NORFENICOL 300 MGML INJECTION VETERINARY

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

FLORFENICOL

Beschikbaar vanaf:

COMEX LTD., ISRAEL

farmaceutische vorm:

SOLUTION FOR INJECTION

Samenstelling:

FLORFENICOL 300 MG/ML

Toedieningsweg:

I.M

Prescription-type:

Required

Geproduceerd door:

NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND

therapeutische indicaties:

Treatment of bovine respiratory disease (BRD) associated with pasteurella haemolytica, pasteurella multocida and haemophilus somnus.

Autorisatie datum:

2021-05-31

Bijsluiter

An authorized leaflet approved by The Ministry of Health: June 2016
Consumer leaflet of veterinary product
Veterinarian prescription only medicine
Animal use only
1.
NAME OF VETERINARY PRODUCT, ROUTE & STRENGTH
Norfenicol 300 mg/ml Injection Veterinary
Solution for I.M. injection
2.
ACTIVE INGREDIENTS
Florfenicol 300 mg/ml
Full excepients list is provided under section 13
3.
WHAT IS THE MEDICINE INDICATED FOR
Therapeutic classification: Antibiotics
The medicine is indicated for the treatment of bovine respiratory
disease
(BRD)
associated
with
pasteurella
haemolytica,
pasteurella multocida and haemophilus somnus.
4.
CONTRA-INDICATIONS
•
Do
not
use
in
adult
bulls
or
boars
intended
for
breeding
purposes.
•
Do not use in cases of hypersensitivity to the active substance
or to any of the excipients.
•
Do not use in cases of known resistance.
•
Not permitted for use in lactating animals producing milk for
human consumption.
5.
SIDE EFFECTS:
- The medicine may cause inflammatory lesions (swelling and
hardness) at the injection site which may persist for 31 days.
- A decrease in food consumption and transient softening of the
feces may occur during the treatment period.
The
treated
animals
recover
quickly
and
completely
upon
termination of treatment.
- In very rare cases, anaphylactic shock has been reported.
Any suspected adverse events should be reported to the Ministry
of Health by clicking on the link below and using an online form
http://forms.gov.il/globaldata/getsequence/getsequence.aspx?form
Type=AdversEffectMedic@moh. gov.il
The
form
can
be
found
on
the
Ministry
of
Health
website
(
www.health.gov.il)
6.
TARGET SPECIES
Cattle
7.
ROUTE AND DOSE FOR EACH TARGET SPECIES
Intramuscular Injection:
20 mg/kg body weight (1 ml/15 kg) to be administered twice 48
hours apart.
The dose volume given at any one injection site should not exceed
10 ml.
8.
ADMINISTRATION METHOD
It is recommended to use a 16-gauge needle.
The injection should only be given in the neck.
It is recommended to treat animals in the early stages

Productkenmerken

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NORFENICOL 300 MG/ML INJECTION VETERINARY
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol
300 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A light yellow to straw coloured solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of bovine respiratory disease (BRD) associated with
_Pasteurella _
_haemolytica_, _Pasteurella multocida _and _Haemophilus somnus_.
4.3
CONTRAINDICATIONS
Do not use in adult bulls intended for breeding purposes.
Do not use in the case of known hypersensitivity to the active
substance or to any of
the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Page 2 of 5
Special precautions for use in animals
The product should be used in conjunction with susceptibility testing
and take into
account official and local antimicrobial policies.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
People with known hypersensitivity to Florfenicol or any of the
excipients should
avoid contact with the veterinary medicinal product. In case of
accidental contact
with skin or eyes, rinse immediately with plenty of water.
In case of accidental self-injection, seek medical advice immediately
and show the
package leaflet or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A decrease in food consumption and transient softening of the faeces
may occur
during the treatment period. The treated animals recover quickly and
completely
upon termination of treatment.
Intramuscular administration may cause inflammatory lesions at the
injection site
which may persist for 14 days.
In very rare cases, anaphylactic shock has been reported.
Reporting suspected adverse reactions:
Reporting suspected adverse reactio