natgillin/translations-raw huggingface dataset:
No adverse reactions have been observed following simultaneous subcutaneous administration of up to 10 implants.
Po sočasni subkutani namestitvi do 10 implantatov niso opazili neželenih učinkov.
Gonadotrophin-releasing hormones (GnRH), ATCvet code:
Gonadotropin sproščujoči hormoni (GnRH), oznaka ATC vet:
The GnRH agonist, deslorelin, acts by suppressing the function of the pituitary-gonadal axis when applied in a low, continuous dose.
Agonist GnRH deslorelin deluje tako, da zavira delovanje hipofizno- gonadne osi, če ga dajemo v majhnem, stalnem odmerku.
This suppression results in the failure of treated animals to synthesise and/ or release follicle stimulating hormone (FSH) and luteinising hormone (LH), the hormones responsible for the maintenance of fertility.
To zaviranje tretiranim živalim prepreči, da bi sintetizirale in/ ali sproščale folikle stimulirajoči hormon (FSH) in luteinizirajoči hormon (LH), ki sta odgovorna za vzdrževanje plodnosti.
4 The continuous low dose of deslorelin will reduce the functionality of the male reproductive organs, libido and spermatogenesis and lower the plasma testosterone levels, from 4-6 weeks after implantation.
Stalen majhen odmerek deslorelina bo 4- 6 tednov po implantaciji zmanjšal funkcionalnost moških reprodukcijskih organov, libido in spermatogenezo in znižal plazemsko koncentracijo testosterona.
Measurement of plasma concentrations of testosterone has demonstrated the persistent pharmacological effect of the continuing presence of deslorelin in the circulation for at least six months following administration of the product.
Meritve plazemskih koncentracij testosterona so pokazale trajen farmakološki učinek stalne prisotnosti deslorelina v krvnem obtoku vsaj šest mesecev po vsaditvi zdravila.
Hydrogenated palm oil Lecithin Sodium acetate anhydrous
Hidrogenirano palmovo olje Lecitin Natrijev acetat, brezvodni
The final sales presentation consists of a cardboard carton containing either two or five individually foil wrapped implanters that have been sterilised, together with an implanting device (actuator) that is not sterilised.
Končni prodajni izdelek predstavlja kartonasta škatla, ki vsebuje bodisi dva bodisi pet implantatorjev, posamič zapakiranih v folijo in steriliziranih, skupaj s pripravo za implantacijo (aktivatorjem), ki ni sterilizirana.
14 December 2007
< datum odločbe Komisije >
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A. < IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN > IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN( ODGOVORNI) ZA SPROŠČANJE SERIJE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
7 A. < IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN > IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN( ODGOVORNI) ZA SPROŠČANJE SERIJE
Hay-on-Wye HR3 5PG United Kingdom
Hay- on- Wye HR3 5PG Velika Britanija
Administer one implant only.
Ne uporabite, če je vrečka iz folije odprta ali poškodovana. Dajajte samo po en implantat.
4.7 mg deslorelin (as deslorelin acetate)
4, 7 mg deslorelin (v obliki deslorelinijevega acetata)
14 PACKAGE LEAFLET Suprelorin 4.7 mg implant for dogs
14 NAVODILO ZA UPORABO Suprelorin 4, 7 mg implantat za pse
Suprelorin is a white to pale yellow cylindrical implant containing 4.7 mg deslorelin (as deslorelin acetate).
Suprelorin je bel do svetlo rumen valjast implantat, ki vsebuje 4, 7 mg deslorelina (v obliki deslorelinijevega acetata).
Store in a refrigerator (2°C – 8°C) Do not freeze
Ne shranjujte v zamrzovalniku.
When administering the product, take care to avoid accidental self-injection by ensuring that animals are suitably restrained and the application needle is shielded until the moment of implantation.
16 Pri dajanju zdravila pazite, da bodo živali primerno imobilizirane in da bo igla za dajanje zdravila zaščitena s pokrovčkom vse do trenutka implantacije, da si zdravila ne bi nehote samoinjicirali.
One out of 75 dogs treated with the product during clinical trials mated and tied with a bitch on heat within six months of implantation, but this did not result in pregnancy.
Eden od 75 psov, ki so prejeli implantat v kliničnih preskusih, se je v šestih mesecih po implantaciji uspešno sparil s psico, ki se je gonila, vendar temu ni sledila brejost.
With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials more than 80% of dogs administered one or more implants, returned to normal plasma testosterone levels (≥ 0.4 ng/ ml) within 12 months of implantation.
Plazemska koncentracija testosterona (ki je uveljavljen nadomestni označevalec plodnosti) se je med kliničnimi preskusi pri več kot 80% psov, ki so jim dali po enega ali več implantatov, v 12 mesecih po implantaciji vrnila na normalne vrednosti (≥0, 4 ng/ ml).
During clinical trials, most of the smaller size dogs (< 10 kg) maintained suppressed levels of testosterone for more than 12 months following implantation.
Med kliničnimi preskusi je večina manjših psov (< 10 kg) vzdrževala znižane koncentracije testosterona več kot 12 mesecev po implantaciji.
Data demonstrates that treatment with the product will reduce the libido of the dog, but other behavioural changes (e. g. male-associated aggression) have not been investigated.
Podatki kažejo, da bo dajanje zdravila zmanjšalo libido psa, niso pa raziskovali drugih vedenjskih sprememb (n. pr. agresivnosti, povezane s samci).
14 December 2007
mesec LLLL
EMEA/ V/ C/ 038 EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
EMEA/ V/ C/ 038 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
What is Suvaxyn Aujeszky 783 + O/ W?
Kaj je zdravilo Suvaxyn Aujeszky 783 + O/ W?
Suvaxyn Aujeszky 783 + O/ W is a vaccine that contains a live attenuated (weakened) form of Aujeszky’ s disease virus strain NIA3-783.
Zdravilo Suvaxyn Aujeszky 783 + O/ W je cepivo, ki vsebuje živo, atenuirano (oslabljeno) obliko virusa Aujeszkyjeve bolezni, sev NIA3- 783.
Suvaxyn Aujeszky 783 + O/ W is a powder and solvent that are made up into an emulsion (a mixture of oil- and water-based liquids) for injection.
Zdravilo Suvaxyn Aujeszky 783 + O/ W je prašek in topilo za pripravo emulzije (zmes tekočin na osnovi olja in vode) za injiciranje.
What is Suvaxyn Aujeszky 783 + O/ W used for?
Za kaj se zdravilo Suvaxyn Aujeszky 783 + O/ W uporablja?
Suvaxyn Aujeszky 783 + O/ W is used to vaccinate pigs from the age of 10 weeks against Aujeszky’ s disease, an illness similar to rabies that is caused by a herpesvirus.
Zdravilo Suvaxyn Aujeszky 783 + O/ W se uporablja za cepljenje prašičev, starih 10 tednov ali več, proti Aujeszkyjevi bolezni, tj. bolezni, podobni steklini, ki jo povzroča herpesvirus.
Vaccination of gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets before) with Suvaxyn Aujeszky 783 + O/ W can also result in immunity in the pig’ s offspring.
Cepljenje mladic (samic, ki še niso imele pujskov) in svinj (samic, ki so že imele pujske) z zdravilom Suvaxyn Aujeszky 783 + O/ W lahko privede tudi do imunosti njihovih potomcev.
Suvaxyn Aujeszky 783 + O/ W is given as two 2-ml injections into the muscle of the neck behind the ear, three to four weeks apart.
Zdravilo Suvaxyn Aujeszky 783 + O/ W se daje v obliki dveh 2 ml injekcij v mišico vratu za ušesom v razmiku treh do štirih tednov.
How does Suvaxyn Aujeszky 783 + O/ W work?
Kako zdravilo Suvaxyn Aujeszky 783 + O/ W deluje?
Suvaxyn Aujeszky 783 + O/ W is a vaccine.
