natgillin/translations-raw huggingface dataset:
In these patients, clinical remission was achieved in 23% of patients at week 28 and 32% of patients at week 52.
Klinična remisija v 28. tednu je bila dosežena pri 23 % takšnih bolnikov, v 52. tednu pa pri 32 % bolnikov.
Vedolizumab should be administered in a healthcare setting equipped to allow management of acute hypersensitivity reactions including anaphylaxis, if they occur.
4.4 Posebna opozorila in previdnostni ukrepi Vedolizumab je treba uporabljati v ustrezno opremljenih zdravstvenih ustanovah, kjer je v primeru pojava akutnih preobčutljivostnih reakcij, vključno z anafilaksijo, mogoče nemudoma uvesti ustrezne ukrepe.
Treatment 2
Drugo zdravljenje
Entyvio treatment is not to be initiated in patients with active, severe infections until the infections are controlled, and physicians should consider withholding treatment in patients who develop a severe infection while on chronic treatment with Entyvio.
Pri bolnikih s hudimi aktivnimi okužbami se zdravljenja z zdravilom Entyvio ne sme uvesti vse dokler okužbe niso ustrezno nadzorovane.
Infusion site reaction (including: Infusion site pain and Infusion site irritation), Infusion related reaction, Chills, Feeling cold
Splošne težave in spremembe na mestu aplikacije pogosti zvišana telesna temperatura občasni reakcija na mestu infundiranja (vključno z bolečino na mestu infundiranja in iritacijo na mestu infundiranja), reakcija, povezana z infundiranjem, mrzlica, občutek mraza
approximately half of patients had previously failed TNFα antagonist therapy.
GEMINI II se približno polovica bolnikov ni odzvala na predhodno zdravljenje z zaviralcem TNFα.
• Patient alert card,
• izobraževalno gradivo za zdravnike, • opozorilno kartico za bolnika.
Health-related quality of life (HRQOL) was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ), a disease specific instrument, and SF-36 and EQ-5D, which are general measures.
Z zdravjem povezano kakovost življenja (HRQOL-“Health-related quality of life”) so ovrednotili z za vnetno bolezen črevesa specifičnim vprašalnikom IBDQ (“Inflammatory Bowel Disease
• prickling or tingling
• mrzlica ali drgetanje,
The risk of malignancy is increased in patients with ulcerative colitis and Crohn's disease.
Pri bolnikih z ulceroznim kolitisom in s Crohnovo boleznijo je tveganje za novotvorbe večje.
In GEMINI I, two cohorts of patients received vedolizumab at week 0 and week 2: cohort 1 patients were randomised to receive either vedolizumab 300 mg or placebo in a double-blind fashion, and cohort 2 patients were treated with open-label vedolizumab 300 mg. To evaluate efficacy at week 52, 373 patients from cohort 1 and 2 who were treated with vedolizumab and had achieved clinical response at week 6 were randomised in a double-blind fashion (1:1:1) to one of the following regimens beginning at week 6: vedolizumab 300 mg every eight weeks, vedolizumab 300 mg every four weeks, or placebo every four weeks.
Za oceno učinkovitosti v 52. tednu so 373 bolnikov iz 1. in 2. kohorte, ki so pri zdravljenju z vedolizumabom dosegli klinični odziv, v 6. tednu randomizirali na dvojno slep način (1:1:1) na enega od naslednjih režimov, ki se je začel v 6. tednu: vedolizumab v odmerku 300 mg na vsakih osem tednov, vedolizumab v odmerku 300 mg na vsake štiri tedne ali placebo na vsake štiri tedne.
Injection site reactions (with symptoms such as dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) have also been reported in patients treated with vedolizumab.
Pri bolnikih, zdravljenih z vedolizumabom, so poročali tudi o reakcijah na mestu injiciranja (s simptomi kot so dispneja, bronhospazem, urtikarija, vročinski oblivi, izpuščaj, zvišan krvni tlak in srčni utrip).
≥ 3 points and ≥ 30% from baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point) at week 6.
