RIAMET Tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Riamet 20 mg/120 mg tablets.
2. Qualitative and quantitative composition
One tablet contains 20 mg artemether and 120 mg lumefantrine. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Light yellow, round tablet with NC debossed on one side and CG on the other.
4.1. Therapeutic indications
Riamet is indicated for the treatment of acute uncomplicated <em>Plasmodium falciparum</em> malaria in adults, children and infants of 5 kg and above. Consideration should be given to official guidance ...
4.2. Posology and method of administration
Posology Adults and children weighing 35 kg and above For patients 12 years of age and above and 35 kg body weight and above, a course of treatment comprises six doses of four tablets i.e. total of 24 ...
4.3. Contraindications
Riamet is contraindicated in: patients with known hypersensitivity to the active substances or to any of the excipients listed in section 6.1. patients with severe malaria according to WHO definition*. ...
4.4. Special warnings and precautions for use
Riamet is not recommended during the first trimester of pregnancy in situations where other suitable and effective antimalarials are available (see section 4.6). Riamet has not been evaluated for the treatment ...
4.5. Interaction with other medicinal products and other forms of interaction
Contraindications of concomitant use Interaction with drugs that are known to prolong the QTc interval Riamet is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential Women using oral, transdermal patch, or other systemic hormonal contraceptives should be advised to use an additional non-hormonal method of birth control for about one ...
4.7. Effects on ability to drive and use machines
Patients receiving Riamet should be warned that dizziness or fatigue/asthenia may occur in which case they should not drive or use machines.
4.8. Undesirable effects
The safety of Riamet has been evaluated in 20 clinical trials with more than 3500 patients. A total of 1810 adults and adolescents above 12 years of age as well as 1788 infants and children of 12 years ...
4.9. Overdose
In cases of suspected overdosage symptomatic and supportive therapy should be given as appropriate, which should include ECG and blood potassium monitoring.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antimalarials, blood schizontocide <b>ATC code:</b> P01BF01 Pharmacodynamic effects Riamet comprises a fixed ratio of 1:6 parts of artemether and lumefantrine, respectively. ...
5.2. Pharmacokinetic properties
Pharmacokinetic characterisation of Riamet is limited by the lack of an intravenous formulation, and the very high interand intra-subject variability of artemether and lumefantrine plasma concentrations ...
5.3. Preclinical safety data
General toxicity The main changes observed in repeat-dose toxicity studies were associated with the expected pharmacological action on erythrocytes, accompanied by responsive secondary haematopoiesis. ...
6.1. List of excipients
Polysorbate 80 Hypromellose Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
PVC/PE/PVDC/aluminium blisters. Packs of 24. No specific pack for the treatment of children and infants is available. The 24-tablets pack should be used for this patient population and the parent or care ...
6.6. Special precautions for disposal and other handling
For the treatment of children and infants, the 24-tablets pack should be prescribed. The prescriber and pharmacist should instruct the parent or care giver on the posology for their child and that a variable ...
7. Marketing authorization holder
Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
8. Marketing authorization number(s)
PL 23860/0024
9. Date of first authorization / renewal of the authorization
30 November 1999 / 29 November 2009
10. Date of revision of the text
30 September 2021
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