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Dynaclav

Main information

  • Trade name:
  • Dynaclav Suspension for Injection for Cattle
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Dynaclav Suspension for Injection for Cattle
    United Kingdom
  • Language:
  • English

Other information

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 41687/4008
  • Last update:
  • 21-12-2016

Summary of Product characteristics

Revised: October 2012

AN: 00752/2012

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Dynaclav Suspension for Injection for Cattle.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance: % w/v

Amoxicillin (as Amoxicillin trihydrate). 14.0

Clavulanic acid (as Potassium clavulanate).   3.5

Excipients:

Butylated Hydroxyanisole  0.008

Butylated Hydroxytoluene 0.008

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Suspension for injection.

An off-white suspension.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle.

4.2 Indications for use, specifying the target species

Dynaclav Injection has a notably broad spectrum of bactericidal activity

against the bacteria commonly found in cattle.

In   vitro  Dynaclav   Injection   is   active   against   a   wide   range   of

clinically important bacteria including:

Gram-positive:   Staphylococci   (including   beta-lactamase   producing

strains),   Streptococci,   Corynebacteria,   Clostridia,  Bacillus   anthracis,

Actinomyces bovis.

Gram-negative:   Escherichia coli  (including beta-lactamase producing

strains),  Salmonella  spp (including beta-lactamase producing strains),

Campylobacter  spp,  Klebsiella  spp,  Proteus  spp,  Pasteurella  spp,

Fusobacterium  necrophorum,   Bacteroides   (including   beta-lactamase

producing strains), Haemophilus spp, Moraxella spp and Actinobacillus

lignieresi.

Page 1 of 6

Revised: October 2012

AN: 00752/2012

Clinically Dynaclav Injection is effective in treating:

Cattle:

Respiratory infections

Soft tissue infections (e.g. joint/navel ill, abscesses etc.)

Metritis

Mastitis.

4.3 Contraindications

The   product   should   not   be   administered   to   rabbits,   guinea   pigs,

hamsters or gerbils.   Caution is advised in its use in other very small

herbivores.

4.4 Special Warnings for each target species

None

4.5 Special precautions for use

Special precautions for use in animals

Use of the product should be based on susceptibility testing of

the bacteria isolated from the animal.   If  this  is not  possible,

therapy should be based on local epidemiological information.

Care   should   be   taken   to   avoid   contaminating   the   remaining

contents of a vial with water.

Clavulanic   acid   is   moisture   sensitive.     It   is   very   important

therefore,   that   a   completely   dry   needle   and   syringe   is   used

when   extracting   suspension   for   injection   in   order   to   avoid

contaminating the remaining contents of the vial with drops of

water.

Contamination   will   result   in   obvious   beads   of   dark,   brown

discolouration corresponding to the introduced water droplets.

Material affected in this way should not be used as it may have

significantly reduced potency.

Special precautions to be taken by the person administering the 

veterinary medicinal product to animals

Care should be taken to avoid self injection.

Penicillins   and   cephalosporins   may   cause   hypersensitivity

(allergy) following injection, inhalation, ingestion or skin contact.

Hypersensitivity   to   penicillins   may   lead   to   cross-reactions   to

cephalosporins   and   vice   versa.     Allergic   reactions   to   these

substances may occasionally be serious.  

Page 2 of 6

Revised: October 2012

AN: 00752/2012

1.  Do not handle this product if you know you are sensitised, 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.

3. If you develop symptoms following exposure such as a skin

rash, you should seek medical advice and show the doctor

this warning.   Swelling of the face, lips or eyes or difficulty

with   breathing   are   more   serious   symptoms   and   require

urgent medical attention.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Use of the product may occasionally result in pain on injection and/or 

local tissue reaction.

4.7 Use during pregnancy, lactation or lay

The product may be used safely in pregnant animals.

4.8 Interaction with other medicinal products and other forms of 

interaction

None known.

4.9 Amounts to be administered and administration route

For intramuscular injection at a dosage rate of 8.75 mg/kg bodyweight

(1 ml per 20 kg bodyweight) daily for 3-5 days.   Shake the vial well

before   use.     After   injection,   massage   the   injection   site.     Use   a

completely dry sterile needle and syringe.   Swab the septum before

removing each dose.

 To ensure the correct dosage, bodyweight should be determined as  

accurately as possible to avoid underdosing.

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

necessary

Potentiated penicillin is of a low order of toxicity and is well tolerated by

the   parenteral  route.    Apart  from   occasional   injection   site  reactions,

which may occur at the recommended dose, no other adverse effects

are to be expected from an accidental overdose.

4.11 Withdrawal period

Animals   must   not   be   slaughtered   for   human   consumption   during

treatment.

Meat : 42 days

Page 3 of 6

Revised: October 2012

AN: 00752/2012

Milk for human consumption must not be taken during treatment

Milk: 60 hours 

5. PHARMACOLOGICAL 

Pharmacotherapeutic group:  Amoxicillin and enzyme inhibitor

ATC Vet Code:  QJ01CR02

5.1 Pharmacodynamic properties

Mode of Action

Amoxicillin:

The   mechanism   by   which   ß-lactam   antibiotics   bind   with   proteins

associated   with   developing   the   bacterial   cell   wall,   resulting   in   the

ultimate  lysis  of  the cell,  is well  established.    In  the case  of Gram-

positive bacteria the ß-lactam can freely pass across the peptidoglycan

layer in the aqueous phase to the site of activity at the cytoplasmic

membrane.     In   the   case   of   Gram-negative   bacteria   there   is   a

hydrophobic barrier outside the peptidoglycan layer.   Broad-spectrum

ß-lactam antibiotics have the ability to cross this barrier by way of small

pores in its structure.

There are three major mechanisms of resistance available to bacteria:

the production of ß-lactamase enzymes, impermeability of the cell wall

by modification of the small pores and by modifications of the amino

acid sequences at the cytoplasmic membrane interface where the cell

wall is constructed.

Clavulanic Acid:

In the absence of specific inhibitor enzymes with ß-lactamase activity,

ß-lactamases   either   form   complexes   with   the   antibiotic   or   cause   a

breakdown of the ß-lactam ring.  In either case the antibacterial activity

is lost.

Clavulanic acid has a ß-lactam ring in its structure which is recognised 

by ß-lactamases as a type of “penicillin”.  The enzyme/clavulanate 

interaction is irreversible and results in the depletion of enzymes 

molecules.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butylated Hydroxyanisole

Butylated Hydroxytoluene

Propylene Glycol Octonoate Decanoate

Page 4 of 6

Revised: October 2012

AN: 00752/2012

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 1

Year.

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

Do not store above 25ºC.

This product does not contain an antimicrobial preservative.

Once a vial has been broached the contents should be used within 28

days.

Discard unused material.

6.5 Nature and composition of immediate packaging

 50 ml and 100 ml siliconised, clear, colourless glass (type II) vials with

nitryl bungs, secured with an aluminium overseal.

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   materias   derived

from   such   veterinary   medicinal   products   should   be   disposed   of   in

accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Listow Limited

9 Belgrave Square

London

SW1X 8PH

8. MARKETING AUTHORISATION NUMBER(S)

Vm

: 41687/4008

9. DATE OF FIRST AUTHORISATION

Date: 17 September 2003

10. DATE OF REVISION OF THE TEXT

Page 5 of 6

Revised: October 2012

AN: 00752/2012

Date: October 2012

Page 6 of 6

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