FrancophonIA/ELRC3.0 huggingface dataset:
English: Silicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin.
Slovenian: Silikon (proti penjenju) Fosfatni pufer Glicerinski pufer Aluminijev hidroksid Saponin
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C - 8 °C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku (2 °C-8 °C).
English: Avoid bubble formation, as this can be irritating at the site of injection.
Slovenian: Izogibajte se nastanku zračnih mehurčkov, saj ti lahko povzročijo draženje na mestu dajanja.
English: *below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission.
Slovenian: *pod stopnjo detekcije z validirano metodo RT-PCR pri 3,68 log10 RNA kopijah/ml, ni prenosa virusa
English: Do not mix with any other veterinary medicinal products.
Slovenian: Ne mešajte z drugimi zdravili za uporabo v veterinarski medicini.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/108/005
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/108/005
English: NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 2-4 suspension for injection for sheep
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI BTVPUR AlSap 2-4 suspenzija za injiciranje za ovce
English: The vaccine contains inactivated bluetongue virus serotypes 2 and 4 with aluminium hydroxide and saponin adjuvants.
Slovenian: Cepivo vsebuje inaktiviran virus modrega jezika, serotip 2 in 4, z aluminijevim hidroksidom in saponini kot adjuvansi.
English: No adverse reactions except those mentioned in section ‘Adverse Reactions' were observed after the administration of a double-dose of vaccine.
Slovenian: Drugi učinki, razen tistih ki so navedeni v poglavju neželeni učinki, niso bili opaženi po dajanju dvojnega odmerka cepiva.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Vaccination may be followed by a small local swelling at the injection site (at most 24 cm²) for a short A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Slovenian: Po cepljenju se lahko na mestu dajanja pojavi prehodna manjša lokalizirana oteklina (največ 24 cm Do 24 ur po cepljenju je možen pojav prehodnega povišanja telesne temperature, ki navadno ne preseže 1,1 °C.
English: Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for serotype 4 and serotype 2, respectively.
Slovenian: Imunost nastopi tri tedne po osnovnem cepljenju za serotip 4 in 5 tednov po osnovnem cepljenju za serotip 2.
English: Once broached, use immediately.
Slovenian: Po odprtju uporabite takoj.
English: PACKAGE LEAFLET FOR: BTVPUR AlSap 2-4 suspension for injection for sheep
Slovenian: NAVODILO ZA UPORABO BTVPUR AlSap 2-4 suspenzija za injiciranje za ovce
English: A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Slovenian: Do 24 ur po cepljenju je možen pojav prehodnega povišanja telesne temperature, ki navadno ne preseže 1,1 °C.
English: The periodic safety update report (PSUR) cycle should be re-started for submission of 6 monthly reports (covering all authorised presentations of this product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
Slovenian: PSUR ciklus je potrebno za trajanje 2 leti ponovno vzpostaviti tako, da se PSUR predaja vsakih 6 mesecev (vključevati mora vsa registrirana pakiranja zdravila).
English: Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.
Slovenian: Aktivna imunizacija ovc proti virusu modrega jezika, serotip 2 in 4, za preprečitev viremije* in zmanjšanje kliničnih znakov.
