natgillin/translations-raw huggingface dataset:
The immune response to Shingrix was unaffected by prior vaccination with live attenuated HZ vaccine.
Predhodno cepljenje z živim oslabljenim cepivom proti HZ ni vplivalo na imunski odziv na cepivo Shingrix.
How Shingrix works
Kako deluje cepivo Shingrix
ATP According-To-Protocol ^ Anti-gE immune response = anti-gE antibody levels, measured by anti-gE enzyme-linked immunosorbent assay (gE ELISA) * Month 3 = 1 month post-dose 2 ** Month 38 = 3 years post-dose 2
^ Imunski odziv anti-gE = raven protiteles proti gE, izmerjena z encimsko vezanim imunosorbentnim preizkusom za anti-gE (gE ELISA).
Shingrix (N=7,695) or placebo (N=7,710) administered 2 months apart, - ZOE-70 (Zoster-022): 13,900 adults ≥ 70 years were randomised to receive two doses of either Shingrix (N=6,950) or placebo (N=6,950) administered 2 months apart.
Prejeli so bodisi dva odmerka cepiva Shingrix (N = 6.950) ali placeba (N = 6.950), uporabljenih v presledku 2 mesecev.
Approximately 13,000 subjects with underlying medical conditions, including conditions associated with a higher risk of HZ, were enrolled in ZOE-50 and ZOE-70.
V študiji ZOE-50 in ZOE-70 je bilo vključenih približno 13.000 preiskovancev z osnovnimi boleznimi, vključno z boleznimi, ki so povezane z večjim tveganjem za HZ.
How Shingrix is given
Kako se daje cepivo Shingrix
Complications related to shingles
Zapleti, povezani s pasovcem
CONDITIONS OR RESTRICTIONS REGARDING SYPPLY AND USE
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
- ZOE-50 (Zoster-006): 15,405 adults ≥ 50 years were randomised to receive two doses of either
- V študiji ZOE-70 (Zoster-022) so 13.900 odraslih, starih ≥ 70 let, randomizirali v dve skupini.
It is not known if Shingrix affects your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni znano, ali cepivo Shingrix vpliva na sposobnost upravljanja vozil in strojev.
N Number of evaluable subjects at the specified time point Q1; Q3 First and third quartiles *** The gE-specific CD4[2+] data in the ≥70 years of age group were generated in ZOE-50 because CD4+ T
*** Podatki o CD4[2+], specifičnih za gE, v skupini ≥ 70 let izvirajo iz študije ZOE-50, ker v študiji ZOE-70
1 Varicella Zoster Virus = VZV 2 adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms
3-O-dezacil-4'-monofosforil lipid A (MPL) iz Salmonella minnesota 50 mikrogramov
≥70 years, especially for general adverse reactions such as myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms.
Pojavnost neželenih učinkov je bila med preiskovanci v starosti od 50 do 69 let večja kot med starimi ≥ 70 let; to zlasti velja za splošne neželene učinke, kot so mialgija, utrujenost, glavobol, mrzlica,
What you need to know before you receive Shingrix
Kaj morate vedeti, preden boste dobili cepivo Shingrix Cepiva Shingrix ne smete dobiti:
Gastrointestinal disorders
Imunsko oslabeli preiskovanci
OTHER SPECIAL WARNING(S), IF NECESSARY Powder and suspension to be reconstituted before administration
Prašek in suspenzijo je treba pred uporabo rekonstituirati
How to store Shingrix
Kako uporabljati cepivo Shingrix
Incidence rate per person years
Inciden čna stopnja na 1000 oseba-let
Shingrix significantly decreased the incidence of HZ compared with placebo in subjects ≥ 50 years (6
Cepivo Shingrix je v primerjavi s placebom značilno zmanjšalo pojavnost HZ tako pri preiskovancih, starih ≥ 50 let (6 primerov v primerjavi z 210 primeri v študiji ZOE-50), kot pri preiskovancih, starih
Varicella Zoster Virus1 glycoprotein E antigen2,3
2 Virus varicella zoster = VZV (Varicella Zoster Virus)
Efficacy against Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN) In two phase III, placebo-controlled, observer-blind efficacy studies of Shingrix:
Učinkovitost proti herpesu zostru (HZ) in postherpetični nevralgiji (PHN) Učinkovitost cepiva Shingrix so raziskali v dveh s placebom kontroliranih študijah III. faze s slepljenim opazovalcem: - V študiji ZOE-50 (Zoster-006) so 15.405 odraslih, starih ≥ 50 let, randomizirali v dve skupini.
