Description
Lysozyme dimer 5 mg/10 ml, solution for injection for horses, cattle, pigs
Marketing Authorisation Holder:
Nika Health Products Spółka z o.o. Parsko 12, 64-030 Śmigiel
Manufacturing authorisation holder responsible for batch release:
Biowet Puławy Sp. z o.o., ul. H. Arciucha 2, 24-100 Puławy
Statement of active and other substances
10 ml of the solution contains:
Active substance: lysozyme dimer 5.0 mg
Preservative: thiomersal 1.0 mg
Transparent, colourless solution.
Indications for use
Horses: To support treatment of bacterial and viral infections, in particular gastrointestinal and respiratory inflammations, as well as skin and outer ear inflammations.
Cattle: To support treatment of bacterial and viral infections, in particular gastrointestinal and respiratory inflammations, as well as mammary gland, skin and outer ear inflammations.
Pigs: To support treatment of bacterial and viral infections, in particular gastrointestinal and respiratory inflammations, as well as skin and outer ear inflammations, and MMA (mastitis metritis agalactia).
Contraindications None.
Adverse reactions None known.
Any adverse reactions emerged after administration of the product or any symptoms not listed in the leaflet (including symptoms reported in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
The report form should be downloaded from https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Dosage for each species, route and method of administration
Horses:
0.02 mg of lysozyme dimer/kg bodyweight (1 ml of the product/25 kg bodyweight) single intramuscular, subcutaneous or intravenous injection.
During concurrent use with antibiotics, 0.01 mg of lysozyme dimer/kg bodyweight (1 ml of the product/50 kg bodyweight) single intramuscular, subcutaneous or intravenous injection.
Cattle:
0.02 mg of lysozyme dimer/kg bodyweight (1 ml of the product/25 kg bodyweight) single intramuscular, subcutaneous or intravenous injection.
During concurrent use with antibiotics, 0.01 mg of lysozyme dimer/kg bodyweight (1 ml of the product/50 kg bodyweight) single intramuscular, subcutaneous or intravenous injection.
Pigs:
0.02 mg of lysozyme dimer/kg bodyweight (1 ml of the product/25 kg bodyweight) single intramuscular, subcutaneous or intravenous injection. During concurrent use with antibiotics, 0.01 mg of lysozyme dimer/kg bodyweight (1 ml of the product/50 kg bodyweight) single intramuscular, subcutaneous or intravenous injection.
Advice on correct administration None.
Withdrawal period Zero days.
Special precautions for storage
Keep out of the reach and sight of children. Store below 20˚C. Do not freeze. Shelf life after first opening the immediate packaging – once opened, use immediately. Do not use after the expiry date stated on the label and outer package.
Special warnings
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Do not eat, drink or smoke while administering the product. Wash hands after each administration of the product.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been assessed in pregnant and lactating animals. Use only following the benefit-risk assessment performed by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction:
Multiple electrolytes injections administered intravenously with lysozyme dimer may reduce its efficacy. Corticosteroids may interact with lysozyme dimer. For this reason, a 3 hour break should be made between injection of Lydium-KLP and multiple electrolytes or corticosteroid administration.
Major incompatibilities: None known.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via waste water or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help protect the environment.
For any information on this veterinary medicinal product, please contact the marketing authorisation holder.
Nika Health Products Sp. z o.o.
Parsko 12, 64-030 Śmigiel
Tel.: +48 65 518 56 08, Mobile: +48 505 15 11 13
e-mail: biuro@nikahp.pl
Pack sizes 5 glass bottles in a cardboard box.
Shelf life 4 years
SPC 2016-11-22
23.07.2019
