prescribing information tolfedine™ - ausrichter · – inhibits prostaglandin synthesis from...
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PRESCRIBING INFORMATIONTolfedine™(tolfenamic acid)
Actions: Tolfenamic acid is a nonsteroidal anti-flammatory drug (nsaid) of the fenamate group. It has adouble action on prostaglandins:– inhibits prostaglandin synthesis from
arachidonic acid– inhibits tissue response to prostaglandins by
occupying receptor sitesIt is a potent analgesic, antipyretic and anti-inflammatory. The anti-inflammatory activity oftolfenamic acid is due to inhibition of cyclooxgenaseleading to a reduction in prostaglandin andthromboxane synthesis, major inflammatory mediators.
Pharmacokinetics: Tolfenamic acid is rapidly absorbedboth orally and following injection.
CATSOrally – Maximum plasma concentrations afteradministration of 4mg/kg results in mean maximumplasma concentration (Cmax) of 5.6µg/ml reached inabout 1 hour. Plasma levels in cats are higher due to ahigh level of entro hepatic recycling which prolongsthe therapeutic action.
Injection – A injection of 4mg/kg of tolfenamic acidresults in mean maximum plasma concentration (Cmax)of 3.9µg/ml in about 1 hour. Levels persist(concentration >0.1µg/ml) for 24-48 hours. Absorptionis particuarly fast in cats.
DOGSOrally – After a single oral administration of 4mg/kgmean maximum plasma concentration (Cmax) of4µg/ml in I hour. At the same dosage taken with foodCmax is 2.3µg/ml.
Injection – Following administration of 4mg/kg byeither (IM or SC) injection the mean maximum plasmaconcentration (Cmax) is 4µg/ml (SC) and 3µg/ml (IM) isreached in 2 hours.
Indications: Conditions requiring non steroidal anti-inflammatory–analgesic–antipyretic therapy in cats anddogs.• post operative pain and inflammation• upper respiratory infections together with
antimicrobials (in cats)• for acute and chronic inflammatory conditions• febrile syndromes (abscess, fever of unknown
origin)• inflammation and locomotor disease.
Contraindications: Do not use in food producinganimals or horses.Do not use in animals with cardiac, hepatic, or renaldisease, showing signs of gastrointestinal ulceration,bleeding, blood dyscrasia or hypersensitivity to theproduct. Do not administer NSAID`s concurrently orwithin 24 hours of each other
DO NOT ADMINISTER BY INTRAMUSCULARINJECTION IN CATS.
TOLFEDINE ® NOT TO BE SNEEZED AT.ANTI-PYRETIC ANTI-INFLAMMATORY ANALGESIC
Undesirable effects: Diarrhoea or vomiting mayoccur in rare cases during treatment. A temporaryincrease in thirst and/or diuresis may occur. In mostcases these signs cease after treatment.
Precautions: Use in animals under six weeks of ageand aged animals may involve additional risks. Ifsuch cases cannot be avoided animals may require areduced dose and careful clinical management.Avoid use in dehydrated, hypovolemic, hypotensiveanimals as there is potential risk of increased renaltoxicity.Do not use in cases where there is acute renalinsufficiency.Although studies in laboratory animals did not showany effects on reproduction, it is advisable not toadminister nsaid`s during gestation.
DOSAGE & ADMINISTRATION:Tolfenamic acid 4mg/kg bodyweight once daily forcats and dog by injection or orally.
Injection : Cats 1mL/10kg bodyweight by subcutaneous injection onlyDogs 1mL/10kg bodyweight by intramuscular or subcutaneous injection
The use of an insulin syringe is advisable in lowweight animals to ensure accurate dosing.A subsequent dose after 24 hours of 1mL/10kgbodyweight by injection or tablets may beadministered.
Tablets:Cats and Dogs; Tolfedine 6mg tablets/1 tablet per 1.5kg body-weight,Tolfedine 60mg tablets/1 tablet per 15kg bodyweight Once daily for 3-5 days
A suggested regime is an initial injection of TolfedineInjectable followed by Tolfedine tablets onsubsequent days.
