| - | - | - |
|---|---|---|
| Product Group | : | Antibacterials |
| Pharmaceutical Form | : | Suspension for Injection |
| Active Ingredient | : | Amoxicillin Trihydrate |
| Target Species | : | Cattle, Sheep, Goat, Cat, Dog |
| Package Form | : | 100 - 250 ml |
For Veterinary Use Only
For Veterinary Use Only
Suspension for Injection
Veterinary Systemic Antibacterial
COMPOSITION
Pimoxil LA is white – light yellow colored sterile suspension containing Amoxicillin trihydrate equivalent to 150 mg Amoxicillin as preservatives, 0.08 mg butylated hydroxyanisole and 0.08 mg butylated hydroxyanisole per ml.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Amoxicillin contains beta-lactam and thiazolidine ring, which are found in all penicillins. It inhibits bacterial cell wall synthesis by inhibiting peptidoglycan synthesis at the final stage. It has a bactericidal effect on the developing microorganisms. Its effect is especially on Gram-positive bacteria, but it is also bactericidal against some Gram-negative bacteria such as Pasteurella multocida and Mannheimia haemolytica. Beta-lactamase producing strains cause degradation of amoxicillin.
Resistance to amoxicillin is mediated by the enzyme beta-lactamase, which causes hydrolysis of the beta-lactam ring. Bacterial beta-lactamases can be encoded in plasmids or bacterial chromosome components. These beta-lactamases are located in the periplasmic region in Gram-negative bacteria, while they are extracellular in Gram-positive bacteria (Staphylococcus aureus).
Gram-positive bacteria can produce large amounts of beta-lactamase. These enzymes are encoded in plasmids and these codes can be transferred to other bacteria.
Gram-negative bacteria produce different types of beta-lactamases, and these enzymes are encoded in chromosomes or plasmids.
There is complete cross-resistance between amoxicillin and other penicillins, especially aminopenicillins.
Pharmacokinetics Properties
Absorption is good and bioavailability is between 60-100% when administered intramuscularly or subcutaneously at a dose of 15 mg/kg. Depending on the species, it reaches its plasma peak level of 1.5 and 4.5 μg/mL 1.5-3 hours after administration. Pharmacokinetic parameters are stable after the second administration 48 hours apart.
Plasma concentration are above MIC90 for more than 32 hours after the first administration and up to 36 hours at the second administration.
Amoxicillin is excreted mainly via the kidneys.
AREA OF USE / INDICATIONS
It is used for the treatment of respiratory, digestive, urogenital systems and skin and soft tissue infections caused by Gram positive and Gram negative amoxicillin-susceptible bacteria containing the bacteria given below;
Clostridium spp. Corynebacterium spp. Erysipelas spp. Fusiformis spp. Haemophilus spp. Pasteurella spp. Streptococci spp. Salmonella spp. Staphylococci Mannheimia haemolytica in cattle, sheep, goat, cat and dog.
USAGE AND DOSAGE
Shake well before using. Use dry and sterile injector.
It is administered at a dose of 15 mg/kg body weight (practically for 1 ml product/10 kg body weight) in the target species.
The injection should be repeated after 48 hours. The weight of the animals should be measured as accurately as possible to ensure the correct amount of product is delivered.
It is applied deep intramuscularly in cattle, sheep and goats, intramuscularly or subcutaneously in cats and dogs. Especially if a small dose of the product is used, the appropriate needle should be used to ensure that the required amount is injected into the animal.
After the administration, the injection area should be massaged in cattle.
Aseptic precautions should be taken as with other injectable products. In cases where there is no clinical response after the second application, the diagnosis should be reviewed and the treatment should be changed if necessary.
The stopper should not be punctured more than 223 times in 100 ml products and more than 556 times in 250 ml products.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
After the administration, the injection area should be massaged in cattle.
Use of this product other than the information given in the summary of product characteristics may lead to the development of bacterial resistance to amoxicillin and decrease the effectiveness of amoxicillin.
Maximum 10 ml in cattle and 5 ml in sheep and goats should be injected into injection area.
Official national and regional antimicrobial policies should be applied when using the product.
Use this product according to the results of susceptibility tests for bacteria obtained from animals. If this is not possible, treatment should be based on regional epidemiological susceptibility data of the target bacteria.
A dry needle should be used because amoxicillin is rapidly hydrolyzed by water. The stopper must be wiped off before each use.
Use during pregnancy and lactation:
No teratogenic, embryotoxic, or maternotoxic effects of amoxicillin were observed in laboratory animal studies. However, studies on the safety of this product in target breed pregnant animals have not been conducted. This product should be used in pregnant animals according to the veterinarian's assessment of benefit/risk.
UNDESIRED EFFECTS
Allergic reactions of varying severity may occur, ranging from mild skin reactions such as urticaria to anaphylactic shock.
Local irritation may be seen rarely. The irritation resolves spontaneously and quickly.
If an allergic reaction occurs, treatment should be discontinued and symptomatic therapy should be administered.
DRUG INTERACTIONS
Tetracyclines, sulfonamides and macrolides are bacteriostatic antibiotics and can inhibit the action of bactericidal antibiotics such as amoxicillin.
Since amoxicillin acts by inhibiting cell wall synthesis, antibiotics that inhibit protein synthesis such as tetracycline may mask the bactericidal effect of amoxicillin.
There is a synergistic effect between beta-lactam antibiotics and aminoglycosides.
Do not mix with other products.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
The recommended dose should not be exceeded. Mild, transient local reactions at the injection site were observed in a limited number of animals at 5 times the therapeutic dose. Anaphylactic reactions, which can lead to death, may occur in susceptible animals.
WITHDRAWAL PERIODS
Meat: 92 days for cattle, 45 days for sheep and goat
Milk: 9 days (18 milkings) for cow, 6,5 days (13 milkings) for sheep and goat.
CONTRAINDICATIONS
This product is not suitable for intravenous or intrathecal use.
It is not applied to animals known to be sensitive to penicillin and/or cephalosporins or to the excipients in its composition.
Not applicable to rabbits, guinea pigs, hamsters, gerbils or other small herbivores.
It is not effective against microorganisms producing beta-lactamase.
It is not used in animals with anuria or oligouria and renal dysfunction.
It is not applied to equidae like other aminopenicillins, due to its effect on the bacterial flora in the cecum.
GENERAL WARNINGS
Consult your veterinary surgeon before using and in case an unexpected effect is observed.
Keep out of reach of children.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
Penicillins and cephalosporins may cause hypersensitivity reactions after injection, skin contact, inhalation or ingestion. Hypersensitivity to penicillins may cause cross-sensitivity to cephalosporins (or opposite). Allergic reactions to these substances can sometimes be serious.
1- If you have been advised not to work with products containing these substances or if you know you are sensitive, do not work with this product.
2- Use this product very carefully and taking all necessary precautions.
3- If exposure to the product, such as skin contact, occurs, you should seek medical assistance. In this case, show the label and leaflet of the product to your doctor. Swelling of the face, lips, or eyes, or difficulty breathing are very serious symptoms and require immediate medical attention.
Wash your hands after using.
DISPOSAL AFTER USE AND WARNINGS FOR NON-TARGET SPECIES
Used or remaining product should be disposed of in accordance with the relevant legislation.
STORAGE CONDITIONS AND SHELF LIFE
Store below 25°C, in the original package without freezing and refrigerating. Protect from light. After opening, it should be consumed within 28 days.
COMMERCIAL PRESENTATION FORM
Offered for sale in 100 ml and 250 ml colorless Type II glass vials with bromobutyl rubber stoppers and flip-off colorless caps vials in cardboard boxes.
PLACE AND CONDITIONS OF SALE
Sold with Veterinary Surgeon’s prescription in pharmacies and veterinary surgeries. (VSP)
APPROVAL DATE OF THE PACKGAGE INSERT: 16.07.2025
MARKETING AUTHORIZATION DATE AND NO: 24.08.2010-023/0016
MARKETING AUTHORIZATION HOLDER
Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
MANUFACTURER COMPANY
FDN İLAÇ SAN. VE TİC. LTD. ŞTİ.
Büyükkayacık OSB Mah. İnsu Sokak No:3 Selçuklu/Konya-Türkiye
