FrancophonIA/ELRC3.0 huggingface dataset:
English: In the phase 2 trial the incidence of Musculoskeletal pain was 64.1 % (all Grades) and 7.8 % (Grade 3) in the olaratumab plus doxorubicin arm and 24.6 % (all Grades) and 1.5 % (Grade 3) in the doxorubicin alone arm.
Croatian: 7,8% (3. stupanj) u skupini liječenoj olaratumabom plus doksorubicinom te 24,6% (svi stupnjevi) i 1,5% (3. stupanj) u skupini liječenoj samo doksorubicinom.
English: Very Common Common a Refer to NCI CTCAE Criteria (Version 4.03) for each Grade of toxicity b Musculoskeletal pain includes arthralgia, back pain, bone pain, flank pain, groin pain,
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često često a Vidjeti NCI CTCAE kriterije (verzija 4.03) za svaki stupanj toksičnosti b Mišićno-koštana bol uključuje artralgiju, bol u leđima, bol u kostima, bol u slabinama, bol u preponama, bol u mišićima i kostima prsišta, bol u mišićima i kostima, mialgiju, grčeve u mišićima, bol u vratu i bol u ekstremitetu c Reakcije na infuziju uključuju anafilaktičke reakcije/anafilaktički šok.
English: NAME OF THE MEDICINAL PRODUCT Lartruvo 10 mg/mL concentrate for solution for infusion
Croatian: NAZIV LIJEKA Lartruvo 10 mg/ml koncentrat za otopinu za infuziju
English: Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab
Croatian: Lartruvo 10 mg/ml koncentrat za otopinu za infuziju olaratumab
English: DO NOT FREEZE OR SHAKE the infusion solution.
Croatian: Otopina za infuziju ne smije se zamrzavati ni tresti.
English: Each millilitre of the concentrate for solution for infusion contains 10 mg of olaratumab.
Croatian: Jedan mililitar koncentrata za otopinu za infuziju sadrži 10 mg olaratumaba.
English: There have been no formal studies with olaratumab in patients with hepatic impairment.
Croatian: Nisu provedena formalna ispitivanja olaratumaba u bolesnika s oštećenjem funkcije bubrega.
English: ADRs which were reported in patients with soft tissue sarcoma treated with olaratumab in combination with doxorubicin in the Phase 2 study are listed below in Table 2 in MedDRA body system organ class, frequency and grade of severity.
Croatian: Tablični popis nuspojava Nuspojave lijeka prijavljene u bolesnika sa sarkomom mekog tkiva liječenih olaratumabom u kombinaciji s doksorubicinom u ispitivanju faze 2 navedene su u sljedećoj Tablici 2 prema MedDRA
English: Add a sufficient quantity of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to make the total volume 250 mL.
Croatian: Dodajte dovoljnu količinu otopine natrijeva klorida za injekciju od 9 mg/ml (0,9 %) u spremnik kako biste dobili ukupan volumen od 250 ml.
English: Very Common None reported
Croatian: Poremećaji živčanog sustava vrlo često nijedan prijavljen slučaj
English: To administer using empty intravenous infusion containers Aseptically transfer the calculated volume of olaratumab into an empty intravenous infusion container.
Croatian: Aseptičnom tehnikom prebacite izračunati volumen olaratumaba u prazan spremnik za intravensku infuziju.
English: Infusion-related reactions (IRRs), including anaphylactic reactions, were reported in clinical trials with olaratumab.
Croatian: U kliničkim ispitivanjima olaratumaba prijavljene su reakcije na infuziju, uključujući anafilaktičke reakcije.
English: PopPK data suggest that no dose adjustments are required in patients with mild hepatic impairment.
Croatian: Podaci iz populacijske farmakokinetičke analize ukazuju na to da nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem funkcije jetre.
English: A doctor experienced in the use of anti-cancer medicines will supervise your Lartruvo therapy.
Croatian: Kako ćete primiti Lartruvo Terapiju lijekom Lartruvo nadzirat će liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva mišićno-koštana bolb vrlo često često
English: Handling instructions Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab
Croatian: Upute za rukovanje Lartruvo 10 mg/ml koncentrat za otopinu za infuziju olaratumab
English: Unopened vial 2 years.
Croatian: 2 godine.
