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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Ilaxten 20 mg tablets (2012)

Εκδότης

Εκδότης A.Menarini Pharma U.K. S.R.L.
Διεύθυνση Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH
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Περιεχόμενα

Name of the medicinal product

Ilaxten 20 mg tablets.

Qualitative and quantitative composition

Each tablet contains 20 mg of bilastine. For a full list of excipients, see section 6.1

Pharmaceutical form

Tablet. Oval biconvex scored white tablets. The score line is only to facilitate breaking for ease of ...

Therapeutic indications

Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.

Posology and method of administration

Route of administration: Oral use. Adults and adolescents (12 years of age and over) 20 mg (1 tablet) ...

Contraindications

Hypersensitivity to the active substance bilastine or to any of the excipients.

Special warnings and precautions for use

Efficacy and safety of bilastine in children under 12 years of age have not been established. In patients ...

Interaction with other medicinal products and other forms of interaction

Interaction with food: Food significantly reduces the oral bioavailability of bilastine by 30%. Interaction ...

Fertility, pregnancy and lactation

Fertility There are no or limited amount of clinical data. A study in rats did not indicate any negative ...

Effects on ability to drive and use machines

A study performed to assess the effects of bilastine on the ability to drive demonstrated that treatment ...

Undesirable effects

The number of adverse events experienced by patients suffering from allergic rhinoconjunctivitis or chronic ...

Overdose

Information regarding acute overdose is limited to experience from clinical trials conducted during the ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antihistamines for systemic use, other antihistamines for systemic use ATC ...

Pharmacokinetic properties

Absorption Bilastine is rapidly absorbed after oral administration with a time to maximum plasma concentration ...

Preclinical safety data

Non-clinical data with Bilastine reveal no special hazard for humans based on conventional studies of ...

List of excipients

Cellulose, microcrystalline Sodium Starch Glycolate (Type A) (derived from potato) Silica, colloidal ...

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

The drug product is packaged in a blister, consisting of two parts: laminate, consisting of oriented ...

Special precautions for disposal and other handling

No special requirements. Any unused product or waste material should be disposed of in accordance with ...

Marketing authorization holder

Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare L-1611 Luxembourg Luxembourg ...

Marketing authorization number(s)

PL 16239/0034

Date of first authorization / renewal of the authorization

08/10/10

Date of revision of the text

January 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.