ColiFin 1 MIU powder for nebuliser solution unit dose vials

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Colistimethate sodium

Dostopno od:

Pari Medical Ltd

Koda artikla:

J01XB01

INN (mednarodno ime):

Colistimethate sodium

Odmerek:

1000000unit

Farmacevtska oblika:

Powder for nebuliser solution

Pot uporabe:

Inhalation

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05010700; GTIN: 9120073451019

Navodilo za uporabo

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLIFIN 1 MILLION INTERNATIONAL UNITS POWDER FOR NEBULISER SOLUTION
Colistimethate sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What ColiFin is and what it is used for
2.
What you need to know before you use ColiFin
3.
How to use ColiFin
4.
Possible side effects
5.
How to store ColiFin
6.
Contents of the pack and other information
1.
WHAT COLIFIN IS AND WHAT IT IS USED FOR
ColiFin is given as an inhalation to treat chronic chest infections in
patients with cystic fibrosis. ColiFin is
used when these infections are caused by specific bacteria called
_Pseudomonas aeruginosa_
.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COLIFIN
DO NOT USE COLIFIN
- If you are allergic (hypersensitive) to colistimethate sodium,
colistin or to other polymyxins.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using ColiFin
- If you have or have had kidney problems
- If you suffer from myasthenia gravis
- If you suffer from porphyria
- If you suffer from asthma
In premature and new-born babies, special care should be taken when
using ColiFin as the kidneys are not
yet fully developed.
Coughing and chest tightness may lead to discontinuation. This may be
relieved by using an inhaled
bronchodilator (e.g. salbutamol) before using ColiFin. Your doctor
will supervise your first dose of ColiFin
and check your lung function before and after dosing.
If chest tightness occurs despite the use of a bronchodilator, please
tell your doctor because

Lastnosti izdelka

OBJECT 1
COLIFIN 1 MIU POWDER FOR NEBULISER SOLUTION
Summary of Product Characteristics Updated 02-Sep-2016 | PARI Pharma
GmbH
1. Name of the medicinal product
ColiFin 1 MIU Powder for Nebuliser Solution
2. Qualitative and quantitative composition
Each 10 ml vial contains 1 MIU equivalent to 80 mg of colistimethate
sodium.
3. Pharmaceutical form
Powder for Nebuliser Solution
White powder
4. Clinical particulars
4.1 Therapeutic indications
ColiFin 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.
Method of administration
For inhalation use.
For use in children younger than 2 years the PARI LC SPRINT Baby (red
nozzle insert) with mask is
recommended.
THE CONTENT OF A VIAL OF COLIFIN 1 MIU SHOULD BE DISSOLVED IN 3 ML OF
STERILE SODIUM CHLORIDE 9
MG/ML (0.9%) SOLUTION.
For instructions on dilution of the product before administration, see
section 6.6.
Predic