Trimetox 6seitig engl - Veyx-Pharma GmbH

Trimethoprim and sulfamerazine have as monosubstances, in each case a
bacteriostatic effect, but as a combination, a bactericidal one. This is caused by
the double blockade of the bacterial cell metabolism (folic acid synthesis) which
leads to an irreversible damage of the bacteria. Obviously, this double blockade
provides an increased efficiency in the sense of a potentiation and furthermore,
it seems to prevent the danger of the development of resistance to a far extent.
The efficacy of trimethoprim combined with sulfamerazine is synergistic, i.e. the
effect of the combination is considerably stronger than those of the two individual
substances.
This combination has an antibacterial effect against many gram-positive and
gram-negative pathogens (E. coli, species of Shigella, Klebsiella and Pasteurella,
Proteus vulgaris, Staphylococci, Streptococci, Pneumococci, Salmonellae and
others).
Trimetox® Powder is easily digested and both foals and mature horses take it in
without problem via the feed.
Pharmacokinetic studies with oral application of Trimetox® Powder gave a high
bioavailability for the component substances sulfamerazine and trimethoprim.
The prescribed dosages rapidly produce a long-acting therapeutically effective
blood level (for Sulfamerazine from 20 mg/l and for trimethoprim from 1 mg/l)
(see Figure). The minimum inhibitory concentrations of numerous bacteria are
reliable attained.
Figure:
Mean values of the sulphamerazine and trimethoprim plasma concentration
following 5-days oral application of Trimetox® Powder in 12-hour
intervals (4.7 g Trimetox Powder per 10 kg/LWt./day)
On the basis of the sudies presented in the re-authorisation process, the withdrawal
period for edible tissues has been reduced to 9 days.
Marketing authorisation holder
Veyx-Pharma GmbH
Soehreweg 6
D-34639 Schwarzenborn, Germany
Statement of the active substances and other ingredients
1 g powder contains:
Active substances:
sulphamerazine 160 mg
trimethoprim 32 mg
� Broad spectrum of activity
� Bactericidal effect through
the combination of
trimethoprim and
sulfamerazine
� Superior bioavailability
Trimetox®
Powder
G 5

Excipient:
Glucose-monohydrate
Pharmaceutical form and content
Powder (500 g, 1,500 g, 5,000 g)
Substance or indication group
Sulfonamide-trimethoprim-combination
Indications
For the treatment of the following diseases caused by sulfamerazine and
trimethoprim sensitive pathogens during the early stages of the infection:
- bacterial infections of the upper respiratory tract
- infections of the gastrointestinal tract
- infections of the urogenital tract
The administration of Trimetox® Powder should be carried out based on an
antibiogram.
Contraindications
- severe liver and kidney function disorders
- damage to the haematopoietic system
- hypersensitivity to sulfonamides or trimethoprim
- resistance to sulfonamides or trimethoprim.
- diseases relating to a severe reduction in fluid intake and severe losses of fluids
Adverse reactions
After the application of Trimetox® Powder the following can occur:
- Liver damages
- Kidney damages, along with haematuria, crystalluria, kidney colic, lack of
appetite, laboured urination
- Allergic reactions
- Changes in the blood profile
- Digestive disorders
In case any of the side-effects given above occurring, then the Trimetox® Powder
must be withdrawn immediately.
Counter measures
In case of indications of kidney damage: fluid intake and alkalising of the urine.
In case of anaphylactic shock: epinephrine (adrenalin) and glucocorticoids i.v.
In case of allergic skin reactions, antihistamines and/or glucocorticoids.
If you notice any serious or other effects not mentioned in this leaflet, please
inform your veterinary surgeon or pharmacist.
Target species
Horses
Dosage for each species, routes and method of administration
To be given orally via the feed.
For the treatment of individual animals.
The following dosage rates are based on the quantity of the active substance for
sulfamerazine and trimethoprim mixed at a fixed ratio of 5 + 1.
90 mg total active substance/kg body weight/day equates to
4.7 g Trimetox® Powder per 10 kg body weight/day
The daily dose should be split into two equal a.m. and p.m. doses.
The treatment is carried out over 3 to 5 consecutive days and for 2 days,
respectively, after the disease symptoms disappear (in case of Salmonella 5 days).
In case of chronic diseases of the respiratory tract and lungs in horses, the
treatment duration of 5 to 10 days may be indicated.
Prior to each application the powder should be freshly mixed into a portion of
feed, ensuring a complete thorough mix is achieved. It should be fed prior to the
main feed ration.
Where no visible improvement in the disease situation is noted following 3
treatment days, then the diagnosis needs to be reassessed and where appropriate
a change in therapy instituted. Confirmation of the pathogen's susceptibility is
recommended.
Advice on correct administration
Use in gestating animals and neonates' demands a strict adherence to the
indication.
To avoid sensitization or contact dermatitis, direct contact with the skin should
be avoided along with inhalation during use and administration. In this instance
suitable gloves and a mask should be worn.
Withdrawal period
Horse: edible tissues 9 days
Should not be administered to mares if their milk is intended for human
consumption.
Special storage precautions
Do not use after the expiry date stated on the label and the outer carton.
Do not store above 25 °C.
The powder must be protected from light.
Special warnings
Interaction with other medicaments and other forms of interaction:
Trimetox® Powder should not be used at the same time as phenylbutazone.
Mixing with other medicaments should be avoided because of possible
incompatibilities.
Overdose:
Following an overdose atactic movements, muscle twitching and convulsions,
along with comatose conditions and liver damages can occur. Trimetox® Powder
must be discontinued immediately. The neurotropic effects are to be treated
symptomatically through the giving of central nervous system sedating substances
(e.g. barbiturates).
In addition to the giving of vitamin K or folic acid, an increase in the renal
excretion of sulfonamide is prescribed through the giving of alkalising substances
(e.g. sodium bicarbonate).
Special precautions for the disposal of unused product or waste materials,
if any:
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal product should be disposed of in accordance with local
requirements.
Veyx-Pharma GmbH · Soehreweg 6 · 34639 Schwarzenborn · Germany
Phone 0049 5686 9986-0 · Fax 0049 5686 1489 · E-Mail zentrale@veyx.de
www.veyx.de
Stand 03/2007