Pulmozyme

Indications

1. This product is suitable for the treatment of pulmonary cystic fibrosis in combination with conventional treatment methods

2. This product alone cannot replace conventional antibacterial treatment. It can be used for patients with respiratory infections and a large amount of purulent sputum. It can reduce the number of antibiotic applications and alleviate respiratory tract infections, thereby reducing the dosage of antibiotics and reducing the cost of hospitalization and other related health care services

Dosage

(1) In most patients with cystic fibrosis, the recommended dose is 2.5 mg once daily inhaled using a recommended jet nebulizer connected to an air compressor system or the eRapid™ nebulizer system Single-dose ampoules

(2) Some patients may benefit from twice daily dosing

(1) Each vial should be squeezed before use to check for leaks. If the solution is cloudy or discolored, discard the ampoule. Once opened, the entire contents of the ampoule must be used or discarded

(2) Do not dilute or mix this drug with other drugs in the atomizer. Mixing this product with other drugs may cause adverse physical, chemical and/or functional changes in the product or mixed compounds

(1) Supplies to be prepared:

①One bottle of this product

②Compressor atomizer cup and bottle cap (screw-in or snap-in)

③Plastic T (no need for side-flow nebulizer or PARI BABY)

④Flexible aerosol tube (no need for side-flow nebulizer or PARI BABY)

⑤Mask (clean) or PARI BABY mask

⑥Long connecting tube

⑦ nose clip (optional, not required for PARI BABY)

(2) Prepare the spray atomizer and compressor:

①Clean a flat desktop.

② Before using this product and the atomizer, wash your hands thoroughly with soap and water, which helps prevent infection (see Figure B)

③Place the atomizer parts on a clean, flat table within easy reach.

④ Test the compressor by turning it on and placing your finger in front of the "air output" or "air" port to feel the air flow. Turn off the compressor (see Figure C)

(3) Collect ampoules of this product and check the expiration date

① Take out 1 from the refrigerator Bag this product in an aluminum foil bag, open the aluminum foil bag, take out 1 ampoule of this product, put the remaining ampoule back into the aluminum foil bag, and then put it back in the refrigerator

② Check the expiration date printed on the ampoule bottle (exp.) (See Figure D)

Do not use this product if it has expired

(4) Check the ampoule of this product

① Check whether the ampoule leaks by turning the ampoule upside down and squeezing it gently (see Figure E). Do not use if ampoule leaks. Throw it away and get a new one.

② Check the liquid in the ampoule to make sure it is clear and free of particles

③If the liquid is turbid or discolored, do not use it and take it back to the pharmacy, hospital or clinic that gave you the medicine

(5) Connect the long connecting pipe to the compressor

① Connect the long connecting pipe to the "air output" or "air" port on the compressor (see Figure F)

(6) Install the mouthpiece

①If you use Sidestream atomizer or PARI BABY atomizer, please skip to step 7

② Push the mouthpiece into the wider end of the plastic T and connect the flexible aerosol tube to the other end of the T (see Figure G)

(7) Remove the cap from the atomizer

① Unscrew or remove the cap from the atomizer cup (see Figure H)

② Place the atomizer cup face up on the table and place the cap upside down on a clean surface (see Figure I)

(8) Open the ampoule of this product

① Firmly hold the pull ring at the bottom of the ampoule and twist off the top without squeezing the ampoule body (see Figure J)

(9) Pour the full dose of this product into the atomizer cup

①Invert the ampoule and squeeze gently, pour the medicine into the atomizer cup, continue squeezing until the ampoule becomes empty, it is very important to squeeze out all the medicine from the ampoule (see Figure K)

②Screw or snap the cap onto the atomizer cup (see Figure L)

(10) Connect the plastic T

①Connect the plastic T to the atomizer cover (see Figure M)

② If you are using Sidestream atomizer, please attach the mouthpiece to the top of the atomizer (see Figure N)

③If you use a PARI BABY nebulizer, please connect the elbow and mask to the nebulizer outlet (see Figure O)

(11) Connect the long connecting tube to the atomizer mouth

① Push up hard and connect the open end of the long connecting tube to the port at the bottom of the atomizer cup (see Figure P)

(12) Turn on the compressor

① Turn on the compressor and check whether there is fog coming out of the atomizer (see Figure Q)

②Use a nebulizer to take this product

(13) Breathe through the mouthpiece

① If you use PARI BABY To give this product to your child, skip to step 14

②Place the mouthpiece between the teeth and over the tongue (see Figure R)

