Therios 300 mg Palatable Tablets for Dogs

Main information

  • Trade name:
  • Therios 300 mg Palatable Tablets for Dogs
  • Available from:
  • Sogeval SA
  • Prescription type:
  • POM-V
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Therios 300 mg Palatable Tablets for Dogs
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • VMD
  • Authorization date:
  • 27-02-2009
  • Last update:
  • 09-08-2016

Patient Information leaflet


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Revised 29/03/2010 – AN 02535/2008

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

UK, AT, IE, PL, CZ,

BE, HU, GK, LUX, NL,

PT Therios 300 mg palatable tablets for dogs

IT, ES, FI Therios 300 mg flavoured tablets for dogs

DE Therios 300 mg aromatisierte Tabletten für Hunde

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Each tablet contains:

Cefalexin (as cefalexin monohydrate).........................................300 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet

Round scored beige palatable tablet

The tablet can be divided into equal halves and quarters

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

For the treatment of bacterial skin infections in dogs (including deep and superficial

pyoderma) caused by organisms sensitive to cefalexin.

For the treatment of urinary tract infections in dogs (including nephritis and cystitis) caused by

organisms sensitive to cefalexin.

4.3 Contraindications

Do not use in animals which are known to be hypersensitive to penicillins.

Do not use in case of severe renal failure

Do not use in rabbits, guinea pigs, hamsters and gerbils.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

i) Special precautions for use in animals

As with other antibiotics which are excreted mainly by the kidneys, systemic accumulation

may occur when renal function is impaired. In case of known renal insufficiency the dose

should be reduced.

The product is not recommended for use in dogs less than 2.5 kg bodyweight.

Wherever possible, the use of the product should be based on susceptibility testing and take

into account official and local antimicrobial policies

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Revised 29/03/2010 – AN 02535/2008

Safety of the excipient, ammonium glycyrrhizate, has not been established in dogs less than

1 year old.

ii) Special precautions to be taken by the person administering the veterinary

medicinal product to animals

Cephalosporins may cause sensitization (allergy) following injection, inhalation, ingestion or

skin contact. Sensitivity to penicillins may lead to cross sensitivity to cephalosporin and vice

versa. Allergic reactions to these substances may occasionally be serious.

1. Do not handle this product if you know you are sensitized or if you have been advised not to

work with such preparations.

2. Handle this product with great care to avoid exposure, taking all recommended

precautions. Wash hands after use.

3. If you develop symptoms following exposure such as skin rash you should seek medical

advice and show the doctor this warning. Swellings of the face, lips or eyes or difficulty

breathing are more serious symptoms and require urgent medical attention.

In the event of accidental ingestion, particularly by a child, seek medial attention and show the

doctor the leaflet

4.6 Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea have been observed in dogs. In rare cases hypersensitivity can occur.

4.7 Use during pregnancy, lactation or lay

Do not use in pregnant or lactating bitches.

4.8 Interaction with other medicinal products and other forms of interaction

In order to ensure efficacy, the product should not be used in combination with bacteriostatic

antibiotics.

Concurrent use of first generation cephalosporins with aminoglycoside antibiotics or some

diuretics such as furosemide can enhance nephrotoxicity risks

4.9 Amounts to be administered and administration route

For oral administration.

15 mg cefalexin per kg bodyweight twice daily (equivalent to 30 mg per kg bodyweight per

day) for duration of:

- 14 days in cases of urinary tract infection

- At least 15 days in cases of superficial infectious dermatitis

- At least 28 days in cases of deep infectious dermatitis

In severe or acute conditions the dose may be safely doubled to 30 mg/kg twice daily. To

allow for accuracy of dosing, tablets can be halved or quartered.

To ensure a correct dosage bodyweight should be determined as accurately as possible to

avoid underdosing.

Therios tablets are well accepted by dogs but may be crushed or added to a small quantity of

food immediately prior to feeding if necessary

Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!

Revised 29/03/2010 – AN 02535/2008

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Trials performed on animals with up to 5 times the recommended twice daily dosage of 15

mg/kg demonstrated that cefalexin was well tolerated.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Cefalexin monohydrate, the active ingredient of the Therios tablets, is a bactericidal antibiotic

of the cephalosporin family, obtained by hemi-synthesis of the 7 amino-cephalosporanic

nucleus.

ATCvet code: QJ01DB01

Pharmacotherapeutic group: Antibacterial for systemic use, first-generation cephalosporin

5.1 Pharmacodynamic properties

Cefalexin acts by inhibiting the nucleopeptide synthesis of the bacterial wall. Cephalosporins

interfere with transpeptidation by acylating the enzyme making it unable to cross-link muramic

acid-containing peptidoglycan strands. The inhibition of the biosynthesis of the material

required to build the cell wall results in a defective cell wall and consequently osmotically

unstable to protoplasts. The combined action results in cell lysis and filament formation.

