COLIRACIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

COLISTIMETHATE SODIUM

Available from:

RAFA LABORATORIES LTD

ATC code:

J01XB01

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR INFUSION

Composition:

COLISTIMETHATE SODIUM 1000000 U/VIAL

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

Therapeutic group:

COLISTIN

Therapeutic area:

COLISTIN

Therapeutic indications:

Antibiotic for treatment of infections caused by micro-organisms sensitive to colistin.

Authorization date:

2020-06-30

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
עדימ(
עדימ(
)תוחיטב
)תוחיטב
חולשל( :ל
(
[e-mail]
ךיראת :
18
ינויב
2015
םש
רישכת
:תילגנאב
COLIRACIN POWDER FOR INJECTION
ירפסמ
:םושיר
119
27
22678
םש
לעב
םושירה :
תודבעמ
אפר
מ"עב
םייונישה
ןולעב
םינמוסמ
:עבצב
בוהצ
,הפסוה=
קורי
.הקיחמ=
ןולעב
ןולעב
אפורל
אפורל
קרפ
ןולעב
טסקט
שדח
ללוכ(
ןומיס
םייונישה
םייתועמשמה
תמועל
טסקטה
)םייקה
CONTRA-
INDICATIONS
Hypersensitivity to the active substance or other polymyxins.
Patients with myasthenia gravis.
SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR USE
Consideration should be given to co-administering colistimethate
sodium with another
antibacterial agent whenever this is possible, taking into account the
remaining
susceptibilities of the pathogen(s) under treatment. As the
development of resistance to
colistin has been reported in particular when it is used as a
monotherapy, co-administration
with other antibacterial should also be considered in order to prevent
the emergence of
resistance.
There are limited clinical data on the efficacy and safety of
colistimethate sodium. The
recommended doses in all subpopulations are equally based on limited
data (clinical and
pharmacokinetic/ pharmacodynamics data). In particular there are
limited safety data for
the use of high doses (> 6 MIU/day) and the use of a loading dose, and
for special
populations (patients with renal impairment and the pediatric
population). Colistimethate
sodium should only be used when other, more commonly prescribed
antibiotics are not
effective or not appropriate.
Renal function monitoring should be performed at the start of
treatment and regularly
during treatment in all patients. The dose of colistimethate sodium
should be adjusted
according to creatinine clearance. Patients who are hypovolaemic or
those receiving other
potentially nephrotoxi

Summary of Product characteristics

1
1
NAME OF THE MEDICINAL PRODUCT
COLIRACIN
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains:
1,000,000 units (1 MIU) of colistimethate sodium (also known as
colistin
sulfomethate sodium).
3
PHARMACEUTICAL FORM
Powder for concentrate for infusion
IM, IV
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antibiotic for treatment of infections caused by micro-organisms
sensitive to colistin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Coliracin injection is usually administered IM or IV.
Coliracin must be reconstituted before use.
_Dosage _
The dose and the treatment duration are determined by the severity and
type of infection and
the age, weight and renal function of the patient as well as the
clinical response. Should
clinical or bacteriological response be slow, the dose may be
increased as indicated by the
patient's condition.
A minimum of 5 days treatment is generally recommended. For the
treatment of respiratory
exacerbations in cystic fibrosis patients, treatment should be
continued for up to 12 days.
_ _
THE RECOMMENDED DOSAGE IN CHILDREN AND ADULTS UP TO 60KG
is 50,000 units/kg/day to
maximum of 75,000 units/kg/day. The total daily dose should be divided
into three doses
given at approximately 8-hour intervals. Serum levels should be
measured if used in the
newborn.
THE RECOMMENDED DOSAGE IN PATIENTS OVER 60 KG
: 1-2 million units three times a day. The
maximum dose is 6 million units in 24 hours.
Dosage should be in line with relevant treatment guidelines. Limited
pharmacokinetic data
from critically ill patients suggest that use of a loading dose and
higher than standard doses
may be appropriate. For severe infections and in critically ill
patients doses up to 9 million
IU per day in divided doses, have been reported in the literature.
Clinical efficacy and safety
data with these regimens are very limited and caution is advised
.
Anomalous distribution in patients with cystic fibrosis may require
higher doses in order to
maintain therapeutic serum levels.
_IV Administration: _
Each dose of Co