natgillin/translations-raw huggingface dataset:
20 hætteglas + 20 fyldte injektionssprøjter + 40 nåle
20 vials + 20 pre-filled syringes + 40 needles
§ Mæslingevirus1 Enders Edmonston stamme (levende, svækket).... ≥ 3, 00 log10 TCID50 * Fåresygevirus1 Jeryl Lynn stamme (levende, svækket (niveau B)) ≥ 4, 30 log10 TCID50 Rubellavirus2 Wistar RA 27/ 3 stamme (levende, svækket)............ ≥ 3, 00 log10 TCID50 Varicellavirus3 Oka/ Merck stamme (levende, svækket)................. ≥ 3, 99 log10 PFU **
Measles virus1 Enders’ Edmonston strain (live, attenuated)............ not less than 3.00 log10 TCID50* Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated)....... not less than 4.30 log10 TCID50 Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)................... not less than 3.00 log10 TCID50 Varicella virus3 Oka/ Merck strain (live, attenuated)........................ not less than 3.99 log10 PFU**
* 50% tissue culture infectious dose ** plaque- forming units 1) Fremstillet i kyllingefosterceller.
2/ 2 * 50% tissue culture infectious dose ** plaque-forming units
2) Fremstillet i human diploid lungefibroblast (WI- 38).
(2) Produced in human diploid lung (WI-38) fibroblasts.
3) Fremstillet i humane diploide (MRC- 5) celler.
(3) Produced in human diploid (MRC-5) cells.
ProQuad pulver og solvens til injektionsvæske, suspension.
ProQuad powder and solvent for suspension for injection.
Levende vaccine mod mæslinger, fåresyge, røde hunde og skoldkopper.
Measles, mumps, rubella and varicella vaccine (live).
Mæslingevirus1 Enders Edmonston stamme (levende, svækket)........... ≥ 3, 00 log10 CCID50 * Fåresygevirus1 Jeryl Lynn stamme (levende, svækket (niveau B))........ ≥ 4, 30 log10 CCID50 * Rubellavirus2 Wistar RA 27/ 3 stamme (levende, svækket).................... ≥ 3, 00 log10 CCID50 * Varicellavirus3 Oka/ Merck stamme (levende, svækket)........................ ≥ 3, 99 log10 PFU **
Measles virus1 Enders’ Edmonston strain (live, attenuated)........ not less than 3.00 log10 CCID50* Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated).. not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated).............. not less than 3.00 log10 CCID50* Varicella virus3 Oka/ Merck strain (live, attenuated)................... not less than 3.99 log10 PFU**
* 50% cell culture infectious dose ** plaque- forming units 1) Fremstillet i kyllingefosterceller.
*50% cell culture infectious dose **plaque-forming units
Før rekonstitution er pulveret en hvid til lysegul kompakt krystallinsk kage, og solvensen er en klar farveløs væske.
Before reconstitution, the powder is a white to pale yellow compact crystalline cake and the solvent is a clear colourless liquid.
5. 1) skal personer fra og med 12 måneder have to doser ProQuad eller en enkelt dosis ProQuad efterfulgt af en til dosis af en monovalent skoldkoppevaccine.
Posology 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).
Officielle rekommandationer kan variere med hensyn til intervallet mellem to doser og anbefaling af 2 doser eller 1 dosis af vacciner, der indeholder mæslinge -, fåresyge -, rubella - og varicellavirus.
Note: applicable official recommendations may vary regarding the interval between doses and the need for two or one doses of measles, mumps and rubella and of varicella-containing vaccine.
ProQuad kan anvendes som anden dosis til personer, fra de er 12 måneder, som tidligere er vaccineret mod mæslinger, fåresyge, røde hunde og skoldkopper.
ProQuad may be used as the second dose in individuals from 12 months of age who have previously received measles, mumps, and rubella vaccine and varicella vaccine.
2 Indgivelsesmåde Vaccinen gives subkutant i regio deltoidea på overarmen eller i den øvre del af regio femoralis anterior.
2 Method of administration The vaccine is to be injected by the subcutaneous route in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
6. 6 vedrørende vejledning i tilberedning.
See section 6.6 for preparation instructions.
MÅ IKKE GIVES SOM INTRAVASKULÆR INJEKTION.
DO NOT INJECT INTRAVASCULARLY.
