ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetalgin 500 mg/ml injectable solution for horses, cattle, pigs and dogs
Metamizol sodium 1 H2O
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml injectable solution contains:
Active substance:
Metamizol sodium 1 H2O
500 mg
Excipients:
Benzyl alcohol
30 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Injectable solution for intramuscular or intravenous administration.
4.
CLINICAL PARTICULARS
4.1
Target species
Horses, cattle, pigs, dogs
4.2
Indications for use, specifying the target species
Dogs:
Disease states which are expected to respond positively to the analgesic, antipyretic,
antiphlogistic and/or spasmolytic action of metamizol. These include in particular
acute and chronic arthritis, rheumatic ailments affecting the muscles and joints,
neuritis, neuralgia and tendovaginitis.
Horses, cattle, pigs:
Disease states which are expected to respond positively to the analgesic, antipyretic,
spasmolytic and/or antiphlogistic action of metamizol.
These include in particular:
- Pain treatment for colic of different aetiology or other convulsive states of the
abdominal cavity of horses and cattle.
- Lumbago
- Oesophageal obstruction
- Febrile diseases such as severe mastitis, MMA (Mastitis-Metritis-Agalactia)
syndrome, swine influenza
- Acute and chronic arthritis, rheumatic ailments affecting the muscles and
joints, neuritis, neuralgia, tendovaginitis
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4.3
Contraindications
Vetaglin should not be used in the following conditions:
- Presence of gastrointestinal ulcers
- Chronic gastrointestinal disorders
- Disorders of the haematopoietic system
- Renal insufficiency
- Coagulopathies
- Bronchial asthma
Do not use in mares whose milk is intended for human consumption.
4.4
Special warnings for each target species
None
4.5
Special precautions for use
Special precautions for use in animals:
Because of the potential risk of shock the intravenous injection of Vetalgin should be
given very slowly. Do not inject subcutaneously, as this can cause tissue irritations.
Hypotonic or unstable circulatory conditions require a strict diagnosis.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals:
None.
4.6
Adverse reactions (frequency and seriousness)
After intramuscular administration transient pain reactions may occur at the injection
site.
Prolonged treatment with Vetaglin at high dose rates can promote development of
the following side effects:
- Irritation and risk of haemorrhage in the gastrointestinal tract
- Impairment of renal function
- Changes in the haematological profile, leukocyte depression
- Allergic reactions
- Bronchospasms in predisposed animals
The haematological status should be monitored during prolonged use.
Any side effects observed after using Vetaglin should be reported to the local
authorities or the marketing authorisation holder.
4.7
Use during pregnancy, lactation or lay
Use in late pregnancy necessitates careful consideration.
The metabolites of metamizol cross the placental barrier and pass into the milk.
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4.8
Interaction with other medicinal products and other forms of interaction
The concurrent use of inducers of liver microsome enzymes (e.g. barbiturates,
phenylbutazone) reduces the half-life of metamizol and hence the duration of action.
The concomitant administration of neuroleptics, especially phenothiazine derivatives,
can lead to severe hypothermia.
The risk of gastrointestinal haemorrhages is increased by the concurrent use of
glucocorticoids. The diuretic action of furosemide is weakened. The concomitant use
of other weak analgesics enhances the actions and side effects of metamizol.
4.9
Amounts to be administered and administration route
Dogs:
Slow intravenous and intramuscular injection
20-50 mg metamizol sodium / kg BW, equivalent to
0.04-0.1 ml Vetaglin per kg BW
Horses:
Slow intravenous injection
20-50 mg metamizol sodium / kg BW, equivalent to
2-5 ml Vetaglin per 50 kg BW
Cattle:
Slow intravenous injection
20-40 mg metamizol sodium / kg BW, equivalent to
2-4 ml Vetaglin per 50 kg BW
Pigs:
Slow intravenous and intramuscular injection
15-50 mg metamizol sodium / kg BW, equivalent to
0.3-1 ml Vetaglin per 10 kg BW
The stated doses are single doses and may be repeated after 8 hours if required.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In the event of an acute overdose, profuse salivation, vomiting, blood pressure fall
and circulatory collapse occur. The first signs are increased respiratory rate and
convulsions, eventually culminating in coma and respiratory paralysis. Vetaglin must
be discontinued at the first sign of an overdose: the subsequent treatment is
symptomatic.
4.11 Withdrawal period(s)
Cattle (i.v.)
Edible tissues
Milk
12 days
4 days
Horses (i.v.)
Edible tissues
12 days
Pigs (i.v., i.m)
Edible tissues
15 days
Do not use in mares whose milk is intended for human consumption.
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5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: other analgesics, Pyrazolone derivates
ATCvet code: QN02BB02
5.1
Pharmacodynamic properties
Metamizol is a pyrazolone derivative and is used as an analgesic, antiphlogistic,
antipyretic and spasmolytic agent.
It is a member of the non-steroidal anti-inflammatory class of drugs, which have
powerful central analgesic and antipyretic activity but less potent antiphlogistic action
(week analgesics).
Like all weak analgesics and non-steroidal anti-inflammatory agents, metamizol
inhibits the synthesis of prostaglandins by blocking cyclooxygenese. The analgesic
and antipyretic activity are primarily due to the inhibition of prostaglandin E2, which is
involved in pain sensation and transmission, both centrally and peripherally.
Metamizol additionally exerts a spasmolytic effect on smooth-muscled organs.
The acute toxicity of metamizol is low. LD50 values are 3127-4800 mg/kg body weight
in rats and mice and 1000 mg/kg body weight in guinea pigs. Dosage levels of 10004000 mg/kg body weight induce sedation and convulsions in the tested species.
Signs of chronic toxicity after prolonged administration occurred in dogs at dose rates
between 400 and 600 mg/kg body weight.
There is no evidence of teratogenicity of metamizol. However, in rats high doses of
metamizol resulted in reduced litter sizes per female, reduced mean foetal weights
and lower progeny survival rates until day 4 of lactation.
Mutagenicity studies were negative. Although a higher incidence of liver tumours was
observed in some strains of mice after prolonged treatment, their formulation was
probably due to a non-genotoxic, hepatotoxic effect.
5.2 Pharmacokinetic particulars
Metabolisation is very rapid. The principal active metabolite is methylaminoantipyrine
which is formed through hydrolisation. Elimination is primarily via the renal route, in
lactating animals also with the milk. The elimination half-life is 4-5 hours in dogs. The
plasma protein binding of the principal metabolites is under 60%.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Benzyl alcohol
Water for injection
6.2
Incompatibilities
None.
6.3
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after first opening the container: 28 days
6.4.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
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6.5
Nature and composition of immediate packaging
Clear glass vial type II containing 50 ml and100 ml injectable solution, closed with a
rubber stopper type I and sealed with an aluminium cap.
Not all pack sizes may be marketed.
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 products should be disposed of in accordance with local
requirements.
7.
MARKETING AUTHORISATION HOLDER
Ιntervet International B.V.
Wim de Korverstraat 35,
5831 AN Boxmeer,
The Netherlands
8.
MARKETING AUTHORISATION NUMBER(S)
Α.Α.Κ Κύπρου:3419
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/10/1972,12/1/2015
10
DATE OF REVISION OF THE TEXT
12/1/2015
11.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
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