natgillin/translations-raw huggingface dataset:
- In cycles 5 to 9, Bortezomib SUN is administered once weekly on days 1, 8, 22 and 29. 
- V krogih 5 do 9 pa enkrat na teden, 1., 8., 22. in 29. dan.
Other medicines and Bortezomib SUN 
Med zaporednimi odmerki zdravila Bortezomib
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m2) and prednisone (60 mg/m2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma. 
(60 mg/m2) pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom so izvedli prospektivno, mednarodno, randomizirano (1:1) odprto klinično študijo faze III (MMY-3002 VISTA) pri 682 bolnikih.
- If local injection site reactions occur following Bortezomib SUN injection subcutaneously, either a less concentrated Bortezomib SUN solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended. 
Če se po subkutanem injiciranju zdravila Bortezomib SUN na mestu injiciranja pojavijo lokalne reakcije, se priporoča, da subkutano injicirate manj koncentrirano raztopino zdravila Bortezomib SUN
Discontinue Bortezomib SUN 
Izpostavljenost bortezomibu
> 1.0 x - 1.5 x ULN Any 
> 1,0-1,5x ULN katera koli ni potrebna zmerna
Table 4: Posology for Bortezomib SUN combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation 
Preglednica 4: Priporočeno odmerjanje zdravila Bortezomib SUN pri bolnikih, s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih je presaditev krvotvornih matičnih celic primerna.
Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* 
Zelo pogosti nevropatije*, periferna senzorična nevropatija,
Common Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache* Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome#, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia 
Organski sistem Pogostnost Neželeni učinek encefalopatija*, posteriorni reverzibilni encefalopatični sindrom#, nevrotoksičnost, motnje s krči*, postherpetična nevralgija, motnje govora*, sindrom nemirnih nog,
VDDx (N=239) 
(n=239)
in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment). 
samostojno ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali deksametazonom pri bolnikih, pri katerih je bolezen napredovala po tem, ko so prejeli vsaj eno predhodno vrsto zdravljenja in so jim že presadili krvotvorne matične celice ali presaditev krvotvornih matičnih celic pri njih ni mogoča; v kombinaciji z melfalanom in prednizonom pri bolnikih, pri katerih bolezni še nismo zdravili in pri njih kemoterapija v velikih odmerkih pred presaditvijo krvotvornih matičnih celic ni mogoča;
Pyrexia*, Fatigue, Asthenia 
zmedenost*, nemir
Common Oedema (inc peripheral), Chills, Injection site reaction*, Malaise* 
Zelo pogosti zvišana telesna temperatura*, utrujenost, astenija Pogosti edem (vključno s perifernim), mrazenje, reakcija na mestu injiciranja*, splošno slabo počutje*
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
1 pre-filled pen 
1 napolnjen injekcijsk peresnik
MA (EU) number (Invented) name 
Številka postopka EMEA Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Pack size 
30 tablet
Strength Pharmaceutical Form 
30 tablets
and Citovirax. 
in Citovirax.
The European Commission issued an EU-wide legally binding decision on this opinion on 28 April 2016. 
Evropska komisija je o tem mnenju dne 28. aprila 2016 izdala pravno zavezujočo odločbo za vso EU.
The company that markets these medicines is F. Hoffmann - La Roche Ltd. and associated companies. 
Ta zdravila tržijo družba F. Hofmann - La Roche Ltd. in povezane družbe.
Cymevene is marketed in all EU member states with the exception of Latvia, Malta and Slovenia. 
Zdravilo Cymevene se trži v vseh državah članicah EU, razen v Latviji, na Malti in v Sloveniji.
It is also available in the EU under the names Cymevan, Cymeven i.v. 
V EU je na voljo tudi pod imeni Cymevan, Cymeven i.v.
It can infect almost anyone but usually remains dormant in healthy people, rarely causing symptoms. 
Okuži lahko skoraj vsakogar, vendar pri zdravih ljudeh običajno ostane mirujoč in le redko povzroči simptome.
Information on the safety and efficacy of Cymevene in children under 12 years of age is limited. 
Podatki o varnosti in učinkovitosti zdravila Cymevene pri otrocih, mlajših od 12 let, so omejeni.
Why was Cymevene reviewed? 
Zakaj je bilo zdravilo Cymevene pregledano?
The CHMP was unable to make recommendations on such use based on currently available data and further assessment should be carried out. 
Odbor CHMP na osnovi trenutno razpoložljivih podatkov ni mogel sprejeti priporočil, zato je treba izvesti dodatno ocenjevanje.