English: b Once the infusion rate has been reduced for a Grade 1 or 2 infusion-related reaction, it is recommended that the lower infusion rate be utilized for all subsequent infusions.
Croatian: National Cancer Institute Common Terminology Criteria for Adverse Events, NCI CTCAE) bNakon što se brzina infuzije smanji zbog reakcije na infuziju 1. ili 2. stupnja, preporučuje se i sve sljedeće infuzije primjenjivati tom smanjenom brzinom.
English: The infusion solution should be prepared using aseptic technique to ensure the sterility of the prepared solution.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Otopinu za infuziju potrebno je pripremiti korištenjem aseptične tehnike kako bi se osigurala sterilnost pripremljene otopine.
English: This medicine is given as an infusion into a vein via a drip.
Croatian: Lijek se primjenjuje infuzijskom pumpom.
English: In case of prefilled intravenous infusion container usage Based on the calculated volume of olaratumab, the corresponding volume of sodium chloride 9 mg/mL (0.9 %) solution for injection should be removed from the prefilled 250 mL intravenous container.
Croatian: Na temelju izračunatog volumena olaratumaba, potrebno je izvaditi odgovarajući volumen otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) iz napunjenog spremnika za intravensku infuziju volumena 250 ml.
English: Inspect the contents of the vials for particulate matter and discolouration.
Croatian: klasifikaciji organskih sustava, učestalosti i stupnju težine.
English: NAME OF THE MEDICINAL PRODUCT Lartruvo 10 mg/mL sterile concentrate olaratumab
Croatian: Lartruvo 10 mg/ml sterilni koncentrat olaratumab
English: The content of the vials should be inspected for particulate matter and discolouration (the concentrate for solution for infusion should be clear to slightly opalescent and colourless to slightly yellow without visible particles) prior to administration.
Croatian: (koncentrat za otopinu za infuziju mora biti bistar do blago opalescentan te bezbojan do bljedožut, bez vidljivih čestica).
English: A sufficient quantity of sodium chloride 9 mg/mL (0.9 %) solution for injection should be added to the container to make the total volume 250 mL.
Croatian: U spremnik treba dodati dovoljnu količinu otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) da bi se dobio ukupan volumen od 250 ml.
English: The efficacy and safety of olaratumab was assessed in a Phase 1b/2, multi-centre study in anthracycline naïve patients with histologically or cytologically confirmed, advanced soft tissue sarcoma not amenable to receive surgery or radiotherapy with curative intent.
Croatian: provedenom u bolesnika s histološki ili citološki potvrđenim uznapredovalim sarkomom mekog tkiva prethodno neliječenih antraciklinom koji nisu bili pogodni za kurativno kirurško ili radioterapijsko liječenje.
English: In case of empty intravenous infusion container usage The calculated volume of olaratumab should be aseptically transferred into an empty intravenous infusion container.
Croatian: Izračunati volumen olaratumaba potrebno je aseptičnom tehnikom prenijeti u prazan spremnik za intravensku infuziju.
English: You will be given medicines to reduce the risk of an infusion-related reaction before you receive Lartruvo.
Croatian: Prije nego što primite lijek Lartruvo, primit ćete lijekove koji će smanjiti rizik od pojave reakcije na infuziju.
English: Spain
Croatian: ŠPANJOLSKA
English: In the olaratumab plus doxorubicin arm, the most serious (Grade ≥3) adverse drug reactions (ADRs) observed were neutropenia (54.7 %) and musculoskeletal pain (7.8 %).
Croatian: (≥ 3. stupnja) bile su neutropenija (54,7%) te mišićno-koštana bol (7,8%).
English: Neutrophil count should be checked prior to Olaratumab dosing on Day 1 and Day 8 of each cycle.
Croatian: Prije primjene olaratumaba 1. i 8. dana svakog ciklusa potrebno je odrediti broj neutrofila.
English: How you are given Lartruvo
Croatian: Ne smijete primiti Lartruvo
English: Only use sodium chloride 9 mg/mL (0.9 %) solution for injection as a diluent.
Croatian: Kao sredstvo za razrjeđivanje smije se koristiti samo otopina natrijeva klorida za injekciju od 9 mg/ml (0,9 %).
