CEDOCARD Solution for infusion (2003)
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Περιεχόμενα
1. Name of the medicinal product
Cedocard i.v infusion.
2. Qualitative and quantitative composition
Isosorbide dinitrate 0.1% w/v.
3. Pharmaceutical form
Sterile colourless solution for intravenous infusion.
4.1. Therapeutic indications
Intravenous Cedocard is indicated in the treatment of unresponsive left ventricular failure secondary to acute myocardial infarction, unresponsive left ventricular failure of various aetiology and severe ...
4.2. Posology and method of administration
Dosage Adults, including the elderly <u>Intravenous route:</u> A dose of between 2mg and 12mg per hour is usually satisfactory. However, dosages up to 20mg per hour administered should be adjusted to the ...
4.3. Contraindications
These are common to all nitrates; known hypersensitivity to nitrates, marked anaemia, cerebral haemorrhage, head trauma, hypovolaemia, and severe hypotension. Use in circulatory collapse or low filling ...
4.4. Special warnings and precautions for use
Cedocard should be used with caution in patients who are suffering from hypothyroidism, malnutrition, severe liver or renal disease or hypothermia. Close attention to pulse and blood pressure is necessary ...
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent intake of drugs with blood pressure lowering properties e.g. beta-blockers, calcium antagonists, vasodilators etc. and or/alcohol may potentiate the hypotensive effect of Cedocard 0.1%. The ...
4.6. Pregnancy and lactation
No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide dinitrate in pregnancy. Safety in pregnancy, however, has not been established. Isosorbide ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
In common with other nitrates, headaches, nausea and tachycardia may occur during administration. Whilst sharp falls in systemic arterial pressure can give rise to symptoms of cerebral flow deficiency ...
4.9. Overdose
General supportive therapy.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Vasodilators used in cardiac diseases organic nitrates. <b>ATC Code:</b> CO1DA08. Isosorbide dinitrate is an organic nitrate, which in common with other cardioactive ...
5.2. Pharmacokinetic properties
Isosorbide dinitrate (ISDN) is eliminated from plasma with a short half-life (about 0.7h). The metabolic degradation of ISDN occurs via denitration and glucuronidation, like all organic nitrates. The rate ...
5.3. Preclinical safety data
None stated.
6.1. List of excipients
Sodium chloride Water for injection Sodium hydroxide 1N Hydrochloric acid solution 2N
6.2. Incompatibilities
Cedocard contains isosorbide dinitrate in isotonic saline and is compatible with commonly employed infusion fluids, no incompatibilities have so far been demonstrated. Cedocard is compatible with glass ...
6.3. Shelf life
5 years, as packaged for sale. Admixtures are stable for approximately 24 hours at room temperature in the recommended containers. Open ampoules or bottles should be used immediately and any unused drug ...
6.4. Special precautions for storage
Store between 15-25°C.
6.5. Nature and contents of container
10ml glass ampoules and 50ml, 100ml glass vials. Clear, Type I glass vials sealed with a grey stopper and a red flip-off aluminium cap, containing 50ml or 100ml of concentrate. The bottle is packed in ...
6.6. Special precautions for disposal and other handling
Example of admixture preparationTo obtain a dose of 6 mg per hour, add 50 ml of Cedocard 0.1% to 450 ml of a suitable vehicle, under aseptic conditions. The resultant admixture (500ml) contains 100 µg/ml ...
7. Marketing authorization holder
Pharmaceutical Trading Co Ltd, 33, Artemidos Av., 6025 Larnaca, Cyprus
8. Marketing authorization number(s)
10381
9. Date of first authorization / renewal of the authorization
24 March 1986 / 24 March 1991
10. Date of revision of the text
19th March 2003
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