PABAL Solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
PABAL 100 micrograms/ml solution for injection.
Qualitative and quantitative composition
Carbetocin 100 micrograms/ml. 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 postpartum haemorrhage due to uterine atony.
Posology and method of administration
Posology Caesarean section under epidural or spinal anaesthesia Withdraw 1 ml of PABAL containing 100 micrograms carbetocin and administer only by intravenous injection, under adequate medical supervision ...
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 listed in section ...
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
Pregnancy Carbetocin is contraindicated during pregnancy and must not be used for the induction of labour (see section 4.3). Breastfeeding No significant effects on milk let-down have been reported during ...
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. <strong>Intravenous administration* – Tabulated ...
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
The pharmacokinetics of carbetocin have been investigated in healthy female subjects. Carbetocin shows biphasic elimination after intravenous administration with linear pharmacokinetics in the dose range ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicology, genotoxicity and local tolerance. A reproductive toxicity study in ...
List of excipients
L-methionine Succinic acid Mannitol Sodium hydroxide 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
Shelf life: 3 years. Shelf life after first opening the vial: the solution should be used immediately. From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes ...
Special precautions for storage
Keep vials in the outer carton, in order to protect from light. Store below 30°C. Do not freeze.
Nature and contents of container
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.
Special precautions for disposal and other handling
PABAL is for intravenous and intramuscular 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 ...
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
October 2019
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