ISOKET 1 mg/ml Concentrate for solution for injection / infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Isoket 1 mg/ml concentrate for solution for injection or infusion.
Qualitative and quantitative composition
Each ml contains 1 mg of isosorbide dinitrate. Each 10 ml ampoule contains 10 mg of isosorbide dinitrate. Each 50 ml bottle contains 50 mg of isosorbide dinitrate. Each 100 ml contains 100 mg of isosorbide ...
Pharmaceutical form
Concentrate for solution for injection or infusion (sterile concentrate). Clear, colourless solution.
Therapeutic indications
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 ...
Posology and method of administration
Posology Adults, including the elderly population Intravenous route A dose of between 2 mg and 12 mg per hour is usually satisfactory. However, dosages up to 20 mg per hour administered should be adjusted ...
Contraindications
Hypersensitivity to the active substance, other nitrates or to any of the excipients listed in section 6.1. These are common to all nitrates: marked anaemia, cerebral haemorrhage, head trauma, diseases ...
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 ...
Interaction with other medicinal products and other forms of interaction
Concurrent intake of drugs with blood pressure lowering properties e.g. beta-blockers, calcium channel antagonists, vasodilators, ACE-inhibitors, monoamine oxidase inhibitors etc. and/or alcohol may potentiate ...
Fertility, pregnancy and lactation
Pregnancy and lactation No data have been reported which would indicate the possibility of adverse effect resulting from the use of isosorbide dinitrate in pregnancy. Safety in pregnancy, however, has ...
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.
Undesirable effects
Undesirable effects frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated ...
Overdose
<u>Symptoms:</u> Fall of blood pressure ≤90 mmHg Pallor Sweating Weak pulse Tachycardia Postural dizziness Headache Asthenia Dizziness Nausea Vomiting Diarrhoea Methaemoglobinaemia has been reported in ...
Pharmacodynamic properties
Pharmacotherapeutic group: Vasodilators used in cardiac diseases, organic nitrates ATC Code: CO01DA08 Pharmacodynamics Isosorbide dinitrate is an organic nitrate, which in common with other cardioactive ...
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 ...
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. ...
List of excipients
Sodium chloride Water for injections Sodium hydroxide (for pH-adjustment) Hydrochloric acid solution (for pH-adjustment)
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 ...
Shelf life
5 years, as packaged for sale. Open ampoules or bottles should be used immediately and any unused drug discarded. Once diluted, chemical and physical in-use stability for 24 hours at 2-8°C has been demonstrated. ...
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.
Nature and contents of container
Ten 10 ml clear glass ampoules. Clear, Type I glass vials sealed with a grey stopper and a red flip-off aluminium cap, containing 50ml or 100ml of concentrate and packed in a cardboard carton. Clear, Type ...
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, dextrose solution, 5-30% glucose solution, Ringers ...
Marketing authorization holder
Norgine Pharmaceuticals Limited, Norgine House, Widewater place, Moorhall Road, Harefield, Middlesex, UB9 6NS, UK
Marketing authorization number(s)
PL 20011/0051
Date of first authorization / renewal of the authorization
Date of latest renewal: 10 February 2002
Date of revision of the text
02/05/2019
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