Primarni opazovani dogodek je bil delež bolnikov s kliničnim odzivom (opredeljeno kot zmanjšanje celotne oceno Mayo za ≥ 3 točke in ≥ 30 % od izhodiščne vrednosti ob sočasnem zmanjšanju podocene krvavitve iz danke za ≥ 1 točko ali absolutna podocena krvavitve iz danke ≤ 1 točke) v 6. tednu.
NAME OF THE MEDICINAL PRODUCT Entyvio 300 mg powder for concentrate for solution for infusion
IME ZDRAVILA Entyvio 300 mg prašek za koncentrat za raztopino za infundiranje
In GEMINI III at week 6 and 10 the respective clinical remission rates were 18% (difference from placebo 3%, 95% CI: -7, 13) and 22% (difference from placebo 8%, 95% CI: -3, 19) when administered without corticosteroids compared to 20% (difference from placebo 11%, 95% CI: 2, 20) and 35% (difference from placebo 23%, 95% CI: 12, 33) respectively when administered with concomitant corticosteroids.
V študiji GEMINI III je delež klinične remisije pri uporabi brez kortikosteroidov v 6. tednu znašal 18 % (razlika v primerjavi s placebom 3 %, 95 % IZ: -7, 13), v 10. tednu pa 22 % (razlika v primerjavi s placebom 8 %, 95 % IZ: -3, 19).
• haemorrhoids
• koprivnica,
Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Zdravilo Entyvio je indicirano za zdravljenje zmerno do močno aktivne Crohnove bolezni pri odraslih bolnikih, če pri predhodnem ustaljenem zdravljenju ali zdravljenju z zaviralcem tumorje nekrotizirajočega faktorja alfa (TNFα) odziv na zdravljenje ni bil zadosten, je izzvenel ali pa bolniki takšnega zdravljenja niso prenašali.
Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Zdravilo Entyvio je indicirano za zdravljenje zmerno do močno aktivnega ulceroznega kolitisa pri odraslih bolnikih, če pri predhodnem ustaljenem zdravljenju ali zdravljenju z zaviralcem tumorje nekrotizirajočega faktorja alfa (TNFα) odziv na zdravljenje ni bil zadosten, je izzvenel ali pa bolniki takšnega zdravljenja niso prenašali.
including corticosteroids, immunomodulators, and/or TNFα antagonists (including primary non-responders).
Vključeni bolniki se niso odzivali na vsaj eno ustaljeno zdravljenje, vključno s kortikosteroidi, imunomodulatorji in/ali zaviralci TNFα (vključno s primarnim neodzivom).
28% receiving vedolizumab every eight weeks, 27% receiving vedolizumab every four weeks, and 13% receiving placebo achieved clinical remission at week 52.
Od teh bolnikov je bila klinična remisija v 52. tednu dosežena pri 28 % bolnikov, ki so vedolizumab prejemali na vsakih osem tednov, 27 % bolnikov, ki so vedolizumab prejemali na vsake štiri tedne, in 13 % bolnikov, ki so prejemali placebo.
No dose-limiting toxicity was seen in clinical trials.
V kliničnih preskušanjih niso opazili toksičnih učinkov, ki bi omejevali velikost odmerka.
Treatment 1
Prvo zdravljenje
Corticosteroid-free clinical remission♠
Trajna klinična remisija# Klinična remisija brez uporabe kortikosteroidov♠
Furthermore, no effects were found of vedolizumab on the proliferative rate or cytotoxicity of a human tumour cell line expressing the α4β7 integrin in vitro.
Razen tega pa tudi in vitro na tumorskih celičnih linijah človeškega izvora z izraženim integrinom α4β7 niso ugotovili učinkov vedolizumaba na delež proliferacij ali citotoksičnih učinkov.
• bloated stomach
• mišični krči,
• stomach flu
• trebušna gripa,
Immune System Disorders
Organski sistem
Week 52 Efficacy Results of GEMINI I
Rezultati učinkovitosti v 52. tednu v študiji GEMINI I Opazovani dogodek
Vedolizumab
Celokupno
• pneumonia
• hemoroidi,
Rash, Pruritus, Eczema, Erythema, Night sweats, Acne
Bolezni kože in podkožja pogosti izpuščaj, srbenje, ekcem, rdečina, nočno znojenje, akna občasni folikulitis
The murine precursor of vedolizumab alleviated gastrointestinal inflammation in colitic cotton-top tamarins, a model of ulcerative colitis.
