Carflexin Flavoured 20mg Tablets

国家: 澳大利亚

语言: 英文

来源: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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下载 资料单张 (PIL)
14-06-2022
下载 产品特点 (SPC)
01-07-2013

有效成分:

CARPROFEN

可用日期:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

INN(国际名称):

carprofen(20mg/Tb)

药物剂型:

ORAL TABLET

组成:

CARPROFEN ANTI-INFLAMMATORY-NONSTEROIDAL Active 20.0 mg/Tb

每包单位数:

100 Tabs

类:

VM - Veterinary Medicine

厂商:

APEX LABORATORIES

治疗组:

DOG | BITCH | CASTRATE | PUPPY

治疗领域:

MUSCULOSKELETAL SYSTEM

疗效迹象:

ANALGESIC | ANTI-INFLAMMATORY AGENT | ANTIPYRETIC | BONE SORENESS | BRUISING | BURSITIS | COLIC | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MUSCLE RELAXANT | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SEDATIVE | SPASMOLYTIC | SPRAINS | STRAINS | TENDON SPRAINS | TRAUMATIC SWELLING

產品總結:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; A non-steroidal anti-inflammatory agent used in the treatment of inflammation and to provide analgesia in dogs.Should not be used in dogs exhibiting hypersensitivity to carprofen. See PRECAUTIONS on label also.

授权状态:

Registered

授权日期:

2023-07-01

资料单张

                                APEX CARPROFEN 20MG TABLETS WITH BEEF FLAVOURING
63924/134515
Product Name:
APVMA Approval No:
Label Name:
APEX CARPROFEN 20MG TABLETS WITH BEEF FLAVOURING
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
20 mg/Tb CARPROFEN
Claims:
Carprofen is a non steroidal anti-inflammatory agent used in the
treatment of inflammation
and to provide analgesia in dogs.
Net Contents:
100 Tabs
Directions for Use:
Restraints:
Contraindications:
Apex Carprofen Tablets should not be used in dogs exhibiting previous
hypersensitivity to
carprofen. The elimination time of NSAIDs, including carprofen, in the
cat is longer than in
the dog, and the therapeutic index is lower. In the absence of
specific data, the use of Apex
Carprofen Tablets in the cat is contraindicated.
Precautions:
As a class, cyclooxygenase inhibitory NSAIDs may be associated with
gastrointestinal and
renal toxicity.
Effects may result from decreased prostaglandin production and
inhibition of the enzyme
cyclooxygenase, which is responsible for the formation of
prostaglandins from arachidonic
acid. When NSAIDs inhibit prostaglandins that cause inflammation they
may also inhibit
those prostaglandins which maintain homeostatic function. These
anti-prostaglandin effects
may result in clinically significant disease in patients with
underlying or pre-existing disease
more often than in healthy patients.
Sensitivity to drug-associated adverse effects varies with the
individual patient. All dogs
should undergo a thorough clinical examination and appropriate
laboratory tests before RLP APPROVED
introduction of NSAID therapy. Appropriate laboratory tests and
periodic re-examination
administration should be considered.
NSAID therapy could unmask disease, which has previously been
undiagnosed due to the
absence of clinical signs. Therefore use with caution in dogs that are
less than 6 weeks of
age, debilitated or aged, have existing cardiac, hepatic or renal
disease, or are dehydrated,
hypovolaemic or hypo
                                
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产品特点

                                Apex Carprofen 20mg, 50mg and 100mg Tablets 
 
Page 1 of 5 
----------------------------------------------------------------------------------------------------------------------------------------------------------- 
MATERIAL SAFETY DATA SHEET 
 
APEX CARPROFEN 20MG, 50MG AND 100MG TABLETS 
AND APEX CARPROFEN 20MG, 50MG AND 100 MG 
TABLETS WITH BEEF FLAVOURING 
CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC 
 
SECTION I   
IDENTIFICATION OF THE MATERIAL AND SUPPLIER 
 
Product Name   
Apex Carprofen Tablets 
Recommended Use 
To treat musculoskeletal disorders and other conditions where 
NSAIDs are indicated. 
Supplier details  
Apex Laboratories Pty Ltd 
   ACN 
000 
397 
240 
   61 
Chivers 
Road 
   Somersby 
NSW 
2250 
 
 
 
+61 2 4372 1661 (Business hours – 8.30am – 5.30pm) 
 
 
 
+61 2 4372 1668 (fax) 
   www.apexlabs.com.au 
Emergency contact 
As above or Poisons Information Centre 131126 (Australia) 
 
 
SECTION II   
HAZARD IDENTIFICATION 
 
Classification 
 
Classified as hazardous according to the criteria of NOHSC  
Risk Phrases 
 
R42/43 May cause sensitisation by inhalation and skin contact 
Safety Phrases   
None allocated 
ADG Class 
 
None allocated 
Hazchem Code  
None allocated 
Poisons Schedule 
S4 
 
 
SECTION III   
COMPOSITION 
 
Ingredients 
 
 
CAS No 
Proportion 
TWA 
mg/m
3
 
STEL 
mg/m
3
 
Carprofen 
    10-<30% not 
set 
 not 
set 
Other non hazardous ingredients 
 
to 100% 
 
 
The TWA exposure value is the average airborne concentration of
a particular substance when calculated over a 
normal 8 hour working day for a 5 day working week over an
entire working lifetime.  The TWA exposure standard 
set by Worksafe Australia for dusts not otherwise specified is
10mg/m
3
.  The STEL (Short Term Exposure Limit) is an 
exposure value that should not be exceeded for more than 15 minutes
and should not be repeated for more than 4 
tim
                                
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