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Kelacyl 100 mg/ml Solution for Injection

Item no: KELACYL
 
Prescription Medicine
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  • 100ml

Kelacyl 100 mg/ml, Solution for Injection for Cattle and Pigs.

Presentation

Solution for injection.

Yellow greenish to yellow brownish, clear solution

Uses

Indications for use, specifying the target species:

In cattle:

- treatment of respiratory infections caused by strains of Histophilus somni, Mannheimia haemolytica, Mycoplasma bovis, Pasteurella multocida susceptible to marbofloxacin.

- treatment of acute mastitis caused by strains of Escherichia coli susceptible to marbofloxacin during the lactation period.

In pigs:

- treatment of Postpartum Dysgalactia Syndrome- PDS-(Metritis Mastitis Agalactia syndromw), caused by bacterial strains susceptible to marbofloxacin.

Dosage and administration

Amounts to be administered and administration route

Cattle:

Respiratory infections:

The recommended dosage is 8 mg marbofloxacin/kg body weight (2ml product/25 kg body weight) in a single injection by intramuscular route. If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites.

In cases of respiratory infections caused by Mycoplasma bovis, the recommended dose is 2 mg marbofloxacin/kg body weight (1 ml product/50 kg body weight), in a single daily injection for 3 to 5 consecutive days, by intramuscular or subcutaneous route. The first injection may be given by the intravenous route.

Acute mastitis:

- Intramuscular or subcutaneous use:

The recommended dosage is 2 mg marbofloxacin/kg body weight (1 ml product/50 kg body weight) in a single daily injection, for 3 consecutive days. The first injection may also be given by the intravenous route.

Pigs (sows):

-Intramuscular use:

The recommended dosage is 2 mg marbofloxacin/kg body weight (1 mg product/50 kg body weight) in a single daily injection,for 3 consecutive days.

To ensure administration of correct dose, body weight should be determined as accurately as possible, to avoid underdosing.

In cattle and pigs, the preferred injection site is the neck area.

The cap may be safely punctured up to 30 times. The user should choose the most appropriate vial size according to the target species to treat.

Contra-indications, warnings, etc

Contraindications

Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).

Do not use in animals with known hypersensitivity to the active substance or to any other quinolone or to any of the excipients.

Special warnings for each target species

None

Special precautions for use

Special precautions for use in animals

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, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions 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.

The efficacy data showed that the product has insufficient efficacy for the treatment of acute forms of mastitis induced by gram-positive bacteria.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to (fluoro)quinolones should avoid contact with the veterinary medicinal product. Care should be taken to avoid accidental self-injection as it can induce a slight irritation.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

In case of contact with skin or eyes, rinse with plenty of water.

Wash hands after use.

Adverse reactions (frequency and seriousness)

Transitory inflammatory lesions can occur at the injection site, without clinical impact, when administered via the intramuscular or subcutaneous route.

Administration by the intramuscular route may cause transient local reactions such as pain and swelling at the injection site and inflammatory lesions which may persist for at least 12 days after injection.

However, in cattle, subcutaneous route was shown to be better tolerated locally than intramuscular route. Therefore, the subcutaneous route is recommended in heavy cattle.

Use during pregnancy, lactation or lay.

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

Safety of the product at 2 mg/kg body weight has been established in pregnant cows and in sucking calves and piglets when used in cows and sows. Can be used during pregnancy and lactation.

Safety of the product at 8 mg/kg body weight has not been established in pregnant cows or in sucking calves when used in cows. Therefore, the dose regimen should be used only according to the benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction

None known.

Overdose (symptoms, emergency procedures, antidotes), if necessary

No signs of overdosage have been observed after administration of 3 times the recommended dose.

Signs as acute neurological disorders may occur when the dose is exceeded. These signs should be treated symptomatically. Do not exceed the recommended dose.

Withdrawal period(s)

Cattle:

8 mg/kg on single occasion (IM)

Meat and offal: 3 days

Milk: 72 hours

 

2 mg/kg for 3 to 5 days (IV/SC/IM)

Meat and offal: 6 days

Milk: 36 hours

 

Pigs (sows):

2 mg/kg for 3 days (IM)

Meat and offal: 4 days

Pharmaceutical precautions

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening the immediate packaging: 28 days

Special precautions for storage

Store in the original package in order to protect from light.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Amber glass type ll vial of 100ml, closed with bromobutyl rubber stopper and aluminium closure

Amber glass type ll vial of 250ml, closed with bromobutyl rubber stopper and aluminium closure

100ml and 250ml vials are individually packed in a carton box.

Six, ten or twelve vials are grouped as a clinical pack.

Shipping charges mainland GB zone1

Value Weight Delivery Charge
Over £49.00 Any Weight FREE
Under £49.00 No weight limit £4.50
Under £49.00 Under 250 grams £3.49

Most orders are despatched the same day and standard delivery is 3 to 5 working days from despatch. FAST Expedited options are available at extra cost - these usually arrive in 24-48hrs from dispatch but delays are possible during busy periods.

Postcodes outside of Zone 1 (including some areas within mainland UK) may incur extra carriage charges due to surcharges imposed by the couriers. These will be calculated on the website at the checkout.

NB: Orders placed with faster delivery must be placed before 13:00 to ensure same day dispatch (excluding weekends and bank holidays). Please also check on the product page that the items ordered show 'In Stock' otherwise your order will be delayed until the stock becomes available, which in most cases will only be 24hrs.

Estimated "Usually shipped in" information is shown against most products

Overseas orders

We no longer send goods outside of the UK.

Prescription Items

Prescription items will be sent on receipt of a valid signed and dated prescription.

Pick up

We offer a pickup service for orders placed over the phone.

Please ring us on 01833 641112 for more information.

Refrigerated Items

Refrigerated items will be sent by carrier or express delivery at a cost of £7.50, with coolpacks, unless you pay for a premium for a refrigerated delivery. We will contact you prior to despatch for your instructions.

We want you to be completely satisfied with any purchase. If not any item* can be returned to us within 14 days of receipt for exchange or refund Please give us a ring for a returns number on 01833 641112 or alternatively email sales@hyperdrug.co.uk to obtain a returns number.

*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.

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