PULMOZYME Dornase alfa 1mg/mL spray solution

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

Dornase alfa, Quantity: 1 mg/mL

Διαθέσιμο από:

Roche Products Pty Ltd

Φαρμακοτεχνική μορφή:

Spray, solution

Σύνθεση:

Excipient Ingredients: water for injections; calcium chloride dihydrate; sodium chloride

Οδός χορήγησης:

Inhalation

Μονάδες σε πακέτο:

30 x 2.5mg/mL (2500 units/2.5mL)

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Chronic administration of Pulmozyme is indicated for the management of demonstrated respiratory complications in cystic fibrosis. Continued use should depend on demonstrating a sustained benefit based on clinical response and, if able to be performed, pulmonary function tests.

Περίληψη προϊόντος:

Visual Identification: Clear, colourless liquid.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1994-11-29

Φύλλο οδηγιών χρήσης

PULMOZYME
®
_PRONOUNCED PULL-MO-ZIME_
_contains the active ingredient dornase alfa_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pulmozyme
inhalation solution.
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 Pulmozyme
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 PULMOZYME IS
USED FOR
Pulmozyme contains the active
ingredient dornase alfa which is an
enzyme.
Pulmozyme is used to help people
who have cystic fibrosis (CF). CF is
a hereditary disease in which
secretions, mainly of the lung
passages and pancreas, are affected.
However, Pulmozyme is not a cure
for this disease.
There are many different types of
medicines used to treat CF.
The enzyme dornase alfa is almost
identical to the one that is found in
people without CF.
Enzymes are proteins that carry out
normal processes in nature. Humans
have hundreds of enzymes to help the
body function properly.
The enzyme in Pulmozyme breaks
down DNA contained in lung
secretions (mucous). CF patients
have too much of this substance.
Breaking down the excessive
amounts of DNA reduces the
thickness of the lung mucous.
As a result, Pulmozyme improves
lung function and eases the
symptoms of breathlessness, cough
and congestion.
Pulmozyme also reduces the chance
of lung infections and lowers the rate
at which the disease affects the lungs.
This decreases the need for injected
(intravenous) antibiotics.
Your doctor, however, may have
prescribed Pulmozyme for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PULMOZYME
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Pulmozyme is not addictive.
BEFORE YOU USE
PULMOZYME
_WHEN YOU MUST NOT USE IT_
D

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION
PULMOZYME
®
(DORNASE ALFA)
Pulmozyme PI 180404
1
1.
NAME OF THE MEDICINE
Dornase alfa
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pulmozyme solution for inhalation contains 1.0 mg/mL dornase alfa
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nebuliser solution, clear, colourless to slightly yellowish solution.
The nominal pH of the solution is 6.3.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic administration of Pulmozyme is indicated for the management of
demonstrated respiratory
complications in cystic fibrosis. Continued use should depend on
demonstrating a sustained benefit
based on clinical response and, if able to be performed, pulmonary
function tests.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended dose for use in most patients is one 2.5 mg single-use
ampoule inhaled once per
day using the recommended nebuliser (see Method of Administration
below).
Patients over the age of 21 may benefit from twice daily (bd) dosing.
Most patients gain optimal benefit from continued daily use of
Pulmozyme. The optimal timing for
the use of Pulmozyme in relation to the use of standard treatments
such as physiotherapy and
antibiotics has not been established.
The recommended dose should not be exceeded because of the
dose-dependent occurrence of "irritant"
side-effects with no additional efficacy.
Cystic fibrosis patients have received up to 10 mg bd for up to 2 out
of 4 weeks intermittently over a
6-month period and these doses are well tolerated, and improved
pulmonary function. The results of
this study indicate that improvement in pulmonary function subsides
within several days of cessation
of therapy. Studies demonstrating the reduction in the rate of
respiratory tract infectious exacerbations
involved chronic, daily administration of dornase alfa. Therefore,
patients should be instructed to take
their medication every day.
Patients who experience adverse events common to cystic fibrosis can
in general safely continue
administration of