Bela-pharm.com

Pharmacuetical form: solution for intramuscular, intravenous or
Active ingredients: Trimethoprim, Sulfadoxine Target species: Horse, cattle, pig, goat, cat, guinea pig Name and address of the marketing authorisation holder:
bela-pharm GmbH & Co.KG, Lohner Str. 19, 49377 Vechta - Germany
Composition:
1.0 ml solution contains:
Pharmacological active substance:
Trimethoprim
Excipients:
Sodium hydroxide, glycerolformal, water for injection.
Pharmaceutical form:
Solution for intramuscular, intravenous or subcutaneous injection.
Clear, yellowish, brownish or reddish solution for injection.
Package size: 100 ml, 250 ml.
Target species: Horse, cattle, pig, goat, cat, guinea pig.
Indications:
Horse, cattle, pig, goat, cat, guinea pig.
For the treatment of infectious diseases in the early stage of infection, caused by bacteria
sensitive to sulfadoxine and trimethoprim. Primary and secondary infections
- of the respiratory tract,
- of the gastro-intestinal tract,
- of the urinary and genital tract,
and the joints.
Contraindications:
- hypersensitivity against sulfonamides or trimethoprim,
- resistance against sulfonamides or trimethoprim,
- severe hepatic and renal malfunctions,
- dehydration,
and disturbances of the haemogram.
Due to the contents of glycerolformal, Sulphix® should not be used in pregnant animals.
The intravenous injection of Sulphix® shall be avoided when drugs acting on the central
nervous system (e.g. anaesthetics, neuroleptics) have been applied.
Do not use in newborn animals.
Do not use in mares, of which the milk is intended for human consumption.
Adverse reactions:
Following administration of Sulphix®, the following undesirable effects may occasionally
occur:
- symptoms of irritation of the injection site after intramuscular or subcutaneous
injection,
- liver damage,- renal damage,- changes in the haemogram (e.g. haemolytic anaemia, agranulocytosis),- sensibilisation reactions (e.g. exanthema, fever).
Following intravenous injection cattle may show systemic reactions (dyspnoe, excitation) for a short time.
In the horse life threatening anaphylactic or anaphylactoid reactions may occur after intravenous injection. On the occurence of allergic reactions, the drug has to be withdrawn immediately and the animal must be treated symptomatically. In anaphylaxis: epinephrine (adrenalin) and corticosteroids i.v.
In allergic skin reactions: antihistaminics and/or glucocorticoids Dosage for each species, route(s) and method of administration:
Horse, cattle, pig, goat and cats.
For intramuscular, intravenous, or subcutaneous injection.
15 mg sulfadoxine-trimethoprim combination / kg body weight (b.w.) per day,
equivalent to 1 ml Sulphix® per 16 kg b.w. per day.
The doses mentioned are related to the amount of the entire active ingredient, consisting of
sulfadoxine and trimethoprim in the relation of 5:1 and is only valid for germs sensitive to
both single components.
Intravenous use in:
horses, cattle, pigs, goats, cats.
Subcutaneous use in: Intramuscular use in: cattle, pigs, goats, cats.
Remarks:
Following intravenous injection in horses life-threatening shock reactions may occur. This
way of application shall by used in this animal species only in vital indications and in form
of an injection of a small amount of the preparation with consequent observation of the
patient and a slow injection of the main portion. The solution injected should have body
temperature. On the first signs of intolerability, the injection has to be stopped immediately
and a treatment of shock shall be initiated, if necessary.
Due to the tissue irritating effect of Sulphix®, larger volumes of injection given by
intramuscular injection in cattle shall be distributed to several injection spots.
Guinea pigs:
For subcutaneous or intramuscular injection:
24 mg sulfadoxine-trimethoprim combination / kg body weight (b.w.) per day,
corresponding to 0.1 ml Sulphix® per kg b.w. per day.
Horses, cattle, pigs, goats, cats, guinea pigs.
The duration of treatment is at least 3 days, better 5 days.
After cessation of symptoms, the treatment with Sulphix® shall be continued for two more
days.
Should there be no significant improvement of the state of health after 1 day of treatment,
the treatment should only be continued, if an antibiogram has clearly demonstrated the
sensitivity of the causative germ, if necessary a change of therapy has to be initiated.
Withdrawal period(s):
Following intravenous injection:
Cattle, goat:
Following intramuscular injection:Cattle, goat : Do not use in mares, of which milk is gained for human consumption.
Special warnings:
Special warnings for each target species:
In the horse life-threatening anaphylactic or anaphylactoid reactions may occur following
intravenous injection.
When using the same way of administration in sedated or anaesthetized horses severe
circulatory failures with incidents of death have been described.
Special precautions for use:
Special precautions for use in animals:
To avoid kidney damage by crystallization, a sufficient water intake has to be ensured during
therapy, the urine can be alkalized in cases.
The use of Sulphix® should be done under consideration of an antibiogram.
Special safety precautions to be taken by the person administering the medicinal product to
animals:
The direct contact with the skin or mucous membranes of the user must be avoided due to the
risk of sensitization.
Use during pregnancy, lactation or lay:
Due to its contents of glycerolformal, Sulphix® must not be used in pregnant animals.
For sulfonamides, the safe use during gestation is not proved. They should only be used,
when the advantage of a treatment clearly exceeds the risks.
Mares, of which milk is taken for human consumption, must be excluded from treatment.
Interaction with other medicinal products and other forms of interaction:
Sulphix® must not be used concomitantly with
- hexamethylentetramin (methenamine),
- phenylbutazone,
- local anaesthetics of the group of para-amino benzoic acid esters (procaine, tetracaine), as
they may cancel out the effect of sulfadoxine locally.
Overdose (symptoms, emergency procedures, antidotes), if necessary:
Following absorption of larger amounts of sulfonamides, atactic movements, muscle jerks
and muscle cramps as well as comateous stages and liver damage have been observed. The
symptomatic treatment of neurotroph effects is done by administration of central sedative
substances, e.g. of barbiturates. Additonally to an administration of vitamin K or folic
acid, an increase of renal excretion by application of alkalising substances (e.g. sodium
bicarbonate) is indicated.
Incompatibilities:
Mixtures with other medicinal products must be avoided due to a risk of possible
incompatibilities.
Special storage precautions:
Keep out of the reach and sight of children.
Shelf life after first opening the container: 7 days.
Residual amounts remaining in the vial must be wasted 7 days after opening.
Do not use after the expiration date stated on the label.
For this veterinary medicinal product no special storage conditions are required.
Special precautions for the disposal of unused product or waste materials:
Remaining quantities shall be preferably given to pollutant collecting points. When wasted
together with the general household waste, it has to be ensured that no misuse of the
pharmaceutical is possible. Veterinary pharmaceuticals must not be wasted with waste
water or sewage systems. Local regulations for the disposal of pharmaceuticals have to be
observed.
Date of revision of the text: 27.10.2009
Marketing authorisation number: 6856907.00.00 (Germany)
For animal treatment only.
Available on prescription only!

Source: http://www.bela-pharm.com/nc/en/produkte/schafe-ziegen.html?download=Sulphix_10-09_01.pdf&did=1372