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EURARTESIM Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Eurartesim 320 mg/40 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 40 mg artenimol (artenimol). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet (tablet). White oblong biconvex film-coated tablet (dimension 16x8mm/thickness 5.5mm) with a break-line and marked on one side with two σ letters. The tablet can be divided into equal ...

4.1. Therapeutic indications

Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, adolescents, children and infants 6 months and over and weighing 5 kg or more. Consideration should be ...

4.2. Posology and method of administration

Posology Eurartesim should be administered over three consecutive days for a total of three doses taken at the same time each day. Dosing should be based on body weight as shown in the table below. Body ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Severe malaria according to WHO definition. Family history of sudden death or of congenital prolongation of ...

4.4. Special warnings and precautions for use

Eurartesim should not be used to treat severe falciparum malaria (see section 4.3) and, due to insufficient data, should not be used to treat malaria due to Plasmodium vivax, Plasmodium malariae or <em> ...

4.5. Interaction with other medicinal products and other forms of interaction

Eurartesim is contraindicated in patients already taking other medicinal products that are known to prolong the QTc interval due to the risk of a pharmacodynamic interaction leading to an additive effect ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are only limited (n=3) amount of data from the use of artenimol/piperaquine during the 1<sup>st</sup> trimester of pregnancy. Based on animal data, Eurartesim is suspected to cause serious ...

4.7. Effects on ability to drive and use machines

Adverse event data collected in clinical trials suggest that Eurartesim has no influence on the ability to drive and operate machines once the patient has recovered from the acute infection.

4.8. Undesirable effects

Summary of the safety profile The safety of Eurartesim has been evaluated in two phase III open-label studies involving 1,239 paediatric patients up to 18 years and 566 adult patients >18 years treated ...

4.9. Overdose

In clinical trials, nine patients received double the cumulative intended dose of Eurartesim. The safety profile of these patients did not differ from that of patients receiving the recommended dose, with ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Antiprotozoals, antimalarials, Artemisinin and derivatives, combinations <b>ATC code:</b> P01BF05 Pharmacodynamic effects Artenimol is able to reach high concentrations ...

5.2. Pharmacokinetic properties

Pharmacokinetic profiles of artenimol and piperaquine have been investigated in animal models and in different human populations (healthy volunteers, adult patients and paediatric patients). Absorption ...

5.3. Preclinical safety data

General toxicity Literature data concerning chronic toxicity of piperaquine in dogs and monkeys indicate some hepatotoxicity and mild reversible depression of total white cell and neutrophil counts. The ...

6.1. List of excipients

<u>Tablet core:</u> Pre-gelatinised starch Dextrin Hypromellose (E464) Croscarmellose sodium Magnesium stearate (E572) <u>Film coating:</u> Hypromellose (E464) Titanium dioxide (E171) Macrogol 400

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

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

6.5. Nature and contents of container

Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9 or 12 tablets.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Alfasigma S.p.A., Via Ragazzi del '99, n. 5, 40133 Bologna, Italy Tel: +39 051 6489602 Fax: +39 051 388689 Email: antonietta.pazardjiklian@alfasigma.com

8. Marketing authorization number(s)

EU/1/11/716/001 EU/1/11/716/002 EU/1/11/716/003 EU/1/11/716/004

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 27 October 2011 Date of latest renewal: 09 September 2016

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