ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1. Name of the veterinary medicinal product:
Gentamycin 5% ,50 mg/ml, solution for injection for cattle, dogs, and cats.
Gentamicin as Gentamicin sulphate.
2. Qualitative and quantitative composition:
1 ml solution for injection contains:
Active substance(s):
Gentamicin
As Gentamicin sulphate
Excipients(s):
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Sodium metabisulphite
50.0 mg
85.0 mg
For a full list of Excipients, see section 6.1.
3. Pharmaceutical form:
Solution for injection
4. Clinical particulars:
4.1 Target specie(s):
Cattle, dog, cat.
4.2 Indications for use, specifying the target species:
For treatment of the following diseases caused by Gentamicin-sensitive
pathogens:
Cattle: infections of the uterus.
Calf:
infections of the respiratory tract (bronchi, lung), infections of the
gastrointestinal tract (enteritis caused by E. coli and Salmonella
spp.), septicaemia, joint infections.
Dog, cats: infections of the respiratory tract, the kidneys and urinary tract
as well as the uterus, the gastrointestinal, inflammations of the
auditory meatus, tonsillitis (not in cats).
4.3 Contraindications:
Do not use in case of:
- Bacterial resistance against Gentamicin, kanamycin, streptomycin
dihydrostreptomycin and paromomycin.
- Renal dysfunction.
- Auditory or equilibral dysfunction.
- Known hypersensitivity against Gentamicin or against other
aminoglycoside antibiotics or any of the Excipients.
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Do not administer concomitantly with bacteriostatic acting antibiotics,
highly active diuretics and potential nephrotoxic medicines.
Do not use concomitantly intravenously or intraabdominally when muscle
relaxans are administered. Do not use in dehydrated animals because of
risk of an acute kidney failure.
4.4 Special warnings for each target species:
Not known.
4.5 Special precautions for use:
Special precautions for use in animals:
Because of the low therapeutic index of Gentamicin, dosage should be
done with respect to the exact body weight.
Generally, the administration of Gentamycin 5% should be done with
respect of an antibiogram.
Because of the risk of incidence of
neuromuscular blockade by intravenous administration, Gentamycin 5%
has to be injected very slowly. Administration of Gentamycin 5% requires
strong indication. In dehydrated animals, fluid balance has to be corrected
before treatment.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals:
Avoid direct contact of the product with the skin or mucosa because of the
risk of sensitisation.
4.6 Adverse reactions (frequency and seriousness):
Disturbances of the auditory and equilibral function and of the kidneys may
be observed after prolonged administration. The dysfunction of the
kidneys may be characterised by proteinuria and an increase of
nonprotein nitrogen content in the blood.
In incidences of neuromuscular blockade, which may lead to cramps,
respiratory distress and collapse, the drug must be withdrawn
immediately. An antidote calcium and neostigmin may be injected. In
allergic and anaphylactic reactions, the drug must be withdrawn
immediately and a corresponding therapy with epinephrine (adrenalin),
antihistaminics and/or glucocorticoids must be implemented. Cats are
especially sensitive to gentamicin.
4.7 Use during pregnancy, lactation or lay:
In mice (s.c. 10 mg gentamicin/kg b.w.) and rats (i.m. 50 mg gentamicin/kg
b.w.) foetotoxic effects have been demonstrated.
Therefore,
administration during pregnancy requires strong indication.
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4.8 Interaction with other medicinal products and other forms of interaction:
Gentamicin increases neuromuscular blockades. Do not use Gentafromm
concomitantly with ototoxic and neurotoxic drugs. The combination
therapy with suitable antibiotics (ß-lactam antibiotics) may induce
synergistic effects. Synergistic effects with acylamino penicillins have
been observed in Pseudomonas aeruginosa and synergistic effects with
cephalosporines have been observed in Klebsiella pneumonia.
4.9 Amounts to be administered and administration route:
By intramuscular, subcutaneous, and slow intravenous application..
Target species
Dosage
Gentamicin
Eq. to gentamicin
Gentamycin 5%
sulphate
Cattle
4 ml/50 kg b.w.
6.80 mg/kg b.w.
4.0 mg/kg b.w.
Calf in the first few months of life
Initial treatment
2 ml/25 kg b.w.
6.80 mg/kg b.w.
4.0 mg/kg b.w.
after the second
1 ml/25kg b.w.
3.40 mg/kg b.w.
2.0 mg/kg b.w.
treatment
Each twice daily at intervals of 12 hours for 3 – 5 days
Dogs older than 2
0.44 ml/5 kg b.w.
7.48 mg/kg b.w.
4.4 mg/kg b.w.
weeks
Dogs younger than
2 weeks
Initial treatment
0.088 ml/1 kg b.w.
7.48 mg/kg b.w.
4.4 mg/kg b.w.
after the 2nd
0.044 ml/1 kg b.w.
3.74 mg/kg b.w.
2.2 mg/kg b.w.
treatment
Each twice daily at intervals of 12 hours, after the 2nd day once daily at intervals of 24
hours for
3 – 10 days
Cats older than 2
0.3 ml/5 kg b.w.
5.10 mg/kg b.w.
