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Frequent asked questions - and answers - archive

What happens when the cartridge with the drug in the Novolizer is empty? How do I know, when the cartridge is empty?
One cartridge of the Novolizer contains 100 or 200 doses of the active substance. The dose counter window shows the number of doses available in the cartridge.

The dose counter starts to count with 100 or 200, respectively, and indicates continuously the number of doses left in the cartridge. During use of the device a labelled scale on the cartridge moves slowly through the dose counter window, step by step, for every single dose taken. To facilitate the readability of the scale the doses are labelled in steps of 20 : "200 - 180 - 160 - ... until 60 and then in steps of 10: "200 - 180 - 160 - ... - 60 - 50 - 40 ."

You should visit the doctor for a new prescription when the dose counter window shows "20" doses left. Then the medication will last for at least another 10 days. A hatched field appears after the number "20" in the dose counter window, which serves as an additional visual reminder indicating that less than 20 doses are left in the cartridge.

You will replace the empty cartridge with a new one when the dose counter window shows "0" doses left in the cartridge at the latest. Even when the dose counter window shows "0" doses left there is still a small amount of drug kept in reserve in the cartridge to provide safe therapy in case of need.

The mechanism of the dose metering button and the mechanism of the control window (RED/GREEN) are not blocked, when the dose counter window shows "0" doses left. However, the empty cartridge should be replaced at this point at the latest.

(This description applies only for the Novolizer device marketed in Europe)

Are there any differences in the therapeutic effect when inhaling through the Novolizer® and inhaling through a pMDI?
Both the pMDI and the Novolizer® contain the same active substance.The kind of application with the two devices is different:

a) In the pMDI, the active substance is in a liquid; a propellant free of chlorofluorocarbon (CFC) gases drives dose release and aerosol formation.

b) In the Novolizer®, the active substance is a powder, aggregated to lactose. The device is breath-actuated and during inhalation through the Novolizer® the active substance is de-aggregated from the lactose particles by a whirl mechanism. The fine particle fraction of the active substance is inhaled into the lungs.

The Novolizer® offers multiple feedback mechanisms confirming correct performed inhalation and giving reassurance about successful delivery of the drug. The Novolizer® is easy to use correctly.

With pMDI following steps for inhalation are required:

  1. Remove cap and shake inhaler.
  2. Breathe out gently.
  3. Put mouthpiece in mouth and at start of inspiration, which should be slow and deep, press canister down and continue to inhale deeply.
  4. Hold breath for 10 seconds, or as long as possible then breathe out slowly.
  5. Wait for a few seconds before repeating steps 2-4.

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How do I or my doctor decide that the Novolizer® is the right inhalation system for me?
The most easy way to decide on this is to inhale through a Novolizer® device for demonstration. This device is identical with the original marketed product and has the same technical features. The only difference is the empty cartridge - without active substance. Using this device for demonstration with its visual and acoustic controls, your physician can instruct you and decide on the suitability of the Novolizer® for you. If you inhaled correctly this will be confirmed by the multiple feedback mechanisms of the Novolizer®. You can try and assure yourself of the correct and successful use of the product.

Do Novolizer® products contain gluten?
No, Novolizer® products are free of gluten (gluten: grain protein). This is important information for patients with coeliac disease, a gluten induced disorder of the mucosa of the small intestine. Even very small amounts of gluten could cause serious enteropathic reactions. The only option is to avoid gluten. Patients with coeliac disease need to be informed that Novolizer® products contain lactose. At the beginning of their gluten free diet, patients should avoid lactose due to a secondary lactase deficiency, which is usually back to normal after about three months.

Can children with lactose intolerance take Novolizer® products?
Children with lactose intolerance may be treated with the Novolizer® products. The amount of lactose absorbed by the mucosa of the gastrointestinal tract, which is relevant in case of lactose intolerance, is minimal. Lactose intolerance is based on the lack of the enzyme lactase, it is not based on an immune response where extremely small amounts could cause an allergic reaction. For patients with lactose intolerance the oral intake of lactose can result in diarrhoea. A much higher amount of lactose than the amount swallowed during inhalation through the Novolizer® products could induce this reaction. Please ask for your own doctors' advice.