FrancophonIA/ELRC3.0 huggingface dataset:
English: Withdrawal of the marketing authorisation application for Solumarv (human insulin) EMA/CHMP/761027/2012
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Solumarv (humani insulin) EMA/130145/2013
English: What was Solumarv expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Solumarv uporabljalo?
English: How is Solumarv expected to work?
Slovenian: Kako naj bi zdravilo Solumarv delovalo?
English: Among these were results from studies that looked at how the body handles Solumarv compared with Humulin S and how these insulins affect blood sugar levels.
Slovenian: Družba je predložila rezultate študij, ki naj bi dokazale, da je zdravilo Solumarv po svoji sestavi, biološki aktivnosti in klinični učinkovitosti podobno referenčnemu zdravilu Humulin S. Med rezultati so bili tudi rezultati študij, v katerih so proučevali, kako se telo odziva na zdravilo Solumarv v primerjavi z zdravilom Humulin S, in kako omenjena insulina vplivata na ravni krvnega sladkorja.
English: The program shall teach the content of the mentioned educational material.
Slovenian: V okviru programa se bodo poučili o vsebini navedenega izobraževalnega gradiva.
English: The Marketing Authorisation Holder shall agree the exact content and format of the educational material and educational program with the national competent authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom se bo dogovoril o natančni vsebini in obliki izobraževalnega gradiva in programa usposabljanja s pristojnim nacionalnim organom.
English: This material shall inform about the
Slovenian: To gradivo mora vsebovati opozorila o
English: Annex IV Conditions to the marketing authorisations
Slovenian: Priloga IV Pogoji dovoljenja za promet z zdravilom
English: • use of pressurized CO2 only
Slovenian: • izključni uporabi stisnjenega plina CO2,
English: If the tag is provided as part of the medicinal product, it should be incorporated in the product information via a variation procedure
Slovenian: Če je kartonček priložen zdravilu, mora biti vključen v informacije o zdravilu v postopku za spremembo.
English: The material shall include the latest Summary of Product Characteristics and the section titled “The following information is intended for medical or healthcare professionals only” of the latest package leaflet.
Slovenian: Gradivo naj vključuje najnovejši povzetek glavnih značilnosti zdravila in poglavje z naslovom „Naslednje informacije so namenjene samo zdravstvenemu osebju najnovejšega navodila za uporabo.
English: • correct pressure and distance from tissue
Slovenian: • pravilnem tlaku in razdalji od tkiva,
English: • requirement to closely monitor blood pressure, pulse rate, oxygen saturation and end tidal CO2 when spraying the product, for the occurrence of gas embolism.
Slovenian: • pogoju, da je treba natančno spremljati spremembe v krvnem tlaku, srčnem utripu, nasičenosti s kisikom ter CO2 v izdihanem zraku ob koncu izdiha zaradi možnosti za pojav plinske embolije,
English: • a yellow tag, to be placed on the device air hose, which provides instructions for use.
Slovenian: • rumen kartonček za namestitev na zračno cev pripomočka, ki vsebuje navodila za uporabo.
English: • restriction to open surgery
Slovenian: • omejitvi na odprto kirurško tehniko,
English: • risk of life-threatening gas embolism if the product is sprayed incorrectly
Slovenian: • tveganju življenjsko nevarne plinske embolije ob nepravilnem pršenju zdravila,
English: • requirement to dry the wound using standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices) prior to using the product
Slovenian: • pogoju, da je treba pred uporabo zdravila rano osušiti s standardnimi tehnikami (npr. z uporabo kompres, tamponov ali uporabo sesalnih naprav med postopkom),
English: • which regulator(s) should be used, in line with manufacturer recommendations and the SmPC instructions for use
Slovenian: • regulatorjih, ki jih je treba uporabiti v skladu s priporočili proizvajalca in z navodilom za uporabo v povzetku glavnih značilnosti zdravila.
English: • labels for the pressure regulator that inform about the correct pressure and distance in open surgery
Slovenian: • oznake za regulator tlaka, ki opozarjajo na pravilen tlak in razdaljo pri odprti kirurški tehniki,
English: The Marketing Authorisation Holder (MAH) shall submit to the national competent authority, within one month of the European Commission decision on this procedure (EMEA/H/A-31/1337), an EU risk management plan for the product according to the EU Good Vigilance Practices which includes the safety concern of gas embolism.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora pristojnemu nacionalnemu organu v enem mesecu od sklepa Evropske komisije v zvezi s tem postopkom (EMEA/H/A-31/1337) predložiti načrt EU za obvladovanje tveganja za zdravilo v skladu z dobro vigilančno prakso EU, ki vključuje varnostni zadržek zaradi plinske embolije.
