Albiotic 330 mg / 100 mg Intramammary Solution

Composition

Each 10 mL syringe contains:

Active substances:

Lincomycin (as lincomycin hydrochloride) 330 mg

Neomycin (as neomycin sulphate) 100 mg

Excipients:

Clear, colourless to slightly yellow liquid.

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Pharmacological properties

4.1 ATCvet code :

QJ51RF03.

4.2 Pharmacodynamics

Lincomycin is a lincosaminide antibiotic derived from Streptomyces lincolnensis. It possesses specific activity against Gram-positive bacteria, particularly Staphylococcus species and Streptococcus species and has little or no activity against Gram-negative bacteria such as Escherichia coli (except anaerobes). Lincomycin has good activity against mycoplasma. Lincomycin binds to the 50S sub-unit of the bacterial ribosome, thereby inhibiting protein synthesis of the cell. It is generally regarded as a bacteriostatic compound.

Neomycin is an aminoglycoside antibiotic derived from Streptomyces fradiae. It has a broad spectrum of activity against both Gram-positive bacteria, including Staphylococcus species and Streptococcus species, and Gram-negative bacteria, including Escherichia coli. It is more active against Staphylococcus species than against Streptococcus species. Neomycin binds to the 30S sub-unit of the bacterial ribosome resulting in a malconfirmation of binding ribosomal protein due to errors in reading the amino acid coding of the mRNA. Neomycin thus compromises translation and hence bacterial protein synthesis.

At high concentration, the aminoglycosides have also been shown to damage the cellular membrane of bacteria and hence are generally regarded as possessing both bacteriostatic and bactericidal properties.

In vitro studies have demonstrated that lincomycin and neomycin in combination have bactericidal activity against Staphylococcus aureus and Escherichia coli and bacteriostatic activity against streptococci. The combination has also demonstrated synergy against Staphylococcus aureus.

4.3 Pharmacokinetics

After recommended infusion of the product, the following mean concentrations of lincomycin and neomycin were measured in individual treated quarters:

1 immediately before second infusion

2 immediately before third (last) infusion

Antibiotic levels in milk above the MIC-values for target pathogens are sustained for the full dosage period and for at least 12 hours thereafter.

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Target species

Lactating cows.

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Indications

For the treatment of mastitis in lactating cattle. The veterinary medicinal is effective against Staphylococcus species (both penicillinase and non-penicillinase producers) including Staphylococcus aureus, Streptococcus species including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis, and coliform bacteria including Escherichia coli.

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Dosage

Administration By intramammary infusion only, taking aseptic precautions.

Dosage Infuse one syringe (10 ml product) into each affected quarter. Repeat this treatment immediately after each of the next two 12 hourly milkings, to give a total of three infusions per infected quarter. The syringe should only be used once.

Where necessary, wash teats or whole udder thoroughly with warm water containing a suitable dairy disinfectant and dry them thoroughly. Milk out the udder completely. Disinfect teat end with a pad of alcohol or other suitable disinfectant. Use a separate pad for each teat.

Directions for insertion are as follows: a. Full insertion: remove the white end cap by pulling straight up. Gently insert full cannula into the teat canal; carefully infuse the product. b. Partial insertion: remove the white end cap by pulling straight up. Gently insert cannula 1/8” into the teat canal; carefully infuse the product.

Push plunger to dispense entire contents and massage the quarter to distribute the product into the milk cistern. Following infusion, it is advisable to dip all teats in an approved teat dip.

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Contraindications

None.

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Adverse reactions

Lactating cows:

None known.

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:

Not applicable.

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

Avoid contact with the veterinary medicinal product. Wash hands and any exposed skin immediately 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 and lactation Can be used during pregnancy and lactation.

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Interactions

This veterinary medicinal product should not be used concomitantly with macrolides e.g., erythromycin, because lincomycin and the macrolides antagonise each other at the site of action, the 50S ribosomal sub-unit.

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Overdose

The veterinary medicinal product is well tolerated. In the event of accidental overdose, it is unlikely that any local or systemic adverse effects will occur in the animal, however, any signs of adverse effect should be immediately reported to the veterinarian concerned.

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Special warnings

None.

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Withdrawal period

Milk: 84 hours.

Meat and offal: 3 days.

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Incompatibilities

None known.

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Immediate packaging

10 ml syringe with a high‑density polyethylene (HDPE) barrel and plunger rod, a bromobutyl rubber plunger and a low‑density polyethylene (LDPE) cap.

Pack size:

Cardboard box containing 24 x 10 ml syringes.

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Storage

Do not store above 30 °C.

Do not freeze.

Keep the syringe in the outer carton in order to protect from light.

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Shelf life

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

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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 30282/4035

8 DATE OF FIRST AUTHORISATION

04 January 2000

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

June 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).

Approved 16 June 2026

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Registration holder

Huvepharma NV

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