• pain, redness and swelling where the injection is given
• bolečina, rdečina in oteklina na mestu, kamor je bilo injicirano cepivo • utrujenost, mrzlica, zvišana telesna temperatura.
In subjects ≥ 70 years with at least one confirmed HZ episode (ZOE-50 and ZOE-70 pooled), Shingrix significantly reduced the use and the duration of HZ-related pain medication by 39.0% (95% CI: 11.9; 63.3) and 50.6% (95% CI: 8.8; 73.2), respectively.
Pri preiskovancih, starih ≥ 70 let z vsaj eno potrjeno epizodo HZ (kumulativno ZOE-50 in ZOE-70), je cepivo Shingrix značilno zmanjšalo uporabo zdravil proti bolečinam, povezanim s HZ, za 39,0 %
Data in subjects ≥ 70 years of age are sourced from the pre-specified pooled analyses of ZOE-50 and
V kumulativni analizi študij ZOE-50 in
Data in subjects ≥ 70 years of age are sourced from the pre-specified pooled analyses of ZOE-50 and ZOE
Podatki za preiskovance, stare ≥ 70 let, izvirajo iz vnaprej določene kumulativne analize študij ZOE-50 in ZOE-70 (mTVC), ker te analize zagotavljajo najrobustnejše ocene učinkovitosti cepiva v tej starostni skupini.
cell activity was not assessed in ZOE-70
aktivnosti celic T CD4+ niso ocenjevali.
1 Injection set = injection syringe + 2 injection needles + cleansing swab.
1 injekcijski set = injekcijska brizga + 2 injekcijski igli + čistilni tampon
Blister (PVC/PVdC/Alu) 100 x 1 capsules (unit dose)
100 x 1 kapsule (za enkratni odmerek)
Blister (PVC/PVdC/Alu) 50 x 1 tablets
50 x 1 tablete (za enkratni odmerek)
Further information on Feraccru can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Feraccru so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose is one capsule taken twice a day, morning and evening, on an empty stomach.
Priporočeni odmerek je ena kapsula dvakrat na dan, zjutraj in zvečer, na prazen želodec.
Treatment duration depends on the severity of the iron deficiency, but generally at least 12 weeks of treatment are required.
Trajanje zdravljenja je odvisno od resnosti pomanjkanja železa, vendar je običajno potrebnih vsaj 12 tednov zdravljenja.
Feraccru received a marketing authorisation valid throughout the EU on 18 February 2016.
Za zdravilo Feraccru je bilo 18. februarja 2016 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Feraccru'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 Feraccru večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Feraccru?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Feraccru?
Feraccru is available as capsules (30 mg).
Zdravilo Feraccru je na voljo v obliki kapsul (30 mg).
Feraccru (ferric maltol) EMA/162888/2018
Feraccru (železov maltol) EMA/162888/2018
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Feraccru 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 Feraccru 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 Feraccru are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Feraccru stalno spremljajo.
This helps correct reduced production of haemoglobin (the oxygen-carrying pigment in red blood cells), anaemia (low levels of red blood cells) and any symptoms of the condition.
To pomaga popraviti zmanjšano tvorbo hemoglobina (pigmenta v rdečih krvnih celicah, ki prenaša kisik), anemijo (nizke ravni rdečih krvnih celic) in vse simptome bolezni.
Other information about Feraccru
Druge informacije o zdravilu Feraccru
Side effects reported with Feraccru are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Feraccru, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For more information about using Feraccru, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Feraccru glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What benefits of Feraccru have been shown in studies?
