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

Προτάσεις

SPC, UK: Rasilez tablets 150 mg (2012)

Εκδότης

Εκδότης Novartis Pharmaceuticals UK Ltd
Διεύθυνση Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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Περιεχόμενα

Name of the medicinal product

Rasilez 150 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 150 mg aliskiren (as hemifumarate). For the full list of excipients, ...

Pharmaceutical form

Film-coated tablet. Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other ...

Therapeutic indications

Treatment of essential hypertension in adults.

Posology and method of administration

Posology The recommended dose of Rasilez is 150 mg once daily. In patients whose blood pressure is not ...

Contraindications

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

Special warnings and precautions for use

General In the event of severe and persistent diarrhoea, Rasilez therapy should be stopped (see section ...

Interaction with other medicinal products and other forms of interaction

Contraindicated (see section 4.3) Dual RAAS blockade: The combination of aliskiren with ARBs or ACEIs ...

Fertility, pregnancy and lactation

Pregnancy There are no data on the use of aliskiren in pregnant women. Rasilez was not teratogenic in ...

Effects on ability to drive and use machines

Rasilez has negligible influence on the ability to drive and use machines. However, when driving vehicles ...

Undesirable effects

Summary of the safety profile Rasilez has been evaluated for safety in more than 7,800 patients, including ...

Overdose

Symptoms Limited data are available related to overdose in humans. The most likely manifestations of ...

Pharmacodynamic properties

Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; renin inhibitor ATC code: C09XA02 ...

Pharmacokinetic properties

Absorption Following oral absorption, peak plasma concentrations of aliskiren are reached after 1-3 hours. ...

Preclinical safety data

Carcinogenic potential was assessed in a 2-year rat study and a 6-month transgenic mouse study. No carcinogenic ...

List of excipients

Crospovidone Magnesium stearate Cellulose, microcrystalline Povidone Silica, colloidal anhydrous Hypromellose ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from moisture.

Nature and contents of container

PA/Alu/PVC – Alu blisters: Packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets. Packs containing ...

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

Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom

Marketing authorization number(s)

EU/1/07/405/001-010 EU/1/07/405/021-030

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 August 2007 Date of latest renewal: 24 August 2012

Date of revision of the text

24 August 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.