Dicural
difloxacin
42
Medicinal product no longer authorised
authorised
Pfizer Limited Ramsgate Road Sandwich
Kent CT13 9NJ
United Kingdom
Pfizer Olot, S.L.U.
Ctra. Camprodón, s/n°, Finca La Riba, Vall de Bianya, 17813 Girona
Spain
Dicural 100 mg/ml oral solution for chickens and turkeys
no
Each ml contains:
Difloxacin (as hydrochloride) 100 mg
Other excipients, including benzyl alcohol, in an aqueous formulation to 1 ml
Medicinal
In chickens and turkeys: Dicural oral solution is indicated for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
In turkeys: Dicural oral solution is also indicated for the treatment of infections caused by Pasteurella multocida.
Dicural oral solution should only be used based on susceptibility testing
Since no studies were performed in clinically lame birds, Dicural oral solution should not be used in birds with existing leg-weakness or in birds suffering from osteoporosis.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
authorised
Chickens (broilers and future breeders)
Turkeys (young turkeys up to 2 kg body weight).
Dicural oral solution must be administrated daily via the drinking water in such a concentration that the dose is 10 mg/kg bodyweight. The administration must be continued for 5 days.
For oral administration in drinking water.
Taking into account the content of difloxacin in the oral solution (10%w/v), the following calculation should be made to determine the volume (ml) to be added for each 1000 litres of water:
number of animals in the house X mean weight of individual animal(kg) X 100
-----------------------------------------------------------------------------------------------------
total water consumption of the house at the previous day (litres)
no
The screw cap on the 1 litre bottle can be used as measuring device. If filled to the brim the measuring device provides 50 ml. For the 250 ml bottle a separate measuring device is placed on the screw cap. Measuring lines indicate the volume supplied.
The medicated drinking water should be prepared freshly each day.
No other source of drinking water should be available during the medication period.
Medicinal
No additional chlorine, for example from the use of water chlorinators, or hydrogen peroxide should be added to the drinking water used with this product.
At concentrations in the water of 0.03% (= 300 ml in 1000 litres) or greater, palatability for turkeys may be affected.
Meat and offal (chicken and turkeys): 24 hours.
Not permitted for use in laying birds producing eggs for human consumption.
Keep out of the reach and sight of children. Do not store above 25 °C.
Protect from light.
Do not freeze.
Shelf-life after first opening the container: 1 month.
Do not use after the expiry date stated on the label after EXP
authorised
Do not use in birds in lay and/or within 4 weeks before the onset of the laying period.>
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
People with known hypersensitivity to quinolones should avoid any contact with the product.
In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device, when handling this product.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
no
Detailed information on this product is available on the website of the European Medicines Agency
For animal treatment only. To be supplied only on veterinary prescription.
Medicinal
Dicural oral solution is a yellowish clear aqueous solution and is supplied in plastic white bottles with a screw cap containing 250 or 1000 ml oral solution. Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
België/Belgique/Belgien Pfizer Animal Health s.a., Tél.: +32 (0)2 554 62 11
Luxembourg
Pfizer Animal Health s.a., Tél.: + 32 (0)2 554 62 11
Република България Pfizer Luxembourg SARL Tel: + 359 2 970 41 71
authorised
Magyarország Pfizer Kft.
Tel: +361 488 3695
Česká republika Pfizer Animal Health
Tel: +420 283 004 111
Malta
Agrimed Limited Tel: +356 21 465 797
Danmark
Pfizer Oy Animal Health Tlf: +358 (0)9 4300 40
Nederland
Pfizer Animal Health B.V., Tel: +31 (0)10 4064 600
Deutschland Pfizer GmbH
Tel: +49 30-5500 5501
Norge
no
Pfizer Oy Animal Health Tlf: +358 (0)9 4300 40
Eesti
Medicinal
Pfizer Animal Health Tel: +370 5 269 17 96
Österreich
Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 52 11 57 20
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Polska
Pfizer Trading Polska Sp. z.o.o. Tel: +48 22 335 61 00
España Pfizer S.L.
