FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare (Les than 1 out of 10.000 patients): - bedwetting - depression - blistering of the skin when exposed to sunlight (phototoxicity) - sudden worsening of kidney function in patients with chronic kidney problems - swelling around the eyes (periorbital oedema) - noise in the ear (tinnitus).
Slovenian: Zelo redki (pri manj kot 1 od 10.000 bolnikov): - močenje postelje - depresija - pojav mehurčkov na koži ob izpostavitvi sončni svetlobi (fototoksičnost) - nenadno poslabšanje delovanja ledvic pri bolnikih s kroničnimi ledvičnimi težavami - otekline okoli oči (periorbitalni edem) - šumenje v ušesih (tinitus) - vlaga v pljučih (pljučni edem)
English: The treating physician decides on the duration of treatment.
Slovenian: Trajanje zdravljenja določi zdravnik, ki vodi zdravljenje.
English: A small fraction of nifedipine passes into the breast milk.
Slovenian: Nifedipin v majhnih količinah prehaja v materino mleko.
English: Store Nifedipine Pharmamatch retard tablets in the original packaging.
Slovenian: Zdravilo Nifedipine Pharmamatch retard tablete shranjujte v originalni ovojnini.
English: When both medicines are concomitantly administered, the clinical response to nifedipine should be monitored and, if necessary, an increase of the nifedipine dose considered.
Slovenian: Pri sočasnem jemanju obeh zdravil je treba spremljati klinični odziv na nifedipin in po potrebi njegov odmerek zvišati.
English: Substances that induce CYP3A4
Slovenian: Snovi, ki inducirajo CYP3A4
English: - giddiness - light headedness - feeling of pressure in the head.
Slovenian: glavobol, vrtoglavica, nejasno zavedanje, občutek pritiska v glavi
English: Upon co-administration of both medicines, the tacrolimus plasma concentrations should be monitored and, if necessary, a reduction in the tacrolimus dose considered.
Slovenian: Pri sočasni uporabi obeh zdravil je treba spremljati plazemske koncentracije takrolimusa in po potrebi preučiti možnosti znižanja odmerka takrolimusa.
English: NAME OF THE MEDICINAL PRODUCT
Slovenian: Ime zdravila
English: Skin and subcutaneous tissue disorders: - Rare:
Slovenian: Bolezni kože in podkožja: - Redki:
English: Titanium dioxide (E172): colouring aid Red iron oxide (E172):
Slovenian: barvilo Rdeči železov oksid (E172): barvilo
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
English: Simultaneous administration of cisapride and nifedipine may lead to increased plasma concentrations of nifedipine.
Slovenian: Zaradi sočasnega dajanja cisaprida in nifedipina se lahko zviša plazemska koncentracija nifedipina.
English: Activated charcoal should be given in 4-hourly doses of 25g for adults, 10g for children if nifedipine has been digested accidentally.
Slovenian: Pri nenamernem zaužitju nifedipina dajemo aktivno oglje vsake štiri ure po 25 g za odrasle oz. 10 g za otroke.
English: Since symptoms of obstruction can occur in patients with pre-existing severe gastrointestinal narrowing, Nifedipine Pharmamatch retard should not be administered to those patients.
Slovenian: Pri bolnikih z obstoječim hudim zoženjem v gastrointestinalnem traktu se lahko pojavijo simptomi obstrukcije, zato ti bolniki ne smejo jemati zdravila Nifedipine Pharmamatch retard.
English: In case of concomitant use, blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered.
Slovenian: Pri sočasnem jemanju je treba spremljati krvni tlak in po potrebi znižati odmerek nifedipina.
English: Rare (more than 1 out of 10.000, but less than 1 out of 1.000 patients): - skin rash - muscle cramps - inflammation of the gums - a mass of foreign material found in the stomach (bezoar) - a slight development in breast tissue in older men (gynaecomastia)
Slovenian: Redki (pri več kot 1 od 10.000 bolnikov, vendar manj kot pri 1 od 1000 bolnikov): - izpuščaj na koži - mišični krči - vnetje dlesni - masa tuje snovi v želodcu (bezoar) - rahel razvoj tkiva dojk pri starejših moških (ginekomastija)
English: EXPIRY DATE Do not use after:
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do:
English: In individual cases, when used in combination with nifedipine, serum quinidine levels have been shown to be suppressed or, after cessation of nifedipine treatment, increased.
Slovenian: Pri sočasnem dajanju nifedipina in kinidina so v posameznih primerih opazili znižanje serumskih koncentracij kinidina, po prenehanju uporabe nifedipina pa zvišanje teh koncentracij.
English: Read all of this leaflet carefully before you start taking using this medicine.
Slovenian: Pred začetkom jemanja uporabo natančno preberite navodilo!
English: Phenytoin induces the CYP3A4 system.
Slovenian: Fenitoin inducira sistem CYP3A4.
English: How to store Nifedipine Pharmamatch retard Further information
Slovenian: Shranjevanje zdravila Nifedipine Pharmamatch retard Dodatne informacije
English: Co-administration of grapefruit juice with nifedipine causes elevated plasma concentrations of nifedipine, due to a decreased first pass metabolism.
Slovenian: Sočasno jemanje grenivkinega soka in nifedipina povzroči zvišane plazemske koncentracije nifedipina zaradi zmanjšane presnove prvega prehoda.
English: Carbamazepine, phenobarbitone and valproic acid Some substances have been shown to influence the plasma concentration of the structurally related calcium antagonist nimodipine, either by enzyme induction (carbamazepine, phenobarbitone) or enzyme inhibition (valproic acid).
Slovenian: Za nekatere od teh snovi so dokazali, da vplivajo na plazemsko koncentracijo strukturno sorodnega antagonista kalcijevih kanalčkov, nimodipina, z indukcijo encimov (karbamazepin, fenobarbiton) ali zaviranjem encimov (valprojska kislina).
English: Caution should be exercised when nifedipine is co-administered with intravenous magnesium sulphate.
Slovenian: Pri sočasnem dajanju nifedipina z intravenskim magnezijevim sulfatom je potrebna previdnost.
English: In patients with possible hyperglycaemia, nifedipine should be given with caution.
Slovenian: Nifedipin je treba previdno predpisovati bolnikom z možno hiperglikemijo.
English: In case of concomitant use of both medicines, blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered.
Slovenian: Pri sočasnem jemanju obeh zdravil je treba spremljati krvni tlak in po potrebi preučiti možnosti znižanja odmerka nifedipina.
English: The usual initial dose is one 30mg tablet once-daily.
Slovenian: Običajen odmerek je ena 30-mg tableta enkrat dnevno.
English: - Keep this leaflet.
Slovenian: izpuščaj na koži
English: Substances that inhibit CYP3A4
Slovenian: Snovi, ki zavirajo CYP3A4
English: - if you have a severe narrowing of the gastrointestinal tract.
Slovenian: - Če imate hudo zoženje prebavnih poti.
English: Severe hypotension due to vasodilatation, and tachycardia or bradycardia are the most likely manifestations of overdose.
Slovenian: Klinični učinki - Pri prekomernem odmerjanju so najverjetnejši znaki huda hipotenzija zaradi vazodilatacije in tahikardija ali bradikardija.
English: HOW TO TAKE NIFEDIPINE PHARMAMATCH RETARD
Slovenian: KAKO JEMATI ZDRAVILO NIFEDIPINE PHARMAMATCH RETARD
English: Prolonged-release tablets.
Slovenian: FARMACEVTSKA OBLIKA Tablete s podaljšanim sproščanjem.
English: Depending on the clinical symptoms, the standard dosage should be gradually increased.
Slovenian: Da dosežemo optimalni učinek, je treba zdravljenje prilagoditi potrebam posameznega bolnika.Na podlagi kliničnih simptomov standardni odmerek postopoma zvišujemo.
English: Carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E533b), titanium dioxide (E171)
Slovenian: Karbomer, koloidni silicijev dioksid (E551), hipromeloza (E464), laktoza monohidrat, magnezijev stearat (E572), metakrilna kislina kopolimer, makrogol, povidon (E1201), rdeči železov oksid (E172), smukec (E553b), titanov dioksid (E171)
English: RVG 31822 - Nifedipine Pharmamatch retard 30 mg, prolonged-release tablets
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET RVG 31822 - Nifedipine Pharmamatch retard 30 mg tablete s podaljšanim sproščanjem
English: Carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E553b) and titanium dioxide (E171).
Slovenian: Karbomer, koloidni silicijev dioksid (E551), hipromeloza (E464), laktoza monohidrat, magnezijev stearat (E572), metakrilna kislina kopolimer, makrogol, povidon (E1201), rdeči železov oksid (E172), smukec (E553b) in titanov dioksid (E171).
English: The CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summaries of Product Characteristics, labelling and package leaflet are set out in Annex III for Nifedipinr Pharmamatch Retard 30/60 mg and associated names (see Annex I).
Slovenian: je CHMP za Nifedipine Pharmamatch Retard 30/60 mg in povezana imena (glejte Dodatek I) priporočil odobritev dovoljenj za promet za katere so Povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo opredeljeni v Dodatku III.
