Ketosan, 100 mg/ml Solution for Injection for Cattle and Pigs

Composition

Each ml contains:

Active substance:

Ketoprofen 100 mg

Excipients:

Clear, slightly yellow solution.

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Pharmacological properties

4.1 ATCvet code: QM01AE03

4.2 Pharmacodynamics

Ketoprofen is a nonsteroidal anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of ketoprofen is based on interfering with the arachidonic acid derivatives metabolism, leading to inhibition of prostaglandin synthesis. Ketoprofen also interferes with the metabolism of lipoxygenase, which causes inhibition of leukotriene synthesis. Furthermore, ketoprofen is an antagonist to bradykinin.

4.3 Pharmacokinetics

Cattle In cattle, the blood plasma half-life is approximately 2.5 hours following intramuscular administration, with maximum plasma concentrations being observed after approximately 30 minutes. The bioavailability in cattle is 90-100 %. The excretion of ketoprofen takes place via the urine, with 90% of the administered dose being excreted in 12 hours. Excretion of ketoprofen is completed after 96 hours.

Pig Following intramuscular injection, ketoprofen is rapidly absorbed. Maximum blood plasma levels are observed after approximately 30 minutes. The excretion of ketoprofen takes place via the urine, with 68% of the administered dose being excreted within 24 hours. Ketoprofen is primarily metabolised by the reduction of the secondary alcohol, which is less pronounced in pigs compared to other species.

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Target species

Cattle and pig.

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Indications

Cattle:

The veterinary medicinal product is indicated for the symptomatic treatment of fever in respiratory infections, as well as analgesic and anti-inflammatory treatment in musculoskeletal ailments and conditions of the udder. In calves, the veterinary medicinal product can be used to alleviate post-operative pain after dehorning or castration.

Pig:

The veterinary medicinal product is indicated for antipyretic and anti-inflammatory treatment in diseases of the respiratory system and the mastitis-metritis-agalactia (MMA) syndrome.

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Dosage

Intramuscular use.

Cattle:

3.0 mg ketoprofen per kg bodyweight, corresponding to 3 ml per 100 kg bodyweight, daily for 1-3 days via intramuscular injection. The maximum volume per injection site in intramuscular injections is 2.6 ml.

Pig:

A single dose of 3.0 mg ketoprofen per kg bodyweight, corresponding to 3 ml per 100 kg bodyweight via intramuscular injection. The maximum volume per injection site in intramuscular injections is 1.7 ml.

The rubber stopper can be safely punctured for up to 15 times. Use of a draw-off needle is recommended when treating large groups of animals. To ensure administration of a correct dosage, body weight should be determined as accurately as possible and dosing devices or syringes with suitable graduations are to be used.

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Contraindications

Do not use in cases of hypersensitivity to the active substance or any of the excipients.

Do not use in animals suffering from gastrointestinal lesions, haemorrhagic diathesis, blood dyscrasia or hepatic, renal or cardiac conditions.

Do not use other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other.

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Adverse reactions

Cattle, pigs:

1 Transient, after repeated intramuscular injection

2 due to its mechanism of action (e.g. inhibition of prostaglandin synthesis).

3 In pigs, after repeated administration, reversible

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Use of this veterinary medicinal product in old animals or animals younger than 6 weeks has risks. If such use is inevitable, careful clinical monitoring of the animal and lowering the dose may be necessary.

Avoid intra-arterial injection.

Do not exceed the recommended dose or treatment duration.

Use caution when using in dehydrated and hypotensive animals, as there is a potential risk of increased renal toxicity.

Animals should have adequate access to drinking water over the course of treatment.

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

People with known hypersensitivity to ketoprofen or benzyl alcohol should avoid contact with the veterinary medicinal product.

This product may cause dizziness and drowsiness. Avoid accidental self-injection and dermal exposure. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. However, do not drive!

This product may cause skin and eye irritation. Avoid contact with skin and eyes. In case of spillage onto skin or eyes, wash the affected area thoroughly with water. If irritation persists, seek medical advice.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

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

Not applicable.

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Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

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Interactions

Do not use this veterinary medicinal product in combination with other NSAIDs or with corticosteroids, diuretics, nephrotoxic drugs or anticoagulants.

Do not use in combination with other drugs that could inhibit the aggregation of thrombocytes and cause gastrointestinal ulceration.

Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.

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Overdose

An overdose of 5 times the recommended dose is tolerated by cattle. Administration of 3 times the recommended dose for 3 consecutive days is tolerated by pigs.

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Special warnings

None.

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Withdrawal period

Cattle:

Meat and offal: 4 days

Milk: zero hours

Pig:

Meat and offal: 5 days

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Incompatibilities

Do not mix with any other veterinary medicinal products.

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Immediate packaging

Amber glass (type II) injection vials of 100 ml closed with a rubber stopper and an aluminium cap in a cardboard box.

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Storage

Do not refrigerate or freeze.

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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.

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable applicable applicable to the veterinary medicinal product concerned.

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Additional information

Vm 48659/4000

8 DATE OF FIRST AUTHORISATION

21 August 2018

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

October 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 16 February 2026

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Registration holder

Interchemie werken De Adelaar BV

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