2, 4. 4 og 6. 1).
History of hypersensitivity to any varicella vaccine or measles, mumps, or rubella vaccine, to any of the excipients, or to neomycin, which may be present as trace residues (see sections 2, 4.4 and 6.1).
Aktuel immunsuppressiv behandling (inklusive høje doser af kortikosteroider).
Current immunosuppressive therapy (including high doses of corticosteroids).
ProQuad er ikke kontraindiceret til personer, der får lokaliserede eller lave doser af parenterale kortikosteroider (fx til astmaprofylakse eller substitutionsterapi).
ProQuad is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e. g. for asthma prophylaxis or replacement therapy).
4. 4).
Humoral or cellular (primary or acquired) immunodeficiency, including hypogammaglobulinemia and dysgammaglobulinemia and AIDS, or symptomatic HIV infection or a CDC Class 2 or higher or an age-specific CD4+ T-lymphocyte percentage < 25% (see section 4.4).
Hos alvorligt immuninkompetente patienter, som ved en fejltagelse blev vaccineret med mæslingevaccine, er der rapporteret subakut encefalitis, pneumonitis og død som direkte konsekvens af en dissemineret virusinfektion, som skyldes mæslingevaccine.
In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
Vaccinationen bør udsættes i tilfælde af sygdom med feber > 38, 5°C.
Vaccination should be postponed during any illness with fever > 38.5°C.
Personer med anafylaktiske, anafylaktoide eller andre akutte reaktioner (fx urticaria, hævelser i mund og hals, åndedrætsbesvær, hypotension eller shock) efter indtagelse af æg kan have en øget risiko for akutte overfølsomhedsreaktioner.
Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e. g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions.
I sådanne tilfælde bør det potentielle risk/ benefit - forhold vurderes nøje, før vaccinationen gives.
The potential risk- to-benefit ratio should be carefully evaluated before considering vaccination in such cases.
3 Personer, der vaccineres med ProQuad, bør undgå salicylater i 6 uger efter vaccination, da der er forekommet Reyes syndrom efter brug af salicylater under en naturligt forekommende skoldkoppe - infektion.
3 Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad as Reye's syndrome has been reported following the use of salicylates during wild-type varicella infection.
Som ved andre vacciner er det muligt, at ProQuad ikke beskytter alle recipienter af vaccinen.
As for any vaccine, vaccination with ProQuad may not result in protection in all vaccine recipients.
4. 3 og 4. 6.
Pregnancy See sections 4.3 and 4.6.
Transmission Hos de fleste modtagelige individer er der 7- 28 dage efter vaccinationen udskilt små mængder af den levende, svækkede røde hundevirus fra næse eller hals.
Transmission Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
Det er ikke dokumenteret, at denne type virus overføres til modtagelige individer i kontakt med de personer, der er blevet vaccineret.
There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
Der foreligger ingen rapporter om den mere svækkede Enders Edmonston mæslingevirusstamme eller Jeryl Lynn- stammen af fåresygevirus fra vaccinerecipienter til modtagelige kontakter.
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.
4. 8).
Post-licensing experience with Varicella Vaccine live (Oka/ Merck) suggests that transmission of varicella vaccine virus may rarely occur between healthy vaccine recipients who develop a varicella- like rash and contacts susceptible to varicella, as well as high-risk individuals susceptible to varicella (see section 4.8).
4. 3) • gravide kvinder uden dokumenteret anamnese med varicella (skoldkopper) eller tidligere infektion påvist ved laboratorieundersøgelse • nyfødte af mødre uden dokumenteret anamnese med skoldkopper eller tidligere infektion påvist ved laboratorieundersøgelse
• immunocompromised individuals (see section 4.3), • pregnant women without documented positive history of varicella (chickenpox) or laboratory evidence of prior infection, • newborn infants of mothers without documented positive history of varicella or laboratory evidence of prior infection.
Trombocytopeni Der foreligger ingen kliniske data om udvikling eller forværring af trombocytopeni hos personer vaccineret med ProQuad.
Thrombocytopenia No clinical data are available regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad.
Efter markedsføring tyder erfaringer med levende vaccine mod mæslinger, fåresyge og røde hunde (MFR- vaccine) dog på, at personer, som lider af trombocytopeni, vil kunne opleve en forværring af denne lidelse efter vaccinationen.
