AMINOPHYLLINE INJECTION BP 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
Aminophylline Injection BP.
Qualitative and quantitative composition
Each ml contains 25mg of Aminophylline Ph Eur. For the full list of excipients, see section 6.1.
Pharmaceutical form
Sterile Injection.
Therapeutic indications
Disease of the cardiovascular system (e.g. an adjunct in the treatment of pulmonary oedema or paroxysmal nocturnal dyspnoea caused by left ventricular heart failure), reversible airways obstruction including ...
Posology and method of administration
Aminophylline Injection BP may be given by slow intravenous injection or intravenous infusion in glucose injection or sodium chloride injection. Aminophylline has a narrow therapeutic index, therefore ...
Contraindications
Aminophylline injection should not be used in patients hypersensitive to ethylenediamine or those allergic to the theophyllines, caffeine or theobromine. Aminophylline should not be administered concomitantly ...
Special warnings and precautions for use
Intravenous Aminophylline must be administered very slowly to prevent dangerous central nervous system and cardiovascular side-effects due to direct stimulating effect of Aminophylline. Aminophylline has ...
Interaction with other medicinal products and other forms of interaction
The following drugs may increase plasma theophylline concentrations: Fluvoxamine: The concomitant use of theophylline and fluvoxamine should usually be avoided. Where this is not possible, patients should ...
Fertility, pregnancy and lactation
Pregnancy It is not known whether theophyllines can cause foetal harm when administered to pregnant women. Although the safe use of theophylline during pregnancy has not been established relative to potential ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Adverse events are usually a consequence of gastrointestinal irritation, stimulation of the central nervous system and effects on the cardiovascular system. Hypotension, arrhythmias and convulsions may ...
Overdose
Aminophylline has a narrow therapeutic index. Theophylline toxicity is most likely to occur when serum concentrations exceed 20 micrograms/ml and becomes progressively more severe at higher serum concentrations. ...
Pharmacodynamic properties
Aminophylline is a soluble derivative of theophylline and is given for its theophylline activity. Aminophylline relaxes smooth muscle and relieves bronchial spasm. It stimulates the myocardium and reduces ...
Pharmacokinetic properties
None stated.
Preclinical safety data
No further information other than that which is included in the Summary of Product Characteristics.
List of excipients
Ethylenediamine Ph. Eur. Water for injections Ph. Eur.
Incompatibilities
Aminophylline injection is not stable in solutions having a pH of substantially less than 8, however, the drug appears to be relatively stable in large volume parenteral solutions over a wide pH range ...
Shelf life
Shelf life: 36 months.
Special precautions for storage
None stated.
Nature and contents of container
10ml clear glass ampoules, packed in cardboard cartons to contain 10 ampoules.
Special precautions for disposal and other handling
Use as directed by a physician.
Marketing authorization holder
hameln pharmaceuticals ltd, Gloucester, UK
Marketing authorization number(s)
PL 01502/0009R
Date of first authorization / renewal of the authorization
12<sup>th</sup> February 1990/11<sup>th</sup> September 2002
Date of revision of the text
23/01/2015
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