English: The MAH shall ensure that, within two years of the European Commission decision on this procedure (EMEA/H/A-31/1337), the product can only be used with a pressure regulator that caps the maximum pressure at 2.5 bars.
Slovenian: Imetnik dovoljenja za promet mora v dveh letih od sklepa Evropske komisije o tem postopku (EMEA/H/A-31/1337) zagotoviti, da je mogoče zdravilo uporabljati le z regulatorjem tlaka, ki omeji najvišji tlak pri 2,5 bara.
English: • a warning card that informs about the correct pressure and distance for the spray application for open surgery
Slovenian: • opozorilno kartico, ki opozarja na pravilen tlak in razdaljo pršenja pri odprti kirurški tehniki,
English: The MAH shall offer an educational program to all users of the spray application of this product.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora vsem uporabnikom tega zdravila v obliki pršila zagotoviti program usposabljanja.
English: The MAH shall ensure that, at the time of the European Commission decision for this procedure (EMEA/H/A-31/1337), all users of the spray application of this product are provided with educational material.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da bodo ob izdaji sklepa Evropske komisije o tem postopku (EMEA/H/A-31/1337) vsi uporabniki tega zdravila v pršilu prejeli izobraževalno gradivo.
English: The MAH shall ensure that, within three months of the European Commission decision on this procedure (EMEA/H/A-31/1337), all users of the spray application of this product are provided with
Slovenian: Imetnik dovoljenja za promet mora v treh mesecih od sklepa Evropske komisije o tem postopku (EMEA/H/A-31/1337) zagotoviti, da vsi uporabniki tega zdravila v pršilu prejmejo
English: The patient should take the tablets at around the same time each day, usually in the morning.
Slovenian: Bolnica mora jemati tablete vsak dan približno ob istem času, najbolje zjutraj.
English: The usual recommended dose is 3 tablets (600 mg) once daily for 21 days followed by a 7-day break to complete a 28-day treatment course.
Slovenian: Priporočeni odmerek so 3 tablete (600 mg) enkrat na dan 21 zaporednih dni, čemur sledi 7 dni brez zdravljenja, tako da celotni cikel traja 28 dni.
English: The mean measure of effectiveness was how long the women lived without their disease getting worse (progression-free survival).
Slovenian: Glavno merilo učinkovitosti je bilo preživetje teh žensk brez poslabšanja bolezni (preživetje brez napredovanja bolezni).
English: What measures are being taken to ensure the safe and effective use of Kisqali?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kisqali?
English: This is a summary of the European public assessment report (EPAR) for Kisqali.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kisqali.
English: Kisqali ribociclib
Slovenian: Kisqali ribociklib
English: The full EPAR for Kisqali 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 Kisqali je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Medicines Agency decided that Kisqali's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Kisqali večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Other information about Kisqali
Slovenian: Druge informacije o zdravilu Kisqali
English: Kisqali is available as 200-mg tablets.
Slovenian: Zdravilo Kisqali je na voljo v obliki 200-miligramskih tablet.
English: Treatment courses should be continued for as long as the medicine continues to work and the patient does not get unacceptable side effects.
Slovenian: Cikle zdravljenja je treba nadaljevati, dokler je zdravilo učinkovito in se pri bolnici ne pojavijo nesprejemljivi neželeni učinki.
English: Kisqali was found to be effective in one main study involving 668 women with HR-positive, HER2negative breast cancer.
Slovenian: Zdravilo Kisqali se je pokazalo kot učinkovito v eni glavni študiji, v katero je bilo vključenih 668 žensk s HR-pozitivnim, HER2-negativnim rakom dojk.
English: Women taking Kisqali with letrozole lived on average 25.3 months without the disease getting worse compared with 16.0 months in those taking placebo with letrozole.
Slovenian: Ženske, ki so jemale zdravilo Kisqali in letrozol, so živele povprečno 25,3 meseca dlje, ne da bi se bolezen poslabšala, v primerjavi s 16,0 meseca pri ženskah, ki so jemale placebo in letrozol.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kisqali 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 Kisqali upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What benefits of Kisqali have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Kisqali izkazalo v študijah?
