Pharmtet 300mg/mL Injection

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OXYTETRACYCLINE AS THE DIHYDRATE

Available from:

PROBUS PHARMACEUTICALS PTY LTD

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

OXYTETRACYCLINE AS THE DIHYDRATE ANTIBIOTIC Active 300.0 mg/ml

Units in package:

100 mL; 250 mL; 500 mL

Class:

VM - Veterinary Medicine

Therapeutic area:

ANTIBIOTIC & RELATED

Product summary:

Poison schedule: 4; Withholding period: MEAT (CATTLE): DO NOT USE less than 35 d ays before slaughter for human consumpti on. Sheep and Pigs: DO NOT USE less tha n 28 days before slaughter for human con sumption. MILK: Milk collected from cow s within 7 days (14 milkings) or ewes wi thin 8 days (16 milkings) following trea tment MUST NOT BE USED for human consump tion or processing or fed to bobby calve s. Any variation by prescribing veterin arian to the approved dose, frequency, d uration, route, disease or target specie s may result in the need to extend the a pproved withhold period.; Host/pest details: CATTLE: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, ATROPHIC RHINITIS, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ERYSIPELAS INFECTION, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MASTITIS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PNEUMONIA, PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; PIGS: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ERYSIPELAS INFECTION, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; SHEEP: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION, BACTERIAL KERATO CONJUNCTIVITIS, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ENZOOTIC ABORTION, ERYSIPELAS INFECTION, FOOTROT - DICHELOBACTER NODOSUS, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; Poison schedule: 4; Withholding period: MEAT (CATTLE): DO NOT USE less than 35 d ays before slaughter for human consumpt ion. Sheep and Pigs: DO NOT USE less th an 28 days before slaughter for human co nsumption. MILK: Milk collected from co ws within 7 days (14 milkings) or ewes w ithin 8 days (16 milkings) following tr eatment MUST NOT BE USED for human consu mption or processing or fed to bobby ca lves. Any variation by prescribing vete rinarian to the approved dose, frequency , duration, route, disease or target sp ecies may result in the need to extend t he approved withhold period.; Host/pest details: CATTLE: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, ATROPHIC RHINITIS, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ERYSIPELAS INFECTION, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MASTITIS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PNEUMONIA, PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; PIGS: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ERYSIPELAS INFECTION, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; SHEEP: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION, BACTERIAL KERATO CONJUNCTIVITIS, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ENZOOTIC ABORTION, ERYSIPELAS INFECTION, FOOTROT - DICHELOBACTER NODOSUS, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
Pharmtet 300mg/mL Injection
89473/124983
Label Name:
Pharmtet 300mg/mL Injection
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
300mg/mL Oxytetracycline (as dihydrate)
Claims:
Pharmtet 300mg/mL Injection is a broad spectrum antibiotic injection
for use in
the treatment of conditions caused by, or associated with, organisms
sensitive to
oxytetracycline in cattle, sheep and pigs.
A wide range of gram-positive and gram-negative bacteria, including
Bordetella
bronchiseptica, Actinomyces pyogenes, Erysipelothrix rhusiopathiae,
Pateurella spp,
Staphylococcus spp and Streptococcus spp are sensitive to
oxytetracycline. Certain
Mycoplasma, Rickettsiae, Protozoa and Chlamydia are also sesnitive to
oxytetracycline.
Pharmtet 300 may be used in the treatment and control of a wide range
of common
systemic, respiratory, urinary and local infections caused by
oxytetracycline organisms.
Specific indications for Pharmtet 300 would therefore include:
pasteurellosis,
pneumonia, atrophic rhinitis, erysipelas, joint-ill/ navel ill, summer
mastitis in cows, ovine
keratoconjunctivitis (pink-eye), footrot and enzootic abortion in
sheep.
Pharmtet 300 is specifically formulated to provide a prolonged action,
resulting in sustained
antibacterial activity. Following intramuscular administration,
effective blood levels persist
for 3-4 days at a dose of 20mg/kg and for 5-6 days at a dose rate of
30mg/kg. Maximum
blood levels are achieved between 4-6 hours following administration,
making Pharmtet
300 suitable for treatment of acute infections.
Net Contents:
100 mL, 250 mL, 500 mL
Directions for Use:
Restraints: RLP APPROVED
Contraindications:
Precautions:
The use of tetracyclines during the period of tooth and bone
development, including late
pregnancy, may lead to discoloration.
If concurrent treatment is administered, use a separate injection
site.
Although Pharmtet 300 is well tolerated, occasionally a slight local
reaction of a tra