NITROCINE Solution for infusion (2018)
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Περιεχόμενα
1. Name of the medicinal product
Nitrocine 1 mg/ml solution for infusion, vial.
2. Qualitative and quantitative composition
Each vial contains 50 mg glyceryl trinitrate in 50 ml (1mg/ml). For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Solution for infusion. Clear colourless and odourless isotonic sterile solution.
4.1. Therapeutic indications
Surgery Nitrocine is indicated for: 1. The rapid control of hypertension during cardiac surgery. 2. Reducing blood pressure and maintaining controlled hypotension during surgical procedures. 3. Controlling ...
4.2. Posology and method of administration
Posology Adults The dose of Nitrocine should be adjusted to meet the individual needs of the patient. The recommended dosage range is 10-200 mcg/min but up to 400 mcg/min may be necessary during some surgical ...
4.3. Contraindications
Nitrocine should not be used in the following cases: Hypersensitivity to the active substance, other nitro compounds or any of the excipients listed in section 6.1. Acute circulatory failure (shock, collapse). ...
4.4. Special warnings and precautions for use
Nitrocine must be used only with particular caution and under medical supervision in: Low filling pressures e.g. in acute myocardial infarction, impaired left ventricular function (left ventricular failure). ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant treatment with other drugs with blood pressure lowering properties e.g. vasodilators (e.g. PDE5 inhibitors such as Sildenafil), calcium channel antagonists, ACE-inhibitors, monoamine oxidase ...
4.6. Fertility, pregnancy and lactation
Fertility Reproduction toxicity studies performed in rats and rabbits using various routes of administration did not reveal any effect on mating, fertility and general reproductive parameters. There is ...
4.7. Effects on ability to drive and use machines
Nitrocine may affect the patients reactivity to an extent that her/his ability to drive or to operate machinery is impaired. This effect is increased in combination with alcohol.
4.8. Undesirable effects
<b>During administration of NITROCINE the following undesirable effects may be observed:</b> SOC: Very common<br />(≥1/10) Common<br /> (≥1/100<br /><1/10) Uncommon <br /> (≥1/1,000<br /> <1/100) Rare ...
4.9. Overdose
Animal experience In rats and mice, significant lethality (LD50) at single intravenous doses of 23.2 mg/kg and 10.6 mg/kg, respectively, was observed. In rats and mice, significant lethality (LD50) at ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> vasodilators used in cardiac diseases <b>ATC Code:</b> C01DA 02 – Organic Nitrates Pharmacodynamics Glyceryl trinitrate reduces the tone of vascular smooth muscle. This ...
5.2. Pharmacokinetic properties
As with all commonly used organic nitrates the metabolic degradation of glyceryl trinitrate occurs via denitration and glucuronidation. The less active metabolites resulting from this biotransformation ...
5.3. Preclinical safety data
Conventional studies of acute and repeated dose toxicity reveal no special hazard to humans. Reproductive and Developmental Toxicity Reproductive toxicity studies, in rats and rabbits using various routes ...
6.1. List of excipients
Glucose Propylene glycol Water for injections Hydrochloric acid (for pH adjustment)
6.2. Incompatibilities
Nitrocine is incompatible with polyvinylchloride (PVC) and severe losses of glyceryl trinitrate (over 40%) may occur if this material is used. Contact with polyvinylchloride bags should be avoided. Polyurethane ...
6.3. Shelf life
<u>As packaged for sale:</u> Nitrocine may be stored unopened for 5 years. The product should be used immediately after opening. <u>Admixture:</u> Chemical and physical in-use stability of the admixture ...
6.4. Special precautions for storage
<u>As packaged for sale:</u> This medicinal product does not require any special storage conditions. For storage of open or admixed product, see Section 6.3.
6.5. Nature and contents of container
Clear glass (type II) vials with rubber closure (Bromobutyl polymer) and aluminium cap containing 50ml. The vials are packed singly in an outer carton. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Vials of Nitrocine are for single use only and should not be regarded as multi-dose containers. Nitrocine contains glyceryl trinitrate in isotonic sterile solution and is compatible with commonly employed ...
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)
PA2118/001/002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 2 August 1983 Date of last renewal: 23 May 2008
10. Date of revision of the text
February 2018
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