Pri tamarinkah ali lisztovih opicah (Saguinus oedipus) s kolitisom, modelu ulceroznega kolitisa, mišji prekurzor vedolizumaba omili gastrointestinalno vnetje.
Vedolizumab does not pass the blood brain barrier after intravenous administration.
Vedolizumab po intravenski aplikaciji ne prehaja skozi krvno-možgansko pregrado.
Entyvio contains the active substance vedolizumab.
Učinkovina zdravila Entyvio je vedolizumab.
One serious adverse reaction of IRR was reported in a Crohn's disease patient during the second infusion (symptoms reported were dyspnoea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) and was successfully managed with discontinuation of infusion and treatment with antihistamine and intravenous hydrocortisone.
koprivnica, pordelost, izpuščaj in zvišan krvni tlak ter pospešen srčni utrip) in so ga uspešno obvladali s prekinitvijo infundiranja in z zdravljenjem z antihistaminikom in intravenskim hidrokortizonom.
(see Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Week 6 Efficacy Results of GEMINI I
Rezultati učinkovitosti v 6. tednu v študiji GEMINI I Opazovani dogodek
• pain in the limb
• bolečina v žrelu,
*p < 0.05 †not statistically significant ‡secondary endpoint to be viewed as exploratory by pre-specified statistical testing procedure §not statistically significant, the other endpoints were therefore not tested statistically ¶n = 157 for placebo and n = 158 for vedolizumab #Sustained clinical remission: clinical remission at weeks 6 and 10 ^Exploratory Endpoint
† ni statistično pomembno ‡ sekundarni opazovani dogodek, eksplorativno po vnaprej določenem statističnem postopku testiranja § ni statistično pomembno, drugi opazovani dogodki zato niso bili statistično obdelani
If you forget or miss your Entyvio infusion
Če ste prenehali uporabljati zdravilo Entyvio
In these patients, clinical remission was achieved in 25% of patients at week 28 and week 52.
Klinična remisija v 28. tednu in 52. tednu je bila dosežena pri 25 % teh bolnikov.
Sustained clinical remission#,¶ Overall
Ohranitev klinične remisije#¶
Use aseptic technique when preparing Entyvio solution for intravenous infusion.
Entyvio raztopino za intravensko infundiranje morate pripraviti v aseptičnih pogojih.
• throat and mouth yeast infection
• glivična okužba žrela in ustne votline,
No vedolizumab clinical trial data are available for patients previously treated with natalizumab or rituximab.
Pri bolnikih, ki so se predhodno zdravili z natalizumabom ali rituksimabom, podatki iz kliničnega preskušanja vedolizumaba niso na voljo.
Crohn's disease is an inflammatory disease of the gastrointestinal tract.
Pri bolnikih z ulceroznim kolitisom in Crohnovo boleznijo vedolizumab zmanjša gastrointestinalno vnetje.
Age does not impact the vedolizumab clearance in ulcerative colitis and Crohn's disease patients based on the population pharmacokinetic analyses.
Analize populacijske farmakokinetike kažejo, da pri bolnikih z ulceroznim kolitisom ali s Crohnovo boleznijo starost ne vpliva na očistek vedolizumaba.
trafficking into the CNS as evidenced by the lack of change in the ratio of CD4 +/CD8
Vedolizumab ni vplival na cirkulacijo celic CD4+ in celic CD8+ v osrednje živčevje, kot je razvidno iz nespremenjenega razmerja CD4+/CD8+ v cerebrospinalni tekočini pred uporabo in po uporabi vedolizumaba pri zdravih prostovoljcih.