Tel: +34 91 4909900
Portugal
Laboratórios Pfizer, Lda. Tel: +351 21 423 55 00
France Pfizer
Tél: +33 (0)1 58 07 46 00
Romania
Pfizer Romania SRL
Tel: + 0040 21 207 28 93
Ireland
Pfizer Healthcare Ireland, trading as: Pfizer Animal Health
Tel: +353 (0) 1 467 6500
authorised
Slovenija
Pfizer Luxembourg SARL Tel: +386 (0) 1 52 11 670
Ìsland
Pfizer Oy Animal Health Tel: +358 (0)9 4300 40
Slovenská republika
Pfizer Luxembourg SARL o.z. Tel: + 421 2 3355 5500
Italia
Pfizer Italia S.r.l.,
Tel: +39 06 3318 2933
Suomi/Finland
no
Pfizer Oy Animal Health, Puh/Tel: +358 (0)9 4300 40
Kύπρος
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Sverige
Pfizer Oy Animal Health Tel: +358 (0)9 4300 40
Medicinal
Latvija
Pfizer Animal Health Tel: +370 5 269 17 96
United Kingdom Pfizer Ltd
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health Tel: +370 5 269 17 96
authorised
Pfizer Limited Ramsgate Road Sandwich
Kent CT13 9NJ
United Kingdom
Pfizer Olot, S.L.U.
Ctra. Camprodón, s/n°, Finca La Riba, Vall de Bianya, 17813 Girona
Spain
no
Dicural 15 mg coated tablets for dogs Dicural 50 mg coated tablets for dogs Dicural 100 mg coated tablets for dogs Dicural 150 mg coated tablets for dogs
Each tablet contains: | ||
Dicural 15 mg | difloxacin (as hydrochloride) | 15 mg |
Dicural 50 mg | difloxacin (as hydrochloride) | 50 mg |
Dicural 100 mg | difloxacin (as hydrochloride) | 100 mg |
Dicural 150 mg | difloxacin (as hydrochloride) | 150 mg |
Medicinal
Dicural coated tablets are indicated for the following clinical conditions in dogs:
Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp.
Superficial pyoderma caused by Staphylococcus intermedius.
Dicural Coated Tablets should only be used based on susceptibility testing.
As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing joints, difloxacin should not be used during the rapid growth phase, that is, do not use in small-and medium breed dogs up to and including 8 months of age, in large breeds up to 1 year of age and in giant breeds up to 18 months of age.
Do not use in epileptic dogs.
authorised
Adverse reactions were rare in dogs treated with difloxacin. The observed reactions were inappetence, emesis, diarrhoea, and anal irritation. These adverse reactions were self-limiting within one or two days and did not require additional treatment.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Dogs
The recommended dose of difloxacin is 5 mg/kg bodyweight per day. Dicural coated tablets should be given once a day for at least 5 days. Superficial pyoderma may require treatment for up to a maximum of 21 days. The tablets should be administered for at least 2 days beyond the cessation of clinical signs.
no
Therapy should be re-evaluated if no improvement is seen within 5 days, or 10 days in the case of superficial pyoderma.
Bodyweight (kg) | Dicural 15 mg | Dicural 50 mg | Dicural 100 mg | Dicural 150 mg | |
Small | 0 - 3 4 - 6 | 1 2 | |||
Medium | 7 - 10 11 - 20 21 - 30 | (3) | 1 2 3 | (1) | (1) |
Large | 31 - 40 41 - 60 | 2 3 | (2) |
Medicinal
For oral use.
Not applicable.
Keep out of the reach and sight of children. Do not store above 25°C. Store in a dry place.
authorised
Do not use after the expiry date stated on the carton after EXP.
People with known hypersensitivity to quinolones should avoid any contact with the product. The use of difloxacin in pregnant or lactating bitches or male stud dogs is not recommended.
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
no
Detailed information on this product is available on the website of the European Medicines Agency
For animal treatment only - to be supplied only on veterinary prescription.
Medicinal
Dicural coated tablets consist of a core tablet containing difloxacin hydrochloride and a highly palatable coating. Each strength of the product is available in packs of 10, 20 and 100 tablets. Not all pack sizes may be marketed.
Difloxacin is an aryl-fluoroquinolone with a broad spectrum of antimicrobial activity. Difloxacin can be bactericidal against many Gram-negative micro-organisms and a selection of Gram-positive micro- organisms.
The fluoroquinolones exert their antibacterial effects against both replicating and dormant micro- organisms. Difloxacin acts primarily through inhibition of bacterial DNA gyrase.
The following organisms were tested and found to be susceptible to difloxacin in vitro: Escherichia coli
Klebsiella spp.
Pasteurella spp. Pseudomonas spp. Staphylococcus intermedius
The following organisms were found to be of intermediate susceptibility:
authorised
Proteus spp. Staphylococcus spp. Streptococcus canis (beta) Streptococcus spp.
Following an oral dose (a plain tablet) in dogs of 5 mg/kg bodyweight, difloxacin reached its average peak plasma concentration of 1.8 µg/ml in approximately 3 hours. Approximately 95 % of the oral dose was absorbed. The elimination half-life averaged 9.3 hours.
Long term daily oral treatment over 180 days at 5 mg/kg bodyweight did not influence difloxacin kinetics, neither by accumulation nor by increased drug metabolism.
Medicinal
no
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Pfizer Animal Health s.a., Tél.: +32 (0)2 554 62 11
Luxembourg
Pfizer Animal Health s.a., Tél.: + 32 (0)2 554 62 11
Република България Pfizer Luxembourg SARL Tel: + 359 2 970 41 71
authorised
Magyarország Pfizer Kft.
Tel: +361 488 3695
Česká republika Pfizer Animal Health
Tel: +420 283 004 111
Malta
Agrimed Limited Tel: +356 21 465 797
Danmark
Pfizer Oy Animal Health Tlf: +358 (0)9 4300 40
Nederland
Pfizer Animal Health B.V., Tel: +31 (0)10 4064 600
Deutschland Pfizer GmbH
Tel: +49 30-5500 5501
Norge
no
Pfizer Oy Animal Health Tlf: +358 (0)9 4300 40
Eesti
Medicinal
Pfizer Animal Health Tel: +370 5 269 17 96
Österreich
Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 52 11 57 20
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Polska
Pfizer Trading Polska Sp. z.o.o. Tel: +48 22 335 61 00
España Pfizer S.L.
Tel: +34 91 4909900
Portugal
Laboratórios Pfizer, Lda. Tel: +351 21 423 55 00
France Pfizer
Tél: +33 (0)1 58 07 46 00
Romania
Pfizer Romania SRL
Tel: + 0040 21 207 28 93
Ireland
Pfizer Healthcare Ireland, trading as: Pfizer Animal Health
Tel: +353 (0) 1 467 6500
authorised
Slovenija
Pfizer Luxembourg SARL Tel: +386 (0) 1 52 11 670
Ìsland
Pfizer Oy Animal Health Tel: +358 (0)9 4300 40
Slovenská republika
Pfizer Luxembourg SARL o.z. Tel: + 421 2 3355 5500
Italia
Pfizer Italia S.r.l.,
Tel: +39 06 3318 2933
Suomi/Finland
no
Pfizer Oy Animal Health, Puh/Tel: +358 (0)9 4300 40
Kύπρος
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Sverige
Pfizer Oy Animal Health Tel: +358 (0)9 4300 40
Medicinal
Latvija
Pfizer Animal Health Tel: +370 5 269 17 96
United Kingdom Pfizer Ltd
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health Tel: +370 5 269 17 96
authorised
Pfizer Limited Ramsgate Road Sandwich
Kent CT13 9NJ
United Kingdom
Pfizer Olot, S.L.U.
Ctra. Camprodón, s/n°, Finca La Riba, Vall de Bianya, 17813 Girona
Spain
no
Dicural 50 mg/ml solution for injection for cattle and dogs
Difloxacin (as hydrochloride) 50 mg/ml
Benzyl alcohol 50 mg/ml
Medicinal
Cattle: Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp
Superficial pyoderma caused by Staphylococcus intermedius.
Do not use in epileptic dogs.
authorised
In target animal safety studies, subcutaneous administration was generally well tolerated. Transient swelling at the injection site following administration may occur.
In target animal safety studies, subcutaneous administration was generally well tolerated. Pruritis and/or local swellings and occasionally a slight pain reaction on injection have been observed. In general the pruritis disappears within a few minutes and the local swelling within a few days.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Cattle (calves and young cattle)\ Dogs
no
Subcutaneous use
The recommended dose is 2.5 mg difloxacin/kg bodyweight/day for 3 days (that is, 5ml/100 kg bodyweight/day). If there is insufficient improvement after 3 days, the treatment can be continued for another 2 days. For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight / day.
The recommended dose is 5.0 mg difloxacin/kg body weight in a single injection Treatment should be continued with Dicural coated tablets (read the package leaflet of this product)
Medicinal
In cattle, the volume administered per injection site should not exceed 7 ml. A new injection site should be used each day.
In dogs, the volume administered per injection site should not exceed 5 ml.
In the absence of incompatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
authorised
Keep out of the reach and sight of children. Do not store above 25-C.
Do not freeze.
Keep the container in the outer carton.
Shelf-life after first use of the product: 28 days.
Do not use after the expiry date stated on the vial after EXP.
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
Dicural 50 mg/ml solution for injection should only be used based on susceptibility testing. The safety of the veterinary medicinal product has not been established during pregnancy and
lactation.
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs) may cause seizures.
Antagonism may be observed with nitrofurantoin.
no
People with a known hypersensitivity to quinolones should avoid any contact with the product.
At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors,
convulsions, etc.) may occur in cattle. Overdosage may also give rise to oedema and swelling in the knee joints.
In dogs the oral administration of difloxacin at up to 5 times the recommended dose rate for 30 days did not result in any adverse reactions.
Medicinal
In another study dogs treated orally with difloxacin at 10 times the recommended dose for 10 days showed occasionally mild adverse reactions such as orange/yellowing discoloration of the faeces, emesis and hypersalivation.
No specific antidotes for difloxacin (or other quinolones) are known, therefore in case of overdosage symptomatic treatment should be given
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
authorised
Detailed information on this product is available on the website of the European Medicines Agency
For animal treatment only. To be supplied only on veterinary prescription.
Dicural 50 mg/ml, solution for injection for cattle and dogs is available in the following presentations: Dogs: 50 ml vial.
Cattle: 50, 100 and 250 ml vials. Not all pack sizes may be marketed.
Medicinal
no
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Pfizer Animal Health s.a., Tél.: +32 (0)2 554 62 11
Luxembourg
Pfizer Animal Health s.a., Tél.: + 32 (0)2 554 62 11
Република България Pfizer Luxembourg SARL Tel: + 359 2 970 41 71
authorised
Magyarország Pfizer Kft.
Tel: +361 488 3695
Česká republika Pfizer Animal Health
Tel: +420 283 004 111
Malta
Agrimed Limited Tel: +356 21 465 797
Danmark
Pfizer Oy Animal Health Tlf: +358 (0)9 4300 40
Nederland
Pfizer Animal Health B.V., Tel: +31 (0)10 4064 600
Deutschland Pfizer GmbH
Tel: +49 30-5500 5501
Norge
no
Pfizer Oy Animal Health Tlf: +358 (0)9 4300 40
Eesti
Medicinal
Pfizer Animal Health Tel: +370 5 269 17 96
Österreich
Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 52 11 57 20
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Polska
Pfizer Trading Polska Sp. z.o.o. Tel: +48 22 335 61 00
España Pfizer S.L.
Tel: +34 91 4909900
Portugal
Laboratórios Pfizer, Lda. Tel: +351 21 423 55 00
France Pfizer
Tél: +33 (0)1 58 07 46 00
Romania
Pfizer Romania SRL
Tel: + 0040 21 207 28 93
Ireland
Pfizer Healthcare Ireland, trading as: Pfizer Animal Health
Tel: +353 (0) 1 467 6500
authorised
Slovenija
Pfizer Luxembourg SARL Tel: +386 (0) 1 52 11 670
Ìsland
Pfizer Oy Animal Health Tel: +358 (0)9 4300 40
Slovenská republika
Pfizer Luxembourg SARL o.z. Tel: + 421 2 3355 5500
Italia
Pfizer Italia S.r.l.,
Tel: +39 06 3318 2933
Suomi/Finland
no
Pfizer Oy Animal Health, Puh/Tel: +358 (0)9 4300 40
Kύπρος
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Sverige
Pfizer Oy Animal Health Tel: +358 (0)9 4300 40
Medicinal
Latvija
Pfizer Animal Health Tel: +370 5 269 17 96
United Kingdom Pfizer Ltd
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health Tel: +370 5 269 17 96