AVOMINE Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Avomine Tablets 25 mg.
2. Qualitative and quantitative composition
Promethazine theoclate. Avomine tablets contain 25 mg of promethazine theoclate. <u>Excipients with known effect:</u> lactose monohydrate and wheat starch. For the full list of excipients, see Section ...
3. Pharmaceutical form
Tablets, 25 mg (white, scored).
4.1. Therapeutic indications
Prevention and treatment of motion sickness.
4.2. Posology and method of administration
Adults Travel sickness Prevention <u>Long journeys:</u> 1 tablet each night at bedtime commencing on the night before travelling. <u>Short journeys:</u> 1 tablet to be taken 1 to 2 hours before the journey ...
4.3. Contraindications
Avomine should not be used in patients who are in a coma or suffering from CNS depression of any cause. It must not be given to patients hypersensitive to promethazine, phenothiazines or to any of the ...
4.4. Special warnings and precautions for use
Avomine may cause mild and temporary confusion or disorientation in certain individuals. Avomine may thicken or dry lung secretions and impair expectoration, it should therefore be used with caution in ...
4.5. Interaction with other medicinal products and other forms of interaction
Care is necessary with patients who take anticholinergic agents, tricyclic antidepressants, sedatives or hypnotics, as such agents are enhanced by Avomine. Alcohol should be avoided during treatment. Combination ...
4.6. Fertility, pregnancy and lactation
Pregnancy (Category C) When given in high doses during late pregnancy, phenothiazines have caused prolonged extrapyramidal disturbances in the child. There is inadequate evidence of safety of the drug ...
4.7. Effects on ability to drive and use machines
Avomine considerably affects the ability to drive a vehicle and operate machines.
4.8. Undesirable effects
More common reactions <u>Gastrointestinal disorders:</u> Dry mouth, epigastric distress, loss of appetite, nausea, vomiting, diarrhoea, constipation. <u>Nervous system disorders:</u> Sedation, restlessness, ...
4.9. Overdose
Overdose Symptoms Symptoms of severe overdosage are variable. The chief symptom of acute poisoning from the ingestion of promethazine is unconsciousness which is, however, commonly delayed. Symptoms are ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antihistamines for systemic use <b>ATC code:</b> R06AD02 Mechanism of Action Antihistamine, antinauseant.
5.2. Pharmacokinetic properties
No data available.
5.3. Preclinical safety data
No data available.
6.1. List of excipients
Dextrin Lactose monohydrate Magnesium stearate Purified talc Starch
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months from date of manufacture.
6.4. Special precautions for storage
Store below 30°C. Protect from light.
6.5. Nature and contents of container
Blister packs containing 10 tablets.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
sanofi-aventis new zealand limited, Level 8, James and Wells Tower, 56 Cawley Street, Ellerslie, Auckland, Telephone: (09) 580 1810
9. Date of first authorization / renewal of the authorization
Date of first approval: 31 December 1969
10. Date of revision of the text
05 October 2018
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