Kakšne koristi zdravila Feraccru so se pokazale v študijah?
Why is Feraccru authorised in the EU?
Zakaj je bilo zdravilo Feraccru odobreno v EU?
An overview of Feraccru and why it is authorised in the EU
Pregled zdravila Feraccru in zakaj je odobreno v EU
Severe side effects include abdominal pain, constipation and diarrhoea.
Resni neželeni učinki vključujejo bolečine v trebuhu, zaprtje in drisko.
In addition, around 65% of patients taking Feraccru achieved normal levels of haemoglobin compared with 10% of those on placebo.
približno 65 % bolnikov, ki so prejemali zdravilo Feraccru, v primerjavi z 10 % bolnikov, ki so prejemali placebo.
Feraccru must not be used in patients with iron overload disorder (haemachromatosis) or in patients receiving repeated blood transfusions.
Zdravilo Feraccru se ne sme uporabljati pri bolnikih z motnjo preobremenitve z železom (hemokromatozo) in pri bolnikih, ki večkrat prejmejo transfuzijo krvi.
What are the risks associated with Feraccru?
Kakšna tveganja so povezana z zdravilom Feraccru?
Feraccru (ferric maltol)
Feraccru (železov maltol)
What is Feraccru and what is it used for?
Kaj je zdravilo Feraccru in za kaj se uporablja?
In a study of 128 patients, those taking Feraccru for 12 weeks had their haemoglobin levels increase on average from 11.0 to 13.2 g/dl whereas in patients taking placebo (a dummy treatment)
V študiji pri 128 bolnikih so imeli tisti, ki so 12 tednov jemali zdravilo Feraccru, raven hemoglobina povprečno med 11,0 in 13,2 g/dl, pri bolnikih, ki so jemali placebo (zdravilo brez učinkovine), pa je raven hemoglobina ostala na približno 11,1 g/dl.
Data on how the medicine is absorbed in the body show that Feraccru can also have an effect on patients with iron deficiency who have not already developed anaemia.
Podatki o absorpciji zdravila v telesu kažejo, da lahko zdravilo Feraccru učinkuje tudi pri bolnikih s pomanjkanjem železa, pri katerih se anemija še ni razvila.
When taken by mouth, it is absorbed by the cells of the gut; the iron is then released from the compound and transported and stored in the body, helping to restore normal levels in patients with iron deficiency.
Ob peroralnem jemanju se pri bolnikih s pomanjkanjem železa absorbira v celice črevesa, železo pa se nato sprosti iz spojine ter se prenese in shrani v telesu, s čimer pripomore k obnovi normalnih ravni.
The most common side effects with Feraccru (which may affect up to 1 in 10 people) are symptoms affecting the gut such as abdominal (belly) pain, flatulence (passing wind), constipation, abdominal discomfort and distension, and diarrhoea; these side effects are usually of mild to moderate intensity.
Najpogostejši neželeni učinki zdravila Feraccru (ki se lahko pojavijo pri največ 1 od 10 bolnikov) so črevesni simptomi, kot so bolečine v trebuhu, napenjanje (vetrovi), zaprtje, nelagodje v trebuhu in napihnjenost ter driska.
The safety profile of Feraccru is considered acceptable, with side effects that are mostly mild to moderate in intensity and in line with those of other iron preparations.
Varnostni profil zdravila Feraccru velja za sprejemljivega, z večinoma blagimi do zmernimi neželenimi učinki, ki so v skladu z neželenimi učinki drugih železovih pripravkov.
Iron is an essential building block for haemoglobin and the body can produce more haemoglobin and correct anaemia once iron stores are replenished.
Ker je železo bistvena sestavina hemoglobina, lahko telo proizvaja več hemoglobina in odpravi anemijo, ko so zaloge železa obnovljene.
Feraccru is an iron-containing medicine used to treat iron deficiency (lack of iron) in adults.
