natgillin/translations-raw huggingface dataset:
Singulair is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
Zdravilo Singulair je indicirano tudi kot profilaksa za astmo, kjer je prevladujoča komponenta bronhokonstrikcija, povzročena s telesno vadbo.
Singulair 4 mg granulado 4 mg Granules
Singulair 4 mg granulado 4 mg Zrnca
Clinical Efficacy: Add-on use
Klinična učinkovitost: uporaba kot dodatno zdravljenje
Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU United Kingdom
Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU Velika Britanija
• Always have your child take SINGULAIR as your doctor has told you.
• Poskrbite, da otrok zdravilo vedno jemlje tako, kot mu je predpisal zdravnik.
For children 2 to 5 years old, SINGULAIR 4 mg chewable tablets and 4 mg granules are available.
Za otroke, stare 2 do 5 let, so na voljo SINGULAIR 4 mg žvečljive tablete in 4 mg zrnca.
Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU, United Kingdom
Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU, Velika Britanija
The dosage is the same for both male and female patients.
Podatkov za bolnike s hudo okvaro jeter ni. Odmerjanje je enako za bolnike obeh spolov.
However, liquids may be taken subsequent to administration.
Lahko pa se tekočino popije po zaužitju zrnc.
• Do not use this medicine after the date shown by the six numbers following EXP on the blister.
• Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vrečki poleg oznake EXP. Prvi dve številki označujeta mesec, zadnje štiri pa leto.
The dosage for paediatric patients 6 months to 5 years of age is one sachet of 4 mg granules daily to be taken in the evening.
Odmerek za otroke, stare 6 mesecev do 5 let, je ena vrečka 4 mg zrnc na dan - zvečer.
Very rare cases of Churg-Strauss Syndrome (CSS) have been reported during montelukast treatment in asthmatic patients (see section 4.4).
Splošne težave in spremembe na mestu aplikacije: astenija/utrujenost, splošno slabo počutje, edem Zelo redko so tekom zdravljenja z montelukastom pri astmatikih poročali o primerih ChurgStraussovega sindroma (glejte poglavje 4.4).
Hepatobiliary disorders: elevated levels of serum transaminases (ALT, AST), cholestatic hepatitis.
Bolezni prebavil: diareja, suha usta, dispepsija, navzea, bruhanje Bolezni jeter, žolčnika in žolčevodov: zvišane vrednosti serumskih transaminaz (ALT, AST), holestatski hepatitis
Paediatric Patients 6 to 14 years old (one 8-week study; n=201) (two 56-week studies; n=615)
Pediatrični bolniki 6 do 14 let (ena 8-tedenska študija; n=201) (dve 56-tedenski študiji; n=615)
QUALITATIVE AND QUANTITATIVE COMPOSITION ONE CHEWABLE TABLET CONTAINS MONTELUKAST SODIUM, WHICH IS EQUIVALENT TO 4 MG MONTELUKAST.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena žvečljiva tableta vsebuje natrijev montelukast, ki ustreza 4 mg montelukasta.
Singulair may also be an alternative treatment option to low-dose inhaled corticosteroids for patients (4 mg OG, CT: 2 to 5 year old) with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.
Zdravilo Singulair se lahko uporabi tudi kot alternativa nizkim odmerkom vdihanih kortikosteroidov za bolnike (4 mg peroralna zrnca, žvečljive tablete: 2 do 5 let starosti) z blago perzistentno astmo, ki nimajo nedavne anamneze resnih astmatičnih napadov, ki so zahtevali uporabo peroralnih kortikosteroidov, ter z dokazano nezmožnostjo uporabe kortikosteroidov za vdihavanje.
The use of montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children with mild persistent asthma should only be considered for patients who do not have a recent history of serious asthma attacks that required oral corticosteroid use and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.1).
O uporabi montelukasta kot alternativi za majhne odmerke inhalacijskih kortikosteroidov pri otrocih z blago persistentno astmo lahko razmislimo le pri bolnikih, ki v zadnjem času niso imeli hudih napadov astme, ki bi zahtevali uporabo peroralnih kortikosteroidov, in pri katerih se je izkazalo, da niso sposobni uporabljati inhalacijskih kortikosteroidov (glejte poglavje 4.1).
White granules
Bela zrnca.