Longterm therapy: A three month study evaluated adosage regime of 4mg/kg for 3 consecutive days aweek for painful locomotor disease in dogs. Theclinical improvement (p<0.05) was significant.
Additional information: For Dosage & Administrationinformation see pack insert and pack label.
Presentation: Injection:Tolfedine Injectable 40mg/mLtolfenamic acid,10 mL (multi-dose) vial; For Cats and Dogs
Tablets: Tolfedine Tablets 6mg tolfenamic acid,For Cats and Minature Dogs 20’s, Tolfedine Tablets 60mg tolfenamic acid,For Dogs (7 – 45>kg) 16’s.
Disposal: Dispose of empty container by wrappingwith paper and putting in the garbage.
Storage: Store below 25˚C (air conditioning).
Manufactured by: Distributed by:
AUSRICHTER PTY LTD ABN 79 000 908 529Unit 2-21 Chester Street, Camperdown NSW 2050Tel: (02) 9517 1166 Fax: (02) 9516 5810Email [email protected]
Vétoquinol SA70204 Lure Cedex France ✔ ✔ ✔
Rapid action in post-operative analgesiaTolfedine provides effective post-operative analgesiccover due to its proven 24 hour action.
Three studies were carried out in dogs followingorthopaedic surgery, under the same environmentaland experimental conditions and the sameanaesthetic protocols, to ascertain the analgesic effectof various drugs. The analgesic effect of tolfenamicacid (4mg/kg) was shown to be equal to that ofpethidine(9)(fig. 8).
Rapid pain relief in acuteflare-ups of osteoarthritisTolfedine has been clinically proven to relievearthritis effectively. A 3 month study to evaluate thedosage regime of 3 consecutive days a week for dogswith painful or locomotor disorders showedsignificant clinical improvement (p<0.05)(10).
Tolfedine® is a Non-Steroidal Anti-inflammatoryDrug licenced for use in both cats and dogs.
Entero-hepatic recirculation
Seru
m co
ncen
tratio
n of
tolfe
nam
ic ac
id u
g/m
l
Time (hours)
SC Cat
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
3020100
Tolfenamic acid delivers the anti-inflammatorypower expected of a modern NSAID and has beenshown to have strong antipyretic and analgesicactivity(1).
The maximum plasma concentration is reachedwithin 2 hours for both injectable and oral routes incats and dogs.
A dosage regime of 4mg/kg tolfenamic acid (eitherby the subcutaneous or the oral route) leads to aneffective plasma concentration for 24 hours, withoutaccumulation of the drug in the body. Thisprolonged action is due to the entero-hepaticrecirculation of tolfenamic acid (fig.1).
Analgesic Effect
Mea
n Pa
in Sc
ore
Time (minutes)
0
5
10
15
20
25
30
PethidineTolfenamic acid (IV)
907560453015
Tolfedine® - Proven Efficacy in DOGS
Pain score measured on a visualanalogue scale from 0 - 100.0 = Pain free
fig.1
fig.8
REFERENCES:-1. Data on file. 2. ‘Tolerance of Tolfenamic Acid tablets in the dog’,
1992, European Registration Dossier ‘Tolerance ofTolfenamic Acid tablets in the cat’, 1992, EuropeanRegistration Dossier.
3. ‘Evaluation of Tolfedine® injectable solution fieldefficacy in the treatment of upper respiratory diseasein cats’, 1992 European Registration Dossier. GuelfiJ F et al, ‘Clinical test: effects of Tolfenamic acid inthe treatment of the common cold in cats; results ofa comparative test’, ,Practique Médicale etChirurgicale de l’Animal de Compagne, 1991vol.26, no.4, 363-367. ‘Field evaluation ofTolfedine® tablets in the treatment of febrilesyndromes in cats’, 1992, European RegistrationDossier. E Thomas et al, ‘Feline fever: the benefits ofa treatment using Tolfenamic Acid’, PractiqueMédicale et Chirurgicale de l’Animal de Compagne,1993, 28, 483-489. ‘Evaluation of Tolfedine® tabletsfield efficacy in the treatment of acute flare-ups ofchronic locomotor disorders in dogs’, 1992,European registration dossier. ClinicalExperimentation with Tolfedine® injectable, 1989,
Internal report. Clinical Experimentation with Tolfedine®
tablets for dogs, 1989, Internal report. S Chaffaux et al,‘Interest of a post operative treatment with tolfenamic acid inmasectomy of the bitch: Results of a blind control study’, Rec.Méd. Vét. 1991, 167 (6) 507-511. Observed side effects withTolfenamic acid reported during clinical trials of Sept 1988 -April 1989 period - Internal report.
