SUMMARY OF PRODUCT FEATURES
1. NAME OF THE MEDICINAL PRODUCT
PREDNISOLONE IVEN Injectable
2. QUALITATIVE AND QUANTITATIVE COMPOSITION, IN ACTIVE PRINCIPLES AND
EXCIPIENT COMPONENTS
Prednisolone Sodium Phosphate…………………………33,75 mg
(Equivalent to Prednisolone base: 25,0 mg)
Benzyl alcohol……………………………………..9,0 mg
Methyl-p-hydroxybenzoate………………………………..1,8 mg
Propyl-p-hydroxybenzoate……………………………….0,2 mg
Disodium edetate…………………………………………0,5 mg
Sodium hydroxide…………………………………………qs
Water for injections, qsp …………………………1,0 ml
3. PHARMACEUTICAL FORM
Injectable solution.
4. PHARMACOLOGICAL PROPERTIES AND PHARMACOKINETIC DATA
Synthetic corticosteroid with glucocorticoid and anti-inflammatory action.
Its gluconeogenic action causes an increase in the storage of glucose in the blood and
of glycogen in the liver. The level of liver glycogen increases at the expense of the
mobilization of fats and protein catabolism. Because of this, the level rises
of amino acids in the blood and there is less transport of amino acids through the
membranes of all extrahepatic cells but transport is increased
hepatic.
Its action on the hydroelectrolytic balance is due to sodium retention,
hypokalemia and metabolic alkalosis, favoring the formation of edema.
It also acts by interfering with the inflammatory reaction by stabilizing the
lysosomal membrane, which prevents the release of hydrolases and the destructive action of
these on the lysosomal membrane.
The stabilization of lysosomes is due to the effect of the corticosteroid on the
inhibition of the enzyme phospholipase, responsible for the release of acid
arachidonic, precursor of PGE-2; keys in inflammation. They also prevent
proliferation of collagen and fibroblasts Inhibit hair growth, inhibit the
phagocytic capacity of neutrophils. They depress the SER, the lymphoid and formation tissue
of antibodies. They also inhibit the release of histamine from mast cells.
In the cardiovascular system, it improves the state of shock by stabilizing
membranes, preventing the release of lysosomal hydrolases and depressant factors
of the myocardium.
In the musculoskeletal system, there is a loss of potassium, calcium, phosphorus and
nitrogen. Which brings with it muscular weakness and favors or intensifies the risk of
Osteoporosis.
85% is absorbed intramuscularly, transporting reversibly bound
to plasma proteins in 90%. It is metabolized by reduction of the hydroxyl group and
PREDNISOLONE IVEN Injectable
also by reduction of the ketone group, its plasmatic half-life being 18-36
hours.
Most of the metabolization occurs in the liver and to a lesser extent in the
kidneys. It is excreted via the bile and kidneys.
5. CLINICAL DATA
5.0 TARGET SPECIES
Bovids, horses (whose meat is not intended for human consumption), dogs and cats.
5.1 THERAPEUTIC INDICATIONS, SPECIFYING THE SPECIES OF
DESTINATION
• In all species: Rheumatoid arthritis.
Allergies
Nonspecific dermatitis.
Bursitis.
Non-specific arthritis.
• Bovidae: Ketosis.
5.2 CONTRAINDICATIONS
Fungus, virus.
Bone diseases (osteoporosis).
Mellitus diabetes.
Chronic infections.
Renal insufficiency.
Heart failure.
Cushing's syndrome.
Peptic ulcer.
Bacterial infections.
Tuberculosis.
5.3 SIDE EFFECTS (FREQUENCY AND SEVERITY)
Increased protein catabolism and therefore loss of muscle mass.
Healing delay.
Risk of fractures due to osteoporosis.
5.4 SPECIAL PRECAUTIONS FOR USE
They have not been described
5.5 USE DURING PREGNANCY AND LACTATION
Do not administer to pregnant females.
5.6 INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF
INTERACTION
With SALICYLATES: Enhances its ulcogenic effect.
With ANTIDIABETICS: Suppresses their antidiabetic effect.