Cefalexin is active against Gram positive and Gram negative bacteria such as

Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp.,., Escherichia

.coli, and Klebsiella spp, . Cefalexin is not inactivated by beta-lactamases produced by Gram

positive bacteria. However, beta-lactamases produced by gram-negative bacteria can inhibit

cefalexin by hydrolysis of the beta-lactam cycle. Resistance is transmitted by plasmidic or

chromosomic route.

Cefalexin is not inactivated by the staphylococcal beta-lactamases but has a moderate

activity against non-transferable (chromosomal) beta-lactamase producing gram-negative

enterobacteriacceae and fastidious gram-negatives. No antibacterial activity is obtained

against Enterobacter spp., P. aeruginosa and Serratia spp.

Cefalexin has a time-dependent bactericidal activity against Staphylococcus spp and

Pasteurella multocida..

The cefalexin critical breakpoints (MIC value) for pathogens of veterinary importance were set

up at:

- Susceptible: = 8 mg/L

- Resistant: > 32 mg/L

Staphylococcus spp, Streptococcus spp, E. coli and Klebsiella spp and P. multocida are

susceptible to cefalexin. MIC90 values for cefalexin determined in target bacterial strains

isolated from diseased dogs in Europe and in the USA are:

- S. pseudintermedius: 2 µg/mL

- S. aureus: 8 µg/mL

- S. canis = 0.5 µg/mL

- Beta-hemolytic Streptococcus spp: 2 µg/mL

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Revised 29/03/2010 – AN 02535/2008

- E. coli: 16 µg/mL

- P. multocida: 2µg/mL

- Klebsiella. spp: 4µg/mL

Resistance to cefalexin may be due to one of the following mechanisms of resistance. Firstly,

the production of various beta-lactamases (cephalosporinase), that inactivate the antibiotic, is

the most prevalent mechanism among gram-negative bacteria. Secondly, a decreased affinity

of the PBPs (penicillin-binding proteins) for beta-lactam drugs is frequently involved for beta -

lactam resistant gram-positive bacteria. Lastly, efflux pumps, extruding the antibiotic from the

bacterial cell, and structural changes in porins, reducing passive diffusion of the drug through

the cell wall, may contribute to improve the resistant phenotype of a bacterium.

Well-known cross-resistance (involving the same resistance mechanism) exists between

antibiotics belonging to the beta -lactam group due to structural similarities. It occurs with b-

lactamases enzymes, structural changes in porins or variations in efflux pumps. Co-

resistance (different resistance mechanisms involved) has been described in E.coli due to a

plasmid harbouring various resistance genes.

5.2 Pharmacokinetic particulars

After single oral administration of the recommended dosage of 15 mg cefalexin per kg

bodyweight to Beagle dogs, plasma concentrations were observed within 30 minutes. The

plasma peak was observed at 1.33 h with a plasma concentration of 21.2µg/ml. The

bioavailability of the active was over 90%. Cefalexin was detected until 24 hours after the

administration. The first urine specimen was collected within 2 to 12 hours with peak

concentrations of cefalexin measured at 430 to 2758 µg / ml within 12 hours.

After repeated oral administration of the same dosage, twice a day for 7 days, plasma peaks

occurred 2 hours later with a concentration of 20µg/ml. Over the treatment period

concentrations were maintained above 1 µg/ml. The mean elimination half life is 2 hours. Skin

levels were around 5.8 to 6.6 µg /g 2 hours after treatment.

5.3 Environmental properties

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Croscarmellose sodium

Silica, colloidal anhydrous

Magnesium stearate

Yeast dried

Biscuit flavour F07012

Ammonium glycyrrhizate

Macrogol 6000

6.2 Incompatibilities

None known

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Revised 29/03/2010 – AN 02535/2008

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening the immediate packaging: 48 hours.

Any divided tablet portions remaining after 48 hours should be discarded.

6.4. Special precautions for storage

Do not store above 25 °

C

Divided tablets should be stored in the blister pack.

6.5 Nature and composition of immediate packaging

Polyvinylchloride blister heat sealed with an aluminium cover foil.

Pack sizes:

Cardboard box with 1 blister of 10 tablets

Cardboard box with 20 blisters of 10 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 product should be disposed of in accordance with local requirements

7. MARKETING AUTHORISATION HOLDER

Sogeval SA

200 avenue de Mayenne – BP 2227

53022 LAVAL Cedex 9

France

Tel: 33.2.43.49.51.51

Fax: 33.2.43.53.97.00

E-mail: sogeval@sogeval.fr

8. MARKETING AUTHORISATION NUMBER

Vm 20749/4004

9. DATE OF FIRST AUTHORISATION

27 February 2009

10 DATE OF REVISION OF THE TEXT

29 March 2010

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable

Summary of Product characteristics


Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!