Zdravilo Suvaxyn Aujeszky 783 + O/ W je cepivo.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a diseases.
Cepiva delujejo tako, da imunski sistem (naravno obrambo telesa) naučijo, kako naj se brani pred boleznijo.
Suvaxyn Aujeszky 783 + O/ W contains small amounts of a weakened form of the virus that causes Aujeszky’ s disease.
Zdravilo Suvaxyn Aujeszky 783 + O/ W vsebuje majhne količine oslabljene oblike virusa, ki povzroča Aujeszkyjevo bolezen.
The vaccine also contains ‘ adjuvants ’ (a compound containing aluminium as well as mineral oil, an emulsifier and a detergent) to stimulate a better response.
Cepivo vsebuje tudi adjuvans (spojino, ki vsebuje aluminij, mineralno olje, emulgator in detergent) za stimulacijo boljšega odziva.
When a pig is given the vaccine, the immune system recognises the weakened viruses as ‘ foreign’ and makes antibodies against them.
Ko prašič prejme cepivo, imunski sistem prepozna oslabljene viruse kot tujke in proti njim razvije protitelesa.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Suvaxyn Aujeszky 783 + O/ W been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Suvaxyn Aujeszky 783 + O/ W raziskano?
The effectiveness of Suvaxyn Aujeszky 783 + O/ W has been studied in a large number of pigs in several farms in studies lasting around two years.
Učinkovitost zdravila Suvaxyn Aujeszky 783 + O/ W so preučevali pri velikem številu prašičev na različnih farmah v okviru raziskav, ki so trajale približno dve leti.
The herds of pigs were monitored for signs of infection with the type of Aujeszky’ s disease virus that is can be caught in the field.
V čredah prašičev so spremljali znake okužbe s vrsto virusa Aujeszkyjeve bolezni, s katerim se je mogoče okužiti v okolju.
What benefit has Suvaxyn Aujeszky 783 + O/ W shown during the studies?
Kakšne koristi je zdravilo Suvaxyn Aujeszky 783 + O/ W izkazalo med raziskavami?
Suvaxyn Aujeszky 783 + O/ W was effective at preventing infection with the virus.
Zdravilo Suvaxyn Aujeszky 783 + O/ W je bilo učinkovito pri preprečevanju okužbe z virusom.
What is the risk associated with Suvaxyn Aujeszky 783 + O/ W?
Kakšna tveganja so povezana z zdravilom Suvaxyn Aujeszky 783 + O/ W?
An increase in body temperature up to about 40.5°C can occur in a small number of pigs, lasting for up to two days.
Tako stanje lahko traja do dva dni.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Koliko časa je potrebno počakati preden se žival lahko zakolje in meso uporabi za prehrano ljudi (karenca)?
Why has Suvaxyn Aujeszky 783 + O/ W been approved?
Zakaj je bilo zdravilo Suvaxyn Aujeszky 783 + O/ W odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn Aujeszky 783 + O/ W exceed the risks for the active and passive immunisation of pigs to prevent or reduce the mortality and clinical signs of Aujeszky’ s disease and to reduce the excretion of Aujeszky’ s disease field virus, and recommended that Suvaxyn Aujeszky 783 O/ W be given a marketing authorisation.
Zato je priporočil, da se za zdravilo Suvaxyn Aujeszky 783 O/ W odobri dovoljenje za promet.
Other information about Suvaxyn Aujeszky 783 + O/ W:
Druge informacije o zdravilu Suvaxyn Aujeszky 783 + O/ W:
The European Commission granted a marketing authorisation valid throughout the European Union for Suvaxyn Aujeszky 783 + O/ W to Fort Dodge Animal Health Holland on 7 August 1998.
Evropska komisija je dovoljenje za promet z zdravilom Suvaxyn Aujeszky 783 + O/ W, veljavno po vsej Evropski uniji, odobrila družbi Fort Dodge Animal Health dne 7. avgusta 1998.
The marketing authorisation was renewed on 7 August 2003.
Dovoljenje za promet z zdravilom je bilo podaljšano 7. avgusta 2003.