English: You should not use Nifedipine Pharmamatch retard to treat an angina attack when it occurs, but rather to reduce the frequency of the angina you experience over time.
Slovenian: Z zdravilom Nifedipine Pharmamatch retard ne smete nikoli zdraviti napada angine, ko se pojavi.
English: Other toxic effects include nausea, vomiting drowsiness, dizziness, confusion, lethargy, flushing, hypoxia, headache, red spots on the face, and unconsciousness to the point of coma
Slovenian: - Drugi toksični učinki vključujejo slabost, bruhanje, zaspanost, omotico, zmedenost, letargijo,
English: 4.7 Effects on ability to drive and use machines In patients that experience dizziness, headache, fatigue or nausea, impaired reaction time may effect ability to drive or to operate machinery This occurs especially at the beginning of treatment, in case of a change in medication or in case of concomitant use of alcohol.
Slovenian: Pri bolnikih, pri katerih se pojavi omotica, glavobol, utrujenost ali slabost, lahko poslabšanje reakcijskega časa vpliva na sposobnost vožnje in upravljanja s stroji.
English: - The other ingredients are: carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E533b) and titanium dioxide (E171).
Slovenian: - Pomožne snovi so: karbomer, koloidni silicijev dioksid (E551), hipromeloza (E464), laktoza monohidrat, magnezijev stearat (E572), metakrilna kislina kopolimer, makrogol, povidon (E1201), rdeči železov oksid (E172), smukec (E553b) in titanov dioksid (E171).
English: - Common:
Slovenian: - Pogosti:
English: Very common (more than 1 out of 10 patients): - headache - flushing - swelling, particularly of the ankles and legs
Slovenian: Zelo pogosti (pri več kot 1 od 10 bolnikov): - glavobol - rdečica - otekanje, zlasti gležnjev in nog - vrtoglavica - nejasno zavedanje - občutek pritiska v glavi.
English: 4.2 Posology and method of administration For oral administration.
Slovenian: 4.2 Odmerjanje in način uporabe
English: Nifedipine Pharmamatch tablets are supplied in blister packs of 28.
Slovenian: Nifedipine Pharmamatch tablete so na voljo v pretisnih omotih po 28 tablet.
English: There are limited data showing that nifedipine is excreted into human breast milk at low levels.
Slovenian: Omejeni podatki dokazujejo, da se nifedipin v majhnih količinah izloča v materino mleko in možnega vpliva na novorojenčka ni mogoče izključiti.
English: Nifedipine Pharmamatch 60 mg tablets are available as prolonged-release tablets in a calendar packaging of 28 tablets (2 blisters of 14 tablets).
Slovenian: Nifedipine Pharmamatch 60 mg tablete so na voljo kot tablete s podaljšanim sproščanjem v koledarski ovojnini z 28 tabletami (2 pretisna omota s 14 tabletami).
English: Nifedipine Pharmamatch 30 mg tablets are available as prolonged-release tablets in a calendar packaging of 28 tablets (2 blisters of 14 tablets).
Slovenian: Nifedipine Pharmamatch 30 mg tablete so na voljo kot tablete s podaljšanim sproščanjem v koledarski ovojnini z 28 tabletami (2 pretisna omota s 14 tabletami).
English: - if you have experienced a collapse which was caused by a heart problem (cardiogenic shock) - if you have a narrowed aorta (aortic stenosis).
Slovenian: - Če ste se kdaj zgrudili zaradi težav s srcem (kardiogeni šok).
English: Nifedipine Pharmamatch retard 30 mg, prolonged-release tablets contain 30 mg nifedipine per tablet.
Slovenian: Nifedipine Pharmamatch retard 30 mg, tablete s podaljšanim sproščanjem, vsebujejo 30 mg nifedipina na tableto.
English: - moisture in lungs (pulmonary oedema) - fainting (syncope) - heart block - peeling or flaking of skin (exfoliative dermatitis) - severe blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (signs of Steven-Johnson syndrome) - skin rashes (erythema multifome, pemphigus, fixed drug eruption, urticaria) - reduced production of red blood cells (aplastic anaemia) - increase in blood potassium levels (when used together with another medicine called propranolol)
Slovenian: Steven-Johnsonovega sindroma) - izpuščaji na koži (multiformni eritem, pemfigus, fiksirane erupcije zaradi zdravil, urtikarija) - zmanjšana tvorba eritrocitov (aplastična anemija) - zvišanje ravni kalija v krvi (pri sočasnem jemanju nifedipina in zdravila propranolola)
English: Nifedipine Pharmamach retard tablets come in a calendar packing of 28 tablets (2 blisters of 14 tablets each).
