Lactatrim

Main information

  • Trade name:
  • Lactatrim MC Intramammary Suspension
  • Pharmaceutical form:
  • Intramammary suspension
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Lactatrim MC Intramammary Suspension
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Cattle
  • Therapeutic area:
  • Antimicrobial

Other information

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 41687/4000
  • Authorization date:
  • 04-03-1997
  • Last update:
  • 18-09-2017

Summary of Product characteristics

Revised: October 2012

AN: 00749/2012

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Lactatrim MC Intramammary Suspension.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 8g syringe contains:

Active Substances:           mg

Trimethoprim  40

Sulfadiazine.          200

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Intramammary suspension.

White to off-white suspension.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (lactating)

4.2 Indications for use, specifying the target species

An   intramammary   suspension   for   the   broad   spectrum   treatment   of   clinical

mastitis in the lactating cow.

Effective   against   gram-positive   and   gram-negative   bacteria   including

Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis and

other   streptococcal   species,  Staphylococcal  spp,  Actinomyces  pyogenes,

Eschericha coli, and other gram-negative bacteria.  

4.3 Contraindications

Do not use in cattle with known sulphonamide sensitivity.

4.4 Special Warnings for each target species

Do not use in cattle with hepatic damage or blood dyscrasias.

Page 1 of 4

Revised: October 2012

AN: 00749/2012

4.5 Special precautions for use

Official, national and regional antimicrobial policies should be taken into account 

when the product is used.

Special precautions for use in animals

None.

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

medicinal product to animals

Take   care   to   avoid   skin   and   eye   contact.   Gloves   should   be   worn   whilst

handling this product. Wash hands and exposed skin after use.

Sulphonamides   may   cause   hypersensitivity   (allergy)   following   injection,

inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may

lead   to   cross   reactions   with   other   antibiotics.    Allergic   reactions   to   these

substances may occassionally be serious.

1. Do not handle this product if you know you are sensitive to sulphonamides.

2. If you develop symptoms following exposure such as a skin rash, you should

seek medical advice and show the doctor this warning.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

Lactatrim MC is safe for use during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

The contents of one syringe should be infused into each affected quarter via the

teat canal, immediately after milking, at 12 hour intervals for three consecutive

milkings.  Clean and disinfect the teat before each treatment.

The syringe may only be used once.

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

Not applicable.

4.11 Withdrawal period

Cattle:

Meat - 7 days

Page 2 of 4

Revised: October 2012

AN: 00749/2012

Milk - 48 hours

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:   Antibacterial

ATC Vet Code:  QJ01EE02

5.1 Pharmacodynamic properties

The   product   contains   trimethoprim   and   sulfadiazine   as   the   active   ingredients

which act with a unique "double-blockade" mode of action.   Each component

disrupts a different vital link in the metabolic chain used by susceptible bacteria

to make nucleic acids and proteins.

Sulfadiazine   inhibits   the   incorporation   of   p-amino   benzoic   (PABA)   acid   into

dihydrofolic acid.

Sulfadiazine  specifically  competes  with   PABA  for   the   enzyme   dihydropteroate

synthetase,   this   selective   bacteriostatic   action   depending   on   the   difference

between bacterial and mammalian cells in the source of folic acid.   Susceptible

microorganisms synthesise folic acid, whereas mammalian cells use preformed

folic acid.

Trimethoprim   selectively   inhibits   the   enzyme   dihydrofolate   reductase   thereby

preventing   the   conversion   of   dihydrofolic   acid   into   tetrahydrofolic   acid,   this

sequential   enzymatic  blockage  resulting   in  a   synergistic  effect   and   enhanced

activity at the site of infection when the two compounds are present.

Thus trimethoprim greatly potentiates the antimicrobial activity of sulphonamides

both in vitro and in vivo.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hydrogenated Caster oil,

Arachis Oil.

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

6.4 Special precautions for storage

Do not store above 25ºC.

Page 3 of 4

Revised: October 2012

AN: 00749/2012

6.5 Nature and composition of immediate packaging

8g syringe (12ml capacity) with high density polyethylene barrel and low density

polyethylene plunger closed with end cap, 6 individual syringes presented in a

blister pack of aluminium foil and clear polyvinyl chloride. 

A carton containing 24 syringes.

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 material 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

 41687/4000

9. DATE OF FIRST AUTHORISATION

Date: 4 March 1997  

10. DATE OF REVISION OF THE TEXT

Date: October 2012

Page 4 of 4

There are no safety alerts related to this product.

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