"Therapeutically equivalent" to Bethkis^® means that Teva's Tobramycin Inhalation Solution is approved by the FDA as therapeutically the same as Bethkis^®.  Teva’s Tobramycin Inhalation Solution has the same active ingredient as Bethkis®.  It works in the body the same way as Bethkis® does to help improve lung function.

Tobramycin Inhalation Solution is a prescription medicine that is used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. Tobramycin Inhalation Solution contains an antibacterial medicine called tobramycin (an aminoglycoside).

It is not known if Tobramycin Inhalation Solution is safe and effective:

- in children under 6 years of age

- in people who have decreased lung volume or a forced expiratory volume in one second (FEV₁) less than 40% or greater than 80% predicted

- in people who are colonized with a bacterium called Burkholderia cepacian

1. See the step-by-step Instructions for Use at the end of the Patient Information leaflet about the right way to take your Tobramycin Inhalation Solution.
2. Take Tobramycin Inhalation Solution exactly as your healthcare provider tells you to. Do not change your dose or stop taking Tobramycin Inhalation Solution unless your healthcare provider tells you to.
3. The usual dose of Tobramycin Inhalation Solution for adults and children over 6 years of age is:
   1. 1 single-dose ampule of Tobramycin Inhalation Solution inhaled 2 times each day using your hand-held PARI LC PLUS Reusable Nebulizer with a PARI Vios air compressor.
4. Each dose of Tobramycin Inhalation Solution should be taken as close to 12 hours apart as possible.
5. You should not take your dose of Tobramycin Inhalation Solution less than 6 hours apart.
6. Tobramycin Inhalation Solution is taken as a breathing treatment (inhalation) with a hand-held PARI LC Reusable Nebulizer with a PARI Vios air compressor. Do not use any other nebulizer for your Tobramycin Inhalation Solution treatment.
7. Do not mix or dilute Tobramycin Inhalation Solution with dornase alfa or other medicines in your nebulizer system.
8. Each treatment of Tobramycin Inhalation Solution should take about 15 minutes.
9. Tobramycin Inhalation Solution should be inhaled while you are sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Nose clips may help you to breathe through your mouth.
10. If you forget to take Tobramycin Inhalation Solution and there are at least 6 hours to your next dose, take your dose as soon as you can. Otherwise, wait for your next dose. Do not double the dose to make up for the missed dose.
11. After taking Tobramycin Inhalation Solution for 28 days, you should stop taking it and wait 28 days. After you have stopped taking Tobramycin Inhalation Solution for 28 days, you should start taking Tobramycin Inhalation Solution again for 28 days. Complete the full 28-day course even if you are feeling better. It is important that you keep to the 28-day on, 28-day off cycle.

If you are taking several other medicines or treatments to treat your cystic fibrosis, you should take your medicines or other treatments before inhaling Tobramycin Inhalation Solution or as directed by your healthcare provider.

Taking Tobramycin Inhalation Solution with certain other medicines can cause serious side effects.

If you are taking Tobramycin Inhalation Solution, you should discuss with your healthcare provider if you should take:

   - other medicines that may harm your nervous system, kidneys, or hearing

   - “water pills” (diuretics) such as ethacrynic acid, furosemide, or intravenous mannitol

   - Urea

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

If you take too much Tobramycin Inhalation Solution, call your healthcare provider or go to the nearest hospital emergency room right away.

Tobramycin Inhalation Solution can cause serious side effects, including:

      - hearing loss or ringing in the ears (ototoxicity). Some people who were treated with tobramycin, the medicine in Tobramycin Inhalation Solution had hearing loss or ringing in the ears. Tell your healthcare provider right away if you have hearing loss or hear noises in your ears (such as ringing or hissing), or if you develop vertigo, dizziness, or difficulty with balance.

      - worsening kidney problems (nephrotoxicity). Your healthcare provider may do a blood test and urine test to check how your kidneys are working while you are taking Tobramycin Inhalation Solution.

      - worsening muscle weakness (neuromuscular disorder). Tobramycin Inhalation Solution can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis or Parkinson’s disease).

      - severe breathing problems (bronchospasm). Tell your healthcare provider right away if you get any of these symptoms of bronchospasm while taking Tobramycin Inhalation Solution:

             - shortness of breath with wheezing

             - coughing and chest tightness

The most common side effects of Tobramycin Inhalation Solution include:

     - worsening of lung problems or cystic fibrosis

     - noisy breathing (rales)

     - abnormal red blood cell activity

     - changes in your voice (hoarseness)

These are not all of the possible side effects of Tobramycin Inhalation Solution.

Call your doctor for medical advice about side effects. You may report side effects to FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later in their lives, while others get it very young. It is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly managed, it will continue to damage your lungs causing further problems to your breathing.

Store Tobramycin Inhalation Solution in the refrigerator at 36°F to 46°F (2°C to 8°C) until needed.

After removing from the refrigerator, or if refrigeration is not available, Tobramycin Inhalation Solution foil pouches (opened or unopened) may be stored at room temperature up to 77 °F (25 °C) for up to 28 days.

If Tobramycin Inhalation Solution is not stored in the refrigerator but at room temperature up to 77 °F (25 °C) it may turn dark. If Tobramycin Inhalation Solution turns dark, it does not change how well Tobramycin Inhalation Solution works. Tobramycin Inhalation Solution can still be used as long as it is stored at room temperature up to 77 °F (25 °C).

Do not use Tobramycin Inhalation Solution after the expiration date printed on the ampule.

Keep Tobramycin Inhalation Solution ampules in the foil pouch and away from light.

Return unopened ampules to the foil pouch.

Keep Tobramycin Inhalation Solution and all medicines out of the reach of children.

Talk to your healthcare provider if you need additional to keep at work, school or other locations. Your prescription should include the number you need. If you are using insurance, the insurance provider may have a maximum number of units they will cover per prescription. Contact your insurance provider for details about your plan.