BIVATOP 200 LONG ACTING INJECTABLE

Land: Australië

Taal: Engels

Bron: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Werkstoffen:

OXYTETRACYCLINE DIHYDRATE

Beschikbaar vanaf:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (Algemene Internationale Benaming):

oxytetracycline as dihydrate(200mg/mL)

farmaceutische vorm:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Samenstelling:

OXYTETRACYCLINE DIHYDRATE ANTIBIOTIC Active 200.0 mg/ml

Eenheden in pakket:

100mL; 250mL; 500mL

klasse:

VM - Veterinary Medicine

Therapeutische categorie:

CATTLE | PIG - PIGLET | PIGS | SHEEP | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW |

Therapeutisch gebied:

ANTIBIOTIC & RELATED

therapeutische indicaties:

ANTIBIOTICS - ORAL, PARENTERAL | AIRSACCULITIS | AMOXYCILLIN SENSITIVE BACTERIA | ANAEROBIC BACTERIAL INFECTION | AVIAN MYCOPLASMAS | CLAVULANIC ACID SENSITIVE | COCCIDIOSIS | CORYZA | CRD | DERMATOSES | DIARRHOEA | ENDOMETRITIS | ENTERITIS | ENZOOTIC PNEUMONIA | ESCHERICHIA COLI | EUROPEAN BROOD DISEASE | GENTAMICIN SENSITIVE | HYPERMOTILITY | INFECTED WOUNDS | INFECTIONS | LACTATING | MASTITIS | PROTOZOAL INFECTIONS | PYOMETRA | SALMONELLOSIS | SINUSITIS | SYSTEMIC BACTERIAL INFECTION

Product samenvatting:

Poison schedule: 4; Withholding period: WHP:Meat-Do not use less than 21 days for cattle and pigs 42 days for sheep before slaughter for human consumption. Milk: Milk collected from cows or ewes within 7 days following treatment MUST NOT BE USED for humun consumption or p rocessing or fed to bobby calves.; Host/pest details: CATTLE: [ANTIBIOTICS - ORAL, PARENTERAL]; PIG - PIGLET: [ANTIBIOTICS - ORAL, PARENTERAL]; PIGS: [ANTIBIOTICS - ORAL, PARENTERAL]; SHEEP: [ANTIBIOTICS - ORAL, PARENTERAL]; For the treatment of conditions caused by, or associated with oxytetracycline-sensitive organisms and infections in cattle, sheep and pigs.DO NOT administer >2 injections to any pig. See Restraints on label also.

Autorisatie-status:

Registered

Autorisatie datum:

2023-07-01

Bijsluiter

Page 1
of
4
BIVATOP 200 LONG ACTING INJECTABLE
APVMA 51637/56736
Version: 16.04.2013
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
BIVATOP 200
LONG ACTING INJECTABLE
ACTIVE CONSTITUENT PER ML:
Multifold Label
BODLE
Oxytetracycline 200
mg
(as oxytetracycline dihydrate).
+
RLP
Approved
For the treatment
of
conditions caused
by,
or associated with oxytetracycline-sensitive organisms and
infections
in
cattle, sheep and pigs.
100 mL (250 mL)
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
RESTRAINTS:
DO
NOT ADMINISTER MORE THAN TWO INJECTIONS TO ANY PIG.
THE USE
OF
TETRACYCLINE DURING THE PERIOD OF TOOTH DEVELOPMENT, INCLUDING LATE
PREGNANCY, MAY
LEAD TO TOOTH DISCOLOURATION. OCCASIONAL SENSITIVITY REACTIONS
(ANAPHYLAXIS) TO OXYTETRACYCLINE
HAVE BEEN KNOWN TO OCCUR, ADMINISTER ADRENALINE IMMEDIATELY.
DOSAGE AND ADMINISTRATION:
Discard
90
days after initial use when stored below 25°C (Air Conditioning).
Cattle: 1
ml/1
0
kg
subcutaneous or intramuscular
Sheep: 1
ml/1
0
kg
intramuscular
Pigs: 1
ml/10
kg
intramuscular
If
necessary a second dose may be administered 72 hours after the initial
dose. The maximum
recommended dose volume is 1
OmL
for intramuscular injection.
Any variation by the prescribing veterinarian to the approved dose,
frequency, duration, route, disease
or target species may result
in
the need
to
extend the approved withholding period.
WITHHOLDING PERIOD:
MEAT (CATTLE): DO NOT USE LESS THAN
21
DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION.
MEAT (SHEEP): DO NOT USE LESS THAN 42 DAYS BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
MEAT (PIGS): DO NOT USE
less
THAN
21
DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION.
---------------
··------
Page 2
of
4
BIVATOP 200 LONG ACTING INJECTABLE
APVMA 51637/56736
Version: 16.04.2013
MILK (CATTLE/SHEEP):
Milk
collected
from
cows
or
ewes
within
7 days
following
treatment
MUST NOT
BE
USED
for
human
consumption
or
processing,
or
fed to
bobby
calves.
TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (PIGS):
DO
NOT
slaughter
for
expor

