Equibactin 250 mg/g + 50 mg/g oral powder for horses

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Sulfadiazine ; Trimethoprim
Available from:
Le Vet Beheer B.V.
ATC code:
QJ01EW10
INN (International Name):
Sulfadiazine ; Trimethoprim
Dosage:
250, 50 milligram(s)/gram
Pharmaceutical form:
Oral powder
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic area:
sulfadiazine and trimethoprim
Authorization status:
Authorised
Authorization number:
VPA10475/037/001
Authorization date:
2019-07-05

Health Products Regulatory Authority

22 July 2019

CRN000VD7

Page 1 of 4

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Equibactin 250 mg/g + 50 mg/g oral powder for horses

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram contains:

Active substances:

Sulfadiazine

​250

Trimethoprim

Excipients:

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral powder.

White to off-white powder.

4 CLINICAL PARTICULARS

4.1 Target Species

Horses.

4.2 Indications for use, specifying the target species

For the treatment of infections in horses caused by micro-organisms susceptible to the combination of trimethoprim and

sulfadiazine, such as infections of the upper respiratory tract, the urogenital system and wound infections.

4.3 Contraindications

Do not use in horses with severe liver or kidney disease.

Do not use in known cases of hypersensitivity to the active substances or to any of the excipients.

Do not use in known cases of resistance to trimethoprim and sulphonamides.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Throughout the treatment, animals should have free access to drinking water to avoid possible crystalluria.

In the treatment of new-born animals and animals with liver damage, caution should be exercised.

Renal impairment may cause accumulation, increasing the risk of side effects in long term treatment.

Use the product cautiously in horses with blood dyscrasias.

Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible,

therapy should be based on epidemiological information and knowledge of susceptibility of the target bacteria at farm level, or

at local/regional level.

Use of the product should be in accordance with official, national and regional antimicrobial policies.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the

product, and may decrease the effectiveness of treatment with other antimicrobials or classes of antimicrobials due to the

potential for cross-resistance.

Health Products Regulatory Authority

22 July 2019

CRN000VD7

Page 2 of 4

In case of infections involving purulent conditions, trimethoprim-sulphonamides combinations are not recommended due to a

diminished efficacy under such conditions.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

This product contains sulfadiazine, a sulphonamide which can cause hypersensitivity reactions following skin contact, inhalation

or accidental ingestion. Hypersensitivity to sulphonamides may lead to cross reactions with other antibiotics. Allergic reactions

to sulphonamides may occasionally be serious.

Contact with the veterinary medicinal product should be avoided. This is especially important for people with known

hypersensitivity to sulphonamides.

Avoid inhalation of dust. Wear either a disposable half-mask respirator conforming to European Standard EN149 or a

non-disposable respirator conforming to European Standard EN140 with filter EN143 when handling this product.

Avoid contact with skin. Rubber gloves should be worn when handling this product. In the case of contact with skin, wash with

soap and water.

If symptoms develop following exposure such as a skin rash or difficulty with breathing and irritation persists, seek medical

advice.

Wash hands thoroughly after use.

4.6 Adverse reactions (frequency and seriousness)

The following adverse reactions can occur:

Hypersensitivity reactions such as urticaria

Inappetence

Gastrointestinal disturbances such as loose faeces, diarrhoea and colitis

Hepatic or renal disorders.

Hematologic effects, such as anaemia, thrombocytopenia, or leukopenia

Haematuria, crystalluria, tubular obstruction

4.7 Use during pregnancy, lactation or lay

Laboratory studies in rats and mice have shown evidence of teratogenic effects at dosages that are above therapeutic dosages.

The safety of the veterinary medicinal product during pregnancy and lactation has not been assessed in the target species; use

in pregnant or lactating mares should therefore be avoided.

4.8 Interaction with other medicinal products and other forms of interactions

Potentiated sulphonamides used in conjunction with alpha2-adrenoceptor agonists like detomidine are known to be able to

cause fatal arrhythmias in the horse.

4.9 Amounts to be administered and administration route

In feed use.

