SUMMARY OF PRODUCT CHARACTERISTICS, TO THE LICENSE

FOR USE № 0022-1437

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Dexamethasone 2 mg / ml

Dexamethasone 2 mg / ml

Solution for injection for dogs and cats, 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.

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;

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– 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.

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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

No data available.

4.9 Amounts to be administered and administration route

Intramuscular, intravenous or intraarticular administration.

Dogs and cats: 0.25 – 2.0 ml.

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

Not applicable.

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 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.

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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 15-25 ° 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.

6.6 Special precautions for the disposal of unused product or waste material

 Any unused veterinary medicinal product or its residues must be

destroyed in accordance with local regulations.

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