DROPIZOL Oral drops, solution (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Dropizol 10 mg/ml oral drops, solution.
Qualitative and quantitative composition
1 ml of oral liquid contains 1 ml of tincture from Papaver somniferum L., succus siccum (Opium, raw) corresponding to 10 mg of morphine. 1 drop contains 50 mg opium tincture corresponding to 0.5 mg (10 ...
Pharmaceutical form
Oral drops, solution. <u>Appearance:</u> dark, reddish brown liquid.
Therapeutic indications
Dropizol is indicated for severe diarrhoea such as diarrhoea caused by cytostatic medication, radiation or neuroendocrine tumours when use of other anti-diarrhoea treatments have not given sufficient effect. ...
Posology and method of administration
Posology Adults 5–10 drops, 2–3 times daily. Individual doses should not exceed 1 ml, and the total daily dose should not exceed 6 ml. The posology should be individualized taking into account the patient ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Opiate dependency. Glaucoma. Severe hepatic or renal impairment. Delirium tremens. Severe head trauma. Risk of ...
Special warnings and precautions for use
Dropizol should only be used following investigations of the etiology causing the symptoms and when first-line treatment has not given adequate results. Dropizol drops should be used with caution in the ...
Interaction with other medicinal products and other forms of interaction
Reduced consciousness and respiratory depression is potentiated by ethanol, hypnotics, general anaesthetics (e.g. barbiturates), MAO inhibitors and psychotropic drugs with a sedative action (e.g. fentiazines), ...
Fertility, pregnancy and lactation
Pregnancy Should be used with caution in pregnant women. Should not be used during the third trimester due to drowsiness and respiratory depression or withdrawal symptoms in the neonate. Breastfeeding ...
Effects on ability to drive and use machines
Due to its undesirable effects, Dropizol may have a major influence on the ability to drive and use machines.
Undesirable effects
Cardiac disorders Not known (cannot be estimated from the available data): Tachycardia, bradycardia Nervous system disorders Very common (≥1/10): Drowsiness Common (≥1/100 to <1/10): Dizziness Not known ...
Overdose
Morphine toxicity. Lethal doses are primarily determined by the morphine content. Symptoms: Depressed level of consciousness increasing to coma. Respiratory depression (apnoea).
Pharmacodynamic properties
Pharmacotherapeutic group: Antipropulsives ATC code: A07DA02 The constipating effect is caused by inhibition of the intestines' peristalsis. Opium alkaloids (opioids and isoquinoline derivatives) induce ...
Pharmacokinetic properties
Is absorbed from the gastrointestinal tract and is eliminated primarily as metabolites excreted in the urine. The duration of action is 3 to 4 hours.
Preclinical safety data
Studies have indicated an association between regular use of opium and increased risk of gastric adenocarcinoma and cancers in the oesophagus, larynx, bladder and lung. The mechanism of this association ...
List of excipients
Ethanol 96% v/v Purified water
Incompatibilities
Not applicable.
Shelf life
30 months. 4 weeks after the bottle has been opened (in-use stability).
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Brown glass bottle with a white LDPE dropper and white polypropylene (PP) childproof closure. Pack sizes of 1 10 ml, 3 10 ml and 10 10 ml. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pharmanovia A/S, Jægersborg Allé 164, DK-2820 Gentofte, Denmark, Tel: +45 3333 7633, Fax: +45 3332 3107, e-mail: info@pharmanovia.com
Marketing authorization number(s)
PL 41284/0003
Date of first authorization / renewal of the authorization
14/09/2017
Date of revision of the text
14/09/2017
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