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SPC, UK: Pabal 100 micrograms in 1ml solution for injection (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Ferring Pharmaceuticals Ltd
Διεύθυνση :
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Δωρεάν εγγραφή

Name of the medicinal product

PABAL 100 micrograms/ml solution for injection.

Qualitative and quantitative composition

Carbetocin 100 micrograms/ml. Oxytocic activity: approximately 50 IU of oxytocin/ampoule For a full list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection. A clear colourless solution.

Therapeutic indications

PABAL is indicated for the prevention of uterine atony following delivery of the infant by Caesarean section under epidural or spinal anaesthesia.

Posology and method of administration

Withdraw 1 ml of PABAL containing 100 micrograms carbetocin and administer only by intravenous injection, under adequate medical supervision in a hospital. PABAL must be administered slowly, over 1 minute ...

Contraindications

During pregnancy and labour before delivery of the infant. Carbetocin must not be used for the induction of labour. Hypersensitivity to carbetocin, oxytocin or to any of the excipients. Hepatic or renal ...

Special warnings and precautions for use

Carbetocin is intended for use only at well equipped specialist obstetrics units with experienced and qualified staff available at all times. The use of carbetocin at any stage before delivery of the infant ...

Interaction with other medicinal products and other forms of interaction

During clinical trials, carbetocin has been administered in association with a number of analgesics, spasmolytics and agents used for epidural or spinal anaesthesia, and no drug interactions have been ...

Pregnancy and lactation

Carbetocin is contraindicated during pregnancy and must not be used for the induction of labour (see section 4.3). No significant effects on milk let-down have been reported during clinical trials. Small ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

The adverse events observed with carbetocin during the clinical trials were of the same type and frequency as the adverse events observed with oxytocin when administered after Caesarean section under spinal ...

Overdose

Overdosage of carbetocin may produce uterine hyperactivity whether or not due to hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions resulting ...

Pharmacodynamic properties

Pharmacotherapeutic group: Oxytocin and analogues ATC code: H01BB03 The pharmacological and clinical properties of carbetocin are those of a long acting oxytocin agonist. Like oxytocin, carbetocin selectively ...

Pharmacokinetic properties

Carbetocin shows a biphasic elimination after intravenous administration with linear pharmacokinetics in the dose range of 400 to 800 micrograms. The terminal elimination half-life is approximately 40 ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicicology and genotoxicity. A reproductive toxicity study in rats, with daily ...

List of excipients

Sodium chloride Glacial acetic acid for pH adjustment Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

2 years. Shelf life after first opening the container: After first opening the ampoule: the solution should be used immediately.

Special precautions for storage

Keep ampoules in the outer carton, in order to protect from light. Store in a refrigerator (2°C to 8°C). Do not freeze.

Nature and contents of container

Type I glass ampoule with a white identification ring and a blue dot indicating the pre-cut area containing 1 ml of solution for injection. Packs of 5 ampoules.

Special precautions for disposal and other handling

PABAL is for intravenous use only. Only clear solutions practically free from particles should be used. Any unused product or waste material should be disposed of in accordance with local requirements. ...

Marketing authorization holder

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

Marketing authorization number(s)

PL 03194/0058

Date of first authorization / renewal of the authorization

5th November 2007

Date of revision of the text

November 2011