English: Your doctor may also give you a smaller dose or delay your dose of Lartruvo if you get serious side effects including a lowering of your white blood cell counts.
Croatian: Ako se tijekom liječenja pojave ozbiljne nuspojave, uključujući smanjenje broja bijelih krvnih stanica, liječnik će Vam možda dati nižu dozu ili odgoditi primjenu doze lijeka Lartruvo.
English: Platelet counts should be checked prior to olaratumab dosing on Day 1 and Day 8 of each cycle.
Croatian: Prije primjene olaratumaba 1. i 8. dana svakog ciklusa potrebno je odrediti broj trombocita.
English: Blood and lymphatic system disorders
Croatian: - Smanjenje broja bijelih krvnih stanica
English: 2 patients in the olaratumab plus doxorubicin arm and none in the doxorubicin arm received both post-study radiotherapy and surgery.
Croatian: I radioterapiju i kirurško liječenje su nakon ispitivanja primila 2 bolesnika u skupini liječenoj olaratumabom plus doksorubicinom, a nijedan bolesnik u skupini liječenoj doksorubicinom.
English: For management and dose adjustments in patients who experience Grade 1 or 2 IRR during the infusion, see section 4.2.
Croatian: Za zbrinjavanje i prilagodbu doze u bolesnika u kojih tijekom infuzije nastupi reakcija na infuziju 1. ili 2. stupnja, vidjeti dio 4.2. U bolesnika koji su prethodno doživjeli reakciju na infuziju 1. ili 2. stupnja preporučuje se premedikacija difenhidraminkloridom (intravenski), paracetamolom i deksametazonom.
English: NAME OF THE MEDICINAL PRODUCT Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab
Croatian: Uputa o lijeku: Informacije za korisnika Lartruvo 10 mg/ml koncentrat za otopinu za infuziju olaratumab
English: Very common (may affect more than 1 in 10 people): - nausea - pain in your muscles, joints or bones (musculoskeletal pain) - low white blood cell counts (including neutrophils and lymphocytes which may increase the
Croatian: - nizak broj bijelih krvnih stanica (uključujući neutrofile i limfocite, što može povećati rizik od
English: No data were available from patients with severe hepatic impairment (total bilirubin > 3.0 times ULN and any AST level).
Croatian: (ukupni bilirubin > 3,0 puta iznad GGN-a i bilo koja vrijednost AST-a).
English: Sodium chloride
Croatian: KLINIČKI PODACI
English: Olaratumab should be immediately and permanently discontinued in patients who experience Grade 3 or 4 IRR (see sections 4.2 and 4.8).
Croatian: 3. ili 4. stupnja (vidjeti dijelove 4.2 i 4.8).
English: Apply usual aseptic procedures.
Croatian: Slijediti uobičajene aseptičke postupke.
English: These resolved within a maximum of 25 days.
Croatian: One nestaju u roku od najviše 25 dana.
English: The target species will also be shown on the label.
Croatian: Ciljne vrste također će biti prikazane na etiketi.
English: Medicines Agency (http://www.ema.europa.eu/).
Croatian: Europske agencije za lijekove (http://www.ema.europa.eu/).
English: 6.2 Major incompatibilities
Croatian: 6.2 Velike inkompatibilnosti
English: The entire content of the bottle should be used immediately after broaching and during the same procedure.
Croatian: Cijeli sadržaj bočice treba upotrijebiti odmah nakon otvaranja bočice i tijekom istog postupka.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Croatian: Nositelj odobrenja za stavljanje u promet mora obavijestiti Europsku komisiju o planovima za stavljanje u promet medicinskog proizvoda odobrenog ovom odlukom.
English: The type of strain included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.
Croatian: Vrsta soja uključena u konačni proizvod bit će prilagođena trenutnoj epidemiološkoj situaciji u vrijeme formuliranja završnog proizvoda i bit će navedena na naljepnici.
English: Date of first authorisation: 25/04/2017.
Croatian: Datum prvog odobrenja: 25/04/2017.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu već navedene u ovoj uputi ili mislite da VMP nije djelovao, molimo obavijestite svog veterinara.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: Sukladno članku 71. Direktive 2001/82/EZ i Europskog Parlamenta i Vijeća s izmjenama i dopunama, država članica može, u skladu s nacionalnim zakonodavstvom zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunoloških veterinarsko-medicinskih proizvoda na cijelom ili na dijelu svog teritorija ako je utvrđeno da:
English: Al3+ (as hydroxide)
Croatian: Al3+ (u obliku hidroksida)
English: Avoid multiple broaching.
