GalluDoxx
Main information
- Trade name:
- GalluDoxx 500 mg/g Powder for Use in Drinking Water/Milk Replacer for Calves, Chickens and Turkeys
- Active ingredient:
- Doxycycline Hyclate
- Available from:
- Huvepharma N.V.
- ATC code:
- QJ01AA02
- INN (International Name):
- Doxycycline Hyclate
- Pharmaceutical form:
- Powder for use in drinking water/milk replacer
- Prescription type:
- POM-V - Prescription Only Medicine – Veterinarian
- Medicine domain:
- Animals
- Medicine type:
- Allopathic drug
Documents
- for healthcare professionals:
- Summary of Product characteristics
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
Localization
- Available in:
-
United Kingdom
- Language:
- English
Therapeutic information
- Therapeutic group:
- Cattle, Chickens, Turkeys
- Therapeutic area:
- Antimicrobial
Other information
Status
- Source:
- VMD - Veterinary Medicines Directorate
- Authorization status:
- Authorized
- Authorization number:
- 30282/4031
- Authorization date:
- 20-12-2016
- Last update:
- 21-12-2016
Summary of Product characteristics
Issued: December 2016
AN: 01227/2015
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GalluDoxx 500 mg/g powder for use in drinking water/milk replacer for calves, chickens
and turkeys.
GalluDoxx 433 mg/g powder for use in drinking water/milk replacer for calves, chickens
and turkeys. (France only)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
Active substance:
Doxycycline hyclate 500 mg (equivalent to 433 mg doxycycline)
Excipient:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for use in drinking water/milk replacer.
Yellowish powder.
4.
CLINICAL PARTICULARS
4.1
Target species
Cattle (pre-ruminant calves)
Chickens (broilers, breeders, replacement pullets) and turkeys.
4.2
Indications for use, specifying the target species
Cattle (pre-ruminant calves)
For the treatment of:
- Pneumonia and shipping fever caused by Pasteurella spp and Mannheimia
haemolytica infections.
Chickens (broilers, breeders, replacement pullets) and turkeys
For the treatment of:
- Ornithosis caused by Chlamydophila psittaci in turkeys;
- Colibacillosis caused by E. coli in chickens and turkeys;
- Chronic Respiratory Disease caused by Mycoplasma gallisepticum in chickens and
turkeys.
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Issued: December 2016
AN: 01227/2015
4.3
Contraindications
Do not use in cases of known hypersensitivity to tetracyclines or the excipient.
Do not administer to animals with severe liver or kidney insufficiency.
Do not use when tetracycline resistance has been detected in the herd/flock due to the
potential for cross resistance
4.4
Special warnings for each target species
The uptake of medication by animals can be altered as a consequence of illness. In
case of insufficient uptake of drinking water or medicated milk replacer, animals should
be treated parenterally. It is necessary to administer medicated milk to calves on an
individual basis.
4.5
Special precautions for use
Special precautions for use in animals
Due to variability (time, geographical) in susceptibility of bacteria for doxycycline,
bacteriological sampling and susceptibility testing of micro-organisms from diseased
animals on farm are highly recommended.
A high resistance rate of E. coli, isolated from chickens, against tetracyclines has been
documented. Therefore the product should be used for the treatment of infections
caused by E. coli only after susceptibility testing has been carried out.
As eradication of the target pathogens may not be achieved, medication should
therefore be combined with good management practices, e.g. good hygiene, proper
ventilation, no overstocking.
Official, national and regional antimicrobial policies should be taken into account when
the product is used.
Use of the product deviating from the instructions given in the SPC may increase the
prevalence of bacteria resistant to doxycycline and may decrease the effectiveness of
treatment with other tetracyclines due to the potential for cross-resistance.
Resistance to tetracyclines has also been reported in calf pathogens (Pasteurella spp.)
in some EU countries.
Page 2 of 7
Issued: December 2016
AN: 01227/2015
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
During the handling of the product, skin contact and inhalation has to be avoided,
taking into account the risk of sensitisation and contact dermatitis.
People with known hypersensitivity to tetracyclines should not handle the product. Wear
impermeable gloves (e.g. rubber or latex) and an appropriate dust mask (e.g.
disposable half-mask respirator conforming to European Standard EN149) when
applying the product. Do not smoke, eat or drink while handling the product. In the
event of eye or skin contact, rinse the affected area with large amounts of clean water
and if irritation occurs, seek medical attention. Wash hands and contaminated skin
immediately after handling the product.
If you develop symptoms following exposure such as skin rash, you should seek
medical advice and show this warning to the physician. Swelling of the face, lips or
eyes, or difficulty with breathing are more serious symptoms and require urgent medical
attention.
4.6
Adverse reactions (frequency and seriousness)
Tetracyclines may in rare cases induce photosensitivity and allergic reactions. If
suspected adverse reactions occur, treatment should be discontinued.
