Mediflox Oral

VETERINARY DRUG PACKAGE LEAFLET

oral MEDIFLOX
Enrofloxacin 100 mg / ml
Oral Solution

Read this leaflet carefully and in its entirety before you start using this veterinary medicinal product, as it contains important information for you. - Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your veterinarian or pharmacist.
- If you get any side effects, please contact your veterinarian, veterinary pharmacist or the National Food Safety Agency.
- These include any possible side effects not mentioned in this leaflet.

In addition to the veterinary medicinal product available only on veterinary prescription:
- This veterinary medicinal product has been prescribed for your animals only. Do not pass it on to other people who may misuse it.

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURER RESPONSIBLE FOR BATCH RELEASE OF THE VETERINARY MEDICINAL PRODUCT
AVE&VETMEDIC DOO, Belgrade
Bregalnička 32, 26300 Vršac
Serbia
2. NAME OF THE VETERINARY MEDICINAL PRODUCT, STRENGTH AND PHARMACEUTICAL FORM
Mediflox oral
Enrofloxacin (100 mg/ml)
1 ml of oral solution contains:
Active substance(s): Enrofloxacin 100 mg
Excipients: Potassium hydroxide 85% 17.5 mg; benzyl alcohol 7.5 mg; purified water up to 1 ml

3. THERAPEUTIC INDICATIONS
Treatment of colibacillosis, salmonellosis and infections caused by mycoplasmas.
Before starting treatment, check the sensitivity of the agent to enrofloxacin by performing an antibiogram. Resistance to this antibiotic may increase during treatment, therefore the mentioned drug should be prescribed in case of a confirmed bacteriological diagnosis and in case of resistance to other antibiotics.
If no improvement is observed after 3 days of starting treatment, it is recommended to change the treatment.

4. CONTRAINDICATIONS
The drug is not prescribed in case of resistance to other quinolone drugs, in order to avoid cross-resistance.
Complete cross-resistance to fluoroquinolones is recorded.
Do not administer to laying hens.

5. ADVERSE REACTIONS
When following the indications for administering the drug according to the package leaflet, there are no side effects. Like fluoroquinolones, enrofloxacin has an adverse effect on the joints, especially in young animals. Therefore, careful monitoring is recommended when increasing the dose and duration of treatment.

6. TARGET SPECIES
Broilers, replacement chickens, broilers for breeding, turkeys

7. DOSAGE FOR EACH SPECIES, METHOD, ROUTE OF ADMINISTRATION AND PRESCRIBED DOSE
The correct dosage is determined taking into account the daily water consumption, which depends on the clinical condition of the animal.
Chickens and turkeys: The general dose of Mediflox oral is 0.10 ml / kg body weight (10 mg enrofloxacin / kg body weight), equivalent to 0.5 liters of the drug (50 ppm enrofloxacin) per 1000 liters of drinking water, or 12 drops of the drug per 1 liter of drinking water, daily, for three consecutive days.

Advice for correct administration:
Administer orally in drinking water.
Fresh solution should be prepared every 24 hours.

8. WITHDRAWAL PERIOD
Meat, eggs and offal: 10 days

9. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store in the original packaging, at temperatures up to 25° C.
Shelf life after first opening – 3 months, at temperatures up to 25˚C.
Shelf life after dilution: 24 hours, at temperatures up to 25˚C.

10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS
Any unused veterinary medicinal product or waste materials derived from such medicinal products should be disposed of in accordance with local requirements.

11. SPECIAL WARNINGS
Do not administer to replacement chickens within 14 days of the start of the laying period.
The use of this veterinary medicinal product should be limited to cases where the agent has been shown to be resistant to other antibiotics; to bacteriological confirmation of the diagnosis and only after a susceptibility test of the bacteria has been performed.
If no improvement is observed after 3 days of treatment, a change of treatment is recommended.
An antagonistic effect is possible with simultaneous use with tetracyclines and macrolide antibiotics. Simultaneous administration with substances containing magnesium or aluminium may reduce the absorption of enrofloxacin.
Concomitant use with substances containing multivalent cations (antacids, milk or milk replacers) reduces the bioavailability of fluoroquinolones.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with known sensitivity to fluoroquinolones should avoid contact with this product. Avoid contact with eyes and skin. Do not eat, drink or smoke when handling this product. If you notice any changes to your skin after exposure, seek medical advice immediately. Swelling of the face, lips or eyes or difficulty breathing are considered serious symptoms requiring urgent medical attention.

12. SHELF LIFE
Shelf life – 3 years.
Shelf life after first opening – 3 months, at temperatures up to 25˚C.
Shelf life after dilution: 24 hours, at temperatures up to 25˚C.

Do not use after the expiry date stated on the packaging

13. LEGAL STATUS
- is issued on the basis of veterinary prescription.

14. NATURE AND COMPOSITION OF THE IMMEDIATE PACKAGING
Polyethylene bottle, 1 L

15. DATE OF LAST REVISION OF THE TEXT
09.05.2019

FOR VETERINARY USE ONLY