Λογότυπο www.galinos.gr Beta
 

Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

Ακολουθήστε μας Λογότυπο Facebook Λογότυπο Twitter

Αναζήτηση σε 63811 καταχωρήσεις
Εικονίδιο αναζήτησης

Βιβλιογραφική αναφορά

Προτάσεις

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

Εκδότης

Εκδότης Medtronic Limited
Διεύθυνση Building 9 –Croxley Green Business Park, Watford, Hertfordshire, WD18 8WW
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

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 ...

Pharmaceutical form

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

Therapeutic indications

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 ...

Contraindications

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 ...

Undesirable effects

Summary of the safety profile The most common adverse reactions related to the use of InductOs were neuralgia ...

Overdose

Use of InductOs in patients undergoing cervical spine surgery in concentrations or amounts greater than ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bone Morphogenetic Proteins; ATC code: ...

Pharmacokinetic properties

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 ...

Incompatibilities

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

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 ...

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)

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
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.