ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
Name of the veterinary medicinal product
ASCOPIR, 40g/100g, soluble powder to be dissolved in drinking water or
liquid feed for oral administration, calves, swine, broilers
2.
Qualitative and quantitative composition
100 g of ASCOPIR contain:
Active ingredient
40.0 g
Acetylsalicylic acid
Excipients
For a full list of excipients see section 6.1.
3.
4.
Pharmaceutical form
Soluble powder to be carefully dissolved in drinking water or liquid feed.
Clinical particulars
4.1.Target species
Calves
Swine
Broiler
4.2. Indications for use, specifying the target species
Swine, broilers, calves: anti-pyretic, analgesic, antiphlogistic and platelet
anti-aggregating, inflammatory, even infective syndromes, osteoarticular
and muscular syndromes, thermal stress.
4.3. Contraindications
Avoid treating dehydrated animals, and those with gastro-enteric
complications.
4.4. Special warnings for each target species
Not to be used in animals which produce milk for human consumption,
and in hens, which produce eggs for the same use.
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4.5. Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Personal protective equipment should be worn when handling the
veterinary medicinal product.
4.6. Adverse reactions (frequency and seriousness)
It may provoke gastric injuries.
4.7. Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established
during pregnancy and lactation. Use only accordingly to the benefit/risk
assessment by the responsible veterinarian.
4.8. Interactions with other medicinal products and other forms of interaction
Avoid the combined administration with other non-steroid antiinflammatory drugs (FANS) and with amino-glycoside antibiotics.
4.9. Amounts to be administered and administration route
Calves: 40 mg of acetylsalicylic acid per kg of body weight, equal to 100
mg of ASCOPIR /kg b.w. /day, to be administered in drinking water or
liquid feed.
Swine: 40 mg of acetylsalicylic acid per kg of body weight, equal to 100
mg of ASCOPIR / kg b.w./day, to be administered in drinking water or
liquid feed.
Broiler: 40 mg of acetylsalicylic acid per kg of body weight, equal to 100
mg of ASCOPIR / kg b.w./day, to be administered in drinking water.
4.10. Overdose (symptoms, emergency procedures and antidotes) if
necessary
Symptoms from overdosage are not known.
Don’t exceed the recommended doses.
4.11. Withdrawal periods
Zero days.
Use not allowed in animals producing milk for human use and during
laying in hens producing eggs for human consumption.
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5.
Pharmacological properties
Pharmacotherapeutic group: others analgesics and antipyretics.
ATC vet code: QN02BA01.
5.1. Pharmacodynamic properties
Acetyl-salicylic acid exercises analgesic, anti-inflammatory, anti-pyretic
and platelet anti-aggregate action, by means of its inhibitory effect on the
biosynthesis of the eicosanoids, arising from the metabolism of
arachidonic acid.
The lacking bradykinin and prostaglandin synthesis, causing
inflammation and the action on the pain receptors at the level of the
peripheral nervous system, is the basis on which the analgesic and antiinflammatory activity rests. In addition, the lack in production of the
endogenous pyrogen (interleukine 1) by the leukocytes, and the
increased heat loss, bring about a temperature decrease, when it is
higher than normal.
ASA, by blocking several arachidonic acid metabolic pathways, favors
the production of prostacycline, which inhibits platelet aggregation and
thereby prevents the formation of thrombi.
5.2. Pharmacokinetic particulars
After its absorption, the bioavailability is very high in all species, and the
diffusivity is excellent in all body compartments of the organism.
It is then metabolized at the hepatic level by conjugation with glycine and
glucuronic acid, from which salicyluric, salicyl-glucuronide, and in a
minimal percentage gentisic acid are derived.
These metabolites are then excreted in the urine in different
concentrations, depending on the metabolizing capacity, which varies
according to the age and species.
6.
Pharmaceutical information
6.1. List of excipients
Sodium citrate.
Sodium carbonate.
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6.2. Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product
must not be mixed with other veterinary medicinal product.
6.3. Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 24
months.
Shelf-life after first opening the immediate packaging: 6 months.
Shelf-life after dilution or reconstitution according to directions: 12 hours.
6.4. Special precautions for storage
The product should be stored in a dry place at temperatures below
+25°C.
6.5. Nature and composition of immediate packaging
The product is packaged into the following direct containers:
100 g sachet, 1 kg sachet, 5 kg bag in PET/AL/PE.
6.6. Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such product
Don’t waste the environment.
All veterinary medicinal products or waste materials derived from such
medicinal products should be disposed of according to local legislation.
7.
Marketing Authorization Holder and Manufacturer responsible of batch
release
Marketing Authorization Holder:
Vétoquinol Italia S.r.l. Via Piana, 265 – 47032 Bertinoro (FC) – Italy
Manufacturer responsible of batch release:
ASCOR CHIMICI S.r.l. Via Piana, 265 47032 Bertinoto (FC) Italy
8.
Marketing Authorization Numbers
100 g sachet
1 kg sachet
5 kg bag
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9.
Date of first Authorization/renewal of the authorization
10.
Date of revision of the text
24/01/2013
Prohibition of sale, supply and/or use
Not applicable
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