TOBRA-DAY tobramycin (as sulfate) 500mg/5 mL Injection vial

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

tobramycin sulfate, Quantity: 762.24 mg (Equivalent: tobramycin, Qty 500 mg)

Verfügbar ab:

Phebra Pty Ltd

INN (Internationale Bezeichnung):

Tobramycin sulfate

Darreichungsform:

Injection, concentrated

Zusammensetzung:

Excipient Ingredients: sulfuric acid; water for injections; sodium hydroxide

Verabreichungsweg:

Intravenous

Einheiten im Paket:

10 x 5 mL vials per carton

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

TOBRA-DAY is indicated for once daily intravenous use in the treatment of cystic fibrosis patients (greater than 5 years old) with acute pulmonary exacerbations caused by susceptible organisms.

Produktbesonderheiten:

Visual Identification: A clear straw coloured, particle-free solution.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2009-07-17

Gebrauchsinformation

Tobra-day® V08
1
TOBRA-DAY® INJECTION
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 IS TOBRA-DAY BEING GIVEN?
Tobra-day contains the active ingredient tobramycin sulfate. Tobra-day
is an antibiotic given to treat serious lung infections
caused by bacteria in patients with cystic fibrosis. It works by
killing the bacteria causing the infection.
For more information, see Section 1. Why is Tobra-day being given? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TOBRA-DAY IS GIVEN?
Do not use if you have ever had an allergic reaction to Tobra-day 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
Tobra-day is given? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Tobra-day 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 IS TOBRA-DAY GIVEN?
Tobra-day is always given to you under the supervision of your doctor
or healthcare professional. Your doctor will decide what
dose and how long you will receive it for.
More instructions can be found in Section 4. How is Tobra-day given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TOBRA-DAY IS BEING GIVEN?
THINGS YOU SHOULD DO
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist
that you have been given Tobra-day.
•
Remind any doctor, dentist, pharmacist or nurse you visit that you
have been given Tobra-
day.
•
If you become pregnant while being given Tobra-day, tell your doctor
immediately.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you have been given
this medicine.
•
Keep all your doctor’s appointments so that your progress can be

Fachinformation

PRODUCT INFORMATION
Australian Product Information – Tobra-day
Page 1 of 13
Version 14.0
TOBRA-DAY®
(TOBRAMYCIN (AS SULFATE))
CONCENTRATED INJECTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Tobramycin sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Tobra-day concentrated injection for intravenous infusion
contains 100 mg tobramycin. The solution is
preservative free. The pH of Tobra-day is between 3.5 and 6.0.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Concentrated injection for intravenous infusion. Tobra-day is a clear
straw coloured solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Tobra-day is indicated for once daily intravenous use in the treatment
of cystic fibrosis (CF) patients (>5 years old)
with acute pulmonary exacerbations caused by susceptible organisms.
4.2
D
OSE AND METHOD OF ADMINISTRATION
In patients with cystic fibrosis, the starting dose is 10 mg
tobramycin per kg body weight per day. The dose is
adjusted according to the results of therapeutic drug monitoring
(TDM).
Initial dose selection (10 mg/kg/day) should be adjusted depending on
renal function and previous patient
experience. Further dose adjustment should take into account the
results of therapeutic drug monitoring, renal
function and audiometry testing.
The intravenous injection is diluted in a minimum volume of 50 mL of
sodium chloride intravenous infusion (0.9%
w/v) or 5% glucose intravenous infusion and infused over thirty to
sixty minutes.
Once diluted the solution should be used as soon as possible. If
storage is necessary the prepared solution should
be refrigerated between 2°C and 8°C and stored for no longer than 24
hours before discarding.
_ _
_Monitoring serum levels of tobramycin: _
Monitoring of tobramycin plasma levels may be carried out by a number
of methods using various nonograms and
computer programs which use the area under curve method (Barclay et
al)
[1]
. Traditional methods of monitoring
for tobramycin toxicity using peak and t