FrancophonIA/ELRC3.0 huggingface dataset:
English: Evaluation of immunogenicity in children from 9 to 12 months of age at the time of first dose A clinical study was conducted with ProQuad administered with a 2-dose schedule, the doses being given 3 months apart in 1,620 healthy subjects from 9 to 12 months of age at the time of first dose.
Croatian: Provedeno je kliničko ispitivanje cjepiva ProQuad primijenjenog prema rasporedu s 2 doze, koje su bile primijenjene u razmaku od 3 mjeseca u 1620 zdravih ispitanika u dobi od 9 do 12 mjeseci u vrijeme prve doze.
English: Clinical studies have shown that immunization with ProQuad elicits rates of antibody responses against varicella virus ≥5 gpELISA Units/ml similar to those observed after vaccination with Varicella Vaccine live (Oka/Merck).
Croatian: ProQuad izaziva stope odgovora protutijela na virus varičele koje su ≥5 gpELISA jedinica/ml, slično onima opaženima nakon cijepljenja živim cjepivom protiv varičele (Oka/Merck).
English: In 2 clinical trials, 1035 subjects were administered a second dose of ProQuad approximately 3 months after the first dose.
Croatian: Djeca koja su primila drugu dozu cjepiva ProQuad U 2 klinička ispitivanja, 1035 ispitanika primilo je drugu dozu cjepiva ProQuad približno 3 mjeseca nakon prve doze.
English: In addition, individuals who experienced thrombocytopenia following the first dose of a live measles, mumps, and rubella vaccine may develop thrombocytopenia with repeat doses.
Croatian: Osim toga, osobe koje su nakon prve doze živog cjepiva protiv morbila, parotitisa i rubele razvile trombocitopeniju mogu je ponovno razviti nakon ponovne primjene doze.
English: How to use ProQuad
Croatian: Kako primjenjivati ProQuad
English: • Uncommon (may affect up to 1 in 100 people): cough.
Croatian: • Manje često (mogu se javiti u do 1 na 100 osoba): kašalj.
English: Solvent for ProQuad
Croatian: Otapalo za ProQuad
English: The most common adverse events reported with the use of ProQuad were: injection-site reactions including pain/tenderness/soreness, redness, swelling or bruising; fever (≥39.4°C rectal equivalent); irritability; rash (including measles-like rash, varicella-like rash, and injection-site rash); upper respiratory infection; vomiting and diarrhoea.
Croatian: Najčešće nuspojave prijavljene uz primjenu cjepiva ProQuad bile su: reakcije na mjestu primjene injekcije uključujući bol/blagu ili jaku osjetljivost na dodir, crvenilo, oticanje ili modrica; vrućica (≥39,4°C rektalni ekvivalent); razdražljivost; osip (uključujući osip sličan morbilima, osip sličan varičeli i osip na mjestu primjene injekcije); infekcija gornjih dišnih puteva; povraćanje i proljev.
English: CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%, children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see sections 4.4 and 4.8).
Croatian: Teška humoralna ili stanična (primarna ili stečena) imunodeficijencija, npr., teška kombinirana imunodefincijencija, agamaglobulinemija i SIDA ili simptomatska infekcija HIV-om ili dobno specifični postotak CD4+ T limfocita u djece mlađe od 12 mjeseci: CD4+ <25%, djece u dobi između 12 i 35 mjeseci: CD4+ <20%; djece u dobi između 36 i 59 mjeseci: CD4+ <15% (vidjeti dijelove 4.4 i
English: • Uncommon (may affect up to 1 in 100 people): seizures with a fever.
Croatian: • Manje često (mogu se javiti u do 1 na 100 osoba): napadaji s vrućicom.
English: Two doses of ProQuad administered by the IM route of administration were as immunogenic as two doses administered by the SC route in terms of antibody response rates and antibody titres to measles, mumps, rubella, and varicella.
