DEXAFORT VETERINARY

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

DEXAMETHASONE AS PHENYLPROPIONATE; DEXAMETHASONE AS SODIUM PHOSPHATE

Διαθέσιμο από:

INTERVET ( ISRAEL) LTD

Φαρμακοτεχνική μορφή:

SUSPENSION FOR INJECTION

Σύνθεση:

DEXAMETHASONE AS PHENYLPROPIONATE 2 MG/ML; DEXAMETHASONE AS SODIUM PHOSPHATE 1 MG/ML

Οδός χορήγησης:

I.M

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

VET PHARMA FRIESOYTHE GMBH, GERMANY

Θεραπευτικές ενδείξεις:

For the treatment of primary ketosis, various inflammatory conditions like arthritis and other orthopedic conditions, shock, stress, allergic conditions in horses, cattle, dogs and cats.

Ημερομηνία της άδειας:

2019-03-18

Φύλλο οδηγιών χρήσης

CONSUMER PACKAGE INSERT FOR VETERINARY MEDICINAL PRODUCT
The medicine is dispensed with a veterinarian's prescription only
For animal use only
1. NAME OF THE MEDICINAL PRODUCT:
DEXAFORT VETERINARY
Suspension for injection
2. COMPOSITION:
Each ml contains:
Active substances:
Dexamethasone (as sodium phosphate) 1 mg
Dexamethasone (as phenylpropionate) 2 mg
Preservative:
Benzyl alcohol 10.4 mg
For the full list of excipients, see section 13 – “Additional
information”.
3. WHAT IS THE MEDICINAL PRODUCT INTENDED FOR:
For
the
treatment
of
primary
ketosis
(acetonaemia),
in
various
inflammatory
conditions
like
arthritis
and
other
orthopedic
conditions,
shock,
stress,
allergic
conditions in horses, cattle, dogs and cats.
Therapeutic group: glucocorticoids
4. CONTRAINDICATIONS:
Do not use in case of sensitivity to the active substance or to any of
the excipients
listed in section 13.
Except in emergency situations the product should not be used in
animals suffering
from:
•Diabetes
•Chronic nephritis
•Renal disease
•Congestive heart failure
•Osteoporosis
•Viral infections during the viraemic stage
5. SIDE EFFECTS:
Anti-inflammatory corticosteroids, such as dexamethasone, are known to
exert a
wide range of side-effects. Whilst single high doses are generally
well tolerated, they
may induce severe side-effects in long term use and when esters
possessing a long
duration of action are administered. Dosage in medium to long term use
should
therefore generally be kept to the minimum necessary to control
symptoms.
Steroids themselves, during treatment, may cause Cushingoid symptoms
involving
significant alteration of fat, carbohydrate, protein and mineral
metabolism. For
example, redistribution of body fat, muscle weakness and wastage and
osteoporosis
may result. During therapy, effective doses suppress the
hypothalamopituitreal-adrenal axis (HPA axis). Following cessation of
treatment,
symptoms of adrenal insufficiency extending to adrenocortical atrophy
can arise and
this may render the animal unable to deal ade

Αρχείο Π.Χ.Π.

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dexafort Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substances:
Dexamethasone (as sodium phosphate)
1mg
Dexamethasone (as phenylpropionate)
2mg
Excipients:
Benzyl alcohol
10.4 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
White to off-white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses, cattle, dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of primary ketosis, various inflammatory conditions
like
arthritis and other orthopedic conditions, shock, stress, allergic
conditions in
horses, cattle, dogs and cats.
4.3
CONTRA-INDICATIONS
Except in emergency situations the product should not be used in
animals
suffering from diabetes, chronic nephritis, renal disease, congestive
heart
failure, osteoporosis and in viral infections during the viraemic
stage.
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients listed in section 6.1.
4.4
SPECIAL WARNING FOR EACH TARGET SPECIES
See 4.6 below.
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
Shake vial well before use.
See 4.3 above and 4.6 below.
(ii)
Special precautions to be taken by the person administering the
medicinal
product to the animals.
Care should be taken to avoid accidental self-injection. In case of
accidental self-injection, seek medical advice immediately and show
the package insert or the label to the physician.
To avoid the risk of self-injection, pregnant women should not handle
the veterinary medicinal product.
Avoid contact with skin and eyes. In the event of accidental eye or
skin
contact, wash/irrigate the area with clean running water. Seek medical
attention if irritation persists. Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Anti-inflammatory corticosteroids, such as dexamethasone, are known to
exert
a wide range o