Productkenmerken

CS: 1.7.2
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LQ1I6
September 2012
ISSUED by BOEHRING
Issue Date :
BIVATOP® 200 LONG ACTING INJECTABLE
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
BIVATOP® 200 LONG ACTING INJECTABLE
PRODUCT NAME
Boehringer Ingelheim Pty. Limited
COMPANY NAME
78 Waterloo Rd North Ryde
NSW 2113 Australia
ADDRESS
1800 038 037
EMERGENCY TEL.
Tel: [phone]
Fax: [phone]
TELEPHONE/FAX
NUMBER
[e-mail]
EMAIL
For the treatment of conditions caused by, or associated with
oxytetracycline-sensitive organisms and infections in cattle, sheep
and pigs.
RECOMMENDED USE
2. HAZARDS IDENTIFICATION
Not classified as hazardous
NON-HAZARDOUS SUBSTANCE.
NON-DANGEROUS GOODS.
Hazard classification according to the criteria of NOHSC.
Dangerous goods classification according to the Australia Dangerous
Goods
Code.
HAZARD
CLASSIFICATION
3. COMPOSITION/INFORMATION ON INGREDIENTS
Each ml contains 200 mg oxytetracycline (as oxytetracycline dihydrate)
INFORMATION ON
COMPOSITION
NAME
CAS
PROPORTION
INGREDIENTS
Oxytetracycline
dihydrate
6153-64-6
<=25 %
Ingredients determined
not to be hazardous
-
Balance
4. FIRST AID MEASURES
No special precautions required. However, if inhaled, remove affected
person
from contaminated area. Keep at rest until recovered. If symptoms
persist seek
medical attention.
INHALATION
Do not induce vomiting. Wash out mouth thoroughly with water. If
symptoms
develop seek medical attention.
INGESTION
Wash affected area thoroughly with soap and water. If symptoms develop
seek
medical attention.
SKIN
If in eyes, hold eyelids apart and flush the eyes continuously with
running
water. Continue flushing for several minutes until all contaminants
are washed
out completely. If symptoms develop and persist seek medical
attention.
EYE
Eyewash and normal washroom facilities.
FIRST AID FACILITIES
Treat symptomatically.
ADVICE TO DOCTOR
For advice in an emergency, contact a Poisons Information Centre
(Phone
Austra

Veiligheidsvoorschriften

B8K3
BATCH NO.:
EXPIRY DATE:
BASE TEMPLATE
120-300-402
XXXXX
REVISION . . . . .
OPERATOR . . . .
DATE . . . . . . . .
ART # . . . . . . . .
ITEM #. . . . . . .
PRODUCT. . . . . .
TYPE/SIZE . . . . . .
TEMPLATE # . . . .
DIMENSIONS
. . .
PDF . . . . . . . . . . .
REV LEVEL. . . . . . .
BOEHRINGER
INGELHEIM
5
hal
19Dec13
3495117-05
83065541
Bivatop 200
ECL/100 mL
686
Base: 5.75” x 2.0”
Insert: 8.5625” x 2.0”
19Dec13 hal
05
BLACK
PMS 287
PMS 2995
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE - RESTRAINTS: DO NOT ADMINISTER MORE THAN TWO
INJECTIONS TO ANY PIG.
THE USE OF TETRACYCLINE DURING THE PERIOD OF TOOTH DEVELOPMENT,
INCLUDING LATE PREGNANCY, MAY
LEAD TO TOOTH DISCOLOURATION. OCCASIONAL SENSITIVITY REACTIONS
(ANAPHYLAXIS) TO OXYTETRACYCLINE
HAVE BEEN KNOWN TO OCCUR, ADMINISTER ADRENALINE IMMEDIATELY.
DOSAGE AND ADMINISTRATION: Discard 90 days after initial use when
stored below 25°C
(Air Conditioning). CATTLE: 1 mL/10 kg subcutaneous or intramuscular.
SHEEP: 1 mL/10 kg
intramuscular. PIGS: 1 mL/10 kg intramuscular. If necessary a second
dose may be administered
72 hours after the initial dose. The maximum recommended dose volume
is 10 mL for intramuscular
injection. Any variation by the prescribing veterinarian to the
approved dose, frequency, duration, route,
disease or target species may result in the need to extend the
approved withholding period.
WITHHOLDING PERIOD: MEAT: CATTLE, PIGS - 21 DAYS; SHEEP - 42 DAYS.
MILK: CATTLE, SHEEP - 7 DAYS.
TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (PIGS): 21 DAYS. EXPORT
SLAUGHTER INTERVAL
(CATTLE/SHEEP): NOT ESTABLISHED.
FIRST AID: I
f poisoning occurs contact a doctor or Poisons Information Centre,
phone Australia 13 11 26.
DISPOSAL: Dispose of empty container by wrapping with paper and
placing in garbage.
STORAGE: Store below 25°C (Air Conditioning).
PRESENTATION: 100 or 250 mL amber glass injection vials.
Distributed by:
Boehringer Ingelheim Pty Limited
Animal Health Division
78 Waterloo Road
NORTH RYDE NSW 2113
APVMA 51637/56736
Biva