Singulair mini 4 mg Granulat4 mg Granules
Singulair mini 4 mg Granulat4 mg Zrnca
NAME OF THE MEDICINAL PRODUCT SINGULAIR 4 mg granules
IME ZDRAVILA SINGULAIR 4 mg zrnca
MARKETING AUTHORIZATION HOLDER [To be completed nationally.]
IMETNIK DOVOLJENJA ZA PROMET [Izpolniti nacionalno.]
QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet of granules contains montelukast sodium, which is equivalent to 4 mg montelukast.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena vrečka zrnc vsebuje natrijev montelukast, ki ustreza 4 mg montelukasta.
“Singulair may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids”
„Zdravilo Singulair se lahko uporabi tudi kot alternativa nizkim odmerkom vdihanih kortikosteroidov za bolnike, stare od 2 do 5 let, z blago perzistentno astmo, ki nimajo nedavne anamneze resnih astmatičnih napadov, ki so zahtevali uporabo peroralnih kortikosteroidov, ter dokazano nezmožnostjo uporabe kortikosteroidov za vdihanje.“
This subsection is not applicable for the SINGULAIR 4 mg granules since they are intended for use in children 6 months to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
Poglavje smiselno ni potrebno, saj so SINGULAIR 4 mg zrnca namenjena za uporabo pri otrocih, starih 6 mesecev do 5 let.
Chewable Tablets Oral use
Žvečljive tablete Peroralna uporaba
The 4 mg granule formulation is bioequivalent to the 4 mg chewable tablet when administered to adults in the fasted state.
Pri uporabi pri odraslih na tešče so 4 mg zrnca bioekvivalentna 4 mg žvečljivim tabletam.
“Singulair is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction”.
„Zdravilo Singulair je indicirano tudi za profilakso astme pri otrocih, starih najmanj 2 leti, pri katerih je prevladujoča komponenta s telesno vadbo povzročena bronhokonstrikcija.“
SINGULAIR PAEDIATRIC4 mg Chewable tablets Oral use
SINGULAIR PAEDIATRIC4 mg Žvečljive tablete Peroralna uporaba
Additionally, the following side effect was reported in clinical studies with SINGULAIR 10 mg filmcoated tablets and 5 mg chewable tablets:
V kliničnih študijah z 10 mg filmsko obloženimi tabletami in 5 mg žvečljivimi tabletami so poročali še o naslednjem neželenem učinku:
• SINGULAIR is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction.
• Zdravilo SINGULAIR je indicirano tudi za profilakso astme pri otrocih, starih najmanj 2 leti, pri katerih je prevladujoča komponenta s telesno vadbo povzročena bronhokonstrikcija.
INFORMATION IN BRAILLE SINGULAIR 4 mg granules
PODATKI V BRAILLOVI PISAVI SINGULAIR 4 mg zrnca
Patients should be evaluated after 2 to 4 weeks for response to montelukast.
Po 2 do 4 tednih je pri bolnikih treba oceniti odziv na zdravljenje z montelukastom.
The use of montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children 2 to 5 years old with mild persistent asthma should only be considered for patients who do not have a recent history of serious asthma attacks that required oral corticosteroid use and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.1).
O uporabi montelukasta kot alternativi za majhne odmerke inhalacijskih kortikosteroidov pri 2 do 5 let starih otrocih z blago persistentno astmo lahko razmislimo le pri bolnikih, ki v zadnjem času niso imeli hudih napadov astme, ki bi zahtevali uporabo peroralnih kortikosteroidov, in pri katerih se je izkazalo, da niso sposobni uporabljati inhalacijskih kortikosteroidov (glejte poglavje 4.1).
4 mg Granules
4 mg Zrnca
However, if your child misses a dose, just resume the usual schedule of one sachet once daily.
Če otrok ni dobil enega odmerka, nadaljujte z običajnim razporedom jemanja, z eno vrečko zrnc enkrat na dan. Ne dajte mu dvojnega odmerka, da bi nadomestili izpuščenega.
It is a leukotriene-1 receptor antagonist.
Zdravilna učinkovina v zdravilu Singulair je montelukast natrij, ki je antagonist receptorja za levkotrien-1.
SINGULAIR 4 mg chewable tablets montelukast
SINGULAIR 4 mg žvečljive tablete montelukast
Skin and subcutaneous tissue disorders: angiooedema, bruising, urticaria, pruritus, rash, erythema nodosum.
