DIGOXIN Solution for injection (2017)
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Περιεχόμενα
Name of the medicinal product
Digoxin 250 micrograms/ml Solution for Injection.
Qualitative and quantitative composition
Each 2ml of solution contains 500 micrograms of Digoxin. Excipient(s) with known effect: Ethanol 96% 0.250 ml. Also contains 2.92 mg sodium per 2ml. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for Injection. Clear, colourless, sterile solution, intended for parenteral administration to human beings.
Therapeutic indications
Cardiac failure Digoxin is indicated in the management of chronic cardiac failure where the dominant problem is systolic dysfunction. The therapeutic benefit of digoxin is greater in patients with ventricular ...
Posology and method of administration
Posology Digoxin Injection is for administration by slow intravenous infusion (see Method of administration below). The dose of digoxin for each patient has to be tailored individually according to age, ...
Contraindications
Hypersensitivity to the active substance(s) or other digitalis glycosides or to any of the excipients listed in section 6.1. Digoxin is contraindicated in: Intermittent complete heart block or second degree ...
Special warnings and precautions for use
Monitoring Patients receiving digoxin should have their serum electrolytes and renal function (serum creatinine concentration) assessed periodically; the frequency of assessments will depend on the clinical ...
Interaction with other medicinal products and other forms of interaction
These may arise from effects on the renal excretion, tissue binding, plasma protein binding and distribution within the body, gut absorptive capacity, P-glycoprotein activity and sensitivity to digoxin. ...
Fertility, pregnancy and lactation
Pregnancy The use of digoxin in pregnancy is not contraindicated, although the dosage and control may be less predictable in pregnant than in non-pregnant women with some requiring an increased dosage ...
Effects on ability to drive and use machines
Since central nervous system and visual disturbances have been reported in patients receiving digoxin, patients should exercise caution before driving, using machinery or participating in dangerous activities. ...
Undesirable effects
In general, the adverse reactions of digoxin are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when digoxin is used ...
Overdose
Symptoms and signs The symptoms and signs of toxicity are generally similar to those described Section 4.8 but may be more frequent and can be more severe. Signs and symptoms of digoxin toxicity become ...
Pharmacodynamic properties
Pharmacotherapeutic group: Cardiac therapy, cardiac glycosides, digitalis glycosides ATC code: C01AA05 Mechanism of action Digoxin increases contractility of the myocardium by direct activity. This effect ...
Pharmacokinetic properties
Absorption The T<sub>max</sub> following IV administration is approximately 1 to 5 hours, while the T<sub>max</sub> for oral administration is 2 to 6 hours. Upon oral administration, digoxin is absorbed ...
Preclinical safety data
Carcinogenesis, mutagenesis Digoxin showed no genotoxic potential in in vitro studies (Ames test and mouse lymphoma). No data are available on the carcinogenic potential of digoxin.
List of excipients
Ethanol Propylene glycol Citric acid monohydrate Disodium hydrogen phosphate Water for injections
Incompatibilities
Not applicable.
Shelf life
Shelf life Unopened: 4 years. After reconstitution: not applicable. After first opening: 4 years*. * If only part of an ampoule is used, discard the remaining solution.
Special precautions for storage
Do not store above 25°C. Keep the ampoule in the outer carton in order to protect from light.
Nature and contents of container
2ml, clear One point cut (OPC) glass ampoules, glass type 1 Ph.Eur. borosilicate glass, packed in cardboard cartons to contain 10 2ml ampoules.
Special precautions for disposal and other handling
If only part used, discard the remaining solution. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland
Marketing authorization number(s)
PL 02848/5934R
Date of first authorization / renewal of the authorization
24/1/91
Date of revision of the text
07/12/2017
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