natgillin/translations-raw huggingface dataset:
This medicinal product does not require any special storage conditions prior to reconstitution.After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator) 
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca Po razredčitvi je infuzijska raztopina stabilna 24 ur pri temperaturi med 2 °C in 8 °C
Iasibon 1 mg concentrate for solution for infusion ibandronic acid 
Iasibon 1 mg koncentrat za raztopino za infundiranje ibandronska kislina
Diarrhoea, vomiting, dyspepsia, gastrointestinal pain, tooth disorder 
Bolezni prebavil diareja, bruhanje, dispepsija, gastrointestina lna bolečina,
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 2 mg concentrate for solution for infusion ibandronic acid 
IME ZDRAVILA IN POT(I) UPORABE Iasibon 2 mg koncentrat za raztopino za infundiranje ibandronska kislina i.v.
Iasibon 2mg is supplied as pack containing 1 ampoule (4 ml type I glass ampoule). 
Zdravilo Iasibon 2 mg je na voljo v škatlah, v katerih je 1 ampula (4 ml ampula iz stekla tipa I).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 1 mg concentrate for solution for infusion ibandronic acid 
IME ZDRAVILA IN POT(I) UPORABE Iasibon 1 mg koncentrat za raztopino za infundiranje ibandronska kislina i.v.
One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate). 
Ena viala z 6 ml koncentrata za raztopino za infundiranje vsebuje 6 mg ibandronske kisline (v obliki natrijevega monohidrata).
Ocular inflammat ion†** 
anafilaktična reakcija/šok†**
Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease) 
Rezultati učinkovitosti (bolniki z rakom dojke z metastatično boleznijo kosti)
A statistically significant improvement in bone pain score was shown for intravenous Ibandronate 6 mg compared to placebo. 
V primerjavi s placebom se je pri ibandronski kislini (6 mg), dani intravensko, pokazalo statistično značilno izboljšanje rezultata pri bolečini v kosteh.
- radiotherapy to bone for treatment of fractures/impending fractures - surgery to bone for treatment of fractures - vertebral fractures - non-vertebral fractures 
Cilj raziskave je sestavljalo več, z okostjem povezanih, dogodkov (SRE - skeletal related event): • zdravljenje kosti z obsevanjem zaradi fraktur/pretečih fraktur;
Iasibon 2 mg is supplied as pack containing 1 ampoule (4 ml type I glass ampoule). 
Zdravilo Iasibon 2 mg je na voljo v pakiranju po 1 ampula (4 ml ampula iz stekla tipa I).
This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus). 
Pomembno je, da vzamete zdravilo pravočasno in pravilno, ker lahko povzroči draženje, vnetje ali razjedo v požiralniku (ezofagosu).
Atypical subtrocha nteric and diaphysea l femoral fractures† 
bolečina v kosteh atipični subtrohante rni zlomi stegnenice in zlomi diafize stegnenice†
Fasting should be continued for at least 30 minutes after taking the tablet. 
Po zaužitju tablete bolnik najmanj 30 minut ne sme zaužiti ničesar.
The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4). 
Najbolj resni neželeni učinki so anafilaktične reakcije/šok, atipični zlomi stegnenice, osteonekroza čeljustnic, draženje prebavil in vnetje oči (glejte odstavek “Opis izbranih neželenih učinkov” in poglavje 4.4).t Zdravljenje je bilo najpogosteje povezano z znižanjem serumskega kalcija na pod spodnjo mejo normale (hipokalciemija), sledi dispepsija.
Cellulose, microcrystalline Crospovidone Maize starch pregelatinised Glycerol dibehenate Silica, anhydrous colloidal 
Koruzni škrob, predgelirani Gliceroldibehenat
Hypocalcaemia* 
(hipokalciemija).
Chest pain, influenzalike illness, malaise, pain 
Bolezni sečil zastajanje seča, ledvična cista
This belongs to a group of medicines called bisphosphonates. 
