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SIGNIFOR Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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

Name of the medicinal product

Signifor 0.3 mg solution for injection. Signifor 0.6 mg solution for injection. Signifor 0.9 mg solution for injection.

Qualitative and quantitative composition

Signifor 0.3 mg solution for injection: One ampoule of 1 ml contains 0.3 mg pasireotide (as pasireotide diaspartate). Signifor 0.6 mg solution for injection: One ampoule of 1 ml contains 0.6 mg pasireotide ...

Pharmaceutical form

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

Therapeutic indications

Treatment of adult patients with Cushings disease for whom surgery is not an option or for whom surgery has failed.

Posology and method of administration

Posology The recommended initial dose is 0.6 mg pasireotide by subcutaneous injection twice a day. Two months after the start of Signifor therapy, patients should be evaluated for clinical benefit. Patients ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe hepatic impairment (Child Pugh C).

Special warnings and precautions for use

Glucose metabolism Alterations in blood glucose levels have been frequently reported in healthy volunteers and patients treated with pasireotide. Hyperglycaemia and, less frequently, hypoglycaemia, were ...

Interaction with other medicinal products and other forms of interaction

Anticipated pharmacokinetic interactions resulting in effects on pasireotide The influence of the P-gp inhibitor verapamil on the pharmacokinetics of subcutaneous pasireotide was tested in a drug-drug ...

Fertility, pregnancy and lactation

Pregnancy There is a limited amount of data from the use of pasireotide in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Pasireotide is not recommended for use ...

Effects on ability to drive and use machines

Signifor may have a minor influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines if they experience fatigue, dizziness or headache ...

Undesirable effects

Summary of the safety profile A total of 201 Cushings disease patients received Signifor in phase II and III studies. The safety profile of Signifor was consistent with the somatostatin analogue class, ...

Overdose

Doses up to 2.1 mg twice a day have been used in healthy volunteers, with the adverse reaction diarrhoea being observed at a high frequency. In the event of overdose, it is recommended that appropriate ...

Pharmacodynamic properties

Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatostatin and analogues ATC code: H01CB05 Mechanism of action Pasireotide is a novel cyclohexapeptide, injectable somatostatin ...

Pharmacokinetic properties

Absorption In healthy volunteers, pasireotide is rapidly absorbed and peak plasma concentration is reached within 0.25-0.5 h. C<sub>max</sub> and AUC are approximately dose-proportional following administration ...

Preclinical safety data

Non-clinical safety data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction ...

List of excipients

Mannitol Tartaric acid Sodium hydroxide 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: 3 years.

Special precautions for storage

Store in the original package in order to protect from light.

Nature and contents of container

One-point-cut colourless, type I glass ampoule containing 1 ml of solution. Each ampoule is packed in a cardboard tray which is placed in an outer box. Packs containing 6 ampoules or multipacks containing ...

Special precautions for disposal and other handling

Signifor solution for injection should be free of visible particles, clear and colourless. Do not use Signifor if the solution is not clear or contains particles. For information on the instructions for ...

Marketing authorization holder

Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800, Puteaux, France

Marketing authorization number(s)

Signifor 0.3 mg solution for injection: EU/1/12/753/001-004 Signifor 0.6 mg solution for injection: EU/1/12/753/005-008 Signifor 0.9 mg solution for injection: EU/1/12/753/009-0012

Date of first authorization / renewal of the authorization

Date of first authorisation: 24 April 2012 Date of latest renewal: 18 November 2016

Πηγαίο έγγραφο

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