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PABAL Solution for injection (2019)

Active ingredients: Carbetocin

Product Name and Form

PABAL 100 micrograms/ml solution for injection.

Pharmaceutical form

Solution for injection.

A clear colourless solution.

Qualitative and Quantitative Composition

Carbetocin 100 micrograms/ml.

For a full list of excipients, see section 6.1.

Chemical substance
Description
Carbetocin

Carbetocin selectively binds to oxytocin receptors in the smooth muscle of the uterus, stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions, and raises the tone of the uterus musculature.

List of excipients

L-methionine
Succinic acid
Mannitol
Sodium hydroxide for pH adjustment
Water for injections

Pack sizes and Marketing

Type I glass vials (2R) with type 1 bromobutyle stoppers with aluminium crimp cap containing 1 ml of solution for injection.

Packs of 5 vials.

Marketing authorization holder
Authorization dates

Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS

5th November 2007

Marketing authorization number:

PL 03194/0058