Tobramycin (Tobi Podhaler)

Trade Name : TOBI Podhaler

Novartis Pharmaceuticals Corporation

CAPSULE

Strength 28 mg/1

TOBRAMYCIN Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tobramycin (Tobi Podhaler) which is also known as TOBI Podhaler and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 28 mg/1 per ml. Read more

Tobramycin (Tobi Podhaler) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • TOBI Podhaler is indicated for the management of cystic fibrosis patients with .
  • Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV) <25% or >80% predicted, or patients colonized with .
  • TOBI Podhaler is an antibacterial aminoglycoside indicated for the management of cystic fibrosis patients with .
  • Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV) <25% or >80%, or patients colonized with ()
  • DO NOT SWALLOW TOBI PODHALER CAPSULES
  • FOR USE WITH THE PODHALER DEVICE ONLY
  • FOR ORAL INHALATION ONLYu00a0
  • TOBI Podhaler capsules must not be swallowed as the intended effects in the lungs will not be obtained. The contents of TOBI Podhaler capsules are only for oral inhalation and should only be used with the Podhaler device.
  • The recommended dosage of TOBI Podhaler for both adults and pediatric patients 6 years of age and older is the inhalation of the contents of four 28 mg TOBI Podhaler capsules twice-daily for 28 days using the Podhaler device.
  • Refer to the Instructions For Use (IFU) for full administration information.
  • Dosage is not adjusted by weight. Each dose of four capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart.
  • TOBI Podhaler is administered twice-daily in alternating periods of 28 days. After 28 days of therapy, patients should stop TOBI Podhaler therapy for the next 28 days, and then resume therapy for the next 28-day on and 28-day off cycle.
  • TOBI Podhaler capsules should always be stored in the blister and each capsule should only be removed IMMEDIATELY BEFORE USE.
  • For patients taking several different inhaled medications and/or performing chest physiotherapy, the order of therapies should follow the physicianu2019s recommendation. It is recommended that TOBI Podhaler is taken last.
  • DO NOT swallow TOBI Podhaler capsules ()n
  • For use with the Podhaler device only ()n
  • For oral inhalation only ()n
  • The recommended dosage is the inhalation of four 28 mg capsules twice-daily for 28 days ()
  • Inhalation powder:
  • 28 mg: clear, colorless hypromellose capsule with u201cNVR AVCIu201d in blue radial imprint on one part of the capsule and the Novartis logo u201cu201d in blue radial imprint on the other part of the capsule.
  • Inhalation powder: 28 mg in a capsule ()
  • TOBI Podhaler is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
  • Known hypersensitivity to any aminoglycoside ()
  • No data
  • Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction (, , )n
  • Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported in clinical trials ()n
  • Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function ()n
  • Bronchospasm can occur with inhalation of TOBI Podhaler ()n
  • Audiograms, serum concentrations, and renal function should be monitored as appropriate ()n
  • Fetal harm can occur when aminoglycosides are administered to a pregnant woman. Apprise women of the potential hazard to the fetus ()
  • The most common adverse reactions (u226510 % of TOBI Podhaler and TOBI patients in primary safety population) are cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, and headache ()
  • No clinical drug interaction studies have been performed with TOBI Podhaler. In clinical studies, patients receiving TOBI Podhaler continued to take dornase alfa, bronchodilators, inhaled corticosteroids, and macrolides. No clinical signs of drug interactions with these medicines were identified.
  • Concurrent and/or sequential use of TOBI Podhaler with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided.
  • Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI Podhaler should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and TOBI Podhaler has not been evaluated.
  • Concurrent and/or sequential use of TOBI Podhaler with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided ()
  • nttu00a0u00a0u00a0u00a0u00a0nt
  • Aminoglycosides can cause fetal harm when administered to a pregnant woman ()
  • Nursing mothers: discontinue drug or nursing, taking into consideration the importance of the drug to the mother ()
  • The maximum tolerated daily dose of TOBI Podhaler has not been established.
