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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Riamet 20/120mg tablets (2011)

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

Riamet 20 mg/120 mg tablets.

Qualitative and quantitative composition

One tablet contains 20 mg artemether and 120 mg lumefantrine. For a full list of excipients, see section ...

Pharmaceutical form

Tablet. Light yellow, round tablet with “NC” debossed on one side and “CG” on the other.

Therapeutic indications

Riamet is indicated for the treatment of acute uncomplicated Plasmodium falciparum malaria in adult, ...

Posology and method of administration

Tablets for oral administration. To increase absorption, Riamet should be taken with food or a milky ...

Contraindications

Riamet is contraindicated in: Patients with known hypersensitivity to the active substances or to any ...

Special warnings and precautions for use

Riamet must not be used in the first trimester of pregnancy in situations where other suitable and effective ...

Interaction with other medicinal products and other forms of interaction

Interaction with other antimalarials (see section 4.4) A drug interaction study with Riamet in man involved ...

Pregnancy and lactation

Pregnancy There is insufficient data from the use of artemether and lumefantrine in pregnant women. Based ...

Effects on ability to drive and use machines

Patients receiving Riamet should be warned that dizziness or fatigue/asthenia may occur in which case ...

Undesirable effects

The safety of Riamet has been evaluated in 20 clinical trials with more than 3500 patients. A total of ...

Overdose

In cases of suspected overdosage symptomatic and supportive therapy should be given as appropriate, which ...

Pharmacodynamic properties

Pharmacotherapeutic group: antimalarials, blood schizontocide ATC code: P01 BF01 Pharmacodynamic effects ...

Pharmacokinetic properties

Pharmacokinetic characterisation of Riamet is limited by the lack of an intravenous formulation, and ...

Preclinical safety data

General toxicity The main changes observed in repeat-dose toxicity studies were associated with the expected ...

List of excipients

Polysorbate 80 Hypromellose Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

PVC/PE/PVDC/aluminium blisters. Packs of 24. No specific pack for the treatment of children and infants ...

Special precautions for disposal and other handling

For the treatment of children and infants, the 24-tablets pack should be prescribed. The prescriber and ...

Marketing authorization holder

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

Marketing authorization number(s)

PL 00101/0566

Date of first authorization / renewal of the authorization

30 November 1999 / 29 November 2009

Date of revision of the text

18 October 2011
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.