English: PACKAGE SIZE 10 doses (10 ml)
Slovenian: VELIKOST PAKIRANJA 10 odmerkov (10 ml)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/108/001 (1 bottle of 100 ml) EU/2/10/108/002 (10 bottles of 100 ml)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/108/001 (1plastenka s 100 ml) EU/2/10/108/002 (10 plastenk s 100 ml)
English: EU/2/10/108/003 (1 bottle of 50 ml) EU/2/10/108/004 (10 bottles of 50 ml) EU/2/10/108/001 (1 bottle of 100 ml) EU/2/10/108/002 (10 bottles of 100 ml)
Slovenian: EU/2/10/108/003 (1 plastenka s 50 ml) EU/2/10/108/004 (10 plastenk s 50 ml) EU/2/10/108/001 (1 plastenka s 100 ml) EU/2/10/108/002 (10 plastenk s 100 ml)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 1 bottle of 50 ml, or of 10 bottles of 50 ml, or of 1 bottle of 100 ml, or of 10 bottles of 100 ml
Slovenian: Škatla z 1 plastenko s 50 ml ali z 10 plastenkami s 50 ml ali z 1 plastenko s 100 ml ali z 10 plastenkami s 100 ml
English: 10 bottles of 50 doses (10 x 50 ml) 100 doses (100 ml) 10 bottles of 100 doses (10 x 100 ml)
Slovenian: 50 odmerkov (50 ml) 10 plastenk s 50 odmerki (10 x 50 ml) 100 odmerkov (100 ml) 10 plastenka s 100 odmerki (10 x 100 ml)
English: Revaccination
Slovenian: Ponovno cepljenje
English: Bluetongue virus serotype 2 antigen .............................................................................. 6.8-9.5 CCID50*, Bluetongue virus serotype 4 antigen .............................................................................. 7.1-8.5 CCID50*, Aluminium hydroxide
Slovenian: Virus modrega jezika, serotip 2, antigen ....................................................................... 6,8-9,5 CCID50*, Virus modrega jezika, serotip 4, antigen ....................................................................... 7,1-8,5 CCID50*, Aluminijev hidroksid
English: It induces an active and specific immunity against bluetongue virus serotypes 2 and 4 in the vaccinated animals.
Slovenian: Pri cepljenih živalih sproži nastanek aktivne in specifične imunosti proti virusu modrega jezika, serotip 2 in 4.
English: Pharmacotherapeutic group: inactivated bluetongue virus vaccine for sheep.
Slovenian: Farmakoterapevtska skupina: inaktivirano cepivo proti virusu modrega jezika za ovce Oznaka ATC vet QI04AA02.
English: EXPIRY DATE EXP {month/year} Once broached, use immediately.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
English: Bluetongue virus serotype 2 antigen ............................................................................... 6.8-9.5 CCID50* Bluetongue virus serotype 4 antigen ............................................................................... 7.1-8.5 CCID50* * Cell culture infectious dose 50% equivalent to titre prior to inactivation (log10) Adjuvants:
Slovenian: Virus modrega jezika, serotip 2, antigen ....................................................................... 6,8-9,5 CCID50*, Virus modrega jezika, serotip 4, antigen ....................................................................... 7,1-8,5 CCID50*, *Infektivni odmerek za celično kulturo 50%, ekvivalent titru pred inaktivacijo (log10)
English: BTV 2 antigen ........................................................................................................... 6.8-9.5 CCID50/ml, BTV 4 antigen ........................................................................................................... 7.1-8.5 CCID50/ml.
Slovenian: antigen BTV 2 ........................................................................................................... 6,8-9,5 CCID50/ml, antigen BTV 4 ........................................................................................................... 7,1-8,5 CCID50/ml.
English: Aluminium hydroxide
Slovenian: Aluminijev hidroksid, Saponin q.s.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Administer one dose of 1 ml subcutaneously according to the following vaccination scheme: Primary vaccination
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1ml of vaccine contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: The name of the medicine was changed to Icandra on 6 February 2009.
Slovenian: Ime zdravila je bilo 6. februarja 2009 spremenjeno v Icandra.
English: The recommended dose of Icandra is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Slovenian: Priporočeni odmerek zdravila Icandra je ena tableta dvakrat dnevno, pri čemer se ena tableta vzame zjutraj, druga pa zvečer.
English: The full EPAR for Icandra 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 Icandra je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Icandra
Slovenian: Druge informacije o zdravilu Icandra
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vildagliptin/Metformin Hydrochloride on 1 December 2008.
Slovenian: Evropska komisija je dovoljenje za promet z vildagliptinom/metforminijevim kloridom, veljavno po vsej Evropski uniji, odobrila dne 1. decembra 2008.
