GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Atosiban acetate injection 6.75 mg/ 0.9ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Atosiban acetate injection 6.75 mg/ 0.9ml
Each 0.9 ml contains:
Atosiban Acetate IP
Equivalent to Atosiban…………….6.75mg
Water for Injection IP………………q.s.

THERAPEUTIC INDICATIONS:

Atosiban is indicated for use in delaying imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 s duration at a rate of at least 4 per 30 min. a cervical dilation of 1-3cm (0-3cm for nulliparas) and effacement of at least 50%

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SCHEDULE : To be sold by retail on the prescription of a Gynecologist .

STORAGE & DOSAGE:

Storage: Store at 2 to 8 degree Celsius. Do not freeze
Dosage: As directed by the Physician. Refer the package insert.

Atosiban acetate injection 6.75 mg/ 0.9ml Technical Specification

Product Name:Atosiban acetate injection
Brand Name:Generic
Strength:6.75 mg/ 0.9ml
Dosage Form:Liquid Injection
Route of Administration:Via Oral Route
Packing:1ml ampoule, 5ml Vial
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Tocolytics
Indication:Atosiban is indicated for use in delaying imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 s duration at a rate of at least 4 per 30 min. a cervical dilation of 1-3cm (0-3cm for nulliparas) and effacement of at least 50%
Storage:Store at 2 to 8 degree Celsius. Do not freeze

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Atosiban acetate injection 6.75 mg/ 0.9ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Atosiban acetate injection 6.75 mg/ 0.9ml
    Each 0.9 ml contains:
    Atosiban Acetate IP
    Equivalent to Atosiban…………….6.75mg
    Water for Injection IP………………q.s.

THERAPEUTIC INDICATIONS:

Atosiban is indicated for use in delaying imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 s duration at a rate of at least 4 per 30 min. a cervical dilation of 1-3cm (0-3cm for nulliparas) and effacement of at least 50%.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SCHEDULE : To be sold by retail on the prescription of a Gynecologist.

STORAGE & DOSAGE:

Storage:Store at 2 to 8 degree Celsius.
Do not freeze.
Dosage:As directed by the Physician. Refer the package insert.