Bolezni kože in podkožja: angioedem, modrice, urtikarija, srbež, izpuščaj, nodozni eritem Bolezni mišično-skeletnega sistema in vezivnega tkiva: artralgija, mialgija vključno z mišičnimi krči
• SINGULAIR also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
• Zdravilo SINGULAIR pri bolnikih, starih 2 leti ali več, pomaga tudi preprečevati ožanje dihalnih poti ob naporu.
This subsection is not applicable for the SINGULAIR 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
Poglavje smiselno ni potrebno, saj so SINGULAIR 4 mg žvečljive tablete namenjene za uporabo pri otrocih, starih 2 do 5 let.
• SINGULAIR may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.2).
• Zdravilo SINGULAIR se lahko uporabi tudi kot alternativa nizkim odmerkom vdihanih kortikosteroidov za bolnike, stare od 2 do 5 let, z blago perzistentno astmo, ki nimajo nedavne anamneze resnih astmatičnih napadov, ki so zahtevali uporabo peroralnih kortikosteroidov, ter dokazano nezmožnostjo uporabe kortikosteroidov za vdihavanje (glejte poglavje 4.2).
The first two numbers indicate the month; the last four numbers indicate the year.
• Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu poleg oznake EXP. Prvi dve številki označujeta mesec, zadnje štiri pa leto.
SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma.
Zdravilo SINGULAIR je indicirano za zdravljenje astme kot dodatno zdravljenje pri tistih 2 do 5 let starih bolnikih z blago do zmerno persistentno astmo, pri katerih astma z inhalacijskimi kortikosteroidi ni ustrezno nadzorovana in pri katerih kratko delujoči agonisti beta za uporabo "po potrebi" ne omogočajo ustreznega kliničnega nadzora astme.
SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 6 months to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma.
Zdravilo SINGULAIR je indicirano za zdravljenje astme kot dodatno zdravljenje pri tistih 6 mesecev do 5 let starih bolnikih z blago do zmerno persistentno astmo, pri katerih astma z inhalacijskimi kortikosteroidi ni ustrezno nadzorovana in pri katerih kratko delujoči agonisti beta za uporabo "po potrebi" ne omogočajo ustreznega kliničnega nadzora astme.
The SINGULAIR 4 mg chewable tablet formulation is not recommended below 2 years of age.
Zdravila SINGULAIR v obliki 4 mg žvečljivih tablet ne priporočamo za mlajše od 2 let.
NAME OF THE MEDICINAL PRODUCT SINGULAIR 4 MG CHEWABLE TABLETS
IME ZDRAVILA SINGULAIR 4 mg žvečljive tablete
HOW TO STORE SINGULAIR
SHRANJEVANJE ZDRAVILA SINGULAIR
PARTICULARS TO APPEAR ON THE OUTER PACKAGING SINGULAIR 4 mg Tablets - Outer Carton
PODATKI NA ZUNANJI OVOJNINI SINGULAIR 4 mg tablete - škatla
The following revision to Section 4.2 of Singulair 4 mg OG SPC was finally accepted:
Sprejet je bil naslednji popravek poglavja 4.2 povzetka glavnih značilnosti zdravila Singulair 4 mg peroralna zrnca:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING SINGULAIR 4 mg Granules- Outer Carton
PODATKI NA ZUNANJI OVOJNINI SINGULAIR 4 mg zrnca - škatla
{To be completed nationally}
Informacije dobite pri {Izpolniti nacionalno}
• scaly and itchy skin
• luščenje kože, srbenje
Route of administration
POSTOPEK UPORABE
SINGULAIR 4 mg granules montelukast
NAVODILO ZA UPORABO SINGULAIR 4 mg zrnca montelukast
Use during lactation
Uporaba v obdobju dojenja
Hyprolose (E 463)
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol hiproloza (E 463) magnezijev stearat
Biotransformation.
Peroralna uporaba.
OTHER {Name of the Marketing Authorisation Holder} [To be completed nationally]
DRUGI PODATKI {Ime imetnika dovoljenja za promet z zdravilom} [Izpolniti nacionalno]
What SINGULAIR looks like and contents of the pack 4 mg SINGULAIR granules are white granules.
4 mg SINGULAIR zrnca so bele barve.
4 mg Chewable tablets Oral use
4 mg Žvečljive tablete Peroralna uporaba
MARKETING AUTHORIZATION NUMBER [TO BE COMPLETED NATIONALLY]
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolniti nacionalno.]