Slovenian: Nifedipine Pharmamatch retard tablete so na voljo v koledarski ovojnini z 28 tabletami (2 pretisna omota s po 14 tabletami).
English: Each tablet contains: 60 mg nifedipine
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje: 60 mg nifedipina
English: please tell your doctor or pharmacist.
Slovenian: Če ste negotovi, obvestite svojega zdravnika ali farmacevta.
English: The possibility of an additive effect resulting in postural hypotension should be borne in mind when Nifedipine Pharmamatch retard is used in combination with other beta-blocking medicinal products and antihypertensive agents.
Slovenian: Pri uporabi zdravila Nifedipine Pharmamatch retard v kombinaciji z drugimi zaviralci adrenergičnih receptorjev beta in zdravili za zdravljenje hipertenzije je treba upoštevati možnost aditivnega učinka, pri čemer bi se pojavila postularna hipotenzija.
English: It is not recommended to drink grapefruit juice when treated with Nifedipine Pharmamatch retard.
Slovenian: V času zdravljenja z zdravilom Nifedipine Pharmamatch retard ni priporočljivo piti grenivkinega soka.
English: It should not be used for secondary prevention of myocardial infarction.
Slovenian: Zdravila Nifedipine Pharmamatch retard ne smemo uporabljati za sekundarno preprečevanje miokardnega infarkta.
English: Nifedipine Pharmamatch retard 60 mg, prolonged-release tablets contain 60 mg nifedipine per tablet.
Slovenian: Nifedipine Pharmamatch retard 60 mg, tablete s podaljšanim sproščanjem, vsebujejo 30 mg nifedipina na tableto.
English: Other interactions with nifedipine
Slovenian: Medsebojno delovanje nifedipina z drugimi zdravili
English: Each tablet contains: 30 mg nifedipine
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje: 30 mg nifedipina
English: What Nifedipine Pharmamatch retard contains
Slovenian: Kaj vsebuje zdravilo Nifedipine Pharmamatch retard
English: Nifedipine Pharmamatch retard 60 mg prolonged-release tablets Nifedipine
Slovenian: Nifedipine Pharmamatch retard 60 mg tablete s podaljšanim sproščanjem nifedipin
English: Grapefruit juice inhibits the CYP3A4 system.
Slovenian: Grenivkin sok zavira sistem CYP3A4.
English: In case of doubt, always contact your doctor or pharmacist.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
English: Important information about some of the ingredients of Nifedipine Pharmamatch retard
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Nifedipine Pharmamatch retard Zdravilo Nifedipine Pharmamatch retard vsebuje laktozo.
English: Nifedipine
Slovenian: Zdravilo Nifedipine
English: Reproductive system and breast disorders: - Uncommon:
Slovenian: Motnje reprodukcije in dojk: - Občasni:
English: Nifedipine Pharmamatch retard 30 mg prolonged-release tablets Nifedipine
Slovenian: Nifedipine Pharmamatch retard 30 mg tablete s podaljšanim sproščanjem nifedipin
English: Each prolonged release tablet contains 60 mg nifedipine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta s podaljšanim sproščanjem vsebuje 60 mg nifedipina.
English: RVG 31823 - Nifedipine Pharmamatch retard 60 mg, prolonged-release tablets DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29 November 2004
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET RVG 31823 - Nifedipine Pharmamatch retard 60 mg tablete s podaljšanim sproščanjem
English: Always take Nifedipine Pharmamatch retard exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Nifedipine Pharmamatch retard natančno upoštevajte zdravnikova navodila.
English: Nifedipine is almost entirely metabolised (> 90%); approximately 70-80% is excreted in urine.
Slovenian: Nifedipin se skoraj v celoti presnovi (> 90 %).
English: A reduction of the nifedipine dose can be considered.
Slovenian: Po potrebi je treba znižati odmerek nifedipina.
English: It should not be used for acute attacks of angina.
Slovenian: Zdravila Nifedipine Pharmamatch retard ne smemo uporabljati za akutne napade angine.
English: Eye disorders: - Uncommon:
Slovenian: Očesne bolezni: - Občasni:
English: Stationsweg Oost 281D
Slovenian: Stationsweg Oost 281D 3930 EB Woudenberg
English: - Very common: peripheral oedema, flushing (facial reddening).
Slovenian: periferni edem, rdečica (na obrazu)
English: Each prolonged release tablet contains 30 mg nifedipine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta s podaljšanim sproščanjem vsebuje 30 mg nifedipina.