Feraccru je zdravilo, ki vsebuje železo in se uporablja za zdravljenje pomanjkanja železa pri odraslih.
How is Feraccru used?
Kako se zdravilo Feraccru uporablja?
Feraccru has been shown to be effective in increasing haemoglobin levels in patients with iron deficiency anaemia.
Dokazano je bilo, da zdravilo Feraccru učinkovito zvišuje raven hemoglobina pri bolnikih z anemijo zaradi pomanjkanja železa.
Feraccru is effective at increasing haemoglobin levels in patients with iron deficiency and anaemia, (defined as haemoglobin levels lower than 12 g/dl for women and 13 g/dl for men).
Zdravilo Feraccru pri bolnikih s pomanjkanjem železa in anemijo (opredeljeno z ravnijo hemoglobina pod 12 g/dl pri ženskah oziroma 13 g/dl pri moških) učinkovito povečuje raven hemoglobina.
The active substance in Feraccru, ferric maltol, is an iron-containing compound.
Učinkovina v zdravilu Feraccru, železov maltol, je spojina, ki vsebuje železo.
For the full list of side effects of Feraccru, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Feraccru, glejte navodilo za uporabo.
How does Feraccru work?
Kako zdravilo Feraccru deluje?
Feraccru contains the active substance ferric maltol.
Zdravilo Feraccru vsebuje učinkovino železov maltol.
For [indication*]
Za zdravljenje [indikacija*]
The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Informacije o zdravilu lahko pristojni organi države članice v sodelovanju z referenčno državo članico naknadno dopolnijo, kot je primerno, v skladu s postopki iz poglavja 4 naslova III Direktive 2001/83/ES.
The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen.
Predpisovalec mora zagotoviti, da se bodo bolniki ali njihovi skrbniki zmožni držati režima odmerjanja enkrat na teden.
If you have any questions, please talk to your doctor or pharmacist before you take this medicine.
Če imate kakršna koli vprašanja, se pred jemanjem tega zdravila pogovorite z zdravnikom ali farmacevtom.
Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy.
Metotreksat smejo predpisovati samo zdravniki s strokovnim znanjem glede uporabe metotreksata in s popolnim razumevanjem tveganj zdravljenja z metotreksatom.
Patient card text
Besedilo opozorilne kartice za bolnika
These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Spremembe zadevnih poglavij informacij o zdravilu so rezultat napotitvenega postopka.
Take/Use [depending on formulation] only once a week
Vzemite/Uporabite [odvisno od formulacije] samo enkrat na teden.
Always show this card to health care professionals not familiar with your methotrexate treatment to alert them about your once weekly use (e.g. on hospital admission, change of care).
To kartico vedno pokažite zdravstvenim delavcem, ki niso seznanjeni z vašim zdravljenjem z metotreksatom, da jih opozorite na uporabo zdravila enkrat na teden (npr. pri sprejemu v bolnišnico, spremembi oskrbe).
Symptoms of overdose are e.g. sore throat, fever, mouth ulcers, diarrhoea, vomiting, skin rashes, bleeding or unusual weakness.
Simptomi prevelikega odmerjanja so npr. vnetje žrela, zvišana telesna temperatura, razjede v ustih, driska, bruhanje, kožni izpuščaji, krvavitev ali neobičajna oslabelost.
On blisters the wording should be printed repeatedly in one or more (e.g. on multilingual packages) rows depending on readability.
Na pretisnih omotih je besedilo treba natisniti večkrat v eni ali več (npr. na večjezičnih ovojninah) vrstah, odvisno od berljivosti.
Dosage errors in the use of <product name> (methotrexate) can result in serious adverse reactions, including death.
Napake pri odmerjanju pri uporabi zdravila <ime zdravila> (metotreksat) lahko povzročijo resne neželene učinke, vključno s smrtjo.
[Using] too much of <product name> (methotrexate) may be fatal.
[Uporaba] prevelikega odmerka zdravila <ime zdravila> (metotreksat) je lahko smrtno nevarna.
Please read this section of the summary of product characteristics very carefully.