Revised 29/03/2010 – AN 02535/2008

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

UK, AT, IE, PL, CZ,

BE, HU, GK, LUX, NL,

PT Therios 300 mg palatable tablets for dogs

IT, ES, FI Therios 300 mg flavoured tablets for dogs

DE Therios 300 mg aromatisierte Tabletten für Hunde

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Each tablet contains:

Cefalexin (as cefalexin monohydrate).........................................300 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet

Round scored beige palatable tablet

The tablet can be divided into equal halves and quarters

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

For the treatment of bacterial skin infections in dogs (including deep and superficial

pyoderma) caused by organisms sensitive to cefalexin.

For the treatment of urinary tract infections in dogs (including nephritis and cystitis) caused by

organisms sensitive to cefalexin.

4.3 Contraindications

Do not use in animals which are known to be hypersensitive to penicillins.

Do not use in case of severe renal failure

Do not use in rabbits, guinea pigs, hamsters and gerbils.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

i) Special precautions for use in animals

As with other antibiotics which are excreted mainly by the kidneys, systemic accumulation

may occur when renal function is impaired. In case of known renal insufficiency the dose

should be reduced.

The product is not recommended for use in dogs less than 2.5 kg bodyweight.

Wherever possible, the use of the product should be based on susceptibility testing and take

into account official and local antimicrobial policies

Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!

Revised 29/03/2010 – AN 02535/2008

Safety of the excipient, ammonium glycyrrhizate, has not been established in dogs less than

1 year old.

ii) Special precautions to be taken by the person administering the veterinary

medicinal product to animals

Cephalosporins may cause sensitization (allergy) following injection, inhalation, ingestion or

skin contact. Sensitivity to penicillins may lead to cross sensitivity to cephalosporin and vice

versa. Allergic reactions to these substances may occasionally be serious.

1. Do not handle this product if you know you are sensitized or if you have been advised not to

work with such preparations.

2. Handle this product with great care to avoid exposure, taking all recommended

precautions. Wash hands after use.

3. If you develop symptoms following exposure such as skin rash you should seek medical

advice and show the doctor this warning. Swellings of the face, lips or eyes or difficulty

breathing are more serious symptoms and require urgent medical attention.

In the event of accidental ingestion, particularly by a child, seek medial attention and show the

doctor the leaflet

4.6 Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea have been observed in dogs. In rare cases hypersensitivity can occur.

4.7 Use during pregnancy, lactation or lay

Do not use in pregnant or lactating bitches.

4.8 Interaction with other medicinal products and other forms of interaction

In order to ensure efficacy, the product should not be used in combination with bacteriostatic

antibiotics.

Concurrent use of first generation cephalosporins with aminoglycoside antibiotics or some

diuretics such as furosemide can enhance nephrotoxicity risks

4.9 Amounts to be administered and administration route

For oral administration.

15 mg cefalexin per kg bodyweight twice daily (equivalent to 30 mg per kg bodyweight per

day) for duration of:

- 14 days in cases of urinary tract infection

- At least 15 days in cases of superficial infectious dermatitis

- At least 28 days in cases of deep infectious dermatitis

In severe or acute conditions the dose may be safely doubled to 30 mg/kg twice daily. To

allow for accuracy of dosing, tablets can be halved or quartered.

To ensure a correct dosage bodyweight should be determined as accurately as possible to

avoid underdosing.

Therios tablets are well accepted by dogs but may be crushed or added to a small quantity of

food immediately prior to feeding if necessary

Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!

Revised 29/03/2010 – AN 02535/2008

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Trials performed on animals with up to 5 times the recommended twice daily dosage of 15

mg/kg demonstrated that cefalexin was well tolerated.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Cefalexin monohydrate, the active ingredient of the Therios tablets, is a bactericidal antibiotic

of the cephalosporin family, obtained by hemi-synthesis of the 7 amino-cephalosporanic

nucleus.

ATCvet code: QJ01DB01

Pharmacotherapeutic group: Antibacterial for systemic use, first-generation cephalosporin

5.1 Pharmacodynamic properties

Cefalexin acts by inhibiting the nucleopeptide synthesis of the bacterial wall. Cephalosporins

interfere with transpeptidation by acylating the enzyme making it unable to cross-link muramic

acid-containing peptidoglycan strands. The inhibition of the biosynthesis of the material

required to build the cell wall results in a defective cell wall and consequently osmotically

unstable to protoplasts. The combined action results in cell lysis and filament formation.

