Dexamethasone 2 mg/ml 100 ml
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Dexamethasone 2 mg / ml
Solution for injection for dogs,cats, horses, pigs, cattle.., 2 mg dexamethasone (as disodium phosphate) / 1 ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
Each ml of solution contains:
2 mg dexamethasone (as disodium phosphate)
Excipients:
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1 Species for which the VMP is intended
Dogs and cats, horses, cattle, pigs…
4.2 Indications for use, specifying the target species
– In inflammatory conditions of the skeletal-muscular system such as arthritis, tendinitis,
tendovaginitis, synovitis;
– Allergic skin conditions;
– Allergic lung conditions such as bronchial asthma.
Dexamethasone is a synthetic glucocorticoid with a strong anti-inflammatory effect.
The pharmacological action and therapeutic indications of the active substance are good
familiar.
As maintenance therapy, dexamethasone can be used to treat various
rheumatic, allergic, dermatological and disease-related diseases known to occur
influenced by anti-inflammatory corticosteroids. The dexamethasone solution may be
administered intravenously when immediate action is required.
4.3 Contraindications
Do not use under the following conditions:
– Viral infections (during the viremic phase);
– Diabetes;
– Osteoporosis;
– Diseases of the heart
– Kidney disease;
– Fungal infections;
– Corneal ulcer;
– Burns;
– Pregnant animals (in high doses).
4.4 Special warnings for each target species of the veterinary medicinal product
Prolonged therapy with the product should be discontinued gradually and administered slowly
decreasing doses of the product.
4.5 Special precautions for use
Special precautions for use in animals
Animals treated with corticosteroids should be under direct medical supervision.
Because of its anti-inflammatory effect, corticosteroids hide the symptoms of infection
the treatment can be stopped to make a further diagnosis.
With prolonged use of the product, patients should be periodically
examined by a veterinarian.
Corticosteroids may cause poor resistance or enhance existing
infection. In the presence of a bacterial infection, the use of antibacterial agents is also required
products and steroidal anti-inflammatory drugs. In case of viral infection, steroids
may worsen or accelerate the disease process.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with established hypersensitivity to dexamethasone should avoid contact with
veterinary medicinal product. Personal protective equipment consisting of
gloves should be worn when working with the veterinary medicinal product.
4.6 Adverse reactions (frequency and seriousness)
– Abortion in the last third of pregnancy;
– Reduced resistance of the organism against all pathogenic microorganisms; septicemia
and septic cystitis; masking an existing infection; immunosuppression;
– With prolonged use, adrenal suppression with adrenal insufficiency in cases of
negative effects such as stress or sudden discontinuation of therapy with the product;
– Active catabolism leading to muscle atrophy, myopathy, delayed healing of
wounds;
– Osteoporosis;
– Inhibition of bone growth and prolongation;
– Atrophy of the skin;
– Diabetes;
– Polyuria, polydipsia;
– Polyphagia;
– Euphoria;
– Ulcers in the gastrointestinal tract;
– Pancreatitis;
– Hyperlipidemia;
– Increased lipolysis;
– Fatty infiltrations in the liver, such as steroid hepatopathy;
– Hypothalamic-pituitary-adrenal system inhibition;
– Thyroid synthesis decreased;
– Increase synthesis in the parathyroid gland;
– Cushing’s disease.
Anti-inflammatory corticosteroids, such as dexamethasone, cause many and many
various adverse reactions. Typically, the single high dose is well tolerated.
The product may cause adverse effects in prolonged use or
when a prodrug containing an ester-containing product is administered.
The dose at mean and long duration of application of the product should be minimal
needed to control the symptoms.
4.7 Use during pregnancy, lactation or lay
The use of the product during pregnancy is not recommended. Its application in
the last third of pregnancy can cause abortion.
4.8 Interaction with other veterinary medicinal products and other forms of veterinary medicinal product
interaction
4.9 Amounts to be administered and administration route
Intramuscular, intravenous, or intraarticular administration at a dose:
dogs, cats – 0.25-0.5 ml per 5 kg or 0.1-0.2 mg dexamethasone per 1 kg of body weight. If necessary, repeat the injection after 2 days;
cattle, horses – 5-10 ml of the drug per 400 kg or 2.5-5 mg of dexamethasone per 100 kg. If necessary, repeat the injection after 3-4 days;
sheep, calves, pigs, foals – 1-2 ml of the drug per 50 kg of body weight or 2-4 mg of dexamethasone per 50 kg.
If necessary, repeat the injection after 3-4 days.
Intra-articular injections are administered to the animal at a dose of 0.25 – 4 ml of the drug.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
There are no adverse reactions other than those described in section 4.6.
4.11 Withdrawal period
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Glucocorticoid hormones
Veterinary Medical Anatomo – Therapeutic Code: QH02AB02
5.1 Pharmacodynamic properties
Dexamethasone is a synthetic corticosteroid and has glucocorticoid activity,
anti-inflammatory, anti-allergic and immunosuppressive activity, as well as a glycogenic one.
It is a synthetic analogue of hydrocortisone, has a similar but stronger anti-inflammatory
therapeutic effect and various hormonal and metabolic effects. Dose of
the dexamethasone required is significantly lower than that of the prednisolone and prednisone.
Contrary to natural corticosteroids, dexamethasone has almost no effect on
the exchange of water and the balance of sodium salts.
5.2 Pharmacokinetic particulars
In general, the half-lives of dexamethasone reported in vitro studies were 53
minutes in horses, 110 – 130 minutes in dogs, and 290 – 335 minutes in cattle. They can be
apply very high single doses of the product without risk of intoxication, such as
animals in shock are required to administer 10 times the normal dose to be clinically effective
effect.
The water-soluble products of dexamethasone (its salts with sodium phosphate) are absorbed
rapidly after intramuscular administration.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium metabisulphite
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Disodium phosphate dodecahydrate
Sodium hydroxide (20% solution)
Acetic acid
Water for injections
6.1 Incompatibilities
Not known.
6.3 Shelf life
Shelf life of the final veterinary medicinal product: 2 years.
Shelf life after first opening the immediate packaging: 28 days.
6.4. Special precautions for storage of the product
Store at 10-25 ° C.
Keep away from light. Store in the original package.
Do not freeze or store refrigerated.
6.5 Nature and composition of immediate packaging
Brown Type II glass vials with red rubber stopper and disposable aluminum
cap of 100 ml.
