Target species Cattle (lactating cows) 4.2 Indications for use, specifying the target species Treatment of mastitis in lactating cows caused by Streptococcus uberis, Streptococcus dysgalactiae, Streptococcus agalactiae and Staphylococcus aureus (beta-lactamase non-producing), susceptible to penicillin. 4.3 Contraindications Do not use in cases of hypersensitivity to penicillins, cephalosporins, and/or any of the excipients. Do not administer intravenously. Do not use in lagomorphs and rodents such as guinea pigs, hamsters or gerbils. Do not administer to animals with renal disease including anuria or oliguria. 4.4 Special warnings for each target species Treatment should be carried out during lactation. 4.5 Special precautions for use This veterinary medicinal product does not contain any antimicrobial preservative. Special precautions for use in animals Using penethamate hydriodide for the treatment of mastitis must be accompanied by hygienic measures to prevent reinfection. Use of the product should be based on susceptibility testing of the 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 veterinary medicinal product is not effective against beta-lactamase producing organisms. Official national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to benzylpenicillin and may decrease the effectiveness of treatment with other beta-lactam antimicrobials due to the potential for cross resistance. 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. • People with known hypersensitivity to penicillins, cephalosporins or any of the excipients should avoid contact with the veterinary medicinal product.. • Handle this product with great care to avoid exposure. Wear gloves when handling the veterinary medicinal product to avoid contact sensitization. • In case of accidental self-injection or 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 doctor. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. • Wash hands after use. 4.6 Adverse reactions (frequency and seriousness) In very rare cases the symptoms of adverse reactions range from mild skin reactions such as urticaria and dermatitis to severe reactions such as anaphylactic shock with tremors, vomiting, salivation, gastrointestinal disorders and laryngeal oedema. In some situations the treatment may lead to secondary infections due to overgrowth of non-target organisms. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 4.7 Use during pregnancy, lactation or lay Pregnancy: Can be used during pregnancy. Lactation: Can be used during lactation 4.8 Interaction with other medicinal products and other forms of interaction The product should not be administered with antibiotics that have a bacteriostatic mode of action. Anti-inflammatories such as salicylates, produce an increase in the elimination half-life of penetamate (iohydrate). In case of joint administration, adjust the dose of the antibacterial
Vat Rate: 20%