Cefaclor-GA

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Vedd Meg Most

Letöltés Betegtájékoztató (PIL)
08-06-2024
Letöltés Termékjellemzők (SPC)
08-06-2024

Aktív összetevők:

Cefaclor monohydrate

Beszerezhető a:

Actavis Pty Ltd

Osztály:

Medicine Registered

Betegtájékoztató

                                 
CEFACLOR-GA
 
_Cefaclor monohydrate 375mg tablets _
Modified release tablets 
_ _
CONSUMER MEDICINE INFORMATION
 
 
WHAT IS IN THIS LEAFLET 
 
THIS LEAFLET ANSWERS SOME OF 
THE COMMON QUESTIONS ABOUT 
CEFACLOR-GA
-
. It does not 
contain all the available 
information.  
 
It does not take the place of 
talking to your doctor or 
pharmacist. 
 
ALL MEDICINES HAVE RISKS AND 
BENEFITS. Your doctor has 
weighed the risks of you taking 
CEFACLOR-GA against the 
benefits the medicine is expected 
to have for you. 
 
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
 
KEEP THIS LEAFLET WITH THE 
MEDICINE. You may need to read 
it again. 
 
WHAT CEFACLOR-GA TABLETS 
ARE USED FOR 
 
CEFACLOR-GA is an antibiotic 
used to treat infections in different 
parts of the body caused by 
bacteria. 
 
CEFACLOR-GA will not work 
against infections caused by 
viruses such as colds or the flu. 
 
CEFACLOR-GA belongs to a 
group of antibiotics called 
cephalosporins (ke-fa-lo-spor-
ins), which are closely related to 
penicillins. 
 
CEFACLOR-GA works by killing 
the bacteria causing your 
infection or by stopping its 
growth. 
 
Your doctor may have prescribed 
CEFACLOR-GA for another 
reason. Ask your doctor if you 
have any questions about why 
CEFACLOR-GA has been 
prescribed for you. 
 
This medicine is available only 
with a doctor’s prescription. 
 
There is no evidence that 
CEFACLOR-GA is addictive 
 
BEFORE YOU START USING 
CEFACLOR-GA TABLETS 
_ _
WHEN YOU MUST NOT TAKE IT 
DO NOT TAKE CEFACLOR-GA 
TABLETS IF: 
•  YOU HAVE AN ALLERGY TO 
CEFACLOR-GA, CEFACLOR, 
OTHER CEPHALOSPORINS OR ANY 
OF THE INGREDIENTS LISTED AT 
THE END OF THIS LEAFLET. 
Some of the symptoms of an 
allergic reaction may include 
skin rash, itching, difficulty 
breathing, swelling of the face, 
lips or tongue. 
•  YOU HAVE HAD A SERIOUS 
ALLERGIC REACTION TO 
PENICILLINS 
•  THE PACKAG
                                
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Termékjellemzők

                                 
CEFACLOR-GA  
_MODIFIED RELEASE TABLETS _
_PRODUCT INFORMATION _
_ _
NAME OF THE MEDICINE 
Cefaclor monohydrate 
 
DESCRIPTION 
Chemical name:
3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic
acid monohydrate.  Molecular 
formula:  C
15
H
14
CIN
3
O
4
S.H
2
O.  CAS registry number: 70356-03-5.  Cefaclor (monohydrate) is
a white to off-
white crystalline powder, slightly soluble in water, but
is insoluble in alcohol and chloroform. 
 
CEFACLOR-GA tablets contain 375 mg cefaclor
anhydrous.  The tablet is a biconvex, capsule shape and 
coloured blue.  CEFACLOR-GA 375 mg is printed in black ink on the
tablet. 
 
CEFACLOR-GA tablets contain: cefaclor as cefaclor monohydrate,
hypromellose (methocel K4MCR premium 
and methocel E5 premium), hydroxypropyl cellulose, lactose,
colloidal anhydrous silica, magnesium stearate 
and purified talc.  The film coating materials
are hypromellose (2910 5cP E464), titanium dioxide (E171), 
polyethylene glycol 400, indigo carmine CI73015 and purified water.
 The printing ink contains purified water, 
iron oxide black, propylene glycol, hypromellose (2910 6cP) and isopropyl
alcohol.  The chemical structure of 
cefaclor monohydrate is shown below: 
_ _
 
 
_ _
H
2
N H
O
N
H
N
S
O
Cl
HO
O
H
2
O
.
H
H
_ _
PHARMACOLOGY 
MICROBIOLOGY 
_In vitro_ tests demonstrate that the bactericidal action of the
cephalosporins results from inhibition of cell wall 
synthesis.  Cefaclor is stable in the presence of bacterial 
β-lactamases; consequently, β-lactamase producing 
organisms resistant to penicillins and some cephalosporins may
be susceptible to cefaclor.  Cefaclor may have 
useful activity against the following organisms _in vitro_ and in
clinical infections. 
 
_Gram-positive organisms: Staphylococcus
aureus, Staphylococcus saprophyticus, Streptococcus pneumoniae _
_and Streptococcus pyrogenes _(group A Streptococci). Note that
cefaclor is not active against methici
                                
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