Potencil 10% premix
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
QUALITATIVE & QUANTITATIVE COMPOSITION
Phenoxymethylpenicillin potassium (penicillin V) 10.0% w/w in an inert carrier.
Premix for medicated feed.
Mechanism of action
Beta-lactam antibiotics, such as the pencillins, prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes which catalyze cross-linkage of the glycopeptide polymer units that form the cell wall. The final step in the action of these substances probably involves inactivation of an inhibitor of autolytic enzymes in the cell wall. They exert a bactericidal action, but cause lysis only of growing cells.
The penicillins are organic acids that are generally available as the sodium or potassium salt of the free acid. Acid hydrolysis limits the systemic availability of most penicillins from oral preparations, but not penicillin V. Penicillins (pK 2.7) are predominantly ionized in plasma, have relatively small apparent volumes of distribution (0.2 – 0.3 L/kg) and have short half lives (0.5 – 1.2 hours) in domestic animals. After absorption, they are widely distributed in the extracelluar fluids of the body, but they cross biological membranes poorly as they are ionized and are poorly soluble in lipids. Entry across biological membranes or through the blood-brain or blood-cerebrospinal fluid barrier is enhanced by inflammation, so that inhibitory drug concentrations may be attained at these sites that are normally inaccessible to penicillin.
Penicillins are eliminated almost entirely by the kidneys which results in very high levels in the urine.
-Indications for Use, Specifying the Target Species
For the treatment and control of Streptococcal meningitis and septicaemia caused by Streptococcus suis II.
Also for the treatment and control of porcine pleuropneumonia caused by Actinobacillus (Haemophilus) pleuropneumoniae, and treatment and control of secondary bacterial pneumonia caused by Pasteurella multocida.
Not for use in liquid feed.
Not for direct feeding to animals.
Not for use in animals known to be hypersensitive to penicillins.
-Undesirable Effects (Frequency and Seriousness)
-Special Precautions for Use
After inclusion of Potencil, feed must be used within 14 days from manufacture, due to the know instability of Potencil.
Close container after use.
Care must be taken to ensure accurate mixing.
Avoid the introduction of contamination during use.
-Use During Pregnancy and Lactation
Studies to determine the safety of this product for use during pregnancy have not been conducted in pigs. Use in pregnant pigs should be in accordance with a benefit/risk assessment by the responsible veterinarian.
-Interaction with other Medicaments and other Forms of Interaction
-Posology and Method of Administration
For oral administration after incorporation in pelleted feed or meal. The recommended dosage for pigs is 10 mg phenoxymethylpenicillin potassium per kg bodyweight daily for up to six consecutive weeks for meningitis and septicaemia, and for up to two weeks for pleuropneumonia and pneumonic pasteurellosis. This is achieved by an inclusion level of 2 kg Potencil/tonne of feed.
When incorporated into pellets, the mix can be pre-conditioned with steam for up to 5 minutes and pelleted at temperatures within the feed of 70°C.
To allow thorough dispersion of the product, Potencil should be mixed with a small quantity of feed prior to mixing into the bulk of the feed.
-Overdose (Symptoms, Emergency Procedures, Antidotes)
5.10Special Warnings for each Target Species
Pigs must not be slaughtered for human consumption during treatment or for 24 hours (1 day) thereafter.
Two years from the date of manufacture.
Once incorporated into feed, it must be used within 14 days.
-Special Precautions for Storage
Do not store above 25°C. Store in a dry place.