Very rare side effects (may affect up to 1 in 10,000 people)
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): • pljučnica,
Bronchitis, Gastroenteritis, Upper respiratory tract infection, Influenza, Sinusitis, Pharyngitis
Infekcijske in parazitske bolezni zelo pogosti nazofaringitis pogosti bronhitis, gastroenteritis, okužba zgornjih dihal, gripa, sinuzitis, faringitis občasni okužba dihal, kandidoza vulve in nožnice, kandidoza ustne sluznice, herpes zoster zelo redki pljučnica
TNFα Antagonist(s) Failure¶,‡
Neodziv na zaviralec (zaviralce) TNFα¶,‡
Very common Headache Common
Bolezni živčevja zelo pogosti glavobol pogosti parestezija
TNFα Antagonist(s) Failure¶
Neodziv na zaviralec (zaviralce) TNFα
• pain at the infusion site
• bolečina v okončini,
• chills or shivering
• zbadanje ali mravljinčenje,
TNFα Antagonist(s) Naïve^
(zaviralci) TNFα^
• swelling
• zgaga,
• rash and redness
• izpuščaj in rdečina,
Concomitant stable doses of oral corticosteroids, immunomodulators, and antibiotics were permitted.
Dovoljena je bila sočasna uporaba peroralnih kortikosteroidov,
GEMINI II contained two cohorts of patients that received vedolizumab at weeks 0 and 2: cohort 1 patients were randomised to receive either vedolizumab 300 mg or placebo in a double-blind fashion, and cohort 2 patients were treated with open-label vedolizumab 300 mg. To evaluate efficacy at week 52, 461 patients from cohorts 1 and 2, who were treated with vedolizumab and had achieved clinical response (defined as a ≥ 70-point decrease in CDAI score from baseline) at week 6, were randomised in a double-blind fashion (1:1:1) to one of the following regimens beginning at week 6: vedolizumab 300 mg every eight weeks, vedolizumab 300 mg every four weeks, or placebo every four weeks.
≥ 70 točk od izhodišča), v 6. tednu randomizirani na dvojno slep način (1:1:1) na enega od naslednjih režimov, ki se je začel v 6. tednu: vedolizumab v odmerku 300 mg na vsakih osem tednov, vedolizumab v odmerku 300 mg na vsake štiri tedne ali placebo na vsake štiri tedne.
Powder for concentrate for solution for infusion in Type 1 glass vial (20 mL) fitted with rubber stopper and aluminium crimp protected by a plastic cap.
6.5 Vrsta ovojnine in vsebina Prašek za koncentrat za raztopino za infundiranje je na voljo v 20 ml stekleni viali (steklo tipa 1),
• heart burn
• glavobol.
Oropharyngeal pain, Nasal congestion, Cough
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti bolečina v ustih in žrelu, kongestija nosne sluznice, kašelj
Fre que ncy
(zaviralci) TNFα
• muscle weakness
• oslabelost mišic,
Respiratory, thoracic and mediastinal disorders
razredčena raztopina z natrijevim kloridom
It is to be reconstituted and further diluted prior to intravenous administration
Pred intravenskim infundiranjem je treba zdravilo rekonstituirati in nadalje razredčiti.
Inspect the reconstituted solution visually for particulate matter and discolouration prior to dilution.
Po rekonstituciji in pred redčenjem raztopino preglejte glede morebitne prisotnosti trdnih delcev in spremembe barve.
Population pharmacokinetic analyses indicate that vedolizumab has a total body clearance of approximately 0.157 L/day and a serum half-life of 25 days.
0,157 l/dan, razpolovni čas v serumu pa 25 dni.
Clinical remission
Ponovna uvedba zdravljenja
Musculoskeletal and connective tissue disorders
Razredčena raztopina z natrijevim kloridom
• chest infection
• okužba v prsnem košu,
• throat pain
• trdo blato,
The combined in-use stability of Entyvio in the vial and infusion bag with sodium chloride 9 mg/mL (0.9%) solution for injection is a total of 12 hours at 20°C-25°C or 24 hours at 2°C-8°C.
(0,9 %) raztopino za injiciranje, je skupno 12 ur pri temperaturi 20 °C-25 °C ali 24 ur pri temperaturi 2 °C-8 °C.
2 This time assumes the reconstituted solution is immediately diluted in the sodium chloride 9 mg/mL (0.9%) solution for injection and held in the infusion bag only.
