Performer

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFACLOR

Available from:

PIAM Farmaceutici S.p.A. Via Fieschi, 8/7 1-16124, Genoa, Italy

ATC code:

J01DC04

INN (International Name):

CEFACLOR 250 mg/5ml

Pharmaceutical form:

GRANULES FOR ORAL SUSPENSION

Composition:

CEFACLOR 250 mg/5ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2006-08-04

Patient Information leaflet

COMPOSITION
GRANULATE FOR ORAL SUSPENSION 250 MG/5 ML
5 ml of suspension contain:
_Active _
_ingredient _
_: _
_ _
C e f a c l o r
m o n o h y d r a t e
e q u i v .
to
Cefaclor 250 mg
_Excipients _
_:_
D i m e t h i c o n e
3 5 0 ,
p o l y s a c c h a r i d e
gum,
modi
fi
e d
s t a r c h ,
e r y t h r o s i n e
E - 1 2 7 ,
a l u m i n i u m
lac,
methylcellulose, sodium laurylsulphate, strawberry
fl
avour,
sucrose.
PHARMACEUTICAL
FORM AND CONTENTS
Granulate
for
extemporaneous
solution
for
oral
use
in
a
100-ml bottle after reconstitution of the solution.
PHARMACOTHERAPEUTIC CATEGORY
Antibiotic per os, belonging to the class of cephalosporins.
H O L D E R
O F
T H E
A U T H O R I Z AT I O N
F O R
P R O D U C T
COMMERCIALIZA
TION
PIAM
Farmaceutici
S.p.A.
-
Via
Fieschi,
8
-
I
-
16121
Genova
MANUFACTURER AND FINAL INSPECTOR
Francia
Farmaceutici
s.r.l.
Via
dei
Pestagalli,
7
–
20138
Milano (Italy)
THERAPEUTIC INDICATIONS
Treatment
of
the
following
infections
caused
by
sensitive
germs:
-
i n f e c t i o n s
o f
t h e
r e s p i r a t o r y
s y s t e m ,
including
p n e u m o n i a ,
b r o n c h i t i s ;
b r e a k t h r o u g h
o f
chronic
bronchitis, pharyngitis and tonsillitis;
-
o t i t i s
o f
t h e
m i d d l e
e a r
(in
fl
a m m a t o r y
p r o c e s s e s
of
bacterial nature affecting the middle ear);
- infections of the skin and soft tissues;
- infections of the urinary system, including pyelonephritis
and cystitis;
- sinusitis;
- gonococcal urethritis.
CONTRA-INDICATIONS
C e f a c l o r
i s
c o n t r a - i n d i c a t e d
f o r
p a t i e n t s
w i t h
a n
overt
allergy
to
cephalosporins
and
to
either
constituent
of
the
product.
Generally contra-indicated during pregnancy and lactation
(see “Use during pregnancy and lactation”).
PRECAUTIONS FOR USE
B e f o r e
t h e r a p y
w i t h
C e f a c l o r
i s
s t a r t e d ,
i t
s h o u l d
be
c a r e f u l l y
i n v e s t i g a t e d
w h e t h e r
t h e
p a t i e n t
h a s
shown
previous
hypersensitivity
reactions
to
cephalosporins
and
to penicillins.
In case of aller

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL SPECIALITY
PERFORMER 250 MG/5 ML GRANULATE FOR ORAL SUSPENSION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_PERFORMER 250 MG/ 5 ML GRANULATE FOR ORAL SUSPENSION _
5 ml of suspension prepared as prescribed contain:
_Active ingredient : _
Cefaclor monohydrate equiv. to Cefaclor
250 mg
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
PERFORMER 250 mg/5 ml of granulate for oral suspension. Granulate for
the preparation
of an extemporaneous suspension for oral use.
4.
CLINICAL INFORMATION
4.1
THERAPEUTIC INDICATIONS
CEFACLOR is indicated for the treatment of the following infections
caused by sensitive
germs:
-
infections of the respiratory system, including pneumonia, bronchitis;
breakthrough of
chronic bronchitis, pharyngitis and tonsillitis;
-
otitis of the middle ear;
-
infections of the skin and soft tissues;
-
infections of the urinary system, including pyelonephritis and
cystitis;
-
sinusitis;
-
gonococcal urethritis.
4.2
POSOLOGY AND ADMINISTRATION
Cefaclor is administered per os.
ADULTS: the normal RDA in adults is 250 mg every 8 hours. Higher doses
may be required
in more severe infections or in those caused by less sensitive germs.
The maximum RDA is
2 g a day, although 4 g doses have been administered to normal
subjects for 28 days with no
unfavourable effects.
For the treatment of acute gonococcal urethritis in both sexes, a
single 3-g administration of
Cefaclor is recommended concurrently with 1 g of probenecid, where
appropriate.
CHILDREN: the normal RDA for children is 20 mg/kg in spaced
administrations at 8-hour
intervals. In more severe infections, in otitis of the middle ear and
in infections caused by
less sensitive germs, a 40 mg/kg/day dose is recommended up to a
maximum 1 g RDA.
ALTERNATIVE POSOLOGY: IN OTITIS OF THE MIDDLE EAR AND IN PHARYNGITIS,
THE TOTAL RDA MAY
BE ADMINISTERED IN SPACED DOSES AT 12-HOUR INTERVALS.
For further details on pediatric use, see instruction leaflet.
4.3
CONTRA-INDICATIONS
Cefaclor is contra-indicated for pa