natgillin/translations-raw huggingface dataset:
• Not known (frequency cannot be estimated from the available data): unusual bleeding or bruising under the skin, swelling of the testicles; tingling of the skin, herpes zoster (shingles); inflammation of the brain (encephalitis); inflammation of the coverings of the brain and spinal cord not caused by bacterial infection (aseptic meningitis), severe skin disorders; stroke; seizures without a fever; joint pain and/or swelling (which could be transient or chronic); and inflammation of the lung (pneumonia/pneumonitis).
• Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): nenavadna krvavitev ali modrice na koži, oteklina mod; mravljinčenje v koži, herpes zoster (pasovec); vnetje možganov (encefalitis); vnetje ovojnice možganov in hrbtenjače, kjer vzrok ni bakterijska okužba (aseptični meningitis); hude bolezni kože; možganska kap; krči brez vročine; bolečine v sklepih in/ali otekanje sklepov (ki je lahko prehodno ali kronično); vnetje pljuč (pljučnica/pnevmonitis).
Other side effects have been reported following administration of ProQuad and some of these were serious.
Po uporabi cepiva ProQuad so poročali tudi o drugih neželenih učinkih, od katerih so bili nekateri resni.
The vaccine response rates were 99.4% for measles, 99.9% for mumps, 98.3% for rubella, and 99.4% for varicella (≥5 gpELISA Units/ml).
Odzivni deleži na cepivo so znašali 99,4 % za ošpice, 99,9 % za mumps, 98,3 % za rdečke in 99,4 % za norice (≥ 5 gpELISA enot/ml).
ProQuad powder for suspension for injection IM/SC
ProQuad prašek za suspenzijo za injiciranje i.m./s.c.
These surveillance data actually suggest that varicella-vaccinated children may have a lower risk of herpes zoster.
Ti podatki stalnega spremljanja pravzaprav nakazujejo, da je pri otrocih, cepljenih proti noricam, tveganje za pojav pasovca lahko manjše.
If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be given under the skin.
Če imate motnjo strjevanja krvi ali majhno število trombocitov v krvi, vam bodo cepivo injicirali pod kožo.
Discard if reconstituted vaccine is not used within 30 minutes.
Če pripravljenega cepiva ne uporabite v 30 minutah, ga zavrzite.
Pain/tenderness/soreness at the injection site was reported at a statistically lower rate in individuals who received ProQuad.
O bolečini/občutljivosti/bolečnosti na mestu injiciranja so statistično redkeje poročali pri otrocih, ki so bili cepljeni s cepivom ProQuad.
In clinical studies involving healthy subjects who received 1 dose of Varicella Vaccine live (Oka/Merck), detectable varicella antibodies were present in most individuals tested for up to 10 years postvaccination.
V kliničnih študijah zdravih oseb, ki so dobile 1 odmerek cepiva z živim virusom noric (Oka/Merck), so bila protitelesa proti noricam zaznavna pri večini pregledanih preiskovancev do 10 let po cepljenju.
Mumps (titre ≥10 ELISA Ab units/mL)
Mumps (titer ≥ 10 ELISA Ab enot/ml)
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Before reconstitution, the powder is a white to pale yellow compact crystalline cake and the solvent is a clear colourless liquid.
Pred rekonstitucijo je prašek bel do bledo rumen kompakten kristalni skupek, vehikel pa je bistra, brezbarvna tekočina.
Tell your doctor if there is anyone who falls into one of the categories above and is expected to be in contact with the person vaccinated after vaccination.
Zdravniku povejte, če bo po cepljenju katera koli od naštetih oseb verjetno v stiku s cepljeno osebo.
There are no reports of transmission of the more attenuated Enders' Edmonston strain of measles virus or the Jeryl Lynn™ strain of mumps virus from vaccine recipients to susceptible contacts.
Ni poročil o prenosu bolj oslabljenega seva Enders' Edmonston virusa ošpic ali seva Jeryl Lynn™ virusa mumpsa s cepljenih oseb na kontaktne osebe, dovzetne za okužbo z virusom ošpic in mumpsa.
