TILDREN INJECTION

Country: Awstralja

Lingwa: Ingliż

Sors: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredjent attiv:

TILUDRONIC ACID AS DISODIUM TILUDRONATE

Disponibbli minn:

CEVA ANIMAL HEALTH PTY LTD

INN (Isem Internazzjonali):

tiludronic acid as disodium(50mg/vial)

Għamla farmaċewtika:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Kompożizzjoni:

TILUDRONIC ACID AS DISODIUM TILUDRONATE BIPHOSPHONATE Active 56.91 mg/Vi

Unitajiet fil-pakkett:

10 vials of 10 mL

Klassi:

VM - Veterinary Medicine

Manifatturat minn:

CEVA ANIMAL HEALTH

Grupp terapewtiku:

HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL

Żona terapewtika:

MUSCULOSKELETAL SYSTEM

Indikazzjonijiet terapewtiċi:

VASCULAR SYSTEM REACTANT | CARDIAC STIMULANT | CORONARY VASODILATOR | NAVICULAR DISEASE | REACTANTS ON VASCULAR SYSTEM | RESPIRATORY STIMULANT | TICK PARALYSIS | VASCULAR SYSTEM | VASODILATION

Sommarju tal-prodott:

Poison schedule: 4; Withholding period: WHP: NOT TO BE USED in horses intended for human consumption.; Host/pest details: HORSE: [VASCULAR SYSTEM REACTANT]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [VASCULAR SYSTEM REACTANT]; For the treatment of lameness with bone and cartilage changes in horses. For the treatment of lameness associated with bone and cartilage changes such as those observed in navicular disease of less than 6 months duration and bone spavin.Contra-indicated in horses younger than 2 years of age. See contraindications and precautions on label.

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2023-07-01

Fuljett ta 'informazzjoni

COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
CEVA ANIMAL HEALTH PTY LTD
TILDREN INJECTION
58057/105979
LABEL NAME:
TILDREN INJECTION
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
50 mg/vial TILUDRONIC ACID (AS DISODIUM TILUDRONATE 56.91 mg/vial)
CLAIMS:
For the treatment of lameness with bone and cartilage changes in
horses.
For the treatment of lameness associated with bone and cartilage
changes such as those
observed in navicular disease of less than 6 months duration and bone
spavin.
NET CONTENTS:
*10 vials of 195 mg/vial freeze dried powder for reconstitution
*10 vials of 10mL water for injectable preparation
DIRECTIONS FOR USE:
Shelf life after reconstitution: As the product contains no
preservatives it should be stored
between
2°C and 8° for no longer than 24 hours following reconstitution.
Refrigerate. Do not freeze.
RESTRAINTS:
DO NOT USE in horses that may be used for human consumption.
CONTRAINDICATIONS:
This product is contraindicated for use in horses younger than 2 years
of age due to the
lack of studies on the side effects of tiludronic acid on the skeleton
of young animals.
This product is not recommended for use in horses with impaired renal
function or with a
history of renal disease.
PRECAUTIONS:
Do not mix the solution of TILDREN Injection with other solutions
containing Ca++ or
Mg++ ions. Tiludronic acid in solution could form a complex with these
ions leading to
precipitation in the medium.
Use of TILDREN Injection is not recommended during pregnancy or
lactation since the
safety of the product has not been assessed in pregnant or lactating
mares. Studies on RLP APPROVED
laboratory animals have not shown any embryotoxic, foetotoxic or
teratogenic effects, nor
any effects on peri- and post-natal development, particularly on the
skeleton.
SIDE EFFECTS:
The main side effects induced by tiludronic acid are benign muscular
tremor, sweating
or colic. These signs were observed in one out of 100 injections in
the clinic

Karatteristiċi tal-prodott

Creation Date: May 2007
Revision Date: September 2012
Version: 2
Next revision due: September 2017
MATERIAL SAFETY DATA SHEET
TILDREN
_ _
Page 1 of 9
COMPANY DETAILS
COMPANY:
ADDRESS:
Ceva Animal Health Pty Limited
11 Moores Road
ABN 54 002 692 426
Glenorie NSW 2157 Australia
TELEPHONE NUMBER:
FACSIMILE NUMBER:
[phone]
[phone]
EMERGENCY TELEPHONE NUMBER:
[phone] (Business Hours)
Poisons Information Centre: 13 11 26
SUBSTANCE IDENTIFICATION
PRODUCT NAME:
_Tildren Injection _
OTHER NAMES:
Tiludronate disodium
[[(4- Chlorophenyl)thio]methylene]bis[phosphonic acid]
MANUFACTURER’S PRODUCT CODE:
83841V
UN NUMBER:
None allocated
DANGEROUS GOODS CLASS AND SUBSIDIARY RISK:
None allocated
HAZCHEM CODE:
None allocated
SUSDP POISONS SCHEDULE NUMBER:
S4
USE:
Treatment of lameness associated with bone and cartilage changes such
as those observed in
navicular disease and bone spavin. For animal treatment only.
STATEMENT OF HAZARDOUS NATURE:
Hazardous according to criteria of NOHSC Australia.
RISK PHRASES:
SECTION 1 – IDENTIFICATION OF MATERIAL AND SUPPLIER
SECTION 2 – HAZARDS IDENTIFICATION
Creation Date: May 2007
Revision Date: September 2012
Version: 2
Next revision due: September 2017
MATERIAL SAFETY DATA SHEET
TILDREN
_ _
Page 2 of 9
No risk phrases identified.
SAFETY PHRASES:
No safety phrases identified.
The substance is a mixture of the ingredients listed below. The
product is in the form of a powder for
reconstitution in water. Each vial contains approximately 195 mg of
powder.
CHEMICAL NAME
CAS NUMBER
PROPORTION
Disodium tiludronate
89987-06-04
56.91 mg per vial
Mannitol
<40%
Sodium chloride
<40%
Sterile water for Injection BP
10ml per vial
_ _
SWALLOWED:
Accidental or deliberate ingestion of the contents of a single vial is
not expected to represent a
significant health hazard. The main risk of exposure is to persons
manufacturing the product. No
specific first aid requirements.
EYE:
May cause transient eye irritation. Avoid contact with eyes. If in
eyes, hold eyes open and flood gentl