COLISTIMETHATE PACKAGE INSERT PDF

Colistimethate sodium or pentasodium colistinmethanesulfonate ( mg Please see product packaging and package insert for complete expiration date and. Page Steps taken after authorisation – summary. Page Summary of Product Characteristics. Product Information Leaflet. Labelling. Product Availability · Contact Us · Make An Inquiry. () Product Summary. Colistimethate for Injection, USP Lyophilized Powder For Injection, USP.

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Colistimethate for Injection, USP (1 Vial)

There are indications that pharmacokinetics in critically ill patients differ from those in patients with less severe physiological derangement and from those in healthy volunteers. If these occur treatment should be withdrawn. Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution. To view the changes to a medicine you must sign up and log in.

Find out more here. Company contact details Beacon Pharmaceuticals. The volume of distribution is relevantly enlarged in critically ill colistimethqte. There is no specific antidote. Therapeutic guidelines should be adhered to.

Par Sterile Products – Products – Colistimethate

Renal function monitoring should be performed at the start of treatment and regularly during treatment in all patients. Hypersensitivity to Colistimethate sodium also known as colistin or to polymyxin B.

The elimination of the active colistin is incompletely characterised. The volume of distribution of colistin coljstimethate healthy subjects is low and corresponds approximately to extracellular fluid ECF. Medicinal products that inhibit peristalsis should not be given.

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Data on potential genotoxicity are limited and carcinogenicity data for colistimethate sodium are lacking. The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity mg CBA. Renal maturity should be taken into consideration when selecting the dose.

Monitoring should be performed for perioral colistimethaye and insdrt in the extremities, which are signs of overdose see section 4. Local irritation at the site of injection may occur.

Colistimethate for Injection, USP (1 Vial) | X-Gen Pharmaceuticals, Inc

The most commonly observed adverse effect of CMS administration was aseptic meningitis see section 4. These are generally mild and resolve during or shortly after treatment. Posology The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients see section 4. The effects are usually reversible on discontinuation of therapy.

Colistimethate sodium has been shown to induce chromosomal aberrations in human lymphocytes in vitro. The data supporting the dose regimen in paediatric patients are very limited. During reconstitution swirl gently to avoid frothing.

Reconstitute the contents of the vial with not more than 7ml water for injection or 0. To bookmark a medicine you must sign up and log in. The likelihood of adverse events may be related to the age, renal function and condition of the patient.

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In case of an allergic reaction, treatment with colistimethate sodium must be discontinued and appropriate measures implemented. Neurotoxicity has been reported often in association with overdose, failure to reduce dose in patients with renal insufficiency and concomitant use of either neuromuscular blocking drugs or other drugs with similar neurological effects. Colistin clearance is decreased in renal impairment, possibly due to increased conversion of CMS.

Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection

Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation.

Name of the medicinal product 2. They may range from mild to lifethreatening in severity. CMS is eliminated predominantly by the kidneys via glomerular filtration. However, single dose studies in human pregnancy show that Colistimethate crosses the placental barrier and there may be a risk of foetal toxicity if repeated doses are given to pregnant patients.

Peak plasma concentrations of colistin have been shown to occur with a delay of up to 7 hours after administration of colistimethate sodium in critically ill patients.