Dynaclav

Main information

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

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

18-5-2018

Unauthorized prescription antibiotic drugs seized from Gigi's Market in Ottawa, ON, may pose serious health risks

Unauthorized prescription antibiotic drugs seized from Gigi's Market in Ottawa, ON, may pose serious health risks

Health Canada has seized four unauthorized drugs from Gigi’s Market, 23 Montreal Road, Ottawa, ON. The products (Ampicillin, Kamox, Medampi and Medomox) are labelled to contain antibiotic drugs (ampicillin or amoxicillin) that can only be dispensed by a healthcare professional to a patient with a valid prescription. The products listed below have not been evaluated by Health Canada for safety, effectiveness or quality and may pose serious health risks.

Health Canada

9-1-2018

Adding Folic Acid to Corn Masa Flour May Prevent Birth Defects

Adding Folic Acid to Corn Masa Flour May Prevent Birth Defects

When consumed by women before and during pregnancy, folic acid, a B vitamin, may help prevent neural tube defects (NTDs).

FDA - U.S. Food and Drug Administration

3-8-2012

Danish Pharmacovigilance Update, 21 June 2012

Danish Pharmacovigilance Update, 21 June 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Decrease in the number of intoxications and suicide attempts using drugs containing acetylsalicylic acid or paracetamol.

Danish Medicines Agency

14-6-2010

Changes in reimbursements for anti-ulcer medicines

Changes in reimbursements for anti-ulcer medicines

The Reimbursement Committee and the Danish Medicines Agency have reviewed medicinal products for the treatment of heartburns, sour eructations and ulcers ('acid-related disorders') in order to assess whether they meet the criteria for public reimbursement.

Danish Medicines Agency

9-4-2010

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders) was open for consultation until 15 March 2010.

Danish Medicines Agency

17-12-2009

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders).

Danish Medicines Agency

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (Active substance: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl Ethyl ester) )-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-poly(ethylene glycol)-este...

Europe -DG Health and Food Safety

15-5-2018

Orphacol (Laboratoires CTRS)

Orphacol (Laboratoires CTRS)

Orphacol (Active substance: Cholic acid) - Centralised - Yearly update - Commission Decision (2018)3061 of Tue, 15 May 2018

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (Active substance: Docosahexaenoic acid ethyl ester) - Orphan designation - Commission Decision (2018)1880 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/235/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Orphan designation - Commission Decision (2018)1877 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/230/17

Europe -DG Health and Food Safety

21-3-2018

EU/3/17/1861 (Roivant Sciences Ireland Limited)

EU/3/17/1861 (Roivant Sciences Ireland Limited)

EU/3/17/1861 (Active substance: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester) - Transfer of orphan designation - Commission Decision (2018)1826 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/299/16/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/14/1363 (IQVIA RDS Ireland Limited)

EU/3/14/1363 (IQVIA RDS Ireland Limited)

EU/3/14/1363 (Active substance: 4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid) - Transfer of orphan designation - Commission Decision (2018)1818 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/14/T/01

Europe -DG Health and Food Safety

8-3-2018

Mycophenolate mofetil, mycophenolic acid

Mycophenolate mofetil, mycophenolic acid

Mycophenolate mofetil, mycophenolic acid (Active substance: mycophenolate mofetil or mycophenolic acid) - Centralised - Art 28 - (PSUR - Commission Decision (2018)1540 of Thu, 08 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10550/201705

Europe -DG Health and Food Safety

5-2-2018

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Active substance: oxalic acid dihydrate) - New authorisation - Commission Decision (2018)684 of Mon, 05 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4296

Europe -DG Health and Food Safety

24-11-2017

Gadolinium

Gadolinium

Gadolinium (Active substance: gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol and gadoteric acid) - Community Referrals - Art 31 - Commission Decision (2017)7941 of Fri, 24 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1437

Europe -DG Health and Food Safety