The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.5 (interactions) and 4.8 (side effects). 
Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.4 (Posebna opozorila in previdnostni ukrepi), 4.5 (Medsebojno delovanje) in 4.8 (Neželeni učinki).
Cymevene has been authorised in the EU via national procedures. 
Zdravilo Cymevene je bilo v EU odobreno po nacionalnih postopkih.
On 25 February 2016, the European Medicines Agency completed a review of Cymevene. 
Evropska agencija za zdravila je 25. februarja 2016 zaključila pregled zdravila Cymevene.
Questions and answers on Cymevene and associated names (ganciclovir, 500 mg powder for concentrate for solution for infusion, intravenous) 
Vprašanja in odgovori v zvezi z zdravilom Cymevene in povezanimi imeni (ganciklovir, 500-mg prašek za koncentrat za raztopino za infundiranje, intravensko)
The medicine can be used in adults and adolescents from 12 years of age. 
Zdravilo Cymevene se lahko uporablja pri odraslih in mladostnikih od 12. leta naprej.
In these patients, CMV can result in severe or life-threatening infections that attack various organs including the lungs, brain and eyes. 
Pri teh bolnikih lahko CMV povzroči hudo oz. življenjsko nevarno okužbo različnih organov, vključno s pljuči, možgani in očmi.
CMV is a common virus that belongs to the herpes virus family. 
CMV je pogost virus, ki spada v družino herpesvirusov.
This has led to divergences across member states in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed. 
To je med državami članicami povzročilo razlike v načinu, kako se zdravilo lahko uporablja, kar se odraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, kjer se zdravilo trži.
Patients with reduced kidney function should receive lower doses of Cymevene. 
Bolniki z oslabljenim delovanjem ledvic morajo prejemati nižje odmerke zdravila Cymevene.
The recommended dose of Cymevene and duration of treatment depend on the weight of the patient and on whether the medicine is used to prevent or treat CMV disease. 
Priporočeni odmerek zdravila Cymevene in trajanje zdravljenja sta odvisna od telesne mase bolnika in od tega, ali se zdravilo uporablja za preprečevanje ali za zdravljenje bolezni zaradi CMV.
Different treatment schedules should be followed during initial and maintenance treatment, in accordance with treatment guidelines. 
Shemi zdravljenja pri začetnem in pri vzdrževalnem zdravljenju se morata razlikovati glede na smernice zdravljenja.
What is Cymevene? 
Kaj je zdravilo Cymevene?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Cymevene in the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Cymevene v Evropski uniji (EU).
When prescribing Cymevene, consideration should be given to official guidance on the appropriate use of antiviral agents. 
Pri predpisovanju zdravila Cymevene je treba upoštevati uradne smernice za ustrezno uporabo protivirusnih zdravil.
For this reason, the CHMP agreed that Cymevene should not be used in pregnant women unless the potential benefit to the mother outweighs the potential risk to the unborn child. 
Odbor CHMP je zato soglašal, da se pri nosečnicah zdravilo Cymevene ne sme uporabljati, razen če je morebitna korist za mater večja od morebitnega tveganja za nerojenega otroka.
Having harmonised the indication, the CHMP also harmonised the recommendations on how to use Cymevene. 
Po uskladitvi indikacij je odbor CHMP uskladil tudi priporočila o načinu uporabe zdravila Cymevene.
Since the use of highly active antiretroviral therapy (HAART) has reduced the risk of CMV disease in patients with HIV infection, preventive treatment with Cymevene is no longer considered necessary. 
Ker je uporaba visokoaktivne protiretrovirusne terapije (HAART) pri bolnikih, okuženih z virusom HIV, zmanjšala tveganje za bolezni zaradi CMV, preventivno zdravljenje z zdravilom Cymevene ni več potrebno.
Cymevene must not be used in patients allergic to its active substance ganciclovir, to a related antiviral medicine, valganciclovir, or to any other ingredients of the medicine. 
Zdravilo Cymevene se ne sme uporabljati pri bolnikih, ki so alergični na zdravilno učinkovino ganciklovir, na sorodno protivirusno zdravilo, valganciklovir, ali na katero koli drugo sestavino zdravila.
Women who could become pregnant must be advised to use effective contraception during treatment with Cymevene and for at least 30 days after treatment has stopped. 
Ženskam, ki bi lahko zanosile, je treba pri zdravljenju z zdravilom Cymevene in še vsaj 30 dni po prenehanju zdravljenja svetovati učinkovito kontracepcijo.