  • In the event of accidental oral ingestion of TOBI Podhaler capsules, systemic toxicity is unlikely as tobramycin is poorly absorbed. Tobramycin serum concentrations may be helpful in monitoring overdosage.
  • Acute toxicity should be treated with immediate withdrawal of TOBI Podhaler, and baseline tests of renal function should be undertaken.
  • Hemodialysis may be helpful in removing tobramycin from the body.
  • In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. In the case of any overdosage, the possibility of drug interactions with alterations in drug disposition should be considered.
  • TOBI Podhaler consists of a dry powder formulation of tobramycin for oral inhalation only with the Podhaler device. The inhalation powder is filled into clear, colorless hypromellose capsules.
  • Each clear, colorless hypromellose capsule contains a spray dried powder of 28 mg of tobramycin active ingredient with 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride, and sulfuric acid (for pH adjustment).
  • The active component of TOBI Podhaler is tobramycin. Tobramycin is an aminoglycoside antibiotic. Its chemical name is -3-amino-3-deoxy-u03b1-D-glucopyranosyl-(1u21924)--[2,6-diamino-2,3,6-trideoxy-u03b1-D-ribo-hexopyranosyl-(1u21926)]-2-deoxy-L-streptamine; its structural formula is:
  • Tobramycin has a molecular weight of 467.52, and its empirical formula is CHNO. Tobramycin is a white to almost white powder; visually free from any foreign contaminants. Tobramycin is freely soluble in water, very slightly soluble in ethanol, and practically insoluble in chloroform and ether.
  • The Podhaler device is a plastic device used to inhale the dry powder contained in the TOBI Podhaler capsule. Under standardized testing at a fixed flow rate of 60 L/min and volume of 2 L for 2 seconds, the Podhaler device has a target delivered dose of 102 mg of tobramycin from the mouthpiece (4 capsules per dose). Peak inspiratory flow rate and inhaled volumes were explored in 96 cystic fibrosis patients aged 6 years and older. Older patients with significant disease progression and associated decreases in forced expiratory volume (FEV) and younger patients with inhaled volumes <1 L were able to generate inspiratory flow rates and volumes required to receive their medication when following the instructions for use. However, no pediatric patients aged 6 to 10 years with FEV less than 40% predicted were evaluated.
  • No data
  • Carcinogenicity studies were not conducted with TOBI Podhaler. A 2-year rat inhalation toxicology study to assess carcinogenic potential of TOBI (tobramycin inhalation solution, USP) has been completed. Rats were exposed to TOBI for up to 1.5 hours per day for 95 weeks. Serum levels of tobramycin of up to 35 mcg/mL were measured in rats, in contrast to the maximum 1.99 u00b1 0.59 mcg/mL level observed in cystic fibrosis patients in TOBI Podhaler clinical trials. There was no drug-related increase in the incidence of any variety of tumor.
  • Additionally, tobramycin has been evaluated for genotoxicity in a battery of in vitro and in vivo tests. The Ames bacterial reversion test, conducted with 5 tester strains, failed to show a significant increase in revertants with or without metabolic activation in all strains. Tobramycin was negative in the mouse lymphoma forward mutation assay, did not induce chromosomal aberrations in Chinese hamster ovary cells, and was negative in the mouse micronucleus test.
  • Subcutaneous administration of up to 100 mg/kg of tobramycin did not affect mating behavior or cause impairment of fertility in male or female rats.
  • The Phase 3 clinical development program included two placebo-controlled studies (Studies 2 and 3) and one open-label study (Study 1), which randomized and dosed 157 and 517 patients, respectively, with a clinical diagnosis of cystic fibrosis, confirmed by quantitative pilocarpine iontophoresis sweat chloride test, well-characterized disease causing mutations in each CFTR gene, or abnormal nasal transepithelial potential difference characteristic of cystic fibrosis.