Croatian: Dvije doze cjepiva ProQuad primijenjene i.m. putem primjene bile su jednako imunogene kao i dvije doze primijenjene s.c. putem u pogledu stope odgovora protutijela i titra protutijela na morbile, parotitis, rubeolu i varičele.
English: Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem P.O.
Croatian: Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem P.O. BOX 581, 2003 PC Haarlem Nizozemska
English: ProQuad is given to help protect your child against measles, mumps, rubella, and varicella (chickenpox).
Croatian: ProQuad se daje zbog zaštite Vašeg djeteta od morbila, parotitisa, rubele i varičele (vodenih kozica).
English: Vaccination with ProQuad may not result in protection in all vaccine recipients.
Croatian: ProQuad ne mora rezultirati zaštitom u svih cijepljenih osoba.
English: The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Croatian: Prije primjene, rekonstituirano cjepivo treba vizualno pregledati da ne sadrži strane čestice i/ili da nema neuobičajeni izgled.
English: Administration of immune globulins concomitantly with ProQuad may interfere with the expected immune response.
Croatian: ProQuad mogu ometati očekivani imunološki odgovor.
English: The following adverse reactions were reported as vaccine related by the investigator in individuals after a single dose of ProQuad.
Croatian: Sljedeće nuspojave su prijavljene nakon primjene jednokratne doze cjepiva ProQuad.
English: The immunogenicity of a single dose of an earlier formulation of ProQuad was comparable to the immunogenicity of a single dose of its individual component vaccines (Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.), currently used in routine vaccination in some countries.
Croatian: Imunogenost jednokratne doze ranije formulacije cjepiva ProQuad bila je podjednaka imunogenosti jednokratne doze pojedinih komponenti cjepiva (živo cjepivo protiv varičele (Oka/Merck) i cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc.), koje se trenutno koriste za rutinsko cijepljenje u nekim zemljama.
English: * See section c c. Description of selected adverse reactions
Croatian: * Vidjeti dio c c.
English: Keep the vial of powder in the outer carton to protect from light.
Croatian: Bočicu s praškom čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: The only vaccine-related systemic adverse reactions reported at a significantly greater rate in individuals who received the earlier formulation of ProQuad compared to individuals who received the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella Vaccine live (Oka/Merck) were fever (≥39.4°C rectal equivalent or abnormal) and measles-like rash.
Croatian: Jedina sustavna nuspojava povezana s cjepivom prijavljena u značajno većoj učestalosti u djece koja su primila raniji oblik cjepiva ProQuad nego u djece koja su primila cjepivo protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc. i živo cjepivo protiv varičele (Oka/Merck) bila je vrućica (≥39,4°C, rektalni ekvivalent ili abnormalna) i osip sličan morbilima.
English: Powder and solvent for suspension for injection in a pre-filled syringe.
Croatian: Prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki.
English: Musculoskeletal, connective tissue and bone disorders Arm pain, Musculoskeletal stiffness
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u ruci, mišićno-koštana ukočenost rijetko
English: ProQuad is a vaccine containing measles, mumps, rubella, and varicella (chickenpox) viruses that have been weakened.
Croatian: ProQuad je cjepivo koje sadrži oslabljene viruse morbila (ospica), parotitisa (zaušnjaka), rubele (crljenca) i varičele (vodenih kozica).
English: The overall safety profile of ProQuad was comparable whether it was administered concomitantly or alone.
Croatian: ProQuad bio je usporediv bilo da se cjepivo primijenilo samo ili istodobno s drugim cjepivima.
English: • Pregnant women who have either not had chickenpox or have not been vaccinated against chickenpox.
Croatian: • Trudnice koje nisu preboljele ili nisu cijepljene protiv vodenih kozica.
English: Other side effects have been reported with the use of at least one of the following: ProQuad, previous formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured by Merck & Co., Inc., or Varicella Vaccine live (Oka/Merck).
Croatian: Ostale nuspojave prijavljene su uz primjenu najmanje jednog od sljedećih cjepiva: ProQuad, prethodni pripravci monovalentnih i kombiniranih cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc., ili živog cjepiva protiv varičele (Oka/Merck).
