Histodine 10 mg/ml Solution for Injection for Cattle

Composition

Each ml contains:

Active substances:

Chlorphenamine maleate 10 mg

(equivalent to 7.03 mg chlorphenamine)

Excipients:

Clear, colourless solution.

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Pharmacological properties

4.1 ATCvet code: QR06AB04

4.2 Pharmacodynamics

Chlorphenamine maleate is a racemic compound classified as an alkyl amine group antihistamine that, due to its chemical characteristics, is able to bind to the H1 receptor present on the cell membrane and therefore compete with the natural endogenous ligand for the same site. Receptor occupation by chlorphenamine maleate does not, in itself, induce pharmacological responses, but significantly inhibits those induced by histamine. On the basis of these observations, chlorphenamine maleate behaves as a direct or reversible competitive receptor antagonist. Chlorphenamine maleate is not able to inhibit the synthesis or release of histamine.

4.3 Pharmacokinetics

After intravenous administration the medicinal product’s plasma concentration drops from 36 ng/mL to the method’s limit of detection (1 ng/mL) 24 hours after administration. The calculated elimination half-life (T1/2ß) is 2.11 hours, the mean residence time (MRT) is 2.35 hours, total clearance (ClB) 1.315 L/kg/h and the volume of distribution (Vd) just over 3 L/kg. Following intramuscular administration, peak concentration (Cmax = 142 ng/mL) is reached in 28 minutes (Tmax). Plasma concentrations then drop rapidly to reach values of 60 and 12 μg/kg after 2 and 8 hours before dropping below the limit of quantification (1 μg/kg) 24 hours after treatment. MRT and bioavailability were 3.58 hours and 100%, respectively. The compound and its metabolites are excreted primarily via the kidneys in urine, with a small amount in unmodified form and the majority as a breakdown product, almost completely, within 24 hours.

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Target species

Cattle.

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Indications

For the symptomatic treatment of conditions associated with histamine release.

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Dosage

Intramuscular or intravenous use.

Intravenous injection should be slow and, if necessary, discontinued for a few minutes (see 3.5).

Adult animals:

0.5 mg Chlorphenamine maleate /kg bodyweight (equivalent to 5 ml/100 kg bodyweight), once a day for three consecutive days.

Calves:

1 mg Chlorphenamine maleate /kg bodyweight (equivalent to 10 ml/100 kg bodyweight), once a day for three consecutive days.

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Contraindications

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

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Adverse reactions

Cattle:

a Weak effect

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 its local representative> 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:

Do not administer via subcutaneous route.

Although intravenous administration has an immediate therapeutic effect, it can have excitatory effects on the CNS. Consequently, administer slowly and interrupt administration for a few minutes if necessary, when using this route.

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

Chlorphenamine can cause sedation. Wash splashes from skin and eyes immediately. Precautions should be taken to avoid accidental self-injection with this drug. Preferably use a guarded needle until the moment of injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. DO NOT DRIVE.

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

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Use only accordingly to the benefit-risk assessment by the responsible veterinarian.

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Interactions

Concomitant use of other antihistamines or barbiturates may boost the sedative effect of chlorphenamine. The use of antihistamines may conceal early signs of ototoxicity caused by some antibiotics (i.e. aminoglycosides and macrolides) and may shorten the effect of oral anticoagulants.

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Overdose

Overdoses up to 4-fold the therapeutic dose have been well tolerated. In very rare cases, local reactions were observed at the injection site. All the reactions were transient and resolved spontaneously.

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Special warnings

None.

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Withdrawal period

Meat and offal: 1 day

Milk: 12 hours

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Incompatibilities

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

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Immediate packaging

Clear Type II glass vials and polypropylene vials containing 100 ml or 250 ml, closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special temperature storage precautions.

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

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 56 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 to the veterinary medicinal product concerned.

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Additional information

Vm 41821/4041

8 DATE OF FIRST AUTHORISATION

06 July 2017

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

May 2026

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: 17 July 2026

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Registration holder

Le Vet Beheer B.V.

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