TETRA-DELTA MILKING COW
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
14-11-2015
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Active ingredient:
NOVOBIOCIN SODIUM, NEOMYCIN SULFATE, PROCAINE BENZYLPENICILLIN, DIHYDROSTREPTOMYCIN SULFATE, PREDNISOLONE
Available from:
Zoetis Ireland Limited
ATC code:
QJ51RV01
INN (International Name):
NOVOBIOCIN SODIUM, NEOMYCIN SULFATE, PROCAINE BENZYLPENICILLIN, DIHYDROSTREPTOMYCIN SULFATE, PREDNISOLONE
Dosage:
105/100/10
Pharmaceutical form:
intramammary Suspension
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Antibacterials and corticosteroids
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2013-12-20
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tetra-Delta Milking Cow
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Intramammary suspension.
Off white oily suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Lactating cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bovine mastitis in lactating cows.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active ingredients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
If redness, irritation or swelling of the quarter persists, discontinue use and redetermine the diagnosis.
During a course of treatment the situation should be reviewed frequently by close veterinary supervision.
Each 10 ml of suspension contains:
Active Substance
Neomycin (as Neomycin Sulphate)
105 mg
Novobiocin (as Novobiocin Sodium)
100 mg
Dihydrostreptomycin (as Dihydrostreptomycin Sulphate) 100 mg
Procaine Benzylpenicillin
100 mg
Prednisolone
10 mg
For a full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 30/10/2015_
_CRN 7022153_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin
contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic
reactions to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such
preparations.
Han
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