TEICOPLANIN SANDOZ teicoplanin 400mg powder for injection vial with diluent ampoule

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

teicoplanin, Quantity: 400 mg

Tilgængelig fra:

Sandoz Pty Ltd

INN (International Name):

Teicoplanin

Lægemiddelform:

Injection, powder for

Sammensætning:

Excipient Ingredients: sodium chloride

Indgivelsesvej:

Intramuscular, Intravenous

Enheder i pakken:

1 vial + 1 ampoule

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Teicoplanin Sandoz 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 beta-lactam antibiotics: bone (osteomyelitis); joints (septic arthritis); blood (non-cardiac bacteraemia, septicaemia).

Produkt oversigt:

Visual Identification: White to light yellow powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Licence status A

Autorisation dato:

2010-08-11

Indlægsseddel

Teicoplanin Sandoz
®
1
TEICOPLANIN SANDOZ®
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 TEICOPLANIN SANDOZ?
Teicoplanin Sandoz contains the active ingredient teicoplanin.
Teicoplanin Sandoz is an antibiotic. It is used to kill bacteria
responsible for infections which can occur in your bones, blood, or
joints. For more information, see Section
1. Why am I using
Teicoplanin Sandoz? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN TEICOPLANIN SANDOZ?
Do not use if you have ever had an allergic reaction to Teicoplanin
Sandoz 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 am given Teicoplanin Sandoz?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Teicoplanin Sandoz 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 TEICOPLANIN SANDOZ?
Teicoplanin Sandoz should be prepared and administered by a qualified
health professional (doctor, pharmacist, or nurse).
More instructions can be found in Section 4. How do I use Teicoplanin
Sandoz?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN TEICOPLANIN SANDOZ?
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 you visit that you are being
given Teicoplanin Sandoz.
THINGS YOU
SHOULD NOT DO
•
Do not receive more than the recommended dose unless your doctor or
p

Produktets egenskaber

220516-Teicoplanin Sandoz-pi
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
TEICOPLANIN SANDOZ
® 400 MG INJECTION (TEICOPLANIN)
1
NAME OF THE MEDICINE
Teicoplanin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Teicoplanin Sandoz 400 mg injection containing a white to pale yellow,
sterile lyophilised
powder, equivalent to 400 mg teicoplanin. It is freely soluble in
water and on reconstitution
gives a clear solution.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Teicoplanin Sandoz 400 mg injection is presented as a sterile,
lyophilised white to light yellow
powder for reconstitution with water for injections.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Teicoplanin Sandoz 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 beta-lactam antibiotics: bone (osteomyelitis); joints
(septic arthritis); blood (non-
cardiac bacteraemia, septicaemia).
4.2
D
OSE AND METHOD OF ADMINISTRATION
NOTE: SPECIAL INSTRUCTIONS APPLY FOR RECONSTITUTION. SEE BELOW.
The reconstituted Teicoplanin Sandoz injection should be administered
intravenously or
intramuscularly. Intravenous dosing may be by slow injection over 5
minutes or by infusion
over 30 minutes.
DOSAGE
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 Teicoplanin Sandoz should not exceed 3
mL (400 mg) at a single
site.
Teicoplanin Sandoz 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 to 12 mg/kg by the intravenous
route every 12 hours for 3
doses, then the daily maintenance dose should be 6 mg/kg.
_Septic arthritis _
220516-Teicoplanin Sandoz