OXYTOCIN Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Oxytocin 10 IU/ml Concentrate for Solution for Infusion.
Qualitative and quantitative composition
Oxytocin. Concentrate for solution for infusion (in 1ml ampoule) containing 10 IU/ml. Excipient(s) with known effect: None. For the full list of excipients, see section 6.1.
Pharmaceutical form
Concentrate for solution for infusion. A clear, colourless, sterile solution in 1ml clear glass ampoules.
Therapeutic indications
<u>Antepartum:</u> Induction of labour for medical reasons; e.g. in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia). Stimulation of labour ...
Posology and method of administration
Posology Induction or enhancement of labour: Oxytocin should not be started for 6 hours, following administration of vaginal prostaglandins. Oxytocin should be administered as an intravenous (i.v.) drip ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypertonic uterine contractions, mechanical obstruction to delivery, foetal distress. Any condition in which, ...
Special warnings and precautions for use
Oxytocin must only be administered as an i.v. infusion and never by i.v. bolus injection as it may cause an acute- short-lasting hypotension accompanied with flushing and reflex tachycardia Induction of ...
Interaction with other medicinal products and other forms of interaction
Interaction resulting in a concomitant use not recommended Prostaglandins and their analogues Prostaglandins and its analogues facilitate contraction of the myometrium hence oxytocin can potentiate the ...
Fertility, pregnancy and lactation
Pregnancy Based on the wide experience with this drug and its chemical structure and pharmacological properties, it is not expected to present a risk of foetal abnormalities when used as indicated. One ...
Effects on ability to drive and use machines
Oxytocin can induce labour, therefore caution should be exercised when driving or operating machines. Women with uterine contractions should not drive or use machines.
Undesirable effects
As there is a wide variation in uterine sensitivity, uterine spasm may be caused in some instances by what are normally considered to be low doses. When oxytocin is used by iv infusion for the induction ...
Overdose
The fatal dose of oxytocin has not been established. Oxytocin is subject to inactivation by proteolytic enzymes of the alimentary tract. Therefore it is not absorbed from the intestine and is not likely ...
Pharmacodynamic properties
Pharmacotherapeutic group: Posterior pituitary lobe hormones ATC code: H01BB02 Mechanism of action Oxytocin is a cyclic nonapeptide that is obtained by chemical synthesis. This synthetic form is identical ...
Pharmacokinetic properties
Absorption Plasma levels of oxytocin following intravenous infusion at 4 milliunits per minute in pregnant women at term were 2 to 5 microunits/ml. Distribution The steady-state volume of distribution ...
Preclinical safety data
Pre-clinical data for oxytocin reveal no special hazard for humans based on conventional studies of single dose acute toxicity, genotoxicity and mutagenicity.
List of excipients
Sodium acetate tri-hydrate Glacial acetic acid Sodium hydroxide Water for injections
Incompatibilities
Oxytocin should not be infused via the same apparatus as blood or plasma, because the peptide linkages are rapidly inactivated by oxytocin-inactivating enzymes. Oxytocin is incompatible with solutions ...
Shelf life
Three years. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial ...
Special precautions for storage
Store between 2°C and 8°C. May be stored up to 30°C for 3 months, but must then be discarded. Store in the original package in order to protect from light.
Nature and contents of container
Clear, Type I, neutral glass, 1ml ampoules. Boxes of 10 or 5 ampoules. Not all packs sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements Snap ampoules: no file required. Oxytocin is compatible with the following infusion fluids, but ...
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Marketing authorization number(s)
PL 29831/0625
Date of first authorization / renewal of the authorization
20/05/2014
Date of revision of the text
12/09/2019
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