscularly (IM) daily for the first 5 days. Subsequent dosing must be determined by the patient's response and must be made no more frequently than once every 2 days and should not increase more than 75 to 150 IU EVENTIN SC / IM per adjustment.The maximum dose of EVENTIN should not exceed 450 IU SC / IM and dosing beyond 12 days is not recommended.

If response to menotropins is appropriate, hCG 5000-10000 units IM is to be given 1 day following the last dose of EVENTIN. The hCG must be withheld if the serum estradiol level is greater than 2000 pg/ml, or if the ovaries are enlarged or if abdominal pain occurs. Follow up must be closely chosen for at least 2 weeks after hCG administration. If there is inadequate follicular development or ovulation without subsequent pregnancy, the course of EVENTIN must be repeated. The couple must be encouraged to have intercourse daily, beginning the day prior to the administration of hCG until ovulation becomes apparent.
 
   
  ASSISTED REPRODUCTIVE TECHNOLOGIES
   
  Patients having received gonadotropin releasing hormone (GnRH) agonist or antagonist pituitary suppression: 225 IU EVENTIN (dissolving 1-6 vials in 1-2 ml sterile saline) SC (lower abdomen alternating sites) or IM as initial dose. Subsequent dosing must be determined by the patient's response and must be made no more frequently than once every 2 days and should not increase more than 75 to 150 IU EVENTIN SC / IM per adjustment.

The maximum dose of EVENTIN should not exceed 450 IU SC / IM and dosing beyond 12 days is not recommended.

Once adequate follicular development is evident, hCG 5000-10000 units IM is to be given to induce follicular maturation in preparation for oocyte retrieval. The hCG must be withheld if the ovaries are abnormally enlarged on the last day of EVENTIN treatment.
   
  Presentations
   
  EVENTIN 75 Injections: 75 IU ampoules.
EVENTIN 150 Injections: 150 IU ampoules
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
 
         
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