4.7
Use during pregnancy, lactation or lay
Laboratory studies with doxycycline in rats and rabbits has not produced any evidence
of teratogenic, embryotoxic or foetotoxic effects.
The safety of the product has not been assessed in breeder chickens. Use only
accordingly to benefit/risk assessment by the responsible veterinarian.
4.8
Interaction with other medicinal products and other forms of interaction
Do not use in conjunction with bactericidal antibiotics, such as penicillins and
cephalosporins.
Do not administer concurrently with feed overloaded with polyvalent cations such as
, Mg
, Zn
and Fe
because the formation of doxycycline complexes with these
cations is possible. Do not administer together with antacids, kaolin and iron
preparations. It is advised that the interval between administration of the product and
administration of products containing polyvalent cations should be 1-2 hours because
the latter limit the absorption of doxycycline.
Doxycycline increases the action of anticoagulants.
4.9
Amounts to be administered and administration route
Route of administration:
Calves: To be administered in drinking water/milk replacer Chickens and turkeys: In
drinking water use
Dosing
Page 3 of 7
Issued: December 2016
AN: 01227/2015
Calves:
Doxycycline hyclate 5 mg per kg body weight, twice a day, equivalent to 10 mg of the
product per kg of animal body weight, twice a day, for 4-7 successive days.
Chickens and turkeys:
20 mg doxycycline hyclate per kg of body weight per day, corresponding to 40 mg of
the product per kg of animal body weight, for 4-7 consecutive days.
The exact daily amount of product should be calculated according to the following
formula, based on the recommended dose, and the number and weight of the animals
to be treated:
mg product / kg body
weight / day
Mean body weight (kg) of
animals to be treated
= .... mg product per
litre drinking water
Mean daily water consumption (litre) per animal
To ensure a correct dosage body weight should be determined as accurately as
possible.
The uptake of medicated water is dependent on the clinical conditions of the animals. In
order to obtain the correct dosage, the concentration in drinking water may have to be
adjusted.
The use of suitably calibrated weighing equipment is recommended if part packs are
used. The daily amount is to be added to the drinking water such that all medication will
be consumed in 12 hours. Medicated drinking water should be freshly prepared every
12 hours. It is recommended to prepare a concentrated pre-solution - not exceeding
100 grams product per litre drinking water - and to dilute this further to therapeutic
concentrations if required. Alternatively, the concentrated solution can be used in a
proportional water medicator. The water should be stirred until full dissolution of the
product is obtained. The solubility of doxycycline decreases at higher pH. Therefore the
product should not be used in hard alkaline water since precipitation might occur
depending on the product concentration. Delayed precipitation might also occur.
Milk replacer: The veterinary medicinal product must first be dissolved in warm water
before adding the milk powder - the maximal concentration to be used is 100 grams of
product per litre of water. The obtained milk replacer solution must be homogenised
and heated to feeding temperature prior to administration. The medicated milk replacer
should be freshly prepared prior to use, used immediately and be constantly stirred to
avoid sedimentation of the active substance.
If a concentration greater than 200 mg per litre of milk is required, animals should be
treated parenterally.
Sufficient access to the system of water supply should be available for the animals to
be treated to ensure adequate water consumption. No other source of drinking water
should be available during the medication period. At the end of treatment period the
water supply should be cleaned adequately to avoid the uptake of remaining quantities
in sub-therapeutic doses.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Page 4 of 7
Issued: December 2016
AN: 01227/2015
In calves acute, sometimes fatal cardiac muscle degeneration may occur after one or
more administrations. Since this is usually related to overdosing, it is important to
calculate the dose correctly.
If suspected toxic reactions do occur due to extreme overdose, the medication should
be discontinued and appropriate symptomatic treatment should be initiated if
necessary.
4.11 Withdrawal period(s)
Calves:
Meat and offal: 28 days
Turkeys:
Meat and offal: 28 days
Chickens Meat and offal: 14 days
Not authorised for use in birds producing eggs for human consumption.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anti-infectives for systemic use, Tetracyclines.
ATCvet code: QJ01AA02.
5.1
Pharmacodynamic properties
Doxycycline is a broad spectrum antibiotic. It inhibits bacterial protein synthesis
intracellularly by binding on the 30-S ribosome subunits. This interferes with binding of
aminoacetyl-tRNA to the acceptor site on the mRNA ribosome complex and prevents
coupling of amino acids to the elongating peptide chains.
Doxycycline inhibits bacteria, mycoplasmae, chlamydiae, rickettsiae, and certain
protozoa.
Organisms other than streptococci with MIC values ≤ 4µg/ml are considered sensitive,
at 8 µg/ml intermediate susceptible and with MIC values ≥16µg/ml resistant to
doxycycline, according to the CLSI data.
