PULMOZYME

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

RECOMBINANT HUMAN DEOXYRIBONUCLEASE

Disponible des:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

Codi ATC:

R05CB13

formulario farmacéutico:

SOLUTION FOR INHALATION

Composición:

RECOMBINANT HUMAN DEOXYRIBONUCLEASE 1 MG/ML

Vía de administración:

INHALATION

tipo de receta:

Required

Fabricat per:

HOFFMANN LA ROCHE, SWITZERLAND

Grupo terapéutico:

DORNASE ALFA (DESOXYRIBONUCLEASE)

Área terapéutica:

DORNASE ALFA (DESOXYRIBONUCLEASE)

indicaciones terapéuticas:

Management of cystic fibrosis not for patients under 5 years of age or with FVC<40% .

Data d'autorització:

2021-07-31

Informació per a l'usuari

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s
prescription only
PULMOZYME
®
Solution for Inhalation
COMPOSITION:
Each 2.5 ml ampoule contains:
Recombinant Human Deoxyribonuclease
)dornase alfa( 2.5 mg )or 2500 U(
For information on inactive ingredients: see
section 6 – “Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains
concise information about the medicine. If you
have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed for the
treatment of your or your child’s ailment. Do
not pass it on to others. It may harm them even
if it seems to you that their medical condition
is similar.
IMPORTANT INFORMATION FOR YOUR ATTENTION:
• The medicine Pulmozyme is intended for
patients suffering from cystic fibrosis.
• Pulmozyme will generally be given to you
together with other medicines for treatment
of your or your child’s illness )see section 2 –
“Drug interactions”(.
• Pulmozyme is given by inhalation using a
device called a “nebuliser”.
• It is important to confirm that the nebuliser you
are using is suitable for Pulmozyme. Please
see section 3 – “How should you use the
medicine?”.
• Pulmozyme is not intended for children under
5 years of age.
• Keep the medicine in the refrigerator )see
section 5 – “How should the medicine be
stored?”(.
1) WHAT IS THE MEDICINE INTENDED
FOR?
The medicine Pulmozyme contains the protein
deoxyribonuclease )also referred to as dornase
alfa(. This protein is a genetically engineered
version of a protein found in the body called
“DNase”. The medicine Pulmozyme is used to
treat people with cystic fibrosis. The medicine
aids in breaking down the thick mucous found
in the lungs and helps the lungs of cystic fibrosis
patients to function
better.
The medicine Pulmozyme
is intended for inhalation
using a device called a
“nebuliser”.
In addition to use of
Pul

Fitxa tècnica

1
Pulmozyme PI_Version 2
PULMOZYME
®
 



RECOMBINANT HUMAN DEOXYRIBONUCLEASE (DORNASE ALFA)
SOLUTION FOR INHALATION 2.5 MG/2.5 ML
1
NAME OF THE MEDICINAL PRODUCT
Pulmozyme
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 2500 U (corresponding to 2.5 mg) of dornase
alfa* per 2.5 ml corresponding
to 1000 U/ml or 1 mg/ml**.
*phosphorylated glycosylated protein human deoxyribonuclease 1
produced in Chinese Hamster
Ovary Cell Line CHO A14.16-1 MSB #757 by recombinant DNA technology
**1 Genentech unit/ml = 1µg/ml
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for inhalation
Clear, colourless to slightly yellowish solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of cystic fibrosis not for patients under 5 years of age or
with FVC< 40%.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
2.5 mg (corresponding to 2500 U) deoxyribonuclease l by inhalation
once daily.
Some patients over the age of 21 years may benefit from twice daily
dosage.
Most patients gain optimal benefit from regular daily use of
Pulmozyme. In studies in which
Pulmozyme was given in an intermittent regimen, improvement in
pulmonary function was lost on
cessation of therapy. Patients should therefore be advised to take
their medication every day without
a break.
Patients should continue their regular medical care, including their
standard regimen of chest
physiotherapy.
Administration can be safely continued in patients who experience
exacerbation of respiratory tract
infection.
Safety and efficacy have not yet been established in patients with
forced vital capacity less than 40%
of predicted.
2
_Paediatric population _
Safety and efficacy have not yet been established in patients under
the age of 5 years.
Method of administration
Inhale the content of one ampoule (2.5 ml of solution) undiluted using
a recommended nebuliser
system (see section 6.6).
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
S