③Breathe in and out slowly through your mouth without blocking the airflow with your tongue

④Do not breathe through your nose. If you have difficulty breathing through your mouth only, please use a nose clip (see Figure S)

⑤If droplets are formed in the long connecting tube during treatment, please don’t worry. When the atomizer starts to spit out, tap the atomizing cup and continue breathing until the atomizing cup becomes empty or no more mist is produced (see Figure T)

⑥If you need to stop the treatment before it ends, or you start to cough, turn off the compressor and do not spill any medicine

⑦To start treatment again, turn on the compressor and continue to breathe in and out slowly through your mouth

⑧With most nebulizers, it usually takes 10 to 15 minutes to complete the treatment

⑨If you are using a Sidestream nebulizer, treatment usually takes 2 to 6 minutes

⑩It is important to inhale the full dose of this product. If you notice a leak in the nebulizer or feel any moisture during treatment, turn off the compressor and check to make sure the nebulizer cap seals properly before continuing (see Figure U)

If you are using the PARI BABY nebulizer to give your child Pulmozyme, follow the instructions in step 14 below, if not, go to step 15

(14) Breathing through a mask

① During treatment, your child can sit, lie down, or stand

② Put the mask gently but firmly on the child's nose and mouth (see Figure V)

③ Make sure there is no air gap between the mask and the child's face. This will help ensure that your child gets the full dose of this product

④It is important to keep the nebulizer body upright throughout the treatment (see Figure V). The elbows allow you to move the mask to fit it while keeping the nebulizer body upright

⑤When the atomizer starts to "spit out", tap the atomizer cup gently and continue treatment until the atomizer becomes empty or stops producing mist (see Figure W)

⑥If you need to stop treatment or your child starts coughing during treatment, turn off the compressor and do not spill any medicine

⑦If you have not taken off the mask and want to start treatment again, please turn on the compressor

⑧If you have removed the mask, please repeat the above steps to put the mask back on your child's face, and then restart the compressor

⑨A complete treatment usually takes 10 to 15 minutes

⑩It is important that your child inhales a sufficient amount of this product. If you notice a leak in the nebulizer or feel moisture during treatment, turn off the compressor and make sure the nebulizer cap is properly sealed before restarting the compressor (see Figure height="133" src="https://images.rxlist.com/images/rxlist/pulmozyme25.gif" width="125" title="Switch off the compressor and make sure the atomizer cap is properly sealed before starting the compressor again - Figure" _src="https://images.rxlist.com/images/rxlist/pulmozyme25.gif">

After treatment:

(15) Prepare the nebulizer for cleaning and storage

Note: Side-flow nebulizers do not use flexible aerosol tubes

① Turn off the compressor and disassemble the nebulizer system, and set aside the flexible aerosol tube and long connecting tube

② Dispose of the ampoule in your household waste

③ Maintain the atomizer and compressor according to the manufacturer's recommendations

Adverse reactions

The most common side effects include: voice change, sore throat, rash, laryngitis, red eyes, eye irritation, eye inflammation, runny or stuffy nose

Contraindications

Contraindicated in patients with known allergy to Dowase alfa, Chinese Hamster Ovary Cell Products, or any component of the product

Storage Method

Refrigerate at 2-8°C, store in its protective foil to protect from light and heat, do not leave at room temperature for more than 24 hours

Applicable people

Adult. Children, pregnant women and the elderly should use it under the guidance of a physician.

Not clear yet

24 months

Dosage form

Inhaled liquid

Manufacturer

Swiss Roche

Components

The main active ingredient of this product is recombinant human deoxyribonuclease I

Character

It is a sterile, transparent, colorless solution

Precautions

1. Cancer, mutation, and impaired fertility

Using this product will not increase the risk of cancer, and data on affecting fertility have also been observed

2. Specific groups

(1) Embryo-fetal toxicity

No data on fetal harm

(2) Lactation

It is unknown whether this product will be present in human milk and the developmental and health benefits of breastfeeding and the mother's clinical need for this product should be considered as well as any potential adverse effects of this product on the breastfed child or from the underlying maternal condition

(3) Pediatric use

The safety and effectiveness of this product combined with standard treatments for cystic fibrosis have been confirmed in pediatric patients and can be used by children under 17 years old

(4) Elderly use

Cystic fibrosis is primarily a disease of children and young adults, and clinical studies of this product did not include a sufficient number of subjects aged 65 or older to determine whether their responses were different from younger subjects

(The above reference is from the RXList drug information database updated in October 2022)