Cymevene can also be used to prevent CMV disease in patients with drug-induced immunosuppression (for example after an organ transplant or chemotherapy). 
Zdravilo Cymevene se lahko uporablja tudi za preprečevanje bolezni zaradi CMV pri bolnikih z zdravili inducirano imunosupresijo (npr. po presaditvi organov ali po kemoterapiji).
However, the virus can cause problems in people with a weakened immune system such as people with acquired immune deficiency syndrome (AIDS) or who are undergoing cancer treatment or taking medicines to prevent rejection of an organ transplant. 
Virus lahko povzroči težave pri ljudeh z oslabljenim imunskim sistemom, kot so ljudje s sindromom pridobljene imunske pomanjkljivosti (aids), bolniki, ki prejemajo zdravila za zdravljenje raka ali zdravila za preprečitev zavrnitve presadka.
The CHMP also agreed that Cymevene should no longer be indicated for the prevention of CMV disease in patients with AIDS. 
Odbor CHMP je soglašal tudi, da zdravilo Cymevene ne sme biti več indicirano za preprečevanje bolezni zaradi CMV pri bolnikih z aidsom.
Cymevene is an antiviral medicine that is used to treat or prevent infection with cytomegalovirus (CMV) in immunocompromised individuals (people with a weakened immune system). 
Zdravilo Cymevene je protivirusno zdravilo, ki se uporablja za zdravljenje in preprečevanje okužb s citomegalovirusom (CMV) pri imunsko oslabelih osebah (ljudeh z oslabljenim imunskim sistemom).
Men whose female partner could become pregnant must be advised to use barrier contraception methods during treatment with Cymevene, and for at least 90 days afterwards. 
Moškim, katerih partnerka bi lahko zanosila, je treba pri zdravljenju z zdravilom Cymevene in še vsaj 90 dni po prenehanju zdravljenja svetovati uporabo pregradnih kontracepcijskih metod.
The CHMP agreed that Cymevene can be used for the treatment of diseases caused by CMV in immunocompromised patients. 
Odbor CHMP je soglašal, da se zdravilo Cymevene lahko uporablja za zdravljenje bolezni, ki jih pri imunsko oslabljenih bolnikih povzroča CMV.
It is not known whether ganciclovir passes into breast milk; however this possibility cannot be excluded and therefore breastfeeding must be discontinued in women treated with Cymevene, to avoid potential serious side effects in breastfed infants. 
Te možnosti ni mogoče izključiti, zato je treba pri ženskah, zdravljenih z zdravilom Cymevene, dojenje prekiniti, da bi se izognili morebitnim resnim neželenim učinkom pri dojenih otrocih.
On 15 September 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Cymevene in the EU. 
Da bi uskladili dovoljenja za promet z zdravilom Cymevene v EU, je Evropska komisija 15. septembra 2014 napotila zadevo na odbor CHMP.
Ganciclovir has the potential to cause birth defects in humans. 
Zdravilo Ganciklovir lahko pri človeku povzroči prirojene anomalije.
Cymevene contains the active substance ganciclovir and is available as a powder to be made into a solution for infusion (drip) into a vein. 
Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Cymevene was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). 
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Cymevene potrebno usklajevanje.
ATCvet code: QI02AD04. 
Oznaka ATC vet: QI02AD04.
It is recommended to use a new applicator for each animal. 
Priporočamo, da za vsako žival uporabite nov aplikator.
<{DD/MM/YYYY}> 
{DD/MM/LLLL}
The following doses and administration methods should be used: 
Uporabiti je treba naslednje odmerke in metode odmerjanja:
Cattle from 9 days of age: 
Govedo od 9 dni starosti:
Date of first authorisation: 29/07/2019 
Datum pridobitve dovoljenja za promet: 29/07/2019
The 5 doses vial is now ready to use. 
Viala s 5 odmerki je zdaj pripravljena za uporabo.
The excipients listed in section 6.1 of the SPC are 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 Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
Cattle from 10 weeks of age: 
Govedo od 10 tednov starosti:
Solvent: Store below 25 °C. 
Vehikel: Shranjujte pri temperaturi pod 25 °C.
The reconstituted vaccine is a slightly yellowish homogeneous suspension. 
Rekonstituirano cepivo je rahlo rumenkasta homogena suspenzija.
*Cell culture infectious dose 50% 
* 50% infektivni odmerek v celični kulturi
Special precautions for use in animals: Vaccinate healthy animals only. 
