Dexadreson Vet.
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Dexadreson, 2 mg/ml, solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
Active substance:
Dexamethasone (as sodium phosphate) 2 mg
Excipient(s):
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless solution for parenteral injection.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle, horses, pigs, dogs and cats.
4.2 Indications for use, specifying the target species
Conditions where the glucocorticoids anti-inflammatory, anti-allergical, immunosuppressive or glucogenetic effects are desired.
Dexadreson gives a shock effect with short duration.
4.3 Contraindications
Cushing disease. Dexadreson should not be used during pregnancy’s last trimester.
4.4 Special warnings <for each target species>
None.
4.5 Special precautions for use
Special precautions for use in animals
Use with caution if there is suspicion of ulcus ventriculi, diabetes mellitus, corneal ulcer, fungal and virus infections, renal insufficiency or congestive heart failure. If administered concurrently with bacterial infections, antibiotics should be administered as well. Due to dexamethasone’s immunosuppressive abilities, concurrent vaccination should be avoided.
Use on young or older individuals, can cause increased risk of side effects. A reduced dose and clinicalobservation during an eventual treatment is therefore necessary.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
Except from substitution therapy, corticosteroid treatments always include an over dosage compared to the physiological condition. Adverse effects do not always depend on the size of the dose and the length of the treatment, but also on the individuals’ sensitivity.
Among these side effects, one can mention:
The individuals own ACTH- and cortisol excretion is inhibited and cushingoid symptoms can occur. Increased glycogenesis, worsening of diabetes mellitus and latent diabetes mellitus can be manifested.
Catabolic effect such as muscle and skin atrophy with delayed wound healing. The immunosuppressant actions may weaken resistance to or exacerbate existing infections. Cattle can experience reduced milk production. Horses can get laminitis.
In rare cases one can observe an increase in potassium and calcium excretion as well as sodium retention.
In very rare cases, hypersensitivity reactions might occur.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports)
4.7 Use during pregnancy, lactation or lay
Pregnancy:
Administration in early pregnancy may cause fetal abnormalities or delayed fetal growth.
Administration in late pregnancy may cause early parturition or abortion.
Treatment of pregnant animal should be avoided and should only be done according to the responsible veterinarians risk/benefit evaluation.
4.8 Interaction with other medicinal products and other forms of interaction
Dexamethasone should not be given together with other anti-inflammatory drugs. In rare cases, administration of Dexamethasone can lead to hypokalemia, and as such potentiate the effect of cardiac glycosides.
Because corticosteroids can depress the immune response, Dexadreson should not be used in combination with vaccines.
4.9 Amounts to be administered and administration route
Species: Dosage (Intramuscular or slow intravenous infusion)
Horses, cattle 0,06 mg/kg (3 ml/100 kg)
Pigs 0,06 mg/kg (3 ml/100 kg, dosage can be repeated after 24 to 48 hours)
Dog, cat 0,1 mg/kg (0,5 ml/10 kg, dosage can be repeated after 24 to 48 hours)
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
High doses can cause drowsiness and lethargy in horse. When treating with a high dose, thrombosis complications can occur due to increased clotting propensity. See also point 4.6.
4.11 Withdrawal period(s)
Cattle: Meat and offal: 8 days
Milk: 72 hours
Pigs: Meat and offal: 2 days
Horses: Meat and offal: 8 days
Not authorized for use in horses producing milk for human consumption.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: corticosteroids for systemic use, glucocorticoids.
ATCvet code: QH02A B02
5.1 Pharmacodynamic properties
Dexamethasone is a fluoro-methyl derived corticosteroid, with anti-inflammatory, anti-allergenic and immunosuppressive properties. Dexamethasone also stimulates glycogenesis leading to elevated sugar levels. The relative efficacy of dexamethasone graded by the anti-inflammatory effect is about 25 times higher than that of hydrocortisone, while its mineralocorticoid effect is minimal.
5.2 Pharmacokinetic particulars
Dexadreson contains the sodium phosphate ester of dexamethasone. Following intramuscular injection this soluble ester of dexamethasone is rapidly absorbed at the area of injection and is rapidly hydrolyzed to dexamethasone. In cattle and horse maximum plasma concentration of dexamethasone is achieved within 20 minutes and in pigs and dogs within 10 minutes. The species cat has not been examined. Half time after intravenous and intra muscular injection is similar, varying between 5-20 hours for relevant species. Bio-availability after intra muscular injection is closer to 100%.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Sodium citrate
Benzyl alcohol
Sodium hydroxide 1 N to pH=7,0-7,8
Citric acid 10% to pH 7,0-7,8
Water for injections
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 8 weeks.
6.4. Special precautions for storage
Do not store above 25C.
Protect from light.
Store bottle in the outer carton.
6.5 Nature and composition of immediate packaging
20 and 50 ml clear glass (Type I Ph.Eur.) vials, closed with a halogenated butyl rubber stopper and sealed with a coded aluminum cap.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Körverstraat 35
Boxmeer, Holland
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
2016-07-15
PROHIBITION OF SALE, SUPPLY AND/OR USE