Tobramycin BNM

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tobramycin 300mg

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

Dosage:

300 mg/5mL

Pharmaceutical form:

Solution for inhalation

Composition:

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

Prescription type:

Prescription

Therapeutic indications:

Tobramycin BNM 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.

Product summary:

Package - Contents - Shelf Life: Ampoule, plastic, LDPE ampoule, 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

Authorization date:

2018-09-25

Patient Information leaflet

1
TOBRAMYCIN BNM
Consumer Medicine Information
TOBRAMYCIN BNM
_TOBRAMYCIN _
Solution for inhalation 300 mg/5 ml
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Tobramycin
BNM.
This leaflet answers some common questions about Tobramycin BNM. It
does not contain
all the available information. The most up-to-date Consumer Medicine
Information can be
downloaded
from
www.medsafe.govt.nz.
Those
updates
may
contain
important
information about the medicine and its use of which you should be
aware.
Reading this leaflet 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 BNM against the benefits this medicine is expected to 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 want to read it again.
WHAT TOBRAMYCIN BNM IS USED FOR
Tobramycin BNM 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 lungs 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
BNM
solution
is
for
administration
by
inhalation
via
a
nebuliser
and
compressor. When you inhale Tobramycin BNM, the antibiotic can get
straight into your
lungs to fight against the infection and to improve your breathing.
2
TOBRAMYCIN BNM
FOR BEST RESULTS, PLEASE USE TOBRAMYCIN BNM AS THIS LEAFLET INSTRUCTS
YOU.
Although Tobramycin BN

Summary of Product characteristics

1
TOBRAMYCIN BNM
TOBRAMYCIN SOLUTION FOR INHALATION 300 MG/5 ML
NEW ZEALAND DATA SHEET
1
TOBRAMYCIN BNM
TOBRAMYCIN BNM
300 mg/5 mL solution for inhalation
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL ampoule contains 300 mg tobramycin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tobramycin BNM is a solution for inhalation.
It is a sterile, clear, slightly yellow solution free from visible
particles.
It has a pH of 4.0 to 5.0 and an osmolality of 150 to 200 mOsm/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tobramycin BNM 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
1
<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
DOSE
_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.
2
TOBRAMYCIN BNM
TOBRAMYCIN SOLUTION FOR INHALATION 300 MG/5 ML
Tobramycin BNM 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 BNM is administered twice daily in alternating periods of
28 days. After 28
days of therapy, patients should stop Tobramycin BNM therapy for the
next 28 days, then
resume therapy for the next 28 days on/28 days off cycle.
METHOD OF ADMINISTRATION
Tobramycin BNM is for oral inhalation only and must not be
administered by any other
route.
The contents of one ampoule should b