AVLOCLOR Tablet (2016)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
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
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: