CHLORAMPHENICOL VUAB 1 G.

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CHLORAMPHENICOL AS SODIUM SUCCINATE

Available from:

DAVID MARGALIT & CO.LTD

ATC code:

S01AA01

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION

Composition:

CHLORAMPHENICOL AS SODIUM SUCCINATE 1 G

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

VUAB PHARMA A.S., CZECH REPUBLIC

Therapeutic area:

CHLORAMPHENICOL

Therapeutic indications:

Typhus and parathyphus, salmonellosis with septic development, meningitis, epiglottis, pertussis and parapertussis, serious infections with aerobe and anaerobe flora (pulmonary, abdominal, gynecologic) and other infections caused by bacteria susceptible to chloramphenicol.

Authorization date:

2022-10-31

Patient Information leaflet

Tel: [phone] Fax: [phone] E-mail: [e-mail]
P.O.Box 16666 Tel-Aviv 6116601, Israel
,ה/דבכ ת/חקור ,ה/אפור
,..ג.א
רישכתה לש וקוויש תליחת לע רשבל םיחמש
וה
:אבה
תירבעב רישכתה םש
:
רולכ באוו לוקיפמ
1
'רג
תילגאב רישכתה םש
:
VUAB 1G
HLORAMPHENICOL
C
ותרוצ
:
Powder for concentrate for solution for injection
היוותה
:
Typhus
and
parathyphus,
salmonellosis
with
septic
development,
meningitis,
epiglottis, pertussis and parapertussis, serious infections with
aerobe and anaerobe
flora (pulmonary, abdominal, gynecologic) and other infections caused
by bacteria
susceptible to chloramphenicol.
ןרציה
:
VUAB Pharma a.s., Czech Republic
םושירה לעב
מ"עב 'תושו תילגרמ דוד :
.
חלש אפורל ןולעה
) תואירבה דרשמ רתאבש תופורתה רגאמב
םוסרפל
www.health.gov.il
(
,
.םושירה לעבל היפ ידי לע ספדומ ולבקל
ןתיו
,הכרבב
מ"עב 'תושו תילגרמ דוד

Summary of Product characteristics

_This leaflet format has been determined _
_by the Ministry of Health and _
_the content thereof has been checked _
_and approved on _
November 2017
SUMMARY OF PRODUCT
CHARACTERISTICS
1. NAME OF THE MEDICINAL
PRODUCT
CHLORAMPHENICOL VUAB 1 G
2. QUALITATIVE AND
QUANTITATIVE COMPOSITION
One injection vial contains
chloramphenicol 1 g (as chlorampheni-
col sodium succinate 1.38 g).
One ml of reconstituted solution
contains approximately chlorampheni-
col 67 mg.
For a full list of excipients, see
section 6.1.
3. PHARMACEUTICAL FORM
Powder for concentrated solution
for injection
White to yellowish-white freeze dried
powder
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Typhus and parathyphus, salmonellosis
with septic development, meningitis,
epiglottis, pertussis and parapertus-
sis, serious infections with aerobe and
anaerobe flora (pulmonary, abdominal,
gynecologic) and other infections
caused by bacteria susceptible to chlo-
ramphenicol.
Chloramphenicol VUAB 1 g can be
used only in serious infections, for
which less potentially dangerous drugs
are ineffective or are contraindicated
(see point 4.4. and 5.1.). Chlorampheni-
col is not indicated for neonates.
Official guidance for using of antibiotics
must be taken in consideration.
4.2. POSOLOGY AND METHOD OF
ADMINISTRATION
Posology
I.v. injection
The dosage depends on the severinity
of infection. The recommended dosage:
Adults: the daily dose is 1 g (as chlo-
ramphenicol base), every 6 – 8 hours
by parenteral application.
Elderly: The usual adult dosage should
be given subject to normal hepatic and
renal function.
_Pediatric population_
Children: The equivalent of 50 mg/kg
chloramphenicol daily in divided doses
every 6 hours (this dose should not be
exceeded). The patient should be
carefully observed for signs of toxicity.
Patients with impaired hepatic and
renal function: Dosage must be
sufficiently reduced. Continuous
control of hepatic and renal function is
performed concurrently.
In exceptional cases, such as patients
with septicemia or meningitis, dosa