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Revised: January 2014
AN: 01215/2013
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cephacare Flavour 500 mg Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substance:
500 mg cefalexin as cefalexin monohydrate.
Excipients:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Beige, flat tablets with a break mark on one side.
4.
CLINICAL PARTICULARS
4.1 Target species
Dogs
4.2 Indications for use, specifying the target species
Treatment of infections of the respiratory tract, gastro-intestinal tract, urogenital
tract, the skin and localised infections in soft tissue caused by bacteria sensitive
to cefalexin.
4.3 Contraindications
Do not use in cases of known hypersensitivity to the active substance, to other
cephalosporins, to other substances of the -lactam group or to any of the
excipients.
Do not use in rabbits, gerbils, guinea pigs and hamsters.
4.4 Special warnings for each target species
None
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4.5 Special precautions for use
(i)
Special precautions for use in animals
Use of the product should be based on susceptibility testing and take
into account official and local antimicrobial policies.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to cefalexin and
may decrease the effectiveness of treatment with penicillins, due to
the potential for cross resistance.
In the case of an allergic reaction, treatment should be withdrawn.
As with other antibiotics which are excreted mainly by the kidneys,
unnecessary accumulation may occur in the body when renal
function is impaired. In cases of known renal insufficiency the dose
should be reduced, antimicrobials known to be nephrotoxic should
not be administered concurrently and the product should be used
only according to a risk/benefit assessment by the responsible
veterinarian.
(ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy)
following injection, inhalation, ingestion or skin contact.
Hypersensitivity to penicillin may lead to cross-reactions to
cephalosporin and vice versa. Allergic reactions to these substances
may occasionally be serious. Do not handle this product if you know
you are sensitised or if you have been advised not to be in contact
with such substances.
Handle this product with great care to avoid exposure, taking all
recommended precautions. If you develop symptoms following
exposure such as skin rash, you should seek medical advice and
show the doctor this warning. Swelling of the face, lips or eyes or
difficulty breathing are more serious symptoms and require urgent
medical attention.
In case of accidental ingestion, seek medical advice immediately and
show the package leaflet or the label to the physician.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
Vomiting has been observed occasionally in dogs when given products
containing cefalexin.
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4.7 Use during pregnancy, lactation or lay
The safety of the product has not been demonstrated in studies in pregnant or
lactating dogs. Use only in accordance with a risk/benefit assessment by the
responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
See section 4.5i Special precautions for use in animals.
The bactericidal activity of cephalosporins is reduced by concomitant
administration of bacteriostatic acting compounds (macrolides, sulphonamides
and tetracyclines).
Nephrotoxicity can be increased when 1st generation cephalosporins are
combined with polypeptide antibiotics, aminoglycosides and some diuretics
(furosemide).
Concomitant use with such active substances should be avoided.
4.9 Amounts to be administered and administration route
For oral administration. A dose of 15 mg/kg twice daily is recommended, to be
doubled where appropriate.
Cephacare flavour 500 mg tablets have a break mark on one side. To enable
more accurate dosing, half tablets may be used as necessary.
Treatment for five days is recommended. Any increase in dose or duration of
use should be according to a risk/benefit assessment by the prescribing
veterinarian (e.g. in cases of chronic pyoderma).
Tablets may be added to food if necessary.
To avoid underdosing, the bodyweight should be accurately determined.
The use of cefalexin tablets of lower strengths is advised for dogs with lower
bodyweights.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
The administration of cefalexin has been shown to produce no serious sideeffects at many times the recommended dose rate.
4.11 Withdrawal period
Not applicable.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group:
Antibacterials for systemic use, other beta-lactam antibacterials, first-generation
cephalosporins.
ATCvet code: QJ01DB01.
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5.1 Pharmacodynamic properties
Cefalexin is a semi-synthetic bactericidal antibiotic belonging to the
cephalosporin group which acts by interference with bacterial cell wall
formation.
Cefalexin is active against a wide range of Gram-positive and Gram-negative
bacteria. The following micro-organisms have been shown to be sensitive to
cefalexin in vitro: Staphylococcus spp (including penicillin-resistant strains),
Streptococcus spp, Corynebacterium spp, Pasteurella multocida, Escherichia
coli, Micrococcus spp, Moraxella spp.
Cefalexin is resistant to the action of staphylococcal penicillinase and is
therefore active against the strains of Staphylococcus aureus that are
insensitive to penicillin (or related antibiotics such as ampicillin or amoxycillin)
because of production of penicillinase.
Cefalexin is also active against the majority of ampicillin-resistant E.coli.
5.2 Pharmacokinetic particulars
Following oral administration, cefalexin is rapidly and almost completely
absorbed. Peak plasma concentrations in the dog (Cmax= 17.49 μg/ml) are
achieved within approximately 1.5 hours (Tmax= 1.55). Cefalexin is excreted in
the urine in high concentrations and has an elimination half life (T 1/2) of
approximately 2.5–3 hours.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate
Potato starch
Magnesium stearate
Beef flavour
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Return any ½ tablet to the blister pack and use within 24 hours.
6.4 Special precautions for storage
Do not store above 25C.
Store in a dry place.
Keep the blister in the outer carton.
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6.5 Nature and composition of immediate packaging
Cephacare flavour 500 mg tablets are supplied in PVC/aluminium foil blister
packs each containing 10 tablets, in cardboard boxes containing 100 or 250
tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
requirements.
7.
MARKETING AUTHORISATION HOLDER
Animalcare Ltd.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
8.
MARKETING AUTHORISATION NUMBER
Vm: 10347/4027
9.
DATE OF FIRST AUTHORISATION
Date: 19 December 2008
10. DATE OF REVISION OF THE TEXT