Tradename Strength
Izmišljeno ime
Pharmaceutical Form
Farmacevtska Ciljna oblika živalska vrsta
Target Route of species administration
Način uporabe zdravila:
Suvaxyn
Suvaxyn Aujeszky
Live attenuated
Živ, atenuiran virus Aujeszkyjeve bolezni, sev NIA3- 783: ≥ 105. 2
Emulsion for
Emulzija za injiciranje po
7 ml glass vial (freeze- 1 x 10
7 ml steklena viala (liofilizirana sestavina)
1 vial of 10
1 x 10 odmerkov
0 days
1 viala z 10 0 dni odmerki in 1
Aujeszky’ s Disease Virus, strain NIA3- 783: ≥ 105.2 CCID50* per dose.
CCID50 * na odmerek.
injection after reconstitution
rekonstituciji
dried component) & doses 22 ml glass bottle (liquid component)
in 22 ml steklenička (tekoča sestavina)
doses and 1 bottle for reconstitution
stekleničko za rekonstitucijo
7 ml glass vial (freeze- 1 x 50
7 ml steklena viala (liofilizirana sestavina)
1 vial of 50
1 x 50 odmerkov
0 days
1 viala s 50 0 dni odmerki in 1
dried component) & doses 105 ml glass bottle (liquid component)
in 105 ml steklenička (tekoča sestavina)
7 ml glass vial (freeze-
7 ml steklena viala (liofilizirana sestavina)
1 vial of 100 0 days
1 x 100 1 viala s 100 0 dni odmerkov odmerki in 1
dried component) & doses 210 ml glass bottle (liquid component)
in 210 ml steklenička (tekoča sestavina)
10 vials of 10 0 days
10 x 10 10 vial z 10 0 dni odmerkov odmerki in 10
doses and 10 bottles for reconstitution
stekleničkami za rekonstitucijo
10 vials of 50 0 days
10 x 50 10 vial s 50 0 dni odmerkov odmerki in 10
7 ml glass vial (freeze-
7 ml steklena viala (liofilizirana
10 vials of 100 0 days
10 x 100 10 vial s 100 0 dni odmerkov odmerki in 10
dried component) & 100 210 ml glass bottle (liquid component)
sestavina) in 210 ml steklenička (tekoča sestavina)
Suvaxyn Aujeszky 783 + O/ W, powder and solvent for emulsion for injection.
Suvaxyn Aujeszky 783 + O/ W Prašek in topilo za pripravo emulzije za injiciranje Za prašiče
Active substance(s) Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion
Zdravilne učinkovine:
CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Živ, atenuiran virus Aujeszkyjeve bolezni, sev NIA3- 783: ≥105. 2. ≥CCID50 * v 2 ml odmerka po pripravi emulzije * CCID50 = količina virusa, ki inficira 50% inokuliranih celičnih kultur
One dose of 2 ml contains Adjuvants:
Adjuvansi:
Aluminium hydroxide Mineral oil (Marcol 52) Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80) Excipient
Aluminijev hidroksid Mineralno olje (Marcol 52) Manidijev monooleat (Arlacel A) Polisorbat 80 (Tween 80)
Powder and solvent for emulsion for injection
Prašek in topilo za pripravo emulzije za injiciranje.
Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky’ s Disease and to reduce the excretion of Aujeszky’ s Disease field virus.
Aktivna imunizacija prašičev, starih 10 tednov z namenom zmanjšanja pogina in klinične manifestacije zaradi Aujeszkyjeve bolezni ter za redukcijo prisotnosti virusa Aujeszkyjeve bolezni v okolju.
Passive immunisation of the progeny of vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky’ s Disease and to reduce the excretion of Aujeszky’ s Disease field virus.
Pasivna imunizacija pujskov, katerih matere so bile cepljene, z namenom zmanjšanja pogina in manifestacije kliničnih znakov zaradi Aujeszkyjeve bolezni in za zmanjšanje prisotnosti virusa v okolju.