  • In the placebo-controlled studies, all patients were aged between 6 and 21 years old and had an FEV at screening within the range of 25% to 80% (inclusive) of predicted normal values for their age, sex, and height based upon Knudson criteria. In addition, all patients were infected with as demonstrated by a positive sputum or throat culture (or bronchoalveolar lavage) within 6 months prior to screening, and also in a sputum culture taken at the screening visit. Among the 76 patients treated with TOBI Podhaler, 37% were males and 63% were females. Thirty-six patients were between 6 and 12 years of age, and 40 patients were between 13 and 21 years of age. Patients had a mean baseline FEV of 56% of predicted normal value.
  • In both studies, >90% of patients received concomitant therapies for cystic fibrosis-related indications. The most frequently used other antibacterial drugs (any route of administration) were azithromycin, ciprofloxacin, and ceftazidime. Consistent with the population of cystic fibrosis patients, the most frequently used concomitant medications included oral pancreatic enzyme preparations, mucolytics (especially dornase alfa), and selective u03b22-adrenoreceptor agonists.
  • Study 2
  • Study 2 was a randomized, 3-cycle, 2-arm trial. Each cycle comprised of 28 days on treatment followed by 28 days off treatment. The first cycle was double-blind, placebo-controlled with eligible patients randomized 1:1 to TOBI Podhaler (4 times 28 mg capsules twice-daily) or placebo. Upon completion of the first cycle, patients who were randomized to the placebo treatment group received TOBI Podhaler for Cycles 2 and 3. The total treatment period was 24 weeks.
  • A total of 95 patients were randomized into Study 2 and received TOBI Podhaler (n=46) or placebo (n=49) in Cycle 1. All patients were less than 22 years of age (mean age 13.3 years) and had not received inhaled antipseudomonal antibiotics within four months prior to screening; 56% were female and 84% were Caucasian. This study was stopped early for demonstrated benefit and the primary analysis used the set of patients included in the interim analysis (n=79); 16 patients did not have data on the primary endpoint at that time. Of the 79 patients included in the interim analysis, 18 patients were excluded due to a failure to meet spirometry quality review criteria as determined by an external review panel. This resulted in a total of 61 patients, 29 in the TOBI Podhaler arm and 32 in the placebo arm, who were included in the primary analysis.
  • In the primary analysis, TOBI Podhaler significantly improved lung function compared with placebo as measured by the relative change in FEV % predicted from baseline to the end of Cycle 1 dosing. This analysis adjusted for the covariates of baseline FEV % predicted, age, and region, and imputed for missing data. Treatment with TOBI Podhaler and placebo resulted in relative increases in FEV % predicted of 12.54% and 0.09%, respectively (LS mean difference = 12.44%; 95% CI: 4.89, 20.00; p=0.002). Analysis of absolute changes in FEV % predicted showed LS means of 6.38% for TOBI Podhaler and -0.52% for placebo with a difference of 6.90% (95% CI: 2.40, 11.40). Improvements in lung function were achieved during the subsequent cycles of treatment with TOBI Podhaler, although the magnitude was reduced (Figure 1).
  • The percentage of patients using new antipseudomonal antibiotics in Cycle 1 was greater in the placebo treatment group (18.4%) compared with the TOBI Podhaler treatment group (13.1%). During the first cycle, 8.7% of TOBI Podhaler patients and 10.2% of placebo patients were treated with parenteral antipseudomonal antibiotics. In Cycle 1, two patients (4.4%) in the TOBI Podhaler treatment group required respiratory-related hospitalizations, compared with six patients (12.2%) in the placebo treatment group.
  • u00a0u00a0u00a0u00a0u00a0Error bars represent the mean relative change (95% CI)
  • Study 3
  • Study 3 was a randomized, double-blind, placebo-controlled trial, similar in design to Study 2. Eligible patients were randomized 1:1 to receive TOBI Podhaler (4 times 28 mg capsules twice-daily) or placebo for one cycle (28 days on-treatment and 28 days off-treatment).
