TOMORROW INTRAMAMMARY INFUSION- cephapirin benzathine suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEPHAPIRIN BENZATHINE (UNII: 90G868409O) (CEPHAPIRIN - UNII:89B59H32VN)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

INN (International Name):

CEPHAPIRIN BENZATHINE

Composition:

CEPHAPIRIN 300 mg in 10 mL

Administration route:

INTRAMAMMARY

Prescription type:

OTC

Therapeutic indications:

For the treatment of mastitis in dairy cows during the dry period. ToMORROW has been shown by extensive clinical studies to be efficacious in the treatment of mastitis in dry cows, when caused by Streptococcus agalactiae and Staphylococcus aureus including penicillin-resistant strains. Treatment of the dry cow with ToMORROW is indicated in any cow known to harbor any of these organisms in the udder at drying off. INDICACIONES Para el tratamiento de mastitis bovina durante el período seco. Extensos estudios clínicos han demostrado que ToMORROW es eficaz en el tratamiento de la mastitis en vacas secas, cuando ésta es causada por el Streptococcus agalactiae y el Staphylococcus aureus, incluyendo cepas resistentes a la penicilina. El tratamiento de la vaca seca con ToMORROW es recomendado para cualquier vaca que se sepa alberga a cualquiera de estos organismos en la ubre al momento del período de secado. Not for Human Use. Este producto no es para administrarse en humanos.

Product summary:

ToMORROW (cephapirin benzathine) for Intramammary Infusion into the Dry Cow. Cephapirin benzathine equivalent to 300 mg cephapirin activity per syringe. Each pail contains 144 x 10 mL syringes and 144 convenient single use alcohol pads. NDC 0010-4718-03. ToMORROW is also supplied in cartons containing 12 x 10 mL syringes with 12 convenient single use alcohol pads. NDC 0010-4718-02. FORMAS DE PRESENTACIÓN ToMORROW (cefapirina benzatínica) para infusión intramamaria en vacas secas. Cefapirina benzatínica equivalente a 300 mg de cefapirina activa por jeringa. Cada cubo contiene 144 jeringas de 10 mL con 144 prácticas toallas desechables humedecidas con alcohol. NDC 0010-4718-03. ToMORROW también viene en una presentación de cajas de 12 jeringas de 10 mL y 12 prácticas toallas desechables humedecidas con alcohol. NDC 0010-4718-02.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

TOMORROW INTRAMAMMARY INFUSION- CEPHAPIRIN BENZATHINE SUSPENSION
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
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TOMORROW
CEPHAPIRIN BENZATHINE
CEFAPIRINA BENZATÍNICA
FOR INTRAMAMMARY INFUSION INTO THE DRY COW
PARA INFUSIÓN INTRAMAMARIA EN VACAS SECAS
Approved by FDA under NADA # 108-114
Aprobado por la FDA con el número de NADA # 108-114
DESCRIPTION
ToMORROW (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.
Each 10 mL disposable syringe contains 300 mg of cephapirin activity
in a stable peanut
oil gel. This product was manufactured by a non-sterilizing process.
DESCRIPCIÓN
ToMORROW (cefapirina benzatínica) para INFUSÍON INTRAMAMARIA en
VACAS SECAS
es una producto que proporciona un amplio espectro de actividad
bactericida contra
organismos grampositivos y gramnegativos. Es un derivado biosintético
del ácido 7-
aminocefalosporánico.
Cada jeringa desechable de 10 mL contiene 300 mg de cefapirina activa
en un gel estable
de aceite de maní (cacahuate). Este producto fue fabricado mediante
un proceso no
esterilizador.
Store at or below 25°C (77°F). Do not freeze. Avoid excessive heat.
Almacenar a una temperatura igual o inferior a 25°C (77°F). No
congelar. Evitar el calor
excesivo.
ACTION
In the non-lactating mammary gland, ToMORROW (cephapirin benzathine)
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 _and _Staphylococcus aureus _including
strains resistant to
penicillin.
To determine the susceptibility of bacteria to cephapirin in the
laboratory, the class disc,
Cephalothin Susceptibility Test Discs, 30 mcg, should b