Encephalitis and encephalopathy
Encefalitis in encefalopatija
Method of administration The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
Način uporabe Cepivo je treba injicirati intramuskularno (i.m.)
Injury and poisoning, and procedural complications Contusion, Non-venomous bite/sting
Poškodbe in zastrupitve in zapleti pri posegih udarnina, nestrupen pik/ugriz redki
Usually for injections into the muscle the thigh area is preferred in young children, whereas for older individuals the upper arm area is the preferred injection site.
Ponavadi je pri injiciranju v mišico pri mlajših otrocih najprimernejše mesto za injiciranje predel stegna, pri starejših posameznikih pa nadlaket.
• Rare: skin infection; varicella (chickenpox).
• Redki: okužba kože; norice;
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
ProQuad must not be mixed in a syringe with other vaccines.
Cepiva ProQuad v injekcijski brizgi ne smete mešati z drugimi cepivi.
• pregnant women without documented positive history of varicella (chickenpox) or laboratory evidence of prior infection,
• nosečnice brez dokumentirane prejšnje okužbe z noricami (varičelo) ali laboratorijskega dokaza prebolele okužbe,
It is recommended that the vaccine be administered immediately after reconstitution, to minimize loss of potency.
Priporočamo, da cepivo uporabite takoj po pripravi, da se izognete izgubi učinkovitosti.
• newborn infants of mothers without documented positive history of varicella or laboratory evidence of prior infection.
• novorojenčki mater brez dokumentirane prejšnje okužbe z noricami ali laboratorijskega dokaza prebolele okužbe.
In the 5- to 12-day timeframe after the administration of the first dose of quadrivalent measles, mumps, rubella and varicella vaccines in children, an increased risk of febrile seizure was observed compared to concomitant administration of measles, mumps, rubella and varicella vaccines (see sections 4.8 and 5.1).
Pri otrocih so v obdobju 5-12 dni po prejemu prvega odmerka štirivalentnega cepiva proti ošpicam, mumpsu, rdečkam in noricam opazili povečano tveganje za vročinske krče v primerjavi s sočasnim cepljenjem s cepivom proti ošpicam, mumpsu in rdečkam ter cepivom proti noricam (glejte poglavji 4.8 in 5.1).
Vaccination with ProQuad may not result in protection in all vaccine recipients.
Cepivo ProQuad lahko ne nudi zaščite vsem cepljenim osebam.
Post-Marketing Observational Safety Surveillance Study Safety was evaluated in an observational study that included 69,237 children vaccinated with ProQuad 12 months to 12 years old and 69,237 matched children in a historical comparison group who were vaccinated concomitantly with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck).
Postmarketinška opazovalna študija spremljanja varnosti Varnost so ocenili v opazovalni študiji, ki je vključevala 69.237 otrok, cepljenih s cepivom ProQuad, starih od 12 mesecev do 12 let, ter 69.237 primerljivih otrok v historični primerjalni skupini, ki so bili sočasno cepljeni s cepivom proti ošpicam, mumpsu in rdečkam, izdelovalca Merck & Co., Inc., in s cepivom z živim virusom noric (Oka/Merck).
Immunogenicity was studied in children 12 through 23 months of age with a negative clinical history of measles, mumps, rubella, and varicella who participated in 5 randomized clinical trials.
Imunogenost so preučevali pri otrocih, starih od 12 do 23 mesecev, brez klinične anamneze ošpic, mumpsa, rdečk ali noric, ki so sodelovali v 5 randomiziranih kliničnih preskušanjih.
ProQuad is available in pack of 1 and pack of 10.
Cepivo ProQuad je na voljo v pakiranjih po 1 in 10.
These patients should be monitored carefully for signs of measles, parotitis, rubella, and varicella.
Te bolnike je treba pozorno spremljati glede znakov ošpic, parotitisa, rdečk in noric.
