País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
colistimethate sodium (Equivalent: colistin, Qty IU)
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Colistimethate sodium
Injection, powder for
Excipient Ingredients:
Intravenous, Intramuscular
vial of powder 150mg
(S4) Prescription Only Medicine
Colistin Link Parental is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitve strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus and Neisseria. Colistin Link Parental has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Pending results of appropriate bacterialogic cultures and sensitvity tests, Colistin Link Parental may be used to initiate therapy in serious infections that are suspected due to gram-negative organisms.
Visual Identification: A fluffy spongy white to slightly yellow powder cake; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-09-20
COLISTIN LINK® 1 COLISTIN LINK® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING COLISTIN LINK? COLISTIN LINK contains the active ingredient colistimethate sodium. COLISTIN LINK is used to treat certain types of bacterial infections. For more information, see Section 1. Why am I using COLISTIN LINK? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE COLISTIN LINK? Do not use if you have ever had an allergic reaction to COLISTIN LINK or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use COLISTIN LINK? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with COLISTIN LINK and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE COLISTIN LINK? • COLISTIN LINK is given as an injection by a doctor or other healthcare professional into a vein or muscle. You may receive doses of this medicine as injections, or infusions (via drip). More instructions can be found in Section 4. How do I use COLISTIN LINK? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING COLISTIN LINK? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using COLISTIN LINK. • Tell your doctor if symptoms of your infection do not improve within a few days, or they become worse. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how this medicine affects you. • This medicine may cause temporary numbness, tingling in the fingers and toes, and dizziness. If you have any of these symptoms, do not drive, or operate machinery. DRINKING ALCOHOL • Be careful when drinking alcohol whilst being given this medi Leer el documento completo
_Page 1 of 7_ AUSTRALIAN PRODUCT INFORMATION-COLISTIN LINK (COLISTIN) 1 NAME OF THE MEDICINE Colistin (as colistimethate sodium) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Colistin Link contains the sodium salt of colistimethate, a polypeptide antibiotic. Each dose contains colistimethate sodium equivalent to colistin 150 mg. When reconstituted each dose provides 150 mg of colistin in 2 mL equivalent to 4,500,000 IU antibiotic activity. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Powder for injection. White to slightly yellow lyophilised powder cake. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Colistimethate sodium is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of _Pseudomonas aeruginosa_ . This antibiotic is not indicated for infections due to _Proteus or _ _Neisseria_ . Colistimethate sodium has proven clinically effective in treatment of infections due to the following gram-negative organisms: _Enterobacter aerogenes_ , _Escherichia coli, Klebsiella pneumoniae _ _and Pseudomonas aeruginosa_ . Pending results of appropriate bacteriologic cultures and sensitivity tests, colistimethate sodium may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms. 4.2 DOSE AND METHOD OF ADMINSTRATION IMPORTANT Colistin Link is supplied in vials containing colistin 150 mg (as colistimethate sodium). Contains no additional antimicrobial agent. Use in one patient on one occasion only, as soon as practicable after reconstitution. RECONSTITUTION The vial should be reconstituted with 2.0 ML water for injections. The reconstituted solution provides 150 mg colistin in 2 mL. During reconstitution swirl GENTLY to avoid frothing. DOSAGE (DOSE AND INTERVAL) _Adults and children-intravenous or intramuscular administration _ Colistin Link should be given in 2 to 4 divided doses at dose Leer el documento completo