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Product information - Chickens
Octacillin® 697 mg/g Powder for Use in
Use during pregnancy and lactation
Pharmacological properties
Shelf life after dilution or reconstitution according Drinking Water for Chickens
Do not use in birds in lay producing eggs for Pharmacotherapeutic group: Beta-lactam Special precautions for storage
Qualitative and quantitative composition
according to the benefit/risk assessment by the This veterinary medicinal product does not Pharmacodynamic properties
require any special storage conditions prior to Interactions
opening. After opening, any remaining content Amoxicillin (as amoxicillin trihydrate) 697 mg/g The active ingredient, amoxicillin, is a bactericidal Amoxicillin exerts its bactericidal action by can be stored for 3 months if stored dry and For a full list of excipients, see Excipients.
antibiotic of the beta-lactam class. It acts inhibition of bacterial cell wall synthesis during re-closed with clip (after folding the edge of the by inhibition of bacterial cell wall synthesis. multiplication. It is therefore in principle not opened sachet). As metal tanks may negatively Amoxicillin is not resistant to the action of beta- influence stability of the product, metal tanks Pharmaceutical form
compatible with bacteriostatic antibiotics lactamases, which can hydrolyse the molecules (e.g. tetracyclines) which inhibit multiplication. should not be used for storage of solutions. Powder for use in drinking water. White to pale causing the beta-lactam ring structure to open, Synergism occurs with beta-lactam antibiotics Keep out of the reach and sight of children.
rendering it antibiotically inactive.
Immediate packaging
Amounts to be administered and administration lactamase is encoded in a plasmid and may be The primary packaging material of the product Clinical particulars
transferred by bacteriophage to other bacteria. comprises aluminium sachets of 100, 250, 500 Target species
In G-bacteria beta-lactamases are encoded in and 1000 grams. Not all pack sizes may be marketed. The sachets consist of the following Chickens (excluding laying birds producing eggs the product per kg live weight (8-16 mg/kg either chromosomes or in plasmids and they materials: on the outside a white layer, inside amoxicillin trihydrate) per day administered in the may be constitutive or inducible. Plasmids drinking water. The higher dose is advised when may be transferred between bacteria through different transparent layers, a sub-layer of Indications for use
treating severe infections. Treatment should be aluminium and an inner layer of polyethylene.
Treatment of infections in chickens caused by given for a period of 3-5 consecutive days. The Some bacteria are intrinsically resistant to Disposal
bacteria susceptible to amoxicillin.
following formula may be used to calculate the amoxicillin, because they have decreased affinity Any unused veterinary medicinal product or Not effective against beta-lactamase producing for the antibiotic. Decreased affinity may also be waste materials derived from such veterinary Grams product no. birds x average live weight (kg) acquired by homologous recombination between medicinal products should be disposed of in Contraindications
_________________________________________ genes of different species. Other instances of Do not use in known cases of hypersensitivity to bacterial resistance are caused by the inability penicillin or other substances of the beta-lactam of the agent to penetrate to its site of action If the required amount of product is calculated Marketing authorisation holder
(some G-bacteria) or by energy dependent efflux by the total daily water intake, the following is systems for pumping the antibiotic out of the Eurovet Animal Health BV, Handelsweg 25, 5531 Do not use in rabbits, guinea pigs, hamsters, gerbils or any other small herbivores.
- Birds 0-4 weeks of age: 6-12 g product/100 In general, practical development of resistance Marketing authorisation number
Adverse reactions
in vitro against amoxicillin like all penicillins Allergic reactions may be observed occasionally - Birds older than 4 weeks: 10-20 g product/100 occurs slowly and stepwise, with an existing Date of the first authorisation or date of
cross-resistance with other penicillins which is of Special precautions for use in animals
practical significance by staphylococci.
administered once daily in the drinking water. Both long term treatment and sub-therapeutic It is advisable to restrict drinking water for susceptibility testing and should take into dosages can select for antimicrobial resistance. approximately 2 hours (less in hot weather) prior account official and local antimicrobial policies.
Amoxicillin is generally active against some Date of revision of the text
to medication. The use of suitably calibrated Inappropriate use of the product may increase weighing equipment for the administration of the bacteria, e.g. penicillin sensitive Staphylococci, the prevalence of bacteria resistance to calculated amount of product is recommended. Streptococci, Pasteurella spp., Clostridium spp., amoxicillin and may decrease its effectiveness.