  • A total of 62 patients were randomized into Study 3 and allocated to TOBI Podhaler (n=32) or placebo (n=30). All patients were less than 22 years of age (mean age 12.9 years) and had not received inhaled antipseudomonal antibiotics within 4 months prior to screening; 64.5% were female and 98.4% were Caucasian.
  • In this study, the results were not statistically significant for the primary lung function endpoint when adjusting for the covariates of age (<13 years, u226513 years) and FEV % predicted at screening (<50%, u226550%) and imputing for missing data. Improvement in lung function for TOBI Podhaler compared with placebo was evaluated using the relative change in FEV % predicted from baseline to the end of Cycle 1 dosing. Treatment with TOBI Podhaler (8.19%) compared to placebo (2.27%) failed to achieve statistical significance in relative change in FEV % predicted (LS mean difference = 5.91%; 95% CI: -2.54, 14.37; p=0.167). Analyses of absolute changes in FEV % predicted showed LS means of 4.86% for TOBI Podhaler and 0.48% for placebo with a difference of 4.38% (95% CI:-0.17, 8.94).
  • Study 1
  • Study 1 was a randomized, open-label, active-controlled parallel arm trial. Eligible patients were randomized 3:2 to TOBI Podhaler (4 times 28 mg capsules twice-daily) or TOBI (300 mg/5 mL twice-daily). Treatment was administered for 28 days, followed by 28 days off therapy (one cycle) for three cycles. The total treatment period was 24 weeks. The time to administer a dose of TOBI Podhaler (10 to 90 percentiles) ranged from 2 to 7 minutes at the end of the dosing period for Cycle 1, and 2 to 6 minutes at the end of the dosing period for Cycle 3.
  • A total of 517 patients were randomized in Study 1 and received TOBI Podhaler (n=308) or TOBI (n=209). Patients were predominantly 20 years of age or older (mean age 25.6 years) with no inhaled antipseudomonal antibiotic use within 28 days prior to study drug administration; 45% were female and 91% were Caucasian.
  • The primary purpose of Study 1 was to evaluate safety. Interpretation of efficacy results in Study 1 is limited by several factors including open-label design, testing of multiple secondary endpoints, and missing values for the outcome of FEV % predicted. The number (%) of patients with missing values for FEV % predicted at Weeks 5 and 25 in the TOBI Podhaler treated group were 40 (13.0%) and 86 (27.9%) compared to 15 (7.2%) and 40 (19.1%) in the TOBI treated group. Using imputation of the missing data, the mean differences (TOBI Podhaler minus TOBI) in the percent relative change from baseline in FEV % predicted at Weeks 5 and 25 were -0.87 (95% CI: -3.80, 2.07) and 1.62 (95% CI: -0.90, 4.14), respectively.
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Information for Patients
  • Information on the long-term efficacy and safety of TOBI Podhaler is limited. There is no information in patients with limited pulmonary reserve (FEV <25% predicted). Decreased susceptibility of Pseudomonas aeruginosa to tobramycin has been seen with use of TOBI Podhaler. The relationship between in vitro susceptibility test results and clinical outcome with TOBI Podhaler therapy is not clear. Occurrence of decreased susceptibility on treatment should be monitored, and treatment with an alternative therapy should be considered if clinical worsening is observed.
  • TOBI Podhaler may not be tolerated by all patients. Patients should be instructed to consider alternative therapy if they are unable to tolerate TOBI Podhaler. Patients should be advised to complete a full 28-day course of TOBI Podhaler, even if they are feeling better. After 28 days of therapy, patients should stop TOBI Podhaler therapy for the next 28 days, and then resume therapy for the next 28-day on and 28-day off cycle.
