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COLOBREATHE Inhalation powder, hard capsule (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Colobreathe 1,662,500 IU inhalation powder, hard capsules.

Qualitative and quantitative composition

Each capsule contains 1,662,500 IU, which is approximately equal to 125 mg of colistimethate sodium.

Pharmaceutical form

Inhalation powder, hard capsule (inhalation powder). Hard transparent PEG-gelatin capsules containing a fine white powder

Therapeutic indications

Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older (see section 5.1). Consideration should ...

Posology and method of administration

Posology Adults and children of 6 years of age and older One capsule to be inhaled twice daily. The dose interval should be as close as possible to 12 hours. The efficacy of Colobreathe has been demonstrated ...

Contraindications

Hypersensitivity to the active substance, colistin sulphate or polymyxin B.

Special warnings and precautions for use

Bronchospasm and coughing Bronchospasm or coughing may occur on inhalation. These reactions usually disappear or significantly diminish with continued use and may be ameliorated by appropriate treatment ...

Interaction with other medicinal products and other forms of interaction

There is no experience of using Colobreathe concurrently with other inhaled antibacterial agents. Caution should be taken with concomitant use with other formulations of colistimethate sodium as there ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of inhaled colistimethate sodium in pregnant women. Studies in animals using parenteral administration have shown reproductive toxicity (see ...

Effects on ability to drive and use machines

Based on the safety profile of colistimethate sodium, neurotoxity may occur with the possibility of dizziness, confusion or visual disturbances. Patients should be warned not to drive or operate machines ...

Undesirable effects

Summary of the safety profile The safety of Colobreathe has been assessed in a total of 237 subjects (225 cystic fibrosis patients and 12 healthy volunteers). Of these, 187 patients aged 6 years and above ...

Overdose

Symptoms Currently there is no experience of overdose with the use of Colobreathe. However, overdose may possibly result in higher systemic exposure. Overdose is unlikely by the inhaled route but has been ...

Pharmacodynamic properties

Pharmacotherapeutic group: antibacterials for systemic use, other antibacterials. ATC Code: J01XB01 Mechanism of action Colistimethate sodium (CMS) is a cyclic polypeptide antibacterial active substance ...

Pharmacokinetic properties

Absorption Colistimethate is not significantly absorbed from the lung after inhalation of Colobreathe. After administration of 1,662, 500IU twice daily for 7 days in adult, adolescent and paediatric cystic ...

Preclinical safety data

Nonclinical data reveal no special hazard for humans based on conventional studies of genotoxicity. Animal studies of safety pharmacology, repeated dose toxicity or toxicity to reproduction, employing ...

List of excipients

Components of the PEG-gelatin hard capsules: Gelatin Polyethylene glycol Purified water Sodium lauryl sulfate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 25°C. Store in the original package until immediately before use in order to protect from moisture.

Nature and contents of container

The capsules are contained in oPA/aluminium/pvc blisters with a peelable lidding foil composed of polyester/aluminium of either 8 or 14 hard capsules in each blister. Colobreathe is available in packs ...

Special precautions for disposal and other handling

Capsules: no special requirements for disposal. The Turbospin device should be discarded after completion of the treatment pack. Colobreathe capsules should only be administered using the Turbospin inhaler ...

Marketing authorization holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherland

Marketing authorization number(s)

EU/1/11/747/001 56 hard capsules (4 blisters of 14 capsules) EU/1/11/747/002 8 hard capsules (1 blister of 8 capsules) EU/1/11/747/003 56 hard capsules (7 blisters of 8 capsules)

Date of first authorization / renewal of the authorization

Date of first authorisation: 13/02/2012 Date of latest renewal: 26/09/2016

Πηγαίο έγγραφο

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