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