KEY INJECTION

País: Austrália

Língua: inglês

Origem: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Compre agora

Folheto informativo - Bula (PIL)

20-06-2017

Características técnicas (SPC)

20-06-2017

Ingredientes ativos:

KETOPROFEN

Disponível em:

CEVA ANIMAL HEALTH PTY LTD

DCI (Denominação Comum Internacional):

ketoprofen(100mg/mL)

Forma farmacêutica:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composição:

KETOPROFEN ANALGESIC Active 100.0 mg/ml

Unidades em pacote:

100mL; 50mL

Classe:

VM - Veterinary Medicine

Fabricado por:

CEVA ANIMAL HEALTH

Grupo terapêutico:

Área terapêutica:

MUSCULOSKELETAL SYSTEM

Indicações terapêuticas:

Resumo do produto:

Poison schedule: 4; Withholding period: WHP: Meat: Cattle: DO NOT USE less than 4 days before slaughter for human con sumption. WHP: Meat: Horses: 28 days. WHP: Milk: Nil TRADE ADVICE EXPORT SLA UGHTER INTERVAL (ESI): ESI not establis hed.; Host/pest details: CATTLE: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; Non-steroidal anti-inflammatory, analgesic, and antipyretic for horses and cattle.Do not administer to animals with severe renal or hepatic insufficiency, gastrointestinal inflammatory disorders or ulceration, or sensitivity to NSAIDs. Perivascular injection should be avoided. Should not be used in animals less than 6 weeks old.

Status de autorização:

Registered

Data de autorização:

2023-07-01

Folheto informativo - Bula

TEMPLATE
FOR
RELEVANT LABEL PARTICULARS (RLPS) (VETERINARY PRODUCTS)
_Select appropriate: _
D
NEW PRODUCT
IZJ
VARIATION: 56418 KEY INJECTION
_Signal heading: _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_PRODUCT _
_NAME: _
Key in
i
ection
_ACTIVE CONSTITUENT!S: _
Active constituent: Ketoprofen lOOmg/mL
_STATEMENT _
_OF _
_CLAIMS: _
Nonsteroidal anti-inflammatory, analgesic
and
antipyretic for horses and
cattle
_NET _
_CONTENTS: _
[50 mL] [100 mL]
_DIRECTIONS _
_FOR _
_USE HEADING: _
DIRECTIONS
FOR
USE:
_RESTRAINTS: _
_CONTRAINDICATIONS: _
This product is contraindicated for nse
in
animals with severe renal or hepatic
INSUFFICIENCY, GASTROINTESTINAL INFLAMMATORY DISORDERS OR ULCERATION,
OR
sensitivity
to
NSAIDS. Perivascular injection should
be
avoided. This
product is contraindicated for use in animals less than 6 weeks old.
Safety
of
use
in
pregnant mares has not been determined.
_PRECAUTIONS: _
Use within
28
days
of
first broaching vial.
_Side effects: _
_DOSAGE _
&
_ADMINISTRATION: _
IMMEDIATE LABEL AND CARTON:
Horses:
10
mL
per 450 kg bw
by
slow
IV
or
IM injection, once daily for up to 5 days. Cattle: 3
mL
per
100 kg bw
by
slow
IV or
IM
injection, once daily for I
-3
days. IM injection to be given in the
anterior
half
of
the neck.
LEAFLET:
Horses: 2.2 mgikg (10
mL
per
450
kg)
bodyweight
by
intramuscular
or slow intravenous injection, once daily for up to 5 days. Cattle: 3
mgikg (3
mL
per
100 kg) bodyweigbt by slow intravenous
or
intramuscular injection,
once daily for I - 3 days. Intramuscular injection to
be
given in the anterior
half
of
the neck.
_GENERAL DIRECTIONS: _
IMMEDIATE LABEL AND CARTON:
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT.
LEAFLET:
PHARMACOLOGY
_Actions _
Ketoprofen
is
a nonsteroidal anti-inflammatory drug (NSAID)
of
the
propionic acid class. Ketoprofen inhibits the cyclooxygenase pathway
of
the
arachidonic acid cascade. Cyclooxygenase is the major enzyme involved
in
+
the coiwersion
of
arachidonic acid to vasoactive prostaglandins, prostacyc

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Características técnicas

PAGE 1 OF 2
MATERIAL SAFETY DATA SHEET:
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
PRODUCT NAME : Key Injection
Parnell Ketoprofen Injection for Horses
Parnell Ketoprofen Injection for Horses and Cattle
OTHER NAMES:
Ketoprofen
RECOMMENDED
USE:
FOR
ANIMAL
TREATMENT
ONLY.
Nonsteroidal
antiinflammatory,
analgesic
and
antipyretic for use in horses (and cattle: New Zealand only).
MANUFACTURER COMPANY DETAILS:
LICENSEE (NEW ZEALAND) DETAILS:
Parnell Manufacturing Pty Ltd
Parnell NZ Co
ADDRESS
ADDRESS
Unit 4, Century Estate
PO Box 73160
476 Gardeners Road
Auckland International Airport
Alexandria, NSW 2015
Manukau 2150
Australia
New Zealand
TELEPHONE NUMBER
TELEPHONE NUMBER
61 (0)2-9667 4411
0800 446 282 (Toll free within NZ)
EMERGENCY TELEPHONE NUMBER
EMERGENCY TELEPHONE NUMBER
61 (0)2-9667 4411 (Business Hours)
0800 446 282 (Business Hours)
FACSIMILE NUMBER
FACSIMILE NUMBER
61 (0)2-9667 4139
0800 727 533 (Toll free within NZ)
2. HAZARDS IDENTIFICATION
Hazardous substance according to criteria of Worksafe Australia.
3. COMPOSITION/INFORMATION ON INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Ketoprofen
22071-15-4
10% w/v
Solubilizing Agent
<10% w/v
Preservative
<10% w/v
Water
7732-18-5
to 100%
4. FIRST AID MEASURES
Wash off any product_ _contacting skin immediately using soap and
water.
SWALLOWED: No specific first aid requirements. Seek medical assistance
if required.
EYE: If in eyes, hold eyes open, flood with water for at least 15
minutes. Seek medical assistance if required.
SKIN: If skin contact occurs remove contaminated clothing and wash
skin thoroughly with soap and water. Seek
medical assistance if required.
INHALED: No specific requirements.
FIRST AID FACILITIES: No specific first aid facilities required.
ADVICE TO DOCTOR: Treat symptomatically as required.
5. FIRE-FIGHTING MEASURES
This material is not considered a fire hazard. Use standard fire
fighting techniques to extinguish fires involving
this material. Use water spray, dry chemical, carbon dioxide or foam.
6. ACCI

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