מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colistimethate sodium
Zambon UK Ltd
J01XB01
Colistimethate sodium
1000000unit
Powder for nebuliser solution
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700; GTIN: 5060045110022
Promixin 1 million International Units (IU) Powder for Nebuliser Solution -1- PACKAGE LEAFLET: INFORMATION FOR THE USER PROMIXIN 1 MILLION INTERNATIONAL UNITS (IU) POWDER FOR NEBULISER SOLUTION colistimethate sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, nurse, physiotherapist or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What Promixin is and what it is used for 2. What you need to know before you take Promixin 3. How to take Promixin 4. Possible side effects 5. How to store Promixin 6. Contents of the pack and other information 1. WHAT PROMIXIN IS AND WHAT IT IS USED FOR Promixin contains colistimethate sodium, and is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis. Promixin is used when these infections are caused by specific bacteria called _Pseudomonas aeruginosa_._ _ This_ _is a very common bacteria that infects the lungs of nearly all patients with cystic fibrosis at some time during their lives. If the infection is not properly controlled it will continue to damage the lungs, causing further problems. Promixin is dissolved in sterile saline (salt water) or sterile water and then breathed (inhaled) into the lungs so that more of the antibiotic can target the bacteria causing the infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROMIXIN In certain circumstances your doctor may decide not to prescribe Promixin. DO NOT USE PROMIXIN AND TELL YOUR DOCTOR IF: • you are ALLERGIC (hypersensitive) to colistimethate sodium, colistin or other polymyxins; IF THIS APPLIES TO YOU, SEE YOUR DOCTOR BEFORE YOU START TAKING PROMIXIN. TAKE SPECIAL CARE WITH PROMIXIN AND קרא את המסמך השלם
OBJECT 1 PROMIXIN 1 MILLION INTERNATIONAL UNITS (IU) POWDER FOR NEBULISER SOLUTION Summary of Product Characteristics Updated 04-Jun-2018 | Profile Pharma Limited 1. Name of the medicinal product Promixin, 1 million International Units (IU) Powder for Nebuliser Solution 2. Qualitative and quantitative composition Each vial contains 1 million International Units (IU) which is approximately equivalent to 80 mg of colistimethate sodium. 3. Pharmaceutical form Powder for nebuliser solution. The powder is white to off-white 4. Clinical particulars 4.1 Therapeutic indications Promixin 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 Promixin for nebulisation is intended for administration by nebulisation using a suitable nebuliser. Drug delivery characteristics from _in vitro_ studies with different nebuliser systems are detailed below; קרא את המסמך השלם