With ANTICOAGULANTS: Suppresses the anticoagulant effect of these.
With DIURETICS: Produces severe hypokalemia.
With INDOMETHACIN: Produces gastrointestinal disturbances.
BARBITURATES, RIFAMPICIN, ANTACIDS, Al, Mg and PHENYTOIN:
They depress the action of the corticosteroid.
PREDNISOLONE IVEN Injectable
5.7 DOSAGE AND METHOD OF ADMINISTRATION
* Via IM:
Cattle: In case of ketosis: 100-200 mg (Equivalent to 4-8 ml of product) repeated
according to severity at 12-24 hours.
Cattle: 10-50 mg (Equivalent to 0,4-2 ml of product)
Horses: 100-200 mg (Equivalent to 4-8 ml of product)
Dogs: 10-30 mg (Equivalent to 0,4-1,2 ml of product)
Cats: 2,5-5 mg (Equivalent to 0,1-0,2 ml of product)
*Via AI: (intra-articular)
Cattle and horses: 40-80 mg (Equivalent to 1,6-3,2 ml of product) repeated at 48
hours.
Dogs: 10-20 mg. (Equivalent to 0,4-0,8 ml of product).
5.8 OVERDOSE (SYMPTOMS, EMERGENCY MEASURES,
ANTIDOTES)
Cushing's Syndrome: May occur when dosage is 4 times normal.
Obesity.
Hyperglycemia.
Increased protein catabolism: Protein deficiencies may appear in the
diet.
steroid myopathy.
Osteoporosis: This occurs in demineralized animals that will have to be
supply anabolic agents and calcium supplements.
Thinning and loss of skin elasticity.
Delayed wound healing.
Peptic ulcer.
Increased sensitivity to infections.
Water retention (edema).
loss of livid
Steroid Withdrawal Syndrome: Rapid or abrupt reduction of treatment
with glucocorticoids can cause a rebound reaction in the basic condition,
development of symptoms of adrenal insufficiency or panmesenchymal reactions
and panangitic.
Hypocalcemia, alkalosis, hypochloremia.
Treatment: symptomatic.
5.9 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not administer to equines whose meat is intended for human consumption.
5.10 WAITING TIME
Meat: 8 days.
Milk: 3 days.
Its use in equines whose meat is intended for human consumption is not allowed.
5.11 SPECIAL SAFETY PRECAUTIONS TO BE TAKEN BY THE
PERSON WHO ADMINISTERS OR HANDLES THE PRODUCT
They have not been described.
6 PHARMACEUTICAL DATA
6.1 INCOMPATIBILITIES (IMPORTANT)
Calcium gluconate, Promazine hydrochloride, Promethazine hydrochloride, Polymyxin B. sulfate,
PREDNISOLONE IVEN Injectable
Chloramphenicol
6.2 VALIDITY PERIOD, WHEN NECESSARY AFTER THE
RECONSTITUTION OF THE PRODUCT OR WHEN THE CONTAINER IS OPENED BY
FIRST TIME
Commercial product: Five years.
6.3 SPECIAL STORAGE PRECAUTIONS
Keep in a cool, dry place and protected from light.
6.4 NATURE AND CONTENTS OF THE CONTAINER
Presentation of 10 ml: Topaz glass container, hydrolytic class I.
6.5 NAME OR COMPANY NAME AND ADDRESS OR BUSINESS HEADQUARTERS OF THE HOLDER
THE MARKETING AUTHORIZATION
Laboratories and Industries IVEN, SA
Vallecas Industrial Estate
C/ Luis I, 56. 28031 MADRID
SPAIN
6.6 SPECIAL PRECAUTIONS TO BE OBSERVED FOR DISPOSAL
THE UNUSED MEDICATION AND/OR THE CONTAINERS
Any unused veterinary medicinal product or residues derived from it
must be disposed of in accordance with local regulations.
FINAL INFORMATION:
– Marketing authorization number: 475 ESP
– Date of authorization/renewal: 15/07/1992
– Last revision of the text: February 14, 2001
– Dispensation conditions: With veterinary prescription.