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Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Telephone: +44 (0)1276 692 255
Fax: +44 (0)1276 698 449
Medical Information Direct Line: +44 (0)1276 698 370
Medical Information e-mail: medinfo.uk@novartis.com
Customer Care direct line: +44 (0)845 741 9442

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 26/09/2011
SPC Tobi 300 mg/5 ml Nebuliser Solution

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 26/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   26-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In Section 4.2 the following wording as shown has ben deleted under sub-headings "Posology" and "Patients with renal impairment":

For data on the degree of absorption of tobramycin after inhalation treatment, please refer to information in section 5.2.

Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin. Patients with serum creatinine 2 mg/dL or more or blood urea nitrogen (BUN) 40 mg/dL or more were not included in clinical studies and

In Section 5.1 under the heading "Other information" the following wording has been deleted/inserted as shown below.

An open-label, uncontrolled study in CF patients aged 6 months and above (including 48 patients below 6 years of age) explored the effect of 28-day and 56-day TOBI treatment on early, non-chronic infection with P.aeruginosa. Both regimens were well-tolerated and resulted in over 90% of the patients being free from P.aeruginosa 1 month after treatment end. Adequately controlled clinical data are not available to date in this population.

 

There are insufficient clinical safety and efficacy data in children < 6 years of age.

In an open-label uncontrolled study, 88 patients with CF (37 patients between 6 months and 6 years, 41 patients  between 6 and18 years of age and 10 patients above 18 years of age) with early (non-chronic) P aeruginosa infection were treated for 28 days with TOBI. After 28 days, patients were randomised 1:1 to either stop (n=45) or to receive a further 28 days treatment (n=43).

Primary outcome was the median time to recurrence of P aeruginosa (any strain ) which was 26.1 and 25.8 months for the 28-day and 56-day groups, respectively. It was found that; 93% and 92% of the patients were free of P aeruginosa infection 1 month after the end of treatment in the 28-day and 56-day groups, respectively. Adequately controlled clinical data are not available to date in this population . The use of TOBI with a dosing regimen longer than 28 days continuous treatment, is not approved.



In Section 5.2 the wording has been amended as shown below.

The median serum concentration of tobramycin 1 hour after inhalation of a single 300 mg dose of TOBI by CF patients was 0.95 mg/mL (range: below limit of quantitation [BLQ] – 3.62μg/mL). After 20 weeks of therapy on the TOBI regimen, the median serum tobramycin concentration 1 hour after dosing was 1.05 mg/mL (range: BLQ- 3.41μg/mL). by amean

The median serum concentration of tobramycin 1 hour after inhalation of a single 300 mg dose of TOBI by CF patients was 0.95 µg/mL (range: below limit of quantitation [BLQ] – 3.62µg/mL). After 20 weeks of therapy on the TOBI regimen, the median serum tobramycin concentration 1 hour after dosing was 1.05 µg/mL (range: BLQ- 3.41µg/mL).For comparison. the  peak concentrations after intravenous or intramuscular administration of a single tobramycin dose of 1.5 to 2mg/kg typically range from 4 to 12 µg/mL.  

 

 

 

Elimination

 

The elimination of tobramycin administered by the inhalation route has not been studied. Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin, however data are not available as .p atients with serum creatinine 2 mg/dL (176,8 mmol/L) or more or blood urea nitrogen (BUN) 40 mg/dL or more were not included in clinical studies.


 

 

 
Updated on 28/10/2010 and displayed until 26/09/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3

Administration of TOBI is contraindicated in any patient with known hypersensitivity to any aminoglycoside or any of the excipients (section 6.1)..


Section 4.8

In controlled clinical trials, voice alterationdysphonia and tinnitus were the only undesirable effects reported in significantly more patients treated with TOBI; (13% TOBI vs 7% control) and (3% TOBI vs 0% control) respectively. These episodes of tinnitus were transient and resolved without discontinuation of TOBI therapy, and were not associated with permanent loss of hearing on audiogram testing. The risk of tinnitus did not increase with repeated cycles of exposure to TOBI.

