Deposel Multidose 50 mg/ml Suspension for Injection
Country: Bretland
Tungumál: enska
Heimild: VMD (Veterinary Medicines Directorate)
Vara einkenni
(SPC)
08-07-2010
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
Selenium
Fáanlegur frá:
Novartis Animal Health UK Ltd
ATC númer:
amended)
INN (Alþjóðlegt nafn):
Selenium
Leyfisstaða:
Expired
Vara einkenni
Revised: July 2010
(ATC vet code amended)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Deposel Multidose
50 mg/ml Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Selenium (as barium selenate 175 mg/ml)
50 mg/ml
Excipients:
Methyl parahydroxybenzoate
2 mg/ml
Propyl parahydroxybenzoate
0.5 mg/ml
Potassium sorbate
2 mg/ml
Disodium edentate
2 mg/ml
Ferric oxide, yellow (E172)
3 mg/ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
Smooth, yellow aqueous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and prevention of selenium deficiency in sheep and cattle
for up to 12 months.
4.3.
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not exceed the recommended dosage.
Page 1 of 4
Revised: July 2010
(ATC vet code amended)
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Shake pack well before use to ensure resuspension of contents. It is
advisable to establish the selenium status of animals prior to treatment.
ii. Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Care should be taken to avoid accidental self-injection.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A nodule is likely to develop at the injection site as a depot of the barium
selenate administered. During the clinical studies, indication of transient pain
in cattle at the injection site was noted during the first week.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
No specific warnings.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known
4.9
A
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