DELTYBA Film-coated tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Deltyba 50 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 50 mg delamanid. <u>Excipient with known effect:</u> each film-coated tablet contains 100 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. ...
Pharmaceutical form
Film-coated tablet (tablet). Round, yellow, film-coated tablet, 11.7 mm in diameter, debossed with DLM and 50 on one side.
Therapeutic indications
Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at ...
Posology and method of administration
Treatment with delamanid should be initiated and monitored by a physician experienced in the management of multidrug-resistant <em>Mycobacterium tuberculosis</em>. Delamanid must always be administered ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Serum albumin <2.8 g/dL (see section 4.4 regarding use in patients with serum albumin ≥2.8 g/dL). Coadministration ...
Special warnings and precautions for use
There are no data on treatment with delamanid for more than 24 consecutive weeks. (see section 4.2). There are no clinical data on the use of delamanid to treat extra pulmonary tuberculosis (e.g. central ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on Deltyba Cytochrome P450 3A4 inducers Clinical drug-drug interactions studies in healthy subjects indicated a reduced exposure to delamanid, of up to 45% following ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of delamanid in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Deltyba is not recommended in pregnancy ...
Effects on ability to drive and use machines
Deltyba is expected to have a moderate influence on the ability to drive and use machines. Patients should be advised not to drive or use machines if they experience any adverse reaction with a potential ...
Undesirable effects
Summary of the safety profile The most frequently observed adverse drug reactions in patients treated with delamanid + Optimised Background Regimen (OBR) (i.e. incidence >10%) are nausea (32,9%), vomiting ...
Overdose
No cases of delamanid overdose have been observed in clinical trials. However, additional clinical data showed that in patients receiving 200 mg twice daily, i.e. total 400 mg delamanid per day, the overall ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimycobacterials, antibiotics ATC code: J04AK06 Mechanism of action The pharmacological mode of action of delamanid involves inhibition of the synthesis of the mycobacterial ...
Pharmacokinetic properties
Absorption Oral bioavailability of delamanid improves when administered with a standard meal, by about 2.7 fold compared to fasting conditions. The peak plasma concentrations are reached in approximately ...
Preclinical safety data
Non-clinical data reveal no specific hazard for humans based on conventional studies for genotoxicity and carcinogenic potential. Delamanid and/or its metabolites have the potential to affect cardiac repolarisation ...
List of excipients
Tablet core: Hypromellose phthalate Povidone all-rac-α-Tocopherol Cellulose, microcrystalline Sodium starch glycolate (type A) Carmellose calcium Silica, colloidal hydrated Magnesium stearate Lactose monohydrate ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
Store in the original package in order to protect from moisture.
Nature and contents of container
Aluminium/Aluminium blister: 48 tablets.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Otsuka Novel Products GmbH, Erika-Mann-Straße 21, 80636, München, Germany
Marketing authorization number(s)
EU/1/13/875/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 April 2014 Date of latest renewal: 22 March 2022
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