- Active immunity:
- Aktivna imunost:
The onset of immunity is from 3 weeks after basic vaccination.
Razvije se v 3 tednih po cepljenju.
The immunity lasts
Imunost traja 3 mesece po osnovnem cepljenju.
for 3 months after basic vaccination.
4. 3 Kontraindikacije
4.3 Contraindications
Niso znane.
4.4 Special warnings for each target species
2 4. 4 Posebna opozorila za vsako ciljno živalsko vrsto
None
Niso potrebna.
Special precautions for use in animals Do not administer in conjunction with other medicinal products.
Posebni previdnostni ukrepi za uporabo pri živalih Ne uporabljajte skupaj z drugimi pripravki.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash and disinfect hands and equipment after use.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Po dajanju si operite in razkužite roke in opremo.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
Če vam je bil ta pripravek nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina in mu pokažite navodila za uporabo.
This product contains mineral oil.
Ta pripravek vsebuje mineralno olje.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Po dajanju si operite in razkužite roke in opremo.
Slight, transient and local reactions up to 2 cm in diameter after first vaccination and up to 5 cm after second vaccination may occur up to 50% of the pigs.
Pri približno 50% živali se lahko po cepljenju pokaže škodljiva reakcija v obliki 2 cm velike otekline po prvem cepljenju in 5 cm velike otekline po drugem cepljenju.
A transient increase in body temperature, up to about 40.5oC and lasting for up to 2 days, may occur in a small number of pigs after vaccination.
Tako stanje lahko traja do 2 dni.
In very rare cases (< 1/ 100000), hypersensitivity can be observed.
V zelo redkih primerih (< 1/ 100000) so opazili preobčutljivostne reakcije.
No information is available on the compatibility of this vaccine with any other.
Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim.
Therefore the safety and efficacy of this product when used with any other (either used on the same day or at different times) has not been demonstrated.
Zato varnosti in učinkovitosti tega zdravila ob uporabi z drugimi zdravili (bodisi na isti ali drugi dan) niso ugotavljali.
For intramuscular use To reconstitute the vaccine, inject 3 ml of solvent into the small vial with the powder.
Za rekonstitucijo cepiva injiciraj 3 ml topila v vialo s praškastim delom.
Shake gently to disolve the vaccine and transfer the disolved vaccine into the vial with the solvent.
Nežno pretresi, da se cepivo raztopi in prenesi raztopljeno cepivo nazaj v stekleničko s topilom.
To avoid foaming, shake gently the vial after reconstitution of the freeze-dried component in the liquid component.
Da preprečiš penjenje, pretresi raztopljeni prašek v topilu zelo nežno.
Use sterile syringes and needles.
Uporabljaj sterilne brizge in igle.
Administer by intramuscular injection of 1 dose (2 ml) per pig in the neck in the area behind the ear.
En odmerek (2 ml) na prašiča apliciraj intramuskularno v vratni predel za ušesom.
3 Basic vaccination of fattening pigs and breeding pigs (gilts, sows and boars): • Inject one dose per fattening pig from the age of 10 weeks.
3 • Z enim odmerkom cepiva cepimo prašiče pitance pri starosti 10 tednov.
A second dose may be injected 3 – 4 weeks after the first injection.
Naslednji odmerek apliciramo 3- 4 tedne po prvem cepljenju.
The presence of maternal antibodies against Aujeszky’ s Disease Virus may have a negative influence on the result of vaccination. • Inject one dose per breeding pigs (gilts, sows and boars) from the age of 10 weeks followed by a second injection 3 – 4 weeks after the first injection.
Cepljenje ponovimo čez 3- 4 tedne.
Re-vaccination of breeding pigs (gilts, sows and boars): • Inject one dose per gilt before the first mating, or • Inject one dose per gilt or sow during each gestation at 3 - 6 weeks before the expected date of farrowing. • Inject one dose per boar at least every 6 months.
• Injiciraj en odmerek na mladico pred prvim parjenjem, ali • Injiciraj en odmerek na mladico ali svinjo v obdobju 3- 6 tednov pred pričakovano gonitvijo • Injiciraj en odmerek na merjasca najmanj vsakih 6 mesecev.
