NITRODERM TTS Transdermal patch (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

NITRODERM TTS 5.

2. Qualitative and quantitative composition

Nitroglycerin on lactose 250mg equivalent to nitroglycerin 25mg. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Transdermal patch.

4.1. Therapeutic indications

Prophylactic treatment of attacks of angina pectoris, as monotherapy or in combination with other anti-anginal agents. Prophylactic treatment of phlebitis and extravasation secondary to venous cannulation ...

4.2. Posology and method of administration

For dermal administration. Adults Angina: Treatment should be initiated with one NITRODERM TTS 5 patch daily. If a higher dosage is required a NITRODERM TTS 10 patch may be substituted. The dosage ...

4.3. Contraindications

Known hypersensitivity to nitroglycerin, and related organic nitrates or any excipient of NITRODERM TTS. Acute circulatory failure associated with marked hypotension (shock). Conditions associated with ...

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when transferring the patient on long‑term therapy to another form of medication, nitroglycerin should be gradually withdrawn and overlapping treatment started. ...

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

Concomitant administration of NITRODERM TTS and other vasodilators e.g PDE5 inhibitors such as sildenafil potentiates the blood pressure lowering effects of NITRODERM TTS. Concomitant treatment with calcium ...

4.6. Fertility, pregnancy and lactation

Pregnancy Like any drug, NITRODERM TTS should be employed with caution during pregnancy, especially in the first 3 months. Animal technology studies have not been conducted with nitroglycerin transdermal ...

4.7. Effects on ability to drive and use machines

NITRODERM TTS 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 ranked in descending order of frequency, as follows: Very common (=1/10); common (=1/100, <1/10); uncommon (=1/1000, <1/100); rare (=1/10,000, <1/1000); very rare (<1/10,000), ...

4.9. Overdose

Signs High doses of glyceryl trinitrate may lead to severe hypotension and reflex tachycardia or to collapse and syncope. Methemoglobinaemia has also been reported following accidental overdosage of nitroglycerin. ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: vasodilators used in cardiac diseases ATC code: C01DA02 Nitroglycerin relaxes smooth muscle. It acts chiefly on systemic veins and large coronary arteries, with ...

5.2. Pharmacokinetic properties

Following single application, plasma concentrations of nitroglycerin reach a plateau within 2 hours, which is maintained throughout the day until patch removal. The height of this plateau is directly proportional ...

5.3. Preclinical safety data

Mutagenicity Standard mutagenicity tests provided contradictory results in vitro. Cell culture and in vivo studies revealed no evidence of mutagenic activity of nitroglycerin, and therefore its use is ...

6.1. List of excipients

The active ingredient is Nitroglycerin 10% w/w on lactose. Other excipients are: lactose monohydrate, dimeticone, silica, colloidal andhydrous, colloidal silicon dioxide, light anhydrous sillicic acid. ...

6.2. Incompatibilities

None.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Individual patches in a sealed pouch (made of paper/PE/AL/surlyn*). 10, 28 or 30 sealed patches in each cardboard container. Aluminium 12µm ± 10%, polyethylene 16G/m² ± 20%, surlyn 20G/m² ± ...

6.6. Special precautions for disposal and other handling

Each Nitroderm TTS patch is sealed in a separate sachet with a tear-off edge to facilitate removal. After removing the white protective backing, apply the Nitroderm TTS patch to a clean, non-hairy, dry ...

7. Marketing authorization holder

Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland LOCAL REPRESENTATIVE: Novartis Pharma Services Inc., Methonis Tower, 73 Archibishop Makarios III Avenue, 1070 Nicosia ...

8. Marketing authorization number(s)

Nitroderm TTS 5: 18485

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 28 September 1999 Date of latest renewal: 19 September 2011

10. Date of revision of the text

20/06/2019

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