CORTEXONAVET

CORTEXONAVET 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Injectable solution.
Clear and colorless solution.

4. CLINICAL DATA

4.1 Target species

Cattle, horses, pigs, dogs and cats.

4.2 Indications for use, specifying the target species

Horses, cattle, pigs, dogs and cats:
Treatment of inflammatory or allergic conditions.
Bovine:
Treatment of primary ketosis (acetonemia).
Labor induction.
Horses:
Treatment of arthritis, bursitis or tenosynovitis.
4.3 Contraindications
Except in emergency situations, do not administer to animals suffering from
diabetes mellitus, renal failure, heart failure, hyperadrenocorticism or
Osteoporosis.

Do not administer in cases of viral infections during the viremic phase or in cases of
systemic fungal infections.
Do not use in animals suffering from gastrointestinal or corneal ulcers, or
Demodicosis.
Do not administer intra-articularly if there is evidence of fractures, joint infections
bacteria and aseptic bone necrosis.
Do not administer in known cases of hypersensitivity to the active substance, to
corticosteroids and any other component of the product.
See section 4.7.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals
The veterinarian should monitor the response to long-term treatment at intervals
regular. The use of corticosteroids in horses has been shown to induce laminitis. By
Therefore, horses receiving treatment with such substances should be monitored frequently.
preparations during the treatment period.
Due to the pharmacological properties of the active substance, special care must be taken
Caution when using the product in animals that have an immune system
weakened.
Except in the case of acetonemia and labor induction, the administration of
corticosteroids is performed to induce an improvement in clinical signs rather than to
get a cure. The underlying disease should be further investigated. When
treats groups of animals, an extraction needle should be used to avoid puncturing
excessively plug.
After intra-articular administration, the use of the
joint for one month and the joint should not be operated on for eight weeks
after using this route of administration.
Special precautions to be taken by the person administering the medicinal product
vet to animals
The product should be used with caution in order to avoid accidental self-injection.
In case of accidental self-injection, consult a doctor immediately and show him the
prospect.
Pregnant women should not handle this veterinary medicinal product.
Avoid contact with skin and eyes. In the case of accidental contact with the eyes or with
skin, wash area with plenty of clean running water.
People with a known hypersensitivity to the active substance or to any of the
excipients should avoid contact with the product.
Wash hands after using the product.

4.7 Use during pregnancy, lactation or lay
Gestation:
Apart from the use of the product to induce parturition in cattle, the
corticosteroids for use in pregnant animals. It is known that the administration in the
early stage of pregnancy produces fetal abnormalities in laboratory animals. The
Administration during the final stage of pregnancy can cause premature labor or miscarriage.
Breastfeeding:
The application of the product in lactating cows can reduce the production of
milk.
See section 4.6.

4.8 Interaction with other medicinal products and other forms of interaction

Simultaneous application with non-steroidal anti-inflammatory drugs can worsen gastroduodenal tract ulcer.
Since corticosteroids can reduce the immune response to the vaccine, dexamethasone should not be given in combination with vaccines or within two weeks of vaccination.
Dexamethasone administration can induce hypokalemia and therefore increase the risk of toxicity due to cardiac glycosides. The risk of hypokalemia may be increased if dexamethasone is administered together with potassium-sparing diuretics.
Concomitant use with anticholinesterases may cause increased muscle weakness in patients with myasthenia gravis.
Glucocorticoids antagonize the effects of insulin.
Concomitant use with phenobarbital, phenytoin, and rifampicin may decrease the effects of dexamethasone.
4.9 Amounts to be administered and administration route
The product can be administered by intravenous or intramuscular injection into
horses, and by intramuscular injection in cows, pigs, dogs and cats. The product
it can also be administered by intra-articular injection in horses. should be used
normal aseptic technique. To measure small volumes less than 1 mL, you must
An appropriately graduated syringe should be used to ensure accurate administration of
the appropriate dose.
For the treatment of inflammatory or allergic conditions, the following are recommended
average dose. However, the dose to be used should be determined according to the severity and
sign duration.

These doses can be repeated at 24-48 intervals if necessary. A site should be used
different injection.
For the treatment of primary ketosis in cattle (acetonemia), 0,02 to
0,04 mg/kg of body weight corresponding to a dose of 5 to 10 ml per cow administered
by intramuscular injection, depending on the size of the cow and the duration of the signs.
Care should be taken not to overdose Channel Island breeds. HE
will require higher doses if the signs were present for a while or if
treating animals that had recurrences. In most cases, the cure is achieved
with a single dose but the dose can be repeated after 48 hours if necessary.
For labor induction: to avoid oversized fetus and edema
mammary in cattle.
A single intramuscular injection of 0,04 mg/kg body weight corresponding to 10 ml per
cow after day 260 of pregnancy.
Labor will normally occur within 48 to 72 hours. If the birth is not
occurs within this period, the dose can be repeated
For the treatment of arthritis, bursitis or tenosynovitis by intra-articular injection into
horses.
Dose: From 1 to 5 ml.

These amounts are not specific and are given merely as a guide. Before
After giving an injection into the joint space or bursa, the volume should be removed
synovial fluid equivalent. Strict asepsis is essential.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
An overdose can induce drowsiness and lethargy in horses.
See section 4.6.
4.11 Wait times
Bovine:
Meat: 8 days
Milk: 72 hours
Porcine:
Meat: 2 days
Horses:
Meat: 8 days
Milk: Its use is not authorized in horses that produce milk for human consumption.

6. PHARMACEUTICAL DATA
6.1 List of excipients
benzyl alcohol
Sodium chloride
Soda citrato
Sodium hydroxide (for pH adjustment)
Citric acid monohydrate (for pH adjustment)
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product should not be
mix with other drugs.
6.3 Validity period
Shelf life of the veterinary medicinal product packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
6.4. Special storage precautions
Store the vial in the outer carton in order to protect from light.
6.5 Nature and composition of immediate packaging
Cardboard box with one 50 or 100 ml type I colorless glass vial, which is closed with a
bromobutyl rubber stopper and sealed with an aluminum cap.
Formats
Box with 1 vial of 50 ml.
Box with 1 vial of 100 ml.
Not all formats may be marketed.

CORTEXONAVET

See technical sheet