BRALTUS tiotropium (as bromide) 13 microgram powder for inhalation hard capsule

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

tiotropium bromide, Quantity: 15.6 microgram (Equivalent: tiotropium, Qty 13 microgram)

Tersedia dari:

Teva Pharma Australia Pty Ltd

Bentuk farmasi:

Capsule, hard

Komposisi:

Excipient Ingredients: lactose monohydrate

Rute administrasi :

Inhalation

Unit dalam paket:

30

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

BRALTUS is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD).,BRALTUS is indicated for the prevention of COPD exacerbations

Ringkasan produk:

Visual Identification: BRALTUS capsules are colourless and transparent. The capsules contain a white powder.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status otorisasi:

Registered

Tanggal Otorisasi:

2018-11-15

Selebaran informasi

BRALTUS
®
B
R
A
L
T
U
S
V
4
.
0
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 BRALTUS?
BRALTUS contains the active ingredient tiotropium (as bromide).
BRALTUS is used to make breathing easier for people with chronic
obstructive pulmonary disease (COPD)
For more information, see Section 1. Why am I using BRALTUS? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BRALTUS?
Do not use if you have ever had an allergic reaction to tiotropium,
atropine, medicines like atropine (e.g. ipratropium or oxitropium) 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
BRALTUS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BRALTUS 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 BRALTUS?
•
The recommended dose for adults is 1 capsule to be inhaled, once a day
•
Inhale the powder in the capsules only using the Zonda
®
device. Do not swallow the capsules. Do not place a capsule directly
into the mouthpiece. Do not open the capsules.
More instructions can be found in Section 4. How do I use BRALTUS? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BRALTUS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
BRALTUS.
•
Tell your doctor immediately if your breathing becomes more difficult
while you are taking BRALTUS.
THINGS YOU
SHOULD NOT DO
•
Do not use BRALTUS more frequently than once daily.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how BRALTUS
affects you.
•
BRALTUS may cause dizziness or blurred vision in some people.
LOOKING AFT

Karakteristik produk

BRALTUS v4.0
1
AUSTRALIAN PRODUCT INFORMATION – BRALTUS
®
(TIOTROPIUM [AS BROMIDE]) POWDER FOR INHALATION, HARD
CAPSULE
1
NAME OF THE MEDICINE
Tiotropium (as tiotropium bromide)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BRALTUS® tiotropium (as bromide) powder for inhalation, hard capsule.
The drug product must be
inhaled with the ZONDA® device.
BRALTUS is a generic version of SPIRIVA. Each capsule of BRALTUS and
SPIRIVA delivers 10 micrograms
of tiotropium and are equivalent.
BRALTUS capsules are colourless and transparent. The capsules contain
a white powder.
Excipient(s) with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
BRALTUS powder for inhalation in capsules.
Each hard BRALTUS capsule contains 13 micrograms tiotropium,
equivalent to 15.6 micrograms
tiotropium bromide.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
BRALTUS is indicated for the long term maintenance treatment of
bronchospasm and dyspnoea
associated
with
chronic
obstructive
pulmonary
disease
(COPD).
BRALTUS
is
indicated
for
the
prevention of COPD exacerbations.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dosage of BRALTUS is inhalation of the contents of one
capsule, once daily with
the ZONDA device, at the same time each day (see ZONDA instructions
for use, in the patient
information leaflet provided in each pack of BRALTUS).
The delivered dose (the dose that leaves the mouthpiece of the ZONDA
inhaler) is 10 micrograms of
tiotropium per capsule.
BRALTUS capsules must not be swallowed.
Do not place a BRALTUS capsule directly into the mouthpiece.
BRALTUS v4.0
2
SPECIAL POPULATIONS:
Elderly patients can use BRALTUS at the recommended dose.
Renally
impaired
patients
can
use
BRALTUS
at
the
recommended dose.
However,
as
with
all
predominantly renally excreted drugs, tiotropium use should be
monitored closely in patients with
moderate to severe renal impairment (see Section 5.2 Pharmacokinetic
properties).
Hepatically impaired patients can use BRALT