Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα
®
 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

INDUCTOS Powder, solvent and matrix for implantation matrix (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

Name of the medicinal product

InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix.

Qualitative and quantitative composition

One vial contains 4 mg (4 mg pack) or 12 mg (12 mg pack) dibotermin alfa. After reconstitution, InductOs contains 1.5 mg/ml dibotermin alfa. Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; ...

Pharmaceutical form

Powder, solvent and matrix for implantation matrix. The powder is white. The solvent is a clear colourless liquid. The matrix is white.

Therapeutic indications

InductOs is indicated for single-level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment ...

Posology and method of administration

InductOs should be used by an appropriately qualified surgeon. Posology InductOs must be prepared exactly in accordance with the directions for preparation (see section 6.6). The appropriate dose is determined ...

Contraindications

InductOs is contraindicated for patients with: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Skeletal immaturity Any active malignancy or patient undergoing ...

Special warnings and precautions for use

Failure to follow the product preparation instructions in section 6.6 and the method of administration in section 4.2 may compromise the safety and efficacy of InductOs. Cervical spine surgery The safety ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. As dibotermin alfa is a protein and has not been identified in the general circulation, it is an unlikely candidate for pharmacokinetic drug-drug interactions. ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of dibotermin alfa in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). Due to the unknown risks to the foetus ...

Effects on ability to drive and use machines

InductOs has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most common adverse reactions for InductOs in lumbar interbody fusion surgery were radiculopathic events, and in acute tibia fracture surgery it was localised infection. ...

Overdose

In case of overdose (i.e. a patient receives a concentration or amount of dibotermin alfa greater than recommended), treatment should be supportive. Use of InductOs in patients undergoing cervical spine ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bone Morphogenetic Proteins ATC code: M05BC01 Dibotermin alfa is an osteoinductive protein that results in the induction of new bone tissue ...

Pharmacokinetic properties

InductOs is active at the site of implantation. In two exploratory studies, pre- and post-surgery serum samples were collected from a few long-bone fracture patients. Dibotermin alfa was not detectable ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated exposure toxicity and genotoxicity. In reproductive toxicity studies in rats, ...

List of excipients

Powder: Sucrose Glycine Glutamic acid Sodium chloride Polysorbate 80 Sodium hydroxide Solvent: Water for injections Matrix: Bovine Type I collagen

Incompatibilities

This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C. Do not freeze. Store in the original package in order to protect from light.

Nature and contents of container

InductOs 4 mg pack contains: Powder in a vial (10 ml; Type I glass) with a stopper (bromobutyl rubber). Solvent in a vial (10 ml; Type I glass) with a stopper (bromobutyl rubber). Two matrices (2.5 cm ...

Special precautions for disposal and other handling

InductOs is prepared immediately prior to use. Dibotermin alfa must only be used following reconstitution with the solvent and matrix provided in the InductOs pack. Once prepared, InductOs contains dibotermin ...

Marketing authorization holder

Medtronic BioPharma B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands, tel +31 (0) 45 566 8000, fax +31 (0) 45 566 8012

Marketing authorization number(s)

EU/1/02/226/001 EU/1/02/226/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 9 September 2002 Date of latest renewal: 20 July 2012

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: