Baytril Max 100 mg/ml Solution for Injection for Pigs

Main information

  • Trade name:
  • Baytril Max 100 mg/ml Solution for Injection for Pigs
  • Available from:
  • Bayer plc
  • Prescription type:
  • POM-V
  • Medicine type:
  • Veterinary

Documents

Localization

  • Available in:
  • Baytril Max 100 mg/ml Solution for Injection for Pigs
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • VMD
  • Authorization date:
  • 05-09-2011
  • Last update:
  • 23-04-2015

Patient Information leaflet


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

Revised: February 2012

AN: 01757/2011

Page 1 of 6

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Baytril Direct 100 mg/ml Injektionslösung für Schweine [AT]

Baytril 1nject 100 mg/ml solution for injection for pigs [BE, LU, NL]

Baytril Inject – Soluzione iniettabile 100mg/ml per suini [IT]

Baytril 1nject-10%, solution injectabile [FR]

Baytril 1nject 100 mg/ml Injektionslösung für Schweine [DE]

Baytril Max 100 mg/ml solution for injection for pigs [IE, UK]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains:

Active substance:

Enrofloxacin 100 mg

Excipient(s):

n-Butanol 30 mg

Benzyl alcohol 20 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection

Clear, yellow solution

4. CLINICAL PARTICULARS

4.1 Target species

Pig

4.2 Indications for use, specifying the target species

For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive

Actinobacillus pleuropneumoniae, Pasteurella multocida and complicated by

Haemophilus parasuis as secondary pathogen in pigs.

4.3 Contraindications

Do not use in the presence of documented hypersensitivity to the

pharmacologically active ingredient or to any of the other ingredients. Do not use in

animals with central nervous system-associated seizure disorders. Do not use in

the presence of existing disorders of cartilage development or musculoskeletal

Revised: February 2012

AN: 01757/2011

Page 2 of 6

damage around functionally significant or weight-bearing joints. Do not use for

prophylaxis.

4.4 Special warnings for each target species

Do not use in case of resistance against other fluoroquinolone due to the potential

for cross-resistance.

4.5 Special precautions for use

i. Special precautions for use in animals

Repeated injections should be administered at different sites.

Official and local antimicrobial policies should be taken into account when

the product is used.

Fluoroquinolones should be reserved for the treatment of clinical conditions

which have responded poorly, or are expected to respond poorly, to other

classes of antimicrobials.

Whenever possible, fluoroquinolones should only be used based on

susceptibility testing.

Use of the product deviating from the instructions given in the SPC may

increase the prevalence of bacteria resistant to the fluoroquinolones and may

decrease the effectiveness of treatment with other quinolones due to the

potential for cross resistance.

Enrofloxacin is eliminated renally. As with all fluoroquinolones, delayed

excretion can therefore be expected in the presence of existing renal

damage.

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

medicinal product to animals

People with known hypersensitivity to (fluoro)quinolones should avoid contact

with the veterinary medicinal product.

Direct contact with the skin should be avoided due to sensitisation, contact

dermatitis and possible hypersensitivity reactions.

Wash any splashes from skin or eyes immediately with water. Do not eat,

drink or smoke while handling the product.

Take care to avoid accidental self-injection. In case of accidental self-

injection, seek medical advice immediately and show the package leaflet or

label to the physician.

4.6 Adverse reactions (frequency and seriousness)

In rare cases, transitory inflammatory reactions (swelling, redness) can occur at the

injection site. These regress within a few days without further therapeutic

measures.

4.7 Use during pregnancy, lactation or lay

Revised: February 2012

AN: 01757/2011

Page 3 of 6

May be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Antagonist effects due to concurrent administration of macrolides and tetracyclines

may occur. Enrofloxacin may interfere with the metabolism of theophylline,

decreasing theophylline clearance resulting in increased plasma levels of

theophylline

4.9 Amounts to be administered and administration route

The dosage for respiratory tract infections is 7.5 mg enrofloxacin per kg body

weight for a single administration.

This corresponds to

0.75 ml Baytril Max solution for injection per 10 kg body weight per day

No more than 7.5 ml should be administered at any one injection site. In cases of

severe or chronic respiratory tract infections, a second injection may be required

after 48 hours.

Method of administration:

For intramuscular injection into the neck muscles behind the ear.

To ensure administration of the correct dosage, body weight should be determined

as accurately as possible to avoid underdosing. The stopper may be safely

punctured up to 20 times.

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

Doses of around 25 mg active ingredient per kg body weight and above may

cause lethargy, loss of appetite and ataxia. No information is available on the

tolerability of doses several times higher than the therapeutic dose (over the

recommended or a prolonged treatment period).

Do not exceed the recommended dose. In accidental overdose there is no

antidote and treatment should be symptomatic.

4.11 Withdrawal period(s)

Meat and offal: 12 days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Fluoroquinolones

Revised: February 2012

AN: 01757/2011

Page 4 of 6

ATCvet code: QJ01MA90

5.1 Pharmacodynamic properties

Enrofloxacin has a spectrum of activity which includes Actinobacillus

pleuropneumoniae, Pasteurella multocida and Haemophilus parasuis.

Enrofloxacin belongs to the fluoroquinolone group of antibiotics. The substance

has bactericidal activity which is mediated by binding to subunit A of DNA gyrase

and the resulting selective inhibition of this enzyme.

DNA gyrase is a topoisomerase. These enzymes are involved in the replication,

transcription and recombination of bacterial DNA. Fluoroquinolones also influence

bacteria in the stationary phase by altering cell wall permeability.

Resistance to fluoroquinolones has been reported to arise from five sources, (i)

point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV

leading to alterations of the respective enzyme, (ii) alterations of drug permeability

in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated

resistance and (v) gyrase protecting proteins. All mechanisms lead to a reduced

susceptibility of the bacteria to fluoroquinolones. Cross-resistance within the

fluoroquinolone class of antimicrobials is common.

The inhibitory and bactericidal concentrations of enrofloxacin are very close, being

either identical or differing by no more than 1-2 dilution steps.

5.2 Pharmacokinetic particulars

Following intramuscular administration in pigs, the active ingredient enrofloxacin is

absorbed very rapidly and almost completely (high bioavailability). Peak serum

concentrations of the active ingredient are reached after 1- 2 hours.

Therapeutic concentrations are maintained for a period of at least 48 hours.

Enrofloxacin has a high volume of distribution. The concentrations in the tissues

and organs mostly significantly exceed serum levels. Organs in which high

concentrations can be expected include the lungs, liver, kidneys, gut and muscle

tissue.

Enrofloxacin is eliminated renally.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Arginine

n-Butanol

Benzyl alcohol

Water for injection

6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not

be mixed with other veterinary medicinal products.

6.3 Shelf life

Revised: February 2012

AN: 01757/2011

Page 5 of 6

Shelf life of the veterinary medicinal product in the unopened container: 3 years

Shelf life after first opening of the container: 28 days

The date of withdrawal of the first dose must be written on the label of the bottle.

6.4 Special precautions for storage

Protect from frost.

6.5 Nature and composition of immediate packaging

100 ml brown glass (Type 1) bottle with chlorobutyl rubber stopper secured by an

aluminium crimp cap.

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

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

8. MARKETING AUTHORISATION NUMBER

Vm 00010/4172

9. DATE OF FIRST AUTHORISATION

Date: 05 September 2011

10. DATE OF REVISION OF THE TEXT

Date: February 2012

PROHIBITION OF SALE, SUPPLY AND/OR USE

Prescription- and pharmacy-only medicine, repeat dispensing prohibited.

Revised: February 2012

AN: 01757/2011

Page 6 of 6

Summary of Product characteristics


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

Revised: February 2012

AN: 01757/2011

Page 1 of 6

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Baytril Direct 100 mg/ml Injektionslösung für Schweine [AT]

Baytril 1nject 100 mg/ml solution for injection for pigs [BE, LU, NL]

Baytril Inject – Soluzione iniettabile 100mg/ml per suini [IT]

Baytril 1nject-10%, solution injectabile [FR]

Baytril 1nject 100 mg/ml Injektionslösung für Schweine [DE]

Baytril Max 100 mg/ml solution for injection for pigs [IE, UK]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains:

Active substance:

Enrofloxacin 100 mg

Excipient(s):

n-Butanol 30 mg

Benzyl alcohol 20 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection

Clear, yellow solution

4. CLINICAL PARTICULARS

4.1 Target species

Pig

4.2 Indications for use, specifying the target species

For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive

Actinobacillus pleuropneumoniae, Pasteurella multocida and complicated by

Haemophilus parasuis as secondary pathogen in pigs.

4.3 Contraindications

Do not use in the presence of documented hypersensitivity to the

pharmacologically active ingredient or to any of the other ingredients. Do not use in

animals with central nervous system-associated seizure disorders. Do not use in

the presence of existing disorders of cartilage development or musculoskeletal

Revised: February 2012

AN: 01757/2011

Page 2 of 6

damage around functionally significant or weight-bearing joints. Do not use for

prophylaxis.

4.4 Special warnings for each target species

Do not use in case of resistance against other fluoroquinolone due to the potential

for cross-resistance.

4.5 Special precautions for use

i. Special precautions for use in animals

Repeated injections should be administered at different sites.

Official and local antimicrobial policies should be taken into account when

the product is used.

Fluoroquinolones should be reserved for the treatment of clinical conditions

which have responded poorly, or are expected to respond poorly, to other

classes of antimicrobials.

Whenever possible, fluoroquinolones should only be used based on

susceptibility testing.

Use of the product deviating from the instructions given in the SPC may

increase the prevalence of bacteria resistant to the fluoroquinolones and may

decrease the effectiveness of treatment with other quinolones due to the

potential for cross resistance.

Enrofloxacin is eliminated renally. As with all fluoroquinolones, delayed

excretion can therefore be expected in the presence of existing renal

damage.

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

medicinal product to animals

People with known hypersensitivity to (fluoro)quinolones should avoid contact

with the veterinary medicinal product.

Direct contact with the skin should be avoided due to sensitisation, contact

dermatitis and possible hypersensitivity reactions.

Wash any splashes from skin or eyes immediately with water. Do not eat,

drink or smoke while handling the product.

Take care to avoid accidental self-injection. In case of accidental self-

injection, seek medical advice immediately and show the package leaflet or

label to the physician.

4.6 Adverse reactions (frequency and seriousness)

In rare cases, transitory inflammatory reactions (swelling, redness) can occur at the

injection site. These regress within a few days without further therapeutic

measures.

4.7 Use during pregnancy, lactation or lay

Revised: February 2012

AN: 01757/2011

Page 3 of 6

May be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Antagonist effects due to concurrent administration of macrolides and tetracyclines

may occur. Enrofloxacin may interfere with the metabolism of theophylline,

decreasing theophylline clearance resulting in increased plasma levels of

theophylline

4.9 Amounts to be administered and administration route

The dosage for respiratory tract infections is 7.5 mg enrofloxacin per kg body

weight for a single administration.

This corresponds to

0.75 ml Baytril Max solution for injection per 10 kg body weight per day

No more than 7.5 ml should be administered at any one injection site. In cases of

severe or chronic respiratory tract infections, a second injection may be required

after 48 hours.

Method of administration:

For intramuscular injection into the neck muscles behind the ear.

To ensure administration of the correct dosage, body weight should be determined

as accurately as possible to avoid underdosing. The stopper may be safely

punctured up to 20 times.

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

Doses of around 25 mg active ingredient per kg body weight and above may

cause lethargy, loss of appetite and ataxia. No information is available on the

tolerability of doses several times higher than the therapeutic dose (over the

recommended or a prolonged treatment period).

Do not exceed the recommended dose. In accidental overdose there is no

antidote and treatment should be symptomatic.

4.11 Withdrawal period(s)

Meat and offal: 12 days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Fluoroquinolones

Revised: February 2012

AN: 01757/2011

Page 4 of 6

ATCvet code: QJ01MA90

5.1 Pharmacodynamic properties

Enrofloxacin has a spectrum of activity which includes Actinobacillus

pleuropneumoniae, Pasteurella multocida and Haemophilus parasuis.

Enrofloxacin belongs to the fluoroquinolone group of antibiotics. The substance

has bactericidal activity which is mediated by binding to subunit A of DNA gyrase

and the resulting selective inhibition of this enzyme.

DNA gyrase is a topoisomerase. These enzymes are involved in the replication,

transcription and recombination of bacterial DNA. Fluoroquinolones also influence

bacteria in the stationary phase by altering cell wall permeability.

Resistance to fluoroquinolones has been reported to arise from five sources, (i)

point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV

leading to alterations of the respective enzyme, (ii) alterations of drug permeability

in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated

resistance and (v) gyrase protecting proteins. All mechanisms lead to a reduced

susceptibility of the bacteria to fluoroquinolones. Cross-resistance within the

fluoroquinolone class of antimicrobials is common.

The inhibitory and bactericidal concentrations of enrofloxacin are very close, being

either identical or differing by no more than 1-2 dilution steps.

5.2 Pharmacokinetic particulars

Following intramuscular administration in pigs, the active ingredient enrofloxacin is

absorbed very rapidly and almost completely (high bioavailability). Peak serum

concentrations of the active ingredient are reached after 1- 2 hours.

Therapeutic concentrations are maintained for a period of at least 48 hours.

Enrofloxacin has a high volume of distribution. The concentrations in the tissues

and organs mostly significantly exceed serum levels. Organs in which high

concentrations can be expected include the lungs, liver, kidneys, gut and muscle

tissue.

Enrofloxacin is eliminated renally.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Arginine

n-Butanol

Benzyl alcohol

Water for injection

6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not

be mixed with other veterinary medicinal products.

6.3 Shelf life

Revised: February 2012

AN: 01757/2011

Page 5 of 6

Shelf life of the veterinary medicinal product in the unopened container: 3 years

Shelf life after first opening of the container: 28 days

The date of withdrawal of the first dose must be written on the label of the bottle.

6.4 Special precautions for storage

Protect from frost.

6.5 Nature and composition of immediate packaging

100 ml brown glass (Type 1) bottle with chlorobutyl rubber stopper secured by an

aluminium crimp cap.

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

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

8. MARKETING AUTHORISATION NUMBER

Vm 00010/4172

9. DATE OF FIRST AUTHORISATION

Date: 05 September 2011

10. DATE OF REVISION OF THE TEXT

Date: February 2012

PROHIBITION OF SALE, SUPPLY AND/OR USE

Prescription- and pharmacy-only medicine, repeat dispensing prohibited.

Revised: February 2012

AN: 01757/2011

Page 6 of 6

There are no safety alerts related to this product.

There are no news related to this product.

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