Posebni previdnostni ukrepi za uporabo pri živalih: Cepite samo zdrave živali.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder. 
Za vse nadaljnje informacije o tem zdravilu se obrnite na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom.
Volume of solvent to be used 
Volumen vehikla, ki ga je treba uporabiti
6 months after intramuscular vaccination. 
6 mesecev po intramuskularnem cepljenju.
Calves may uncommonly display a peak in temperature of at least 1.7°C two days after vaccination that resolves the next day without treatment. 
Pri teletih se občasno pojavi porast telesne temperature vsaj 1,7 °C dva dni po cepljenju, ki izzveni naslednji dan brez zdravljenja.
Do not use this veterinary medicinal product and the solvent after the expiry date which is stated on the carton and the label. 
Tega zdravila in vehikla ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in nalepki.
For the 25 doses vial, once the freeze-dried powder is in suspension, withdraw all the suspension obtained from the vaccine vial and inject it into the vial containing the remaining solvent. 
Za vialo s 25 odmerki, potem, ko je prašek posušen z zamrzovanjem v suspenziji, odstranite vso suspenzijo, dobljeno iz viale s cepivom, in jo vbrizgajte v vialo, v kateri je ostanek vehikla.
Each dose of 2 ml contains: 
En 2 ml odmerek vsebuje:
Pharmacotherapeutic group: Immunological for Bovidae, Cattle, Live viral vaccines, bovine respiratory syncytial virus (BRSV). 
Farmakoterapevtska skupina: Imunološka zdravila za votloroge, govedo, živa virusna cepiva, bovini respiratorni sincicijski virus (BRSV).
Overdose (symptoms, emergency procedures, antidotes): No adverse reactions occurred following the administration of an overdose. 
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Po prevelikem odmerjanju ni bilo neželenih učinkov.
To stimulate active immunity against bovine respiratory syncytial virus. 
Za spodbujanje aktivne imunosti proti bovinemu respiratornemu sincicijskemu virusu.
Laboratorios Hipra, S.A. Carretera C-63 Km 48.300 Polígon Industrial El Rieral, 17170 Amer (Girona) Spain 
Laboratorios Hipra, S.A. Carretera C-63 Km 48.300 Polígon Industrial El Rieral, 17170 Amer (Girona) Španija
For nasal use, spray the required volume of the vaccine into the animal's nostrils (1 ml in each nostril) using an intranasal applicator (droplet size: 25-220 µm). 
Za nazalno uporabo razpršite potrebni volumen cepiva v nosnici živali (1 ml v vsako nosnico) z intranazalnim aplikatorjem (velikost kapljic: 25-220 µm).
Solvent for NASYM 
Vehikel za NASYM
No adverse reactions other than those described in section 4.6 occurred following the administration of an overdose. 
Po prevelikem odmerjanju ni bilo drugih neželenih učinkov, razen tistih, ki so opisani v poglavju 4.6.
Name and address of the manufacturers of the biological active substance 
Ime in naslov proizvajalca biološke učinkovine
Shake until the freeze-dried powder is in suspension. 
Stresajte, dokler ni liofilizirani prašek v obliki suspenzije.
Reconstitute the vaccine with the corresponding volume of solvent: 
Cepivo rekonstituirajte z ustreznim volumnom vehikla:
Each dose of 2 ml contains: Lyophilisate: 
En 2 ml odmerek vsebuje: Liofilizat:
Lyophilisate: Store and transport refrigerated (2 °C - 8 °C). 
Liofilizat: Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
Active immunisation of cattle to reduce virus shedding and respiratory clinical signs caused by bovine respiratory syncytial virus infection. 
Aktivna imunizacija goveda za zmanjšanje izločanja virusa in respiratornih kliničnih znakov, ki jih povzroča okužba z bovinim respiratornim sincicijskim virusom.
5 doses 25 doses 
5 odmerkov 25 odmerkov
Nasal use or intramuscular use. 
Nazalna uporaba ali intramuskularna uporaba.
Do not mix with any other veterinary medicinal product, except with the solvent supplied for use with the veterinary medicinal product . 
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen za uporabo s tem zdravilom.
Primary vaccination (nasal use): Spray 1 ml into each nostril (so the total volume administered is 2 ml). 
Primarno cepljenje (nazalna uporaba): V vsako nosnico razpršite 1 ml (tako da je celotni aplicirani volumen 2 ml).
Slight alteration of faecal consistency may be commonly observed post-vaccination. 
