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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: INLYTA (2013)

Εκδότης

Εκδότης Pfizer Limited
Διεύθυνση Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
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

Inlyta 1 mg film-coated tablets. Inlyta 3 mg film-coated tablets. Inlyta 5 mg film-coated tablets. Inlyta ...

Qualitative and quantitative composition

1 mg film-coated tablets: Each film-coated tablet contains 1 mg of axitinib. 3 mg film-coated tablets: ...

Pharmaceutical form

Film-coated tablet (tablet). 1 mg: Red oval film-coated tablet debossed with “Pfizer” on one side and ...

Therapeutic indications

Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after ...

Posology and method of administration

Treatment with Inlyta should be conducted by a physician experienced in the use of anticancer therapies. ...

Contraindications

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

Special warnings and precautions for use

Specific safety events should be monitored before initiation of, and periodically throughout, treatment ...

Interaction with other medicinal products and other forms of interaction

In vitro data indicate that axitinib is metabolised primarily by CYP3A4/5 and, to a lesser extent, CYP1A2, ...

Fertility, pregnancy and lactation

Pregnancy There are no data regarding the use of axitinib in pregnant women. Based on the pharmacological ...

Effects on ability to drive and use machines

Axitinib has a minor influence on the ability to drive and use machines. Patients should be advised that ...

Undesirable effects

Summary of the safety profile The most important serious adverse reactions reported in patients receiving ...

Overdose

There is no specific treatment for axitinib overdose. In a controlled clinical study with axitinib for ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE17 Mechanism ...

Pharmacokinetic properties

After oral administration of axitinib tablets, the mean absolute bioavailability is 58% compared to intravenous ...

Preclinical safety data

Repeat dose toxicity Major toxicity findings in mice and dogs following repeated dosing for up to 9 months ...

List of excipients

Tablet core: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

1 mg, 3 mg, 5 mg, 7 mg film-coated tablets: Aluminium/aluminium blister containing 14 film-coated tablets. ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. ...

Marketing authorization holder

Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom

Marketing authorization number(s)

EU/1/12/777/001 EU/1/12/777/002 EU/1/12/777/003 EU/1/12/777/004 EU/1/12/777/005 EU/1/12/777/006 EU/1/12/777/007 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 3 September 2012

Date of revision of the text

08/2013
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.