However, post-marketing experience with live measles, mumps, and rubella vaccine indicates that individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.
Endvidere vil personer, som fik trombocytopeni efter første dosis af en levende MFR- vaccine, kunne få trombocytopeni ved gentagne doser.
In addition, individuals who experienced thrombocytopenia following the first dose of a live measles, mumps, and rubella vaccine may develop thrombocytopenia with repeat doses.
4. 8).
The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination with ProQuad in such cases (see section 4.8).
Andet Der foreligger ingen kliniske data for ProQuad hos personer med kendt human immundefekt virus uden påvist immunsuppression.
Other No clinical data are available for ProQuad in individuals who are known to be infected with human immunodeficiency viruses without evidence of immunosuppression.
4. 3).
Careful risk-to-benefit evaluation should be done for these subjects (see section 4.3).
Børn i behandling for tuberkulose har ikke oplevet forværring af sygdommen ved vaccination med vaccine med levende mæslingevirus.
Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunized with live measles virus vaccine.
4. 3).
No studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis (see section 4.3).
4 Profylakse efter eksposition Der foreligger ingen kliniske data om ProQuad administreret efter eksposition for mæslinger, fåresyge, røde hunde eller skoldkopper.
4 Post-exposure prophylaxis No clinical data are available for ProQuad administered after exposure to measles, mumps, rubella, or varicella.
Profylakse efter eksposition for skoldkopper og mæslinger er dog påvist for henholdsvis levende skoldkoppevaccine (Oka/ Merck) og vacciner med mæslingevirus fremstillet af Merck & Co., Inc.
However, post-exposure prophylaxis for varicella and measles has been demonstrated with Varicella Vaccine live (Oka/ Merck) and the measles-containing vaccines manufactured by Merck & Co., Inc., respectively.
4. 4).
Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad (see section 4.4).
Immunglobulin (Ig) og varicel- zoster immunglobulin (VZIG) må ikke gives samtidig med ProQuad.
Do not give immunoglobulin (IG) or Varicella Zoster Immune Globulin (VZIG) concomitantly with ProQuad.
Samtidig administration af immunglobuliner og ProQuad kan påvirke det forventede immun - respons.
Administration of immune globulins concomitantly with ProQuad may interfere with the expected immune response.
Vaccinationen bør udsættes i mindst 3 måneder efter blod - eller plasmatransfusion eller administration af immunglobuliner (Ig).
Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG).
Hvor langt intervallet bør være mellem transfusion eller Ig- administration og vaccination vil dog afhænge af transfusionstypen eller indikationen for og doseringen af Ig (fx 5 måneder for VZIG).
5 months for VZIG).
Administration af blodprodukter, der indeholder varicel- zoster virusantistoffer, inklusive VZIG og andre immunglobulinpræparater, inden for 1 måned efter en dosis ProQuad kan nedsætte immunresponset på vaccinen og dermed nedsætte vaccinens beskyttende effekt.
Administration of varicella zoster virus antibody-containing blood products, including VZIG or other immune globulin preparations, within 1 month following a dose of ProQuad may reduce the immune response to the vaccine and hence reduce its protective efficacy.
Hvis der skal foretages tuberkulintest, skal den administreres enten på et tidspunkt før, samtidig med eller mindst 4- 6 uger efter vaccination med ProQuad.
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.
Der foreligger ingen undersøgelser af ProQuad til gravide kvinder.
Studies have not been conducted with ProQuad in pregnant women.
4. 1, 4. 3 og 4. 4).
Therefore, ProQuad should not be administered to pregnant females; furthermore, pregnancy should be avoided for 3 months following vaccination (see sections 4.1, 4.3 and 4.4).
Med henblik på rådgivning af kvinder, som ved en fejltagelse blev vaccineret under graviditet, eller som blev gravide inden for 3 måneder efter vaccination, skal lægen være opmærksom på følgende:
In order to advise women who are inadvertently vaccinated when pregnant or who become pregnant within 3 months after vaccination, the physician should be aware of the following:
1) Rapporter tyder på, at hvis kvinder får naturligt forekommende mæslinger under graviditeten, indebærer det øget risiko for fostret.
(1) Reports have indicated that contracting of wild-type measles during pregnancy enhances foetal risk.
