TULIEVE- tulathromycin injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

tulathromycin (UNII: Q839I13422) (tulathromycin - UNII:Q839I13422)

Inapatikana kutoka:

Norbrook Laboratories Limited

Njia ya uendeshaji:

INTRAMUSCULAR

Dawa ya aina:

PRESCRIPTION

Matibabu dalili:

BRD -Tulieve Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. IBK -Tulieve Injectable Solution is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. Foot Rot -Tulieve Injectable Solution is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii. BRD -Tulieve Injectable Solution is indicated for the treatment of BRD associated with M. haemolytica, P.multocida, H. somni, and M. bovis. Tulieve Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae,Pasteurella mu

Bidhaa muhtasari:

Tulieve Injectable Solution is available in the following package sizes: 50 mL vial, 100 mL vial, 250 mL vial, 500 mL vial, 1000 mL vial Approved by FDA under ANADA # 200-723 Tulieve® is a registered trademark of Norbrook Laboratories Limited Made in the UK Manufactured by: Norbrook Laboratories Limited, Newry, BT35 6PU, Co. Down, Northern Ireland To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Norbrook at 1 -866-591 -5777. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1 -888-FDA-VETS or http://www.fda.gov/reportanimalae. Revised Feb 2022 023670I01 Norbrook ®

Idhini hali ya:

Abbreviated New Animal Drug Application

Tabia za bidhaa

TULIEVE- TULATHROMYCIN INJECTION, SOLUTION
NORBROOK LABORATORIES LIMITED
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TULIEVE
(TULATHROMYCIN INJECTION)
Injectable Solution
ANTIBIOTIC
100 MG OF TULATHROMYCIN/ML
For use in beef cattle (including suckling calves), non-lactating
dairy cattle (including
dairy calves), veal calves, and swine. Not for use in female dairy
cattle 20 months of age
or older.
CAUTION: Federal (USA) law restricts this drug use by or on the order
of a licensed
veterinarian.
DESCRIPTION:
Tulieve Injectable Solution is a ready-to-use sterile parenteral
preparation containing
tulathromycin, a semi-synthetic macrolide antibiotic of the subclass
triamilide. Each mL
of Tulieve contains 100 mg of tulathromycin, 500 mg propylene glycol,
19.2 mg citric
acid and 5 mg monothioglycerol. Sodium hydroxide or hydrochloric acid
may be added
to adjust pH.
Tulieve consists of an equilibrated mixture of two isomeric forms of
tulathromycin in a
9:1 ratio.
Figure 1.
Structures of the isomers are shown below.The chemical names of the
isomers are
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[[2,6-dideoxy-3-C-methyl-3-0-methyl-4-C-
[(propylamino)methyl]-a-L-ribo-hexopyrano-syl]oxy]-2-ethyl-3,4,10-trihydroxy-
3,5,8,10,12,14-
hexamethyI-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-
hexopyranosyl]-oxy]-1-oxa-6-azacyclopentadecan-15-one and
(2R,3R,6R,8R,9R,10S,11
S,12R)-11-[[2,6-dideoxy-3-C-methyl-3-0-methyl-4-C-[(propylamino)methyl]-a-L-ribo-
®
®
hexopyrano-syl]oxy]-2-[(1R,2R)-1,2-dihydroxy-1-methylbutyl]-8-hydroxy-3,6,8,10,12-
pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-
4-azacyclotridecan-13-one, respectively.
INDICATIONS
BEEF AND NON-LACTATING DAIRY CATTLE
BRD-Tulieve Injectable Solution is indicated for the treatment of
bovine respiratory
disease (BRD) associated with _Mannheimia haemolytica, Pasteurella
multocida,_
_Histophilus somni,_ and _Mycoplasma bovis;_ and for the control of
respiratory disease in
cattle at high risk of developing BRD associated with _Mannheimia
haemolytica,_
_Pasteurella multocida, Hi