ISUPREL Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Isuprel 0.2 mg/mL Solution for injection.
Qualitative and quantitative composition
Each mL of the sterile 1:5000 solution contains 0.2 mg of Isoprenaline hydrochloride. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection. A colourless, sterile, non pyrogenic solution.
Therapeutic indications
Isuprel is indicated for: Mild or transient episodes of heart block that do not require electric shock or pacemaker therapy. Serious episodes of heart block and Adams-Stokes attacks (except when caused ...
Posology and method of administration
Isuprel can be administered by the intravenous, intramuscular, subcutaneous or intracardiac routes. Isuprel should generally be started at the lowest recommended dose and the rate of administration gradually ...
Contraindications
Use of Isuprel is contraindicated in patients with tachyarrhythmias; tachycardia or heart block caused by digitalis intoxication; ventricular arrhythmias which require inotropic therapy; recent myocardial ...
Special warnings and precautions for use
Isoprenaline injection should generally be started at the lowest recommended dose. This may be gradually increased if necessary while carefully monitoring the patient. Isoprenaline injection, by increasing ...
Interaction with other medicinal products and other forms of interaction
Adrenaline Isuprel and adrenaline should not be administered simultaneously because both medicines are direct cardiac stimulants and their combined effects may induce serious arrhythmias. The medicines ...
Fertility, pregnancy and lactation
Fertility No data available. Pregnancy Category A. Medicines which have been taken by a large number of pregnant women of childbearing age without any proven increase in the frequency of malformation or ...
Effects on ability to drive and use machines
No data available.
Undesirable effects
Serious effects to Isuprel are infrequent. The following effects, however, have been reported: <u>CNS:</u> Nervousness, headache, dizziness, restlessness, tension, fear of excitement, and rarely, nausea, ...
Overdose
The acute toxicity of isoprenaline in animals is much less than that of adrenaline. Excessive doses in animals or man can cause a striking drop in blood pressure, and repeated large doses in animals may ...
Pharmacodynamic properties
Mechanism of action Isoprenaline hydrochloride (also called isoproterenol hydrochloride) is 3,4-Dihydroxy-alpha- (isopropylamino) methyl benzyl alcohol hydrochloride, a synthetic sympathomimetic amine ...
Pharmacokinetic properties
Isoprenaline is readily absorbed when given parenterally. The half-life of isoprenaline hydrochloride is brief lasting only a few minutes following intravenous administration and up to 2 hours after subcutaneous ...
Preclinical safety data
Genotoxicity No data available. Carcinogenicity No data available. Reproductive and developmental toxicity No data available.
List of excipients
Citric acid Disodium edetate Hydrochloric acid Nitrogen Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water for injection
Incompatibilities
No data available.
Shelf life
Shelf life: 18 months.
Special precautions for storage
Store below 25°C. Protect from Light.
Nature and contents of container
Injection, 200 microgram/1 mL ampoules: 25s; 1 mg/5 mL ampoules: 10s.
Special precautions for disposal and other handling
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer New Zealand Limited, P O Box 3998, Auckland, New Zealand, 1140, Toll Free Number: 0800 736 363
Date of first authorization / renewal of the authorization
31 Dec 1969
Date of revision of the text
12 February 2019
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