DASSELTA Film-coated tablet (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Dasselta 5 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 5 mg desloratadine. <u>Excipient with known effect:</u> Each film-coated tablet contains 16.15 mg lactose (as monohydrate). For the full list of excipients, see section ...
3. Pharmaceutical form
Film-coated tablet. Light blue, round, film-coated tablets with beveled edges (diameter: 6.5 mm, thickness: 2.3-3.5 mm).
4.1. Therapeutic indications
Dasselta is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: allergic rhinitis (see section 5.1), urticaria (see section 5.1).
4.2. Posology and method of administration
Posology Adults and adolescents (12 years of age and over) The recommended dose of Dasselta is one tablet once a day. Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week ...
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to loratadine.
4.4. Special warnings and precautions for use
In the case of severe renal insufficiency, Dasselta should be used with caution (see section 5.2). Desloratadine should be administered with caution in patients with medical or familial history of seizures, ...
4.5. Interaction with other medicinal products and other forms of interaction
No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1). Paediatric population Interaction ...
4.6. Fertility, pregnancy and lactation
Pregnancy A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/neonatal toxicity of desloratadine. Animal studies do not indicate direct or indirect ...
4.7. Effects on ability to drive and use machines
Desloratadine has no or negligible influence on the ability to drive and use machines based on clinical trials. Patients should be informed that most people do not experience drowsiness. Nevertheless, ...
4.8. Undesirable effects
Summary of the safety profile In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with ...
4.9. Overdose
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher. Treatment In the ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other antihistamines for systemic use <b>ATC code:</b> R06AX27 Mechanism of action Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral ...
5.2. Pharmacokinetic properties
Absorption Desloratadine plasma concentrations can be detected within 30 minutes of administration. Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal ...
5.3. Preclinical safety data
Desloratadine is the primary active metabolite of loratadine. Non-clinical studies conducted with desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in ...
6.1. List of excipients
<u>Tablet core:</u> Microcrystalline cellulose (E460) Hypromellose (E464) Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment) Maize starch Lactose monohydrate Talc ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years. Shelf life after first opening of the tablet container: 3 months.
6.4. Special precautions for storage
Store in the original package in order to protect from moisture.
6.5. Nature and contents of container
Blister (OPA/Alu/PVC//Alu): 7, 10, 20, 30, 50, 90 and 100 film-coated tablets, in a box. Tablet container (HDPE, volume 60 ml), PP closure with desiccant: 250 film-coated tablets, in a box. Not all pack ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
8. Marketing authorization number(s)
7 film-coated tablets: EU/1/11/739/001 10 film-coated tablets: EU/1/11/739/002 20 film-coated tablets: EU/1/11/739/003 30 film-coated tablets: EU/1/11/739/004 50 film-coated tablets: EU/1/11/739/005 90 ...
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 28 November 2011 Date of latest renewal: 16 August 2016
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
