Enrotron Solution for injection 100mg 100ml by vet pharmacy online

Product Ref: FOENR05 Category: E

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€ 55.85

Vat Rate: 20%

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4. CLINICAL PARTICULARS 4.1 Target Species Cattle Pigs 4.2 Indications for use, specifying the target species Cattle Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp. Treatment of acute severe mastitis caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old. Pigs Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mycoplasma spp. and Actinobacillus pleuropneumoniae. Treatment of infections of the urinary tract caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused by enrofloxacin susceptible strains of Escherichia coli and Klebsiella spp. Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli. 4.3 Contraindications Do not use for prophylaxis. Do not use in cases of known hypersensitivity to fluoroquinolones or to any of the excipients. Do not use when resistance / cross resistance to (fluoro)quinolones is known to occur. Refer to section 4.5. Do not use in growing horses because of possible deleterious damage on articular cartilage. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals The safety of the product has not been established in pigs or calves when administered by the intravenous route and use of this route of administration is not recommended in these animal groups. Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinoones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction. Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg bw during 14 days. The use of enrofloxacin in growing lambs at the recommended dose for 15 days caused histological changes in the articular cartilage, not associated with clinical signs. Special precautions to be taken by the person administering the veterinary medicinal product to animals The product is an alkaline solution. Direct contact with skin should be avoided due to sensitisation, contact dermatitis and possible hypersensitivity reactions to (fluoro)quinolones. Wear gloves. In case of eye or skin contact, rinse immediately with water. Do not eat, drink or smoke whilst handling the product. Care should be taken to avoid accidental self-injection. If accidental self injection occurs seek medical advice immediately and show the package leaflet or the label to the physician. Other precautions None known. 4.6 Adverse reactions (frequency and seriousness) Local tissue reactions may occasionally occur at the injection site. Normal sterile precautions should be taken. 4.7 Use during pregnancy orlactation Can be used during pregnancy and lactation. 4.8 Interaction with other medicinal products and other forms of interaction Antagonistic effects due to concurrent administration of macrolides, and tetracyclines may occur. Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline.
Vat Rate: 20%

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Category	POM-V
Temperature	Ambient
MA/VM/EU No:	24745/4028
Species	cattle pig
VMD Link	Product Information Database (defra.gov.uk)
NOAH Link
Dosage	4.9 Amounts to be administered and administration route Intravenous, subcutaneous or intramuscular use. Repeated injections should be made at different injection sites. To ensure a correct dosage, body weight (bw) should be determined as accurately as possible to avoid underdosing. 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 enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 5 days. The product can be administered by slow intravenous or subcutaneous administration. Acute mastitis caused by Escherichia coli: 5 mg enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, by slow intravenous injection once daily for two consecutive days. The second dose may be administered by the subcutaneous route. In this case, the withdrawal period following subcutaneous injection applies. 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 Escherichia coli: 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. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Do not exceed the recommended dosage. In accidental overdose there is no antidote and treatment should be symptomatic. No signs of over dosage were observed in pigs following administration of the product at five times the recommended therapeutic dose.
Withdrawals	4.11 Withdrawal Period(s) Cattle: Following intravenous injection: Meat and offal: 5 days. Milk: 3 days. Following subcutaneous injection: Meat and offal: 12 days. Milk: 4 days. Pigs: Meat and offal: 13 days.