English: By blocking CDK4 and CDK6, Kisqali slows the growth of HR-positive breast cancer cells.
Slovenian: Z zaviranjem encimov CDK4 in CDK6 zdravilo Kisqali upočasni rast HR-pozitivnih celic raka dojk.
English: Kisqali can only be used when the cancer cells have receptors for certain hormones on their surface (HR-positive) and do not have large quantities of another receptor called HER2 (HER2-negative).
Slovenian: Zdravilo Kisqali se sme uporabljati le, če imajo rakave celice na površini receptorje za določene hormone (so HR-pozitivne) in ne proizvajajo nenormalno velikih količin receptorja, imenovanega HER2 (so HER2-negativne).
English: Why is Kisqali approved?
Slovenian: Zakaj je bilo zdravilo Kisqali odobreno?
English: What are the risks associated with Kisqali?
Slovenian: Kakšna tveganja so povezana z zdravilom Kisqali?
English: The active substance in Kisqali, ribociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which are important for regulating the way cells grow and divide.
Slovenian: Zdravilna učinkovina v zdravilu Kisqali, ribociklib, zavira dejavnost encimov, imenovanih od ciklina odvisni kinazi (CDK) 4 in 6, ki sta pomembni pri uravnavanju rasti in delitve celic.
English: If the patient gets severe side effects the doctor may reduce the dose of Kisqali, or interrupt or stop treatment with the medicine.
Slovenian: Če se pri bolnici pojavijo resni neželeni učinki, bo zdravnik odmerek zdravila Kisqali morda zmanjšal ali zdravljenje z njim prekinil oz. ustavil.
English: The Agency considered that Kisqali's pattern of side effects has been fairly well established and the side effects appear manageable.
Slovenian: Agencija je presodila, da je vzorec neželenih učinkov pri zdravilu Kisqali razmeroma dobro raziskan in da se zdijo neželeni učinki obvladljivi.
English: Kisqali is a cancer medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women.
Slovenian: Kisqali je zdravilo za zdravljenje raka, ki se uporablja pri napredovalem ali metastatskem raku dojk (raku, ki se je razširil v druge dele telesa) pri ženskah po menopavzi.
English: What is Kisqali and what is it used for?
Slovenian: Kaj je zdravilo Kisqali in za kaj se uporablja?
English: For more information about treatment with Kisqali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Kisqali preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Kisqali can only be obtained with a prescription and treatment should be started by a doctor experienced in the use of cancer treatments.
Slovenian: Predpisovanje in izdaja zdravila Kisqali je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: Kisqali must not be used in patients who are hypersensitive (allergic) to any of the ingredients or to peanuts or soya.
Slovenian: Zdravila Kisqali ne smejo uporabljati bolnice, ki so preobčutljive za (alergične na) katero koli sestavino zdravila, arašide ali sojo.
English: The most common side effects with Kisqali (which may affect more than 1 in 5 people) are low levels of white blood cells, headache, back pain, nausea (feeling sick), vomiting, diarrhoea, constipation, tiredness, hair loss and rash.
Slovenian: Najpogostejši neželeni učinki zdravila Kisqali (ki se lahko pojavijo pri več kot 1 bolnici od 5) so nizko število belih krvnih celic, glavobol, bolečine v hrbtu, navzea (siljenje na bruhanje), bruhanje, driska, zaprtost, utrujenost, izpadanje las in izpuščaj.
English: The most common severe side effects with Kisqali (which may affect more than 1 in 50 people) are low levels of white blood cells, nausea, vomiting, tiredness, back pain, abnormal blood tests for liver function and low levels of phosphate in the blood (hypophosphataemia).
Slovenian: Najpogostejši resni neželeni učinki zdravila Kisqali (ki se lahko pojavijo pri več kot 1 bolnici od 50) so nizko število belih krvnih celic, navzea, bruhanje, utrujenost, bolečina v hrbtu, nenormalni izvidi krvnih preiskav delovanja jeter in znižana raven fosfatov v krvi (hipofosfatemija).
English: It is not intended to provide practical advice on how to use Kisqali.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: In this study, women received either Kisqali with letrozole (an aromatase inhibitor) or placebo (a dummy treatment) with letrozole.
Slovenian: V tej študiji so ženske prejele bodisi zdravilo Kisqali z letrozolom (zaviralcem aromataze) ali placebo (zdravilo brez zdravilne učinkovine) z letrozolom.
