TARGOCID teicoplanin 400mg injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

teicoplanin, Quantity: 400 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium chloride

Administration route:

Intravenous, Intramuscular

Units in package:

3.14mL diluent ampoule, 1 x 400mg vial (25mL) and

Prescription type:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Therapeutic indications:

Targocid is indicated for the treatment of the following infections due to staphylococci or streptococci, which cannot be treated satisfactorily with less toxic agents, including B-lactam antibiotics: - Bone - osteomyelitis; Joints - septic arthritis; Blood - non-cardiac bacteraemia, septicaemia.

Product summary:

Visual Identification: Ivory coloured lyophilised powder.; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-02-22

Patient Information leaflet

TARGOCID
®
T
A
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G
O
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I
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®
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 BEING GIVEN TARGOCID?
Targocid contains the active ingredient teicoplanin. Targocid
injection is an antibiotic. It is used to kill bacteria responsible
for
infections which can occur in your blood, bones or joints. For more
information, see Section 1. Why am I being given Targocid? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN TARGOCID?
Do not use if you have ever had an allergic reaction to Targocid 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, ARE PREGNANT OR PLAN TO BECOME PREGNANT,
OR ARE BREASTFEEDING OR PLANNING TO BREASTFEED. For more information,
see Section 2. What should I know before I am given
Targocid? in the full CMI. What if I am taking other medicines?
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Targocid 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 WILL I BE GIVEN TARGOCID?
•
Targocid injection should be prepared and administered by a qualified
health professional (doctor, pharmacist or nurse). More
instructions can be found in Section 4. How will I be given Targocid?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN TARGOCID?
THINGS YOU
SHOULD DO
•
Call your doctor straight away if you notice any symptoms of serious
skin reactions, including blistering of
your skin, mouth, eyes or genitals, a red scaly widespread rash and
blisters accompanied by a fever, or
flu-like symptoms and a rash on your face and body with a fever.
•
Remind any doctor, dentist or pharmacist that you visit that you are
being given Targocid.
THINGS YOU
SHOULD NOT DO
•
Do not receive more than the recommended dose unless your doctor or
pharmacist tells you to.
•
Do not stop rece

Summary of Product characteristics

targocid-ccdsv4-piv7-21feb22
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION – TARGOCID
(TEICOPLANIN)
1
NAME OF THE MEDICINE
Teicoplanin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains lyophilised teicoplanin 460 mg* and sodium chloride
24.8 mg with an
accompanying ampoule containing Water for injections 3.14 mL*.
* An overage is included to allow withdrawal of the correct dose.
The reconstituted solution contains:
For a 400 mg vial:
400 mg/3.0 mL of teicoplanin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for injection.
Sterile, pyrogen-free ivory white powder for reconstitution with water
for injections. It is freely
soluble in water and on reconstitution gives a clear solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Targocid is indicated for the treatment of the following serious
infections due to staphylococci
or streptococci, which cannot be treated satisfactorily with less
toxic agents, including β-lactam
antibiotics:
Bone
-
osteomyelitis
Joints
-
septic arthritis
Blood -
non-cardiac bacteraemia, septicaemia
targocid-ccdsv4-piv7-21feb22
Page 2 of 12
4.2
DOSE AND METHOD OF ADMINISTRATION
NOTE: SPECIAL INSTRUCTIONS APPLY FOR RECONSTITUTION. SEE BELOW.
The reconstituted Targocid injection should be administered
intravenously or intramuscularly.
Intravenous dosing may be by slow injection over 5 minutes or by
infusion over 30 minutes.
Maintenance dosage is once daily; however, initially a loading dose
regimen of three doses at
12-hourly intervals is recommended, for rapid attainment of
steady-state plasma levels.
The dose is to be adjusted on bodyweight whatever the weight of the
patient.
An intramuscular injection of Targocid should not exceed 3 mL (400 mg)
at a single site.
Targocid should not be administered by intraventricular route, due to
risk of seizure.
ADULTS:
_SEPTICAEMIA/BACTERAEMIA, ACUTE OR CHRONIC OSTEOMYELITIS: _
Treatment should be started with 6-12 mg/kg by the I.V. route every 12
hours for 3 doses then
the daily mai