CEFA-DRI Suspension

Pays: Canada

Langue: français

Source: Health Canada

Ingrédients actifs:

Céphapirine (Céphapirine-benzathine)

Disponible depuis:

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.

Dosage:

300MG

forme pharmaceutique:

Suspension

Composition:

Céphapirine (Céphapirine-benzathine) 300MG

Mode d'administration:

Intramammaire

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Groupe thérapeutique:

Bétails

Descriptif du produit:

Numéro de groupe d'ingrédients actifs (GIA) :0131396001

Statut de autorisation:

APPROUVÉ

Date de l'autorisation:

2023-09-08

Notice patient

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
CEFA-DRI
® (CEPHAPIRIN BENZATHINE)
INTRAMAMMARY SUSPENSION /PROPOSED LABELING COMPONENTS
BIAH: Version August 10, 2023
Page 1 of 15
PACKAGE INSERT (ENGLISH)
DIN 02173255
PR
CEFA-DRI
®
CEPHAPIRIN BENZATHINE
INTRAMAMMARY SUSPENSION
(DRY COWS)
VETERINARY USE ONLY
Sterile
DESCRIPTION: Cefa-Dri® (Cephapirin benzathine) for intramammary
infusion into the dry cow is a
product which provides a wide range of bactericidal activity against
gram-positive and gram-
negative organisms. It is derived biosynthetically from
7-aminocephalosporanic acid.
The chemical name for cephapirin benzathine is:
(6R,7R)-3-(hydroxymethyl)-8-oxo-7-[2-(4-pyridylthio)
acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
compound with
N,N
′
-dibenzylethylenediamine (2:1)
_ _
The chemical structure of cephapirin benzathine is:
_ _
Its empirical formula is: (C
17
H
17
N
3
O
6
S
2
)
2
· C
16
H
20
N
2
ACTIVE INGREDIENT: Each 10 mL disposable sterile syringe contains 300
mg of Cephapirin activity in
a stable peanut oil gel.
STORAGE: Store between 15
℃
- 25°C. Do not freeze.
BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
CEFA-DRI
® (CEPHAPIRIN BENZATHINE)
INTRAMAMMARY SUSPENSION /PROPOSED LABELING COMPONENTS
BIAH: Version August 10, 2023
Page 2 of 15
ACTION: In the non-lactating mammary gland, Cefa-Dri® provides
bactericidal levels of the active
antibiotic, Cephapirin, for a prolonged period of time. This prolonged
activity is due to the low
solubility of the Cephapirin benzathine and to the slow-release gel
base.
Cephapirin is bactericidal to susceptible organisms; it is known to be
highly active against
Streptococcus agalactiae.
To determine the susceptibility of bacteria to Cephapirin in the
laboratory, the class disc,
Cephalothin Susceptibility Test Discs, 30 mcg, should be used.
INDICATIONS: For the treatment of mastitis caused by Streptococcus
agalactiae in dairy cows
during the dry period.
Cefa-Dri® has been shown by extensive clinical studies to be
efficacious in the treatmen