CETRINE Film-coated tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Cetrine 10 mg Film-coated Tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg cetirizine dihydrochloride. <u>Excipients with known effect:</u> Also contains 81.8mg lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets. White, oblong film-coated tablet, scored on one side. The scoreline is to allow the tablet to be divided into equal halves.
4.1. Therapeutic indications
Cetrine is indicated in adults and paediatric patients 6 years and above: for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. for the relief of symptoms of chronic ...
4.2. Posology and method of administration
Posology Children aged from 6 to 12 years 5mg twice daily (a half a tablet twice daily). Adults and adolescents over 12 years of age 10 mg once daily (1 tablet). Elderly patients Data do not suggest that ...
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, to hydroxyzine or to any piperazine derivatives. Patients with severe renal impairment of less than 10ml/min creatinine ...
4.4. Special warnings and precautions for use
At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5g/L). Nevertheless, precaution is recommended if alcohol is taken concomitantly. ...
4.5. Interaction with other medicinal products and other forms of interaction
Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic ...
4.6. Pregnancy and lactation
Pregnancy For cetirizine prospectively collected data on pregnancy outcomes do not suggest potential for maternal or foetal/embryonic toxicity above background rates. Animal studies do not indicate direct ...
4.7. Effects on ability to drive and use machines
Objective measurements of driving ability, sleep latency and assembly line performance have not demonstrated any clinically relevant effects at the recommended dose of 10mg. However, patients who experience ...
4.8. Undesirable effects
Clinical Studies Overview Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache. In some ...
4.9. Overdose
a) Symptoms Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect. Adverse events reported after an intake ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antihistamines for systemic use. Piperazine derivatives <b>ATC code:</b> R06A E07: Antiallergic Agent Cetirizine, a human metabolite of hydroxyzine, is a potent and selective ...
5.2. Pharmacokinetic properties
The steady-state peak plasma concentrations is approximately 300ng/ml and is achieved within 1.0 ± 0.5h. No accumulation is observed for cetirizine following daily doses of 10mg for 10 days. The distribution ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
6.1. List of excipients
Lactose monohydrate Microcrystalline cellulose Silica, colloidal anhydrous Magnesium stearate <u>For film-coating:</u> Lactose monohydrate Titanium dioxide (E171) Hypromellose Macrogol 4000
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Cetrine 10 mg tablets are packed into PVC/Al strips and inserted into a carton. Cetrine 10 mg tablets are available in packs of 30 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Rowex Ltd, Bantry, Co. Cork, Ireland
8. Marketing authorization number(s)
PA0711/075/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 06 August 2004 Date of last renewal: 06 August 2009
10. Date of revision of the text
April 2019
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