Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Colistimethate sodium
Noridem Enterprises Limited
J01XB01
Colistimethate sodium
Powder for nebuliser solution
colistin
Not marketed
2023-02-17
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER COLISTIMETHATE SODIUM 1 MILLION IU POWDER FOR NEBULISER SOLUTION COLISTIMETHATE SODIUM_ _2 MILLION IU 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Colistimethate sodium is and what it is used for 2. What you need to know before you use Colistimethate sodium 3. How to use Colistimethate sodium 4. Possible side effects 5. How to store Colistimethate sodium 6. Contents of the pack and other information 1. WHAT COLISTIMETHATE SODIUM IS AND WHAT IT IS USED FOR This medicine _ _ contains the active substance colistimethate sodium. Colistimethate sodium is an antibiotic. It belongs to a group of antibiotics that are called polymyxins. This medicine _ _ is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis. Colistimethate sodium is used when these infections are caused by specific bacteria called _Pseudomonas aeruginosa. _ 2. WHAT YOU NEED TO KNOW BEFORE YOU USE COLISTIMETHATE SODIUM DO NOT USE COLISTIMETHATE SODIUM - If you are allergic to colistimethate sodium, colistin or to other polymyxins . WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Colistimethate sodium if: - you have or have had kidney problems - you suffer from myasthenia gravis (disease characterized by muscle weakness) - you suffer from porphyria - you suffer from asthma Some people may experience a feeling of tightness in the chest due to narrowing of the airways when Read the complete document
Health Products Regulatory Authority 04 July 2023 CRN00DLNK Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colistimethate sodium 2 million IU Powder for nebuliser solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 2 million IU colistimethate sodium. 3 PHARMACEUTICAL FORM Powder for nebuliser solution. White to off-white powder. pH of 1 vial Colistimethate sodium 2 million IU powder in 4 ml: 6.5 - 8.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Colistimethate sodium by inhalation is indicated for the management of adult and paediatric 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 million IU two to three times per day (max 6 million IU/day) _ _ _Children < 2 years_ 0.5-1 million IU twice daily (max 2 million IU/ day) Relevant clinical guidance on treatment regimens, including duration of treatment, periodicity and co-administration of other antibacterial agents should be adhered to. Special populations _ _ _Elderly_ 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_ Health Products Regulatory Authority 04 July 2023 CRN00DLNK Page 2 of 7 Dose adjustment is not considered necessary. Method of administration For inhalation use. Suitable nebulisers are the reusable jet nebulisers including the PARI LC PLUS or the PARI LC SPRINT, Read the complete document