3.0 mg/kg b.w.
weeks
Cats younger than
2 weeks
Initial treatment
0.03 ml/0.5 kg b.w.
5.10 mg/kg b.w.
3.0 mg/kg b.w.
nd
after the 2
0.015 ml/0.5 kg b.w. 2.55 mg/kg b.w.
1.5 mg/kg b.w.
treatment
Each twice daily at intervals of 12 hours for 3 – 10 days
If after 3 days of treatment no therapeutical effects is obvious, diagnosis
must be verified, and if necessary, therapy must be changed.
If in case of proven sensitivity of the pathogens a longer duration of
therapy than usual should be necessary, a regular control of the renal
function must be done due to the danger of possible renal damage.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary:
Overdose and fast intravenous administration may induce neuromuscular
blockade which may lead to cramps, respiratory distress and collapse.
The drug must be withdrawn immediately and the in the paragraph
“adverse reactions” mentioned counteractions are to be fulfilled. In
allergic and anaphylactic reactions, the drug must be withdrawn
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immediately and a corresponding therapy with epinephrine (adrenaline),
antihistaminics and/or glucocorticoids must be implemented.
Due to the oto- and nephrotoxic properties of gentamicin, overdosage will
lead to corresponding symptoms. An immediate withdrawal of the drug
is necessary.
4.11 Withdrawal period(s):
Cattle, calf (edible tissues):
Cattle (milk):
95 days
6 days
5. Pharmacological particulars
ATCvet Code: QJ01GB03/gentamicin
Pharmacotherapeutic group: aminoglycoside
5.1 Pharmacodynamic particulars:
Gentamicin is an aminoglycosid antibiotic, gained from cultures of
Micromonospora purpurea, resp. Micromonospora echinospora.
It acts bactericidal due to inhibition of bacterial protein synthesis of
proliferating germs by binding to the ribosomal structures and is effective
against Gram-positive and Gram-negative pathogens (Proteus and
Pseudomonas spp., E. coli) and certain fungi and mycoplasmas. During
translation from DVA to RNA failure occurs and also formation of peptid
conjunctions is disturbed. Pathogens are classified as susceptible if
values of MIC ranging between 1 – 4 μg / ml.
Development of resistance against gentamicin occurs slowly and is
plasmid mediated. Resistance against gentamicin is accompanied by
resistance against other aminoglycosides like neomycin, kanamycin,
streptomycin, and dihydrostreptomycin, whereas vice versa resistant
germs are still sensitive to gentamicin.
5.2 Pharmacokinetic particulars:
Following parenteral administration (i.m. or s.c.), gentamicin is almost
completely absorbed from the injection site. The absorption after
subcutaneous application in cats turned out with 76%, whereas after
intramuscular injection, it turned out with 76%. After administration of
therapeutic doses (3-5 mg/kg b.w.), within 30 to 90 minutes maximal levels
in the blood are reached. According to the animal species peak levels
may reach more than 20 μg / ml (in cats).
Due to its polar molecular structure in the physiological pH range,
gentamicin hardly crosses biological membranes. Its distribution
compartment is therefore restricted to the extra cellular space. The
gentamicin concentrations obtained in tissue remain low and do not reach
values as obtained in the blood, with the exception of the renal cortex and
the inner ear, where an undesired accumulation of gentamicin due to an
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active transport is reached. The effect is supported in case of disturbed
renal function. The volume of distribution differs in the animal species
between 0.2 and 0.5 ml/kg. The distribution increases significantly when
the membranes show an increased permeability due to inflammation.
The binding of gentamicin to plasma proteins reaches about 20 to 30%,
depending on animal species.
Elimination of gentamicin after parenteral administration occurs almost
entirely by glomerular filtration with 24 hours. Elimination is characterised
by an initial phase followed by a time determining terminal phase (t½ß).
Elimination half-life is about 1.5 hours in cattle, dogs, and cats, in calves
about 3 hours.
6. Pharmaceutical particulars
6.1 List of Excipients:
Methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium
metabisulphite, water for injections.
6.2 Incompatibilities:
In additionally other drugs are administered, application should be done
separately to avoid any risk of interactions (inactivation) e.g. know for
mixtures with carbenicillin.
6.3 Shelf-life:
Shelf-life
Of the finished product as packaged for sale: 2 years
Of the finished product after first opening the container: 42 days
6.4 Special precautions for storage:
Store below 25°C! Protect from light!
6.5 Nature and composition of immediate packaging:
Glass vial (brown coloured, hydrolytic resistance of type II) containing 100
ml solution for injection.
6.6 Special precautions for the disposal of unused veterinary medicinal
product of waste materials derived from the use of such products:
Any unused veterinary medicinal product or waste material derived from
such veterinary medicinal products should be disposed of in accordance
with local requirements.
7. Marketing authorisation holder:
Demetrios Christoforou Ltd
Tseriou Avenue 169
2048,Strovolos,Nicosia
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8. Marketing authorisation number:11959
9. Date of first authorisation/Renewal of the authorisation:
12/10/1998
10. Date of revision of the text:
29/7/2010
11. Prohibition of sale, supply and/or use:
Not applicable
12. Legal status:
On prescription
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