DERMATRANS Transdermal patch (2017)

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Περιεχόμενα

1. Name of the medicinal product

DERMATRANS 5 mg/24 h transdermal patch.

2. Qualitative and quantitative composition

One transdermal patch contains 15.70 mg of glyceryl trinitrate/6.38 cm² delivering 5 mg of glyceryl trinitrate in 24 hours (0.2 mg/hour). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Transdermal patch. Each patch is circular, light yellow and transparent with printed identification code (NR5), covered by a square both sides aluminised and both sides siliconised protective liner.

4.1. Therapeutic indications

Preventive treatment of angina pectoris either alone or in combination with other anti-anginal therapy.

4.2. Posology and method of administration

Different strengths of DERMATRANS are available. Treatment is usually initiated with one DERMATRANS 5 mg/24 h applied to the skin once daily. DERMATRANS 5 mg/24 h delivers 0.2 mg/h of glyceryl trinitrate. ...

4.3. Contraindications

Hypersensitivity to the active substance, related organic nitrates or to any of the excipients listed in section 6.1. Acute circulatory failure associated with marked hypotension (shock). Conditions associated ...

4.4. Special warnings and precautions for use

Warnings As with other nitrate preparations, when transferring the patient on long-term therapy to another form of medication, glyceryl trinitrate should be gradually withdrawn and overlapping treatment ...

4.5. Interaction with other medicinal products and other forms of interaction

Interactions resulting in a concomitant use contraindicated Concomitant administration of DERMATRANS and other vasodilators (e.g PDE5 inhibitors such as sildenafil) potentiates the blood-pressure-lowering ...

4.6. Fertility, pregnancy and lactation

Pregnancy Like any drug, DERMATRANS should not be prescribed during pregnancy, especially in the first 3 months, unless there are compelling reasons for doing so. The benefits for the mother must be weighed ...

4.7. Effects on ability to drive and use machines

DERMATRANS, 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). ...

4.8. Undesirable effects

Adverse drug reactions are listed by MedDRA System-Organ Class (SOC). Within each System-Organ Class the adverse drug reactions are ranked by frequency, with the most frequent first. Within each frequency ...

4.9. 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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Vasodilators used in cardiac disease, organic nitrates ATC code: C01DA02 Mechanism of action Glyceryl trinitrate, as other organic nitrates, is a potent dilator ...

5.2. Pharmacokinetic properties

Glyceryl trinitrate is rapidly hydrolysed by liver enzymes, which are a major factor in bioavailability. Peak concentrations of glyceryl trinitrate following sub-lingual administration occur within 4 minutes ...

5.3. Preclinical safety data

Glyceryl trinitrate is an organic nitrate which has been used for many years in clinical therapy in a variety of pharmaceutical forms and which is very well documented in the scientific literature. Local ...

6.1. List of excipients

Acrylate-vinylacetate copolymer (Durotak 387-2516) Hydroabietyl phthalate (Cellolyn 21 E) Butyltitanate polymer Lacquered polypropylene foil

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Three years.

6.4. Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5. Nature and contents of container

Immediate packaging: The adhesive side of the patch is covered by a square both side aluminised and siliconised protective liner that is removed before use; each patch is sealed in a sachet consisting ...

6.6. Special precautions for disposal and other handling

Tear open the sachet at the indentation (do not use scissors to avoid damaging the patch) and remove the patch. The patch must be used immediately after opening the sachet. Hold the patch between the thumb ...

7. Marketing authorization holder

Rottapharm Ltd, Damastown Industrial Park, Mulhuddart, Dublin 15

8. Marketing authorization number(s)

PA0868/006/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 14 April 2000 Date of last renewal: 14 April 2010

10. Date of revision of the text

February 2017

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