SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Sulfatrim (16 mg/ml + 80 mg/ml) Oral Drops

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances per ml:

Trimethoprim 16 mg

Sulfamethoxazole 80 mg

Excipient(s):

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral drops.

Colourless to light yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Rabbits, pigeons and Bearded Dragons.

4.2 Indications for use, specifying the target species

Treatment of gastrointestinal infections caused by protozoa (namely coccidian) sensitive to the combination of trimethoprim and sulfamethoxazole.

4.3 Contraindications

Do not use in cases with severe renal or hepatic impairment.

Do not use the product for prophylaxis.

Donotuseincasesofknownhypersensitivitytotheactivesubstancesorthe excipients.

4.4 Special warnings for each target species

Thisisalimitedmarketingauthorisationandefficacyoftheproductissupportedbya verysmallamountofdatafortheaboveindications.Suspectedlackofefficacyofthe productmustbereportedtotheMarketingAuthorisationHolderortheVeterinary Medicines Directorate.

As with all other anti-infectives, prolonged use may result inthedevelopment of resistantstrains.

4.5 Special precautions for use

Special precautions for use in animals

Maintainpatienthydration duringtreatment.

Theproductshouldbeusedwithcautioninpatientswithdiminishedrenalorhepatic function,orurinaryobstruction,duetothepossibleincreasedriskofsideeffectsasa result ofdecreaseddrugclearance.

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

People with known hypersensitivity to sulfonamides should avoid contact with the veterinary medicinal product.

In case of reaction of hypersensitivity after exposure (such as skin rash), seek medical advice and show the package leaflet or the label to the physician. In case of severe reactions (swelling of the face, lips or eyes), seek prompt medical attention and take the package leaflet with you.

Take care to avoid direct contact with skin and eyes. If contact occurs, wash affected area with copious amounts of clean water. Seek medical advice if irritation persists.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Sulfonamides can cause various hypersensitivity reactions or signs of gastrointestinal disease by altering the normal gut flora.Regurgitation may be seen in birds.

CNS stimulation and myelin degeneration have been noted after very high dosages.

4.7 Use during pregnancy, lactation or lay

No studies ofuseofthe productinpregnantor lactatinganimals have been conducted. Sulfonamidescrosstheplacentaandmayreachfoetallevelsof50%orgreaterofthose foundinmaternalserum;teratogenicityhasbeenreportedinsomelaboratoryanimals whengivenatveryhighdoses.Bothactivesubstancescrosstheplacentaandare distributedinmilk.Theyshouldbeusedinpregnantanimalsonlywhenthebenefit:risk assessmentbytheresponsibleveterinarianindicatesthatbenefitsclearlyoutweighthe risks oftherapy.

4.8 Interaction with other medicinal products and other forms of interaction

Antacids may decrease the oral bioavailability of sulfonamides if administered concurrently.

Sulfonamides may give false-positive results for urine glucose determinations when using the Benedict's method.

4.9 Amounts to be administered and administration route

For oral administration.

To ensure a correctdosage, bodyweight shouldbe determined as accurately as possibletoavoidunder-dosing.

Species	Dose (mg/kg) TMP+SMZ	Frequency daily	ml solution/kg	Durations (days)
Rabbit	20 - 30	2	0.2 – 0.3	10 - 14
Pigeon	25 - 50	2	0.2 – 0.5	10 - 14
Bearded dragon	15 – 20	1*	0.15 – 0.2	7 – 14

* Someliteratureadvisesalternatedaydosingafterthesecond dosehasbeenadministered.

Thisisalimitedmarketingauthorisationandtheabovedosagesareinaccordancewith thosereportedfortheactivesubstancesinthetargetspecies.Anysuspectedadverse eventsorsuspectedlackofefficacymustbereportedtotheMarketingAuthorisation Holder or theVeterinaryMedicines

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

Sulfonamides(ortheirmetabolites)canprecipitateintheurine,particularlywhengiven athighdosagesforprolongedperiods.Acidicurineorhighlyconcentratedurinemay also contribute toincreased risk ofcrystalluria,haematuriaandrenal tubule obstruction.

4.11 Withdrawal period(s)

Donotusetheproductinanimalsintendedforhumanconsumptionorinthoseanimals producingeggsfor humanconsumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use, Sulfonamides and Trimethoprim.

ATCvet code: QJ01EW10.

5.1 Pharmacodynamic properties

Sulfamethoxazoleactsasafalsesubstrateinthesynthesisoffolicacidand trimethopriminhibitsdihydrofolatereductase.Incombination,theeffectissynergistic and inhibitssequentialsteps inthe synthesisoftetrahydrofolic acid.

5.2 Pharmacokinetic particulars

Sulamethoxazoleisaweakorganicacidandtrimethoprimisalipid-solubleorganic base.Eachdrughasdifferentpharmacokineticparameters(absorption,distribution, elimination)ineachspecies.Incombination,theyarethoughttobewelldistributed throughoutthebody.Theyarerenallyexcretedunchangedviaglomerularfiltrationand tubularsecretionandmetabolisedby theliver.Sulfonamides areprimarily acylatedand conjugatedwithglucuronicacidandtrimethoprimismetabolisedtooxideand hydroxylated metabolites.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Coconut aroma

Sodium hydroxide

Glycerol

Glycerol formal

Water for injections

6.2 Incompatibilities

Do not mix this product with other veterinary medicinal products.

6.3 Shelf life

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

Shelf-life after first opening the immediate packaging: 10 days

Shelf-life after dilution or reconstitution according to directions: 4 hours.

6.4. Special precautions for storage

Do not store above 25C.

Do not refrigerate or freeze.

Protect from light.

Store in the original container.

Following dilution in tap water, any medicated water remaining after 4 hours should be discarded.

6.5 Nature and composition of immediate packaging

10 ml or 30 ml brown glass bottle (Class 3) with a low density polyethylene syringe insert and a high density polyethylene dropper screw-cap.

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 materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Le Vet B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 19994/4024

9. DATE OF FIRST AUTHORISATION

28 March 2014

10. DATE OF REVISION OF THE TEXT

July 2014

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Prescription Only Medicine (POM-V)

Approved: 23/07/2014