Spada v skupino zdravil,
Receiving this medicine 
NAČIN IZDAJANJA ZDRAVILA
Psychiatric disorders 
Organskisistem
Ocular inflamma tion†** 
osteonekroza čeljustnic†**,
On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Iasibon has no or negligible influence on the ability to drive and use machines 
Glede na farmakodinamske in farmakokinetične lastnosti ter poročane neželene učinke pričakujemo,
radiotherapy to bone for treatment of fractures/impending fractures surgery to bone for treatment of fractures vertebral fractures non-vertebral fractures 
FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje Bistra, brezbarvna raztopina
• pelvic pain, discharge, itching or pain in the vagina 
• bolečina v medenici, izcedek iz nožnice, srbenje ali bolečina v nožnici,
Acetylsalicylic acid and NSAIDs 
žolčnika in žolčevodov holelitiaza
Bone pain * 
Bolečina v kosteh *
• stomach and tummy pain, indigestion, being sick vomiting or having diarrhoea (loose bowels) 
• bolečina v želodcu in trebuhu, slaba prebava, slabost, bruhanje ali driska,
Haemorrage, duodenal ulcer, gastritis, dysphagia, dry mouth 
bolečina v trebuhu, dispepsija, navzea krvavitev, razjeda na dvanajstniku, gastritis, disfagija, suha usta
Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Iasibon and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. 
Če se pri bolnikih med zdravljenjem z zdravilom Iasibon pojavijo disfagija, bolečina pri požiranju, retrosternalna bolečina ali pojav ali poslabšanje zgage, morajo zdravljenje z zdravilom Iasibon prekiniti in poiskati zdravniško pomoč.
Diarrhoea, vomiting, dyspepsia, gastrointest inal pain, tooth disorder 
Bolezni prebavil diareja, bruhanje, dispepsija, gastrointest inalna bolečina,
NAME OF THE MEDICINAL PRODUCT Iasibon 6 mg concentrate for solution for infusion ibandronic acid 
Navodilo za uporabo Iasibon 6 mg koncentrat za raztopino za infundiranje ibandronska kislina
NAME OF THE MEDICINAL PRODUCT Iasibon 1 mg concentrate for solution for infusion ibandronic acid 
Navodilo za uporabo Iasibon 1 mg koncentrat za raztopino za infundiranje ibandronska kislina
Atypical subtrochant eric and diaphyseal femoral fractures† 
Presnovne in prehranske motnje hipokalcie mija **
NAME OF THE MEDICINAL PRODUCT Iasibon 2 mg concentrate for solution for infusion ibandronic acid 
Navodilo za uporabo Iasibon 2 mg koncentrat za raztopino za infundiranje ibandronska kislina
Table 1 Adverse Reactions Reported for Intravenous Administration of Ibandronic Acid 
Neželeni učinki o katerih so poročali pri intravenskem dajanju zdravila ibandronsko kislino.
Reproductive toxicity: 
Vplivi na sposobnost za razmnoževanje
If you are not sure, talk to your doctor or pharmacist before having Iasibon. 
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
Ocular inflammation 
Bolezni pruritus
50 mg film-coated tablet every second day is recommended (see section 5.2). 
Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) se priporoča prilagoditev odmerka na eno 50 mg filmsko obloženo tableto vsak drugi dan (glejte poglavje 5.2).
Reproductive system and breast disorders 
Motnje reprodukcije in dojk bolečine v medenici
Hepatobiliary disorders 
imenovano difosfonati.
Skin disorder, ecchymosis 
Bolezni kože in podkožja bolezen kože, ehimoza osip, plešavost
Paraesthesia, dysgeusia (taste perversion) 
OVOJNINAH Nalepka (ampula)
Hypersensitivity bronchospasm†, angioedema†, Anaphylactic reaction/shock† 
Bolezni imunskega sistema preobčutljivost bronhospazem† angioedem†
Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronate 
Neželeni učinki o katerih so poročali pri peroralnem dajanju zdravila Iasibon
Gastrointesti nal disorders 
Bolezni živčevja parestezija, disgevzija
ATCvet code: QI09AD03. 
Oznaka ATCvet: QI09AD03.
Use vaccination devices according to the manufacturer's instructions. 
