Bula do remedy Pulmozyme

the package insert of the medicine Pulmozyme. Therapeutic class of Antigripais.

what For?

daily administration of Pulmozyme, along with the conventional therapy, is
indicated in the treatment of patients with cystic fibrosis to reduce the frequency of the
respiratory infections requiring intravenous antibiotics and improve respiratory function.

Pharmacokinetics

How it works?

When 2.5 mg of Pulmozyme was administered by inhalation, the 18 patients with
CF, were obtained from average concentrations in the sputum of 3 mg/ml of DNase after 15 minutes.

The average concentrations in the sputum declined to about 0.6 mg/ml, on average, two hours
after the inhalation. Inhalation of up to 10 mg of Pulmozyme, three times a day, for 4 patients
CF patients for six consecutive days, has not resulted in significant elevation of
plasma concentrations of DNase above endogenous levels normal. After administration
up to 2.5 mg of Pulmozyme twice daily for six months, 321 patients
CF was not observed accumulation of DNase in the plasma.

Contraindications

When should I not use?

Pulmozyme is contraindicated for patients with proven hypersensitivity to dornase
alpha, products originating from cells of the chinese hamster ovary or to the components of the product.

Dosage

How to use?

The recommended dose for most patients with cystic fibrosis is of a light bulb
with unit dose of 2.5 mg, once a day, using the nebulizer recommended. Some
patients may benefit with the administration twice a day (see Clinical Experience,
Table 1). The clinical studies were conducted with the following nebulizers and compressors:
jet nebulizer disposable Hudson T Up-draft II jet nebulizer disposable Marquest
Acom II, together with the compressor Pulmo-Aide and the nebulizer reusable PARI LC jet
along with the compressor PARI PRONEB. The safety and efficacy have been demonstrated
only with the use of the systems of misting recommended. There are not, up to the moment,
clinical data supporting the safety and efficacy of administration of Pulmozyme
other systems nebulizers. The patient should follow the manufacturer’s instructions on the use and
maintenance of the equipment. Pulmozyme should not be diluted or mixed with other
medicines in the nebulizer. Mixing of Pulmozyme to other drugs can
to determine changes in physical, chemical and/or functional effects on Pulmozyme or in the compound
added.

Side Effects

What are the evils that can cause me?

The patients have been exposed to Pulmozyme for up to 12 months in clinical studies. In a
large clinical study randomized, placebo-controlled trial in which 600 patients received
Pulmozyme at a dose of 2.5 mg, twice a day, for six months, the majority of
adverse events were more common with the Pulmozyme than with placebo, and
likely representing the sequelae of lung pathology based. In most of the cases,
in that events were increased in patients treated with rhDNase, they were,
usually mild in nature and transient, not requiring dosage alterations. Few
patients experienced adverse events resulting in discontinuation permanent
Pulmozyme, being the index of discontinuation similar to placebo (2%) and to
Pulmozyme (3%).

The events more frequent in patients treated with Pulmozyme compared with those treated
with placebo are listed in Table 2.

Table 2
Adverse events Reported in a Controlled Study
Event Adverso1xdia Placebo Pulmozyme Pulmozyme 2xdia
N=325 N=322 N=321
RouquidãoFaringiteLaringiteRash
cutâneoDor torácicaConjuntivite
7% 33% 12% 36% 3% 16% 40% 4%
1% 7% 10% 18% 4% 12% 21% 5%
16% 2%
EVENTS OBSERVED WITH INDICES SIMILAR IN PATIENTS
TREATED WITH
PULMOZYME AND PLACEBO
The organism as a whole
Gastrointestinal
Abdominal pain, asthenia, fever, flu syndrome, ill
be, sepseObstrução bowel, pathology of the gall bladder
biliary pathology, liver pathology, pancreatic
System Metabolic-Nutritional
The Respiratory system
Diabetes Mellitus, hypoxia, loss of pesoApnéia,
bronchiectasis, bronchitis, changes of the characteristics
the esputo, increased cough, dyspnea, haemoptysis,
reduced lung function, nasal polyps,
pneumonia, pneumothorax, rhinitis, sinusitis, increased
volume of sputum, wheezing.

The mortality rates observed in controlled trials were similar for the placebo
(1%) and Pulmozyme (1%). The causes of deaths were consistent with the evolution of the
cystic fibrosis and included apnea, cardiac arrest, kidnapping cardiopulmonary, cor pulmonale,
heart failure, hemoptysis massive, pneumonia, pneumothorax, and respiratory failure.

Warnings and Precautions

what should I know before using?

Overdose

what to do if someone use a larger amount than is recommended?

Studies of inhaled single-dose conducted in rats and monkeys with doses up to 180 times
greater than those used routinely in the clinical studies were well tolerated. The
oral administration of single doses of Pulmozyme up to 200 mg/kg were also well
tolerated in rats. Patients with cystic fibrosis have received up to 20 mg, two times a
day, for up to 6 days, and 10 mg, twice a day, intermittently (2 weeks on and 2
weeks without medication) during 168 days. These doses were well tolerated.