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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

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Mimpara (2012)

Εκδότης

Εκδότης Amgen Ltd
Διεύθυνση 240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD
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

Mimpara® 30 mg film-coated tablets. Mimpara® 60 mg film-coated tablets. Mimpara® 90 mg film-coated tablets. ...

Qualitative and quantitative composition

Each tablet contains 30 mg cinacalcet (as hydrochloride). Each tablet contains 60 mg cinacalcet (as hydrochloride). ...

Pharmaceutical form

Film-coated tablet (tablet). Light green, oval, film-coated tablet marked “AMG” on one side and “30” ...

Therapeutic indications

Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance ...

Posology and method of administration

Secondary hyperparathyroidism Adults and elderly (> 65 years): The recommended starting dose for adults ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Seizures In clinical studies seizures were observed in 1.4% of Mimpara treated patients and 0.7% of placebo-treated ...

Interaction with other medicinal products and other forms of interaction

Effect of other medications on cinacalcet Cinacalcet is metabolised in part by the enzyme CYP3A4. Co-administration ...

Fertility, pregnancy and lactation

Pregnancy There are no clinical data from the use of cinacalcet in pregnant women. Animal studies do ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, certain ...

Undesirable effects

Secondary hyperparathyroidism Data presented from controlled studies include 656 patients who received ...

Overdose

Doses titrated up to 300 mg once daily have been safely administered to patients receiving dialysis. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents ATC code: H05BX01 Mechanism of ...

Pharmacokinetic properties

Absorption After oral administration of Mimpara, maximum plasma cinacalcet concentration is achieved ...

Preclinical safety data

Cinacalcet was not teratogenic in rabbits when given at a dose of 0.4 times, on an AUC basis, the maximum ...

List of excipients

Tablet core: Pre-gelatinised starch (maize) Microcrystalline cellulose Povidone Crospovidone Magnesium ...

Incompatibilities

Not applicable.

Shelf life

Blister: 4 years. Bottle: 4 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Aclar/PVC/PVAc/Aluminium blister containing 14 tablets. Pack sizes of 1 blister (14 tablets), 2 blisters ...

Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed ...

Marketing authorization holder

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

Marketing authorization number(s)

EU/1/04/292/001 – carton with 14 tablets. EU/1/04/292/002 – carton with 28 tablets. EU/1/04/292/003 – ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 October 2004 Date of latest renewal: 23 September 2009

Date of revision of the text

21 February 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.