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Actidose-Aqua Advance (2010)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Alliance Pharmaceuticals
Διεύθυνση :
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Δωρεάν εγγραφή

Name of the medicinal product

Actidose-Aqua Advance.

Qualitative and quantitative composition

Actidose-Aqua Advance contains 1.04 g of Activated Charcoal/5 ml.

Pharmaceutical form

Suspension for oral administration.

Therapeutic indications

For the emergency treatment of acute poisoning and drug overdosage where substances such as those listed in section 5.1 have been ingested. The list is not exhaustive and Actidose-Aqua Advance may be of ...

Posology and method of administration

The container should be shaken thoroughly prior to administration. If the dose of poison that has been ingested is known, a ratio of 10:1 (activated charcoal:toxin) may be used to determine the optimal ...

Contraindications

Use of Actidose-Aqua Advance is contra-indicated in persons who are not fully conscious.

Special warnings and precautions for use

Actidose-Aqua Advance is not recommended for patients who have ingested corrosive agents such as strong acids or alkalis since the activated charcoal may obscure endoscopic visualisation of oesophageal ...

Interaction with other medicinal products and other forms of interaction

Actidose-Aqua Advance will adsorb most medicaments and many other chemical substances. If a specific antidote is to be administered the likelihood of its adsorption by activated charcoal should be borne ...

Fertility, pregnancy and lactation

The safety of this medicinal product for use in human pregnancy has not been established. Experimental animal studies are insufficient to assess the safety with respect to the development of the embryo ...

Effects on ability to drive and use machines

None known.

Undesirable effects

Both the patient and health care professionals should be aware that Actidose-Aqua Advance will produce black stools. A laxative may be given concurrently to accelerate the removal of the activated charcoal-toxin ...

Overdose

Actidose-Aqua Advance is well tolerated and due to its lack of toxicity overdosage requiring treatment is unlikely. A laxative may be administered to enhance elimination of the product.

Pharmacodynamic properties

Activated charcoal has a high adsorptive capacity for a wide range of compounds including many of those which are most commonly encountered in deliberate and accidental poisoning. Substances adsorbed include ...

Pharmacokinetic properties

Activated charcoal is not absorbed from the gastrointestinal tract or subject to any metabolic processes. It is eliminated in the faeces.

Preclinical safety data

Activated charcoal is essentially inert pharmacologically and it would therefore be expected to be virtually devoid of toxicity, other than any ill effects arising from mechanical obstruction of the gut, ...

List of excipients

Sucrose Propylene glycol Glycerine Citric Acid Purified water

Incompatibilities

None known.

Shelf life

Two years.

Special precautions for storage

Store at 15 30°C. Do not refrigerate.

Nature and contents of container

Low density polyethylene bottles containing 120 ml. Low density polyethylene bottles containing 240 ml. Low density polyethylene tubes containing 120 ml.

Special precautions for disposal and other handling

Shake well before use.

Marketing authorization holder

Alliance Pharmaceuticals Ltd Avonbridge House 2 Bath Road Chippenham Wiltshire SN15 2BB UK

Marketing authorization number(s)

PL 16853/0119

Date of first authorization / renewal of the authorization

26 March 1996

Date of revision of the text

14th July 2010
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