TOBI SOLUTION FOR INHALATION

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

TOBRAMYCIN

Предлага се от:

DEXCEL LTD, ISRAEL

АТС код:

J01GB01

Лекарствена форма:

SOLUTION FOR INHALATION

Композиция:

TOBRAMYCIN 300 MG / 5 ML

Начин на приложение:

INHALATION WITH NEBULISER

Вид предписание :

Required

Произведено от:

CATALENT PHARMA SOLUTIONS, USA

Терапевтична група:

TOBRAMYCIN

Терапевтична област:

TOBRAMYCIN

Терапевтични показания:

TOBI is indicated for the management of pulmonary Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients age 6 years or older.

Дата Оторизация:

2020-12-31

Листовка

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
THE DISPENSING OF THIS MEDICINE REQUIRES A DOCTOR'S PRESCRIPTION
READ THE PACKAGE INSERT CAREFULLY IN ITS ENTIRETY
BEFORE USING THIS MEDICINE
TOBI
®
SOLUTION FOR INHALATION
SOLUTION FOR INHALATION
COMPOSITION:
Each ampoule of 5 ml contains:
Tobramycin 300 mg
INACTIVE INGREDIENTS:
Sodium chloride, water for injections, sodium hydroxide, sulfuric
acid.
THERAPEUTIC GROUP: Aminoglycoside antibiotics.
Each ampoule (5 ml) contains 11.25 mg sodium
THERAPEUTIC ACTIVITY:
For the management of cystic fibrosis patients with Pseudomonas
aeruginosa.
TOBI SOLUTION FOR INHALATION contains antibiotic called tobramycin.
TOBI SOLUTION FOR INHALATION is a solution to be inhaled with a
specific
nebulizer and a suitable compressor; the solution is contained in a
ready-
to-use ampoule.
When TOBI SOLUTION FOR INHALATION is inhaled, the antibiotic can get
directly
to the lungs to fight against the bacteria causing the infection, and
to improve
your breathing.
Pseudomonas aeruginosa is a very common bacterium that infects the
lungs
of nearly everyone with cystic fibrosis at some time during their
lives. Some
people do not get this infection until later on in their lives, while
others get
it very young. It is one of the most damaging bacteria for people with
cystic
fibrosis. If the infection is not properly fought, it continues to
damage the
lungs causing further breathing problems.
WHEN SHOULD THE PREPARATION NOT BE USED?
Do not use this medicine if you are breastfeeding.
Do not use this medicine if you are allergic (hypersensitive) to
tobramycin,
to any of its ingredients or to any other aminoglycoside antibiotic.
If you think you may be allergic, ask the doctor for advice.
DO NOT TAKE THIS MEDICINE WITHOUT CONSULTING A DOCTOR BEFORE STARTING
TREATMENT:
Inform the doctor if you have or if you have ever had hearing problems
(including noises in the ears and dizziness); kidney problems; unusual
difficulty
in breathing with wheezing or coughing, c

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
TOBI Solution for Inhalation
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 5ml contains tobramycin 300mg as a single dose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for inhalation.
Clear, slightly yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TOBI is indicated for the management of pulmonary Pseudomonas
aeruginosa infection in
cystic fibrosis (CF) patients age 6 years or older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
TOBI is for oral inhalation only and must not be administered by any
other route.
The dose of TOBI is the same for all patients regardless of age or
weight. The recommended
dosage for adults and children 6 years of age and older is one
single-use ampoule (300 mg/5
mL) administered twice daily (BID) for 28 days. TOBI is taken in
alternating cycles of 28
days on drug followed by 28 days off drug. Each dose should be inhaled
as close as possible
to 12 hours apart and not less than six hours apart.
Safety and efficacy have not been demonstrated in patients under the
age of 6 years, patients
with FEV
1
(Forced Expiratory Volume in 1 second) <25% or >75% predicted, or
patients
colonized with _Burkholderia cepacia_.
SPECIAL POPULATIONS
_ _
_Elderly patients (≥ 65 years) _
There are insufficient data in this population to support a
recommendation for or against dose
adjustment. Renal function in elderly patients should be taken into
account while using TOBI
(see nephrotoxicity information in section 4.4 and excretion
information in section 5.2).
_Patients with renal impairment _
Tobramycin is primarily excreted unchanged in the urine and renal
function is expected to
affect the exposure to tobramycin. Patients with serum creatinine 2
mg/dl or more or blood
urea nitrogen (BUN) 40 mg/dl or more were not included in clinical
studies and there are no
data in this population to support a recommendation for or against
dose adjustment with
TOBI. Please also refer to nephrot