VENTOLIN Solution for injection (2015)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Ventolin Injection 500 micrograms (0.5mg) in 1ml.
Qualitative and quantitative composition
Ventolin Injection 500 micrograms (0.5mg) in 1ml (500 micrograms/ml) is presented as ampoules of 1ml, each containing 500 micrograms salbutamol as salbutamol sulfate BP in a sterile isotonic solution. ...
Pharmaceutical form
A colourless or faintly straw coloured solution for injection.
Therapeutic indications
Ventolin Injection is indicated in adults and adolescents. Ventolin Injection provides short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. It ...
Posology and method of administration
Ventolin Injection may be administered by the subcutaneous, intramuscular or intravenous route, under the direction of a physician. Adults Subcutaneous route: 500 micrograms (8 micrograms/kg body weight) ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion. ...
Special warnings and precautions for use
Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment, including lung-function testing, as patients are ...
Interaction with other medicinal products and other forms of interaction
Salbutamol and non-selective beta-blocking drugs such as propranolol, should not usually be prescribed together.
Fertility, pregnancy and lactation
Pregnancy Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. As with the majority of drugs, there ...
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) ...
Overdose
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including ...
Pharmacodynamic properties
Pharmacotherapeutic group: Selective beta<sub>2</sub>-adrenoreceptor agonists ATC Code: R03CC02 Salbutamol is a selective beta<sub>2</sub>-adrenoceptor agonist. At therapeutic doses it acts on beta<sub> ...
Pharmacokinetic properties
Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally and partly by metabolism to the inactive 4'-O-sulfate (phenolic sulfate) which is also excreted primarily ...
Preclinical safety data
In common with other potent selective β2-agonists, salbutamol has been shown to be teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of fetuses were found to have cleft palate ...
List of excipients
Sodium chloride Sodium hydroxide pellets Dilute sulfuric acid Water for injections Nitrogen (oxygen free)
Incompatibilities
None stated.
Shelf life
36 months. 24 hours shelf life of admixtures with infusion fluids.
Special precautions for storage
Store below 30°C and keep the ampoule in the outer container in order to protect from light.
Nature and contents of container
Clear, neutral glass ampoules, packed in plastic trays with a cardboard sleeve over the trays. Pack size: 1ml ampoules in plastic trays of 5.
Special precautions for disposal and other handling
The only recommended diluents for Ventolin Injection are water for injections BP, sodium chloride injection BP, sodium chloride and dextrose injection BP or dextrose injection BP. All unused admixtures ...
Marketing authorization holder
Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Marketing authorization number(s)
PL 10949/0084
Date of first authorization / renewal of the authorization
6 September 2000
Date of revision of the text
05/02/2015
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
