מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colistimethate sodium
Teva UK Ltd
J01XB01
Colistimethate sodium
2000000unit
Powder for solution for injection
Inhalation; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700; GTIN: 5014398001353
OBJECT 1 COLOMYCIN INJECTION Summary of Product Characteristics Updated 18-May-2016 | Teva UK Limited 1. Name of the medicinal product COLOMYCIN INJECTION 1 million or 2 million International Units. Powder for solution for injection, infusion or inhalation. 2. Qualitative and quantitative composition Each vial contains either 1 million or 2 million International Units Colistimethate Sodium. For excipients, see 6.1. 3. Pharmaceutical form Powder for solution for injection, infusion or inhalation. 1 million IU/vial: Sterile white powder in a 10ml colourless glass vial with a red 'flip-off' cap. 2 million IU/vial: Sterile white powder in a 10ml colourless glass vial with a lilac 'flip-off' cap. 4. Clinical particulars 4.1 Therapeutic indications Colomycin by intravenous administration 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). Colomycin by inhalation is also 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 SYSTEMIC TREATMENT 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 9 million IU/day in 2-3 divided doses In patients who are critically ill, a קרא את המסמך השלם