Pripomočke za cepljenje uporabljajte v skladu z navodili proizvajalca.
Date of first authorization: 24/08/2017. 
Datum pridobitve dovoljenja za promet: 24/08/2017.
These resolve without treatment within few hours. 
Te reakcije izginejo brez zdravljenja v nekaj urah.
The most common spreading route is via direct contact but spreading via contaminated objects or via the air cannot be excluded. 
Najpogostejša pot širjenja je z neposrednim stikom, ni pa mogoče izključiti širjenja prek okuženih predmetov ali po zraku.
A single booster dose is given every 6 months. 
Vsakih 6 mesecev se aplicira en ponovitveni odmerek.
Intramuscular injection: 2 ml in the neck. 
Intramuskularna injekcija: 2 ml v vrat.
It stimulates active immunity against PRRS virus. 
Stimulira aktivno imunost proti virusu PRRS.
Fattening pigs: 
Prašiči pitanci:
Mass vaccination can be used in herds in which the prevalence of European PRRS virus has been established. 
Masovno cepljenje se lahko uporabi v čredah, kjer je bila ugotovljena prevalenca evropskega virusa PRRS.
Vaccine (lyophilisate): 
Cepivo (liofilizat):
The solvent may be stored outside a refrigerator at 15 °C - 25 °C. 
Vehikel se lahko shrani zunaj hladilnika pri 15 °C - 25 °C.
It is advised to vaccinate all target pigs within a herd from the earliest recommended age onwards. 
Priporočljivo je cepiti vse ciljne prašiče v čredi od najmanjše priporočene starosti dalje.
Duration of immunity: 26 weeks after vaccination. 
Trajanje imunosti: 26 tednov po cepljenju.
Vaccinated animals may excrete the vaccine strain for more than 16 weeks following vaccination. 
Cepljene živali lahko vakcinalni sev izločajo še več kot 16 tednov po cepljenju.
25 doses 50 doses 125 doses 
25 odmerkov 50 odmerkov 125 odmerkov
Lactation: The safety of the vaccine has not been established during lactation. 
Laktacija: Varnost cepiva v obdobju laktacije ni bila ugotovljena.
2 ml in the neck. 
2 ml v vrat.
Use sterile syringes and needles. 
Uporabljajte sterilne igle in brizge.
In cases where the vials containing the solvent and the lyophilisate are stored separately, verify prior to reconstituting the lyophilisate that the lot number mentioned on the vial containing the solvent is identical to the lot number mentioned on the vial containing the lyophilisate. 
V primerih, kadar se viale, ki vsebujejo vehikel, in viale ki vsebujejo liofilizat, shranjujejo ločeno, pred rekonstitucijo liofilizata preverite, ali je številka serije, navedena na viali ki vsebuje vehikel, enaka številki serije, navedeni na viali, ki vsebuje liofilizat.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in viali, po EXP.
Each dose (2 ml) contains: Lyophilisate: 
Vsak odmerek (2 ml) vsebuje: Liofilizat:
The use of a multi-dosing syringe is recommended. 
Priporočljiva je uporaba brizg za večkratno odmerjanje.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009. 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina, ki je v osnovi biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe(ES) št. 470/2009.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/ ). 
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
Onset of immunity: 21 days after vaccination. 
Nastop imunosti: 21 dni po cepljenju.
Care should be taken to avoid the introduction of the vaccine strain into an area where PRRS virus is not already present. 
Treba je paziti, da ne vnesete vakcinalnega seva na območje, kjer virus PRRS še ni prisoten.
The reaction evolved to form hard tissue and formation of a scab, which very commonly lasted up to more than 44 days. 
Iz reakcije je nastalo trdo tkivo in kraste, kar je zelo pogosto trajalo več kot 44 dni.
The vaccine contains a modified live PRRS virus (genotype 1, subtype 1). 
Cepivo vsebuje modificirani živi virus PRRS (genotip 1, subtip 1).
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
SPC so bodisi dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe
A local reaction involving transiently the whole neck region was very commonly observed (red-purple dark, erythematous swelling, causing itching, vesicle formation, increased local temperature, and, occasionally, pain). 
Zelo pogosto je bila opažena prehodna lokalna reakcija na celotnem področju vratu (rdeče-vijolična temna eritematozna oteklina, ki povzroča srbenje, nastanek mehurjev, lokalno povečanje temperature in občasno bolečine).
Transfer approximately 5 ml of solvent to the vial containing the lyophilisate and ensure complete reconstitution. 
Približno 5 ml vehikla vnesite v vialo z liofilizatom in zagotovite popolno rekonstitucijo.
Pigs for fattening: A single dose of 2 ml is given to pigs from 1 day of age onwards. 
Prašiči pitanci: Enkraten odmerek 2 ml se aplicira prašičem od 1. dneva starosti dalje.
The maximum size of the local reactions was bigger (2 cm) and the maximum duration was in general longer (up to 9 days in pre-breeding sows). 
Lokalne reakcije so bile večje (2 cm) in trajanje daljše (do 9 dni pri svinjah pred brejostjo).
Special warnings for use in animals: 
Posebni previdnostni ukrepi za uporabo pri živalih:
Do not use in herds where European PRRS virus has not been detected by reliable diagnostic methods. 
KONTRAINDIKACIJE Ne uporabite v čredah, kjer evropski virus PRRS ni bil potrjen s preverjenimi diagnostičnimi metodami.
Needles for administration should be appropriate for the size of the pig. 
Za injiciranje uporabite igle, ki so primerne za velikost prašičev.
The vaccine strain can spread to in contact pigs. 
Vakcinalni sev se lahko razširi na prašiče, ki so v stiku z okuženimi prašiči.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 
NAVEDBA UČINKOVIN(E) IN DRUGEIH SESTAVIN
Transfer back the reconstituted solution into the solvent vial (containing the remaining solvent): 25 doses are reconstituted into 50 ml solvent, 50 doses are reconstituted into 100 ml solvent, and 125 doses are reconstituted into 250 ml solvent. 
Rekonstituirano raztopino prenesite nazaj v vialo z vehiklom (v kateri je preostal vehikel): 25 odmerkov se rekonstituira v 50 ml vehikla, 50 odmerkov se rekonstituira v 100 ml vehikla in 125 odmerkov se rekonstituira v 250 ml vehikla.
Pharmacotherapeutic group: immunologicals for Suidae, live viral vaccines. 
IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: Imunološka zdravila za prašiče (Suidae), živa virusna cepiva.
Vaccine efficacy has been demonstrated in laboratory vaccination and challenge studies using a genotype 1 subtype 1 strain. 
Učinkovitost cepiva je bila dokazana pri laboratorijskem cepljenju in v študijah z okužbo z virusom z uporabo seva genotipa 1 in podtipa 1.
Casein hydrolysate Lactose monohydrate Sorbitol 70% (solution) Sodium hydroxide Water for injections Dilution medium 
Liofilizat: dekstran 40 kazein hidrolizat laktoza monohidrat sorbitol 70 % (raztopina) natrijev hidroksid voda za injekcije medij za redčenje
Pigs (pigs for fattening, gilts and sows). 
Prašiči (prašiči pitanci, mladice in plemenske svinje).
Do not use in boars producing semen, as PRRS virus can be shed in semen. 
Ne uporabite pri plemenskih merjascih, ki so namenjeni za proizvodnjo semena, saj se virus lahko širi preko semena.
For active immunisation of clinically healthy pigs from 1 day of age in a porcine respiratory and reproductive syndrome (PRRS) virus contaminated environment, to reduce viraemia and nasal shedding caused by infection with European strains of PRRS virus (genotype 1). 
Aktivna imunizacija klinično zdravih prašičev, od prvega dneva starosti, v okolju, ki je okuženo z virusom prašičjega reprodukcijskega in respiratornega sindroma (PRRS), za zmanjšanje viremije in širjenja virusa z nosnim izcedkom, ki jo povzročajo evropski sevi virusa PRRS (genotip 1).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (25, 50 and 125 doses) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (25, 50 in 125 odmerkov)
Sodium chloride 0.9% solution 
natrijev klorid 0,9%, raztopina
Upon administration of a 10-fold overdose in piglets, anaphylactic-type reactions (tremor, apathy and/or vomiting) were very commonly observed shortly after vaccination; these signs resolved without treatment within a few hours. 
