TOBRAMYCIN SUN tobramycin 300 mg/5 mL solution for inhalation ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tobramycin, Quantity: 300 mg

Available from:

Sun Pharma ANZ Pty Ltd

Pharmaceutical form:

Inhalation, conventional

Composition:

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

Administration route:

Inhalation

Units in package:

56 x 5mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tobramycin solution 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 ? 80 % predicted at screening, or patients colonized with Burkholderia cepacia (see CLINICAL TRIALS).

Product summary:

Visual Identification: A clear, colorless to light yellow solution, free from visible particulates.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2017-12-15

Patient Information leaflet

TOBRAMYCIN SUN
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 USING TOBRAMYCIN SUN?
Tobramycin SUN contains the active ingredient tobramycin. Tobramycin
SUN is used for the management of cystic fibrosis
patients with _P. aeruginosa_ infections.
For more information, see Section 1. Why am I using Tobramycin SUN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TOBRAMYCIN SUN?
Do not use if you have ever had an allergic reaction to tobramycin,
any antibiotics that belong to the aminoglycoside group
(e.g. amikacin, gentamicin, neomycin, or streptomycin) 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 use
Tobramycin SUN?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Tobramycin SUN 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 DO I USE TOBRAMYCIN SUN?
•
The recommended dose of Tobramycin SUN is one 300 mg/5 mL ampoule
twice daily (every 12 hours) for 28 days.
•
Tobramycin SUN solution is contained in a ready-to-use ampoule and
formulated for inhalation therapy using a PARI LC
PLUS reusable nebuliser and a De Vilbiss Pulmo-Aide®air compressor or
PARI Pro-Neb System reusable nebuliser.
More instructions can be found in Section 4. How do I use Tobramycin
SUN?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TOBRAMYCIN SUN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Tobramycin SUN.
•
Keep Tobramycin SUN in the foil pouch (opened or unopened) in the pack
until it is time for your dose.
•
Consult the package insert supplied with Tobramycin SUN for detailed
information and dia

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – TOBRAMYCIN SUN
(TOBRAMYCIN) SOLUTION FOR INHALATION
1
NAME OF THE MEDICINE
Tobramycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TOBRAMYCIN SUN single-use 5 mL ampoule contains 300 mg tobramycin
and 11.25 mg
sodium chloride in sterile water for injections. Sulfuric acid and
sodium hydroxide are added to
adjust the pH. Nitrogen is used for purging. All ingredients meet the
Ph.Eur. requirements. The
formulation contains no preservatives.
3
PHARMACEUTICAL FORM
TOBRAMYCIN
SUN
solution
for
inhalation
is
specifically
developed
for
administration
by
inhalation.
TOBRAMYCIN SUN is a clear, colourless to light yellow solution, free
from visible particulates.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Tobramycin solution 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 ≥ 80 % predicted at screening, or patients colonized
with _Burkholderia cepacia_
(see Section 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage is not adjusted by age or weight. The doses should be taken as
close to 12 hours apart as
possible; they should not be taken less than six hours apart. In case
of a missed dose with at least
6 hours until the next dose, the patient should take the dose as soon
as possible.
Otherwise, the patient should wait for the next dose and not inhale
more medication to make up
for the missed dose.
TOBRAMYCIN SUN is administered twice daily in alternating periods of
28 days. After 28 days of
therapy, patients should stop therapy for the next 28 days, and then
resume therapy for the next
28 day on/28 day off cycle.
Therapy should be initiated by a physician experienced in the
management of cystic fibrosis.
Treatment with TOBRAMYCIN SUN should be continued on a cyclical basis
for as long as the
TOBRAMYCIN SUN PI v2
1
physician considers that the patient is gaining clinical be