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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

OSIGRAFT Powder for suspension for implantation (2016)

Αναφορές

Βιβλιογραφική αναφορά

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

Name of the medicinal product

Osigraft 3.3 mg powder for suspension for implantation.

Qualitative and quantitative composition

Each vial contains 3.3 mg of eptotermin alfa*. * Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. For a full list of excipients, see section 6.1.

Pharmaceutical form

Powder for suspension for implantation. White to off-white granular powder.

Therapeutic indications

Treatment of non-union of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible. ...

Posology and method of administration

Posology Osigraft should be used by an appropriately qualified surgeon. The recommended dose is one single administration in adults. Depending on the size of the bone defect, more than one 1 g vial of ...

Contraindications

Osigraft must not be used in patients who: have a known hypersensitivity to the active substance or to collagen; have skeletal immaturity; have known autoimmune disease, including rheumatoid arthritis, ...

Special warnings and precautions for use

Precaution for use Osigraft does not provide any biomechanical strength and should be used with internal or external fixation where initial mechanical stabilisation is required. However, external fixation ...

Interaction with other medicinal products and other forms of interaction

The pivotal clinical trial supporting the approval of Osigraft did not include the use of synthetic bone void fillers. Post market surveillance data has signalled that the use of the product in combination ...

Fertility, pregnancy and lactation

Women of child-bearing potential Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with the medicine. Contraception in males and females Women ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

The following table of adverse reactions was compiled from those observed and recorded during clinical trials. A similar pattern of adverse reactions has been recorded from spontaneous reporting with an ...

Overdose

No case of overdose has been reported.

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for treatment of bone diseases, bone morphogenetic proteins ATC code: M05BC02 Osigraft is an osteoinductive and osteoconductive medicinal product. Mechanism of action ...

Pharmacokinetic properties

There are no data on the pharmacokinetics of the active substance in man. However, results from Osigraft implantation studies in animals demonstrate that the active substance eptotermin alfa is largely ...

Preclinical safety data

Single dose and repeat dose studies in a range of animal models (rats, dogs and primates) were performed. The results of these showed no unanticipated or systemic effects of toxicity during the observation ...

List of excipients

Bovine collagen (vacuum dried)

Incompatibilities

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

Shelf life

Shelf life: 3 years. The reconstituted product should be used immediately.

Special precautions for storage

Store in a refrigerator (2°C-8°C).

Nature and contents of container

Powder in a glass vial (Type 1, borosilicate) sealed with a stopper (butyl rubber) and a crimp cap (aluminium). The primary package is maintained sterile within a blister pack, comprised of two (inner ...

Special precautions for disposal and other handling

Reconstitution Each vial of Osigraft is reconstituted with 2 to 3 ml of sterile 9 mg/ml sodium chloride solution (0.9% w/v) prior to use. Sterile sodium chloride solution for injection and contents of ...

Marketing authorization holder

Olympus Biotech International Limited, 40 Upper Mount Street, Dublin 2, Ireland Tel +353 87 9278653, medicalinfo@olympusbiotech.com

Marketing authorization number(s)

EU/1/01/179/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 18.05.2001 Date of latest renewal: 18.05.2011

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