Po aplikaciji 10-kratnega odmerka pri pujskih je zelo pogost pojav reakcij anafilaktičnega tipa (tresavica, apatija in/ali bruhanje) kmalu po cepljenju; te reakcije izginejo brez zdravljenja nekaj ur po cepljenju.
EXP {month/year} Once broached use immediately. 
EXP {mesec/leto} Načeto zdravilo uporabite takoj.
In addition, vaccination of seronegative 1-day-old piglets was demonstrated to significantly reduce lung lesions against challenge administered at 26 weeks post vaccination. 
Poleg tega so dokazali, da cepljenje seronegativnih, 1 dan starih pujskov bistveno zmanjša pljučne lezije v primeru okužbe z virusom, vnesenim 26 tednov po cepljenju.
Solvent: Sodium chloride 0.9% solution: qs 1 dose. 
Vehikel: natrijev klorid 0,9%, raztopina: qs 1 odmerek
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ
Local reactions, in the form of soft/hard swelling (below or equal to 0.7 cm diameter) without heat or pain, were very commonly observed at the injection site and resolved within 5 days. 
Zelo pogoste so bile lokalne reakcije na mestu injiciranja v obliki mehke/trde otekline (do premera 0,7 cm), brez vročine ali bolečine, ki so izginile v 5 dneh.
High-density polyethylene (HDPE) vials of 50, 100 or 250 ml of solvent, with a chlorobutyl elastomer closure and sealed with an aluminium cap. 
Viale iz polietilena visoke gostote (HDPE) s 50, 100 ali 250 ml vehikla, s klorbutilnim gumijastim zapiralom in aluminijasto zaporko.
Vaccination of seronegative 2-weeks-old piglets was demonstrated to significantly reduce lung lesions and oral shedding against challenge administered at 28 days and at 16 weeks post-vaccination. 
Dokazali so tudi, da cepljenje seronegativnih 2 tedna starih pujskov, bistveno zmanjša pljučne lezije in širjenje virusa z ustnimi izločki v primeru okužbe z virusom, vnesenim 28 dni in 16 tednov po cepljenju.
Solvent: clear, colourless solution. 
Vehikel: bistra, brezbarvna raztopina.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE HDPE vials (100 ml or 250 ml) 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI HDPE viale (100 ml ali 250 ml)
Do not use in PRRS virus-naïve pregnant gilts and sows in the second half of gestation because the vaccine strain may cross the placenta. 
Ne uporabite pri na PRRS virus imunološko naivnih brejih mladicah in plemenskih svinjah v drugi polovici brejosti, saj lahko vakcinalni sev prehaja preko posteljice.
Reconstitute the lyophilisate with the supplied solvent. 
Liofilizat rekonstruirajte s priloženim vehiklom.
Type 1 hydrolytic glass vials of 15 ml (25, 50 or 125 doses), with a bromobutyl elastomer closure and sealed with an aluminium cap. 
tipa 1, po 15 ml (25, 50 ali 125 odmerkov), z brombutilnim gumijastim zapiralom in aluminijasto zaporko.
Special precautions should be taken to avoid spreading of the vaccine strain to unvaccinated animals (e.g. PRRS virus-naïve pregnant gilts and sows in second half of gestation) that should remain free from PRRS virus. 
Potrebni so posebni previdnostni ukrepi, da bi se izognili širjenju vakcinalnega seva na necepljene živali (npr.: na PRRS virus imunološko naivne breje mladice in plemenske svinje v drugi polovici brejosti), ki jih je treba zaščititi pred virusom PRRS.