STATEMENT OF ACTIVE SUBSTANCE(S) One sachet of granules contains montelukast sodium, which is equivalent to 4 mg montelukast.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena vrečka zrnc vsebuje natrijev montelukast, kar ustreza 4 mg montelukasta.
METHOD OF ADMINISTRATION Oral use.
NAVODILO ZA UPORABO
NAME OF THE MEDICINAL PRODUCT SINGULAIR 4 mg chewable tablet montelukast
NAVODILO ZA UPORABO SINGULAIR 4 mg žvečljive tablete montelukast
Do not give SINGULAIR to your child if he/she
Otroku ne dajte zdravila SINGULAIR:
"SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting β-agonists provide inadequate clinical control of asthma".
„Zdravilo SINGULAIR je indicirano za zdravljenje astme kot dodatno zdravljenje pri tistih bolnikih, starih od 2 do 5 let, z blago do zmerno perzistentno astmo, ki bolezni ne morejo zadostno nadzorovati z vdihavanjem kortikosteroidov in s kratkotrajno delujočimi β-agonisti, uporabljenimi po potrebi.“
• SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma.
• Zdravilo SINGULAIR je indicirano za zdravljenje astme kot dodatno zdravljenje pri tistih bolnikih, starih od 2 do 5 let, z blago do zmerno perzistentno astmo, ki bolezni ne morejo zadostno nadzorovati z vdihavanjem kortikosteroidov in s kratkotrajno delujočimi β-agonisti, uporabljenimi po potrebi.
"SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 6 months to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting β-agonists provide inadequate clinical control of asthma".
„Zdravilo SINGULAIR je indicirano za zdravljenje astme kot dodatno zdravljenje pri tistih bolnikih, starih od 6 mesecev do 5 let, z blago do zmerno perzistentno astmo, ki bolezni ne morejo zadostno nadzorovati z vdihavanjem kortikosteroidov in s kratkotrajno delujočimi β-agonisti, uporabljenimi po potrebi.“
SINGULAIR may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.2).
Zdravilo SINGULAIR se lahko uporabi za zdravljenje blage persistentne astme pri bolnikih, starih 2 do 5 let, namesto majhnega odmerka inhalacijskega kortikosteroida, in sicer pri otrocih, ki v zadnjem času niso imeli hujših napadov astme, ki bi zahtevali uporabo peroralnih kortikosteroidov, in pri katerih se je izkazalo, da niso zmožni uporabljati inhalacijskih kortikosteroidov (glejte poglavje 4.2).
You should consult your doctor before taking SINGULAIR if you are breast-feeding or intend to breast-feed.
Če dojite ali nameravate dojite, se pred začetkom jemanja zdravila SINGULAIR posvetujte z zdravnikom.
If your child takes more SINGULAIR than he/she should Contact your child's doctor immediately for advice.
Če karkoli od tega opazite pri otroku, se takoj posvetujte z zdravnikom.
Immediate packaging
dovoljenja za promet
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
Virus pasje kuge, sev CDV Bio 11/A Virus pasjega adenovirusa tipa 2, sev CAV-2 Bio 13 Virus pasjega parvovirusa tipa 2b, sev CPV-2b Bio 12/B Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15
--1 Lyophilisate (live attenuated) Canine distemper virus, strain CDV Bio 11/A
--1 Liofilizat (živi atenuirani)
Most of these reactions last for 2 to 3 days.
Večina teh reakcij je trajala od dva do tri dni.
Overall, the vaccine effectiveness was similar across ages.
Na splošno je bila učinkovitost cepiva podobna pri vseh starostih.
If necessary, the second dose can be given later but within 6 months after the first dose.
Po potrebi se drugi odmerek lahko injicira pozneje, najpozneje pa šest mesecev po prejemu prvega odmerka.
Further information on Shingrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Več informacij o zdravilu Shingrix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Shingrix was assessed in two main studies in around 30,000 adults.
Zdravilo Shingrix so ocenjevali v dveh glavnih študijah pri približno 30 000 odraslih.
It also contains an ‘adjuvant' which is made of substances to help strengthen the immune responses to the vaccine.
Vsebuje tudi adjuvans, narejen iz snovi, ki okrepijo imunski odziv na cepivo.
What measures are being taken to ensure the safe and effective use of Shingrix?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Shingrix?
After a patient has had chickenpox, the virus can lie dormant in the nerves and become active again if the immune system (the body's natural defences) weakens due, for example, to ageing or to an illness.