Der er observeret en øget forekomst af spontan abort, dødfødsel, medfødte misdannelser og præmaturitet som følge af naturligt forekommende mæslinger under graviditet.
Increased rates of spontaneous abortion, stillbirth, congenital defects and prematurity have been observed subsequent to wild-type measles during pregnancy.
Der foreligger ikke tilstrækkelige undersøgelser af anvendelse af (vacciner med) den svækkede stamme mæslingevirus under graviditet.
There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy.
2) Fåresyge i de første 3 måneder af graviditeten kan øge forekomsten af spontan abort.
However, it would be prudent to assume that the vaccine strain of virus is also capable of inducing adverse foetal effects; (2) Mumps infection during the first trimester of pregnancy may increase the rate of spontaneous abortion.
3) I en 15- årig undersøgelse omfattende over 1100 gravide kvinder, som fik vaccine mod røde hunde inden for 3 måneder før eller efter undfangelsen (hvor 635 kvinder fik Wistar RA 27/ 3- stammen), havde ingen af de nyfødte anomalier, som kunne henføres til kongenit rubellasyndrom and (4) Vild- type varicella er kendt for at medføre skade på fostre, og er forbundet med en øget risiko for herpes zoster i det første leveår og alvorlig varicella hos det nyfødte spædbarn.
Although mumps vaccine virus has been shown to infect the placenta and foetus, there is no evidence that it causes congenital malformations in humans; (3) In a 15-year survey involving over 1100 pregnant women who received rubella vaccine within 3 months before or after conception (of whom 635 received the Wistar RA 27/ 3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome; and (4) Wild-type varicella is known to cause foetal harm, and is associated with an increased risk of herpes zoster in the first year of life and severe varicella in the newborn infant.
De officielle rekommandationer kan variere med hensyn til varigheden af den periode, hvor kvinder bør undgå graviditet efter en vaccination.
5 Note: official recommendations may vary regarding the duration of the waiting period that is recommended for avoiding pregnancy following vaccination.
Undersøgelser har vist, at kvinder, der ammer efter fødslen, og som er vaccineret med levende, svækket røde hundevirus, kan udskille virus i modermælken og overføre den til brystbarnet.
Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants.
Det er ikke påvist, at skoldkoppevirus fra vaccine udskilles i modermælk.
There is no evidence that varicella vaccine virus is excreted in breast milk.
Det vides ikke, om mæslinge - eller fåresygevirus fra vaccine udskilles i human modermælk. og det bør derfor overvejes nøje, før ProQuad administreres til en kvinde, der ammer.
Therefore, caution should be exercised when considering whether to administer ProQuad to a breast-feeding woman.
Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre motorkøretøj og betjene maskiner.
No studies on the affects on the ability to drive or use machinery have been performed.
I 5 kliniske forsøg blev ProQuad administreret uden andre vacciner til 6038 børn i alderen 12- 23 måneder.
In 5 clinical trials, ProQuad was administered without concomitant vaccines to 6038 children 12 through 23 months of age.
Børnene i disse studier fik enten den nuværende køleskabs- stabile formulering eller en tidligere formulering af ProQuad.
The children in these studies received either the current refrigerator-stable formulation or an earlier formulation of ProQuad.
Børnene i disse forsøg blev fulgt i seks uger efter vaccinationen.
Children in these studies were monitored for six weeks post vaccination.
Sikkerheden af de to forskellige formuleringer var sammenlignelig efter en enkelt dosis..
The safety profiles were comparable for the two different formulations after a single dose.
De eneste vaccinerelaterede systemiske bivirkninger, som optrådte signifikant hyppigere hos personer, som fik den tidligere formulering af ProQuad, sammenlignet med personer som fik MFR- vaccinen fremstillet af Merck & Co., Inc. og Varicella Vaccine Live (Oka/ Merck), var feber (≥38, 9°C svarende til oral temperatur eller febril) og mæslingelignende udslæt.
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 (≥ 38.9°C oral equivalent or abnormal) and measles-like rash.
Såvel feber som mæslingelignende udslæt indtraf sædvanligvis inden for 5- 12 dage efter vaccinationen, varede i kort tid og forsvandt uden varige følger.
Both fever and measles-like rash usually occurred within 5 to 12 days following the vaccination, were of short duration and resolved with no long-term sequelae.
