ZIREX Film-coated tablet
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Περιεχόμενα
1. Name of the medicinal product
Zirex 10 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg cetirizine dihydrochloride. <u>Excipient with known effect:</u> This product contains 85.2 mg lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. White, capsule shaped, film-coated tablets, scored and embossed with R/R on the same side. The tablet can be divided into equal doses.
4.1. Therapeutic indications
Cetirizine 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 10 mg once daily (1 tablet). Special population Elderly subjects Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. Renal impairment ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, to hydroxyzine or to any piperazine derivatives. Patients with severe renal impairment at less than 10 mL/min ...
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 0.5 g/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. Fertility, 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 10 mg. 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
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 of ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antihistamines for systemic use <b>ATC code:</b> R06AE07 Mechanism of action Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral ...
5.2. Pharmacokinetic properties
Absorption The steady-state peak plasma concentrations is approximately 300 ng/mL and is achieved within 1.0 ± 0.5 h. The distribution of pharmacokinetic parameters such as peak plasma concentration (C ...
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
<u>Core:</u> Lactose monohydrate Maize starch Povidone Magnesium stearate <u>Film-coating:</u> Hypromellose Macrogol 400 Titanium dioxide Talc
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
PVC/Aluminium blisters Pack-sizes of 10, 30, 100 and 1000 film-coated tablets. PP containers with PE closure. Pack-size of 1000 film-coated tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
20193
9. Date of first authorization / renewal of the authorization
Date of first authorization: 28 February 2007 Date of latest renewal: 20 February 2013
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