Quinoflox 100 mg/ml Solution for Injection for Cattle and Pigs

phase), because it could select antimicrobial-resistant bacteria within the intestinal
microbiota of the calf and increase the faecal shedding of these bacteria.

Special precautions to be taken by the person administering the veterinary
medicinal product to animals:
People with known hypersensitivity to fluoroquinolones should avoid contact with
the veterinary medicinal product.
Direct contact with the skin should be avoided because of sensitisation, contact
dermatitis and possible hypersensitivity reactions to fluoroquinolones.
Avoid skin and eye contact. Wash any splashes from skin or eyes immediately with
water.
Wash hands after use. Do not eat, drink or smoke whilst handling the veterinary
medicinal product.
Care should be taken to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
Special precautions for the protection of the environment:
In countries where feeding of fallen stock to scavenger bird populations is permitted
as a conservation measure (see Commission Decision 2003/322/EC), the possible
risk to hatching success should be considered before feeding carcasses of livestock
recently treated with this veterinary medicinal product.
3.6 Adverse events
Cattle
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Digestive tract disorders (e.g. diarrhoea)
, and
Circulatory shock.
1
These signs are generally mild and transient.
As a result of circulatory impairment following intravenous treatment.
Pigs
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Digestive tract disorders (e.g. diarrhoea)
, and
Injection site reaction and Injection site
inflammation.
1
These signs are generally mild and transient.
After intramuscular administration. They may persist up to 28 days after the
injection.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian,
to either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See also section 16 of the
package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
Cattle
The safety of the veterinary medicinal product has been established in pregnant
cows during the 1st quarter of pregnancy. The veterinary medicinal product can be
used in pregnant cows during the 1st quarter of pregnancy.
The use of the veterinary medicinal product in cows during the 3 last quarters of
pregnancy should be based on a benefit-risk assessment by the responsible
veterinarian.
The veterinary medicinal product can be used in cows during lactation.
Pigs
The safety of the veterinary medicinal product has not been established during
pregnancy. Use only accordingly to the benefit-risk assessment by the responsible
veterinarian.
The veterinary medicinal product can be used in sows during lactation.
3.8 Interaction with other medicinal products and other forms of interaction
Do not use enrofloxacin concomitantly with antimicrobial substances acting
antagonistically to quinolones (e.g. macrolides, tetracyclines or phenicols).
Do not use concurrently with theophylline as the elimination of theophylline may be
delayed.
3.9 Administration routes and dosage
Intravenous, subcutaneous or intramuscular use.
Repeated injections should be made at different injection sites.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
Cattle
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 3-5
days.
Acute mycoplasma-associated arthritis due to
2 years old
for 5 days.
The veterinary medicinal product can be administered by slow intravenous or
subcutaneous administration.
Not more than 10 ml should be administered at one subcutaneous injection site.
Pigs
2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/20 kg bw, once daily by
intramuscular injection for 3 days.
Alimentary tract infection or septicaemia caused by : 5 mg of
enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by intramuscular
injection for 3 days.
In pigs, the injection should be made in the neck at the ear base.
Not more than 3 ml should be administered at one intramuscular injection site.
3.10 Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
In cases of accidental overdoses digestive tract disorders (e.g. vomiting, diarrhoea)
and neurological disorders may occur.
In pigs, no adverse effects were reported after the administration of 5 times the
recommended dose.
In cattle overdose has not been documented.
In accidental overdose there is no antidote and treatment should be symptomatic.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary medicinal
products in order to limit the risk of development of resistance
3.12 Withdrawal periods
Cattle:
Following intravenous injection:
Meat and offal: 5 days.
Milk: 72 hours.
Following subcutaneous injection:
Meat and offal: 12 days.
Milk: 96 hours.
Pigs:
Meat and offal: 13 days.