4. Data on file. 5. Vane JR, Botting RM, ‘New insights into mode of action of
antiinflammatory drugs’, Inflamm. Res. 1995, 44: 1 -10. 6. A P Ricketts et al, ‘Evaluation of selective inhibition of canine
cyclooxygenase 1 and 2 by carprofen and other nonsteroidalanti-inflammatory drugs’, AJVR November 1998, Vol 59,No.11.
7. ‘Evaluation of Tolfedine® injectable solution field efficacy inthe treatment of upper respiratory disease in cats’, 1992European Registration Dossier.
8. ‘Field evaluation of Tolfedine® tablets in the treatment offebrile syndromes in cats’, 1992, European RegistrationDossier.
9. Fonda D, Perini A`Analgesic efficacy with tolfenamic acidafter orthopaedic surgery in dogs`, Veterinary SurgeryDepartment, University of Milan.
10.Data on file.
Proven SafetyWhen Tolfedine was administered to cats and dogsfor 10 days at double the therapeutic dosage (8mg/kg/day) by the oral route, it did not lead todigestive disorders or haemorrhagic diarrhoea and itdid not modify blood clotting time(2).
In field trials carried out under routine veterinarypractice conditions (287 dogs & 180 cats), adverseeffects were monitored(3). The results are shown infigure 2.
Excellent Renal ToleranceA study to assess the influence of tolfenamic acid onrenally impaired dogs showed that there was noaccumulation of the drug in the body andelimination of tolfenamic acid actually increased inrenally impaired dogs. Tolfenamic acid cantherefore be used safely in the renally impaired orgeriatric dog, with no adjustment to the dosageregime necessary (4). It is however contra-indicated inacute renal insufficiency.
Low gastro-ulcerative effectNSAIDs substantially more selective for inhibitingCOX2 (cyclo-oxygenase 2) than COX1 (cyclo-oxygenase 1) have been shown to be well toleratedwith regard to adverse effects on the gastrointestinalsystem during clinical trials in humans (5).
In a recent study, tolfenamic acid was shown to be15 times more potent in inhibiting canine COX2than COX1, ranked second highest among theveterinary licenced products (6)(fig.3).
0.1
1
10
100
1000
KetoprofenFlunixinMeloxicamTolfenamicAcid
Carprofen
COX2 Selectivity
COX1
: CO
X2 ra
tio
15
129
2.9
0.6
0.2
Tolfedine® - Proven Efficacy in DOGS
% animals with no adverse effects(vomiting & diarrhoea)
Perce
ntag
e
0
20
40
60
80
100
DogCatTolfenamic acid 3-7 mg/kg/day
96.5%94.4%
Higher value for the ratio indicates greaterselectivity for canine COX2
“I bet the dog willneed his Tolfedine® soon!”
fig.2
fig.3
Rapid Recovery in UpperRespiratory Tract InfectionsCats are particularly sensitive to infections of theupper respiratory tract, often resulting in an impairedsense of smell and subsequent appetite loss. Loss ofappetite is a critical symptom for the cat and also forthe owner, who judges the cat to be in recovery onlywhen it is eating again. A quick return to appetite istherefore desirable.
In a clinical trial, 55 cats suffering from acute felineinfluenza were treated; 25 with Tolfedine 4%injection and 30 with a placebo injectablesolution(7). Both groups also received amoxycillin(30mg/kg/48hr on D0, D2 & D4).
