KETOFEN 10%

Country: New Zealand

Language: English

Source: Ministry for Primary Industries

Active ingredient:

ketoprofen

Available from:

Ceva Animal Health (NZ) Limited

INN (International Name):

ketoprofen

Composition:

ketoprofen 100 g/litre

Therapeutic area:

Anti-inflammatory

Authorization status:

ACVM Registered

Authorization date:

1993-03-11

Summary of Product characteristics

Page 1 of 6 MAY 2022
_Carton Label Panel: Front and back _
FOR ANIMAL TREATMENT ONLY
HARMFUL – KEEP OUT OF REACH OF CHILDREN
RESTRICTED VETERINARY MEDICINE
KETOFEN
® 10%
Injectable solution
ACTIVE CONSTITUENT: 0.1 G/ML KETOPROFEN
NON-STEROIDAL ANTI-INFLAMMATORY INJECTABLE SOLUTION.
READ THE PACKAGE INSERT COMPLETELY BEFORE USE
50 mL vial [100 mL][250 mL]
(Cattle / Horse pictograph)
(Ceva logo)
_Panel: Top flap _
KETOFEN
®
10%
INJECTABLE SOLUTION
Batch:
Exp:
Page 2 of 6 MAY 2022
_Panel: LHS _
DIRECTIONS FOR USE: For Indications – Recommendations –
Contraindications: SEE LEAFLET
DOSAGE AND ADMINISTRATION
USE THE CONTENTS WITHIN 28 DAYS OF FIRST BROACHING OF THE VIAL.
DISCARD THE UNUSED
PORTION.
•
Cattle: Administer by the intravenous or intramuscular route in the
neck.
Dose: 3mL per 100kg bodyweight (3 mg active ingredient per kg) for 1-3
consecutive days.
•
Sport and Race Horses: Administer intravenously.
Dose:
-
Musculoskeletal disorders: 1mL per 45kg bodyweight (2.2 mg active
ingredient per kg)
once daily for 3-5 consecutive days.
-
Colic: 1mL per 45 kg bodyweight (2.2 mg active ingredient per kg). A
single injection is
usually sufficient. Repeat if necessary after clinical reassessment of
the horse.
IT IS AN OFFENCE FOR USERS OF THIS PRODUCT TO CAUSE RESIDUES EXCEEDING
THE RELEVANT MRL
IN THE FOOD NOTICE: MAXIMUM RESIDUE LEVELS FOR AGRICULTURAL COMPOUNDS.
WITHHOLDING PERIOD:
CATTLE PRODUCING MEAT AND OFFAL FOR HUMAN CONSUMPTION MUST NOT BE SOLD
FOR SLAUGHTER
DURING TREATMENT OR WITHIN 4 DAYS OF THE LAST TREATMENT.
MILK – NIL.
HORSES – 63 DAYS.
FIRST AID: If poisoning occurs, contact a doctor or Poisons
Information Centre, phone New Zealand
0800 POISON (0800 764 766).
DISPOSE of empty container by wrapping with paper and putting in
garbage.
STORE below 30ºC (Room temperature). Keep the vial in an outer carton
in order to protect from
light.
EPA GROUP STANDARD NUMBER: HSR100757
WARNING: HARMFUL IF SWALLOWED. MAY CAUSE SKIN IRRITATION OR SERIOUS
EYE
IRRITATION. Do not eat, drink, or smoke when usi