NAM PHUC THINH TRADING CO., LTD

RIKETRON N

Sulfadimidine/Trimethoprim

Solution for injection

COMPOSITION
1 ml contains:
Sulfadimidine sodium ....... 215.8 mg (equivalent to 200 mg sulfadimidine)
Trimethoprim .................... 40.0 mg

PHARMACEUTICAL FORM
Solution for injection.
TARGET SPECIES
Horses, cattle and pigs.

INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infectious diseases at an early state of infection, caused by germs sensitive to sulfadimidine and trimethoprim.
Primary and secondary infections of the respiratory tract, the gastrointestinal tract, the urogenital tract, the skin and the claws.

CONTRAINDICATIONS
Do not use in case of aciduria.
Do not use in case of hypersensitivity to the active substances sulfonamide and trimethoprim.
Do not use in case of resistance against the active substances sulfonamide and trimethoprim.
Do not use in case of severe disturbances of liver and kidney functions.
Do not use in case of damage of the hematopoietic system.
Do not use in case of diseases which are accompanied by reduced consumption of water or loss of fluids.
Do not inject intravenous in case of previous or parallel application of substances with central nervous effects (e.g. anesthetics, neuroleptics).
Do not use simultaneously with bactericidal antibiotics.
Do not use in lactating mares which are intended to produce milk for human consumption.

ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Allergic reactions; alterations on blood cell counts; kidney or liver damage.
At the site of injection, irritation or even necrosis may occur.
In cattle, in some cases, after intravenous injection short lasting systemic reactions (dyspnea, excitation) may occur.
In horses, after intravenous injection, dangerous anaphylactic and anaphylactoid shock reactions may occur.
In the same type of application severe anomalies with or without death have been described in anesthetized or sedated horses in individual cases.
Particularly, during prolonged treatment with sulfonamides symptoms indicating a crystal precipitation may occur (hematuria, crystalluria, renal colic, compulsive urination). In such cases, treatment with sulfonamides should be stopped immediately, and fluids, eventually with the addition of sodium bicarbonate, should be administered.

In case of allergic symptoms, treatment should be stopped immediately and a symptomatic therapy should be administered as it follows:
- anaphylactic shock reactions: epinephrine (adrenalin) and glucocorticoids i.v.
- allergic skin reactions: antihistamines and/ or glucocorticoids

AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Horses: Slow intravenous use.
Cattle and pigs: Intramuscular or slow intravenous use.
16 to 24 mg of total active ingredients per kg b.w. and day, corresponding to 1 ml for each 10 to 15 kg b.w.; for instance:

Duration of treatment is generally 3 to 5 days. After reduction of clinical symptoms treatment should be continued for two more days. If after a máximum of 3 days no significant improvement is observed, check the diagnosis and, if necessary, a change in treatment should be carried out.

To ensure correct dosage and to avoid underdosing, the body weight should be determined as accurately as possible.
The above-mentioned dosages apply only when the pathogen is sensitive to sulfadimidine and trimethoprim.
Intravenous injections should be applied slowly.
High volumes of solution should be parted and injected at different injection sites, because of tissue-irritating characteristics of RIKETRON N. The maximal volume of 20 ml per site of injection should not be exceeded.
In horses, life-threatening shock reactions may be observed in case of intravenous use. For this reason, this administration route should only be chosen in extreme cases. Furthermore, the horse should be treated with a small pre-injection in advance, in order to observe the reaction of the patient. Only afterwards, a slow injection of the complete amount should be done.

In this regard, the solution should be warmed to body temperature. In case of first symptoms of incompatibility, injection should be stopped immediately and a shock treatment should be started if necessary.

WITHDRAWAL PERIODS
Meat: Cattle and horses: 12 days; Pigs: 10 days.
Milk: Cattle: 5 days; Not authorised for use in mares producing milk for human consumption.

SPECIAL PRECAUTIONS FOR STORAGE
Protect from light.

SPECIAL WARNING:

Special warnings for each target species
After intravenous application in horses, life-threatening anaphylactic or anaphylactoid shock reaction could be observed.
Special precautions for use
Special precautions for use in animals
To avoid disturbances of kidney functions caused by crystalluria, a sufficient amount of water should be provided; eventually urine may be alkalized.
The use in neonatal animals requires strict indications.

The veterinary medicinal product should be used in accordance with a sensitivity test (antibiogram) and the official and local regulations for the use of antibiotics.
Use of the product other than that described herein may increase the prevalence of sulfadimidine- and/or trimethoprim-resistant bacteria and reduce the effectiveness of sulfonamide and/or trimethoprim treatment due to potential cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid direct contact with skin or mucosa because of the potential risk of sensitization.
In case of hypersensitivity after contact with the veterinary medicinal producto (e.g. reddened skin) seek medical attention and present the package leaflet or label. In case of severe hypersensitivity reactions (e.g. swelling of the face, swelling of the eyes or swelling of the lips), seek immediate medical attention and present the package leaflet. Do not eat, drink, or smoke during use.

Adverse reactions (frequency and seriousness)
Allergic reactions; alterations on blood cell counts; kidney or liver damage.
At the site of injection, irritation or even necrosis may occur.
In cattle, in some cases, after intravenous injection short lasting systemic reactions (dyspnea, excitation) may occur.
In horses, after intravenous injection, dangerous anaphylactic and anaphylactoid shock reactions may occur.
In the same type of application severe anomalies with or without death have been described in anesthetized or sedated horses in individual cases.
Particularly, during prolonged treatment with sulfonamides symptoms indicating a crystal precipitation may occur (hematuria, crystalluria, renal colic, compulsive urination). In such cases, treatment with sulfonamides should be stopped immediately, and fluids, eventually with the addition of sodium bicarbonate, should be administered.

In case of allergic symptoms, treatment should be stopped immediately and a symptomatic therapy should be administered as it follows:
- anaphylactic shock reactions: epinephrine (adrenalin) and glucocorticoids i.v.
- allergic skin reactions: antihistamines and/ or glucocorticoids

Use during pregnancy, lactation or lay
Use in pregnant animals requires strict indication.
Do not use in lactating mares which are intended to produce milk for human consumption.
Interaction with other medicinal products and other forms of interaction
Do not mix the veterinary product with other substances in one syringe, in order to avoid incompatibilities. Local anaesthetics from the group of paraaminobenzoic acids (procaine, tetracaine) could locally neutralize the effect of sulfadimidine.

Overdose (symptoms, emergency procedures, antidotes), if necessary
After absorption of high amounts of sulfonamides, ataxic movements, muscle twitching and spasms as well as coma and liver damages can be observed. A symptomatic treatment of neurotropic signs should be done by application of central sedating substances, e.g. barbiturates. In addition to an administration with vitamin K or folic acid, an increase of renal excretion of sulfonamides should be forced via alkaline substances (e.g. sodium bicarbonate). In case of low urine pH level, which is typically observed in carnivores, or in case of diseases where the pH level was lowered or the renal excretion is reduced, a crystallization of sulfonamides in renal tubule can be observed. As a result, inappetence, hematuria, crystalluria, renal colic, and compulsive urination may occur. If you observe such symptoms, treatment should be stopped and an appropriate amount of fluid, eventually with addition of sodium bicarbonate, should be administrated.

SHELF LIFE
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

PACKAGING

Glass vials of brown glass, closed with rubber stopper and aluminium cap.
100 ml, 12x100 ml
Not all pack sizes may be marketed.

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 products should be disposed of in accordance with local requirements.

MARKETING AUTHORISATION HOLDER
aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany