METACAM 15 MG/ML ORAL SUSPENSION FOR HORSES

Krajina: Austrália

Jazyk: angličtina

Zdroj: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktívna zložka:

MELOXICAM

Dostupné z:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (Medzinárodný Name):

meloxicam(15mg/mL)

Forma lieku:

ORAL SOLUTION/SUSPENSION

Zloženie:

MELOXICAM UNGROUPED Active 15.0 mg/ml

Počet v balení:

100mL; 250mL

Trieda:

VM - Veterinary Medicine

Terapeutické skupiny:

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

Terapeutické oblasti:

MUSCULOSKELETAL SYSTEM

Terapeutické indikácie:

COLIC | MUSCULOSKELETAL CONDITIONS | ARTHRITIS | ARTHROSIS | BURSITIS | EXTERNAL MYOPATHY | INFLAMATION OF SOFT TISSUES AN | OSTEITIS | OSTEOARTHRITIS | TENDON AND LIGAMENT SPRAINS | TENDONITIS | TENOSYNOVITIS | TRAUMATIC JOINT AND CONNECTIVE

Prehľad produktov:

Poison schedule: 4; Withholding period: MEAT WHP (HORSES): DO NOT USE less tha n 28 days before slaughter for human co nsumption.; Host/pest details: HORSE: [COLIC, MUSCULOSKELETAL CONDITIONS]; For the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.Contraindicated for use in pregnant or lactating mares as no data has been established also in horses less than 6 weeks of age. Refer to product leaflet also.

Stav Autorizácia:

Registered

Dátum Autorizácia:

2023-07-01

Príbalový leták

METACAM 15 MG/ML ORAL SUSPENSION FOR HORSES
63170/135205
Product Name:
APVMA Approval No:
Label Name:
METACAM 15 MG/ML ORAL SUSPENSION FOR HORSES
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
15 mg/mL MELOXICAM
Claims:
Alleviation of inflammation and relief of pain in both acute and
chronic musculo-skeletal
disorders in horses.
Net Contents:
100 mL
250 mL
Directions for Use:
Restraints:
Contraindications:
Contraindicated for use in pregnant or lactating mares.
Contraindicated for use in horses less than 6 weeks of age.
The use of the product is contraindicated in animals suffering from
gastrointestinal
disorders such as irritation and haemorrhage, impaired hepatic,
cardiac or renal function
and haemorrhagic disorders, or where there is evidence of individual
hypersensitivity to the
product.
Contraindicated for concurrent administration with glucocorticoids or
other non-steroidal
anti-inflammatory drugs, or with anti-coagulant agents.
Precautions:
Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as
there is a potential
risk of renal toxicity. RLP APPROVED
Side Effects:
In clinical trials some side effects consistent with the use of
Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs) were observed such as slight urticaria and
diarrhoea.
Symptoms were reversible. In very rare cases loss of appetite,
lethargy, abdominal pain
and colitis have been reported. In very rare cases anaphylactoid
reactions which may
be serious (including fatal) may occur and should be treated
symptomatically. If adverse
reactions occur, treatment should be discontinued and the advice of a
veterinarian should
be sought.
In case of overdosing a symptomatic treatment should be initiated.
Dosage and
Administration:
Use the contents within 6 months of first broaching the container.
Discard the unused
portion.
Shake well before use.
To be administered at a dosage of 0.6 mg/kg bodyweight, once daily, up
to 14 days.
To be administered ei

Súhrn charakteristických

CS: 1.7.2
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LQ1IC
September 2012
ISSUED by BOEHRING
Issue Date :
METACAM® 15MG/ML ORAL SUSPENSION FOR HORSES
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
METACAM® 15mg/mL ORAL SUSPENSION FOR HORSES
PRODUCT NAME
Boehringer Ingelheim Pty. Limited
COMPANY NAME
78 Waterloo Rd North Ryde
NSW 2113 Australia
ADDRESS
1800 038 037
EMERGENCY TEL.
Tel: [phone]
Fax: [phone]
TELEPHONE/FAX
NUMBER
[e-mail]
EMAIL
Alleviation of inflammation and relief of pain in both acute and
chronic
musculo-skeletal disorders.
RECOMMENDED USE
2. HAZARDS IDENTIFICATION
Not classified as hazardous
NON-HAZARDOUS SUBSTANCE.
NON-DANGEROUS GOODS.
Hazard classification according to the criteria of NOHSC.
Dangerous goods classification according to the Australia Dangerous
Goods
Code.
HAZARD
CLASSIFICATION
3. COMPOSITION/INFORMATION ON INGREDIENTS
Each mL contains 15 mg Meloxicam.
COMPOSITION,
INFORMATION ON
INGREDIENTS
NAME
CAS
PROPORTION
INGREDIENTS
Ingredients determined
not to be hazardous
Balance
Meloxicam
(4-hydroxy-2-methyl-N-
(5-methyl-2-thiazolyl)-
2H-1,2-benzothiazine-3-
carboxamide-1,1-dioxide
)
71125-38-7
15 mg/mL
4. FIRST AID MEASURES
No special precautions required. However, if inhaled, remove affected
person
from contaminated area. Keep at rest until recovered. If symptoms
persist seek
medical attention.
INHALATION
Do not induce vomiting. Wash out mouth thoroughly with water. If
symptoms
develop seek medical attention.
INGESTION
Wash affected area thoroughly with soap and water. If symptoms develop
seek
medical attention. Contact a physician immediately and show the packet
insert
or label to the physician.
SKIN
If in eyes, hold eyelids apart and flush the eyes continuously with
running
water. Continue flushing for several minutes until all contaminants
are washed
out completely. If symptoms develop and persist seek medical
attention.
EYE
Eyewash and normal washroom facilities.
FIRST AID FACILITI