PULMOZYME Nebuliser solution (2017)
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Περιεχόμενα
Name of the medicinal product
Pulmozyme 2500 U/2.5 ml, nebuliser solution.
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 ...
Pharmaceutical form
Nebuliser solution. Clear, colourless to slightly yellowish solution.
Therapeutic indications
Management of cystic fibrosis patients with a forced vital capacity (FVC) of greater than 40% of predicted and over 5 years of age to improve pulmonary function.
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability of PULMOZYME In order to improve the traceability of Pulmozyme the trade name of the administered dornase alfa and the batch number should be clearly recorded in the patient file.
Interaction with other medicinal products and other forms of interaction
Pulmozyme can be effectively and safely used in conjunction with standard cystic fibrosis therapies such as antibiotics, bronchodilators, pancreatic enzymes, vitamins, inhaled and systemic corticosteroids, ...
Pregnancy and lactation
Pregnancy The safety of dornase alfa has not been established in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, or embryofoetal development ...
Effects on ability to drive and use machines
Pulmozyme has no or negligible influence on the ability to drive and use machines.
Undesirable effects
The adverse event data reflect the clinical trial and post-marketing experience of using Pulmozyme at the recommended dose regimen. Adverse reactions attributed to Pulmozyme are rare (<1/1000). In most ...
Overdose
The effect of Pulmozyme overdosage has not been established. In clinical studies, cystic fibrosis patients have inhaled up to 20 mg Pulmozyme twice daily (16 times the recommended daily dose) for up to ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> respiratory system <b>ATC code:</b> R05CB13 Mechanism of action Recombinant human DNase is a genetically engineered version of a naturally occurring human enzyme which ...
Pharmacokinetic properties
Absorption Inhalation studies conducted in rats and non-human primates show a low percentage of dornase alfa systemic absorption, <15% for rats and <2% for monkeys. Consistent with the results of these ...
Preclinical safety data
Non-clinical data based on standard studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction do not indicate a specific safety risk for humans. ...
List of excipients
Sodium chloride Calcium chloride dihydrate Water for injections
Incompatibilities
Pulmozyme is an unbuffered aqueous solution and should not be diluted or mixed with other drugs or solutions in the nebuliser bowl. Mixing of this solution could lead to adverse structural and/or functional ...
Shelf life
3 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Keep the ampoule in the outer carton in order to protect from light. A single brief exposure to elevated temperatures (less than or equal to 24 hours at up to 30°C) does ...
Nature and contents of container
2.5 ml of nebuliser solution in an ampoule (low density polyethylene plastic). Pack sizes of 6 and 30. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
The contents of one 2.5 mg (2500 U) single-use ampoule of Pulmozyme sterile solution for inhalation should be inhaled once a day using a recommended nebuliser. Pulmozyme should not be mixed with other ...
Marketing authorization holder
Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
Marketing authorization number(s)
PL 00031/0335
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 January 1994 Date of latest renewal: 11 March 2009
Date of revision of the text
21 April 2017
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