English: General disorders and administration site conditions Fever
Croatian: Opći poremećaji i reakcije na mjestu primjene vrućica
English: It is not known whether measles or mumps vaccine virus is secreted in human milk.
Croatian: Nije poznato izlučuje li se virus morbila ili parotitisa u majčino mlijeko.
English: Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks' Salts, MEM, neomycin, phenol red, HCl, NaOH.
Croatian: Saharoza, hidrolizirana želatina, urea, natrijev klorid, sorbitol, natrijev glutamat, natrijev fosfat, natrijev bikarbonat, kalijev fosfat, kalijev klorid, podloga 199 s Hanksovim solima, MEM, neomicin, fenolno crvenilo, HCl, NaOH.
English: Additionally, other adverse events have been reported with postmarketing use of ProQuad and/or in clinical studies and post-marketing use of either the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., the monovalent component vaccines of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or Varicella Vaccine live (Oka/Merck).
Croatian: Nadalje, drugi štetni događaji prijavljeni su prilikom primjene cjepiva ProQuad nakon njegova stavljanja u promet i/ili u kliničkim ispitivanjima i prilikom primjene cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc., monovalentnih cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc. ili živog cjepiva protiv varičele (Oka/Merck) nakon njihova stavljanja u promet.
English: ProQuad elicits rates of antibody responses against measles, mumps, and rubella similar to those observed after vaccination with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Croatian: ProQuad postiže stope odgovora protutijela na viruse morbila, parotitisa i rubele koji je sličan onom primijećenom nakon cijepljenja cjepivom protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc.
English: The doctor has a more complete list of side effects for ProQuad and for the vaccine components for ProQuad (the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella Vaccine live (Oka/Merck)).
Croatian: Liječnik ima potpuniji popis nuspojava cjepiva ProQuad i sastojaka u cjepivu ProQuad (cjepivo protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc. i živo cjepivo protiv varičele (Oka/Merck)).
English: Complications of varicella from vaccine strain including herpes zoster and disseminated disesase such as aseptic meningitis and encephalitis have been reported in immunocompromised or immunocompetent individuals.
Croatian: U imunokompromitiranih ili imunokompetentnih osoba prijavljene su komplikacije povezane sa sojem virusa varičela sadržanog u cjepivu, uključujući herpes zoster i diseminiranu bolest kao što je aseptički meningitis i encefalitis.
English: How to store ProQuad
Croatian: Kako čuvati ProQuad
English: Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks' Salts, MEM, neomycin, phenol red, hydrochloric acid and sodium hydroxide.
Croatian: Saharoza, hidrolizirana želatina, urea, natrijev klorid, sorbitol, natrijev glutamat, natrijev fosfat, natrijev bikarbonat, kalijev fosfat, kalijev klorid, podloga 199 s Hanksovim solima, MEM, neomicin, fenolno crvenilo, kloridna kiselina, natrijev hidroksid.
English: ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age.
Croatian: ProQuad je indiciran za istodobno cijepljenje osoba starijih od 12 mjeseci protiv morbila, parotitisa, rubele i varičele.
English: The risk-to-benefit ratio should be carefully evaluated before considering vaccination with ProQuad in such cases (see section 4.8).
Croatian: ProQuad treba pažljivo procijeniti omjer rizika i koristi (vidjeti dio 4.8).
English: These results were similar to the immune response rates induced by concomitant administration of a single dose of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. at separate injection sites.
Croatian: Ovi su rezultati bili slični stopama imunološkog odgovora izazvanog istodobnom primjenom jednokratne doze živog cjepiva protiv varičele (Oka/Merck) i cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc. primjenjenih na različita injekcijska mjesta.
