Product information - Pigs and Chickens Summary of Product Characteristic Use during pregnancy and lactationOverdose
Because doxycycline is highly lipid soluble,
Qualitative and quantitative composition
Doxycycline has a low affinity for forming
it has a good tissue penetration. Respiratory
1 g of powder contains: Active substance:
recommended dose resulted in no clinical signs
tract tissue: plasma ratios of 1.3 (healthy lungs),
Doxycycline hyclate 500 mg, corresponding to
demonstrated that doxycycline scarcely affects
that could be attributed to treatment. Poultry
1.9 (pneumonic lungs) and 2.3 (nasal mucosa)
skeleton formation. No negative effects were
tolerate double overdoses of doxycycline (40
have been reported for doxycycline. Plasma
For a full list of excipients, see Excipients.
observed in poultry after the administration of
mg/kg body weight) without any clinical effect.
protein binding is high (over 90%). Doxycycline
Pharmaceutical form Withdrawal periods
is scarcely metabolised. Doxycycline is primarily
Powder for use in drinking water. Yellow
In the absence of specific studies the use of the
product is not recommended during pregnancy
Chickens: Meat and offal - 3 days, following a
Pharmaceutical particulars Clinical particulars
dose rate of 10 mg/kg body weight for 4 days.
Meat and offal - 12 days, following a dose rate
Pigs and chickens (broiler, pullet, breeder).
Do not combine with antibiotics that are
bacteriocidal, e.g. penicillins or cephalosporins.
Eggs: Not authorised for use in laying birds
Solubility of doxycycline is pH dependent.
Pigs: For the treatment of the clinical signs
Absorption of doxycycline can be decreased in
producing eggs for human consumption. Do not
Precipitation will occur in an alkaline solution.
associated with porcine respiratory disease
the presence of high quantities of calcium, iron,
use within 4 weeks of onset of the laying period
In the absence of compatibility studies, this
caused by Actinobacillus pleuropneumoniae,
magnesium or aluminium in the diet. Do not
Pharmacological particulars
product must not be mixed with other veterinary
administer together with antacids, kaolin or iron
Pharmacotherapeutic group: Antibacterial,
hyopneumoniae susceptible to doxycycline. Chickens: Where clinical disease is present
It is advised that the interval between the
Shelf life of the veterinary medicinal product as
in the flock, to reduce mortality, morbidity, and
administration of other products containing
clinical signs and to reduce lesions due to
polyvalent cations should be 1-2 hours because
Shelf life after first opening the immediate
Pasteurellosis caused by Pasteurella multocida
they limit the absorption of tetracyclines.
tetracycline antibiotics. These antibiotics have
or to reduce morbidity and lesions in respiratory
a broad-spectrum of antimicrobial activity,
Shelf life after dilution or reconstitution according
sharing the same basic structure of polycyclic
to directions: After reconstitution with water,
The solubility of the product is pH dependent
any product remaining after 24 hours should be
and will precipitate if mixed in alkaline solution.
Doxycycline is primarily a bacteriostatic drug.
Do not use in case of hypersensitivity to the
Do not store the drinking water in metallic
It exerts its action by inhibiting the protein
active substance or to any of the excipients.
synthesis of the bacterial cell. Inhibition of
This veterinary medicinal product does not
Do not use in animals with an impaired liver
Amounts to be administered and administration
bacterial protein synthesis results in disturbance
require any special storage conditions. Keep the
of all functions necessary for the life of bacteria.
bag tightly closed after first opening in order to
Special precautions for use in animals
Administration orally with the drinking water.
Cell-division and the formation of the cell wall in
protect from moisture. Keep out of the reach
Due to likely variability (time, geographical),
The recommended dose in pigs is: 12.5 mg
susceptibility of bacteria to doxycycline
doxycycline hyclate (25 mg product) per kg
Doxycycline is a broad-spectrum antibiotic,
(especially susceptibility of A. pleuropneumoniae
body weight per day for 4 consecutive days. If
active against a large number of gram-positive
and O. rhinotracheale) may differ from country to
no improvement in clinical signs is seen within
and 10x100g in a carton box. Formed from a
country and even farm to farm, bacteriological
this time, the diagnosis should be reviewed and
micro-organisms, Mycoplasmata, Chlamydiae
polyester/polyethylene/aluminium/polyethylene
treatment changed. In case of severe infections
or a polyester/polyethylene/aluminium/ionomer
the medication period may be prolonged for a
For Ornithobacterium rhinotracheale results
laminate. Not all pack sizes may be marketed.
be based on culture and sensitivity of micro-
maximum of 8 consecutive days as determined
demonstrate a great variation from high to low
organisms from diseased cases on the farm. If
by the attending veterinary surgeon.
susceptibility, depending on the geographical
Any unused veterinary medicinal product or
this is not possible, therapy should be based
The recommended dose in chickens is: 10
waste materials derived from such veterinary
on local (regional, farm level) epidemiological
mg doxycycline hyclate (20 mg product) per kg
In pig pathogens resistance against doxycycline
medicinal products should be disposed of in
information about susceptibility of the target
body weight per day for 3-4 consecutive days
may also vary; susceptibility figures of A.
