Products

Merional

Highly Purified (hMG)
 

Expand All
Collapse All

Active ingredient

Highly Purified Human Menopausal Gonadotropin (hMG).
 

Indications

  • Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate. 
  • Stimulation of multifollicular development in patients undergoing assisted reproductive technologies (ART) such as in-vitro fertilization (IVF), gamete intrafallopian transfer (GIFT) and zygote intrafallopian transfer (ZIFT).
  • Merional 75 IU may be given in combination with human Chorionic Gonadotrophin (hCG) for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism. 
  • Merional is indicated for use in adults only.

Dosage and Administration

  • Male infertility: Spermatogenesis stimulation: Merional (75 IU or 150 IU)
    is administered 2-3 times per week. This treatment should be continued for at least 3 months before any improvement in spermatogenesis can be expected.
  • Female infertility: A commonly used regimen commences at 75-150 IU of Merional and is increased according to the patient’s response.
  • The maximum daily dose is usually not higher than 225 IU.
  • If a patient fails to adequately respond after 4 weeks of treatment, the cycle should be abandoned and the patient should recommence at a higher initial dose than in the previous cycle.

Contraindication

Merional should not be administered to children or to patients who have: 
• Hypersensitivity to the active substance menotrophin or to any of the excipients.
• Tumours of the hypothalamus or pituitary gland and to females who have: 
- Ovarian enlargement or a cyst not due to polycystic ovarian disease.
- Gynaecological haemorrhages of unknown cause. 
- Ovarian, uterine or mammary carcinoma. 
• Merional should not be used when an effective response cannot be achieved, such as: 
In females: 
• Primary ovarian failure. 
• Malformation of sexual organs incompatible with pregnancy. 
• Fibroid tumours of the uterus incompatible with pregnancy.
In males: 
• Primary testicular insufficiency.

Side effects

  • The undesirable effects observed with Merional are generally mild and transitory.
  • The most common adverse reactions are ovarian cysts, injection site reactions and headache occurring in up to 10% of female patients.
  • The most serious adverse reactions are severe OHSS and complications associated with this condition such as ovarian torsion and thromboembolism.

Drug Interaction

  • Concomitant use of Merionalwith other agents used to stimulate ovulation (e.g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use GnRH agonists to induce pituitary suppression may increase the dosage of Merional needed to elicit an adequate ovarian response. No other clinically significant drug interactions have been reported.
  • Merional should not be administered as mixture with other medicinal products in the same injection.

Pregnancy and Lactation

  • Merional 75 IU should not be administered during pregnancy. No teratogenic risk has been reported following controlled ovarian hyperstimulation, in clinical use with gonadotrophins.
  • In case of exposure during pregnancy clinical data are insufficient to exclude a teratogenic effect. 
  • Breastfeeding Merional should not be used during breast-feeding.
  • During lactation the secretion of prolactin can entail a poor response to ovarian stimulation.

Warning and Precaution

  • Ovarian Hyperstimulation Syndrome (OHSS) or multiple pregnancies may occur.
  • To minimize the risks, ultrasound scans as well as estradiol measurements are recommended. 

Package and Storage

• Package:
- Carton containing 1 vial of Merional 75 IU and 1 ampoule of solvent (1 ml)
- Carton containing 10 vials of Merional 75 IU and 10 ampoules of solvent (1 ml)
• Storage:
- Do not store above 25°C.
- Store in the original pack, in order to protect from light.

Mother Company

Manufactured by IBSA