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AVLOCLOR Tablet (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Avloclor 250 mg Tablets.

Qualitative and quantitative composition

Tablets containing 250 mg chloroquine phosphate, which is equivalent to 155 mg chloroquine base. For a full list of excipients, see section 6.1.

Pharmaceutical form

Tablets.

Therapeutic indications

Treatment of malaria. Prophylaxis and suppression of malaria. Treatment of amoebic hepatitis and abscess. Treatment of discoid and systemic lupus erythematosus. Treatment of rheumatoid arthritis.

Posology and method of administration

The dose should be taken after food. Treatment of malaria P. falciparum and P. malariae infections Adults: A single dose of four tablets, followed by two tablets six hours later and then two tablets a ...

Contraindications

Known hypersensitivity to chloroquine or any other ingredients of the formulation. Concomitant use with amiodarone (See section 4.5).

Special warnings and precautions for use

When used as malaria prophylaxis official guidelines and local information on prevalence of resistance to anti-malarial drugs should be taken into consideration. Chloroquine has been shown to cause severe ...

Interaction with other medicinal products and other forms of interaction

Drugs known to prolong QT interval / with potential to induce cardiac arrhythmia Chloroquine should be used with caution in patients receiving drugs known to prolong the QT interval e.g. Class IA and III ...

Pregnancy and lactation

Pregnancy Avloclor should not be used during pregnancy unless, in the judgement of the physician, potential benefit outweighs the risk. Short-term malaria prophylaxis Malaria in pregnant women increases ...

Effects on ability to drive and use machines

Defects in visual accommodation may occur on first taking Avloclor and patients should be warned regarding driving or operating machinery.

Undesirable effects

The adverse reactions which may occur at doses used in the prophylaxis or treatment of malaria are generally not of a serious nature. Where prolonged high dosage is required, i.e. in the treatment of rheumatoid ...

Overdose

Features Chloroquine is highly toxic in overdose and children are particularly susceptible. The chief symptoms of overdosage include circulatory collapse due to a potent cardiotoxic effect, respiratory ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiprotozoals, Antimalarials ATC code: P01BA01 The mode of action of chloroquine on plasmodia has not been fully elucidated. Chloroquine binds to and alters the properties of ...

Pharmacokinetic properties

Studies in volunteers using single doses of chloroquine phosphate equivalent to 300mg base have found peak plasma levels to be achieved within one to six hours. These levels are in the region of 54-102 ...

Preclinical safety data

Avloclor has been widely used for many years in clinical practice. There is no animal data which adds significant information relevant to the prescriber, to that covered elsewhere in this document.

List of excipients

Magnesium stearate (E572) Maize starch

Incompatibilities

None have been reported or are known.

Shelf life

5 years.

Special precautions for storage

Do not store above 30°C. Protect from light and moisture.

Nature and contents of container

HDPE bottle of 100s and PVC/Aluminium Foil Blister Pack of 20s

Special precautions for disposal and other handling

No special instructions.

Marketing authorization holder

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom

Marketing authorization number(s)

PL 16853/0143

Date of first authorization / renewal of the authorization

18/06/2000 / 03/06/2005

Date of revision of the text

03/10/2016

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