In 5 clinical trials, ProQuad was administered without concomitant vaccines to 6038 children 12 through 23 months of age.
V 5-ih kliničnih preskušanjih je bilo s cepivom ProQuad brez sočasnih drugih cepiv cepljenih 6.038 otrok, starih 12 do 23 mesecev.
Do not give immunoglobulin (IG) or Varicella Zoster Immune Globulin (VZIG) concomitantly with ProQuad.
Sočasno s cepivom ProQuad ne dajajte imunoglobulinov (IG) ali Varicella-Zoster imunoglobulina (VZIG).
• Pregnant women who have either not had chickenpox or have not been vaccinated against chickenpox.
• Nosečnicami, ki še niso imele noric ali niso bile cepljene proti noricam.
No specific studies have been conducted in individuals from 2 years of age who had not previously received measles, mumps, rubella, and varicella vaccines.
Specifičnih študij pri otrocih nad 2 leti starosti, ki predhodno še niso prejeli cepiv proti ošpicam, mumpsu, rdečkam in noricam, niso izvedli.
These adverse events include:
Ti neželeni učinki so:
In a clinical trial, 2 cases of herpes zoster were reported in 2108 healthy subjects 12 through 23 months of age who were vaccinated with one dose of ProQuad and followed for 1 year.
Primeri pasovca (herpes zoster) v kliničnih študijah V kliničnem preskušanju so poročali o 2 primerih pasovca med 2108 zdravimi osebami, starimi 12 do 23 mesecev, ki so jih cepili z enim odmerkom cepiva ProQuad in spremljali 1 leto.
Women of child-bearing age should take the necessary precautions to avoid pregnancy for 1 month following vaccination.
Ženske v rodni dobi morajo 1 mesec po cepljenju ustrezno poskrbeti, da ne zanosijo.
Arthritis and/or arthralgia (usually transient and rarely chronic)* , Musculoskeletal pain, Myalgia, Pain of the hip, leg, or neck, Swelling
Pogostnost artritis in/ali artralgija (običajno prehodna in redko kronična)*, mišično-skeletne bolečine, mialgija, bolečine v kolku, nogi ali vratu, otekanje neznana pogostnost
If you or your child get any side effects, talk to your doctor or pharmacist.
Če vi ali vaš otrok opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
If the person to be vaccinated has a blood clotting disorder or low levels of platelets, the vaccine should be given under the skin because bleeding may occur following administration into the muscle.
Če ima oseba, ki bo cepljena, motnjo strjevanja krvi ali majhno število trombocitov, je treba cepivo injicirati pod kožo, saj se lahko po injiciranju v mišico pojavijo krvavitve.
At least one month must elapse between the first and second dose of any live viral attenuated vaccine.
Med prvim in drugim odmerkom katerega koli cepiva z oslabljenim živim virusom mora miniti vsaj en mesec.
• Very common (may affect more than 1 in 10 people): injection site complaints including pain/tenderness/soreness, redness; fever (38.9°C or higher);
• Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb): težave na mestu injiciranja, vključno z bolečino/občutljivostjo/bolečnostjo in rdečino; zvišana telesna temperatura (38,9 ºC ali več);
Animal reproduction studies have not been conducted with ProQuad.
Študij sposobnosti razmnoževanja na živalih s cepivom ProQuad niso izvedli.
The presence of detectable antibody was assessed by an appropriately sensitive enzyme-linked immunosorbent assay (ELISA) for measles, mumps (wild-type and vaccine-type strains), and rubella, and by gpELISA for varicella.
Prisotnost zaznavnih protiteles so ocenili z ustrezno občutljivim encimsko-imunskim testom (ELISA) za ošpice, mumps (divji in cepilni sevi) in rdečke ter z gpELISA za norice.
Individuals from 12 months of age should receive two doses of ProQuad or a single dose of ProQuad followed by a second dose of a monovalent varicella vaccine to ensure optimal protection against varicella (see section 5.1).
