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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

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Βιβλιογραφική αναφορά

Προτάσεις

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

Εκδότης

Εκδότης Ferring Pharmaceuticals Ltd
Διεύθυνση Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
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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. Oxytocic activity: approximately 50 IU of oxytocin/ampoule For a full list ...

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 ...

Posology and method of administration

Withdraw 1 ml of PABAL containing 100 micrograms carbetocin and administer only by intravenous injection, ...

Contraindications

During pregnancy and labour before delivery of the infant. Carbetocin must not be used for the induction ...

Special warnings and precautions for use

Carbetocin is intended for use only at well equipped specialist obstetrics units with experienced and ...

Interaction with other medicinal products and other forms of interaction

During clinical trials, carbetocin has been administered in association with a number of analgesics, ...

Pregnancy and lactation

Carbetocin is contraindicated during pregnancy and must not be used for the induction of labour (see ...

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 ...

Overdose

Overdosage of carbetocin may produce uterine hyperactivity whether or not due to hypersensitivity to ...

Pharmacodynamic properties

Pharmacotherapeutic group: Oxytocin and analogues ATC code: H01BB03 The pharmacological and clinical ...

Pharmacokinetic properties

Carbetocin shows a biphasic elimination after intravenous administration with linear pharmacokinetics ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...

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 ...

Shelf life

2 years. Shelf life after first opening the container: After first opening the ampoule: the solution ...

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). ...

Nature and contents of container

Type I glass ampoule with a white identification ring and a blue dot indicating the pre-cut area containing ...

Special precautions for disposal and other handling

PABAL is for intravenous use only. Only clear solutions practically free from particles should be used. ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.