English: For more information about treatment with Icandra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Icandra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Icandra.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Icandra.
English: Vildagliptin / metformin hydrochloride
Slovenian: Icandra vildagliptin/metforminijev klorid
English: The company that makes Eucreas has agreed that its scientific data can be used for Icandra.
Slovenian: Družba, ki proizvaja zdravilo Eucreas, se strinja, da se lahko znanstveni podatki tega zdravila uporabijo za zdravilo Icandra.
English: Therefore, the Committee decided that the benefits of Icandra are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor je zaključil, da so koristi zdravila Icandra večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The most common side effects with Icandra (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Slovenian: Najpogostejši neželeni učinki zdravila Icandra (opaženi pri več kot 1 bolniku od 10) so slabost, bruhanje, driska, bolečina v trebuhu in izguba teka.
English: The applicant also presented the results of two studies showing that the active substances in the two strengths of Icandra were absorbed in the body in the same way as when they were taken as separate tablets.
Slovenian: Predlagatelj je predstavil tudi rezultate dveh študij, ki kažeta, da je telo zdravilni učinkovini v obeh jakostih zdravila Icandra absorbiralo enako, kot pri njunem jemanju v obliki ločenih tablet.
English: What benefit has Icandra shown during the studies?
Slovenian: Kakšne koristi je zdravilo Icandra izkazalo med študijami?
English: The choice of tablet strength to start with depends on the patient's current treatment and the expected effects of Icandra, but it is recommended to provide a dose of metformin similar to the dose already being taken.
Slovenian: Izbira začetne jakosti tablete je odvisna od bolnikovega dotedanjega zdravljenja in pričakovanega učinka zdravila Icandra, vendar je priporočljivo,da je odmerek metformina podoben odmerku, ki ga bolnik že jemlje.
English: Icandra should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Slovenian: Zdravila Icandra se ne sme uporabljati pri bolnikih, ki imajo zmerne ali hude težave z ledvicami ali imajo težave z jetri.
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 Icandra.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Icandra, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Elderly patients taking Icandra should have their kidney function monitored regularly.
Slovenian: Pri starejših bolnikih, ki jemljejo zdravilo Icandra, je treba redno spremljati delovanje ledvic.
English: Icandra should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Slovenian: Zdravila Icandra ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) vildagliptin, metformin ali katero koli drugo sestavino zdravila.
English: Taking Icandra with or just after food may reduce any stomach problems caused by metformin.
Slovenian: Jemanje zdravila Icandra sočasno s hrano ali neposredno po obroku lahko ublaži želodčne težave, ki jih povzroča metformin.
English: The studies with Galvus as an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to support the use of Icandra in the same indications.
Slovenian: Študije zdravila Galvus kot dodatnega zdravila metforminu, metforminu in sulfonilsečnini ali metforminu, sulfonilsečnini in insulinu, so bile uporabljene v podporo zdravilu Icandra za iste indikacije.
English: Icandra contains two active substances, which each have a different mode of action.
Slovenian: Zdravilo Icandra vsebuje dve zdravilni učinkovini, ki imata različen način delovanja.
English: For the full list of all side effects reported with Icandra, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Icandra, glejte navodilo za uporabo.
English: What is the risk associated with Icandra?
Slovenian: Kakšna tveganja so povezana z zdravilom Icandra?
English: Why has Icandra been approved?
Slovenian: Zakaj je bilo zdravilo Icandra odobreno?
English: Patients already taking vildagliptin and metformin should switch to Icandra containing the same amounts of each active substance.
Slovenian: Bolniki, ki že jemljejo vildagliptin in metformin naj preidejo na zdravilo Icandra, ki ti dve učinkovini vsebuje v enakih odmerkih.
English: Icandra is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
Slovenian: Zdravilo Icandra vsebuje zdravilni učinkovini vildagliptin in metforminijev klorid.