Pri posameznikih, starih od 12 mesecev dalje, sta za zagotovitev optimalne zaščite proti noricam potrebna dva odmerka cepiva ProQuad ali en odmerek cepiva ProQuad in za njim drugi odmerek enovalentnega cepiva proti noricam (glejte poglavje 5.1).
Metabolism and nutrition disorders Anorexia, Decreased appetite
Presnovne in prehranske motnje anoreksija, zmanjšan apetit občasni dehidracija redki
Additionally, GMTs for measles, mumps, and rubella were similar to those following a second dose of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. given concomitantly with placebo (for safety information, see section 4.8).
Poleg tega so bila GMT za ošpice, mumps in rdečke podobna kot po drugem odmerku cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc., danega sočasno s placebom (za podatke o varnosti glejte poglavje 4.8).
Anaphylactoid reaction, Anaphylaxis and related phenomenon such as Angioneurotic oedema, Facial oedema, and Peripheral oedema, Anaphylaxis in individuals with or without an allergic history
Pogostnost anafilaktoidna reakcija, anafilaksija in povezani pojavi, kot so angionevrotični edem, obrazni edem in periferni edem, anafilaksija pri posameznikih z anamnezo alergije ali brez nje neznana pogostnost
The risk-to-benefit ratio should be carefully evaluated before considering vaccination with ProQuad in such cases (see section 4.8).
V takšnih primerih pa je treba pred odločitvijo za cepljenje s cepivom ProQuad skrbno ovrednotiti razmerje med tveganjem in koristjo cepljenja (glejte poglavje 4.8).
Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks after immunization with ProQuad.
Če je potreben tuberkulinski test, ga je treba opraviti kadar koli pred cepljenjem s cepivom ProQuad, hkrati z njim ali vsaj 4 do 6 tednov po njem.
Therefore, administration of any of these products should be avoided within 1 month after a dose of ProQuad unless considered to be essential.
Zato se je treba 1 mesec po cepljenju s cepivom ProQuad izogibati dajanju katerega koli od teh pripravkov, razen če je nujno potrebno.
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).
Klinične študije so pokazale, da cepljenje s cepivom ProQuad vzpodbudi raven protitelesnega odziva proti virusu noric ≥ 5 gpELISA enot/ml, ki je podobna kot po cepljenju s cepivom z živim virusom noric (Oka/Merck).
The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulin (IG), or varicella zoster immune globulin (VZIG).
Zdravnik lahko odloži cepljenje za vsaj 3 mesece po transfuziji krvi ali plazme ali po prejemu imunoglobulinov ali imunoglobulina proti virusu varicella-zoster.
ProQuad can be given at the same time as other childhood vaccines such as Prevenar, and/or hepatitis A vaccine, or with vaccines containing diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, or hepatitis B. A different place for the injection will be used for each vaccine.
Cepivo ProQuad se lahko da sočasno z drugimi cepivi za otroke, kot je cepivo Prevenar in/ali cepivo proti hepatitisu A, ali s cepivi proti davici, tetanusu, oslovskemu kašlju (acelularno cepivo), Haemophilusu influenzae tipa b, otroški paralizi (inaktivirano cepivo) ali hepatitisu B. Vsako cepivo bo injicirano na drugo mesto.
Post-marketing experience with live measles, mumps, and rubella vaccine indicates that individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.
Postmarketinške izkušnje z živim cepivom proti ošpicam, mumpsu in rdečkam kažejo, da se lahko pri posameznikih z obstoječo trombocitopenijo po cepljenju pojavi še hujša trombocitopenija.
It is not known whether measles or mumps vaccine virus is secreted in human milk.
Ni znano, ali se cepilni virus ošpic ali mumpsa izloča v materino mleko.
In circumstances where contact with high-risk individuals susceptible to varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus.
Kadar se stiku z osebami z velikim tveganjem, ki so sprejemljive za norice, ni mogoče izogniti, je treba pretehtati morebitno tveganje prenosa cepilnega virusa noric ter tveganje okužbe z divjim sevom noric in njenega prenosa.