English: Kisqali is used with an aromatase inhibitor (a cancer medicine that reduces oestrogen).
Slovenian: Zdravilo Kisqali se jemlje z zaviralcem aromataze (zdravilom proti raku, ki zmanjšuje raven estrogena).
English: For practical information about using Kisqali, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Kisqali naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Kisqali used with an aromatase inhibitor increased the time it took for the disease to get worse in postmenopausal women with HR-positive and HER2negative breast cancer that is advanced or metastatic.
Slovenian: Zdravilo Kisqali v kombinaciji z zaviralcem aromataze je pri ženskah po menopavzi s HR-pozitivnim in HER2-negativnim rakom dojke, ki je napredoval ali metastaziral, podaljšalo čas do poslabšanja bolezni.
English: How is Kisqali used?
Slovenian: Kako se zdravilo Kisqali uporablja?
English: How does Kisqali work?
Slovenian: Kako zdravilo Kisqali deluje?
English: Kisqali contains the active substance ribociclib.
Slovenian: Zdravilo Kisqali vsebuje zdravilno učinkovino ribociklib.
English: Date of first authorisation: 24th May 2018
Slovenian: Datum prve odobritve: 24. maj 2018
English: This may not be relevant for the target population.
Slovenian: To morda ni relevantno za ciljno populacijo.
English: Available data are described in section 5.2.
Slovenian: Razpoložljivi podatki so opisani v poglavju 5.2.
English: This can sometimes be severe and prolonged.
Slovenian: Včasih je lahko huda in dolgotrajna.
English: Clinical data are not available.
Slovenian: Klinični podatki niso na voljo.
English: Up to 10
Slovenian: Do 10
English: Alcohol (Alcohol present in medicines)
Slovenian: Alkohol (alkohol, prisoten v zdravilih)
English: Biological analyses:
Slovenian: Biološke analize:
English: Summary of the safety profile:
Slovenian: Povzetek varnostnega profila:
English: There are also links to other websites about rare diseases and treatments.
Slovenian: kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: These resolved subsequently.
Slovenian: Te težave so se pozneje odpravile.
English: Animal studies do not indicate a teratogenic potential.
Slovenian: Študije na živalih ne navajajo teratogenega potenciala.
English: This medicinal product is contraindicated in the following cases:
Slovenian: To zdravilo je kontraindicirano v naslednjih primerih:
English: However, reduced alertness may also be of concern when participating in road traffic.
Slovenian: Vendar je lahko zmanjšana pozornost pomembna tudi pri udeležbi v cestnem prometu.
English: After first opening 30 days.
Slovenian: Po prvem odprtju 30 dni.
English: The medicine should be given at the same time each day.
Slovenian: Zdravilo je treba dajati vsak dan ob istem času.
English: Tel: + 33 (0)1 58 28 16 80 Fax: + 33 (0)1 58 28 16 90
Slovenian: Tel. št.: + 33 (0)1 58 28 16 80 Faks: + 33 (0)1 58 28 16 90
English: Those not already mentioned above, which could happen in children as well are listed below.
Slovenian: Tisti, ki niso omenjeni zgoraj in ki se lahko pojavijo tudi pri otrocih, so navedeni v nadaljevanju.
English: For first use 1.
Slovenian: Za prvo uporabo 1.
English: It is administered directly into the child's mouth.
Slovenian: Daje se neposredno v otrokova usta.
English: In very rare cases, an intolerance to alcohol may occur.
Slovenian: V redkih primerih se lahko pojavi intoleranca na alkohol.
English: In all cases, HbA1c must be monitored every three months.
Slovenian: V vseh primerih je treba raven HbA1c preverjati vsake tri mesece.
English: - excessive hunger, headache
Slovenian: - prekomerna lakota, glavobol
English: − in patients with porphyria;
Slovenian: − pri bolnikih s porfirijo;
English: (In rare cases, it has taken 4 months to wean off insulin completely).
Slovenian: (V redkih primerih so bili za popolno prenehanje zdravljenja z insulinom potrebni 4 meseci).
English: Glibenclamide should not be given during pregnancy.
Slovenian: Glibenklamid se ne sme dajati med nosečnostjo.
English: The plasma glibenclamide levels in the simulated paediatric population were approximately 30%-60% lower than the adult levels.
Slovenian: Ravni glibenklamida v plazmi v simulirani pediatrični populaciji so bile za približno 30 %-60 % nižje od ravni pri odraslih.
