Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Para-aminosalicylic acid
Eurocept International B. V.
J04AA01
para-aminosalicylic acid
Antimycobacterials
Tuberculosis
Granupas is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see section 4.4).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 11
Authorised
2014-04-07
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GRANUPAS 4 G GASTRO-RESISTANT GRANULES para-aminosalicylic acid 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What GRANUPAS is and what it is used for 2. What you need to know before you take GRANUPAS 3. How to take GRANUPAS 4. Possible side effects 5. How to store GRANUPAS 6. Contents of the pack and other information 1. WHAT GRANUPAS IS AND WHAT IT IS USED FOR GRANUPAS contains para-aminosalicylic acid which is used in adults and children aged 28 days and older to treat resistant tuberculosis in combination with other medicines, in cases of resistance or intolerability with other treatments. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRANUPAS DO NOT TAKE GRANUPAS • if you are allergic to para-aminosalicylic acid or any of the other ingredients of this medicine (listed in section 6). • if you have severe kidney disease. If you are not sure, talk to your doctor or pharmacist before taking GRANUPAS. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking GRANUPAS • if you have liver problems or mild or moderate kidney disease • if you have a stomach ulcer • if you are infected with HIV CHILDREN Use of GRANUPAS is not recommended in newborn babies (under 28 days of age). OTHER MEDICINES AND GRANUPAS Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to tell your doctor if you are taking any of the following: • Antitube Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT GRANUPAS 4 g gastro-resistant granules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 4 g of para-aminosalicylic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant granules The granules are small off white/ light brown coloured approximately 1.5 mm diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GRANUPAS is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults_ 4 g (one sachet) three times per day. The recommended schedule is 4 g every 8 hours. GRANUPAS can be taken with food. Maximum daily dose is 12 g. Usual duration of treatment is 24 months. _Desensitization_ Desensitization can be accomplished by starting with 10 mg para-aminosalicylic acid (PAS) given as a single dose. The dosage is doubled every 2 days until reaching a total of 1 gram after which the dosage is divided to follow the regular schedule of administration. If a mild temperature rise or skin reaction develops, the increment is to be dropped back one level or the progression held for one cycle. Reactions are rare after a total dosage of 1.5 g. _Paediatric population_ The optimal dose regimen in children is uncertain. Limited pharmacokinetic data suggest no substantial difference between adults and children. For infants, children and adolescents the dosage will be adapted to the patient’s weight at 150 mg/kg per day, divided in two intakes. A dosing spoon is provided to measure small doses below 4 g for young children. The safety and efficacy of para-aminosalicylic acid in neonates have not been established. No da Прочетете целия документ