Colomycin 1million unit powder for solution for injection vials

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Colistimethate sodium

Tilgængelig fra:

Teva UK Ltd

ATC-kode:

J01XB01

INN (International Name):

Colistimethate sodium

Dosering:

1000000unit

Lægemiddelform:

Powder for solution for injection

Indgivelsesvej:

Intravenous; Inhalation

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 05010700; GTIN: 5014398151003

Produktets egenskaber

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