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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Prolia (2012)

Εκδότης

Εκδότης Amgen Ltd
Διεύθυνση 240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD
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Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Prolia® 60 mg solution for injection in a pre-filled syringe.

Qualitative and quantitative composition

Each pre-filled syringe contains 60 mg of denosumab in 1 ml of solution (60 mg/ml). Denosumab is a human ...

Pharmaceutical form

Solution for injection (injection). Clear, colourless to slightly yellow solution.

Therapeutic indications

Treatment of osteoporosis in postmenopausal women at increased risk of fractures. Prolia significantly ...

Posology and method of administration

Posology The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once ...

Contraindications

Hypocalcaemia (see section 4.4). Hypersensitivity to the active substance or to any of the excipients ...

Special warnings and precautions for use

Calcium and Vitamin D supplementation Adequate intake of calcium and vitamin D is important in all patients. ...

Interaction with other medicinal products and other forms of interaction

In an interaction study, Prolia did not affect the pharmacokinetics of midazolam, which is metabolized ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of Prolia in pregnant women. Reproductive toxicity ...

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile The overall safety profile of Prolia was similar in postmenopausal women ...

Overdose

There is no experience with overdose in clinical studies. Denosumab has been administered in clinical ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for the treatment of bone diseases – Other drugs affecting bone structure ...

Pharmacokinetic properties

Absorption Following subcutaneous administration of a 1.0 mg/kg dose, which approximates the approved ...

Preclinical safety data

In single and repeated dose toxicity studies in cynomolgus monkeys, denosumab doses resulting in 100 ...

List of excipients

Acetic acid, glacial* Sodium hydroxide (for pH adjustment)* Sorbitol (E420) Polysorbate 20 Water for ...

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...

Shelf life

3 years. Prolia may be stored at room temperature (up to 25°C) for up to 30 days in the original container. ...

Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in ...

Nature and contents of container

One ml solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge ...

Special precautions for disposal and other handling

Before administration, the Prolia solution should be inspected. Do not inject the solution if it contains ...

Marketing authorization holder

Amgen Europe B.V. Minervum 7061 NL-4817 ZK Breda The Netherlands

Marketing authorization number(s)

EU/1/10/618/001 EU/1/10/618/002 EU/1/10/618/003

Date of first authorization / renewal of the authorization

26 May 2010

Date of revision of the text

15 November 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.