English: Afebrile convulsions or seizures, Bell's palsy, Cerebrovascular accident, Dizziness, Dream abnormality, Encephalopathy*, Guillain-Barré syndrome, Measles inclusion body encephalitis (see section 4.3), Ocular palsies, Paraesthesia, Polyneuritis, Polyneuropathy, Subacute sclerosing panencephalitis*, Syncope, Transverse myelitis, Tremor
Croatian: Poremećaji živčanog sustava febrilne konvulzije*, pospanost manje često ataksija, konvulzije, glavobolja, vrištavo plakanje, hiperkinezija, hipersomnija, letargija, tremor rijetko afebrilne konvulzije ili napadaji, Bellova paraliza, cerebrovaskularni događaj, omaglica, neuobičajeni snovi, encefalopatija*, Guillain-Barréov sindrom, encefalitis s inkluzijskim tjelešcima nakon cijepljenja protiv morbila (vidjeti dio 4.3), okularna paraliza, parestezija, polineuritis, polineuropatija, subakutni sklerozirajući panencefalitis*, sinkopa, transverzalni mijelitis, tremor nepoznato
English: Postdose 1 Postdose 2
Croatian: Nakon 1. doze
English: Investigations Weight loss
Croatian: Pretrage gubitak tjelesne težine rijetko
English: If you or your child get any side effects, talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu kod sebe ili Vašeg djeteta, potrebno je obavijestiti liječnika ili ljekarnika.
English: • Common (may affect up to 1 in 10 people): injection site complaints including swelling or bruising; irritability; rash (including measles-like rash, varicella-like rash, and injection-site rash); upper respiratory infection; vomiting and diarrhoea.
Croatian: • Često (mogu se javiti u do 1 na 10 osoba): tegobe na mjestu primjene injekcije uključujući oticanje ili stvranje modrica; razdražljivost; osip (uključujući osip sličan morbilima (ospicama), osip sličan varičeli i osip na mjestu primjene injekcije); infekcija gornjih dišnih puteva; povraćanje i proljev.
English: Agitation, Apathy, Clinging, Emotional changes, Nervousness, Restlessness
Croatian: Psihijatrijski poremećaji razdražljivost često plakanje, nesanica, poremećaj spavanja manje često agitacija, apatija, neodvajanje od roditelja, emocionalne promjene, nervoza, nemir rijetko
English: Blood and the lymphatic system disorders Leukocytosis, Lymphadenopathy
Croatian: Poremećaji krvi i limfnog sustava leukocitoza, limfadenopatija rijetko limfadenitis, regionalna limfadenopatija, trombocitopenija nepoznato
English: Following the dose of ProQuad, GMTs for measles, mumps, rubella, and varicella were similar to those following a second dose of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. administered concomitantly at separate injection sites.
Croatian: Nakon primjene doze cjepiva ProQuad, geometrijski srednji titar za morbile, parotitis i rubelu bio je sličan titru nakon druge doze živog cjepiva protiv varičele (Oka/Merck) i cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc. primijenjenih istodobno na različita injekcijska mjesta.
English: Children who received ProQuad at 4 through 6 years of age after primary immunization with Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Croatian: Djeca koja su primila ProQuad u dobi između 4 i 6 godina nakon primarnog cijepljenja živim cjepivom protiv varičele (Oka/Merck) i cjepivom protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc.
English: ProQuad - Powder in vial and solvent in pre-filled syringe without needle - Pack of 1, 10, 20
Croatian: ProQuad - prašak u bočici i otapalo u napunjenoj štrcaljki bez igle - pakiranja od 1, 10, 20
English: In eight clinical studies, the overall rates of adverse reactions after a second dose of ProQuad were generally similar to, or lower than, those seen with the first dose.
Croatian: ProQuad bile su općenito slične onima opaženim nakon prve doze ili manje.
English: In three of these studies, the rates of injection-site erythema and swelling were statistically significantly higher after the second dose than after the first dose; however, in the remaining five studies, the rates of each of these reactions were similar after the first and second dose.
Croatian: Međutim, u preostalih pet ispitivanja, stope svake od ovih reakcija bile su slične nakon prve i druge doze.