English: Nervous system disorders: - Uncommon:
Slovenian: Bolezni živčevja: - Občasni:
English: Respiratory, thoracic and mediastinal disorders: - Very rare:
Slovenian: pljučni edem, sinkopa, srčni blok Bolezni dihal, prsnega koša in mediastinalnega prostora: - Zelo redki:
English: Nifedipine Pharmamatch retard 60 mg prolonged-release tablets
Slovenian: IME ZDRAVILA Nifedipine Pharmamatch retard 60 mg tablete s podaljšanim sproščanjem
English: colouring aid
Slovenian: SEZNAM POMOŽNIH SNOVI
English: Nifedipine Pharmamatch retard 30 mg prolonged-release tablets
Slovenian: IME ZDRAVILA Nifedipine Pharmamatch retard 30 mg tablete s podaljšanim sproščanjem
English: In patients with hepatic impairment careful monitoring is required and, in severe cases, a lowering of the dose may be necessary.
Slovenian: Pri bolnikih z jetrno okvaro je potrebno skrbno spremljanje.
English: The recommended dose is 350 mg once every 3 weeks.
Slovenian: Priporočeni odmerek je 350 mg enkrat vsake tri tedne.
English: However, the study involved a small number of patients and additional data are required.
Slovenian: Ker pa je opravljena študija vključevala majhno število bolnikov, je potrebnih več podatkov.
English: Further information on Libtayo can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/libtayo.
Slovenian: Nadaljnje informacije o zdravilu Libtayo so na voljo na spletni strani agencije: www.ema.europa.eu/medicines/human/EPAR/libtayo.
English: Treatment can continue for as long as the disease remains stable and the patient does not experience unacceptable side effects.
Slovenian: Zdravljenje se nadaljuje tako dolgo, dokler bolezen ostaja stabilna in bolnik nima nesprejemljivih neželenih učinkov.
English: The European Medicines Agency therefore decided that Libtayo's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Libtayo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: As for the medicine's safety, its side effects are manageable and similar to those seen in other cancer treatments of this type.
Slovenian: Kar zadeva varnost zdravila, so njegovi neželeni učinki obvladljivi in podobni tistim, ki so bili opaženi pri drugih tovrstnih zdravilih za zdravljenja raka.
English: In a main study involving a total of 193 patients, the cancer shrank in around 39% of patients with metastatic disease who received 350 mg Libtayo every 3 weeks for around one year.
Slovenian: V glavni študiji, v kateri je sodelovalo skupaj 193 bolnikov, se je rak skrčil pri približno 39 % bolnikov z metastatskim rakom, ki so približno eno leto prejemali 350 mg zdravila Libtayo vsake tri tedne.
English: What measures are being taken to ensure the safe and effective use of Libtayo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Libtayo?
English: The company will also investigate whether the medicine works differently depending on the levels of PD-L1 produced by the cancer cells.
Slovenian: Podjetje bo prav tako proučilo, ali je delovanje zdravila odvisno od ravni PD-L1, ki jo proizvajajo rakave celice.
English: Treatment with Libtayo must be started and supervised by a doctor experienced in treating cancer.
Slovenian: Zdravljenje z zdravilom Libtayo mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: As for all medicines, data on the use of Libtayo are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Libtayo stalno spremljajo.
English: Libtayo is given as an infusion (drip) into a vein lasting 30 minutes.
Slovenian: Zdravilo Libtayo se daje kot (kapalna) infuzija v veno, ki traja 30 minut.
English: Among patients with locally advanced disease who received Libtayo every 2 weeks (at a dose of 3 mg/kg bodyweight) for around 2 years, 44% of patients showed shrinkage of their cancer.
Slovenian: Med bolniki z lokalno napredovalim rakom, ki so približno dve leti prejemali zdravilo Libtayo (v odmerku 3 mg/kg telesne mase) vsaka dva tedna, se je rak skrčil pri 44 % bolnikov.
English: Libtayo has been given ‘conditional authorisation'.
Slovenian: Zdravilo Libtayo je pridobilo „pogojno dovoljenje za promet“.
English: Side effects reported with Libtayo are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Libtayo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Libtayo authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Libtayo odobreno v EU?
English: Other information about Libtayo
Slovenian: Druge informacije o zdravilu Libtayo
English: An overview of Libtayo and why it is authorised in the EU
Slovenian: Pregled zdravila Libtayo in zakaj je odobreno v EU
English: What is Libtayo and what is it used for?
Slovenian: Kaj je zdravilo Libtayo in za kaj se uporablja?
English: What benefits of Libtayo have been shown in studies?
Slovenian: Kakšne koristi zdravila Libtayo so se pokazale v študijah?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Libtayo have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Libtayo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about using Libtayo, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Libtayo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.