English: It should therefore not be prescribed for these patients, and the use of an alternative treatment is strongly recommended, if available.
Slovenian: Zato se takim bolnikom ne bi smel predpisovati in, če je na voljo, se močno priporoča uporaba drugačnega zdravljenja.
English: This medicine is not intended to be used in pregnant women and patients planning a pregnancy should inform their doctor.
Slovenian: To zdravilo ni namenjeno uporabi pri nosečnicah, bolnice, ki načrtujejo nosečnost, pa se morajo posvetovati z zdravnikom.
English: Kidney failure does not affect its elimination as long as creatinine clearance remains above 30 ml/min.
Slovenian: Odpoved ledvic ne vpliva na njegovo izločanje, dokler je očistek kreatinina večji od 30 ml/min.
English: General aspects
Slovenian: Splošni vidiki
English: Incorrect control of plasma sugar (see section 2 “Do not give AMGLIDIA”)
Slovenian: Nepravilen nadzor sladkorja v plazmi (glejte poglavje 2 „Ne dajajte zdravila AMGLIDIA“)
English: Healthcare professionals or patients should never use another syringe than the one provided in the box to avoid dosing errors which could result in serious harm.
Slovenian: Zdravstveni delavci ali bolniki ne smejo nikoli uporabiti druge brizge razen tiste, ki je priložena v škatli, da se preprečijo napake pri odmerjanju, ki bi lahko povzročile resno škodo.
English: Centre Spécialités Pharmaceutiques 76-78 Avenue du midi 63800 Cournon d'Auvergne France
Slovenian: Centre Spécialités Pharmaceutiques 76-78 Avenue du midi 63800 Cournon d'Auvergne Francija
English: Always give the medicine before feeding,
Slovenian: Zdravilo vedno dajte pred hranjenjem.
English: Overall, the safety profile of Glibenclamide is in line with the safety profile of others sulfonylureas.
Slovenian: Na splošno je varnostni profil glibenklamida skladen z varnostnim profilom drugih sulfonilsečnin.
English: - Increase in sensitivity of the skin to sunlight.
Slovenian: - večja občutljivost kože na svetlobo;
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1 000 do < 1/100), redki (≥ 1/10 000 do < 1/1 000), zelo redki (< 1/10 000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Adolescents are not in need of this oral suspension formulation.
Slovenian: Mladostnikom ni treba jemati te formulacije (peroralne suspenzije).
English: Concomitant use of alcohol and glibenclamide should be avoided.
Slovenian: Sočasni uporabi alkohola in glibenklamida se je treba izogibati.
English: If there is no alternative, the decision for each patient must consider the danger of haemolysis and the potential benefit expected from the treatment.
Slovenian: Če ni alternative, je treba pri sprejemanju odločitve za posameznega bolnika upoštevati nevarnost hemolize in morebitne pričakovane koristi zdravljenja.
English: It should be ensured that the proper dose and strength are communicated and dispensed.
Slovenian: Zagotoviti je treba, da se sporočita in izdata ustrezen odmerek in jakost.
English: This medicine may cause allergic reactions, which may be serious in isolated cases, including difficulties to breath, low blood pressure and shock.
Slovenian: To zdravilo lahko povzroči alergijske reakcije, ki so lahko v posameznih primerih resne ter lahko vključujejo oteženo dihanje, nizek krvni tlak in šok.
English: Patients occasionally may have very high glucose values, i.e. > 20 mmol/L (> 360 mg/dL).
Slovenian: Občasno imajo lahko bolniki zelo velike vrednosti glukoze, tj. > 20 mmol/l (> 360 mg/dl).
English: Patients must be closely monitored for at least 48 hours and, depending on the patient's condition at this time, the physician will decide if additional monitoring is necessary.
Slovenian: Bolnike je treba skrbno spremljati vsaj 48 ur, nato pa se zdravnik glede na bolnikovo stanje odloči, ali je potrebno nadaljnje spremljanje.
English: It is recommended to wait for the child has swallowed the medicine before reverting back to lying position.
Slovenian: Priporočljivo je, da počakate, da otrok pogoltne zdravilo, preden se vrne nazaj v ležeči položaj.
English: Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če vaš otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katero koli drugo zdravilo.
English: If your child presents any of theses symptoms, you should immediately go to the nearest emergency department.
Slovenian: Če se pri vašem otroku pojavi kateri koli od teh simptomov, takoj obiščite najbližji urgentni oddelek.