Prednisolone ad us. vet. - Veyx-Pharma GmbH

� Excellent gluconeogenetic effect
� Antiphlogistic
� Antiallergic
Prednisolone
ad us. vet.
10 mg/ml suspension for injection
Active substance: prednisolone
F 2.6
Prednisolone is a synthetic glucocorticoid with a medium term effect. Prednisolone
promotes the gluconeogenesis and thus it induces a rapid increase in the blood
glucose level and the glycogen content in the liver. In particular, this effect is
used therapeutically for metabolic disorders (e.g. ketosis). Furthermore,
prednisolone is effective as an antiphlogistic, anti-proliferative and antiallergic.
The antiphlogistic and antiallergic effect is based on inhibiting inflammatory
tissue reactions, as well as preventing the release of histamine. Moreover,
prednisolone inhibits the formation of mediators of inflammation from the
arachidonic acid cascade, and also, in fact, the products of cyclooxygenesis
(prostaglandins) as well as the lipoxygenesis (leukotrienes).
Name and address of the marketing authorization holder and of the
manufacturing authorisation holder responsible for batch release
Veyx-Pharma GmbH
Soehreweg 6
34639 Schwarzenborn, Germany
Name of the veterinary medicinal product:
Prednisolone ad us. vet.
10 mg/ml suspension for injection for cattle, horses, dogs and cats
Active substance: prednisolone
Statement of the active substance and other ingredients
1 ml contains:
Active substance:
Prednisolone 10.0 mg
Excipients:
Benzyl alcohol 20.0 mg
Indications
Prednisolone ad us. vet. is effective palliatively (supportively) in the therapy of
the following diseases:
For intramuscular and subcutaneous use for primary ketosis in cattle, for allergies,
in case of noninfectious traumatic or degenerative inflammations, for sterile
inflammatory processes and for a complementary therapy in noninfectious skin
diseases. For intra-articular application in case of acute non-infectious arthritis,
bursitis and tendovaginitis.
With the application of prednisolone, the indication is always to be checked
thoroughly.
Contraindications
Prednisolone ad us. vet. is not be used for:
– Existing gastrointestinal ulcera, poorly healing wounds and abscesses, fractures
– Aseptic bone necrosis (intra-articular use)
– Septic processes in the joint region (intra-articular use)
– Viral infections, systemic mycosis
– Generally immune deficiency
– Glaucoma, cataract
– Osteoporosis, hypocalcaemia
– Hyperadrenocorticism
– Hypertension
– Pancreatitis
– In cattle during the final third of gestation
– In food-producing horses.
Existing bacterial and parasitic infections must be eliminated in the first instance
using an appropriate treatment prior to the commencement of the therapy with
Prednisolone ad us. vet.
Relative contraindications that demand special preventive measures are:
– Diabetes mellitus (controlling blood values and where appropriate increasing
the insulin dosage)
– Congestive cardiac insufficiency (careful monitoring)
– Chronic kidney insufficiency (careful monitoring)
– Epilepsy (avoidance of long-term therapy)

The application of glucocorticoids should only occur after strict positioning
of the indication in:
– Growing animals and old animals
– Suckling animals
– Gestating animals, because of the inadequately clarified potentially
teratogenic effects of prednisolone
– Equines, as glucocorticoid induced laminitis can occur as a complication.
With vaccinations, an appropriate time interval should be maintained for a
therapy with glucocorticoids. An active immunisation should not be carried
out during and for 2 weeks after a glucocorticoid therapy. The development
of an adequate immunity through a protective vaccination that was carried
out up to 8 weeks prior to the commencement of therapy can be affected.
