Country: Israel
Language: English
Source: Ministry of Health
RECOMBINANT HUMAN DEOXYRIBONUCLEASE
ROCHE PHARMACEUTICALS (ISRAEL) LTD
R05CB13
SOLUTION FOR INHALATION
RECOMBINANT HUMAN DEOXYRIBONUCLEASE 1 MG/ML
INHALATION
Required
HOFFMANN LA ROCHE, SWITZERLAND
DORNASE ALFA (DESOXYRIBONUCLEASE)
DORNASE ALFA (DESOXYRIBONUCLEASE)
Management of cystic fibrosis not for patients under 5 years of age or with FVC<40% .
2021-07-31
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 Read the complete document
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 Read the complete document