What does the SPC contain?
What does the SPC contain?
What does the Summary of Product Characteristics (SPC) for a veterinary medicinal product contain?
The Summary of Product Characteristic (SPC) is produced in collaboration with the marketing authorisation applicant and the regulatory authorities. The use of the veterinary product is closely monitored even after the granting of the marketing authorisation. Should new properties or undesirable effects occur in wider use, they are recorded in the SPC and the package information leaflet.
The SPC for a veterinary medicinal product contains 11 main headings:
1. Name of the veterinary medicinal product (ELÄINLÄÄKEVALMISTEEN NIMI)
The name of the veterinary medicinal product may be an invented name or it may be accompanied by details descriptive of the strength and pharmaceutical form of the veterinary medicinal product (examples indented).
WETQVET 25 mg/ml solution for injection
2. Qualitative and quantitative composition (LAADULLINEN JA MÄÄRÄLLINEN KOOSTUMUS)
The composition of the product is given in this section. The names of the substances are given by using their international names (preferably INN, International Non-proprietary Name) and the quantities of one unit dose (e.g. tablet) or volume are given.
One millilitre of the product contains 25 mg of wetkviin.
In addition to the active agents, excipients which may affect the safe use of the product must also be stated. These include any preservatives used, for example.
3. Pharmaceutical form (LÄÄKEMUOTO)
The pharmaceutical form of the veterinary medicinal product is described under this heading detailing whether it is a tablet, capsule, effervescent powder, oral liquid, eye drops, intravenous infusion etc. The appearance of the product may also be represented, e.g.
Solution for injection
A clear pink liquid
4. Pharmacological properties (FARMAKOLOGISET OMINAISUUDET)
4.1 Pharmacodynamic properties (Farmakodynamiikka)
The section on pharmacodynamic properties describes the main effects of the veterinary medicinal product on the organ system and possibly also the mechanism of action.
Wetkviini is an anti-inflammatory analgesic which reversibly inhibitis cyclo-oxygenase.
The pharmacotherapeutic group, i.e. the classification of the product in the ATC system, is also given in this section.
The ATC Code of all veterinary medicinal products begins with the letter Q.
Pharmacotherapeutic group: Anti-inflammatory analgesics, ATC Code: QM01XX99.
4.2 Pharmacokinetic properties (Farmakokinetiikka)
The paragraph on pharmacokinetic properties describes the various stages of the medicinal product in the organ system; the absorption, distribution, metabolism and excretion.
Wetkviini is well absorbed after intramuscular injection in sheep. The bioavailability of a recommended intramuscular dose of 1 mg/kg is 90% and the peak plasma concentration (0.4 microg/ml) is obtained within one hour. The elimination half-life is 3 hours. The drug is almost completely excreted unchanged via the kidneys.
5. Clinical particulars (KLIINISET TIEDOT)
5.0 Target species (Kohde-eläinlaji)
The approved target species are listed in this section. If the product is intended only for a certain age group or other group, this should also be mentioned.
Beef cattle (dairy cow)
5.1 Indications for use (Käyttöaiheet)
The paragraph on the therapeutic indications includes the purposes for which the veterinary medicinal product may be used in each target species in accordance with the conditions of the marketing authorisation, e.g.
In dairy cows: as an analgesic in arthritis and in laminitis
In sheep: as an analgesic in arthritis.
5.2 Contraindications (Vasta-aiheet)
This paragraph describes the situations in which the veterinary medicinal product should not be used (definitive contraindications).
Do not use in animals with hypersensitivity to wetkviini or any of the ingredients of the product.
This section may also include information about animal species which do not tolerate the product.
5.3 Undesirable effects (frequency and seriousness) (Haittavaikutukset)
All undesirable effects found during clinical trials will be described here, including their prevalence, e.g.:
As a result of an intramuscular injection, about one tenth of sheep treated may exhibit a reaction with a diameter of 5 cm at the injection site. The reaction usually disappears within about a week.
5.4 Special precautions for use (Käyttöön liittyvät erityiset varotoimet)
This section warns about use in animals with a renal or hepatic disorder, for example, or use in very young and very old animals (relative contraindications).
In animals with a renal disorder the excretion of the active agent may be considerably reduced.
5.5 Use during pregnancy and lactation (Tiineys ja laktaatio)
It must be ensured that administration of the medication to pregnant or lactating animals is safe even for the offspring. Associated safety information is given in this section.
