SPC, UK: InductOs 12 mg kit for implant
||Building 9 –Croxley Green Business Park, Watford, Hertfordshire, WD18 8WW
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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 ...
Kit for implant. The kit consists of a white powder for solution, a clear colourless solvent and a white ...
InductOs is indicated for single-level (L4 – S1) anterior lumbar spine fusion as a substitute for autogenous ...
Posology and method of administration
InductOs should be used by an appropriately qualified surgeon. Posology The directions for preparation ...
InductOs is contraindicated for patients with: Hypersensitivity to the active substance or to any of ...
Special warnings and precautions for use
Failure to follow the product preparation instructions for InductOs may compromise its safety and effectiveness. ...
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 ...
Pregnancy and lactation
Pregnancy and women of childbearing potential There are no adequate data from the use of dibotermin alfa ...
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 ...
Summary of the safety profile The most common adverse reactions related to the use of InductOs were neuralgia ...
Use of InductOs in patients undergoing cervical spine surgery in concentrations or amounts greater than ...
Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bone Morphogenetic Proteins; ATC code: ...
InductOs is active at the site of implantation. In two exploratory studies, pre- and post-surgery serum ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans on conventional studies of pharmacology, acute ...
List of excipients
Powder: Sucrose Glycine Glutamic acid Sodium chloride Polysorbate 80 Sodium hydroxide Solvent: Water ...
This medicinal product must not be mixed with other medicinal products, except those mentioned in section ...
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 ...
Special precautions for disposal and other handling
InductOs is prepared immediately prior to use. Dibotermin alfa must be used only with the accompanying ...
Marketing authorization holder
Medtronic BioPharma B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands tel +31 (0) 45 566 8000 ...
Marketing authorization number(s)
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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί
πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.