HALOCUR ORAL SOLUTION FOR TREATMENT OF CALVES

Država: Avstralija

Jezik: angleščina

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Prenos Navodilo za uporabo (PIL)
11-03-2021
Prenos Lastnosti izdelka (SPC)
20-06-2017

Aktivna sestavina:

HALOFUGINONE BASE AS THE LACTATE

Dostopno od:

INTERVET AUSTRALIA PTY LIMITED

INN (mednarodno ime):

halofuginone(0.5g/L)

Farmacevtska oblika:

ORAL SOLUTION/SUSPENSION

Sestava:

HALOFUGINONE BASE AS THE LACTATE ANTIPROTOZOAL Active 0.5 g/L

Enote v paketu:

490mL; 980mL

Razred:

VM - Veterinary Medicine

Izdeluje:

INTERVET AUSTRALIA

Terapevtska skupina:

CALF | BEEF CALF | BOVINE | CALF - PODDY | CALF - PREWEANING | CALF - SUCKER | DAIRY CALF | NEONATAL CALF

Terapevtsko območje:

PARASITICIDES

Terapevtske indikacije:

DIARRHEOA CAUSE CRYPTOSPORIDIUM PARVUM | CRYPTOSPORIDIUM PARVUM

Povzetek izdelek:

Poison schedule: 4; Withholding period: MEAT AND OFFAL: DO NOT USE LESS THAN 13 DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMP TION. DO NOT SLAUGHTER FOR EXPORT FOR 1 7 DAYS AFTER LAST TREATMENT. THE ESI ON THIS LABEL WAS CORRECT AT THE TIME OF L ABEL APPROVAL. BEFORE USING THIS PRODUCT CONFIRM THE CURRENT ESI FROM INTERVET A USTRALIA ON 1800 033 461 (AUSTRALIAN CAL LERS ONLY) OR VIA THE APVMA WEBSITE AT: www.apvma.gov/residues/ESI.shtml; Host/pest details: CALF: [DIARRHEOA CAUSE CRYPTOSPORIDIUM PARVUM]; Poison schedule: 4; Withholding period: WHP: MEAT AND OFFAL: DO NOT USE LESS THAN 13 DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION. ESI: DO NOT SLAUGHTER FO R EXPORT FOR 17 DAYS AFTER LAST TREATME NT. THE ESI ON THIS LABEL WAS CORRECT A T THE TIME OF LABEL APPROVAL. BEFORE US ING THIS PRODUCT CONFIRM THE CURRENT E SI FROM INTERVET AUSTRALIA ON 1800 033 461 (AUSTRALIAN CALLERS ONLY) OR VIA TH E APVMA WEBSITE AT: www.APVMA.gov/resi dues/ESI.shtml; Host/pest details: CALF: [DIARRHEOA CAUSE CRYPTOSPORIDIUM PARVUM]; Poison schedule: 4; Withholding period: ; Host/pest details: CALF: [DIARRHEOA CAUSE CRYPTOSPORIDIUM PARVUM]; An aid in the control and prevention of diarrhoea caused by Cryptosporidium parvum in calves.DO NOT expose calves to a second period of treatment. DO NOT treat calves over 21 days of age. DO NOT use where diarrhoea has been established for more than 24 hours and in weak animals. OTHER PRECAUTIONS, SPECIAL PRECAUTIONS, etc: SEE LABEL.

Status dovoljenje:

Registered

Datum dovoljenje:

2023-07-01

Navodilo za uporabo

                                HALOCUR ORAL SOLUTION FOR TREATMENT OF CALVES
57163/129146
Product Name:
APVMA Approval No:
Label Name:
HALOCUR ORAL SOLUTION FOR TREATMENT OF CALVES
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
Constituent
Statements:
0.5 g/L HALOFUGINONE BASE (as the lactate)
Claims:
An aid in the control and prevention of diarrhoea caused by
Cryptosporidium parvum in
calves.
INDICATIONS
In new born calves:
- For the prevention of diarrhoea due to a confirmed diagnosis of
Cryptosporidium parvum,
on properties with a history of cryptosporidiosis, treatment should be
commenced within
24
-
48 hours of birth.
- For the control of diarrhoea caused by Cryptosporidium parvum,
treatment should be
commenced within 24 hours after onset of diarrhoea.
Net Contents:
490 mL
980 mL
Directions for Use:
Restraints:
DO NOT expose calves to a second period of treatment.
DO NOT treat calves over 21 days of age.
Contraindications:
Precautions:
For ORAL administration only - DO NOT inject. RLP APPROVED
Do not administer to calves that have an empty stomach.
Do not use where diarrhoea has been established for more than 24 hours
and in weak
animals.
For treatment of anorexic calves, the product should be administered
in half a litre of
electrolyte solution.
Calves should receive sufficient colostrum according to standard calf
rearing management
practices.
Halocur should be used where Cryptosporidium parvum has been confirmed
as a cause
of diarrhoea. There are several diagnostic methods available to
confirm the presence of C.
parvum including laboratory examination of faecal samples for oocysts
as well as ELISA
technologies. Laboratory examination must be used to rule out other
infectious agents as
contributing factors.
Special precautions:
As symptoms of toxicity may occur at 2 times the therapeutic dose, it
is important to strictly
adhere to the recommended dose rate. Symptoms of toxicity include
diarrhoea, visible
blood in faeces, decline in milk co
                                
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Lastnosti izdelka

                                PRODUCT NAME: HALOCUR 0.5MG/ML ORAL SOLUTION FOR TREATMENT OF CALVES
MATERIAL SAFETY DATA SHEET PAGE: 1 OF 5
THIS REVISION ISSUED: FEBRUARY, 2007
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Halofuginone is an quinazolinone alkaloid.
TRADE NAME:
HALOCUR 0.5MG/ML ORAL SOLUTION FOR TREATMENT OF CALVES
RECOMMENDED USE:
An aid in the control and prevention of diarrhoea caused by
_Cryptospiridum parvum _in
calves.
APVMA NO:
57163
CREATION DATE:
February, 2007
THIS REVISION DATE:
February, 2007
STATEMENT OF HAZARDOUS NATURE:
THIS PRODUCT IS CLASSIFIED AS:
N, Dangerous to the environment. Not classified as hazardous according
to the
criteria of ASCC.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R50/53. Very toxic to aquatic organisms, may cause long-term adverse
effects to the aquatic
environment.
SAFETY PHRASES:
S20, S23, S25, S60, S61. When using, do not eat or drink. Do not
breathe mists. Avoid contact with
eyes. This material and its container must be disposed of as hazardous
waste. Avoid release to the environment. Refer to
special instructions/Safety Data Sheets.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Clear yellowish liquid.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. However product may be mildly irritating, 
                                
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