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16 items found.
Item # PUL/080415/0147(4)
A four-page brochure describing the CF mucus progression and the roles Pulmoz...
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Item # PUL/011415/0004(6)
A four-page brochure describing how Pulmozyme works and the roles that other ...
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Item # PUL/011415/0004(2)A(1)
A four-page brochure describing how PulmozymeŽ works and the roles that oth...
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Item # PUL/060815/0099(2)
Production update to the transition book series. Minor changes have been imp...
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Item # PUL/060815/0100(2)
Production update to the transition book series. Minor changes have been imp...
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Item # PUL/060815/0101(2)
Production update to the transition book series. Minor changes have been imp...
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Item # PULMOZYMEPI
PulmozymeŽ PI (03/19/18)
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Item # PUL/092316/0045A(1)
A mucus model acts as a tool to demonstrate the differences between CF mucu...
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Item # PUL/052517/0021(1)
A leave behind is designed to support on label discussions with customers reg...
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Item # PUL/042115/0051(1)
A one-page, two-side printed leave behind designed to show the step-by-step...
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Item # PUL/120814/0037(3)
A book designed to educate the younger CF patient population about cystic f...
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Item # PUL/032715/0032(2)
A book designed to educate the younger CF patient population about cystic f...
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Item # PUL/062915/0118(3)
The Pulmozyme Co-pay program brochure and holders are materials that can be u...
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Item # PUL/042115/0054(2)
The Pulmozyme 30-day Voucher Brochure can be provided to CF patients that are...
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Item # ACS/010319/0006
The Prescriber Service Form replaces the SMN. It includes patient, insurance ...
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Item # ACS/110518/0147(1)
The Patient Consent Form replaces the PAN. This form is signed and dated by t...
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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

Pulmozyme® (dornase alfa) is indicated for daily administration in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.

In CF patients with an FVC ≥ 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics.

IMPORTANT SAFETY INFORMATION

Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.

The most common adverse reactions associated with the use of Pulmozyme include: voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC of ≥ 10%, fever, dyspepsia, and dyspnea. There have been no reports of anaphylaxis attributed to the administration of Pulmozyme. Mild to moderate urticaria and mild skin rash have been observed and have been transient.

PEDIATRIC USE

The safety and effectiveness of Pulmozyme have been established in pediatric patients 5 years of age and older. The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 65 patients with cystic fibrosis aged 3 months to < 5 years. While clinical trial data are limited in pediatric patients younger than 5 years of age, the use of Pulmozyme should be considered for pediatric CF patients who may experience potential benefit in pulmonary function or who may be at risk of respiratory tract infection.

The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 pediatric patients with cystic fibrosis 3 months to 10 years of age (65 aged 3 months to < 5 years, 33 aged 5 to ≤ 10 years). The PARI BABY™ reusable nebulizer (which uses a facemask instead of a mouthpiece) was utilized in patients unable to demonstrate the ability to inhale or exhale orally throughout the entire treatment period (54/65, 83% of the younger; and 2/33, 6% of the older patients). Overall, the nature of adverse reactions was similar to that seen in the placebo-controlled trials in older patients. The number of patients reporting cough was higher in the younger age group as compared to the older age group (29/65, 45%; compared to 10/33, 30%) as was the number reporting moderate to severe cough (24/65, 37%; compared to 6/33, 18%). The number of patients reporting rhinitis was higher in the younger age group as compared to the older age group (23/65, 35%; compared to 9/33, 27%) as was the number reporting rash (4/65, 6% as compared to 0/33, 0%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see the Pulmozyme full Prescribing Information for additional Important Safety Information. For other information, please see Pulmozyme Instructions for Use.