Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colistimethate sodium
Pari Medical Ltd
J01XB01
Colistimethate sodium
2000000unit
Powder for nebuliser solution
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700; GTIN: 9120073451026
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER COLIFIN 2 MILLION INTERNATIONAL UNITS POWDER FOR NEBULISER SOLUTION Colistimethate sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 ColiFin is and what it is used for 2. What you need to know before you use ColiFin 3. How to use ColiFin 4. Possible side effects 5. How to store ColiFin 6. Contents of the pack and other information 1. WHAT COLIFIN IS AND WHAT IT IS USED FOR ColiFin is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis. ColiFin is used when these infections are caused by specific bacteria called _Pseudomonas aeruginosa_ . 2. WHAT YOU NEED TO KNOW BEFORE YOU USE COLIFIN DO NOT USE COLIFIN - If you are allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using ColiFin - If you have or have had kidney problems - If you suffer from myasthenia gravis - If you suffer from porphyria - If you suffer from asthma In premature and new-born babies, special care should be taken when using ColiFin as the kidneys are not yet fully developed. Coughing and chest tightness may lead to discontinuation. This may be relieved by using an inhaled bronchodilator (e.g. salbutamol) before using ColiFin. Your doctor will supervise your first dose of ColiFin and check your lung function before and after dosing. If chest tightness occurs despite the use of a bronchodilator, please tell your doctor because Přečtěte si celý dokument
OBJECT 1 COLIFIN 2 MIU POWDER FOR NEBULISER SOLUTION Summary of Product Characteristics Updated 01-Sep-2016 | PARI Pharma GmbH 1. Name of the medicinal product ColiFin 2 MIU Powder for Nebuliser Solution 2. Qualitative and quantitative composition Each 10 ml vial contains 2 MIU equivalent to 160 mg of colistimethate sodium. 3. Pharmaceutical form Powder for Nebuliser Solution White powder 4. Clinical particulars 4.1 Therapeutic indications ColiFin is indicated for the management in adult and paediatric of chronic pulmonary infections due to _Pseudomonas aeruginosa_ in patients with cystic fibrosis (see section 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration It is recommended that colistimethate sodium (CMS) should be administered under the supervision of physicians with appropriate experience in its use. Posology The dosage can be adjusted depending on the severity of the condition and clinical response. Recommended dose range: _Administration via inhalation_ _Adults, adolescents and children ≥ 2 years _ 1-2 MIU two to three times per day (max. 6 MIU/day) _Children < 2 years _ 0.5-1 MIU twice daily (max. 2 MIU/day) Relevant clinical guidance on treatment regimens, including duration of treatment, periodicity and co- administration of other antibacterial agents should be adhered to. _Older people_ Dose adjustment is not considered necessary. _Renal impairment_ Dose adjustment is not considered necessary, however, caution is advised in patients with renal impairment (see sections 4.4 and 5.2). _Hepatic impairment_ Dose adjustment is not considered necessary. Method of administration For inhalation use. For use in children younger than 2 years the PARI LC SPRINT Baby (red nozzle insert) with mask is recommended. THE CONTENT OF A VIAL OF COLIFIN 2 MIU SHOULD BE DISSOLVED IN 4 ML OF STERILE SODIUM CHLORIDE 9 MG/ML (0.9%) SOLUTION. For instructions on dilution of the product before administration, see section 6.6. Predi Přečtěte si celý dokument