GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Menotrophin for Injection BP 75 IU
B. Menotrophin for Injection BP 150 IU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Menotrophin for Injection BP 75 IU
a. Each vial contains:
Freeze Dried
Menotrophin B.P. Equivalent to
the activity of Follicle
Stimulating Hormone (FSH)…………75 I.U.
Luteinizing Hormone (LH)……………75 I.U.
b. 1 Ampoule containing:
Sodium Chloride Injection BP…….0.9% w/v


B. Menotrophin for Injection BP 150 IU
a. Each vial contains:
Freeze Dried
Menotrophin B.P. Equivalent to
the activity of Follicle
Stimulating Hormone (FSH)…………150 I.U.
Luteinizing Hormone (LH)……………150 I.U.
b. 1 Ampoule containing:
Sodium Chloride Injection BP…….0.9% w/v

THERAPEUTIC INDICATIONS:

Menotrophins, in conjunction with HCG, is indicated for primary or secondary menostasia induced by secretion deficiency of gonadotropins and fertilitas feminis induced by anovulation.

DIRECTION OF USE:

Intramuscular Injection: Dissolve HMG in 1 to 2 ml of Sodium Chloride Injection IP.
For the start (the 5th day of period),
75IU to 150IU is given, once a day.
After 7 day, the dosage is adjusted in terms of estrogen level and follicle growth and the dose increases to 125 to 225 IU daily.

CAUTION & WARNING:

CAUTION: Do not use in case any foreign particulate matter is observed inside the vial.
HUMAN MENOPAUSAL GONADOTROPIN (HMG)
HIGHLY PURIFIED (HP)
FOR HOSPITAL USE ONLY
FOR WOMEN’S HEALTH
Injection vial + Medicinal halogenating butyl rubber plug; ampoule.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Water for Injection BP Ampoule is not manufactured by us.
* Not to be sold without water for injection.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE: Store at 2-8°C.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by the Physician.

Menotrophin for Injection BP 75 IU Technical Specification:

Product Name:Menotrophin for Injection BP 75 IU
Brand Name:Generic
Strength:75 IU, 150 IU
Dosage Form:Dry Powder Injection (Sterile) freeze-dried
Packing:1 vial + 1 Ampoule of solvent
Route of Administration:For IM/SC USE ONLY
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Gonadotropins; Ovulation Stimulators
Indication: This medication is used to treat certain fertility problems in women. It provides follicle stimulating hormone (FSH) and luteinizing hormone (LH) that help stimulate healthy ovaries to make eggs.
Storage:Store at 2-8°C.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Menotrophin for Injection BP 75 IU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Menotrophin for Injection BP 75 IU
    a)Each vial contains:
    Freeze Dried
    Menotrophin B.P. Equivalent to
    the activity of Follicle
    Stimulating Hormone (FSH)…………75 I.U.
    Luteinizing Hormone (LH)……………75 I.U.
    b)1 Ampoule containing:
    Sodium Chloride Injection BP…….0.9% w/v

THERAPEUTIC INDICATION:

Menotrophins, in conjunction with HCG, is indicated for primary or secondary menostasia induced by secretion deficiency of gonadotropins and fertilitas feminis induced by anovulation.

DIRECTION OF USE:

Intramuscular Injection: Dissolve HMG in 1 to 2 ml of Sodium Chloride Injection IP.

For the start (the 5th day of period),

75IU to 150IU is given, once a day.

After 7 day, the dosage is adjusted in terms of estrogen level and follicle growth and the dose increases to 125 to 225 IU daily.

CAUTION AND WARNING:

CAUTION: Do not use in case any foreign particulate matter is observed inside the vial.

HUMAN MENOPAUSAL GONADOTROPIN (HMG)

HIGHLY PURIFIED (HP)

FOR HOSPITAL USE ONLY

FOR WOMEN’S HEALTH

Injection vial + Medicinal halogenating butyl rubber plug; ampoule.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Water for Injection BP Ampoule is not manufactured by us.

* Not to be sold without water for injection.

WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store at 2-8°C.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

DOSAGE: As directed by the Physician.