Potem ko je bolnik prebolel norice, virus lahko v živcih ostane v mirujočem stanju in se spet aktivira, če imunski sistem (naravna odpornost telesa) oslabi, na primer zaradi staranja ali bolezni.
The most common side effects with Shingrix (which may affect more than 1 in 10 people) are reactions at the site of injection (such as pain, redness and swelling), chills, fever, muscle pain, tiredness, headache and side effects of the digestive system such as nausea, vomiting, diarrhoea and stomach pain.
Najpogostejši neželeni učinki zdravila Shingrix (ki se lahko pojavijo pri več kot 1 bolniku od 10) so reakcije na mestu injiciranja (kot so bolečina, rdečina in oteklina), mrzlica, zvišana telesna temperatura, bolečine v mišicah, utrujenost, glavobol in neželeni učinki v prebavilih, kot so slabost, bruhanje, driska in bolečine v želodcu.
It is available as a powder and a suspension to be mixed together by a doctor or a nurse before being injected into the upper arm muscle.
Zdravilo je na voljo v obliki praška in suspenzije, ki ju zdravnik ali medicinska sestra zmeša pred injiciranjem v mišico nadlahti.
The European Medicines Agency therefore decided that Shingrix's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Shingrix večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
In both studies, the main measure of effectiveness was the number of people having shingles in the group receiving the vaccine compared with the group receiving placebo (a dummy vaccine).
V obeh študijah je bilo glavno merilo učinkovitosti število ljudi, ki so zboleli za pasovcem, in sicer v skupini, ki je prejela cepivo, v primerjavi s skupino, ki je prejela placebo (cepivo brez zdravilne učinkovine).
The vaccination course consists of 2 injections given 2 months apart.
Sklop cepljenja je sestavljen iz dveh injekcij z dvomesečnim razmakom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Shingrix have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Shingrix upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
As for all medicines, data on the use of Shingrix is continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Shingrix stalno spremljajo.
For more information about using Shingrix, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Shingrix glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The studies also looked at the number of people who had post-herpetic neuralgia after vaccination.
V študijah so ugotavljali tudi število ljudi, ki so po cepljenju zboleli za postherpetično nevralgijo.
Other information about Shingrix
Druge informacije o zdravilu Shingrix
Shingrix (herpes zoster vaccine, recombinant, adjuvanted)
Shingrix (cepivo proti herpesu zostru, rekombinantno, z adjuvansom)
Shingrix can only be obtained with a prescription and should be used according to official recommendations.
Predpisovanje in izdaja zdravila Shingrix je le na recept, uporabljati pa se mora v skladu z uradnimi priporočili.
Why is Shingrix authorised in the EU?
Zakaj je bilo zdravilo Shingrix odobreno v EU?
Side effects reported with Shingrix are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Shingrix, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Side effects related to the use of Shingrix seemed to be mostly temporary and were manageable with standard care.
Zdi se, da so neželeni učinki, povezani z uporabo zdravila Shingrix, večinoma začasni in obvladljivi s standardnim zdravljenje.
Looking at the results for adults in this age group from both studies together, 25 adults out of 8,250 who received Shingrix had shingles within 4 years after vaccination compared with 284 out of 8,346 who received placebo.
Skupna analiza rezultatov odraslih te starostne skupine iz obeh študij je pokazala, da je 25 odraslih od 8 250, ki so prejeli zdravilo Shingrix, po štirih letih po cepljenju zbolelo za pasovcem, v primerjavi z 284 od 8 346, ki so prejeli placebo.
An overview of Shingrix and why it is authorised in the EU
Pregled zdravila Shingrix in zakaj je odobreno v EU
What benefits of Shingrix have been shown in studies?
Kakšne koristi zdravila Shingrix so se pokazale v študijah?
Shingrix has been shown to be highly effective at preventing shingles and post-herpetic neuralgia across all age groups older than 50 years for at least 4 years after vaccination.
Dokazali so, da je zdravilo Shingrix zelo učinkovito pri preprečevanju pasovca in postherpetične nevralgije pri vseh starostnih skupinah od 50. leta starosti naprej, in sicer vsaj štiri leta po cepljenju.
The second study involved adults aged 70 and over who received either Shingrix or placebo.
Druga študija je vključevala odrasle, starejše od 70 let, ki so prejeli zdravilo Shingrix ali placebo.