AIVLOSIN- tylvalosin tartrate granule, for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Tylvalosin tartrate (UNII: AL5667FY0W) (Tylvalosin - UNII:9T02S42WQO)

Disponível em:

Pharmgate Animal Health LLC

DCI (Denominação Comum Internacional):

Tylvalosin tartrate

Composição:

Tylvalosin 62.5 g in 100 g

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION

Indicações terapêuticas:

Control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE. Control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups of swine intended for slaughter in buildings experiencing an outbreak of SRD. NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. May cause skin irritation. Tylvalosin Tartrate has been shown to cause hypersensitivity reactions in laboratory animals. People with known hypersensitivity to Tylvalosin Tartrate should avoid contact with this product. In case of accidental ingestion, seek medical advice. When handling Aivlosin® Water Soluble Granules and preparing medicated drinking water, avoid direct contact with the eyes and skin. Wear a dust mask, coveralls and impervious gloves when mixing and handling this product. Eye protection is recommended. In

Resumo do produto:

Aivlosin® Water Soluble Granules is packaged in 160- and 400-gram sachets supplied in boxes holding 10 and 5 sachets respectively.

Status de autorização:

New Animal Drug Application

Características técnicas

AIVLOSIN- TYLVALOSIN TARTRATE GRANULE, FOR SOLUTION
PHARMGATE ANIMAL HEALTH LLC
----------
Approved by FDA under NADA # 141-336
AIVLOSIN®
(62.5% w/w Tylvalosin as Tylvalosin Tartrate)
WATER SOLUBLE GRANULES
FOR USE ONLY IN THE DRINKING WATER OF SWINE INTENDED FOR SLAUGHTER.
NOT FOR USE IN LACTATING OR PREGNANT FEMALES, OR MALES AND FEMALES
INTENDED
FOR BREEDING.
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
PRODUCT DESCRIPTION:
Aivlosin (Tylvalosin Tartrate) Water Soluble Granules is a water
soluble granular powder
for oral use by administration in the drinking water. Each gram of
Aivlosin Water
Soluble Granules contains 0.625 grams of tylvalosin as tylvalosin
tartrate.
ANTIBIOTIC CLASSIFICATION:
Tylvalosin, the active ingredient in Aivlosin® Water Soluble
Granules, is a macrolide
antibiotic.
INDICATIONS:
Control of porcine proliferative enteropathy (PPE) associated with
_Lawsonia intracellularis_
infection in groups of swine in buildings experiencing an outbreak of
PPE.
Control of swine respiratory disease (SRD) associated with_ Bordetella
bronchiseptica,_
_Haemophilus parasuis, Pasteurella multocida, Streptococcus suis,_ and
_Mycoplasma_
_hyopneumoniae_ in groups of swine intended for slaughter in buildings
experiencing an
outbreak of SRD.
DOSAGE AND ADMINISTRATION:
Prepare drinking water medicated with 50 parts per million Tylvalosin
as shown in the
following table.
AIVLOSIN WATER SOLUBLE GRANULES
SACHET SIZE
160 GRAMS 400 GRAMS
Tylvalosin content of sachet (grams)
100
250
Recommended volume of stock solution (US
gallons)
4
10
®
®
®
gallons)
Volume of drinking water (US gallons)
528
1320
Final tylvalosin inclusion rate in drinking water
50 parts per million
(ppm)
Administer continuously in drinking water for five (5) consecutive
days.
Keep water supply equipment clean and in good operating condition.
Clean water
medication equipment before and after each use. Do not mix or
administer Tylvalosin
medicated water using equipment made of galvanized metal. Galva