FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Slovenian: • če se je pri vas kdaj pojavila kakršnakoli alergijska reakcija (poleg nenadne, življenjsko ogrožajoče alergijske reakcije) na katerokoli sestavino tega cepiva (navedeno v poglavju 6), ali na tiomersal, jajčne in piščančje beljakovine, ovalbumin, formaldehid, gentamicinijev sulfat (antibiotik) ali natrijev deoksiholat.
English: In another clinical study (D-Pan-H5N1-010), 297 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Slovenian: V drugi klinični študiji (D-Pan-H5N1-010) je 297 preiskovancev, starejših od 60 let (razdeljenih v skupine od 61 do 70, 71 do 80 ter > 80 let), dobilo ali en ali dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 (H5N1) na dan 0 in 21.
English: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
Slovenian: Viala z emulzijo: natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) voda za injekcije
English: Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Slovenian: Prepandrix suspenzija in emulzija za emulzijo za injiciranje prepandemsko cepivo proti gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
English: Skin and subcutaneous tissue disorders Common: ecchymosis at the injection site, sweating increased Uncommon: pruritus, rash
Slovenian: Pogosti: ekhimoza na mestu injiciranja, močnejše znojenje Občasni: srbenje, izpuščaj
English: “Possible side effects” may affect your ability to drive or use tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nekateri neželeni učinki, našteti v poglavju 4, "Možni neželeni učinki", lahko vplivajo na vašo sposobnost vožnje in upravljanja z orodji in s stroji.
English: Month N=38
Slovenian: 24. mesec n=38
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 12 months apart were 84.0% and 100%, respectively.
Slovenian: Enaindvajset dni po drugem odmerku je bil pri preiskovancih, ki so dobili cepivo v presledku 12 mesecev, delež serološke zaščite 84,0 % in delež odziva na cepivo 100 %.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Slovenian: razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo 3,75 mikrogramom hemaglutinina/odmerek *Antigen: uporabljen sev (PR8-IBCDC-RG2), ki je podoben sevu A/Indonesia/05/2005 (H5N1)
English: In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21.
Slovenian: V klinični študiji (D-Pan-H5N1-012) so preiskovanci, stari od 18 do 60 let, dobili cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno bodisi iz A/Vietnam/1194/2004 bodisi Indonesia/5/2005 šest mesecev po enem ali dveh primarnih odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 na dan 0 (en odmerek) oz. na dan 0 in 21 (dva odmerka).
English: An extended dosing interval was investigated in study D-H5N1-012 in which a group of subjects 1860 years of age received two doses of Prepandrix containing the A/Vietnam/1194/2004 strain 6 months or 12 months apart.
Slovenian: V študiji D-H5N1-012 so raziskali podaljšan presledek med odmerki: skupina preiskovancev, starih od 18 do 60 let, je v tej študiji dobila dva odmerka cepiva Prepandrix v presledku 6 mesecev ali 12 mesecev.
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkusstraße 40, D-01069 Dresden Germany
Slovenian: KG Zirkusstraße 40, D-01069 Dresden
English: There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.
Slovenian: Razen nekaterih neželenih učinkov, ki so se bolj pojavili po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri otrocih, starih < 6 let, povečanja po drugem odmerku ni bilo, ne glede na to, ali so otroci prejeli polovični odmerek za odrasle ali odmerek za odrasle.
English: Talk to your doctor or nurse before you are given Prepandrix:
Slovenian: Preden dobite cepivo Prepandrix, se posvetujte z zdravnikom ali medicinsko sestro:
English: NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection.
Slovenian: FARMACEVTSKA OBLIKA suspenzija in emulzija za emulzijo za injiciranje
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Cepivo Prepandrix je na voljo v dveh vsebnikih:
English: 3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT.
Slovenian: 3Obnovitveni dejavnik: razmerje geometrične sredine titra (GMT) po obnovitvenem odmerku in GMT pred obnovitvenim odmerkom.
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1):
Slovenian: Navzkrižni imunski odzivi na cepivo z adjuvansom AS03 in vsebnostjo 3,75 µg HA, pridobljenega iz A/Vietnam/1194/2004 (H5N1)
English: There are no data with Prepandrix using the subcutaneous route.
Slovenian: Podatkov o subkutani uporabi cepiva Prepandrix ni.
English: Prepandrix may be used in lactating women.
Slovenian: Cepivo Prepandrix se lahko uporabi v obdobju dojenja.
