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PROVIGIL / PROVIGIL HP:

 
 
 
   
   
   
 
 


 
   
 
     
     
 
  Composition
   
  Each ampoule of freeze dried PROVIGIL 1000 / 2000 / 5000 / 10000 contains:
  Human Chorionic Gonadotrophin.....1000 / 2000 / 5000 / 10000 IU
Mannitol.....12 mg
Potassium Dihydrogen Orthophosphate.....0.46 mg
Dipotassium Hydrogen Orthophosphate.....0.36 mg
Reconstitute with 1ml of sodium chloride Injection (0.9%w/v) IP provided in the pack
   
   
  Therapeutic Indications & Usage
   
  PROVIGIL is indicated for induction of ovulation and pregnancy in the anovulatory, infertile women in whom the cause of anovulation is secondary and not due to primary ovarian failure, & who has been appropriately pretreated with human menotropins. It is also indicated for selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to pituitary failure) in males, as well as for prepubertal (between four and nine years of age) cryptorchidism not due to anatomical obstruction.
   
   
  Contraindications
   
  PROVIGIL is contraindicated in precocious puberty, prostatic carcinoma or other androgen dependent neoplasm, those hypersensitive to human chorionic gonadotropin (hCG) and during pregnancy.
   
   
  Precautions
   
  Since fluid retention can occur with hCG, PROVIGIL must be given with caution in cardiac or renal disease, migraine, epilepsy and asthma.
   
   
  Warnings
   
  Induction of androgen secretion by hCG (PROVIGIL) may induce precious puberty in those treated for cryptorchidism. Multiple births can result due to hCG (PROVIGIL) treatment. Safety and efficacy of hCG (PROVIGIL) during lactation and in children have not been established.
   
   
  Adverse Reactions
   
  hCG (PROVIGIL) can cause headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, hypersensitivity reaction and pain at site of injection.
   
  The principal serious adverse reactions to hCG (PROVIGIL) include ovarian hyperstimulation, rupture of ovarian cysts with resultant hemoperitoneum and arterial thromboembolism.
   
   
  Recommended Dosage & Administration
   
  Induction of Ovulation and Pregnancy: 1 PROVIGIL 5000 / PROVIGIL 10000 ampoule intramuscular (IM) one day following the last dose of menotropins.
   
  Hypogonadotropic Hypogonadism in Males: ½-1 PROVIGIL 1000 ampoule IM three times a week for 3 weeks followed by the same dose IM twice a week for 3 weeks. Alternatively, 2 PROVIGIL 2000 ampoules IM three times a week for 6-9 months, following the dose can be reduced to 1 PROVIGIL 2000 ampoule IM three times weekly for an additional 3 months.
   
  Prepubertal Cryptorchidism:
 
  • 2 PROVIGIL 2000 ampoules IM three times a week for 3 weeks; or
  • 1 PROVIGIL 5000 ampoule IM alternate day for 4 injections; or
  • ½-1 PROVIGIL 1000 ampoule IM for 15 such injections over a period of 6 weeks; or
  • ½ PROVIGIL 1000 ampoule IM three times a week for 4-6 weeks; if not successful, another similar course is begun one month later giving 1 PROVIGIL 1000 ampoule IM.
   
  Presentations
   
  PROVIGIL/ PROVIGILHP 2000 Injections: 2000 IU ampoules.
PROVIGIL/ PROVIGIL HP 5000 Injections: 5000 IU ampoules.
PROVIGIL / PROVIGIL HP 10000 Injections: 10000 IU ampoules.
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
   
 
         
 
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