ISOKET Solution for infusion or injection (2016)

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Περιεχόμενα

1. Name of the medicinal product

Isoket 0.5 mg/ml Solution for Infusion or Injection.

2. Qualitative and quantitative composition

Each ml contains 0.5 mg of isosorbide dinitrate. Each 10 ml pre-filled syringe contains 5 mg of isosorbide dinitrate. Each 50 ml bottle contains 25 mg of isosorbide dinitrate. Excipients: Each ml ...

3. Pharmaceutical form

Solution for infusion or injection. Clear, colourless solution.

4.1. Therapeutic indications

1. Intravenous Isoket 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

Adults, including the elderly Intravenous route Isoket 0.5 mg/ml (undiluted) is intended for intravenous administration by slow infusion via a syringe pump. Alternatively it can be administered as an admixture ...

4.3. Contraindications

These are common to all nitrates: hypersensitivity to isosorbide dinitrate, other nitrates or any of the excipients, marked anaemia, cerebral haemorrhage, head trauma, diseases associated with an increased ...

4.4. Special warnings and precautions for use

Isoket should be used with caution and under medical supervision in patients who are suffering from: hypothyroidism, malnutrition, severe liver or renal disease hypothermia orthostatic syndrome The development ...

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 Isoket. This might ...

4.6. Pregnancy and lactation

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 ...

4.7. Effects on ability to drive and use machines

As for other drugs which produce changes in blood pressure, patients taking Isoket should be warned not to drive or operate machinery if they experience dizziness or related symptoms.

4.8. Undesirable effects

During administration of Isoket the following undesirable effects may be observed: Nervous system disorders: headache, dizziness, somnolence. Cardiac disorders: tachycardia, angina pectoris ...

4.9. Overdose

Symptoms: Fall of blood pressure ≤90 mmHg Pallor Sweating Weak pulse Tachycardia Postural dizziness Headache Asthenia Dizziness Nausea Vomiting Diarrhoea Methaemoglobinaemia has been reported in ...

5.1. Pharmacodynamic properties

ATC Code: C02DA08 Vasodilators used in cardiac diseases Isosorbide dinitrate is an organic nitrate, which in common with other cardioactive nitrates, is a vasodilator. It produces decreased left ...

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

Acute toxicity Acute toxicity of isosorbide dinitrate was related to an exaggerated pharmacodynamic effect. Animal studies showed good local tolerability of the undiluted isosorbide dinitrate solution. ...

6.1. List of excipients

Sodium chloride Water for injection Hydrochloric acid for pH adjustment Sodium hydroxide for pH adjustment

6.2. Incompatibilities

Polyvinyl chloride (PVC) or polyurethane (PU) giving sets and containers should not be used since significant losses of the active ingredient by adsorption occur and it has not been verified how the dose ...

6.3. Shelf life

50ml glass bottles (glass type 1): 5 years as packaged for sale. 50ml glass bottles (glass type 2): 2 years as packaged for sale. Open bottles should be used immediately and any unused drug discarded. ...

6.4. Special precautions for storage

Unopened: There are no special precautions for storage of the product as packaged for sale. Once diluted: See Section 6.3 for storage conditions of the diluted solution.

6.5. Nature and contents of container

50 ml glass bottles (glass type 1 or 2) with a laminated rubber stopper. The stopper consists of butyl rubber. The inner side of the stopper, coming into contact with the product is laminated with a film, ...

6.6. Special precautions for disposal and other handling

Isoket contains isosorbide dinitrate in isotonic solution and is compatible with commonly employed infusion fluids, such as sodium chloride solution, 5-30% glucose solution, Ringers solution and solutions ...

7. Marketing authorization holder

Merus Labs Luxco II S.à r.l., 26-28, rue Edward Steichen, L-2540 Luxembourg

8. Marketing authorization number(s)

PL 44374/0020

9. Date of first authorization / renewal of the authorization

October 2003

10. Date of revision of the text

August 2016

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