Zelo natančno preberite to poglavje povzetka glavnih značilnosti zdravila.
The warning should read as follows:
Opozorilo mora biti zapisano, kot sledi:
Please read section 3 of this leaflet very carefully.
Zelo natančno preberite 3. poglavje tega navodila za uporabo.
{For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below} Summary of product characteristics
{Za vsa zdravila v Prilogi I je obstoječe informacije o zdravilu treba spremeniti (vstaviti, zamenjati ali izbrisati besedilo, kot je primerno), tako da bodo izražale odobreno besedilo, ki je navedeno spodaj.}
On other immediate packaging it should be implemented once only in a prominent place.}
Na drugih stičnih ovojninah ga je treba vstaviti samo enkrat na vidnem mestu.}
OTHER SPECIAL WARNING(S), IF NECESSARY A framed warning should be placed at the front of the outer package in a clearly visible place, e.g. after the information on the name and the active substance; the letters should be of appropriate size; the respective wording and frame should be in red colour on a white background, but ensuring that it contrasts with the rest of the packaging.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Na prednjo stran zunanje ovojnine je treba na jasno vidno mesto, npr. za podatki o imenu in učinkovini, vključiti uokvirjeno opozorilo; črke morajo biti primerne velikosti; besedilo in okvir morata biti rdeče barve na belem ozadju, hkrati pa morata biti v kontrastu s preostalo ovojnino.
The warning should read as follows:}
Opozorilo mora biti zapisano, kot sledi:}
Amendments to relevant sections of the product information
Spremembe zadevnih poglavij informacij o zdravilu
Any recommendations to split the dose should be deleted from the SmPC.
Vsa priporočila o razdelitvi odmerka je treba izbrisati iz povzetka glavnih značilnosti zdravila.
{For parenteral formulations (solution for injection in prefilled syringes or pens), the warning should be implemented once in a prominent place of the immediate packaging if space allows.}
{Za parenteralne formulacije (raztopina za injiciranje v napolnjenih injekcijskih brizgah ali injekcijskih peresnikih) je treba opozorilo vstaviti enkrat na vidnem mestu na stični ovojnini, če je za to na voljo dovolj prostora.}
Take only once a week on ……………………………………………………….
Vzemite samo enkrat na teden v ……………………………………………………….
(include weekday of intake in full)
(napišite v celoti zapisan dan v tednu, ko je treba vzeti zdravilo)
• All methotrexate-containing medicinal products with at least one indication requiring once weekly dosing: {This section should be amended as follows (new text underlined, deleted text strikethrough):} Only physicians with experience in the various properties of the medicinal product and its mode of action should prescribe methotrexate.
• Vsa zdravila, ki vsebujejo metotreksat, z vsaj eno indikacijo, ki zahteva odmerjanje enkrat na teden: {To poglavje je treba popraviti, kot sledi (novo besedilo podčrtano, izbrisano besedilo prečrtano):} Metotreksat smejo predpisovati samo zdravniki, seznanjeni z lastnostmi zdravila in njegovim načinom delovanja.
• Parenteral formulations of methotrexate-containing products with at least one indication requiring treatment once a week (e.g. rheumatologic/dermatological diseases or Crohn's disease)
• Parenteralne formulacije zdravil, ki vsebujejo metotreksat, z vsaj eno indikacijo, ki zahteva zdravljenje enkrat na teden (npr. revmatološke/dermatološke bolezni ali Crohnova bolezen)
• All methotrexate-containing medicinal products with at least one indication requiring treatment once a week (e.g. rheumatologic/dermatological diseases or Crohn's disease): {Any reference to dividing the dose for indications requiring treatment once a week should be removed from the package leaflet.}
• Vsa zdravila, ki vsebujejo metotreksat, z vsaj eno indikacijo, ki zahteva zdravljenje enkrat na teden (npr. revmatološke/dermatološke bolezni ali Crohnova bolezen): {Vse omembe razdeljevanja odmerka za indikacije, ki zahtevajo zdravljenje enkrat na teden, je treba izbrisati iz navodila za uporabo.}
OTHER SPECIAL WARNING(S), IF NECESSARY {For parenteral formulations, a warning e.g. in red should be implemented once in a prominent place on the intermediate packaging.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA {Za parenteralne formulacije je treba enkrat vstaviti opozorilo npr. v rdeči barvi na vidnem mestu na vmesni ovojnini.