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Prepandrix Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Slovenian: Suspenzija za emulzijo za injiciranje za Prepandrix prepandemsko cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom)
English: Immune response to A/Vietnam/1194/2004 3-5 years 21 days after 2nd dose 6 months after vaccination
Slovenian: Imunski odziv proti A/Vietnam/1194/2004 3 do 5 let 21 dni po 2. odmerku 6 mesecev po cepljenju
English: NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Slovenian: Navodilo za uporabo Prepandrix suspenzija in emulzija za emulzijo za injiciranje prepandemsko cepivo proti gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
English: Seroprotection rate1 Booster seroconversion rate2 Booster factor3
Slovenian: Delež serokonverzije2 Faktor serokonverzije3
English: Full dose N=42
Slovenian: Polni odmerek n=42
English: Seroconversion rate
Slovenian: Delež serokonverzije2
English: The vaccine should be administered in accordance with the recommended posology (see section 4.2).
Slovenian: Po mešanju je količina cepiva Prepandrix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 4.2).
English: Shivering NA=not available
Slovenian: drgetanje NP = ni podatka
English: In a clinical study (D-Pan-H5N1-009), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Slovenian: V klinični študiji (D-Pan-H5N1-009) so otroci, stari od 3 do 5 in od 6 do 9 let, dvakrat dobili bodisi polni odmerek (0,5 ml) bodisi polovični odmerek (0,25 ml) cepiva z adjuvansom AS03, z vsebnostjo
English: In another clinical study (D-Pan-H5N1-015), 39 subjects aged 18-60 years received a dose of AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Slovenian: V drugi klinični študiji (D-Pan-H5N1-015) je 39 preiskovancev, starih od 18 do 60 let, dobilo cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA, pridobljenega iz A/Indonesia/05/2005 štirinajst mesecev potem, ko so dobili dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz
English: Prepandrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Slovenian: Cepivo Prepandrix vsebuje tiomersal kot konzervans.
English: Split influenza virus, inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Slovenian: razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo: uporabljenemu sevu (PR8-IBCDC-RG2) podobnemu sevu A/Indonesia/05/2005 (H5N1) 3,75 mikrogramov**na 0,5 ml odmerek
English: • Swollen glands in your neck, armpit or groin
Slovenian: • oteklina vratnih, podpazdušnih ali dimeljskih bezgavk.
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Slovenian: 1Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HIhaemagglutination inhibition ) ≥ 1:40;
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4fold increase in titre;
Slovenian: 2Delež serokonverzije: delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra; 3Faktor serokonverzije: razmerje med geometrično sredino titra (GMT) po cepljenju in GMT pred cepljenjem.
English: What Prepandrix contains
Slovenian: Prepandrix.
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Slovenian: 1Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI) ≥ 1:40;
English: It should be given at the same time each day.
Slovenian: Kapljice je treba dajati vsak dan ob istem času.
English: The values were lowered by about 8-10 mmHg.
Slovenian: Vrednosti so se znižale za približno 8-10 mmHg.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ganfort on 19 May 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ganfort, veljavno po vsej Evropski uniji, izdala 19. maja 2006.
English: What measures are being taken to ensure the safe and effective use of Ganfort?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ganfort?
English: The full EPAR for Ganfort can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ganfort je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Ganfort
Slovenian: Druge informacije o zdravilu Ganfort
English: Four main studies have been performed involving 1,964 adults with ocular hypertension or glaucoma.
Slovenian: Opravljene so bile štiri glavne študije, v katere je bilo vključenih 1 964 odraslih z očesno hipertenzijo ali glavkomom.
English: This is a summary of the European public assessment report (EPAR) for Ganfort.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ganfort.
English: Ganfort is given as one drop in the affected eye(s) once a day, either in the morning or the evening.
Slovenian: Zdravilo Ganfort se daje po eno kapljico v prizadeto(-i) oko(očesi) enkrat dnevno, zjutraj ali zvečer.
English: In addition, more patients given Ganfort had a drop in pressure of more than 20% (67.9% against 48.9%).
Slovenian: Poleg tega je bilo pri več bolnikih, ki so jim dajali zdravilo Ganfort, zabeleženo znižanje tlaka za več kot 20 % (67,9 % v primerjavi z 48,9 %).
English: For more information about treatment with Ganfort, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ganfort preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Ganfort lowered the pressure to less than 18 mmHg in 18.7% of these patients compared with 10.2% with bimatoprost only.