Date: January 2014
PROHIBITION OF SALE, SUPPLY AND/OR USE
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LABELLING AND PACKAGE LEAFLET
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AN: 01215/2013
A. LABELLING
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AN: 01215/2013
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cephacare flavour 500 mg tablets for dogs.
Cefalexin as cefalexin monohydrate.
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 500 mg cefalexin as cefalexin monohydrate.
Beef flavoured, beige, flat tablets with a break mark on one side.
3.
PHARMACEUTICAL FORM
Tablet
4.
PACKAGE SIZE
100 tablets
250 tablets
5.
TARGET SPECIES
Dogs
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For oral administration.
A dose of 15 mg/kg twice daily is recommended, to be doubled where appropriate.
To enable more accurate dosing, half tablets may be used as necessary.
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
See package leaflet for user warnings and disposal advice. Penicillins and
cephalosporins may occasionally cause severe allergic reactions.
10. EXPIRY DATE
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AN: 01215/2013
EXP: DD/MM/YY
Return any ½ tablet to the blister pack and use within 24 hours.
11. SPECIAL STORAGE CONDITIONS
Do not store above 25C.
Keep the blister in the outer carton.
Store in a dry place.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS
OR WASTE MATERIALS, IF ANY
See package leaflet for user warnings and disposal advice.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the sight and reach of children
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Animalcare Ltd.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
16. MARKETING AUTHORISATION NUMBER(S)
17. MANUFACTURER’S BATCH NUMBER
BN:
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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cephacare flavour 500 mg tablets for dogs.
500 mg cefalexin
2.
NAME OF THE MARKETING AUTHORISATION HOLDER
Animalcare Ltd.
3.
EXPIRY DATE
EXP: DD/MM/YY
4.
BATCH NUMBER
BN:
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
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AN: 01215/2013
B. PACKAGE LEAFLET
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AN: 01215/2013
PACKAGE LEAFLET
Cephacare flavour 500 mg tablets for dogs
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
AND OF THE MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
Animalcare Ltd.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
UK
Manufacturers responsible for batch release:
Lelypharma B.V.
Zuiveringweg 42
8243 PZ
Lelystad
The Netherlands
Produlab Pharma B.V.
Forellenweg 16
4941 SJ
Raamsdonksveer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cephacare flavour 500 mg tablets for dogs.
Cefalexin as cefalexin monohydrate.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER
INGREDIENT(S)
Each tablet contains:
Active substance:
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AN: 01215/2013
500 mg cefalexin as cefalexin monohydrate
Beef flavoured, beige, flat tablets with a break mark on one side.
4.
INDICATIONS
Treatment of infections of the respiratory tract, gastrointestinal tract, urogenital tract,
the skin and localised infections in soft tissue caused by bacteria sensitive to
cefalexin.
5.
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance, to other
cephalosporins, to other substances of the -lactam group or to any of the
excipients.
Do not use in rabbits, gerbils, guinea pigs and hamsters.
6.
ADVERSE REACTIONS
Vomiting has been observed occasionally in dogs when given products containing
cefalexin.
If you notice any serious effects or other effects not mentioned in this leaflet, please
inform your veterinary surgeon.
7.
TARGET SPECIES
Dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF
ADMINISTRATION
For oral administration. A dose of 15 mg/kg twice daily is recommended, to be
doubled where appropriate.
9.
ADVICE ON CORRECT ADMINISTRATION
Cephacare flavour 500 mg tablets have a break mark on one side. To enable more
accurate dosing, half tablets may be used as necessary.
Treatment for 5 days is recommended. Any increase in dose or duration of use
should be according to a risk/benefit assessment by the prescribing veterinarian (e.g.
in cases of chronic pyoderma).
Tablets may be added to food if necessary.
To avoid underdosing, the bodyweight should be accurately determined.
The use of cefalexin tablets of lower strengths is advised for dogs with lower
bodyweights.
10. WITHDRAWAL PERIOD
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AN: 01215/2013
Not applicable
11. SPECIAL STORAGE PRECAUTIONS
Return any ½ tablet to the blister pack and use within 24 hours.
Keep the blister pack in the outer carton.
Keep out of the sight and reach of children.
Do not store above 25C.
Store in a dry place.
Do not use this veterinary medicinal product after the expiry date which is printed on
the blister and carton after “Exp”. The expiry date refers to the last day of the month.
12. SPECIAL WARNINGS
For animal treatment only
Use of the product should be based on susceptibility testing and take into account
official and local antimicrobial policies.
Use of the product deviating from the instructions given in the SPC may increase the
prevalence of bacteria resistant to cefalexin and may decrease the effectiveness of
treatment with penicillins, due to the potential for cross resistance.
In the case of an allergic reaction, treatment should be withdrawn.
The administration of cefalexin has been shown to produce no serious side-effects at
many times the recommended dose rate.
As with other antibiotics which are excreted mainly by the kidneys, unnecessary
accumulation may occur in the body when renal function is impaired. In cases of
known renal insufficiency the dose should be reduced, antimicrobials known to be
nephrotoxic should not be administered concurrently and the product should be used
only according to a risk/benefit assessment by the responsible veterinarian.
The bactericidal activity of cephalosporins is reduced by concomitant administration
of bacteriostatic acting compounds (macrolides, sulphonamides and tetracyclines).
Nephrotoxicity can be increased when 1st generation cephalosporins are combined
with polypeptide antibiotics, aminoglycosides and some diuretics (furosemide).
Concomitant use with such active substances should be avoided.
The safety of the product has not been demonstrated in studies in pregnant or
lactating dogs. Use only in accordance with a risk/benefit assessment by the
responsible veterinarian.
Page 14 of 16
Revised: January 2014
AN: 01215/2013
User warnings
Penicillins and cephalosporins may cause hypersensitivity (allergy) following
injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead
to cross-reactions to cephalosporins and vice versa. Allergic reactions to these
substances may occasionally be serious.

