Colistin-Link

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Colistimethate sodium 384.6 mg/mL

Available from:

Link Pharmaceuticals Ltd

INN (International Name):

Colistimethate sodium 384.6 mg/mL

Dosage:

150 mg/2mL

Pharmaceutical form:

Powder for injection

Composition:

Active: Colistimethate sodium 384.6 mg/mL

Units in package:

Vial, glass, 150mg, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Xellia Pharmaceuticals ApS

Therapeutic indications:

The treatment of acute or chronic infections due to sensitive strains of certain Gram-negative bacilli; particularly when the infection is caused by sensitive strains of Pseudomonas aeruginosa, and the following Gram-negative organisms; Aerobacter aerogenes, Escherichia coli, Klebsiella pneumoniae. 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.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 150mg - 1 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1973-03-15

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

COLISTIN LINK
Link Pharmaceuticals Ltd
Colistin-Link New Zealand Data Sheet
Page 1 of 7
NEW ZEALAND DATA SHEET
1. COLISTIN-LINK® 150 mg/2 mL powder for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains colistimethate sodium (equivalent to colistin 150
mg).
Once reconstituted, each mL of solution contains 75 mg of colistin.
3. PHARMACEUTICAL FORM
Powder for injection.
Colistin Link is supplied in vials containing colistimethate sodium
for injection, USP
(equivalent to 150 mg colistin per vial) as a white to slightly yellow
lyophilized cake
containing the equivalent of 4,500,000 IU antibiotic activity.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
The treatment of acute or chronic infections due to sensitive strains
of certain
Gram-negative bacilli; particularly when the infection is caused by
sensitive strains _of _
_Pseudomonas aeruginosa_, and the following Gram-negative organisms;_
Aerobacter _
_aerogenes, Escherichia coli, Klebsiella pneumoniae_.
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 ADMINISTRATION
IMPORTANT
Colistin Link is supplied in vials containing colistimethate sodium.
RECONSTITUTION
The
vial
should
be
reconstituted
with
2.0 mL
sterile
water
for
injections.
The
reconstituted solution provides 150 mg colistin in 2 mL.
During reconstitution swirl gently to avoid frothing.
ADULTS AND CHILDREN:
Intravenous or intramuscular administration given in two to four
divided doses at
dose levels of 2.5 to 5 mg/kg/day for patients with normal renal
function depending
on the severity of the infection.
INTRAMUSCULAR ADMINISTRATION:
Should be given by deep intramuscular injection in two to four divided
doses.
INTRAVENOUS ADMINISTRATION:
Should be given by intravenous injection in two divided doses.
Administer half the
total daily dose slowly over 3 to 5 minutes. The remaining half of the
total