THERACALCIUM INJECTABLE CALCIUM SUPPLEMENT

Nazione: Australia

Lingua: inglese

Fonte: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Compra

Foglio illustrativo Foglio illustrativo (PIL)
19-06-2017
Scheda tecnica Scheda tecnica (SPC)
19-06-2017

Principio attivo:

CALCIUM AS CALCIUM GLUCOHEPTONATE; CALCIUM AS CALCIUM GLUCONATE; BORIC ACID

Commercializzato da:

Vetoquinol Australia Pty Ltd

INN (Nome Internazionale):

Ca as gluconate(31.25g/L)+Ca as gluceptate(8.2g/L)

Forma farmaceutica:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composizione:

CALCIUM AS CALCIUM GLUCOHEPTONATE CARBOHYDRATE Active 0.82 g/100ml; CALCIUM AS CALCIUM GLUCONATE MINERAL-CALCIUM-SALT Active 3.125 g/100ml; BORIC ACID MINERAL-BORON-ACID Other 8.2 g/100ml

Confezione:

100mL; Unit=100mL

Classe:

VM - Veterinary Medicine

Gruppo terapeutico:

CAT | CATTLE | DOG | GOAT | HORSE | PIGS | SHEEP | BEEF | BILLY | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUCK | BUFF

Area terapeutica:

NUTRITION & METABOLISM

Indicazioni terapeutiche:

CALCIUM SUPPLEMENT

Dettagli prodotto:

Poison schedule: 5; Withholding period: WHP: N/A; Host/pest details: CAT: [CALCIUM SUPPLEMENT]; CATTLE: [CALCIUM SUPPLEMENT]; DOG: [CALCIUM SUPPLEMENT]; GOAT: [CALCIUM SUPPLEMENT]; HORSE: [CALCIUM SUPPLEMENT]; PIGS: [CALCIUM SUPPLEMENT]; SHEEP: [CALCIUM SUPPLEMENT]; Poison schedule: 5; Withholding period: ; Host/pest details: CAT: [CALCIUM SUPPLEMENT]; CATTLE: [CALCIUM SUPPLEMENT]; DOG: [CALCIUM SUPPLEMENT]; GOAT: [CALCIUM SUPPLEMENT]; HORSE: [CALCIUM SUPPLEMENT]; PIGS: [CALCIUM SUPPLEMENT]; SHEEP: [CALCIUM SUPPLEMENT]; Injectable calcium supplement for cattle, horses, sheep, goats, pigs, dogs and cats. An aid in the treatment of hypocalcaemia including milk fever in cattle.

Stato dell'autorizzazione:

Stopped

Data dell'autorizzazione:

2021-07-01

Foglio illustrativo

                                Draft Label Text: Theracalcium Injectable Calcium Supplement
Immediate container label: Main Panel
Text appearing above the Header and below the Footer lines is not
included in the label
May 2016
Page 1
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
THERACALCIUM
INJECTABLE CALCIUM SUPPLEMENT
ACTIVE CONSTITUENTS (PER 100 ML):
3.125 G CALCIUM (AS CALCIUM GLUCONATE) AND
0.82 G CALCIUM (AS CALCIUM GLUCOHEPTONATE).
Also contains Boric Acid 8.2 g/100 mL.
INJECTABLE CALCIUM SUPPLEMENT
FOR CATTLE, HORSES, SHEEP, GOATS, PIGS, DOGS AND CATS
AN AID IN THE TREATMENT OF HYPOCALCAEMIA INCLUDING MILK FEVER IN
CATTLE
100ML
[LOGO]
VÉTOQUINOL
APPROVED NON-RLP
AMENDMENT MADE
Draft Label Text: Theracalcium Injectable Calcium Supplement
Immediate container label: Ancillary Panel 1
Text appearing above the Header and below the Footer lines is not
included in the label
May 2016
Page 2
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE
Discard the unused portion of the container within 28 days of initial
broaching.
For Intramuscular and subcutaneous administration (piglets
subcutaneous injection only)
Adult Cattle
100 mL
Adult Horses
50 mL – 100 mL
Foals and Calves
20 mL – 30 mL
Sheep and Goats
20 mL – 30 mL
Adult Pigs
10 mL – 15 mL
Piglets (S.C. only)
1 mL – 2 mL
Dogs
2 mL – 10 mL
Cats
1 mL – 2 mL
CAUTION: AVOID CARCASS DAMAGE
1.
Sterilise all injection apparatus by boiling before use. Avoid use of
strong
disinfectants on apparatus.
2.
Maintain cleanliness at all times.
3.
Keep needles sharp and clean; replace frequently.
4.
Use needles of appropriate gauge and length. For subcutaneous
administration, use
shortest needle possible, certainly not exceeding 15 mm.
5.
As far as possible avoid injection of animals in wet weather or under
dusty conditions.
6.
Intramuscular injections should be made into muscle tissue on the side
of the neck.
Subcutaneous injections should be made under the skin high on the neck
behind the
ear.
Draft Label Text: Theracalcium Injectable Calcium Supplement
Im
                                
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Scheda tecnica

                                PRODUCT NAME: THERACALCIUM® INJECTABLE CALCIUM SUPPLEMENT
PAGE: 1 OF 5
THIS VERSION ISSUED: OCTOBER, 2015
SAFETY DATA SHEET
Issued by: Vetoquinol Australia Pty Ltd
Phone: 1800 032 355
(BUSINESS HOURS)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETOQUINOL AUSTRALIA PTY LTD
PHONE: 1800 032 355 (BUSINESS HOURS)
UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK,
FAX: 1800 648 460
BRISBANE AIRPORT, QLD 4008
CHEMICAL NATURE:
Calcium gluconate, calcium glucoheptonate and boric acid in water
solution.
TRADE NAME:
THERACALCIUM® INJECTABLE CALCIUM SUPPLEMENT
APVMA CODE:
41611
PRODUCT USE:
Prevention and treatment of calcium deficiency in Cattle, horses,
sheep, goats, pigs,
dogs and cats.
CREATION DATE:
OCTOBER, 2015
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
T, Toxic. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
R60, R61. May impair fertility. May cause harm to the unborn child.
SAFETY PHRASES:
S25, S36. Avoid contact with eyes. Wear suitable protective clothing.
SUSMP CLASSIFICATION:
S5
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: DANGER
HAZARD STATEMENT:
H360: May damage fertility or the unborn child.
PREVENTION
P102: Keep out of reach of children.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and
understood.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT
                                
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