  • Patients should be advised that if they have been prescribed a 7-day pack of TOBI Podhaler either immediately before or during a 28-day treatment with TOBI Podhaler, then they must count each day of use toward the 28 day on-treatment part of their cycle. Patients should only take a total of 28 consecutive days of treatment during a cycle.
  • Similarly, patients should be advised that if they have been prescribed a 1-day pack of TOBI Podhaler either immediately before or during a 28-day treatment with TOBI Podhaler, then they must count each day of use toward the 28 day on-treatment part of their cycle. Patients should only take a total of 28 consecutive days of treatment during a cycle.
  • It is important for patients to understand how to correctly administer TOBI Podhaler capsules using the Podhaler device. It is recommended that caregivers and patients be adequately trained in the proper use of the TOBI Podhaler prior to use. [See Instructions for Use at the end of the Patient Information leaflet.] Caregivers should provide assistance to children using TOBI Podhaler (including preparing the dose for inhalation) particularly for those aged 10 years or younger, and should continue to supervise them until they are able to use the Podhaler device properly without help.
  • For patients taking several different inhaled medications and/or performing chest physiotherapy, advise the patient regarding the order in which they should take the therapies. It is recommended that TOBI Podhaler be taken last.
  • Ototoxicity
  • Inform patients that ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI Podhaler clinical studies. Physicians should consider an audiogram at baseline, particularly for patients at increased risk of auditory dysfunction. If a patient reports tinnitus or hearing loss during TOBI Podhaler therapy, the physician should refer that patient for audiological assessment.
  • Patients should be reminded that vestibular toxicity may manifest as vertigo, ataxia, or dizziness.n
  • Bronchospasm
  • Inform patients that bronchospasm can occur with inhalation of TOBI Podhaler.
  • Risks Associated with Aminoglycosides
  • Inform patients of adverse reactions associated with aminoglycosides such as nephrotoxicity and neuromuscular disorders.
  • Laboratory Tests
  • Inform patients of the need to monitor hearing, serum concentrations of tobramycin, or renal function as necessary during treatment with TOBI Podhaler.
  • Pregnancy
  • Inform patients that aminoglycosides can cause fetal harm when administered to a pregnant woman. Advise them to inform their doctor if they are pregnant, become pregnant, or plan to become pregnant.
  • Cough
  • Inform patients that cough was reported with the use of TOBI Podhaler in clinical trials. If coughing that may be experienced with TOBI Podhaler becomes bothersome or cannot be tolerated, advise patients that tobramycin inhalation solution or alternative therapeutic options may be considered.
  • T2015-141October 2015
  • Patient Information
  • TOBI (TOH-bee) Podhaler (POD-hay-ler)
  • (tobramycin inhalation powder)
  • For Oral Inhalation
  • Important information: Do not swallow TOBI Podhaler capsules. TOBI Podhaler capsules are used only with the Podhaler device and inhaled through your mouth (oral inhalation). Never place a capsule in the mouthpiece of the Podhaler device.
  • Read this Patient Information before you start using TOBI Podhaler and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • What is TOBI Podhaler?
  • TOBI Podhaler is a prescription medicine used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. TOBI Podhaler contains an antibacterial medicine called tobramycin (an aminoglycoside).
  • It is not known if TOBI Podhaler is safe and effective:
  • Who should not use TOBI Podhaler?
  • Do not use TOBI Podhaler if you are allergic to tobramycin, any of the ingredients in TOBI Podhaler, or to any other aminoglycoside antibacterial.
  • What should I tell my healthcare provider before using TOBI Podhaler?
  • Before you use TOBI Podhaler, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take
  • Using TOBI Podhaler with certain other medicines can cause serious side effects.
  • If you are using TOBI Podhaler, you should discuss with your healthcare provider if you should take:
  • 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.
  • How should I use TOBI Podhaler?
  • What are the possible side effects of TOBI Podhaler?
