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SPC: TOBI Podhaler Inhalation powder, hard capsule (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

TOBI Podhaler 28 mg inhalation powder, hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 28 mg tobramycin. For the full list of excipients, see section 6.1.

Pharmaceutical form

Inhalation powder, hard capsule. Clear colourless capsules containing a white to almost white powder, with NVR AVCI printed in blue on one part of the capsule and Novartis logo printed in blue on the other ...

Therapeutic indications

TOBI Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 ...

Posology and method of administration

Posology The dose of TOBI Podhaler is the same for all patients within the approved age range, regardless of age or weight. The recommended dose is 112 mg tobramycin (4 28 mg capsules), administered twice ...

Contraindications

Hypersensitivity to the active substance and any aminoglycoside, or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Ototoxicity Ototoxicity, manifested as both auditory toxicity (hearing loss) and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed with TOBI Podhaler. Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data on the use of tobramycin via inhalation in pregnant women. Animal studies with tobramycin do not indicate a teratogenic effect (see section 5.3). However, aminoglycosides ...

Effects on ability to drive and use machines

TOBI Podhaler has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions in the main safety, active-controlled clinical study with TOBI Podhaler versus tobramycin nebuliser solution in cystic fibrosis ...

Overdose

Adverse reactions specifically associated with overdose of TOBI Podhaler have not been identified. The maximum tolerated daily dose of TOBI Podhaler has not been established. Tobramycin serum concentrations ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials ATC Code: J01GB01 Mechanism of action Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius. ...

Pharmacokinetic properties

Absorption The systemic exposure to tobramycin after inhalation of TOBI Podhaler is expected to be primarily from the inhaled portion of the medicinal product as tobramycin is not absorbed to any appreciable ...

Preclinical safety data

Non-clinical data reveal that the main hazard for humans, based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, or toxicity to reproduction, consists of renal toxicity and ototoxicity. ...

List of excipients

Capsule content: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) Calcium chloride Sulfuric acid (for pH adjustment)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years. Discard the Podhaler device and its case 1 week after first use.

Special precautions for storage

TOBI Podhaler capsules must always be stored in the blister to protect from moisture and only removed immediately before use.

Nature and contents of container

The hard capsules are supplied in PVC/PA/Alu/PVC- PET/Alu blisters. The Podhaler inhalation device and its storage case are made from plastic materials (polypropylene). TOBI Podhaler is supplied in monthly ...

Special precautions for disposal and other handling

Only TOBI Podhaler capsules are to be used in the Podhaler device. No other inhaler may be used. TOBI Podhaler capsules must always be stored in the blister (capsule card), and only removed immediately ...

Marketing authorization holder

Mylan IRE Healthcare Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Marketing authorization number(s)

EU/1/10/652/001-003

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 July 2011 Date of latest renewal: 18 February 2016

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