May be used in pregnant ewes and cows.
Details of administration in laying hens or animals used for breeding are also given in this section, whereas details of administration in animals producing milk for human consumption are found in section 5.10.
5.6 Interaction with other veterinary medicinal products and other forms of interaction (Yhteisvaikutukset muiden eläinlääkevalmisteiden kanssa sekä muut yhteisvaikutukset)
This paragraph gives details of any harmful interactions that may occur, for example, between the product in question and other medicinal products.
No other anti-inflammatory analgesics should be used within 24 hours of the use of this product, because they may compete for the plasma protein binding sites.
5.7 Posology and method of administration (Annostus ja antotapa)
This section will include the route of administration, frequency of administration and dose per kg of body weight per day, and also the duration of the course of treatment.
In dairy cows: either intravenous or intramuscular injection of 0.5 mg/kg once daily for 3-5 days.
5.8 Overdose (Yliannostus)
The clinical symptoms, severity and duration of symptoms including treatment are described in this paragraph.
An overdose may cause diarrhoea. Symptomatic treatment is indicated.
5.9 Special warnings for each target species (Erityisvaroitukset kohde-eläinlajeittain)
Any information emerging in clinical trials and important to consider in view of safe and effective use of the product is given in this section.
Intravenous injection is recommended in sheep, because intramuscular injection causes rather severe reactions at the injection site.
5.10 Withdrawal period (Varoaika)
The withdrawal period is the time that has elapsed from the administration of the medication, during which time the animal may not be slaughtered, nor may its produce (milk, eggs, honey) be used for human consumption.
Meat 8 days
Milk 3 days
5.11 Special precautions to be taken by the person administering the veterinary medicinal product to animals. (Mahdolliset varotoimenpiteet. joita eläinlääkevalmistetta antavan henkilön on noudatettava)
In this section the user is advised to administer the veterinary medicinal product without putting the safety of the user at risk.
The product is an irritant. Following inadvertent self injection, contact should be made with a doctor.
6. Pharmaceutical particulars (FARMASEUTTISET TIEDOT)
6.1 Major incompatibilities (Yhteensopimattomuudet)
This section will state if the veterinary medicinal product should not be mixed in the same solution with another product.
6.2 Shelf life (Kestoaika)
This section will state the shelf life of the veterinary medicinal product in a closed package, diluted according to instructions and in an opened package.
6.3 Special precautions for storage (Säilytystä koskevat erityiset varotoimet)
This section describes the conditions for storage.
Store below 25 ºC.
Store in the original container.
6.4 Nature and contents of container (Pakkaustyyppi ja pakkauskoko)
The paragraph lists all the package sizes and types for which marketing authorisation has been approved. Not all pack sizes may be marketed in Finland.
An injection bottle made of polyethylene containing 100 ml, closed with a bromobutyl cap and an aluminium seal.
6.5 Special precautions for the disposal of unused medicinal product or waste materials, if any (Erityiset varotoimet käyttämättömien eläinlääkevalmisteiden tai niistä peräisin olevien jätemateriaalien hävittämiselle)
Instructions for safe disposal of any unused veterinary medicinal product or waste materials are given in this section. Warnings about any possibility of the product being poisonous to water organisms are also given here.
7. Prohibition of sale, supply and/or use (MYYNTIÄ, TOIMITTAMISTA JA/TAI KÄYTTÖÄ KOSKEVA KIELTO)
On the basis of the country's disease free status or adopted eradication programme, Finland may prohibit the sale, distribution and use of an immunological product. The product therefore has a valid marketing authorisation but its use in Finland is prohibited.
8. Name and address of the marketing authorisation holder (MYYNTILUVAN HALTIJAN NIMI JA OSOITE)
9. Marketing authorisation number(s) (MYYNTILUVAN NUMERO(T))
10. Date of first authorisation (MYYNTILUVAN MYÖNTÄMISPÄIVÄMÄÄRÄ / UUDISTAMISPÄIVÄMÄÄRÄ)
The paragraph gives the original date of authorisation, or, if the authorisation has been renewed, the renewal date is given. This section may also be empty.
24.12.1995 / 20.12.2000
11. Date of revision of the text (TEKSTIN MUUTTAMISPÄIVÄMÄÄRÄ)
This section contains the date of the most recent revision of the SPC.