 

Additional undesirable effects, some of which are common sequelae of the underlying disease, but where a causal relationship to TOBI could not be excluded were: sputum discolouredation, respiratory tract infection, myalgia, nasal polyps and otitis media.

 

In the POSTMARKETING phase, undesirable effects have been reported at the following frequencies:

 

 

 

 

Body as a Whole

 

 

 

Rare:

Chest pain, Asthenia, Fever, Headache, Pain,

Very Rare:

Abdominal pain, Fungal infection, Malaise, Back pain, Allergic reactions including urticaria and pruritus

Infections and infestations

 

Rare:

Laryngitis

Very Rare:

Oral candidiasis, fungal infection

Blood and lymphatic system disorders

 

Very Rare:

Lymphadenopathy

Immune system disorders

 

Very Rare:

Hypersensitivity

Metabolism and nutrition disorders

 

Rare:

Anorexia

Nervous system disorders

 

 

Rare:

Headache, Ddizziness, aphonia

 

Very Rare:

Somnolence

 

Ear and labyrinth disorders

 

 

 

Rare:

Tinnitus, Taste perversion, Hhearing loss, Aphonia

Very Rare:

Ear disorder, Eear pain

Respiratory, thoracic and mediastinal disorders

 

 

Uncommon:

Voice alteration, Dysphonia, dyspnoea, Ccough increased, Ppharyngitis

Rare:

Bronchospasm, chest discomfort, tightness, cough, shortness of breath, Llung disorder, productive cough, Sputum Increased, Hhaemoptysis, Lung function decreased, Laryngitis, Eepistaxis, Rrhinitis, Aasthma

Very Rare:

Hyperventilation, Hhypoxia, Ssinusitis

Digestive SystemGastrointestinal disorders

 

Rare:

Dysgeusia, Nnausea, Anorexia, Mmouth ulceration, Vvomiting

Very Rare:

Diarrhoea, abdominal painOral moniliasis

 

Skin and subcutaneous tissue disorders

 

Rare:

Rash

Very Rare:

Urticaria, pruritus

Musculoskeletal, connective tissue and bone disorders

Very Rare:

Back pain

General disorders and administration site conditions

Rare:

Asthenia, pyrexia, chest pain, pain

Very Rare:

Malaise

Investigations

 

Rare:

Pulmonary function test decreased

Haemic and Lymphatic System

 

 

 

Very Rare:

Lymphadenopathy

 

Nervous System

 

 

 

Rare:

Dizziness

 

 

Very Rare:

Somnolence

 

 

Respiratory System

 

 

 

Uncommon:

Voice alteration (including hoarseness), Dyspnoea, Cough increased, Pharyngitis

Rare:

Bronchospasm, chest tightness, cough, shortness of breath, Lung disorder, Sputum Increased,

 

Haemoptysis, Lung function decreased, Laryngitis, Epistaxis,

 

Rhinitis, Asthma

 

 

Very Rare:

Hyperventilation, Hypoxia, Sinusitis

 

Special Senses

 

 

 

Rare:

Tinnitus, Taste perversion, Hearing loss, Aphonia

 

Very Rare:

Ear disorder, Ear pain

 

Skin and Appendages

 

 

 

Rare:

Rash

 

 

 

In open label studies and post-marketing experience, some patients with a history of prolonged previous or concomitant use of intravenous aminoglycosides have experienced hearing loss (see 4.4). Parenteral aminoglycosides have been associated with hypersensitivity, ototoxicity and nephrotoxicity (see 4.3, 4.4).


Section 6.2

TOBI should not be diluted or In the absence of compatibilities studies, this medicinal product must not be mixed with any other medicinal product in the nebuliser.


Section 6.3

For single use. The contents of the whole ampoule should be used immediately after opening (see section 6.6). Discard any remaining contents.


Section 9

Include 9th December 2009 for the date of renewal.
Updated on 28/09/2006 and displayed until 28/10/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
 Change in Market Authorisation Holder from Chiron to Novartis
Updated on 28/09/2006 and displayed until 28/09/2006
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  tobramycin