Slovenian: Zdravilo Ganfort je znižalo tlak na manj kot 18 mmHg pri 18,7 % teh bolnikov v primerjavi z 10,2 % pri samostojni uporabi bimatoprosta.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ganfort have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ganfort upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: If more than one type of eye drop is being used, each one should be given at least five minutes apart.
Slovenian: Če bolnik uporablja več vrst kapljic za oči, je treba zdravila uporabiti v razmiku najmanj pet minut.
English: What benefit has Ganfort shown during the studies?
Slovenian: Kakšne koristi je zdravilo Ganfort izkazalo med študijami?
English: The CHMP decided that Ganfort's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Ganfort večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: The main measures of effectiveness were the average reduction in eye pressure or the number of patients whose eye pressure fell below the target of 18 mmHg (making it within the normal range).
Slovenian: Glavno merilo učinkovitosti je bilo povprečno znižanje tlaka v očesu ali število bolnikov, pri katerih se je tlak v očesu znižal pod ciljno vrednost 18 mmHg (znižanje na običajno vrednost).
English: Ganfort is an eye drops solution that contains two active substances: bimatoprost (0.3 mg/ml) and timolol (5 mg/ml).
Slovenian: Zdravilo Ganfort je raztopina v obliki kapljic za oči, ki vsebuje dve zdravilni učinkovini: bimatoprost (0,3 mg/ml) and timolol (5 mg/ml).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ganfort.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Ganfort, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The studies compared Ganfort with bimatoprost, timolol, or bimatoprost and timolol given at the same time after three weeks to four months of treatment.
Slovenian: V študijah so zdravilo Ganfort primerjali z bimatoprostom, timololom ali bimatoprostom in timololom, uporabljenima sočasno, po treh tednih do štirih mesecih zdravljenja.
English: Ganfort was, however, more effective than bimatoprost in patients whose pressure was not controlled with eye drops containing prostaglandins alone.
Slovenian: Vendar pa je bilo zdravilo Ganfort učinkovitejše od bimatoprosta pri bolnikih, pri katerih tlak ni bil nadzorovan s kapljicami za oči, ki vsebujejo samo prostaglandine.
English: What is the risk associated with Ganfort?
Slovenian: Kakšna tveganja so povezana z zdravilom Ganfort?
English: The most common side effect (seen in more than 1 patient in 10) is conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye).
Slovenian: Najpogostejši neželeni učinek (opažen pri več kot 1 bolniku od 10) je konjunktivna hiperemija (zvišan dotok krvi v oko, kar povzroči njegovo pordelost).
English: ‘Ocular hypertension' is when the pressure in the eye is higher than normal.
Slovenian: Očesna hipertenzija je stanje, pri katerem je tlak v očesu višji od običajnega.
English: It is used in adults with ‘open angle glaucoma' or ocular hypertension who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions).
Slovenian: Uporablja se pri odraslih z glavkomom odprtega zakotja ali očesno hipertenzijo, ki se ne odzivajo dovolj na kapljice za oči, ki vsebujejo antagoniste adrenergičnih receptorjev beta ali analoge prostaglandina (drugi vrsti zdravil, ki se uporabljajo za zdravljenje teh bolezni).
English: Ganfort must not be used in patients who have asthma or severe lung disease, or in patients with some heart conditions.
Slovenian: Zdravilo Ganfort se ne sme uporabljati pri bolnikih z astmo, hudim pljučnim obolenjem ali nekaterimi srčnimi obolenji.
English: For the full list of all side effects reported with Ganfort, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ganfort, glejte navodilo za uporabo.
English: Raised pressure in the eye causes damage to the retina (the light sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Slovenian: Zvišan očesni tlak poškoduje mrežnico (membrano na zadnji strani zrkla, ki je občutljiva za svetlobo) in vidni živec, ki pošilja signale iz očesa v možgane.
English: Overall, the studies showed that Ganfort is effective in lowering eye pressure.
Slovenian: Na splošno so študije pokazale, da zdravilo Ganfort učinkovito znižuje očesni tlak.
English: Ganfort contains two active substances, bimatoprost and timolol, which lower the pressure in the eye in different ways.
Slovenian: Zdravilo Ganfort vsebuje dve zdravilni učinkovini: bimatoprost in timolol, ki na različne načine znižujeta tlak v očesu.
English: Why has Ganfort been approved?
Slovenian: Zakaj je bilo zdravilo Ganfort odobreno?
English: Ganfort is used to reduce the pressure inside the eye.
Slovenian: Zdravilo Ganfort se uporablja za zniževanje tlaka v očesu.
