Colobreathe 1,662,500unit inhalation powder capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Colistimethate sodium

Available from:

Teva UK Ltd

INN (International Name):

Colistimethate sodium

Dosage:

1662500unit

Pharmaceutical form:

Inhalation powder

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700; GTIN: 5014398003494

Summary of Product characteristics

OBJECT 1
COLOBREATHE
Summary of Product Characteristics Updated 26-Mar-2018 | Teva UK
Limited
1. Name of the medicinal product
Colobreathe 1,662,500 IU inhalation powder, hard capsules
2. Qualitative and quantitative composition
Each capsule contains 1,662,500 IU, which is approximately equal to
125 mg of colistimethate sodium.
3. Pharmaceutical form
Inhalation powder, hard capsule (inhalation powder)
Hard transparent PEG-gelatin capsules containing a fine white powder.
4. Clinical particulars
4.1 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 be given to official guidance on the appropriate
use of antibacterial active
substances.
4.2 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 in a study of
24-weeks duration. Treatment may be
continued for as long as the physician considers that the patient is
obtaining clinical benefit.
_Renal impairment_
No dose adjustment is considered to be necessary (see section 5.2).
_Hepatic impairment_
No dose adjustment is considered to be necessary (see section 5.2).
_Paediatric population_
The safety and efficacy of Colobreathe in children under 6 years of
age have not been established. No
data are available.
Method of administration
For inhalation use only.
Colobreathe capsules are to be used only with the Turbospin powder
inhaler.
The capsules must not be swallowed.
To ensure proper administration of the medicinal product, the patient
should be shown how to use the
inhaler by a physician or other health professional, with the first
dose being given under medical
supervision.
If other treatments are being taken, they should be taken in the
following order:
Inhaled bronchodilators
Chest physiotherap