Croatian: Izbjegavajte višestruko otvaranje bočice.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Croatian: Upotreba ovog veterinarsko medicinskog proizvoda dozvoljena je samo pod određenim uvjetima u okviru zakonodavstva Europske zajednice o kontroli bolesti plavog jezika.
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi injection type vaccination system when larger dose presentations are used.
Croatian: Da se izbjegne nehotična kontaminacija cjepiva tijekom upotrebe, preporučuje se upotrebljavati sustav cijepljenja s višestrukim injekcijama kada se primjenjuju veće doze.
English: Off-white or pink liquid.
Croatian: Zagasito bijela ili ružičasta tekućina.
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Osobe koje namjeravaju proizvoditi, uvoziti, posjedovati, prodavati, opskrbljivati i primjenjivati ovaj veterinarsko medicinski proizvod moraju se prvo savjetovati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju jer te aktivnosti mogu biti zabranjene u određenoj državi članici, na cijelom ili na dijelu njenog teritorija, sukladno nacionalnim propisima.
English: Local reactions may increase slightly following the second dose, in this case lasting up to 15 days.
Croatian: Lokalne reakcije mogu se lagano pojačati nakon druge doze, u tom slučaju traju do 15 dana.
English: The level of efficacy for other species may differ from that observed in sheep and cattle.
Croatian: Razina učinkovitosti cjepiva na drugim vrstama može biti različita od razine opažene kod ovaca i goveda.
English: Once broached, use immediately.
Croatian: Jednom otvoren, odmah upotrijebiti.
English: Camprodon s/n "la Riba" 17813 Vall de Bianya Girona
Croatian: Camprodon s/n "la Riba" 17813 Vall de Bianya
English: Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje zajedno s nekim drugim veterinarsko-medicinskim proizvodom.
English: Pregnancy: Can be used during pregnancy in sheep and cattle.
Croatian: Graviditet: Može se primijeniti tijekom graviditeta u ovaca i goveda.
English: - 2nd injection: after 3 weeks.
Croatian: - 2. injekcija: nakon 3 tjedna.
English: No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
Croatian: Nisu dostupne informacije o upotrebi cjepiva kod seropozitivnih životinja, uključujući one s antitijelima stečenima od majke.
English: There is evidence of BTV-1 seroneutralising antibodies indicative of protection for up to 21 months after primary vaccination.
Croatian: Postoje dokazi o BTV-1 seroneutralizirajućim protutijelima koji ukazuju na zaštitu do 21 mjeseca nakon osnovnog cijepljenja.
English: 2nd injection: after 3 weeks.
Croatian: 2. injekcija: nakon 3 tjedna.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Croatian: Odluku o primjeni ovog cjepiva prije ili poslije nekog drugog veterinarsko-medicinskog proizvoda treba donositi od slučaja do slučaja.
English: Detailed information on this veterinary medicinal product is available on the website of the European
Croatian: DATUM REVIZIJE TEKSTA Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici
English: 20 ml (10 doses)
Croatian: 20 ml (10 doza)
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi nakon
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost nuspojava određena je sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja manifestira nuspojavu(e) - česte (više od 1, ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1, ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1, ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve)
English: Shake gently immediately before use.
Croatian: Pažljivo protresti neposredno prije upotrebe.
English: A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of a two-fold overdose.
Croatian: Prolazni porast rektalne temperature, ne veći od 2 ° C, može se pojaviti u 10% životinja tijekom 24 sata nakon primjene dvostruku preporučene doze.
English: High density polyethylene (HDPE) bottles of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal.
Croatian: Bočice od polietilena visoke gustoće (HDPE) od 20, 100 ili 240 ml s čepom od klorobutilnog elastomera i aluminijskim poklopcem.
English: Avoid bubble formation, as this can be irritating at the site of injection.
Croatian: Izbjegavati formiranje mjehurića jer mogu nadraživati mjesto primjene cjepiva.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje zajedno s nekim drugim veterinarsko-medicinskim proizvodom.
