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
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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
(3) take “the pill” (3) Proguanil (Paludrine®): There are several dangerous myths regarding Chloroquine (Nivaquine® or Daramal® or • Prophylaxis does not make the diagnosis • Dosage: Two tablets every day starting one • It does protect against the development of week prior to exposure until four weeks after. • Contra-indications: Known allergy to • Prophylaxis is no
Be Good to Yourself - Tips for those who take medication medicine to help you with a mental how much, what time of day, and whether health problem, it’s important to be or not you should take your medication informed. Many things can affect how with food. If you don’t know, ask your well your medication works for you. doctor. Smoking, alcohol and drug use, over the D O N ’ T T