In addition, pre-pregnancy vaccination of clinically healthy gilts and sows, non-PRRS virus-naïve (i.e. either previously immunised against PRRS virus via vaccination or exposed to PRRS virus via field infection) or PRRS virus-naïve, was demonstrated to reduce the transplacental infection caused by PRRS virus during the last third of pregnancy, and to reduce the associated negative impact on reproductive performance (reduction of the occurrence of stillbirths, of piglet viraemia at birth and at weaning, of lung lesions and of viral load in lungs in piglets at weaning). 
PRRS (PRRS virus imunološko ne-naivne),(npr. so bile predhodno imunizirane proti virusu PRRS s cepljenjem ali pa so bile izpostavljene naravni okužbi z virusom PRRS) ali pa še nimajo protiteles proti virusu PRRS (PRRS virus imunološko naivne), pred začetkom brejosti, zmanjša okužbo z virusom PRRS preko posteljice, v tretji fazi brejosti in hkrati zmanjša negativen vpliv na reprodukcijo
* Porcine respiratory and reproductive syndrome virus ** Cell culture infectious dose 50% 
**50% infektivnega odmerka za tkivno kulturo
The administration of the vaccine to pregnant PRRS virus-naïve gilts and sows in the second half of gestation may have an impact on their reproductive performance. 
Cepljenje na PRRS virus imunoško naivnih brejih svinj v drugi polovici brejosti lahko vpliva na reprodukcijske rezultate.
Lyophilisate: off-white freeze-dried pellet. 
Liofilizat: umazano bele liofilizirane pelete.
Lyophilisate: 
Brejost:
Solvent for suspension for injection 
Vehikel za suspenzijo za injiciranje
Can be used in PRRS virus-naïve gilts and sows pre-breeding or in the first half of gestation. 
Lahko se uporablja pri na PRRS virus imunološko naivnih mladicah in plemenskih svinjah pred brejostjo ali v prvi polovici brejosti.
Newly introduced PRRS virus-naïve animals (e.g. replacement gilts from PRRS virus-negative herds) should be vaccinated prior to pregnancy. 
Na novo vključene živali, ki še niso bile izpostavljene virusu PRRS (npr. nadomestne mladice iz čred, ki niso okužene z virusom PRRS), je treba cepiti pred brejostjo.
Local reactions in the form of swellings are very common and resolve spontaneously within 32 days. 
Zelo pogoste so tudi lokalne reakcije v obliki oteklin, ki spontano izginejo v 32 dneh.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vials (15 ml, containing 25, 50 or 125 doses) 
Steklene viale (po 15 ml, ki vsebujejo 25, 50 ali 125 odmerkov)
A transient increase in rectal temperature (0.5 °C on average, and up to 1.4 °C individually) may very commonly occur within 4 days after vaccination. 
Zelo pogosto se pojavi prehodno zvišanje rektalne temperature (povprečno 0,5 °C, v posameznih primerih tudi do 1,4 °C) v 4 dneh po cepljenju.
Gilts and sows: A single dose of 2 ml is given prior to introduction into the sow herd, approximately 4 weeks prior to breeding. 
Mladice in plemenske svinje: Enkraten odmerek 2 ml se aplicira pred vključitvijo v čredo svinj,
Cardboard box of 1 vial of 15 ml (125 doses) and 1 vial of 250 ml of solvent. 
Kartonska škatla z 1 vialo po 15 ml (125 odmerkov) in 1 vialo z 250 ml vehikla.
Modified live PRRSV*, strain 96V198: 102.2 - 105.2 CCID50** 
Učinkovina: Modificirani živi virus PRRSV*, sev 96V198: 102,2- 105,2 CCID50**
Local reactions in the form of swellings are very common and resolve spontaneously within 9 days. 
Zelo pogoste so tudi lokalne reakcije v obliki oteklin, ki spontano izginejo v 9 dneh.
Cardboard box of 1 vial of 15 ml (50 doses) and 1 vial of 100 ml of solvent. 
Kartonska škatla z 1 vialo po 15 ml (50 odmerkov) in 1 vialo s 100 ml vehikla.
Can be used in non-PRRS virus-naive gilts and sows in the second half of gestation. 
Lahko se uporablja pri na PRRS virus imunološko ne-naivnih mladicah in plemenskih svinjah v drugi polovici brejosti.