Tolfedine promoted return to appetite andincreased the success rate of therapy due to its fastaction and anti-pyretic power (fig.4 & 5).
Rapid Recoveryin Febrile SyndromesFever in cats is a common and non-specificcondition and, if left untreated, can lead to anorexia,weight loss and anaemia. Loss of appetite is oftenthe first indication of fever and presents a commonand frequently frustrating clinical scenario.
A clinical trial of 36 cats with anorexia and pyrexiashowed that Tolfedine increases the rate of recoveryin cats with febrile syndromes due to its rapid anti-pyretic action (8).
Tolfedine produced a significant decrease intemperature from Day 1 regardless of the cause ofpyrexia (fig. 6).
The average time for return to appetite withTolfedine was significantly less than the placebo,occurring 24 hours earlier (fig. 7).
Both results were particularly notable in nonabscess-linked fevers, where the symptoms of feverare evident but diagnosis is often very difficult. Thefast reduction in temperature and return to appetiteachieved with Tolfedine is of considerable benefit inthese cases.Tolfedine® - Proven Efficacy in CATS
Tolfedine® - Proven Efficacy in CATS
Return to appetite
Mean
App
etite
Scor
e
0.0
0.5
1.0
1.5
2.0
2.5
TolfedinePlacebo
1 NormalAppetite score:
4 Anorexia
Day 7Day 4Day 2Day 1Day 0
Success rate of therapy
Perce
ntag
e
0
20
40
60
80
100
PlaceboTolfedine
Tolfedine 4%(4mg/kg/day)
70%87%
Reduction in temperature
Tem
pera
ture
o C
37.5
38.0
38.5
39.0
39.5
40.0
40.5 TolfedinePlacebo
(38.5 oC Normal)
Day 4Day 3Day 2Day 1Day 0
Average time for return to appetiteHo
urs
0
10
20
30
40
50
Placebo n 16Tolfedine n 20
40
10
fig.4
fig.5
fig.6
fig.7
“I bet the cat won’t sneezeat his Tolfedine® now!”
Rapid Recovery in UpperRespiratory Tract InfectionsCats are particularly sensitive to infections of theupper respiratory tract, often resulting in an impairedsense of smell and subsequent appetite loss. Loss ofappetite is a critical symptom for the cat and also forthe owner, who judges the cat to be in recovery onlywhen it is eating again. A quick return to appetite istherefore desirable.
In a clinical trial, 55 cats suffering from acute felineinfluenza were treated; 25 with Tolfedine 4%injection and 30 with a placebo injectablesolution(7). Both groups also received amoxycillin(30mg/kg/48hr on D0, D2 & D4).
Tolfedine promoted return to appetite andincreased the success rate of therapy due to its fastaction and anti-pyretic power (fig.4 & 5).
Rapid Recoveryin Febrile SyndromesFever in cats is a common and non-specificcondition and, if left untreated, can lead to anorexia,weight loss and anaemia. Loss of appetite is oftenthe first indication of fever and presents a commonand frequently frustrating clinical scenario.
A clinical trial of 36 cats with anorexia and pyrexiashowed that Tolfedine increases the rate of recoveryin cats with febrile syndromes due to its rapid anti-pyretic action (8).
Tolfedine produced a significant decrease intemperature from Day 1 regardless of the cause ofpyrexia (fig. 6).
The average time for return to appetite withTolfedine was significantly less than the placebo,occurring 24 hours earlier (fig. 7).
Both results were particularly notable in nonabscess-linked fevers, where the symptoms of feverare evident but diagnosis is often very difficult. Thefast reduction in temperature and return to appetiteachieved with Tolfedine is of considerable benefit inthese cases.Tolfedine® - Proven Efficacy in CATS
Tolfedine® - Proven Efficacy in CATS
Return to appetite
Mean
App
etite
Scor
e
0.0
0.5
1.0
1.5
2.0
2.5
TolfedinePlacebo
1 NormalAppetite score:
4 Anorexia
Day 7Day 4Day 2Day 1Day 0
Success rate of therapy
Perce
ntag
e
0
20
40
60
80
100
PlaceboTolfedine
Tolfedine 4%(4mg/kg/day)
70%87%
Reduction in temperature
Tem
pera
ture
o C
37.5
38.0
38.5
39.0
39.5
40.0
40.5 TolfedinePlacebo
(38.5 oC Normal)
Day 4Day 3Day 2Day 1Day 0
Average time for return to appetite
Hour
s
0
10
20
30
40
50
Placebo n 16Tolfedine n 20
40
10
fig.4
fig.5
fig.6
fig.7
“I bet the cat won’t sneezeat his Tolfedine® now!”
Proven SafetyWhen Tolfedine was administered to cats and dogsfor 10 days at double the therapeutic dosage (8mg/kg/day) by the oral route, it did not lead todigestive disorders or haemorrhagic diarrhoea and itdid not modify blood clotting time(2).
In field trials carried out under routine veterinarypractice conditions (287 dogs & 180 cats), adverseeffects were monitored(3). The results are shown infigure 2.
Excellent Renal ToleranceA study to assess the influence of tolfenamic acid onrenally impaired dogs showed that there was noaccumulation of the drug in the body andelimination of tolfenamic acid actually increased inrenally impaired dogs. Tolfenamic acid cantherefore be used safely in the renally impaired orgeriatric dog, with no adjustment to the dosageregime necessary (4). It is however contra-indicated inacute renal insufficiency.
Low gastro-ulcerative effectNSAIDs substantially more selective for inhibitingCOX2 (cyclo-oxygenase 2) than COX1 (cyclo-oxygenase 1) have been shown to be well toleratedwith regard to adverse effects on the gastrointestinalsystem during clinical trials in humans (5).
In a recent study, tolfenamic acid was shown to be15 times more potent in inhibiting canine COX2than COX1, ranked second highest among theveterinary licenced products (6)(fig.3).
0.1
1
10
100
1000
KetoprofenFlunixinMeloxicamTolfenamicAcid
Carprofen
COX2 Selectivity
COX1
: CO
X2 ra
tio
15
129
2.9
0.6
0.2
Tolfedine® - Proven Efficacy in DOGS
% animals with no adverse effects(vomiting & diarrhoea)
Perce
ntag
e
0
20
40
60
80
100
DogCatTolfenamic acid 3-7 mg/kg/day
96.5%94.4%
Higher value for the ratio indicates greaterselectivity for canine COX2
“I bet the dog willneed his Tolfedine® soon!”
fig.2
fig.3
Rapid action in post-operative analgesiaTolfedine provides effective post-operative analgesiccover due to its proven 24 hour action.
Three studies were carried out in dogs followingorthopaedic surgery, under the same environmentaland experimental conditions and the sameanaesthetic protocols, to ascertain the analgesic effectof various drugs. The analgesic effect of tolfenamicacid (4mg/kg) was shown to be equal to that ofpethidine(9)(fig. 8).
Rapid pain relief in acuteflare-ups of osteoarthritisTolfedine has been clinically proven to relievearthritis effectively. A 3 month study to evaluate thedosage regime of 3 consecutive days a week for dogswith painful or locomotor disorders showedsignificant clinical improvement (p<0.05)(10).
Tolfedine® is a Non-Steroidal Anti-inflammatoryDrug licenced for use in both cats and dogs.
Entero-hepatic recirculation
Seru
m co
ncen
tratio
n of
tolfe
nam
ic ac
id u
g/m
l
Time (hours)
SC Cat
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
3020100
Tolfenamic acid delivers the anti-inflammatorypower expected of a modern NSAID and has beenshown to have strong antipyretic and analgesicactivity(1).
The maximum plasma concentration is reachedwithin 2 hours for both injectable and oral routes incats and dogs.
A dosage regime of 4mg/kg tolfenamic acid (eitherby the subcutaneous or the oral route) leads to aneffective plasma concentration for 24 hours, withoutaccumulation of the drug in the body. Thisprolonged action is due to the entero-hepaticrecirculation of tolfenamic acid (fig.1).