How to use ProQuad
Kako uporabljati cepivo ProQuad
After 2 doses, the seroprotection rates against measles were 98.1% when the first dose was given at 11 months, compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective met).
Po 2 odmerkih so bile stopnje serozaščite proti ošpicam 98,1 %, če so s prvim odmerkom cepili v starosti 11 mesecev, v primerjavi z 98,9 %, če so s prvim odmerkom cepili v starosti 12 mesecev (neinferiornost je bila v študiji dokazana).
Most cases of varicella reported in recipients of 1 dose or 2 doses of vaccine were mild.
Večina primerov noric po cepljenju z 1 ali 2 odmerkoma je bilo blagih.
When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the measles, mumps, rubella, and varicella viruses.
Po cepljenju začne imunski sistem (naravna obramba telesa) izdelovati protitelesa proti virusom ošpic, mumpsa, rdečk in noric.
• Newborn infants of mothers who have either not had chickenpox or have not been vaccinated against chickenpox.
• Novorojenčki mater, ki še niso imele noric ali niso bile cepljene proti noricam.
Before mixing with the solvent, the powder vaccine is a white to pale yellow compact crystalline cake.
Pred mešanjem z vehiklom je cepivo v prašku bel do bledo rumen kompakten kristalni skupek.
• If the person to be vaccinated has any illness with fever higher than 38.5°C; however, low grade fever itself is not a reason to delay vaccination.
38,5 °C; malo zvišana telesna temperatura pa sama po sebi ni vzrok, da bi cepljenje odložili.
Based on isolated case reports from post-marketing surveillance for Varicella Vaccine live (Oka/Merck), the possibility exists that varicella vaccine virus may rarely be transmitted to contacts of recipients of ProQuad who develop or do not develop a varicella-like rash (see section 4.4).
Na podlagi posameznih primerov, o katerih so poročali med postmarketinškim spremljanjem cepiva z živim virusom noric (Oka/Merck), obstaja možnost, da se cepilni virus noric v redkih primerih lahko prenese na osebe, ki so bile v stiku s prejemniki cepiva ProQuad, pri katerih se pojavi noricam podoben izpuščaj ali pa ne (glejte poglavje 4.4).
Post-marketing experience with Varicella Vaccine live (Oka/Merck) suggests that transmission of varicella vaccine virus may rarely occur between healthy vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella, as well as high-risk individuals susceptible to varicella (see section 4.8).
Izkušnje iz obdobja trženja cepiva z živim virusom noric (Oka/Merck) kažejo, da lahko redko pride do prenosa cepilnega virusa noric z zdravih cepljenih oseb (pri katerih se pojavi noricam podoben izpuščaj ali pa ne) na kontaktne osebe, sprejemljive za norice, pa tudi na osebe z velikim tveganjem, sprejemljive za norice (glejte poglavje 4.8).
After two doses, the seroprotection rates against measles were 94.6% when the first dose was given at 9 months, compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective not met).
Po dveh odmerkih so bile stopnje serozaščite proti ošpicam 94,6 %, če so s prvim odmerkom cepili v starosti 9 mesecev, v primerjavi z 98,9 %, če so s prvim odmerkom cepili v starosti 12 mesecev (neinferiornost v študiji ni bila dokazana).
Post-exposure prophylaxis
Profilaksa po izpostavitvi
Consistent with clinical study data on the timing of fever and measles-like rash, a post-marketing observational study in children 12 to 60 months of age revealed an approximate two-fold increase (0.70 per 1000 vs. 0.32 per 1000 children) in the risk of febrile seizures in the 5- to 12-day timeframe after a first dose of ProQuad (N=31,298) compared with concomitant administration of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck) (N=31,298).These data suggest one additional case of febrile seizure per 2600 children vaccinated with ProQuad compared with separate administration of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck).
