NITROCINE Solution for infusion Ref.[50442] Active ingredients: Glyceryl trinitrate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2018  Publisher: Merus Labs Luxco II S.à.R.L., 26-28 rue Edward Steichen, L-2540, Luxembourg

Product name and form

Nitrocine 1 mg/ml solution for infusion, vial.

Pharmaceutical Form

Solution for infusion.

Clear colourless and odourless isotonic sterile solution.

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.

Active Ingredient Description
Glyceryl trinitrate

Glyceryl trinitrate is a vasodilator and is used for angina of effort. Vasodilation is achieved by the releasing of free redical nitric oxide which activates guanylate cyclase and increases synthesis of guanosine 3′ and 5′-monophosphate with resultant effects on the phosphorylation of proteins in smooth muscle. If taken in excess, its vasodilatory effect can cause headache.

List of Excipients

Glucose
Propylene glycol
Water for injections
Hydrochloric acid (for pH adjustment)

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

PA2118/001/002

Date of first authorisation: 2 August 1983
Date of last renewal: 23 May 2008

Drugs

Drug Countries
NITROCINE Estonia, Lithuania, South Africa

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