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), with one or two unattached needles, in a pack size of 1, 10 and 20.
Croatian: Prašak u bočici (staklo) s čepom (butil guma) i otapalo u napunjenoj štrcaljki (staklo) s čepom klipa (klorobutil guma) i zatvaračem vrha (stiren-butadien guma), s jednom ili dvije nepričvršćene igle, u pakiranju od 1, 10 i 20.
English: Potassium phosphate
Croatian: ŠTRCALJKA S OTAPALOM
English: ProQuad - Powder in vial and solvent in vial - Pack of 1, 10
Croatian: ProQuad - prašak u bočici i otapalo u bočici - pakiranje od 1, 10
English: Bronchiolitis, Candida nappy rash, Candidiasis, Cellulitis, Infectious croup, Viral gastroenteritis, Hand-foot-mouth disease, Influenza, Pseudocroup, Respiratory infection, Skin infection, Tonsillitis, Varicella
Croatian: Infekcije i infestacije infekcija gornjih dišnih puteva često infekcija uha, gastroenteritis, nazofaringitis, otitis media, faringitis, rozeola, virusna infekcija, virusni osip manje često bronhiolitis, pelenski osip prouzročen kandidom, kandidijaza, celulitis, infektivni krup, virusni gastroenteritis, bolest šake, stopala i usta, influenca, pseudokrup, respiratorna infekcija, infekcija kože, tonzilitis, varičela
English: 2 Wistar RA 27/3 strain (live, attenuated)............... not less than 3.00 log10 CCID50* Varicella virus
Croatian: 2, soj Wistar RA 27/3 .......................ne manje od 3,00 log10 CCID50* živi, atenuirani virus varičele
English: 2 Wistar RA 27/3 strain (live, attenuated)...............not less than 3.00 log10 CCID Varicella virus
Croatian: 2, soj Wistar RA 27/3........................ne manje od 3,00 log10 CCID živi, oslabljeni virus varičele
English: Conjunctivitis, Eye discharge, Eyelid inflammation, Eye irritation, Eye swelling, Ocular hyperaemia, Tearing, Visual discomfort
Croatian: Poremećaji oka konjunktivitis, iscjedak iz oka, upala vjeđe, iritacija oka, oticanje oka, očna hiperemija, suzenje, nelagoda u očima rijetko edem vjeđe, iritacija, optički neuritis, retinitis, retrobulbarni neuritis nepoznato
English: 20 vials (powder) + 20 pre-filled syringes without needle (solvent).
Croatian: 20 bočica (prašak) + 20 napunjenih štrcaljki bez igle (otapalo).
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without needle, in a pack size of 1, 10 and 20.
Croatian: Prašak u bočici (staklo) s čepom (butil guma) i otapalo u napunjenoj štrcaljki (staklo) s čepom klipa (klorobutil guma) i zatvaračem vrha (stiren-butadien guma), bez igle, u pakiranju od 1, 10 i 20.
English: 1 Jeryl Lynn™ (Level B) strain (live, attenuated)... not less than 4.30 log10 CCID50* Rubella virus
Croatian: 1, soj Jeryl Lynn™ [Razina B] ....ne manje od 4,30 log10 CCID50*
English: 1 vial (powder) + 1 pre-filled syringe (solvent)+ 2 needles.
Croatian: 1 bočica (prašak) + 1 napunjena štrcaljka (otapalo) + 2 igle.
English: 1 Jeryl Lynn™ (Level B) strain (live, attenuated)...not less than 4.30 log10 CCID Rubella virus
Croatian: 1, soj Jeryl Lynn™ [Razina B].....ne manje od 4,30 log10 CCID
English: However, the efficacy of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. has been demonstrated in numerous studies.
Croatian: Međutim, brojna druga ispitivanja pokazala su djelotvornost živog cjepiva protiv varičele (Oka/Merck) i cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc.
English: • Infants between 9 and 12 months of age: ProQuad may be administered from 9 months of age.