The recommended dose is 30 mg of the active substances together (i.e. 25 mg sulfadiazine and 5 mg trimethoprim) per kg

body weight, equivalent to 10 g powder per 100 kg, once or twice daily for 5 days. Frequency of dosing is decided on basis of

the susceptibility of the pathogens involved and location of the infection.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid under dosing. The use of

suitably calibrated weighing equipment for the administration of the calculated.

amount of the product is recommended when using the jars or parts of the sachets.

The powder can be mixed in a handful of feed immediately prior to dosing. The active ingredients in the powder have a bitter

taste. Adding molasses or other sweetener to the feed can facilitate administration of the product. The remaining feed should

be withheld until half an hour after the horse has eaten the feed with the medicine. Should a horse continue to reject the

medicated feed, treatment should be continued with another pharmaceutical form with the same actives.

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

In case of an overdose loose faeces or diarrhoea may be observed. This is generally self-limiting, but if needed can be treated

symptomatically, e.g. fluid therapy in case of dehydration.

Health Products Regulatory Authority

22 July 2019

CRN000VD7

Page 3 of 4

4.11 Withdrawal period(s)

Meat and offal: 20 days.

Milk: Not permitted for use in mares producing milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use, Combinations of sulphonamides and trimethoprim, incl. derivatives,

sulfadiazine and trimethoprim.

ATCvet code: QJ01EW10

5.1 Pharmacodynamic properties

Sulfadiazine is a bacteriostatic antibiotic belonging to the sulphonamide group which acts by interference with the synthesis of

nucleic acids. Trimethoprim is a reductase inhibitor which also interferes with the synthesis of bacterial nucleic acids.

Trimethoprim and sulfadiazine each have a bacteriostatic action, but together they have a synergistic bactericidal effect by

intervening in two consecutive steps of the bacterial folate metabolism.

The combination of trimethoprim and sulfadiazine has a broad antibacterial spectrum for both gram positive and gram

negative bacteria. 'Chromosomal mutation and plasmid-mediated resistance are described for sulphonamides and its

combinations. Resistance is widespread among bacteria isolated from animals reflecting extensive use over time. There is

complete cross-resistance between sulphonamides.'

5.2 Pharmacokinetic particulars

At the recommended dosage for horses of 30 mg of the active substances together (i.e. 25 mg sulfadiazine and 5 mg

trimethoprim) per kg body weight mean maximum plasma concentrations obtained after a single dose are about 13

micrograms/ml of sulfadiazine and approximately 1.0 micrograms/ml of trimethoprim after 2.3 and 1.7 hours respectively. The

plasma half-life is approximately 7 hours for sulfadiazine and about 3 hours for trimethoprim. Both substances are metabolized

in the liver; sulfadiazine by acetylation and glucuronidation and trimethoprim by hydroxylation and glucuronidation. Excretion

is primarily by the kidney and only to a lesser extent in the faeces.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glucose monohydrate

Silica, colloidal anhydrous

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal

products.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening the immediate packaging (jars): 3 months

Shelf-life after first opening the immediate packaging (sachets): 24 hours if stored dry and re-closed with clip (after folding the

edge of the opened sachet)

Shelf life after incorporation into meal: use immediately

6.4 Special precautions for storage

Keep the sachets and jars tightly closed after first opening in order to protect from moisture.

This veterinary medicinal product does not require any special temperature storage conditions.

Health Products Regulatory Authority

22 July 2019

CRN000VD7

Page 4 of 4

6.5 Nature and composition of immediate packaging

White HDPE jars with a LDPE cap containing 105 g, 210 g or 420 g powder.

White PP jars with a LDPE cap containing 840 g powder.

PET/PE/Alu/PE/LLDPE sachets containing 5 g, 15 g, 30 g, 60 g or 100 g powder.

Cardboard boxes containing 10, 20 or 28 aluminum sachets each containing 5 g, 15 g, 30 g or 60 g powder.

Cardboard boxes containing 10 aluminum sachets each containing 100 g powder.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the

use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be

disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Le Vet Beheer B.V.

Wilgenweg 7

3421 TV Oudewater

Netherlands

8 MARKETING AUTHORISATION NUMBER(S)

VPA10475/037/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 05 July 2019

10 DATE OF REVISION OF THE TEXT

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