Analgesic Effect
Mea
n Pa
in Sc
ore
Time (minutes)
0
5
10
15
20
25
30
PethidineTolfenamic acid (IV)
907560453015
Tolfedine® - Proven Efficacy in DOGS
Pain score measured on a visualanalogue scale from 0 - 100.0 = Pain free
fig.1
fig.8
REFERENCES:-1. Data on file. 2. ‘Tolerance of Tolfenamic Acid tablets in the dog’,
1992, European Registration Dossier ‘Tolerance ofTolfenamic Acid tablets in the cat’, 1992, EuropeanRegistration Dossier.
3. ‘Evaluation of Tolfedine® injectable solution fieldefficacy in the treatment of upper respiratory diseasein cats’, 1992 European Registration Dossier. GuelfiJ F et al, ‘Clinical test: effects of Tolfenamic acid inthe treatment of the common cold in cats; results ofa comparative test’, ,Practique Médicale etChirurgicale de l’Animal de Compagne, 1991vol.26, no.4, 363-367. ‘Field evaluation ofTolfedine® tablets in the treatment of febrilesyndromes in cats’, 1992, European RegistrationDossier. E Thomas et al, ‘Feline fever: the benefits ofa treatment using Tolfenamic Acid’, PractiqueMédicale et Chirurgicale de l’Animal de Compagne,1993, 28, 483-489. ‘Evaluation of Tolfedine® tabletsfield efficacy in the treatment of acute flare-ups ofchronic locomotor disorders in dogs’, 1992,European registration dossier. ClinicalExperimentation with Tolfedine® injectable, 1989,
Internal report. Clinical Experimentation with Tolfedine®
tablets for dogs, 1989, Internal report. S Chaffaux et al,‘Interest of a post operative treatment with tolfenamic acid inmasectomy of the bitch: Results of a blind control study’, Rec.Méd. Vét. 1991, 167 (6) 507-511. Observed side effects withTolfenamic acid reported during clinical trials of Sept 1988 -April 1989 period - Internal report.
4. Data on file. 5. Vane JR, Botting RM, ‘New insights into mode of action of
antiinflammatory drugs’, Inflamm. Res. 1995, 44: 1 -10. 6. A P Ricketts et al, ‘Evaluation of selective inhibition of canine
cyclooxygenase 1 and 2 by carprofen and other nonsteroidalanti-inflammatory drugs’, AJVR November 1998, Vol 59,No.11.
7. ‘Evaluation of Tolfedine® injectable solution field efficacy inthe treatment of upper respiratory disease in cats’, 1992European Registration Dossier.
8. ‘Field evaluation of Tolfedine® tablets in the treatment offebrile syndromes in cats’, 1992, European RegistrationDossier.
9. Fonda D, Perini A`Analgesic efficacy with tolfenamic acidafter orthopaedic surgery in dogs`, Veterinary SurgeryDepartment, University of Milan.
10.Data on file.
PRESCRIBING INFORMATIONTolfedine™(tolfenamic acid)
Actions: Tolfenamic acid is a nonsteroidal anti-flammatory drug (nsaid) of the fenamate group. It has adouble action on prostaglandins:– inhibits prostaglandin synthesis from
arachidonic acid– inhibits tissue response to prostaglandins by
occupying receptor sitesIt is a potent analgesic, antipyretic and anti-inflammatory. The anti-inflammatory activity oftolfenamic acid is due to inhibition of cyclooxgenaseleading to a reduction in prostaglandin andthromboxane synthesis, major inflammatory mediators.
Pharmacokinetics: Tolfenamic acid is rapidly absorbedboth orally and following injection.
CATSOrally – Maximum plasma concentrations afteradministration of 4mg/kg results in mean maximumplasma concentration (Cmax) of 5.6µg/ml reached inabout 1 hour. Plasma levels in cats are higher due to ahigh level of entro hepatic recycling which prolongsthe therapeutic action.
