Histodine 10 mg/ml Solution for Injection for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Chlorpheniramine Maleate

Available from:

Le Vet Beheer B.V.

ATC code:

QR06AB04

INN (International Name):

Chlorpheniramine Maleate

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Miscellaneous

Authorization status:

Authorized

Authorization date:

2017-07-06

Summary of Product characteristics

Revised; May 2022
AN: 01469/2021 & 01470/2021
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Histodine 10 mg/ml solution for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Chlorphenamine maleate
10 mg
(equivalent to 7.03 mg chlorphenamine)
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
1.0 mg
Propyl parahydroxybenzoate
0.2 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the symptomatic treatment of conditions associated with histamine
release.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not administer via subcutaneous route.
Revised; May 2022
AN: 01469/2021 & 01470/2021
Page 2 of 4
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.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Chlorphenamine has a weak sedative effect.
4.7 USE DURING PREGNANCY AND LACTATION
The safety of the product has not been established during pregnancy
and lactation.
Use only according to the benefit-risk assessment by the respo