in case of infections caused by P. multocida pleuropneumoniae in particular may differ from
Marketing authorisation holder (if different
As eradication of the target pathogens may not
and 20 mg doxycycline hyclate (40 mg product)
country to country and even farm to farm. from distributor)
be achieved, medication should therefore be
per kg body weight per day for 3-4 consecutive
Eurovet Animal Health BV, Handelsweg 25, 5531
combined with good management practices,
days in case of infections caused by O.
micro-organisms against tetracyclines in general
e.g. good hygiene, proper ventilation, no
have been reported: decreased accumulation
Marketing authorisation number
Based on the dose to be used, and the number
of tetracyclines (decreased permeability of the
Special precautions to be taken by the person
and weight of the animals to be treated,
bacterial cell wall and active efflux), protein
Date of the first authorisation or date of administering the veterinary medicinal product
the exact daily amount of product can be
protection of the bacterial ribosome, enzymatic
calculated. The following formula can be used
inactivation of the antibiotic and rRNA mutations
If you know you are allergic to the tetracycline
to calculate the concentration of the product in
(preventing the tetracycline binding to ribosome).
Date of revision of the text
class of antibiotics, special care should be taken
Tetracycline resistance is usually acquired by
when handling this product or the medicated
means of plasmids or other mobile elements
Any other information
mg product/kg body weight per day x mean
solution. During preparation and administration
body weight (kg) of animals to be treated
For animal treatment only. To be supplied only
________________________________________
of the medicated drinking water, skin contact
Mean daily water consumption (l) per animal drinking water
resistance between tetracyclines has also been
with the product and inhalation of dust particles
described. Due to the greater liposolubility and
Manufacturing authorisation holder responsible
should be avoided. Wear impermeable gloves
greater facility to pass through cell membranes
for batch release: Eurovet Animal Health
(e.g. rubber or latex) and an appropriate dust
(in comparison to tetracycline), doxycycline
mask (e.g. disposable half-mask respirator
possible. The uptake of medicated drinking
retains a certain degree of efficacy against
conforming to European Standard EN149) when
water depends on the clinical condition of the
microorganisms with acquired resistance to
Legal category
pigs/chickens. In order to obtain the correct
In the event of eye or skin contact, rinse the
Significant changes
affected area with large amounts of clean water
has to be adjusted accordingly. The use of
Doxycycline is absorbed in the stomach and the
GTIN (Global Trade Item No)
and if irritation occurs, seek medical attention.
suitably calibrated weighing equipment is
first part of the duodenum. Compared to the
Soludox 500 mg/g Powder for Use in Drinking
Wash hands and contaminated skin immediately
recommended if part packs are used. The daily
older tetracyclines the absorption of doxycycline
after handling the product. If you develop
amount is to be added to the drinking water
is less affected by the presence of bivalent
symptoms following exposure such as skin rash,
such that all medication will be consumed in
cations in food. Bioavailability in non-fasted pigs
you should seek medical advice and show this
24 hours. Medicated drinking water should
warning to the physician. Swelling of the face,
be refreshed or replaced every 24 hours. It
Following oral administration at a dose of 12.8
lips or eyes, or difficulty with breathing are more
is recommended to prepare a concentrated
mg/kg body weight, steady state concentrations
serious symptoms and require urgent medical
pre-solution, approximately 100 grams product
during medication range between a Cmin of
per litre drinking water, and to dilute this further
0.40 µg/ml in the early morning to a Cmax of
Do not smoke, eat or drink while handling the
to therapeutic concentrations if required.
0.87 µg/ml in the late afternoon in pigs.
Alternatively, the concentrated solution can
Following administration of doxycycline hyclate
Take measures to avoid producing dust when
be used in a proportional water medicator.
at an actual dose of 21 mg/kg body weight to
incorporating the product into water.
Solubility of the product is pH dependent and
chickens mean plasma concentrations above 1
Avoid direct contact with skin and eyes when
it may precipitate if it is mixed in hard alkaline
µg/ml were reached within 6 hours and lasted
handling the product to prevent sensitisation
drinking water. Use at minimum concentrations
for 6 hours after cessation of medication. From
of 200 mg powder per litre drinking water in
24 hours up to 96 hours after start of treatment
areas with hard alkaline drinking water (hardness
Tetracyclines may, in very rare cases, induce
above 10.2°d and pH more than 8.1). During
photosensitivity and allergic reactions. If
Following administration of doxycycline hyclate
suspected adverse reactions occur, treatment
have access to other water sources than the
at an actual dose of 10 mg/kg body weight
should be discontinued. Inform your veterinary
steady-state plasma concentrations ranged from
surgeon if adverse reactions occur that are not
0.75 to 0.93 µg/g between 12 and 96 hours
COPD THE DISEASE COPD THE DISEASE How do the lungs normally work? The chest contains two lungs, one lung on the right side of the chest, the other on the left side of the chest. Each lung is made up of sections called lobes. The lung is soft and protected by the ribcage. The purposes of the lungs are to bring oxygen (abbreviated O2), into the body and to remove carbon dioxide (abbreviate
Product information - Pigs and Chickens