Fluxverse
Danofloxacin 25 mg
Composition:
Each milliliter contains:
Danofloxacin (as mesylate) … .. .. .. .. .. .. .. .. .. .. .. .. …. … … 25 mg
Characteristics:
Danofloxacin is a fluoroquinolone derivative with a broad spectrum of activity. Its bactericidal effect is achieved by inhibiting the microbial DNA geras enzyme. It is effective against a wide range of Gram-negative bacteria, including Pseudomonas aeruginosa and Klebsiella, as well as bacilli and cocci, including Enterococcus, Haemophilus influenzae, Moraxella catarrhalis (Branhamella catarrhalis), and Neisseria gonorrhoeae. It is also effective against some Gram-positive microorganisms and mycoplasma species.
Target types
Cows and pigs.
Reasons
cows
– Treatment of respiratory tract infections such as bronchitis caused by Mannheimia haemolytica and Pasteurella multocida bacteria, which are sensitive to danofloxacin.
– Treatment of gastroenteritis in newborns using Escherichia coli K99+, sensitive to danofloxacin.
pigs
– Treatment of respiratory tract infections using Pasteurella multocida and Actinobacillus pleuronomonia, which are sensitive to danofloxacin.
Treatment of neonatal enteritis caused by danofloxacin-sensitive Escherichia coli
Dosage and method of administration
Method: Intramuscular injection (neck muscles)
For the complete product
Cattle: 1 ml of solution per 20 kg of body weight, once a day for 3 days.
The treatment can be extended for two more days if the animals have not fully recovered after the third injection.
– In cows weighing more than 400 kg, the intramuscular dose should not exceed 20 ml in the same place.
– Pigs: 1 ml of solution per 20 kg of body weight, once a day for 3 days, intramuscularly.
– In pigs weighing over 100 kg, the intramuscular dose is divided so that it does not exceed 5 ml in the same place.
– To ensure adherence to the dosage, it is recommended to use a 1 ml syringe graduated at 1/100 when treating neonatal enteritis in pigs.
Warnings and precautions
(a) Special precautions for use on animals
1- The use of fluoroquinolones should be based on antimicrobial sensitivity testing whenever possible, taking into account official and local antibiotic use policies.
2- Fluoroquinolones should be reserved for treating clinical conditions that have not responded well to other classes of antibiotics, or are expected to respond poorly to other classes of antibiotics.
3- Using this drug outside the scope of the recommendations of the Drug Policy Committee (SPC) may lead to an increased prevalence of fluoroquinolone-resistant bacteria and may reduce the effectiveness of treatment with other quinolones due to the possibility of cross-resistance.
4- Taking very high doses of fluoroquinolones may cause erosion of joint cartilage. Therefore, special attention must be paid to adhering to the prescribed dosages. The use of fluoroquinolones may reduce the effectiveness of other quinolone therapies due to the potential for cross-resistance.
4. At very high doses, fluoroquinolones may cause erosion of joint cartilage. Therefore, special attention must be paid to respecting the prescribed doses. (ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Wash your hands after use.
In case of skin contact, clean the exposed area with soap and water.
In case of accidental contact with the eyes, rinse them immediately with plenty of water.
(iii) Use during pregnancy, breastfeeding, or ovulation.
Studies conducted on laboratory animals have shown side effects on reproduction.
Repeated treatment with daily doses of 2.5 mg danofloxacin per kilogram of body weight for 5 consecutive days did not indicate side effects in pregnant or lactating cows.
The safety of this product in pigs during pregnancy and lactation has not been established. Its use is not recommended during pregnancy and lactation.
(iiii) Special precautions must be taken when disposing of unused veterinary medical products or waste resulting from their use.
Empty containers and any product residues must be disposed of in accordance with established practices and governed by waste regulations.
Contraindications
It is prohibited for use in animals that are highly sensitive to danofloxacin.
Overdose (symptoms, emergency procedures, antidote), when necessary.
Cattle: No signs of drug overdose were observed after taking five times the recommended dose.
Symptoms of an overdose include head tremors, dizziness, and mild depression.
Pigs: When given ten times the recommended dose, all treated animals suffer from reduced mobility, and one-third of them develop redness around the anus.
In newborn piglets, no side effects of the drug were observed after they were given three times the recommended daily dose for three consecutive days.
Side effects:
Cows: Unknown.
Pigs: Administering the specific drug causes a local inflammatory reaction in the tissues, which may last for up to 14 days after the last dose.
Withdrawal period
cows
– Meat and offal: 5 days.
Milk: Two days.
pigs
– Meat and offal: 6 days.
Storage: Store at a temperature not exceeding 30°C, keep away from light, and use immediately after opening.
Package
A cardboard box containing amber glass vials (type II) containing solution in sizes of 20, 50, 75, 100, 200, 250 ml, sealed with a bromobutyl rubber stopper and non-reusable aluminum caps, with a label and leaflet inside.
Registration number: 5204/2021
Manufactured by Alexandria Pharmaceutical and Chemical Industries Company, end of Gamila Bouhired Road – Al-Awaid, Alexandria.
Phone: 033302221
For the benefit of Al-Saeed Pharmaceutical Industries Company, Andalusia Tower, Al-Bahr Street, Al-Walidiyah, Assiut.
Telephone/Fax:
0882134586
lnfo@upperegypt-pharma.com
Website: www.upperegypt-pharma.com
