Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
Delamanid
Otsuka Novel Products GmbH
J04AK06
delamanid
Antimycobacterials
Tuberculosis, Multidrug-Resistant
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 least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 25
Authorised
2014-04-27
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DELTYBA 50 MG FILM-COATED TABLETS delamanid This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Deltyba is and what it is used for 2. What you need to know before you take Deltyba 3. How to take Deltyba 4. Possible side effects 5. How to store Deltyba 6. Contents of the pack and other information 1. WHAT DELTYBA IS AND WHAT IT IS USED FOR Deltyba contains the active substance delamanid, an antibiotic for the treatment of tuberculosis in the lung caused by bacteria that are not killed by the most commonly used antibiotics to treat tuberculosis. It must always be taken together with other medicines for treating tuberculosis. Deltyba is used in adults, adolescents, children and infants who are weighing at least 10 kg. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DELTYBA DO NOT TAKE DELTYBA: - if you are allergic to delamanid or any of the other ingredients of this medicine (listed in section 6). - if you have very low levels of albumin, in the blood. - if you are taking medicines that strongly increase the activity of a certain liver enzyme called ‘CYP450 3A4’ (e.g. carbamazepine [a medicine used to treat epilepsy and prevent seizures]). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Deltyba 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg delamanid. Excipient with known effect Each film-coated tablet contains 100 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Round, yellow, film-coated tablet, 11.7 mm in diameter, debossed with ‘DLM’ and ‘50’ on one side. 4. CLINICAL PARTICULARS 4.1 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 least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with delamanid should be initiated and monitored by a physician experienced in the management of multidrug-resistant _Mycobacterium tuberculosis_ . Delamanid must always be administered as part of an appropriate combination regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB) (see sections 4.4 and 5.1). Treatment with an appropriate combination regimen should continue after completion of the 24-week delamanid treatment period according to WHO guidelines. It is recommended that delamanid is administered by directly observed therapy (DOT). Posology _Adults _ The recommended dose for adults is 100 mg twice daily for 24 weeks. _Adolescents and children _ Paediatric patients with a body weight of 3 - ≥ Izlasiet visu dokumentu