COLISTIN LINK colistimethate sodium (equivalent to colistin 150 mg, 4,500,000 IU) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

colistimethate sodium (Equivalent: colistin, Qty IU)

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International Name):

Colistimethate sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous, Intramuscular

Units in package:

vial of powder 150mg

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Registered

Authorization date:

1991-09-20

Patient Information leaflet

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

Summary of Product characteristics

_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