Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colistimethate sodium
Kent Pharma (UK) Ltd
J01XB01
Colistimethate sodium
1000000unit
Powder for solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700; GTIN: 5060061160117
PATIENT INFORMATION LEAFLET COLISTIMETHATE SODIUM 1 MILLION I.U. POWDER FOR SOLUTION FOR INJECTION 1 MILLION INTERNATIONAL UNITS/VIAL THE NAME OF YOUR MEDICINE IS Colistimethate sodium 1 Million I.U. Powder for Solution for Injection. It is referred to as Colistimethate in this leaflet. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, nurse or pharmacist. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the doctor, nurse or pharmacist. IN THIS LEAFLET: 1. What Colistimethate is and what it is used for 2. What you need to know before you are given Colistimethate 3. How Colistimethate is given 4. Possible side-effects 5. Storing Colistimethate 6. Further information 1. W HAT C OLISTIMETHATE IS AND WHAT IT IS USED FOR Colistimethate is given by injection to treat some types of serious infections caused by certain bacteria. Colistimethate is used when other antibiotics are not suitable. 2. W HAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN C OLISTIMETHATE Colistimethate is not suitable for everyone. Some people MUST NOT have this injection. Do not have the injection: If you are allergic (hypersensitive) to colistimethate, colistin or to other polymyxins. If you are unsure about anything, ask your doctor before you have the injection. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Colistimethate - If you have or have had kidney problems. - If you suffer from myasthenia gravis - If you suffer from porphyria In premature and new-born babies, special care should be taken when using Colistimethate as the kidneys are not yet fully developed. OTHER MEDICINES AND COLISTIMETHATE - medicines which can affect how your kidneys function. Taking such medicines at the same time as Colistimethate can increase the risk of damage to the kidneys - medicines which can affect your nervous system. Taking such medicines at the same time as Colistimethate can increase the risk of side read_full_document
OBJECT 1 COLISTIMETHATE SODIUM 1 MILLION I.U. POWDER FOR SOLUTION FOR INJECTION Summary of Product Characteristics Updated 12-Jun-2018 | Beacon Pharmaceuticals 1. Name of the medicinal product Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection 2. Qualitative and quantitative composition Colistimethate Sodium 1 Million I.U. (International Units) 3. Pharmaceutical form Powder for Solution for Injection White lyophilised powder in a glass vial. 4. Clinical particulars 4.1 Therapeutic indications Colistimethate Sodium is indicated in adults and children including neonates for the treatment of serious infections due to selected aerobic Gram-negative pathogens in patients with limited treatment options (see sections 4.2, 4.4, 4.8 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration The dose to be administered and the treatment duration should take into account the severity of the infection as well as the clinical response. Therapeutic guidelines should be adhered to. The dose is expressed in international units (IU) of colistimethate sodium (CMS). A conversion table from CMS in IU to mg of CMS as well as to mg of colistin base activity (CBA) is included at the end of this section. Posology The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients (see section 4.4): Adults and adolescents Maintenance dose 9MIU/day in 2-3 divided doses In patients who are critically ill, a loading dose of 9 MIU should be administered. The most appropriate time interval to the first maintenance dose has not been established. Modelling suggests that loading and maintenance doses of up to 12 MIU may be required in patients with good renal function in some cases. Clinical experience with such doses is however extremely limited and safety has not been established. The loading dose applies to patients with normal and impaired renal functions including those on renal read_full_document