5 ml (300 mg) rekonstituirane raztopine zdravila Entyvio dodajte v 250 ml sterilne raztopine za injiciranje natrijevega klorida 9 mg/ml (0,9 %) in vsebino infuzijske vrečke nežno premešajte
Clinical response Clinical remission§ Mucosal healing¶
Klinični odziv Klinična remisija§
TNFα Antagonist(s) Naïve
Crohnova bole ze n
Exploratory analysis showed clinically meaningful improvements were observed for the vedolizumab every four weeks and every eight weeks groups in GEMINI II and the improvements were significantly greater as compared with the placebo group from baseline to week 52 on EQ-5D and EQ-5D VAS scores, total IBDQ score, and IBDQ subscales of bowel symptoms and systemic function.
Eksplorativna analiza je pokazala klinično pomembno izboljšanje pri uporabi vedolizumaba na vsake štiri tedne in na vsakih osem tednov v študiji GEMINI II.
World Health Organization.
1Svetovna zdravstvena organizacija.
The CHMP concluded
je CHMP sklenil
Available on http://www.who.int/wer/2011/wer8629.pdf 29(86) Ref Type: Internet Communication
Dostopno na http://www.who.int/wer/2011/wer8629.pdf
There is an estimated theoretical risk of severe malformations attributed to the rubella containing vaccine that varies between 0.5% and 1.3%.
Ocenjeno teoretično tveganje hudih okvar, ki jih je mogoče pripisati cepivu, ki vsebuje virus rdečk, znaša od 0,5 % do 1,3 %.
Based on the above, Belgium national competent authorities triggered a referral under Article 31 of Directive 2001/83/EC on 9 March 2012, requesting the CHMP to review the benefit/risk of these vaccines in the above mentioned populations, i.e. pregnant women and subjects with immune deficiencies.
Na podlagi zgoraj navedenega so belgijski nacionalni pristojni organi 9. marca 2012 sprožili napotitveni postopek na podlagi člena 31 Direktive 2001/83/ES, v katerem CHMP naproša za ponovno presojo razmerja med tveganji in koristmi teh cepiv pri zgoraj omenjenih populacijah, tj. nosečnicah in osebah z imunskimi pomanjkljivostmi.
Immunocompromised subjects
Osebe z oslabljenim imunskim sistemom
Grounds for variation to the terms of the marketing authorisations
Razlogi za spremembo pogojev dovoljenj za promet z zdravilom
The CHMP acknowledged that MMRV vaccines should remain contraindicated in patients with severely impaired humoral and/or cellular immune systems such as severe combined immunodeficiency (SCID) and agammaglobulinemia.
CHMP je potrdil, da morajo cepiva MMRV ostati kontraindicirana pri bolnikih s hudo oslabljenim humoralnim in/ali celičnim imunskim sistemom, kot sta huda kombinirana imunska pomanjkljivost in agamaglobulinemija.
However, it was noted by the CHMP that the data from post-marketing surveillance and pregnancy registry were limited due to the current contraindication in the product information and were too poorly documented to draw any conclusion.
Vendar je CHMP ugotovil, da je podatkov iz postopka spremljanja v obdobju trženja in nosečniškega registra premalo zaradi trenutne kontraindikacije v informacijah o zdravilu in da so ti preslabo dokumentirani za postavitev kakršnega koli sklepa.
• that vaccination with MMRV vaccines may be considered in patients with selected immune deficiencies when the benefit outweighs the risk of vaccination.
• da je o cepljenju s cepivi MMRV možno razmisliti pri bolnikih z nekaterimi oblikami imunske pomanjkljivosti, kadar je korist teh cepiv večja od tveganja pri cepljenju.
Moreover, a warning should be added as vaccination may be considered in patients with selected immune deficiencies (e.g. IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases), if the benefit outweighs the risk of vaccination.
Poleg tega je treba dodati opozorilo, da je cepivo mogoče uporabiti pri bolnikih z nekaterimi oblikami imunske pomanjkljivosti (npr. pomanjkljivostmi podrazreda IgG, prirojeno nevtropenijo, kronično granulomatozno boleznijo in pomanjkljivostmi komplementa), če so koristi cepljenja večje od z njim povezanih tveganj.
Having considered all available data, the CHMP is of the opinion that MMRV vaccination should continue to be contraindicated in pregnant women.