Smerter og ømhed omkring injektionsstedet forekom med en statistisk lavere hyppighed hos personer, som fik ProQuad.
Pain/ tenderness/ soreness at the injection site was reported at a statistically lower rate in individuals who received ProQuad.
Den eneste vaccinerelaterede bivirkning, som forekom hyppigere blandt recipienter af ProQuad end blandt recipienter af Varicella Vaccine live (Oka/ Merck) og MFR- vaccinen fremstillet af Merck & Co., Inc., var udslæt ved injektionsstedet.
Inc. was rash at the injection site.
Børn, som fik anden dosis ProQuad Forekomsten af bivirkninger efter anden dosis ProQuad svarede enten generelt til eller var lavere end forekomsten efter første dosis.
Children who received a second dose of ProQuad The rates of adverse reactions after a second dose of ProQuad were generally similar to, or lower than, those seen with the first dose.
5. 1).
The fever rate was lower after the second dose than after the first dose (see section 5.1 for study description).
Børn, som fik ProQuad i alderen 4- 6 år efter primær immunisering med levende skoldkoppevaccine (Oka/ Merck) og MFR- vaccinen fremstillet af Merck & Co., Inc.
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.
Forekomsten og typen af bivirkninger, som sås i den forsøgsgruppe, der fik ProQuad, svarede generelt til forekomsten i de grupper, der fik levende skoldkoppevaccine (Oka/ Merck) og MFR- vaccinen fremstillet af Merck & Co., Inc.
The rates and types of adverse reactions seen in the study group that received ProQuad were generally similar to those seen in the groups that received Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
5. 1).
(see section 5.1 for study description).
Der er ikke udført specifikke forsøg med personer fra og med 2 år, som ikke tidligere var vaccineret mod mæslinger, fåresyge, røde hunde og skoldkopper.
No specific studies have been conducted in individuals from 2 years of age who had not previously received measles, mumps, rubella, and varicella vaccines.
Flere bivirkninger blev fremprovokeret i de kliniske forsøg, og de er angivet med symbolet (‡).
Several adverse events were solicited in the clinical studies and are designated with the symbol (‡).
Hertil kommer, at andre uønskede hændelser er rapporteret under anvendelse efter markedsføringen af ProQuad og/ eller i kliniske forsøg og efter markedsføring af enten MFR- vaccinen fremstillet af Merck & Co., Inc., vacciner med de monovalente komponenter svarende til MFR - vaccinen fremstillet af Merck & Co., Inc. eller levende skoldkoppevaccine (Oka/ Merck).
Additionally, other adverse experiences have been reported with post- marketing 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).
Disse bivirkninger er anført nedenfor uden hensyntagen til kausalitet eller hyppighed (hyppighed ikke kendt).
These adverse effects are listed below without regard to causality or frequency (frequency not known).
6 [meget almindelig, (≥ 1/ 10), almindelig (≥ 1/ 100, < 1/ 10), ikke almindelig (≥ 1/ 1. 000 < 1/ 100), sjælden (≥ 1/ 10. 000, < 1/ 1. 000) og meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data)]
6 [Very common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100); Rare (≥ 1/ 10,000, < 1/ 1,000), including isolated reports; not known (cannot be estimated from the available data)]
Infektioner og parasitære sygdomme Almindelig: øvre luftvejsinfektion.
Infections and infestations Common: upper respiratory infection.
Ikke almindelig: øreinfektioner, gastroenteritis, nasopharyngitis, otitis media, pharyngitis, roseola, virusinfektion, virusudslæt.
Uncommon: ear infection, gastroenteritis, nasopharyngitis, otitis media, pharyngitis, roseola, viral infection, viral rash.
Ikke kendt:
Rare: bronchiolitis, candida nappy rash, candidiasis, cellulitis, infectious croup, viral gastroenteritis, hand-foot-mouth disease, influenza, pseudocroup, respiratory infection, skin infection, tonsillitis, varicella ‡, viral conjunctivitis.
Aseptisk meningitis (se nedenfor), atypiske mæslinger, epididymitis, herpes zoster, infektion, influenza, mæslinger, orchitis, fåresyge.
Not known: aseptic meningitis (see below), atypical measles, epididymitis, herpes zoster, infection, influenza, measles, orchitis, parotitis.