RUPATADINE Oral solution (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Rupatadine 1 mg/ml oral solution.
Qualitative and quantitative composition
Each ml of oral solution contains: 1 mg of rupatadine (as fumarate). Excipients: Sucrose 300 mg/ml Methyl Parahydroxybenzoate (E218) 1.00 mg/ml For a full list of excipients, see section 6.1.
Pharmaceutical form
Oral solution. Clear yellow solution.
Therapeutic indications
Rupafin 1 mg/ml oral solution is indicated for the symptomatic treatment of: Allergic rhinitis (including persistent allergic rhinitis) in children aged 2 to 11 years (see section 5.1). Urticaria in children ...
Posology and method of administration
Children aged 2 to 11 years. Dosage in children weighing equal or more than 25 kg: 5 ml (5 mg of rupatadine) of oral solution once a day, with or without food. Dosage in children weighing equal or more ...
Contraindications
Hypersensitivity to rupatadine or to any of the excipients.
Special warnings and precautions for use
Safety of rupatadine oral solution in children aged less than 2 years has not been established. The combination of rupatadine with potent CYP3A4 inhibitors should be avoided and with moderate CYP3A4 inhibitors ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed in children with rupatadine oral solution. Interaction studies have only been performed in adults and adolescents (over 12 years of age) with rupatadine 10 mg ...
Fertility, pregnancy and lactation
Pregnancy Data on a limited number (2) of exposed pregnancies indicate no adverse effects of rupatadine on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological ...
Effects on ability to drive and use machines
Rupatadine 10 mg had no influence on the ability to drive and use machines in a performed clinical trial. Nevertheless, care should be taken before driving or using machinery until the patients individual ...
Undesirable effects
Clinical trials with rupatadine oral solution in children aged 2-11 years included 626 patients. From these, 147 patients were treated with rupatadine 2.5 mg, 159 patients were treated with rupatadine ...
Overdose
No case of overdose has been reported in adults and children. In a clinical safety study in adults rupatadine at daily dose of 100 mg during 6 days was well tolerated. The most common adverse reaction ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antihistamines for systemic use ATC code: R06AX28 Rupatadine is a second-generation antihistamine, long-acting histamine antagonist, with selective peripheral H1-receptor ...
Pharmacokinetic properties
Paediatric population In the subgroup of children 2-5 and 6-11 years old, rupatadine was rapidly absorbed and the mean C<sub>max</sub> was of 1.9 and 2.5 ng/ml after repeated oral dose, respectively. In ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential. More than 100 times the clinically ...
List of excipients
Propylene glycol Citric acid anhydrous Disodium phosphate anhydrous Saccharin sodium Sucrose Methylparahydroxybenzoate (E218) Quinoline yellow (E104) Banana flavour (Blend of flavouring substances, flavouring ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 30 months. The shelf life after first opening is the same as the expiry date placed on the box and the bottle.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
120 ml amber polyethylene terephthalate (PET) bottle with low density polyethylene (LDPE) perforated stopper closed with yellow high density polyethylene (HDPE) child-resistant closure in a cardboard box ...
Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
J. Uriach y Compañia, S.A., Av. Camí Reial, 51-57, 08184 Palau-solità i Plegamans (Spain), Telephone: +34 93 864 96 92, Fax: +34 93 864 66 06
Marketing authorization number(s)
PL11906/0009
Date of first authorization / renewal of the authorization
27/03/2012
Date of revision of the text
24/06/2018
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