English: • in combination with a sulphonylurea (another type of anti-diabetes medicine) together with diet and exercise, in patients whose diabetes is not satisfactorily controlled on metformin and a sulphonylurea.
Slovenian: • v kombinaciji s sulfonilsečnino (drugo vrsto zdravila proti sladkorni bolezni) skupaj z dieto in telesno vadbo pri bolnikih, pri katerih bolezen ni zadostno nadzorovana z metforminom in sulfonilsečnino;
English: Icandra is used to treat adults with type 2 diabetes.
Slovenian: Zdravilo Icandra se uporablja za zdravljenje sladkorne bolezni tipa 2.
English: • in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone;
Slovenian: • pri bolnikih, pri katerih se bolezni ne da zadostno nadzorovati z največjim odmerkom metformina,
English: What is Icandra used for?
Slovenian: Za kaj se zdravilo Icandra uporablja?
English: How has Icandra been studied?
Slovenian: Kako je bilo zdravilo Icandra raziskano?
English: What is Icandra?
Slovenian: Kaj je zdravilo Icandra?
English: How does Icandra work?
Slovenian: Kako zdravilo Icandra deluje?
English: How is Icandra used?
Slovenian: Kako se zdravilo Icandra uporablja?
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2018
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 20. november 2018
English: B Carefully pull the needle cap straight out and away from your body.
Slovenian: B Skrbno potegnite pokrovček igle naravnost z nje in proč od vašega telesa.
English: • some changes may occur in your blood, but these will be detected by routine blood tests.
Slovenian:  pojavijo se lahko nekatere spremembe v krvi, vendar jih zaznamo z rutinskimi krvnimi preiskavami.
English: to < 1/1,000)
Slovenian: do < 1/1,000)
English: For safety reasons: Do not grasp the plunger.
Slovenian: Zaradi varnosti: Ne primite brizge za bat.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1328/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/18/1328/001
English: Your doctor may decide that it would be more convenient for you to inject Pelmeg yourself.
Slovenian: Mogoče se bo zdravnik odločil, da bi bilo za vas prikladneje, če si zdravilo Pelmeg injicirate sami.
English: QR code to be included <www.pelmeg.eu>
Slovenian: Oznaka QR <www.pelmeg.eu>
English: However, the long-term effects of Pelmeg have not been established in AML; therefore, it should be used with caution in this patient population.
Slovenian: Vendar dolgoročni učinki zdravila Pelmeg pri AML niso ugotovljeni, zato ga je treba pri tej populaciji bolnikov uporabljati previdno.
English: • breathing problems.
Slovenian:  težave pri dihanju.
English: If you forget to inject Pelmeg
Slovenian: Če ste si pozabili injicirati zdravilo Pelmeg
English: What Pelmeg is and what it is used for
Slovenian: Kaj je zdravilo Pelmeg in za kaj ga uporabljamo
English: • Pelmeg is given as an injection into the tissue just under the skin (subcutaneous injection).
Slovenian: • Zdravilo Pelmeg se daje kot injekcija v tkivo tik pod kožo (subkutano injiciranje).
English: Pelmeg left at room temperature for more than 96 hours should be discarded.
Slovenian: Zdravilo Pelmeg, ki je bilo na sobni temperaturi več kot 96 ur, je treba zavreči.
English: What Pelmeg is and what it is used for What you need to know before you use Pelmeg How to use Pelmeg
Slovenian: Kaj je zdravilo Pelmeg in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Pelmeg Kako uporabljati zdravilo Pelmeg
English: Pelmeg therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Slovenian: Zdravljenje z zdravilom Pelmeg morajo uvesti in nadzorovati zdravniki, izkušeni v onkologiji in/ali hematologiji.
English: Therefore, physicians should use caution when prescribing Pelmeg in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
Slovenian: Zato morajo biti zdravniki previdni, kadar predpisujejo zdravilo Pelmeg bolnikom s srpastocelično dispozicijo ali s srpastocelično anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo tega zdravila z zvečanjem vranice in vazookluzivno krizo.