IMMUNOLOGICAL PROPERTIES
IMUNOLOŠKE ZNAČILNOSTI
QI 09 AD 01
QI 09 AD 01 Cepivo proti Aujeszkyjevi bolezni
The active substance stimulates active immunity against Aujeszky’ s Disease in pigs.
Zdravilna učinkovina povzroči nastanek aktivne imunosti proti Aujeszkyjevi bolezni pri prašičih.
The gE- (glycoprotein E negative) characteristic of the vaccine virus makes it possible to distinguish between antibodies induced by vaccination with this product and those induced by field infection with Aujeszky’ s Disease Virus, if the vaccine is used in association with an appropriate diagnostic test.
Glikoprotein E negativen (gE -) je značilen za cepivo in se odlikuje ravno v tem, da omogoča s specifičnim diagnostičnim testom potrditev prisotnosti protiteles, nastalih zaradi cepljenja in izključitev protiteles, pridobljenih z okužbo virusov Aujeszkyjeve bolezni iz okolja.
Therefore, the product is suitable to be used in eradication programmes against Aujeszky’ s Disease field virus in pigs based on the presence or absence of antibodies against the gE-antigen of that virus.
Tako je pripravek primeren za uporabo za program eradikacije proti virusom Aujeszkyjeve bolezni pri prašičih, temelječ na prisotnosti ali odsotnosti specifičnih protiteles proti gE- antigenu tega virusa.
Aluminium hydroxide Mineral oil (Marcol 52)l Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80) Thiomersal Disodiumhydrogenphosphate Sodiumhydrogenphosphate Mannitol Water for injections
Aluminijev hidroksid Mineralno olje (Marcol 52) l Manidijev monooleat (Arlacel A) Polisorbat 80 (Tween 80) Tiomersal Dinatrijev hidrogenfosfat Natrijev hidrogenfosfat Manitol Voda za injiciranje
4 6.2 Incompatibilities
4 6. 2 Inkompatibilnosti
Shelf-life of the veterinary medicinal product as packaged for sale (powder):
Rok uporabnosti veterinarskega zdravila, pakiranega za prodajo (prašek):
Shelf-life of the veterinary medicinal product as packaged for sale (solvent):
2 leti Rok uporabnosti veterinarskega zdravila, pakiranega za prodajo (topilo):
Shelf-life after reconstitution according to directions:
2 leti Rok uporabnosti po rekonstituciji v skladu z navodili:
Store and transport refrigerated (2°C – 8°C).
Shranjujte in prevažajte v hladilniku (2 C- 8 ˚C).
Solvent for emulsion for injection:
Topilo za pripravo emulzije za injiciranje:
20 ml, 100 ml or 200 ml bottles of Type I hydrolytic glass containing solvent for the 10-doses, 50- doses or 100-doses presentation.
20 ml, 100 ml ali 200 ml stekleničke iz hidrolitičnega stekla (tip I), ki vsebujejo topilo za 10, 50 ali 100 odmerkov cepiva.
The bottles are closed with a butyl rubber stopper and sealed with an aluminium cap.
Kartonska škatla z 1 vialo praška in 1 stekleničko topila ali z 10 vialami s praškom in 10 stekleničkami topila.
6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any.
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp Nizozemska
22.08.2008
DATUM REVIZIJE BESEDILA
Prohibition of sale, supply and/ or use
PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
The import, sale, supply and/ or use of Suvaxyn Aujeszky 783 + OW is or may be prohibited in certain Member States on the whole or part of their territory pursuant to National animal health policy.
Uvoz, prodaja, oskrba in/ ali uporaba pripravka Suvaxyn Aujeszky 783+OW je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/ or use Suvaxyn Aujeszky 783 + OW must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati Suvaxyn Aujeszky 783+OW, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, še pred uvozom prodajo, oskrbo in/ ali uporabo.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN
STATEMENT OF THE MRLs
POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM