Tobramycin Wockhardt

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Tobramycin 300mg

متاح من:

Maple Healthcare Limited

جرعة:

300 mg/5mL

الشكل الصيدلاني:

Solution for inhalation

تركيب:

Active: Tobramycin 300mg Excipient: Sodium chloride Sodium hydroxide Sulfuric acid Water for injection

نوع الوصفة الطبية :

Prescription

الخصائص العلاجية:

Tobramycin Wockhardt is indicated for the management of cystic fibrosis patients with P. aeruginosa infections. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonised with Burkholderia cepacia.

ملخص المنتج:

Package - Contents - Shelf Life: Ampoule, plastic, LDPE, 5 mL - 56 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at or below 25°C protect from light

تاريخ الترخيص:

2019-01-17

نشرة المعلومات

New Zealand Consumer Medicine Information
TOBRAMYCIN WOCKHARDT
Tobramycin
300 mg/ 5 mL, Solution for Inhalation
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Tobramycin
Wockhardt.
This leaflet answers some common questions about Tobramycin Wockhardt.
It does
not contain all the available information. It does not take the place
of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Tobramycin Wockhardt against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT TOBRAMYCIN WOCKHARDT IS USED FOR
TOBRAMYCIN WOCKHARDT contains an antibacterial agent, tobramycin,
which is
active against a common lung infection that occurs in patients with
cystic fibrosis
(CF).
Tobramycin belongs to a class of antibiotics called aminoglycosides.
It works by
killing or stopping the growth of the bacteria that cause the
infection.
The bacterium that commonly infects the lung of most cystic fibrosis
patients at some
stage of their lives is Pseudomonas aeruginosa. It is one of the most
damaging
bacteria for people with CF.
Some people do not get this infection until later on in their lives,
while others get it
very young. If the infection is not properly fought, it will continue
to damage your
lungs, causing further problems with your breathing.
Tobramycin Wockhardt solution has been specially formulated for
administration by
inhalation via a nebuliser and compressor. When you inhale Tobramycin
Wockhardt,
NZ CMI Tobramycin Wockhardt V1.0
May 2019
the antibiotic can get straight into your lungs to fight against the
infection and to
improve your breathing.
FOR BEST RESULTS, PLEASE USE TOBRAMYCIN WOCKHARDT AS THIS LEAFLET
INSTRUCTS
YOU.
Although Tobramycin Wockhardt does not cure your condition, it does
help control it.
Tobramycin Wockhardt is not recommended for use in children younger
th

خصائص المنتج

Version 1.0 11 Dec 2018
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
TOBRAMYCIN WOCKHARDT Tobramycin 300 mg/5 mL, Solution for inhalation.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL ampoule contains a sterile solution of tobramycin 300 mg
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Solution for inhalation.
TOBRAMYCIN WOCKHARDT is a sterile, clear slightly yellow,
non-pyrogenic, aqueous
solution with the pH and salinity adjusted specifically for
administration by a compressed
air driven reusable nebuliser.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TOBRAMYCIN WOCKHARDT injection is indicated for the management of
cystic fibrosis
patients with
_P. aeruginosa_
infections. Safety and efficacy have not been demonstrated in
patients under the age of 6 years, patients with FEV <25% or >75%
predicted, or patients
colonised with
_Burkholderia_
_cepacia_
(see Section 5.1 Pharmacodynamic properties: Clinical
trials)
4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE
ADULTS AND PAEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
The recommended dosage for both adults and paediatric patients 6 years
of age and older is
one single-use ampoule (300 mg) administered twice daily for 28 days.
Dosage is not adjusted
by weight. All patients should be administered 300 mg twice daily. The
doses should be taken
as close to 12 hours apart as possible; they should not be taken less
than six hours apart.
tobramycin is inhaled while the patient is sitting or standing upright
and breathing normally
through the mouthpiece of the nebuliser. Nose clips may help the
patient breathe through the
mouth.
Tobramycin is administered twice daily in alternating periods of 28
days. After 28 days of
therapy, patients should stop tobramycin therapy for the next 28 days,
and then resume
therapy for the next 28 days on/28 days off cycle.
METHOD OF ADMINISTRATION
TOBRAMYCIN WOCKHARDT is supplied as a single-use ampoule and is
administered by
inhalation, over a 10 to 15 minute period, using a hand-help PARI