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TRAJENTA Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Trajenta 5 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 5 mg of linagliptin. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet (tablet). 8 mm diameter round, light red film-coated tablet debossed with D5 on one side and the Boehringer Ingelheim logo on the other.

Therapeutic indications

Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: Monotherapywhen metformin is inappropriate due to intolerance, or contraindicated ...

Posology and method of administration

Posology The dose of linagliptin is 5 mg once daily. When linagliptin is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly. When linagliptin is ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

General Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Hypoglycaemia Linagliptin alone showed a comparable incidence of hypoglycaemia to ...

Interaction with other medicinal products and other forms of interaction

In vitro assessment of interactions Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes. It is not an inducer ...

Fertility, pregnancy and lactation

Pregnancy The use of linagliptin has not been studied in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a ...

Effects on ability to drive and use machines

Linagliptin has no or negligible influence on the ability to drive and use machines. However patients should be alerted to the risk of hypoglycaemia especially when combined with sulphonylurea and/or insulin. ...

Undesirable effects

Summary of the safety profile In the pooled analysis of the placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo was similar to linagliptin 5 mg (63.4% versus ...

Overdose

Symptoms During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were generally well tolerated. There is no experience ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors ATC code: A10BH05 Mechanism of action Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase ...

Pharmacokinetic properties

The pharmacokinetics of linagliptin has been extensively characterised in healthy subjects and patients with type 2 diabetes. After oral administration of a 5 mg dose to healthy volunteers or patients, ...

Preclinical safety data

Liver, kidneys and gastrointestinal tract are the principal target organs of toxicity in mice and rats at repeat doses of linagliptin of more than 300 times the human exposure. In rats effects on reproductive ...

List of excipients

Tablet core: Mannitol Pregelatinised starch (maize) Maize starch Copovidone Magnesium stearate Film coating: Hypromellose Titanium dioxide (E171) Talc Macrogol (6000) Iron oxide red (E172)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Perforated alu/alu unit dose blisters in cartons containing 10 1, 14 1, 28 1, 30 1, 56 1, 60 1, 84 1, 90 1, 98 1, 100 1 and 120 1 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany

Marketing authorization number(s)

EU/1/11/707/001 (10 1 tablets) EU/1/11/707/002 (14 1 tablets) EU/1/11/707/003 (28 1 tablets) EU/1/11/707/004 (30 1 tablets) EU/1/11/707/005 (56 1 tablets) EU/1/11/707/006 (60 1 tablets) EU/1/11/707/007 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 24 August 2011 Date of latest renewal: 22 March 2016

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