The calculated total daily amount of powder is Salmonella spp., Haemophilus paragallinarum, Any other information
Special precautions to be taken by the person
scattered onto the surface of 5-10 litres of clean and E. coli. Resistance amongst E. coli strains is For animal treatment only. To be supplied only on administering the veterinary medicinal
water and stirred until evenly dispersed. This product to animals
solution is then added, whilst stirring, into an Pharmacokinetic properties
amount of drinking water that will be consumed Penicillins and cephalosporins may cause within approximately 2 hours. Maximum solubility Following oral medication amoxicillin is rapidly hypersensitivity (allergy) following injection, Legal category
of the product in water is approximately 6 g/litre.
absorbed. Maximum amoxicillin concentrations (between 1-2 µg/ml) are reached within 1-2 Hypersensitivity to penicillins may cause cross- If, however, continuous medication is preferred hours. Serum protein binding is low. Amoxicillin reactions to cephalosporins and vice versa. then the drinking water should be refreshed with is widely distributed throughout the body. Allergic reactions to these substances may medicated water at least twice daily. In all cases Significant changes
Amoxicillin is mainly eliminated via the kidneys ensure that there is no access to unmedicated in the active form. A smaller part of the water whilst medicated water is being offered. 1. People with known hypersensitivity to penicillin administered dose of amoxicillin is excreted in When all medicated water has been consumed, GTIN (Global Trade Item No)
or cephalosporin should avoid contact with the bile. Plasma half-life time of amoxicillin in turn on the normal water supply again. Any Octacillin 697 mg/g Powder for Use in Drinking unused medicated water should be discarded 2. Handle this product with great care to To ensure a correct dosage body weight should Pharmaceutical particulars
Octacillin 697 mg/g Powder for Use in Drinking be determined as accurately as possible to avoid impervious gloves and either a disposable Excipients
underdosing. The uptake of medicated water half mask respirator conforming to European Sodium carbonate monohydrate, sodium citrate, depends on the clinical condition of the animals. In order to obtain the correct dosage the Octacillin 697 mg/g Powder for Use in Drinking respirator conforming to European Standard concentration of amoxicillin has to be adjusted Incompatibilities
EN140 with a filter to EN143 when mixing and handling the product. Wash hands after use.
In the absence of compatibility studies, this Overdose
veterinary medicinal product must not be mixed 3. If you develop symptoms following exposure, with other veterinary medicinal products.
such as a skin rash, you should seek medical advice and show the doctor this warning. Shelf life
Withdrawal period
Swelling of the face, lips or eyes or difficulty Shelf life of the veterinary medicinal product as Meat and offal: 1 day; Eggs: Not authorised for with breathing are more serious symptoms use in laying birds producing eggs for human and require urgent medical attention.
Shelf life after first opening the immediate Adverse reactions
Hypersensitivity reactions may occur.
Product information - Pigs
Octacillin® 697 mg/g Powder for Use in
advice and show this warning to the physician. avoid underdosing. The uptake of medicated Drinking Water for Pigs
Swelling of the face, lips or eyes, or difficulty water depends on the clinical condition of Shelf life after dilution or reconstitution according with breathing are more serious symptoms and the animals. In order to obtain the correct Qualitative and quantitative composition
dosage the concentration of amoxicillin has Special precautions for storage
1 gram of powder contains: Active substance: Adverse reactions
The veterinary medicinal product as packaged concentration of the pre-diluted medicated water Amoxicillin 697 mg equivalent to amoxicillin Hypersensitivity reactions may occur, the severity for sale requires no special storage conditions. is approximately 8 grams of product per litre. varying from skin rash to anaphylactic shock. If After opening/reconstitution: Do not store above The proportioner setting should be changed For a full list of excipients, see Excipients.
suspected adverse reactions occur, treatment 25ºC. Any remaining content can be stored for 1 accordingly. Make sure the animals do not have month if stored dry and re-closed with clip (after access to non-medicated water during the Use during pregnancy and lactation
folding the edge of the opened sachet). Keep out Pharmaceutical form
period when the medicated water is given. Once Studies in laboratory animals (rats, rabbits) Powder for use in drinking water. White to pale all the medicated water has been drunk, turn did not show a teratogenic, embryotoxic or Immediate packaging
the drinking water system back on. Discard any maternotoxic effect of amoxicillin. The safety of excess medicated water after 12 hours. The use Multilayer sachets with pack sizes of 100 g, the product in pregnant and lactating sows was of suitably calibrated scales is recommended 250 g, 500 g or 1 kg. Not all pack sizes may be Clinical particulars
not demonstrated. Use during pregnancy and for administering the calculated amount of the marketed. The sachets consist of the following Target species
lactation should only be according to the benefit/ materials: on the outside a white layer, inside risk assessment by the responsible veterinarian.
Overdose
different transparent layers, a sub-layer of Indications for use
Interactions
aluminium and an inner layer of polyethylene.
