VALOID Tablet (2018)
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Περιεχόμενα
1. Name of the medicinal product
Valoid 50 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 50mg of cyclizine hydrochloride. <u>Excipient with known effect:</u> Lactose (60mg/tablet). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White, biconvex, uncoated tablet, scored; coded T4A. The scoreline is to facilitate breaking for ease of swallowing and to divide into equal doses.
4.1. Therapeutic indications
Valoid is indicated in adults and children aged 6 years and over for the prevention and treatment of nausea and vomiting, including: Motion sickness. Nausea and vomiting caused by narcotic analgesics and ...
4.2. Posology and method of administration
Posology To prevent motion sickness Valoid Tablets should be taken about one to two hours before departure. Elderly There have been no specific studies of Valoid Tablets in the elderly. Experience has ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Cyclizine is contraindicated in the presence of acute alcohol intoxication. The anti-emetic properties of cyclizine ...
4.4. Special warnings and precautions for use
As with other anticholinergic agents, Valoid Tablets may precipitate incipient glaucoma and should be used with caution and appropriate monitoring in patients with glaucoma, urinary retention, obstructive ...
4.5. Interaction with other medicinal products and other forms of interaction
Valoid Tablets may have additive effects with alcohol and other central nervous system depressants e.g. hypnotics, tranquillisers, anaesthetics, antipsychotics, barbiturates. Valoid Tablets enhance the ...
4.6. Fertility, pregnancy and lactation
Pregnancy In the absence of any definitive human data, the use of Valoid in pregnancy is not advised. Breast-feeding Cyclizine is excreted in human milk, however, the amount has not been quantified Fertility ...
4.7. Effects on ability to drive and use machines
Studies designed to detect drowsiness did not reveal sedation in healthy adults who took a single oral therapeutic dose (50 mg) of cyclizine. Patients should not drive or operate machinery until they have ...
4.8. Undesirable effects
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: Very common: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 ...
4.9. Overdose
Symptoms Symptoms of acute toxicity from cyclizine arise from peripheral anticholinergic effects and effects on the central nervous system. Peripheral anticholinergic symptoms include dry mouth, nose and ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Piperazine derivatives <b>ATC Code:</b> R06AE03 Mechanism of action Cyclizine is a histamine H1 receptor antagonist of the piperazine class, which is characterised by ...
5.2. Pharmacokinetic properties
Absorption H<sub>1</sub>-blockers are well absorbed from the GI tract. Following oral administration effects develop within 30 minutes, are maximal within 1-2 hours and last, for cyclizine, for 4-6 hours. ...
5.3. Preclinical safety data
Mutagenicity Cyclizine was not mutagenic in a full Ames test, including use of S9-microsomes but can nitrosate in vitro to form mutagenic products. Carcinogenicity No long term studies have been conducted ...
6.1. List of excipients
Lactose monohydrate Potato starch Acacia Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
Amber glass or polyethylene bottles with polyethylene tamper-evident caps for pack size 100 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Amdipharm Limited,Temple Chambers, 3 Burlington Road, Dublin 4, Ireland
8. Marketing authorization number(s)
PA1142/001/002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1979 Date of last renewal: 01 April 2009
10. Date of revision of the text
July 2018
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