Adverse reactions
– ACTH suppression, reversible disuse atrophy of the adrenal cortex
– Immunosuppression with elevated risk of infection and negative outcomes
for the course of infections
– Delayed healing of wounds and bones, osteoporosis, arthropathy, muscular
atrophy, retarded growth with disturbed bone growth and damage of the
bone matrix in young animals
– Diabetogenic effect with reduced glucose tolerance, steroid induced diabetes
mellitus and worsening of an existing diabetes mellitus
– Cushing-syndrome
– Pancreatitis
– Degradation of the myoclonic threshold, manifestation of a latent epilepsy,
euphoriant effect, states of excitement, sporadic depression in cats, in
dogs – sporadic depression and aggressivity
– Atrophoderma
– Glaucoma, cataract
– Polydipsia, polyphagia, polyuria
– Gastrointestinal ulcers
– Reversible hepatopathy
– Thrombotic tendency
– Hypertension
– Sodium retention with oedema formation, hypokaliaemia, hypocalcaemia
– Induction of parturition in cattle in the final third of gestation, subsequently
increased retained placenta
– Temporary reduction in milk yield in cattle
– Laminitis in horses
If you notice any serious effects or other effects not mentioned in this leaflet,
please inform your veterinary surgeon or pharmacist.
Target species
Horse, cattle, dog, cat
Dosage for each species, routes and method of administration
For intramuscular, subcutaneous and intra-articular injection.
For single application.
Horse: 0.5 to 1.0 mg prednisolone per kg body weight i.m./s.c.,
equivalent to
0.05 to 0.1 ml Prednisolone ad us. vet. per kg body weight.
5 to 250 mg prednisolone per joint intra-articular,
equivalent to
0.5 to 25 ml Prednisolone ad us. vet. per joint.
Cattle: 0.2 to 0.5 mg prednisolone per kg body weight i.m./s.c.,
equivalent to
0.02 to 0.05 ml Prednisolone ad us. vet. per kg body weight
5 to 250 mg prednisolone per joint intra-articular, equivalent to
0.5 to 25 ml Prednisolone ad us. vet. per joint.
Dog, Cat: 0.2 to 0.5 mg prednisolone per kg body weight i.m./s.c.,
equivalent to
0.02 to 0.05 ml Prednisolone ad us. vet. per kg body weight
5 to 20 mg prednisolone per joint intra-articular, equivalent to
0.5 to 2 ml Prednisolone ad us. vet. per joint.
Advice on correct administration
Care should be taken with intra-articular application that the maximum
systemic dose based on the weight of the animal is not exceeded.
Shake before use.
Withdrawal period
Cattle: Edible tissues: 18 days, Milk: 1 day
Horse: Not applicable
In horses intended for human consumption, following the final treatment a
withdrawal period of 6 months for meat, offal and milk is to be adhered to.
There is a compulsory documentation requirement for pharmaceutical
treatments in the Equine passport (Part III B).
In horses not intended for human consumption, the requirements for a
withdrawal period do not apply and recording in the equine passport is
voluntary (Part III B).
Special storage precautions
Do not store above 25 °C. Keep the vial in the outer carton.
Do not use after the expiry date which is stated on the label and box.
Once broached, use within 28 days.
Special warnings
Special precautions for use in animals:
A severe progression of infections can occur under glucocorticoid therapy,
such as Prednisolone ad us. vet. The veterinarian responsible for the therapy
is to be notified where there is an outbreak of infections.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals:
Not applicable
Interaction with other medicaments and other forms of interaction:
Mixing with other medicaments is to be avoided because of possible
incompatibility.
– Decreased cardiac glycoside tolerance following potassium deficiency
– Intensified potassium losses with simultaneous giving of thiazide and loop
diuretics.
– Increased risk of gastrointestinal ulcers and gastrointestinal bleeding with
simultaneous treatment of nonsteroidal antiphlogistics
– Decreased efficacy of insulin
– Decreased glucocorticoid efficacy with the giving of enzyme inducing
medicaments (e.g. barbiturates)
– Increased intraocular pressure in a combined treatment with anticholinergics
– Decreased efficacy of anticoagulants
– Suppression of skin reactions with intracutaneous allergy tests
Special precautions for the disposal of unused or waste materials, if any:
Medicines should not be disposed of via wastewater or household waste. Ask
your veterinary surgeon how to dispose of medicines no longer required.
These measures should help to protect the environment.
Other information
Vial (100 ml)
To be supplied only on veterinary prescription
Veyx-Pharma is GMP, DIN EN ISO 9001: 2000 and QS certified.
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
06/2009