English: Per dose of 2 ml:
Croatian: U dozi od 2 ml:
English: Method of administration (sheep and cattle)
Croatian: Način primjene (ovce i goveda)
English: It can be used during lactation in cattle.
Croatian: Može se koristiti kod krava tijekom laktacije.
English: In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or national competent authorities on the current vaccination policies against bluetongue virus (BTV).
Croatian: U ovoj kategoriji životinja cjepivo treba primjenjivati samo nakon što nadležni veterinar i nacionalna nadležna tijela, naprave procjenu omjera koristi i rizika, u skladu s važećem odredbama o cijepljenju protiv virusa bolesti plavog jezika (BTV).
English: These reactions take the form in most cases of a diffuse swelling of the injection site (persisting for not more than 7 days) or of palpable nodules up to a size of 60 cm2 (subcutaneous granuloma, decreasing in size over time but possibly persisting for more than 50 days).
Croatian: Ove reakcije u većini slučajeva javljaju se u obliku difuzne otekline mjesta primjene (koja traje najviše 7 dana) ili opipljivih čvorića (nodula) veličine do 60 cm2 (potkožnih granuloma čija se veličina s vremenom smanjuje, ali mogu biti prisutni dulje od 50 dana).
English: After administration with a double dose (4 ml), reactions in sheep are similar to those seen after administration of a single dose, but injection site reactions may persist for a longer time (general swelling at the injection site persisting for not more than 9 days or subcutaneous granuloma possibly persisting for more than 63 days).
Croatian: Nakon primjene dvostruke doze (4 ml), reakcije kod ovaca slične su reakcijama zabilježenima nakon primjene jednostruke doze, ali reakcije na mjestu primjene mogu potrajati dulje vrijeme (opće otekline na mjestu primjene traju najviše 9 dana ili potkožni granulom koji može trajati više od 63 dana).
English: The safety of the vaccine has not been established during lactation in sheep.
Croatian: Nije utvrđena neškodljivost ovog cjepiva tijekom laktacije u ovaca.
English: Zoetis Manufacturing & Research Spain, S.L.
Croatian: Naziv i adresa proizvođača biološki djelatne tvari Zoetis Manufacturing & Research Spain, S.L. Ctra.
English: Shelf life after first opening the container: use immediately.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: koristiti odmah nakon otvaranja.
English: 4.11 Withdrawal period(s)
Croatian: 4.11 Karencija (e)
English: SC (sheep) / IM (cattle)
Croatian: PUT(EVI) PRIMJENE SC (ovce) / i.m. (goveda)
English: To stimulate active immunity of sheep and cattle against bluetongue virus serotype(s) related to those contained in the vaccine.
Croatian: Za stimulaciju aktivnog imuniteta ovaca i goveda protiv serotipova virusa bolesti plavog jezika sadržanih u cjepivu.
English: Sheep and cattle
Croatian: Ovc i goveda
English: A transient increase in rectal temperature, not exceeding 1.6 °C, may very commonly occur during the 48 hours following vaccination.
Croatian: Vrlo je čest prolazni porast rektalne temperature, ne veći od 1,6°C, tijekom 48 sati nakon cijepljenja.
English: Cardboard box with 1 bottle of 10 doses (20 ml).
Croatian: Kartonska kutija s 1 bočicom od 10 doza (20 ml).
English: Zulvac BTV suspension for injection for sheep
Croatian: Zulvac BTV suspenzija za injekciju za ovce
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Croatian: Nije utvrđena neškodljivost i djelotvornost cjepiva kod mužjaka za rasplod.
English: Subcutaneous use (sheep) or intramuscular use (cattle).
Croatian: NAČIN I PUT(EVI) PRIMJENE Subkutana primjena (ovce) ili intramuskularna primjena (goveda).
English: Duration of immunity: 12 months after completion of the primary vaccination scheme.
Croatian: Trajanje imunosti: 12 mjeseci nakon dovršetka sheme primarnog cijepljenja.
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Croatian: Ukoliko se primjenjuje u ostalih domaćih i divljih vrsta preživača za koje se smatra da su ugroženi, cjepivo treba pažljivo primijeniti.
English: Primary vaccination
Croatian: Primarno cijepljenje