For cattle MIC90 values for Pasteurella multocida of 0.5 µg/ml and of 2µg/ml for
Mannheimia haemolytica have been reported in literature (2014). Resistance varies for
both organisms between 0 and 22% in relation to the geographical origin of the strains
(2014)
In poultry literature indicates that Mycoplasma spp. (2008) and Chlamydophila psittaci
(2013) demonstrate good susceptibility. Resistance rate for M. gallisepticum is low (0-
6%).
Four resistance mechanisms acquired by micro-organisms against tetracyclines in
general have been reported: decreased accumulation of tetracyclines (decreased
permeability of the bacterial cell wall and active efflux), protein protection of the
bacterial ribosome, enzymatic inactivation of the antibiotic and rRNA mutations
(preventing the tetracycline binding to ribosome). Tetracycline resistance is usually
acquired by means of plasmids or other mobile elements (e.g. conjugative
transposons). Cross-resistance between tetracyclines has also been described. Due to
Page 5 of 7
Issued: December 2016
AN: 01227/2015
the greater liposolubility and greater facility to pass through cell membranes (in
comparison to tetracycline), doxycycline retains a certain degree of efficacy against
micro-organisms with acquired resistance to tetracyclines.
5.2
Pharmacokinetic particulars
Doxycycline is quickly and almost completely absorbed from the intestine. The
distribution of doxycycline and penetration of doxycycline throughout most body tissues
is good.
Following absorption, tetracyclines are hardly metabolised. In contrast to the other
tetracyclines, doxycycline is mainly excreted via the faeces.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Lactose monohydrate
6.2
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be
mixed with other veterinary medicinal products.
6.3
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf life after first opening the immediate packaging: 3 months.
Shelf life after reconstitution in drinking water: 24 hours.
Shelf life after reconstitution in milk replacer: Use immediately. Do not store.
6.4
Special precautions for storage
This veterinary medicinal product does not require any special temperature storage
conditions. After first opening keep the bag tightly closed in order to protect from
moisture.
6.5
Nature and composition of immediate packaging
Bag formed from polyethylene/aluminium/polyethylene terephthalate laminate.
Pack sizes:
Bag of 1 kg
Bag of 5 kg
Not all pack sizes may be marketed.
Page 6 of 7
Issued: December 2016
AN: 01227/2015
6.6
Special precautions for the disposal of unused veterinary medicinal product
or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal product should be disposed of in accordance with local
requirements.
7.
MARKETING AUTHORISATION HOLDER
Huvepharma N.V.
Uitbreidingstraat 80
B-2600 Antwerpen
Belgium
8.
MARKETING AUTHORISATION NUMBER
Vm 30282/4031
9.
DATE OF FIRST AUTHORISATION
20 December 2016
10.
DATE OF REVISION OF THE TEXT
December 2016
Approved: 20/12/2016
Page 7 of 7
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Updated Date: Oct 19, 2017 EST
US - DailyMed
11-10-2017
![DOXYCYCLINE HYCLATE (Doxycycline) Tablet [Amneal Pharmaceuticals LLC]](/web/assets/global/img/flags/us.png)
DOXYCYCLINE HYCLATE (Doxycycline) Tablet [Amneal Pharmaceuticals LLC]
Updated Date: Oct 11, 2017 EST
US - DailyMed
10-10-2017
![DOXYCYCLINE HYCLATE (Doxyclycline Hyclate) Tablet, Coated [Lupin Pharmaceuticals, Inc.]](/web/assets/global/img/flags/us.png)
DOXYCYCLINE HYCLATE (Doxyclycline Hyclate) Tablet, Coated [Lupin Pharmaceuticals, Inc.]
Updated Date: Oct 10, 2017 EST
US - DailyMed
4-10-2017
![DOXYCYCLINE (Doxycycline Hyclate) Tablet, Coated [NuCare Pharmaceuticals,Inc.]](/web/assets/global/img/flags/us.png)
DOXYCYCLINE (Doxycycline Hyclate) Tablet, Coated [NuCare Pharmaceuticals,Inc.]
Updated Date: Oct 4, 2017 EST
US - DailyMed
2-10-2017
![DOXYCYCLINE (Doxycycline Hyclate) Tablet, Coated [PD-Rx Pharmaceuticals, Inc.]](/web/assets/global/img/flags/us.png)
DOXYCYCLINE (Doxycycline Hyclate) Tablet, Coated [PD-Rx Pharmaceuticals, Inc.]
Updated Date: Oct 2, 2017 EST
US - DailyMed
25-9-2017
![DOXYCYCLINE HYCLATE Capsule [Contract Pharmacy Services-PA]](/web/assets/global/img/flags/us.png)
DOXYCYCLINE HYCLATE Capsule [Contract Pharmacy Services-PA]
Updated Date: Sep 25, 2017 EST
US - DailyMed