English: Ganfort was more effective than timolol on its own and was as effective as bimatoprost.
Slovenian: Zdravilo Ganfort je bilo učinkovitejše od samostojne uporabe timolola in enako učinkovito kot bimatoprost.
English: In addition, Ganfort was shown to be as effective as bimatoprost and timolol given at the same time.
Slovenian: Dokazano je bilo tudi, da je zdravilo Ganfort enako učinkovito kot sočasna uporaba bimatoprosta in timolola.
English: By lowering the pressure, Ganfort reduces the risk of damage.
Slovenian: Zdravilo Ganfort z zniževanjem tlaka zmanjša nevarnost poškodb.
English: Bimatoprost is a prostaglandin analogue, (a copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Bimatoprost on its own has already been approved in the European Union under the name Lumigan.
Slovenian: Bimatoprost je analog prostaglandina (kopija naravnega prostaglandina), ki deluje tako, da poveča odtok tekočine iz očesa.
English: How has Ganfort been studied?
Slovenian: Kako je bilo zdravilo Ganfort raziskano?
English: What is Ganfort?
Slovenian: Kaj je zdravilo Ganfort?
English: How is Ganfort used?
Slovenian: Kako se zdravilo Ganfort uporablja?
English: Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol has been commonly used to treat glaucoma since the 1970s.
Slovenian: Timolol je v splošni uporabi za zdravljenje glavkomov že od sedemdesetih let prejšnjega stoletja dalje.
English: What is Ganfort used for?
Slovenian: Za kaj se zdravilo Ganfort uporablja?
English: How does Ganfort work?
Slovenian: Kako zdravilo Ganfort deluje?
English: The Member States should agree the local implementation of the patient card system.
Slovenian: Države članice se morajo dogovoriti o lokalnem izvajanju sistema kartic bolnika.
English: • The feasibility of collecting detailed data relating to the indication in order to monitor closely the offlabel use within the national territory.
Slovenian: • o možnosti zbiranja podrobnih podatkov v zvezi z indikacijo, da bi skrbno nadzorovali nenamensko uporabo znotraj nacionalega teritorija;
English: The Member States shall ensure that the MAH implements a pregnancy prevention programme (PPP) within their territory.
Slovenian: Države članice morajo zagotoviti, da imetnik dovoljenja za promet z zdravili izvaja program za preprečevanje nosečnosti (PPN) znotraj svojega teritorija.
English: Patient Card
Slovenian: Kartica bolnika
English: • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans including a summary of the results of study CC-5013TOX-004
Slovenian: • potrebo po izogibanju fetalni izpostavljenosti zaradi teratogenosti lenalidomida pri živalih in pričakovanega teratogenega učinka lenalidomida na človeka, vključno s povzetkom rezultatov študije CC-5013-TOX004;
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO IZVAJATI DRŽAVE ČLANICE
English: • That lenalidomide is teratogenic in animals and is expected to be teratogenic in humans.
Slovenian: • opozorilo, da je lenalidomid teratogen pri živalih in se pričakuje teratogenost pri človeku;
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da se izvajajo vsi spodaj opisani pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila:
English: • That Revlimid may cause neutropenia and thrombocytopenia and the need for regular blood tests
Slovenian: • da zdravilo Revlimid lahko povzroča nevtropenijo in trombocitopenijo; potrebne so redne krvne preiskave;
English: • The set-up of national measures to assess the effectiveness of and compliance with the PPP
Slovenian: • o vzpostavitvi nacionalnih ukrepov za določanje učinkovitosti in soglasje s PPN-jem.
English: The Educational brochures for patients should be of 3 types:
Slovenian: Izobraževalne brošure za bolnike naj bodo treh vrst:
English: The Member States should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the MAH and ensure that the materials contain the key elements as described below.
Slovenian: Države članice se morajo dogovoriti z imetnikom dovoljenja za promet z zdravili o končnem besedilu Neposrednega obvestila zdravstvenim delavcem in vsebinah paketa s podatki za zdravnike in zagotoviti, da gradiva vsebujejo ključne elemente, kot so opisane spodaj.
English: • Description of the patient card and its necessity
Slovenian: • opis kartice bolnika in razlago, zakaj je nujna;
English: • That the patient should not give Revlimid to any other person
Slovenian: • opozorilo, da bolnik ne sme dajati zdravila Revlimid nobeni drugi osebi;
English: • Description of the PPP
Slovenian: • opis PPN-ja;