Do not handle this product if you know you are sensitised or if you have been
advised not to be in contact with such substances.

Handle this product with great care to avoid exposure, taking all
recommended precautions.

If you develop symptoms following exposure such as skin rash you should
seek medical advice and show the doctor this warning. Swelling of the face,
lips or eyes or difficulty breathing are more serious symptoms and require
urgent medical attention.

In case of accidental ingestion, seek medical advice immediately and show
the package leaflet or the label to the physician.

Wash hands after use.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIAL, IF ANY
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
September 2009
15. OTHER INFORMATION
Cefalexin is a semi-synthetic bactericidal antibiotic belonging to the cephalosporin
group which acts by interference with bacterial cell wall formation.
Cefalexin is active against a wide range of Gram-positive and Gram-negative
bacteria. The following micro-organisms have been shown to be sensitive to
cefalexin in vitro: Staphylococcus spp (including penicillin-resistant strains),
Streptococcus spp, Corynebacterium spp, Pasteurella multocida, Escherichia coli,
Micrococcus spp, Moraxella spp.
Cefalexin is resistant to the action of staphylococcal penicillinase and is therefore
active against the strains of Staphylococcus aureus that are insensitive to penicillin
(or related antibiotics such as ampicillin or amoxycillin) because of production of
penicillinase.
Page 15 of 16
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AN: 01215/2013
Cefalexin is also active against the majority of ampicillin-resistant E.coli.
Following oral administration, cefalexin is rapidly and almost completely absorbed.
Peak plasma concentrations in the dog (Cmax= 17.49 μg/ml) are achieved within
approximately 1.5 hours (Tmax= 1.55). Cefalexin is excreted in the urine in high
concentrations and has an elimination half life (T 1/2) of approximately 2.5–3 hours.
Cephacare flavour 500 mg tablets are supplied in packs of 100 and 250 tablets.
Not all pack sizes may be marketed.
Prescription Only Medicine
20 February 2014
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