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TRULICITY Solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Trulicity 0.75 mg solution for injection in pre-filled pen. Trulicity 1.5 mg solution for injection in pre-filled pen.

Qualitative and quantitative composition

Trulicity 0.75 mg solution for injection: Each pre-filled pen contains 0.75 mg of dulaglutide* in 0.5 ml solution. Trulicity 1.5 mg solution for injection: Each pre-filled pen contains 1.5 mg of dulaglutide* ...

Pharmaceutical form

Solution for injection (injection). Clear, colourless solution.

Therapeutic indications

Trulicity is indicated in adults with type 2 diabetes mellitus to improve glycaemic control as: Monotherapy: When diet and exercise alone do not provide adequate glycaemic control in patients for whom ...

Posology and method of administration

Posology Monotherapy The recommended dose is 0.75 mg once weekly. Add-on therapy The recommended dose is 1.5 mg once weekly. For potentially vulnerable populations, such as patients ≥75 years, 0.75 mg ...

Contraindications

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

Special warnings and precautions for use

Dulaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Dulaglutide is not a substitute for insulin. Diabetic ketoacidosis has been reported ...

Interaction with other medicinal products and other forms of interaction

Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. Dulaglutide should be used with caution in patients receiving ...

Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of dulaglutide in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Therefore, the use of dulaglutide ...

Effects on ability to drive and use machines

Trulicity has no or negligible influence on the ability to drive or use machines. When it is used in combination with a sulphonylurea or insulin, patients should be advised to take precautions to avoid ...

Undesirable effects

Summary of safety profile In the completed phase II and phase III registration studies, 4,006 patients were exposed to dulaglutide alone or in combination with other glucose lowering medicinal products. ...

Overdose

Effects of overdose with dulaglutide in clinical studies have included gastrointestinal disorders and hypoglycaemia. In the event of overdose, appropriate supportive treatment should be initiated according ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins, glucagon-like peptide-1 (GLP-1) analogues ATC code: A10BJ05 Mechanism of action Dulaglutide is a long-acting ...

Pharmacokinetic properties

Absorption Following subcutaneous administration to patients with type 2 diabetes, dulaglutide reaches peak plasma concentrations in 48 hours. The mean peak (C<sub>max</sub>) and total (AUC) exposures ...

Preclinical safety data

Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeat-dose toxicity. In a 6-month carcinogenicity study in transgenic mice, there was no ...

List of excipients

Sodium citrate Citric acid, anhydrous Mannitol Polysorbate 80 Water for injections

Incompatibilities

In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze. Store in original package in order to protect from light. In use: Trulicity may be stored unrefrigerated for up to 14 days at a temperature not above 30°C. ...

Nature and contents of container

Glass syringe (type I) encased in a disposable pen. Each pre-filled pen contains 0.5 ml of solution. Packs of 2 and 4 pre-filled pens and multipack of 12 (3 packs of 4) pre-filled pens. Not all pack sizes ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Instructions for use The pre-filled pen is for single-use only. The instructions for using the ...

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Marketing authorization number(s)

EU/1/14/956/001 EU/1/14/956/002 EU/1/14/956/003 EU/1/14/956/006 EU/1/14/956/007 EU/1/14/956/008

Date of first authorization / renewal of the authorization

Date of first authorisation: 21 November 2014

Πηγαίο έγγραφο

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