Ob upoštevanju vseh razpoložljivih podatkov je CHMP bil mnenja, da mora ostati cepljenje proti MMVR še naprej kontraindicirano pri nosečnicah.
Annex II Scientific conclusions and grounds for variation to the terms of the Marketing Authorisations
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
Monovalent and multivalent measles, mumps, rubella and/or varicella containing vaccines (MMRV) are live attenuated vaccines which are indicated in vaccination of adults and children against these viruses.
Eno- in večvalentna cepiva, ki vsebujejo viruse ošpic, mumpsa, rdečk in/ali noric (MMRV), so živa oslabljena cepiva, indicirana za cepljenje odraslih in otrok proti tem virusom.
On the basis of the most recent published data on rubella containing vaccines, in particular for pregnant women Belgium national competent authorities considered it was justified to review whether monovalent and multivalent MMRV vaccines should remain contraindicated in pregnant women as vaccination in some individual cases may outweigh the risk.
Na podlagi najnovejših objavljenih podatkov o cepivih, ki vsebujejo virus rdečk, so belgijski nacionalni pristojni organi sklenili, da je zlasti pri nosečnicah upravičeno pregledati, ali naj eno- in večvalentna cepiva MMRV ostanejo kontraindicirana pri nosečnicah, saj so lahko koristi cepljenja v nekaterih posameznih primerih večje od z njim povezanih tveganj.
Taking into account that rubella and varicella vaccination induce a fast immune response that make post-exposure prophylaxis possible, based on available evidence and as reflected in WHO recommendation, the CHMP considered that there are sufficient data to reduce the period post-vaccination where pregnancy should be avoided.
Ker cepljenje proti rdečkam in noricam izzove hiter imunski odziv, ki omogoča zaščito po izpostavitvi, je CHMP na podlagi razpoložljivih dokazov in priporočil SZO menil, da podatki zadoščajo za skrajšanje obdobja po cepljenju, v katerem naj ženske ne zanosijo.
• that the data were sufficient to amend the product information to mention that pregnancy should be avoided for 1 month (instead of 3 months) following vaccination.
• da podatki zadoščajo, da se informacije o zdravilu spremenijo in se obdobje, v katerem naj ženske po cepljenju ne zanosijo, skrajša na 1 mesec (namesto 3 mesecev).
However, the CHMP concluded that the current contraindication for use of MMRV vaccines in immunocompromised subjects should be amended to clarify that, according to WHO guidelines and scientific data, for HIV-infected patients age specific %CD4+ is to be included.
Vendar pa je CHMP zaključil, da je treba trenutno kontraindikacijo za uporabo cepiv MMRV pri bolnikih z oslabljenim imunskim sistemom spremeniti tako, da se skladno s smernicami SZO in znanstvenimi podatki za bolnike, okužene z virusom HIV, vključi starostno specifični odstotek CD4+.
The CHMP considered that the contraindication should be harmonised and adjusted according to WHO guidance and scientific data and that although these vaccines are generally contraindicated in immunocompromised subjects, some individuals may benefit from vaccination.
CHMP je menil, da je treba kontraindikacijo uskladiti in prilagoditi v skladu s smernicami SZO in znanstvenimi podatki ter da lahko cepljenje koristi nekaterim posameznikom, čeprav so ta cepiva navadno kontraindicirana pri osebah z oslabljenim imunskim sistemom.
• the CHMP considered the referral under Article 31 of Directive 2001/83/EC for monovalent and multivalent measles, mumps, rubella and varicella containing vaccines.
• CHMP je obravnaval napotitveni postopek iz člena 31 Direktive 2001/83/ES za eno- in večvalentna cepiva, ki vsebujejo viruse ošpic, mumpsa, rdečk in noric;
• that the data provided were too limited and poorly documented to draw any conclusion and therefore without any sufficient data monovalent and multivalent MMRV vaccines should remain contraindicated during pregnancy.
• da je podatkov premalo in da so ti preslabo dokumentirani, da bi omogočali sklepe, zato morajo eno- in večvalentna cepiva proti MMRV zaradi odsotnosti zadostnih podatkov ostati kontraindicirana med nosečnostjo;