XYZAL Oral solution (2019)
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Περιεχόμενα
Name of the medicinal product
Xyzal 0.5 mg/ml oral solution.
Qualitative and quantitative composition
1 ml of oral solution contains 0.5 mg levocetirizine dihydrochloride. Excipients with known effect: 0.675 mg methyl parahydroxybenzoate/ml 0.075 mg propyl parahydroxybenzoate/ml 0.4 g maltitol liquid/ml ...
Pharmaceutical form
Oral solution. Clear and colourless solution.
Therapeutic indications
Xyzal 0.5 mg/ml oral solution is indicated for symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 2 years and above.
Posology and method of administration
Posology Adults and adolescents 12 years and above: The daily recommended dose is 5 mg (10 ml of solution). Elderly Adjustment of the dose is recommended in elderly patients with moderate to severe renal ...
Contraindications
Hypersensitivity to the active substance, to cetirizine, to hydroxyzine, to any other piperazine derivatives or to any of the other excipients listed in section 6.1. Severe renal impairment at less than ...
Special warnings and precautions for use
Precaution is recommended with concurrent intake of alcohol (see section 4.5). Xyzal contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with levocetirizine (including no studies with CYP3A4 inducers); studies with the racemate compound cetirizine demonstrated that there were no clinically relevant ...
Pregnancy and lactation
Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of levocetirizine in pregnant women. However, for cetirizine, the racemate of levocetirizine, a large amount ...
Effects on ability to drive and use machines
Comparative clinical trials have revealed no evidence that levocetirizine at the recommended dose impairs mental alertness, reactivity or the ability to drive. Nevertheless, some patients could experience ...
Undesirable effects
Clinical studies Adults and adolescents above 12 years of age In therapeutic studies in women and men aged 12 to 71 years, 15.1% of the patients in the levocetirizine 5 mg group had at least one adverse ...
Overdose
Symptoms Symptoms of overdose may include drowsiness in adults. In children, agitation and restlessness may initially occur, followed by drowsiness. Management of overdoses There is no known specific antidote ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antihistamines for systemic use, piperazine derivatives ATC code: R06AE09 Mechanism of action Levocetirizine, the enantiomer of cetirizine, is a potent and selective antagonist ...
Pharmacokinetic properties
The pharmacokinetics of levocetirizine are linear with dose- and time-independent with low inter-subject variability. The pharmacokinetic profile is the same when given as the single enantiomer or when ...
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.
List of excipients
Sodium acetate trihydrate (for pH adjustment) Glacial acetic acid (for pH adjustment) Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Glycerol 85% Maltitol liquid (E965) Saccharin sodium ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years. After first opening: 3 months.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Type III amber glass bottle closed with a white polypropylene child-resistant closure in a cardboard box also containing a 10 ml oral syringe graduated at 0.25 ml (polyethylene, polystyrene). Pack sizes: ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE
Marketing authorization number(s)
PL 00039/731
Date of first authorization / renewal of the authorization
Date of first authorisation: 21-Mar-2007 Date of latest renewal: 06-Oct-2014
Date of revision of the text
27/03/2019
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