Injection – A injection of 4mg/kg of tolfenamic acidresults in mean maximum plasma concentration (Cmax)of 3.9µg/ml in about 1 hour. Levels persist(concentration >0.1µg/ml) for 24-48 hours. Absorptionis particuarly fast in cats.
DOGSOrally – After a single oral administration of 4mg/kgmean maximum plasma concentration (Cmax) of4µg/ml in I hour. At the same dosage taken with foodCmax is 2.3µg/ml.
Injection – Following administration of 4mg/kg byeither (IM or SC) injection the mean maximum plasmaconcentration (Cmax) is 4µg/ml (SC) and 3µg/ml (IM) isreached in 2 hours.
Indications: Conditions requiring non steroidal anti-inflammatory–analgesic–antipyretic therapy in cats anddogs.• post operative pain and inflammation• upper respiratory infections together with
antimicrobials (in cats)• for acute and chronic inflammatory conditions• febrile syndromes (abscess, fever of unknown
origin)• inflammation and locomotor disease.
Contraindications: Do not use in food producinganimals or horses.Do not use in animals with cardiac, hepatic, or renaldisease, showing signs of gastrointestinal ulceration,bleeding, blood dyscrasia or hypersensitivity to theproduct. Do not administer NSAID`s concurrently orwithin 24 hours of each other
DO NOT ADMINISTER BY INTRAMUSCULARINJECTION IN CATS.
TOLFEDINE ® NOT TO BE SNEEZED AT.ANTI-PYRETIC ANTI-INFLAMMATORY ANALGESIC
Undesirable effects: Diarrhoea or vomiting mayoccur in rare cases during treatment. A temporaryincrease in thirst and/or diuresis may occur. In mostcases these signs cease after treatment.
Precautions: Use in animals under six weeks of ageand aged animals may involve additional risks. Ifsuch cases cannot be avoided animals may require areduced dose and careful clinical management.Avoid use in dehydrated, hypovolemic, hypotensiveanimals as there is potential risk of increased renaltoxicity.Do not use in cases where there is acute renalinsufficiency.Although studies in laboratory animals did not showany effects on reproduction, it is advisable not toadminister nsaid`s during gestation.
DOSAGE & ADMINISTRATION:Tolfenamic acid 4mg/kg bodyweight once daily forcats and dog by injection or orally.
Injection : Cats 1mL/10kg bodyweight by subcutaneous injection onlyDogs 1mL/10kg bodyweight by intramuscular or subcutaneous injection
The use of an insulin syringe is advisable in lowweight animals to ensure accurate dosing.A subsequent dose after 24 hours of 1mL/10kgbodyweight by injection or tablets may beadministered.
Tablets:Cats and Dogs; Tolfedine 6mg tablets/1 tablet per 1.5kg body-weight,Tolfedine 60mg tablets/1 tablet per 15kg bodyweight Once daily for 3-5 days
A suggested regime is an initial injection of TolfedineInjectable followed by Tolfedine tablets onsubsequent days.
Longterm therapy: A three month study evaluated adosage regime of 4mg/kg for 3 consecutive days aweek for painful locomotor disease in dogs. Theclinical improvement (p<0.05) was significant.
Additional information: For Dosage & Administrationinformation see pack insert and pack label.
Presentation: Injection:Tolfedine Injectable 40mg/mLtolfenamic acid,10 mL (multi-dose) vial; For Cats and Dogs
Tablets: Tolfedine Tablets 6mg tolfenamic acid,For Cats and Minature Dogs 20’s, Tolfedine Tablets 60mg tolfenamic acid,For Dogs (7 – 45>kg) 16’s.
Disposal: Dispose of empty container by wrappingwith paper and putting in the garbage.
Storage: Store below 25˚C (air conditioning).
Manufactured by: Distributed by:
AUSRICHTER PTY LTD ABN 79 000 908 529Unit 2-21 Chester Street, Camperdown NSW 2050Tel: (02) 9517 1166 Fax: (02) 9516 5810Email [email protected]
Vétoquinol SA70204 Lure Cedex France ✔ ✔ ✔