OTHER SPECIAL WARNING(S), IF NECESSARY {For oral formulations, a warning e.g. in red should be implemented on the immediate packaging.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA {Za peroralne formulacije je treba na stično ovojnino vstaviti opozorilo npr. v rdeči barvi.
Take only once a week on …………………………………………………….. (include weekday of intake in full) *[Indication] should be inserted by the MAHs in grouped terms, e.g. colitis, arthritis psoriasis, where applicable.
Vzemite samo enkrat na teden v …………………………………………………….. (napišite v celoti zapisan dan v tednu, ko je treba vzeti zdravilo) *[Indikacija] mora biti vstavljena s strani imetnika dovoljenja za promet z zdravilom in poimenovana s skupnim izrazom, npr. kolitis, artritis, psoriaza, kjer je to ustrezno.
• Parenteral formulations of methotrexate-containing medicinal products with at least one indication requiring treatment once a week and oncologic indication:
• Parenteralne formulacije zdravil, ki vsebujejo metotreksat, z vsaj eno indikacijo, ki zahteva zdravljenje enkrat na teden, in onkološko indikacijo:
• Oral formulations of methotrexate-containing medicinal products only with indications requiring treatment once a week: {The following wording should be included on the outer packaging}
• Peroralne formulacije zdravil, ki vsebujejo metotreksat, samo z indikacijami, ki zahtevajo zdravljenje enkrat na teden: {Na zunanjo ovojnino je treba vključiti naslednje besedilo}
IF YOU USE METHOTREXATE FOR ONE OF THE ABOVE MENTIONED INDICATIONS, YOU SHOULD ONLY TAKE METHOTREXATE ONCE A WEEK Write here in full the day of the week for intake: ______________ Do not take more than the prescribed dose.
ČE UPORABLJATE METOTREKSAT ZA ENO OD ZGORAJ NAVEDENIH INDIKACIJ, GA MORATE JEMATI SAMO ENKRAT NA TEDEN
• Parenteral formulations of methotrexate-containing medicinal products only with indications requiring treatment once a week:
• Parenteralne formulacije zdravil, ki vsebujejo metotreksat, samo z indikacijami, ki zahtevajo zdravljenje enkrat na teden:
• Oral formulations of methotrexate-containing medicinal products with at least one indication requiring treatment once a week: {This section should include the following wording:} THIS PATIENT CARD IS ONLY INTENDED FOR PATIENTS WHO USE A METHOTREXATECONTAINING MEDICINE FOR <INDICATIONS INSERTED BY THE MAHS IN GROUPED TERMS, E.G. COLITIS, ARTHRITIS, PSORIASIS, AS PER INDICATIONS LISTED IN PACKAGE LEAFLET>.
TA OPOZORILNA KARTICA ZA BOLNIKA JE NAMENJENA SAMO BOLNIKOM, KI UPORABLJAJO ZDRAVILO, KI VSEBUJE METOTREKSAT, ZA ZDRAVLJENJE <INDIKACIJE, KI JIH VSTAVI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM S SKUPNIM IZRAZOM, NPR. KOLITIS, ARTRITIS, PSORIAZA, SKLADNO Z INDIKACIJAMI, NAVEDENIMI V NAVODILU ZA UPORABO>.
For [indication*] use only once a week *[Indication] should be inserted by the MAHs in grouped terms, e.g. colitis, arthritis psoriasis, where applicable.
*[Indikacija] mora biti vstavljena s strani imetnika dovoljenja za promet z zdravilom s skupnim izrazom, npr. kolitis, artritis, psoriaza, kjer je to ustrezno.