Skladno s podatki iz klinične študije glede časovne pojavnosti zvišane telesne temperature in ošpicam podobnega izpuščaja je postmarketinška opazovalna študija pri otrocih, starih 12 do 60 mesecev, pokazala približno dvakratno povečanje (0,70 na 1000 otrok oz. 0,32 na 1000 otrok) tveganja za vročinske krče v obdobju 5-12 dni po prvem odmerku cepiva ProQuad (n = 31.298) v primerjavi s sočasno uporabo cepiva proti ošpicam, mumpsu in rdečkam, izdelovalca Merck & Co., Inc., in cepiva z živim virusom noric (Oka/Merck) (n = 31.298).
Varicella caused by vaccine strain was observed in post-marketing use with Varicella Vaccine live (Oka/Merck).
Norice, povzročene s cepilnim sevom, so opazili v obdobju trženja cepiva z živim virusom noric (Oka/Merck).
• A side effect after vaccination with measles, mumps, or rubella (in a single vaccine or combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. or ProQuad) that involved easy bruising or bleeding for longer than usual.
• Neželeni učinek po cepljenju proti ošpicam, mumpsu ali rdečkam (pri cepljenju z enovalentnim ali kombiniranim cepivom, kot je cepivo proti ošpicam, mumpsu in rdečkam, izdelovalca Merck & Co., Inc., ali ProQuad), pri katerem so se hitro pojavljale modrice ali je krvavitev trajala dlje kot ponavadi.
Antibody responses against varicella virus ≥5 gpELISA Units/ml in the glycoprotein enzyme-linked immunosorbent assay (gpELISA, a highly sensitive assay which is not commercially available) have been shown to be highly correlated with long-term protection.
glycoprotein enzyme-linked immunosorbent assay - zelo občutljiv test, ki ni komercialno dostopen) je pokazal veliko sovpadanje z dolgoročno zaščito.
In a second long-term surveillance study, five cross-sectional surveys on varicella incidence, each from a random sample of approximately 8,000 children and adolescents 5 to 19 years of age, were conducted over 15 years, from 1995 (pre-vaccine) through 2009.
V drugi dolgoročni nadzorovalni študiji so v 15 letih od leta 1995 (obdobje pred cepivom) do konca leta 2009 opravili pet presečnih analiz pojavnosti noric, vsako iz naključnega vzorca približno 8.000 otrok in mladostnikov, starih 5 do 19 let.
There is no evidence that varicella vaccine virus is excreted in breast milk.
Ni dokazov, da se cepilni virus noric izloča v materinem mleku.
To ensure optimal protection against chickenpox and measles, two doses of ProQuad should be given at least three months apart.
Za zagotovitev optimalne zaščite proti noricam in ošpicam morajo med prvim in drugim odmerkom cepiva ProQuad miniti vsaj 3 meseci.
Children who received 2 doses of ProQuad intramuscularly or subcutaneously In a clinical trial, 405 children received 2 doses of ProQuad, either by the intramuscular or subcutaneous route of administration.
V kliničnem preskušanju je 405 otrok prejelo 2 odmerka cepiva ProQuad, bodisi intramuskularno ali subkutano.
After reconstitution, 1 dose (0.5 ml) contains (live, attenuated):
Po pripravi cepiva 1 odmerek (0,5 ml) vsebuje (živ, oslabljen):
In 2 clinical trials, 1035 subjects were administered a second dose of ProQuad approximately 3 months after the first dose.
Otroci, ki so dobili drugi odmerek cepiva ProQuad V 2 kliničnih preskušanjih je 1035 oseb dobilo drugi odmerek cepiva ProQuad približno 3 mesece po prvem cepljenju.
Musculoskeletal, connective tissue and bone disorders Arm pain, Musculoskeletal stiffness
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v rokah, mišično-skeletna okorelost redki
Skin and subcutaneous tissue disorders Measles-like rash
Bolezni kože in podkožja ošpicam podoben izpuščaj
Solvent for ProQuad
Vehikel za ProQuad