PROMIXIN 1 million International Unit Powder for nebuliser solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

COLISTIN MESILATE SODIUM

Available from:

Zambon S.p.A.

ATC code:

J01XB01

INN (International Name):

COLISTIN MESILATE SODIUM

Dosage:

1 million International Unit

Pharmaceutical form:

Powder for nebuliser solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Polymixins

Authorization status:

Authorised

Authorization date:

2018-01-19

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Promixin, 1 million International Units (IU), Powder for Nebuliser
Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 million International Units (IU) which is
approximately equivalent to 80 mg of Colistimethate
Sodium.
3 PHARMACEUTICAL FORM
Powder for nebuliser solution.
The powder is white to off-white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Promixin is indicated for the management in adult and paediatric of
chronic pulmonary infections due to_ Pseudomonas_
_aeruginosa_ in patients with cystic fibrosis (see section 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that colistimethate sodium (CMS) should be
administered under the supervision of physicians with
appropriate experience in its use.
Posology
The dosage can be adjusted depending on the severity of the condition
and clinical response.
Recommended dose range:
_Administration via inhalation_
_Adults, adolescents and children_
_2 years_
1-2 MIU two to three times per day (max 6 MIU/day)
_Children < 2 years_
0.5-1 MIU twice daily (max 2 MIU/ day)
Relevant clinical guidance on treatment regimens, including duration
of treatment, periodicity and co-administration of
other antibacterial agents should be adhered to.
_Older people_
Dose adjustment is not considered necessary.
_Renal impairment_
Dose adjustment is not considered necessary, however caution is
advised in patients with renal impairment (see
sections 4.4 and 5.2).
_Hepatic impairment_
Dose adjustment is not considered necessary.
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