Treatment of infections caused by bacteria The bactericidal effect of amoxicillin is Disposal
Withdrawal period
Any unused veterinary medicinal product or Pigs: Pleuropneumonia caused by Actinobacillus
waste materials derived from such veterinary pleuropneumoniae; Meningitis caused by Amounts to be administered and
medicinal products should be disposed of in administration route
Pharmacological particulars
Contraindications
Pigs: The recommended daily dose is 16 mg
Pharmacotherapeutic group: ß-lactam-antibiotic, Penicillins with extended spectrum.
amoxicillin trihydrate, corresponding to 14 mg Marketing authorisation holder (if
hypersensitivity to penicillin and other substances amoxicillin, per kg of body weight, i.e. 20 mg of different from distributor)
the product per kg of body weight equivalent Pharmacodynamic properties
Eurovet Animal Health BV, Handelsweg 25, 5531 to 1 gram product per 50 kg body weight per Do not use in rabbits and rodents such as guinea The active ingredient, amoxicillin, is a day. The product is to be administered in the bactericidal, mainly time-dependant antibiotic Marketing authorisation number
drinking water for 3-5 consecutive days. In case Special warnings for use in animals
of the beta-lactam class. It acts by inhibition of severe infections the medication period must of bacterial cell wall synthesis. Amoxicillin has Inappropriate use of the veterinary medicinal be prolonged to 5 days as determined by the a bactericidal effect on a wide range of gram- product may increase the prevalence of bacteria positive and gram-negative bacteria.
Date of the first authorisation or date of
resistant to amoxicillin. Use of the product should Bolus dosage: It is recommended to administer The MIC50/MIC90 of Actinobacillus be based on susceptibility testing and take into the product once a day via the drinking water pleuropneumoniae is 0.25 µg/ml. The MIC50/ account official and local antimicrobial policies.
for a limited period of time. Shut off the drinking MIC90 of Streptococcus suis is ≤ 0.03 µg/ml.
water system for approximately two hours In general, practical development of resistance Date of revision of the text
altered as a consequence of illness. In case (shorter time in warm weather) until the time of in vitro against amoxicillin like all penicillins of insufficient uptake of water, pigs should be medication. Sprinkle the calculated daily quantity occurs slowly and stepwise, with an existing treated parenterally. Do not use in animals with of powder on the surface of 5-10 litres water. cross-resistance with other penicillins which is of serious kidney malfunction including anuria and Mix thoroughly until the powder has dissolved. Any other information
practical significance by staphylococci. Both long Mix this solution by stirring into the volume of For animal treatment only. To be supplied only on term treatment and sub-therapeutic dosages can Special precautions to be taken by the person drinking water that will be drunk within about select for antimicrobial resistance. Resistance administering the veterinary medicinal product to beta-lactam antibiotics is essentially linked to Continuous treatment: The table below shows beta-lactamases which hydrolyse them.
Legal category
Penicillins and cephalosporins may cause the guidelines for administering the product, Pharmacokinetic properties
hypersensitivity (allergy) following injection, assuming consumption of 100 litres drinking With this veterinary medicinal product high amoxicillin concentrations are quickly reached in Significant changes
Hypersensitivity to penicillins may lead to cross- consumption of 1 litre per 10 kg of body weight the blood. After oral administration, amoxicillin is sensitivity to cephalosporins and vice versa. in pigs under 4 months and 0.66 litre per 10 kg Allergic reactions to these substances may of body weight in pigs over 4 months.
GTIN (Global Trade Item No)
This antibiotic is well distributed to all organs Octacillin 697 mg/g Powder for Use in Drinking and tissues, where also high concentrations are Do not handle this product if you know you are reached. Amoxicillin is largely excreted by the sensitised or if you have been advised not to In the case of continuous treatment, the medicated kidneys in the unchanged form. A smaller part of water must be changed twice daily. Based on the dose Octacillin 697 mg/g Powder for Use in Drinking the administered dose of amoxicillin is excreted Handle this product with care to avoid exposure, to be used, and the number and weight of the animals taking all recommended precautions. Do not to be treated, the exact daily amount of product can be smoke, eat or drink while handling the product. calculated. The following formula can be used to calculate During preparation and administration of the Pharmaceutical particulars
the concentration of the product in drinking water: medicated drinking water, skin contact with the Excipients
product and inhalation of dust particles should Sodium carbonate monohydrate, soldium citrate, be avoided. Wear gloves and an appropriate –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––- dust mask when applying the product. Wash Mean water consumption (l) per animal on previous day* Incompatibilities
hands and contaminated skin immediately after In the absence of compatibility studies, this * Prepare an amount of medicated water to be veterinary medicinal product must not be mixed In the event of eye or skin contact, rinse the consumed within the next 12 hours. Any unused with other veterinary medicinal products.
affected area with large amounts of clean water medicated water should be discarded after 12 Shelf life
and if irritation occurs, seek medical attention.
hours, and fresh medicated water, for the next 12 hours, should be prepared.
Shelf life of the veterinary medicinal product as If you develop symptoms following exposure such as skin rash, you should seek medical To ensure a correct dosage, body weight should be determined as accurately as possible to Shelf life after first opening the immediate

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