Croatian: • Dojenčadi u dobi od 9 do 12 mjeseci:
English: • Individuals 12 months of age and older: To ensure optimal protection against chickenpox, two doses of ProQuad should be given at least one month apart.
Croatian: Kako bi se osigurala optimalna zaštita protiv varičela, treba dati dvije doze cjepiva ProQuad u razmaku od najmanje jednog mjeseca.
English: EU/1/05/323/010 - pack of 1 EU/1/05/323/011 - pack of 10 EU/1/05/323/013 - pack of 20
Croatian: EU/1/05/323/010 - pakiranje od 1 EU/1/05/323/011 - pakiranje od 10 EU/1/05/323/013 - pakiranje od 20
English: Clinical studies have demonstrated that ProQuad can be given simultaneously (but at separate injection sites) with Prevenar and/or hepatitis A vaccine, or with monovalent or combination vaccines comprised of diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, or hepatitis B antigen.
Croatian: A ili s monovalentnim ili kombiniranim cjepivima koja sadrže antigen difterije, tetanusa, acelularnog pertusisa, tipa b Haemophilus influenzae, inaktiviranog poliomijelitisa ili hepatitisa B.
English: Ear and labyrinth disorders Ear pain
Croatian: Poremećaji uha i labirinta bol u uhu rijetko nervna (perceptivna) gluhoća nepoznato
English: Lymphadenitis, Regional lymphadenopathy, Thrombocytopenia
Croatian: Subakutni sklerozirajući panencefalitis (SSPE)
English: Merck Sharp & Dohme d.o.o.
Croatian: Merck Sharp & Dohme Corp.
English: 10 vials (powder) + 10 vials (solvent).
Croatian: 10 bočica (prašak) + 10 bočica (otapalo).
English: 1 vial (powder) + 1 pre-filled syringe (solvent)+ 1 needle.
Croatian: 1 bočica (prašak) + 1 napunjena štrcaljka (otapalo) + 1 igla.
English: Injection site complaints (Burning and/or Stinging of short duration, Eczema, Oedema/Swelling, Hive-like rash, Hematoma, Induration, Lump, Vesicles, Wheal and Flare), Inflammation, Lip abnormality, Papillitis, Roughness/Dryness, Stiffness, Trauma, Varicella-like rash, Venipuncture site haemorrhage, Warm sensation, Warm to touch
Croatian: ‡ na mjestu injiciranja, osip na mjestu injiciranja često astenija/umor, krvarenje na mjestu injiciranja, induracija ili toplina na mjestu injiciranja, nakupina tkiva na mjestu injiciranja, malaksalost manje često bolest nalik gripi, deskvamacija na mjestu injiciranja, promjena boje kože na mjestu injiciranja, svrbež na mjestu injiciranja, nespecifični osip na mjestu injiciranja, reakcija na mjestu injiciranja, ožiljak na mjestu injiciranja, hipertermija, bol rijetko tegobe na mjestu injiciranja (kratkotrajno žarenje i/ili probadanje, ekcem, edem/oticanje, osip sličan koprivnjači, hematom, induracija, kvrga, mjehurići, otoci i crvenilo), upala, promjena usnica, papilitis, ogrubjelost/suhoća, ukočenost, trauma, osip sličan varičeli, krvarenje na mjestu venepunkcije, osjećaj topline, toplina na dodir nepoznato
English: 1 vial (powder) + 1 vial (solvent).
Croatian: 1 bočica (prašak) + 1 bočica (otapalo).
English: ProQuad - Powder in vial and solvent in pre-filled syringe with 2 unattached needles - Pack of
Croatian: ProQuad - prašak u bočici i otapalo u napunjenoj štrcaljki s pričvršćenom iglom - pakiranje od
English: EU/1/05/323/003 - pack of 1 EU/1/05/323/004 - pack of 10
Croatian: EU/1/05/323/003 - pakiranje od 1 EU/1/05/323/004 - pakiranje od 10