1 mg / ml (2,500 U / 2.5 ml) solution for the alpha of the nebulizer thorns

What Pulmozyme is and what it is used for

Pulmozyme contains the alpha active ingredient alpha. It is a manufactured version of a protein that is found in your body and is called DNase.

Pulmozyme is used in patients with cystic fibrosis. It works by dissolving the thick mucus present in the lungs. This helps the lungs of patients with cystic fibrosis to function better.

Pulmozyme is inhaled (inhaled) with something called a nebulizer (see section 3: How to use Pulmozyme). You will usually continue to take your other medicines for cystic fibrosis while taking Pulmozyme (see “Other medicines and Pulmozyme” in section 2).

What you need to know before you use Pulmozyme

Do not use Pulmozyme

  • if you are allergic (hypersensitive) to the alpha of thorns or any of the other ingredients of Pulmozyme (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Pulmozyme.

Children

Pulmozyme is not recommended for children under 5 years of age. Talk to your doctor or pharmacist before using Pulmozyme if it has been prescribed for a child under 5 years of age.

Other medicines and Pulmozyme

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and natural remedies. This is because Pulmozyme may affect the effectiveness of other medicines. In addition, other medicines may affect the way Pulmozyme works.

You can continue to take your other common medicines for cystic fibrosis while taking Pulmozyme (for example, antibiotics, pancreatic enzymes, bronchodilators, and painkillers). If you are not sure before using Pulmozyme, talk to your doctor or pharmacist.

Pregnancy and breastfeeding

Do not use Pulmozyme if you are pregnant, trying to conceive, or breastfeeding, unless your doctor tells you to.

Driving and using machines

Pulmozyme is unlikely to affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Pulmozyme

Always use Pulmozyme exactly as your doctor has told you. Pulmozyme is inhaled (inhaled) using a nebulizer (see “Which nebulizer to use”). Consult a doctor if you are unsure.

During the Pulmozyme treatment, you should continue with your standard treatment with breathing exercises.

People who are 5 years or older

  • You should use Pulmozyme every day.
  • The recommended dose is one ampoule each day, inhaled using your nebulizer.
  • If you are over 21 years old, your doctor may tell you to take one ampoule twice a day.

Persons under 5 years

Pulmozyme is not recommended for children under 5 years of age.

Which nebulizer to use

Use a nebulizer such as:

  • Hudson T Up-draft II / Pulmo-Aide, Airlife Misty / Pulmo-Aide, custom-made Respirgard / Pulmo-Aide, or AcornII / Pulmo-Aide.
  • Pulmozyme can also be used with a reusable nebulization system such as Pari LL / Inhailerboy, Pari LC / Inhailerboy, or Master. Aiolos / 2 Aiolos, Side Stream / CR50 or MobilAire or Porta -Neb.
  • Part eFlow Rapid nebulizer, a general electronic nebulizer with a vibrating diaphragm can be used. Part eFlow Rapid nebulizer should be cleaned according to the manufacturer’s instructions. In addition, it is recommended that the Pari Easycare cleaning additive be used after every seventh use.
  • Ultrasonic nebulizers should not be used as they may prevent Pulmozyme from working properly.

Carefully read and follow the manufacturer’s instructions for using each nebulizer. Talk to your doctor who can tell you which nebulizer can be used with Pulmozyme.

How to use Pulmozyme with the nebulizer

When preparing the nebulizer for use with Pulmozyme, keep these important points in mind :

  • Do not mix Pulmozyme with other liquids or medicines in the nebulizer.
  • Do not use leftover Pulmozyme, this should always be discarded.
  • If you have a reusable nebulizer, remember to clean it after use. The manufacturer of the nebulizer can advise on the best way to clean the nebulizer after using Pulmozyme.
  • If anyone else uses your Pulmozyme accidentally, they should contact a doctor immediately.

Using your nebulizer

  • Make sure the nebulizer is clean.
  • Break off the top of a Pulmozyme ampoule.
  • Pour the contents into the nebulizer chamber.
  • Follow the nebulizer instructions and inhale Pulmozyme at once.

If you use more Pulmozyme than you should

If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice.

If you forget to use Pulmozyme

• If you forget to take a dose, take it as soon as you remember.

• If it is soon time for your next dose, do not take the missed dose.

Do not take a double dose to make up for a forgotten dose.

If you stop using Pulmozyme

If you stop using Pulmozyme, your chest symptoms may get worse. Talk to your doctor if you would like to stop using Pulmozyme.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Pulmozyme can cause side effects, although not everybody gets them. Pulmozyme side effects are uncommon. They occur in less than 1 in 1000 users.

Side effects include:

  • Chest pain.
  • Fever.
  • Anxious stomach (indigestion).
  • Changes in the voice, including hoarseness or loss of voice.
  • Sore throat.
  • Difficulty breathing.
  • Runny or stuffy nose and sneezing ( rhinitis ).
  • Irritation of the eye ( conjunctivitis ). Symptoms include red and itchy eyes and discharge from the eye.
  • Skin rash, which may be uneven and itchy ( hives ).
  • When you start treatment, your lung function may deteriorate and you may form more mucus than normal. This effect is usually transient.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Pulmozyme

  • The Pulmozyme ampoules should be stored in a refrigerator (2ºC -8ºC) in the original carton. Sensitive to light.
  • You can still use an ampoule if it has been left outside the refrigerator for a short time at a higher temperature (only stored outside the refrigerator once and for a maximum of 24 hours at a maximum of 30ºC).
  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
  • Do not dispose of leftover ampoules in drains or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Keep them only if your doctor tells you to.

Contents of the pack and other information

Marketing Authorization Holder and Manufacturer

Content declaration

  • The active substance of Pulmozyme 1 mg/ml (2,500 U / 2.5 ml), nebulizer solution is the alpha of the thorns. This is also called recombinant human deoxyribonuclease I or rhDNase. 2.5 ml solution contains 2500 units (or 2.5 mg) of alpha thorns.
  • The other ingredients are sodium chloride, calcium chloride dihydrate, and water for injections.

What Pulmozyme Nebulizer Solution looks like and what contents of the pack
Pulmozyme solution for nebulizer is supplied in clear plastic ampoules. The ampoules contain 2.5 ml of liquid. The drug is clear and colorless to slightly yellowish.

Pulmozyme is available in cartons containing 6 or 30 ampoules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Roche AB
Box 1228

171 23 Solna

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Muhammad Nadeem

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