English: Pelmeg is for use in adults aged 18 and over.
Slovenian: Zdravilo Pelmeg je namenjeno uporabi pri odraslih, starih 18 ali več let.
English: Your doctor has given you Pelmeg to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Slovenian: Vaš zdravnik vam je predpisal zdravilo Pelmeg, da bi spodbudilo vaš kostni mozeg (tisti del kosti, ki izdeluje krvničke) k izdelavi več belih krvničk, ki pomagajo vašemu telesu boriti se proti okužbam.
English: 31002 Pamplona (Navarra), Spain
Slovenian: 31002 Pamplona (Navarra)
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Pelmeg therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Pelmeg, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: This may be a sign of a problem with your spleen (splenomegaly)
Slovenian: To je lahko znak, da imate težave z vranico (splenomegalija).
English: Sweet's syndrome (acute febrile dermatosis)1,2; Cutaneous vasculitis1,2
Slovenian: Sweetov sindrom (akutna febrilna dermatoza)1,2; kožni vaskulitis1,2
English: *Sodium acetate is prepared by mixing sodium acetate trihydrate and acetic acid.
Slovenian: * Natrijev acetat je pripravljen z mešanjem natrijevega acetata trihidrata in ocetne kisline.
English: Pelmeg has not been tested in pregnant women.
Slovenian: Zdravila Pelmeg pri nosečnicah niso preskusili.
English: Accidental exposure to freezing temperatures for two periods of less than 72 hours each does not adversely affect the stability of Pelmeg.
Slovenian: Nehotena izpostavitev temperaturam pod lediščem za največ dve obdobji, od katerih nobeno ne traja dlje kot 72 ur, nima negativnega vpliva na stabilnost zdravila Pelmeg.
English: Important Before you use a Pelmeg pre-filled syringe with automatic needle guard, read this important information:
Slovenian: Pred uporabo zdravila Pelmeg v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle preberite te pomembne informacije:
English: Do not shake Pelmeg vigorously as this may affect its activity.
Slovenian: Zdravila Pelmeg ne smete močno stresati, ker to lahko vpliva na njegovo delovanje.
English: If you develop or are likely to develop cancers of the blood, you should not use Pelmeg, unless instructed by your doctor.
Slovenian: Če se vam bodo pojavili ali je verjetno, da se vam bodo pojavili krvni raki, ne smete uporabljati zdravila Pelmeg, razen če vam to naroči zdravnik.
English: If you have forgotten a dose of Pelmeg, you should contact your doctor to discuss when you should inject the next dose.
Slovenian: Če ste pozabili odmerek zdravila Pelmeg, se posvetujte z zdravnikom glede tega, kdaj si boste injicirali naslednji odmerek.
English: Other medicines and Pelmeg
Slovenian: Druga zdravila in zdravilo Pelmeg
English: • nausea and headaches.
Slovenian:  siljenje na bruhanje in glavoboli.
English: • you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine.
Slovenian:  če ste alergični na pegfilgrastim, filgrastim, beljakovine, ki izvirajo iz E. coli, ali katero koli sestavino tega zdravila.
English: • Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Slovenian:  vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
English: • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.6 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,6 ml
English: The safety and efficacy of Pelmeg administration in de novo AML patients aged < 55 years with cytogenetics t (15;17) have not been established.
Slovenian: Varnost in učinkovitost uporabe zdravila Pelmeg pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko t(15;17), nista ugotovljeni.
English: Pinch your injection site to create a firm surface.
Slovenian: C Stisnite mesto injiciranja, da boste ustvarili trdno površino.
English: Pelmeg may be exposed to room temperature (not above 30º C) for a maximum single period of up to 96 hours.
Slovenian: Zdravilo Pelmeg sme biti izpostavljeno sobni temperaturi (ne nad 30 °C) za enkratno obdobje, ki ne sme preseči 96 ur.