Geepenil vet 300 mg/ml Powder and Solvent for Solution for Injection

Composition

Each powder vial contains:

Active substance:

Benzylpenicillin sodium 24 g

Each solvent vial contains:

Water for injection 64 ml

Each ml of the reconstituted product contains:

Active substance:

Benzylpenicillin sodium 300 mg

Excipients:

Powder vial: white or almost white crystalline powder

Solvent vial: clear, colourless liquid

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Pharmacological properties

4.1 ATCvet Code: QJ01CE01.

4.2 Pharmacodynamics

The active substance is benzylpenicillin. Penicillin has a bactericidal effect by interfering with the cell-wall synthesis and the effect is time-dependent. Benzylpenicillin is active against gram-positive aerobic and anaerobic bacteria as well as certain gram-negative bacteria, such as Pasteurella, Fusobacterium and Haemophilus species.

Beta-lactamase producing staphylococci are resistant. Betahaemolytic streptococci are usually sensitive. Bacteria with the MIC value ≤ 0.5 µg/ml are sensitive, those with MIC 1 µg/ml have intermediate sensitivity and those with MIC ≥ 2 µg/ml are resistant.

4.3 Pharmacokinetics

Half-time of benzylpenicillin is < 1 hour in horses. Penicillin is widely distributed into extracellular fluid. Penicillin crosses biological membranes to a limited extent; however, its penetration increases in connection with inflammation, i.e. penetration into the CNS and udders increases in connection with meningitis and mastitis. Benzylpenicillin is excreted via the kidneys.

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Target species

Horse.

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Indications

Infections caused by micro-organisms sensitive to benzylpenicillin in horse.

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Dosage

To prepare a ready-to-use solution, mix 64 ml of sterile water with 24 g benzylpenicillin sodium. This provides 80 ml of solution for injection with the concentration of 300 mg/ml.

The package contains a transfer needle. Instructions for use for the transfer needle:

1. Remove one of the two protective caps of the transfer needle and pierce the water vial with the needle.

2. Remove the remaining protective cap of the transfer needle and pierce the powder vial from above with it.

3. Turn the vials upside down and let all water flow into the powder vial, then remove the transfer needle and the empty water vial.

4. Shake the powder vial to mix the powder with water. Once the solution turns clear, it is ready for use.

10-20 mg/kg body weight intravenously (slowly), equivalent of 3.3 – 6.7 ml/100 kg body weight, 2 times a day. The treatment should last a minimum of 4 days.

To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

The reconstituted solution is a clear, colourless liquid.

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Contraindications

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

Do not use this product in the treatment of diseases caused by beta-lactamase producing staphylococci.

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Adverse reactions

Horse:

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:

This medicinal product must not be administered intramuscularly to horses because it causes local irritation.

Use of the product should be based on susceptibility testing of bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

The usual aseptic precautions should be followed when administered the product.

Not for intrathecal administration.

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

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

Avoid skin contact with this product if you know you are sensitised, or if you have been advised not to work with such preparations.

Handle this product with great care to avoid exposure.

If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

This product may cause eye irritation.

Avoid contact with the eyes.

In the event of accidental eye contact, rinse the affected eye(s) with plenty of clean water.

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

Pregnancy:

Can be used during pregnancy.

Lactation:

Can be used during lactation.

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Interactions

Bactericidal effect of penicillin is prevented if bacteriostatic agents, like erythromycin or tetracyclines, are used concomitantly.

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Overdose

In general, benzylpenicillin has a wide margin of safety and negative effects occur very seldom.

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Special warnings

Penicillins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

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Withdrawal period

Not authorised for use in horses intended for human consumption.

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Incompatibilities

Penicillin is inactivated by oxidizing and reducing agents, alcohol, glycol, acids, alkalis and high temperature. In addition to these, penicillin may be inactivated by the presence of zinc, copper, chromium, manganese and special iron ions in solution.

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Immediate packaging

Powder:

Colourless, glass vials (100 ml) (type II) glass vials closed with rubber stoppers (chlorobutyl) and aluminium seal and flip-off cap.

Solvent:

Colourless, glass vials (100 ml) (type I), closed with rubber stoppers (chlorobutyl) and aluminium seal and flip-off cap.

Polystyrene transfer needle

Pack sizes:

Cardboard box with 1 pair of vials (powder and solvent) and transfer needle

Cardboard box with 10 pairs of vials (powder and solvent) and transfer needles

Cardboard box with 40 (4 x 10) pairs of vials (powder and solvent) and transfer needles

Not all pack sizes may be marketed.

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Storage

Powder and solvent:

Store below 25°C. Keep the vials in the outer carton in order to protect from light.

Reconstituted product:

Store the reconstituted product in a refrigerator (2 – 8°C).

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after reconstitution according to directions: 24 hours

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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 06043/4007

8 DATE OF FIRST AUTHORISATION

21 October 2020

9 DATE OF THE LAST REVISION OF THE 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

Approved: 22 May 2026

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Registration holder

Orion Corporation

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