MINITRAN 5 Adhesive transdermal patch (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Minitran 5 mg/24 h, transdermal patch.
Qualitative and quantitative composition
Minitran 5 has a surface area of 6.7 sq cm and contains 18 mg of glyceryl trinitrate. The average amount delivered in 24 hours is 5 mg. For the full list of excipients, see section 6.1
Pharmaceutical form
Adhesive transdermal patch.
Therapeutic indications
Minitran 5 is indicated for: Prophylaxis of angina pectoris either alone or in combination with other anti-anginal therapy. Maintenance of venous patency at peripheral infusion sites.
Posology and method of administration
Posology Prophylaxis of angina pectoris Adults The response to nitrates differs between individuals, and the minimum effective dose should be prescribed in each case. It is therefore recommended that treatment ...
Contraindications
Minitran is contraindicated for patients with: Known hypersensitivity to glyceryl trinitrate, and related organic nitrates or any excipient of Minitran. Acute circulatory failure associated with marked ...
Special warnings and precautions for use
Warnings Minitran is not indicated for the treatment of acute angina attacks requiring rapid relief. Minitran should be used only under strict medical supervision in recent myocardial infarction or acute ...
Interaction with other medicinal products and other forms of interaction
Interactions resulting in a concomitant use contraindicated Concomitant administration of Minitran and other vasodilators (e.g. PDE5 inhibitors such as sildenafil [Viagra]), potentiates the blood-pressure-lowering ...
Fertility, pregnancy and lactation
Fertility There is no data available on the effect of Minitran on fertility in humans. Pregnancy As with all drugs Minitran should not be prescribed during pregnancy, particularly during the first trimester, ...
Effects on ability to drive and use machines
Minitran, especially at the start of treatment or dose adjustments, may impair the reactions or might rarely cause orthostatic hypotension and dizziness (as well as exceptionally syncope after overdosing). ...
Undesirable effects
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10) ...
Overdose
Signs High doses of glyceryl trinitrate may lead to severe hypotension and reflex tachycardia or to collapse and syncope. Methaemoglobinaemia has also been reported following accidental overdosage. Management ...
Pharmacodynamic properties
Pharmacotherapeutic group: Vasodilators used in cardiac diseases, organic nitrates ATC Code: C01DA02 Mechanism of action Nitroglycerin, the active constituent of Minitran is a dilator of smooth muscle, ...
Pharmacokinetic properties
When Minitran is applied to the skin, nitroglycerin is absorbed continuously through the skin into the systemic circulation and thus reaches the target organs (heart, vascular system) before deactivation ...
Preclinical safety data
Not applicable.
List of excipients
Isooctyl acrylate/Acrylamide copolymer (93:7) Ethyl oleate BP Glyceryl monolaurate Low density polyethylene film One side silicone coated polyester film
Incompatibilities
None known.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Minitran must be stored at room temperature (below 25°C) under exclusion of light and moisture.
Nature and contents of container
Each patch is individually packed in a heat sealed foil sachet. Cartons contain 30 patches.
Special precautions for disposal and other handling
The patch is covered by a protective polyester film, which is detached and discarded before use.
Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0177
Date of first authorization / renewal of the authorization
28 February 1999 / 7 December 2005
Date of revision of the text
May 2018
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