  • TOBI Podhaler can cause serious side effects, including:
  • The most common side effects of TOBI Podhaler include:
  • Laboratory tests show reduced tobramycin activity against bacteria in some patients with the use of TOBI Podhaler. The relationship between these lab results and how well TOBI Podhaler works is not clear. Let your healthcare provider know if your symptoms worsen.
  • Some patients may be unable to continue TOBI Podhaler and need to consider alternative therapies. Tell your healthcare provider about any side effect that bothers you enough to stop treatment or that does not go away.
  • These are not all of the possible side effects of TOBI Podhaler. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • General information about the safe and effective use of TOBI Podhaler.
  • Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use TOBI Podhaler for a condition for which it was not prescribed. Do not give TOBI Podhaler to other people, even if they have the same problem you have. It may harm them.
  • This leaflet summarizes the most important information about TOBI Podhaler. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about TOBI Podhaler that was written for healthcare professionals.
  • For more information, go to www.TOBIPodhaler.com or call 1-877-999-TOBI (8624).
  • What are the ingredients in TOBI Podhaler?
  • Active ingredient: tobramycin
  • Inactive ingredients: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride, and sulfuric acid (for pH adjustment)
  • What is n- Pseudomonas aeruginosa?
  • 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.
  • T2015-40March 2015
  • Instructions for Use
  • TOBI Podhaler
  • Important Information:
  • Follow the instructions below for using your TOBI Podhaler. You will breathe in (inhale) the medicine in the TOBI Podhaler capsules using the Podhaler device. If you have any questions, ask your healthcare provider or pharmacist.
  • TOBI Podhaler is available as a 28-day, 7-day, and 1-day supply package.
  • Each TOBI Podhaler package contains (See Figure A):
  • Or:
  • Or:
  • Note:
  • Getting ready:
  • Preparing your TOBI Podhaler dose
  • Your Podhaler device comes in a storage case with a lid. The device itself has a removable mouthpiece, a capsule chamber and a button at its base (See Figure C).
  • Step 1:
  • Step 2:
  • Step 3:
  • Note: Each blister card contains 8 TOBI Podhaler capsules - 4 capsules for inhalation in the morning and 4 capsules for inhalation in the evening.
  • Step 4:
  • Step 5:
  • Step 6: n- Note:
  • Step 7: n- Do not
  • Step 8: n- Do not
  • Step 9: n- Do not
  • Taking your TOBI Podhaler dose (you will need to repeat steps 10 to 14 for each capsule so you inhale each capsule 2 times in order to empty it):
  • Step 10: n- Do not
  • Step 11:
  • Step 12:
  • Step 13: Removen- hold your breath
  • Step 14: n- Do not
  • Step 15: n- using the same capsule.
  • Step 16:
  • Step 17:
  • u00a0u00a0u00a0u00a0u00a0If the capsule empty, see u201cWhat to do with a capsule that has not been emptiedu201d below for instructions.
  • What to do with a capsule that has not been emptied:
  • Note:
  • Step 18:
  • After your TOBI Podhaler dose:
  • Step 19: n- Do not
  • Step 20: n- Do not
  • Step 21: n- dry cloth
  • Step 22:
  • Step 23:
  • How should I store TOBI Podhaler?
  • This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936
  • u00a9 Novartis
  • T2016-101December 2016
  • Revised: December 2016
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 28 mg per capsule
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0630-35
  • TOBIu2122 Podhaleru2122
  • (tobramycin inhalation powder)
  • 28 mg per capsule
  • 4 weekly packs x 56 capsules per pack
  • For Oral Inhalation Only
  • Do not swallow TOBIu00ae Podhaleru2122 capsules
  • TOBIu00ae Podhaleru2122 capsules are for use with the Podhaleru2122 device only
  • Contents:4 weekly packs, each containing:56 capsules (7 blister cards of 8 capsules)1 Podhaleru2122 devicePatient information leaflet1 Reserve Podhaleru2122 devicePrescribing Information

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