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SPC, UK: InductOs 12 mg kit for implant (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Medtronic Limited
Διεύθυνση :
Building 9 –Croxley Green Business Park, Watford, Hertfordshire, WD18 8WW
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Δωρεάν εγγραφή

Name of the medicinal product

InductOs 12 mg kit for implant.

Qualitative and quantitative composition

One vial contains 12 mg dibotermin alfa. After reconstitution, InductOs contains 1.5 mg/ml dibotermin alfa. Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein ...

Pharmaceutical form

Kit for implant. The kit consists of a white powder for solution, a clear colourless solvent and a white matrix.

Therapeutic indications

InductOs is indicated for single-level (L4 – S1) anterior lumbar 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 ...

Posology and method of administration

InductOs should be used by an appropriately qualified surgeon. Posology The directions for preparation for each kit should be followed exactly, using the appropriate amount of InductOs for the intended ...

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 for InductOs may compromise its safety and effectiveness. Care and caution should be used to prevent overfilling of the construct and/or intervertebral ...

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. ...

Pregnancy and lactation

Pregnancy and women of childbearing potential There are no adequate data from the use of dibotermin alfa in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential ...

Effects on ability to drive and use machines

Since InductOs has no systemic effect, it is expected that InductOs has no or negligeable influence on the ability to drive or use machinery.

Undesirable effects

Summary of the safety profile The most common adverse reactions related to the use of InductOs were neuralgia in spine surgery and localised infection in tibia fracture repair. The most severe adverse ...

Overdose

Use of InductOs in patients undergoing cervical spine surgery in concentrations or amounts greater than those recommended in section 4.2 for the approved indications has been associated with reports of ...

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 on conventional studies of pharmacology, acute and repeat exposure toxicity. In reproductive toxicity studies in rats, where dibotermin alfa was administered ...

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

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

Each kit of InductOs is provided with: 12 mg of sterile dibotermin alfa powder in a 20 ml vial (Type I glass) stoppered with a bromobutyl rubber closure sealed with an aluminum flip-off seal and plastic ...

Special precautions for disposal and other handling

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

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

Date of first authorization / renewal of the authorization

Date of first authorisation: 9 September 2002 Date of latest renewal: 24 July 2012

Date of revision of the text

07/2012