GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Menotropin for Injection IP 75 IU
B. Menotropin for Injection IP 150 IU
B. Menotropin for Injection IP 150 IU
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Menotropin for Injection IP 75 IU
a. Each vial contains:
Freeze Dried
Menotropin I.P. Equivalent to
the activity of Follicle
Stimulating Hormone (FSH)…………75 I.U.
Luteinizing Hormone (LH)……………75 I.U.
Mannitol IP ………………………………. q.s.
Potassium Dihydrogen phosphate BP……. q.s.
Dipotassium hydrogen phosphate BP…… q.s.
b. 1 Ampoule containing:
Sodium Chloride Injection IP…….0.9% w/v
B. Menotropin for Injection IP 150 IU
a. Each vial contains:
Freeze Dried
Menotropin I.P. Equivalent to
the activity of Follicle
Stimulating Hormone (FSH)…………150 I.U.
Luteinizing Hormone (LH)……………150 I.U.
Mannitol IP ………………………………. q.s.
Potassium Dihydrogen phosphate BP……. q.s.
Dipotassium hydrogen phosphate BP…… q.s.
b. 1 Ampoule containing:
Sodium Chloride Injection IP…….0.9% w/v
a. Each vial contains:
Freeze Dried
Menotropin I.P. Equivalent to
the activity of Follicle
Stimulating Hormone (FSH)…………75 I.U.
Luteinizing Hormone (LH)……………75 I.U.
Mannitol IP ………………………………. q.s.
Potassium Dihydrogen phosphate BP……. q.s.
Dipotassium hydrogen phosphate BP…… q.s.
b. 1 Ampoule containing:
Sodium Chloride Injection IP…….0.9% w/v
B. Menotropin for Injection IP 150 IU
a. Each vial contains:
Freeze Dried
Menotropin I.P. Equivalent to
the activity of Follicle
Stimulating Hormone (FSH)…………150 I.U.
Luteinizing Hormone (LH)……………150 I.U.
Mannitol IP ………………………………. q.s.
Potassium Dihydrogen phosphate BP……. q.s.
Dipotassium hydrogen phosphate BP…… q.s.
b. 1 Ampoule containing:
Sodium Chloride Injection IP…….0.9% w/v
THERAPEUTIC INDICATIONS:
Menotropins, 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.
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 SCHEDULE:
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.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG:Not to be sold by retail without the prescription of a Registered Medical Practitioner.
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.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: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.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by the Physician.
Menotropin (hMG) for Injection IP 150 IU Technical Specification:
| Product Name: | Menotropin (hMG) for Injection IP 150IU |
| Brand Name: | Menotaj |
| 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, Hormones |
| 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:
- Menotropin (hMG) for Injection IP 150 IU
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Menotropin (hMG) for Injection IP 150 IU
a)Each vial contains:
Freeze Dried
Menotropin I.P. Equivalent to
the activity of Follicle
Stimulating Hormone (FSH)…………150 I.U.
Luteinizing Hormone (LH)……………150 I.U.
Mannitol IP ………………………………. q.s.
Potassium Dihydrogen phosphate BP……. q.s.
Dipotassium hydrogen phosphate BP…… q.s.
b)1 Ampoule containing:
Sodium Chloride Injection iP…….0.9% w/v
THERAPEUTIC INDICATION:
Menotropins, 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.
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 SCHEDULE:
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.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: 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.
