Download Dexadreson solution for injection ENG PL

PACKAGE LEAFLET
Dexadreson, 2 mg/ml, solution for injection
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer:
Intervet International B.V.
P.O. Box 31
NL-5830 AA Boxmeer
Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dexadreson, 2 mg/ml, solution for injection
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
Active substance: Dexamethasone (as sodium phosphate 2 mg
Excipients: Sodium chloride, sodium citrate, benzyl alcohol, sodium hydroxide, citric acid
10%, water for injections.
4.
INDICATION(S)
Conditions where the glucocorticoids anti-inflammatory, anti-allergical, immunosuppressive or
glucogenetic effects are desired.
Dexadreson gives a shock effect with short duration.
5.
CONTRAINDICATIONS
Dexadreson should not be used during pregnancy’s last trimester or to animals with Cushing disease.
6.
ADVERSE REACTIONS
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.
Examples of such side effects are:
Muscle and skin atrophy with delayed wound healing. Worsening of diabetes. Inhibition of the
immune system and activation of infections.
Milk production can be reduced in cattle.
Horses can get laminitis.
The fluid and salt balance can in rare cases be disturbed.
In very rare cases, hypersensitivity reactions might occur
In rare cases the active substance dexamethasone may cause low blood calcium levels and thereby
potentiate the effect of a certain kinds of heart medicines (cardiac glycosides).
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)
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Cattle, horses, pigs, dogs and cats.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Species:
Horses, cattle,
Pigs
Dog, cat
Dosage (Intramuscular or slow intravenous infusion)
0,06 mg/kg (3 ml/100 kg)
0,06 mg/kg (3 ml/100 kg, dosage can be repeated after 24 to 48 hours)
0,1 mg/kg (0,5 ml/10 kg, dosage can be repeated after 24 to 48 hours)
9.
ADVICE ON CORRECT ADMINISTRATION
10.
WITHDRAWAL PERIOD
Cattle:
Meat and offal:
Milk:
8 days
72 hours
Pigs:
Horses:
Meat and offal:
Meat and offal:
2 days
8 days
Not authorized for use in horses producing milk for human consumption.
11.
SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 25 C
Protect from light
Store bottle in outer carton
Do not use after expiry date stated on carton
Shelf life after first opening the container: 8 weeks
12.
SPECIAL WARNING(S)
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 clinical
observation during an eventual treatment is therefore necessary.
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.
Interaction with other medicinal products and other forms of interaction
Dexamethasone should not be given together with other anti-inflammatory drugs.
Overdose
High doses can cause drowsiness and lethargy in horse. When treating with a high dose, thrombosis
complications can occur due to increased clotting propensity
13.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help
to protect the environment.
14.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
2016-07-15
15.
OTHER INFORMATION
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.