Cefalexin is active against Gram positive and Gram negative bacteria such as

Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp.,., Escherichia

.coli, and Klebsiella spp, . Cefalexin is not inactivated by beta-lactamases produced by Gram

positive bacteria. However, beta-lactamases produced by gram-negative bacteria can inhibit

cefalexin by hydrolysis of the beta-lactam cycle. Resistance is transmitted by plasmidic or

chromosomic route.

Cefalexin is not inactivated by the staphylococcal beta-lactamases but has a moderate

activity against non-transferable (chromosomal) beta-lactamase producing gram-negative

enterobacteriacceae and fastidious gram-negatives. No antibacterial activity is obtained

against Enterobacter spp., P. aeruginosa and Serratia spp.

Cefalexin has a time-dependent bactericidal activity against Staphylococcus spp and

Pasteurella multocida..

The cefalexin critical breakpoints (MIC value) for pathogens of veterinary importance were set

up at:

- Susceptible: = 8 mg/L

- Resistant: > 32 mg/L

Staphylococcus spp, Streptococcus spp, E. coli and Klebsiella spp and P. multocida are

susceptible to cefalexin. MIC90 values for cefalexin determined in target bacterial strains

isolated from diseased dogs in Europe and in the USA are:

- S. pseudintermedius: 2 µg/mL

- S. aureus: 8 µg/mL

- S. canis = 0.5 µg/mL

- Beta-hemolytic Streptococcus spp: 2 µg/mL

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Revised 29/03/2010 – AN 02535/2008

- E. coli: 16 µg/mL

- P. multocida: 2µg/mL

- Klebsiella. spp: 4µg/mL

Resistance to cefalexin may be due to one of the following mechanisms of resistance. Firstly,

the production of various beta-lactamases (cephalosporinase), that inactivate the antibiotic, is

the most prevalent mechanism among gram-negative bacteria. Secondly, a decreased affinity

of the PBPs (penicillin-binding proteins) for beta-lactam drugs is frequently involved for beta -

lactam resistant gram-positive bacteria. Lastly, efflux pumps, extruding the antibiotic from the

bacterial cell, and structural changes in porins, reducing passive diffusion of the drug through

the cell wall, may contribute to improve the resistant phenotype of a bacterium.

Well-known cross-resistance (involving the same resistance mechanism) exists between

antibiotics belonging to the beta -lactam group due to structural similarities. It occurs with b-

lactamases enzymes, structural changes in porins or variations in efflux pumps. Co-

resistance (different resistance mechanisms involved) has been described in E.coli due to a

plasmid harbouring various resistance genes.

5.2 Pharmacokinetic particulars

After single oral administration of the recommended dosage of 15 mg cefalexin per kg

bodyweight to Beagle dogs, plasma concentrations were observed within 30 minutes. The

plasma peak was observed at 1.33 h with a plasma concentration of 21.2µg/ml. The

bioavailability of the active was over 90%. Cefalexin was detected until 24 hours after the

administration. The first urine specimen was collected within 2 to 12 hours with peak

concentrations of cefalexin measured at 430 to 2758 µg / ml within 12 hours.

After repeated oral administration of the same dosage, twice a day for 7 days, plasma peaks

occurred 2 hours later with a concentration of 20µg/ml. Over the treatment period

concentrations were maintained above 1 µg/ml. The mean elimination half life is 2 hours. Skin

levels were around 5.8 to 6.6 µg /g 2 hours after treatment.

5.3 Environmental properties

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Croscarmellose sodium

Silica, colloidal anhydrous

Magnesium stearate

Yeast dried

Biscuit flavour F07012

Ammonium glycyrrhizate

Macrogol 6000

6.2 Incompatibilities

None known

Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!

Revised 29/03/2010 – AN 02535/2008

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening the immediate packaging: 48 hours.

Any divided tablet portions remaining after 48 hours should be discarded.

6.4. Special precautions for storage

Do not store above 25 °

C

Divided tablets should be stored in the blister pack.

6.5 Nature and composition of immediate packaging

Polyvinylchloride blister heat sealed with an aluminium cover foil.

Pack sizes:

Cardboard box with 1 blister of 10 tablets

Cardboard box with 20 blisters of 10 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 product should be disposed of in accordance with local requirements

7. MARKETING AUTHORISATION HOLDER

Sogeval SA

200 avenue de Mayenne – BP 2227

53022 LAVAL Cedex 9

France

Tel: 33.2.43.49.51.51

Fax: 33.2.43.53.97.00

E-mail: sogeval@sogeval.fr

8. MARKETING AUTHORISATION NUMBER

Vm 20749/4004

9. DATE OF FIRST AUTHORISATION

27 February 2009

10 DATE OF REVISION OF THE TEXT

29 March 2010

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable

There are no safety alerts related to this product.

There are no news related to this product.

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