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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

SIGNIFOR Powder and solvent for suspension 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 10 mg powder and solvent for suspension for injection. Signifor 20 mg powder and solvent for suspension for injection. Signifor 30 mg powder and solvent for suspension for injection. Signifor ...

Qualitative and quantitative composition

Signifor 10 mg powder and solvent for suspension for injection: One vial contains 10 mg pasireotide (as pasireotide pamoate). Signifor 20 mg powder and solvent for suspension for injection: One vial contains ...

Pharmaceutical form

Powder and solvent for suspension for injection (powder for injection). Powder: slightly yellowish to yellowish powder. Solvent: clear, colourless to slightly yellow or slightly brown solution.

Therapeutic indications

Treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue. Treatment of ...

Posology and method of administration

Posology Acromegaly The recommended initial dose for the treatment of acromegaly is 40 mg of pasireotide every 4 weeks. The dose may be increased to a maximum of 60 mg for patients whose growth hormone ...

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 in which pasireotide was administered via the subcutaneous route have shown reproductive toxicity ...

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 The safety profile of pasireotide intramuscular use is consistent with the somatostatin analogue class, except for the higher degree and frequency of hyperglycaemia seen with ...

Overdose

In the event of overdose, it is recommended that appropriate supportive treatment be initiated, as dictated by the patients clinical status, until resolution of the symptoms.

Pharmacodynamic properties

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

Pharmacokinetic properties

Pasireotide for intramuscular use is formulated as microspheres for long-acting release. After a single injection, the plasma pasireotide concentration shows an initial burst release on the injection day, ...

Preclinical safety data

Non-clinical safety data from studies performed with pasireotide administered via the subcutaneous route reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated ...

List of excipients

Powder: Poly(D,L-lactide-co-glycolide) (50-60:40-50) Poly(D,L-lactide-co-glycolide) (50:50) Solvent: Carmellose sodium Mannitol Poloxamer 188 Water for injections

Incompatibilities

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

Shelf life

3 years.

Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze.

Nature and contents of container

Powder: brownish vial (glass) with rubber stopper (chlorobutyl rubber), containing the active substance (pasireotide). Solvent: colourless pre-filled syringe (glass) with front and plunger stopper (chlorobutyl ...

Special precautions for disposal and other handling

There are two critical steps in the reconstitution of Signifor. Not following them could result in failure to deliver the injection appropriately. The injection kit must reach room temperature. Remove ...

Marketing authorization holder

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

Marketing authorization number(s)

Signifor 10 mg powder and solvent for suspension for injection: EU/1/12/753/018 Signifor 20 mg powder and solvent for suspension for injection: EU/1/12/753/013 Signifor 30 mg powder and solvent for suspension ...

Date of first authorization / renewal of the authorization

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

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