Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
tobramycin, Quantity: 28 mg
Viatris Pty Ltd
Tobramycin
Capsule, hard
Excipient Ingredients: hypromellose; titanium dioxide; calcium chloride dihydrate; Carnauba Wax; carrageenan; potassium chloride; butan-1-ol; distearoylphosphatidylcholine; isopropyl alcohol; indigo carmine aluminium lake; sulfuric acid; Shellac; purified water; propylene glycol
Inhalation
8 capsules + 1 Podhaler, 224 capsules + 5 Podhalers
(S4) Prescription Only Medicine
TOBI solution and TOBI Podhaler are indicated for the management of cystic fibrosis patients with P. aeruginosa infections. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 less than or equal to 25 % or greater than or equal to 80 % predicted at screening, or patients colonized with Burkholderia cepacia. (See CLINICAL TRIALS)
Visual Identification: Clear, colourless capsule marked in blue with Mylan logo and "MYL TPH"; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2012-03-06
TOBI ® PODHALER ® T O B I ® P o d h a l e r ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING TOBI PODHALER? TOBI Podhaler contains the active ingredient tobramycin. TOBI Podhaler is used to treat lung infections caused by a bacterium called Pseudomonas aeruginosa, in patients who have cystic fibrosis. For more information, see Section 1. Why am I using TOBI Podhaler? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TOBI PODHALER? Do not use if you have ever had an allergic reaction to tobramycin or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use TOBI Podhaler? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with TOBI Podhaler and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE TOBI PODHALER? • The usual dose for all patients aged 6 years and older is 4 capsules for inhalation taken every 12 hours (each morning and evening). • Do not exceed the recommended dose. More instructions can be found in Section 4. How do I use TOBI Podhaler? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TOBI PODHALER? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using TOBI Podhaler. • Once removed from the blister strip, use the capsule immediately. • Use a new Podhaler device after 7 days. Discard the old one. • Tell your doctor if you become pregnant while using TOBI Podhaler. • Keep all of your doctor's appointments so that your progress can be checked. • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using TOBI Podhaler. THINGS Read the complete document
AUSTRALIAN PRODUCT INFORMATION TOBI ® & TOBI ® PODHALER ® _Tobramycin_ _ _ 1 NAME OF THE MEDICINE Tobramycin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TOBI solution for inhalation (TOBI solution) and TOBI Podhaler capsules for inhalation (TOBI Podhaler) are two different formulations of tobramycin specifically developed for administration by inhalation. TOBI SOLUTION FOR INHALATION Each TOBI solution single-use 5 mL ampoule contains 300 mg tobramycin and 11.25 mg sodium chloride in sterile water for injections. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives. TOBI PODHALER Each TOBI Podhaler capsule contains tobramycin 28 mg, distearoylphosphatidylcholine, calcium chloride dihydrate, and sulfuric acid. The hard capsule shell contains hypromellose, potassium chloride, carrageenan, carnauba wax, butan-1-ol, indigo carmine aluminium lake, isopropyl alcohol, propylene glycol, purified water, shellac, titanium dioxide. 3 PHARMACEUTICAL FORM TOBI SOLUTION FOR INHALATION AMPOULE TOBI solution is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebuliser. TOBI PODHALER CAPSULES FOR INHALATION TOBI Podhaler includes clear, colorless hypromellose capsules containing a white to almost-white powder for inhalation. The capsules have ”MYL TPH” in blue radial imprint on one part of the capsule and the Mylan logo in blue radial imprint on the other part of the capsule. The capsules must be administered specifically with a Podhaler® device provided in the same pack. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS TOBI solution and TOBI Podhaler are indicated for the management of cystic fibrosis patients with _P. _ _aeruginosa _infections. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV 1 < 25 % or > 80 % predicte Read the complete document