Po cepljenju se pogosto opazi rahle spremembe v konsistenci iztrebkov.
Duration of immunity: 2 months after nasal vaccination. 
Trajanje imunosti: 2 meseca po nazalnem cepljenju.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ
Inject the 10 ml of solvent into the vial containing the lyophilisate (freeze-dried powder). 
Injicirajte 10 ml vehikla v vialo z liofilizatom (prašek posušen z zamrzovanjem).
Full immunity is established from 21 days after nasal vaccination. 
Polna imunost je vzpostavljena po 21. dnevu po aplikaciji v nos.
Solvent: Homogeneous-clear solution. 
Vehikel: Homogena, bistra raztopina.
Solvent: Polyethylene (PET) vials of 10 ml or 50 ml, sealed with a bromobutyl rubber stopper and aluminium cap. 
Vehikel: polietilenske (PET) viale z 10 ml ali 50 ml, zaprte z zamaškom iz bromobutilne gume in aluminijasto zaporko.
Primary vaccination (intramuscular injection): One intramuscular injection of 2 ml should be given, followed by a second intramuscular injection of 2 ml given 4 weeks later. 
Primarno cepljenje (intramuskularna injekcija): Aplicirajte eno intramuskularno injekcijo po 2 ml, ki ji 4 tedne pozneje sledi druga intramuskularna injekcija po 2 ml.
Reduction of respiratory clinical signs (but not a reduction of virus shedding) is observed 5 days after nasal vaccination. 
5 dnii po aplikaciji v nos je opazno zmanjšanje respiratornih kliničnih znakov (ne pa zmanjšanje izločanja virusa).
Use only sterile needles and syringes for administration. 
Za injiciranje uporabljajte le sterilne igle in injekcijske brizge.
Number of doses in vial of lyophilisate 
Število odmerkov v viali liofilizata
Revaccination: One intramuscular injection of 2 ml should be given 6 months after completion of the primary vaccination scheme and then every 6 months after the last revaccination. 
Revakcinacija: Eno intramuskularno injekcijo po 2 ml aplicirajte 6 mesecev po zaključku sheme primarnega cepljenja in nato vsakih 6 mesecev po zadnjei revakcinaciji.
21 days after the second dose of the two dose intramuscular vaccination schedule. 
21 dni po drugem odmerku pri intramuskularnem dajanju.
Lyophilisate (vaccine): 10 ml type I glass vials of 5 or 25 doses, sealed with a bromobutyl rubber stopper and aluminium cap. 
Liofilizat (cepivo): 10 ml viale iz stekla tipa I s 5 odmerki ali 25 odmerki, zaprta z zamaškom iz bromobutilne gume in aluminijasto zaporko.
Shelf life of the solvent: 5 years 
Rok uporabnosti vehikla: 5 let.
Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Sodium chloride 
Vehikel: kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat natrijev klorid kalijev klorid voda za injekcije
10 vials of lyophilisate (50 doses) 10 vials of lyophilisate (250 doses) 
10 vial liofilizata (50 odmerkov) 10 vial liofilizata (250 odmerkov)
10 vials of solvent (100 ml) 10 vials of solvent (500 ml) 
10 vial vehikla (100 ml) 10 vial vehikla (500 ml)
Revaccination: One intramuscular injection of 2 ml should be given 2 months after the primary vaccination, and then every 6 months after the last revaccination. 
Revakcinacija: Eno intramuskularno injekcijo po 2 ml aplicirajte 2 meseca po primarnemu cepljenju in nato vsakih 6 mesecev po zadnji revakcinaciji.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (1x5 doses and 1x25 doses) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (1x5 odmerkov in 1x25 odmerkov)
25 doses 
25 odmerkov
Potassium dihydrogen phosphate Dipotassium phosphate 
NZ amin sorbitol kalijev dihidrogenfosfat kalijev hidrogenfosfat
Avoid contamination during reconstitution and use. 
Med rekonstitucijo in uporabo pazite, da ne pride do kontaminacije.
1 vial of lyophilisate and 1 vial of solvent (5 doses) 1 vial of lyophilisate and 1 vial of solvent (25 doses) 
1 viala liofilizata in 1 viala vehikla (5 odmerkov) 1 viala liofilizata in 1 viala vehikla (25 odmerkov)
la Selva, 135 17170 Amer (Girona) SPAIN 
la Selva, 135 17170 Amer (Girona) ŠPANIJA
la Selva 135, 17170 Amer (Girona) Spain 
la Selva 135, 17170 Amer (Girona) Španija