FrancophonIA/ELRC3.0 huggingface dataset:
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 Pantecta Control.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pantecta Control, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila
English: It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection).
Slovenian: Zdravilo Pantecta Control se ne uporabljati z atazanavirjem (zdravilom za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti [HIV]).
English: Other information about Pantecta Control
Slovenian: Druge informacije o zdravilu Pantecta Control:
English: This prevents the active substance from being destroyed by the acid in the stomach.
Slovenian: S tem se prepreči, da bi kislina v želodcu
English: The active substance in Pantecta Control, pantoprazole, is a proton pump inhibitor.
Slovenian: Zdravilna učinkovina zdravila Pantecta Control, pantoprazol, je zaviralec protonske črpalke.
English: What is the risk associated with Pantecta Control?
Slovenian: Kakšna tveganja so povezana z zdravilom Pantecta Control?
English: Why has Pantecta Control been approved?
Slovenian: Zakaj je bilo zdravilo Pantecta Control odobreno?
English: It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of
Slovenian: Menil je tudi, da je glede na izkušnje z uporabo pantoprazola dostopnost zdravila Pantecta Control brez medicinskega nadzora ustrezna.
English: How has Pantecta Control been studied?
Slovenian: Kako je bilo zdravilo Pantecta Control raziskano?
English: What is Pantecta Control used for?
Slovenian: Za kaj se zdravilo Pantecta Control uporablja?
English: How is Pantecta Control used?
Slovenian: Kako se zdravilo Pantecta Control uporablja?
English: How does Pantecta Control work?
Slovenian: Kako zdravilo Pantecta Control deluje?
English: It is therefore difficult to recommend an optimal method.
Slovenian: Zato je težko priporočiti optimalno metodo.
English: Equipment that you need
Slovenian: Oprema, ki jo potrebujete
English: These can be taken from you or from a donor.
Slovenian: Odvzeti jih je možno vam ali darovalcu.
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Slovenian: Čeprav tega medsebojnega delovanja formalno niso raziskovali, pa ni nobenih dokazov za to, da je tako medsebojno delovanje škodljivo.
English: These symptoms generally develop in a rapid fashion.
Slovenian: Ti simptomi se ponavadi razvijajo zelo hitro.
English: • think you may be pregnant, or
Slovenian: • menite, da bi lahko bili noseči ali
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča je zdravilo treba uporabiti takoj.
English: Period of study
Slovenian: Obdobje študije
English: International Retrospective Study (2006)
Slovenian: Mednarodna retrospektivna študija (2006)
English: cells mean that direct comparison between different studies is difficult.
Slovenian: pomeni, da je neposredna primerjava med različnimi študijami težavna.
English: Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Slovenian: Poiščite udobno, dobro osvetljeno, čisto površino in nanjo položite vso opremo, ki jo potrebujete, da je na dosegu roke.
English: Do not warm Grastofil in any other way (for example, do not warm it in a microwave or in hot water).
Slovenian: Ne segrevajte zdravila Grastofil na noben drug način (na primer, ne segrevajte ga v mikrovalovni pečici ali v vroči vodi).
English: Some of the information you require is given at the end of this leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.
Slovenian: Nekatere informacije, ki jih potrebujete, najdete na koncu tega navodila, vendar morate za pravilno zdravljenje vaše bolezni tesno in stalno sodelovati z zdravnikom.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Slovenian: Kot pri vseh terapevtskih beljakovinah obstaja možnost nastanka imunogenosti.
English: Meta-Analysis a
Slovenian: Meta-analiza a
English: Sarkhej Bavla Highway Moraiya; Taluka: Sanand, Ahmedabad - 382213 Gujarat, India
Slovenian: Sarkhej Bavla Highway Moraiya; Taluka: Sanand, Ahmedabad - 382213 Gujarat, Indija
English: Overall, reports were more common after intravenous administration.
Slovenian: Na splošno so bila ta poročila pogostejša po intravenskem dajanju.
English: Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Grastofil).
Slovenian: Vaš zdravnik ali medicinska sestra vam bo dala navodila, kako se to opravi (glejte spodnje podatke o navodilih za injiciranje zdravila Grastofil).
English: Put the needle fully into the skin as shown by your nurse or doctor.
Slovenian: Iglo dajte popolnoma v kožo, kot vam je pokazala medicinska sestra ali zdravnik.
English: If you see blood in the syringe, pull the needle out and re-insert it in another place.
Slovenian: Če vidite kri v brizgi, potegnite iglo ven in jo ponovno vstavite na drugem mestu.
English: Remove the syringe from the refrigerator.
Slovenian: Odstranite brizgo iz hladilnika.
English: In some disease types, however, longer treatment lasting up to about one month may be required.
Slovenian: Vendar pa je pri nekaterih vrstah obolenj potrebno tudi daljše zdravljenje, ki lahko traja do enega meseca.
English: The volume of distribution in blood is approximately 150 mL/kg.
Slovenian: Volumen porazdelitve v krvi je približno 150 ml/kg.
English: Important: do not try to give yourself an injection unless you have received training from your doctor or nurse.
Slovenian: Pomembno: ne poskušajte si dati injekcije, če prej niste bili deležni usposabljanja s strani vašega zdravnika ali medicinske sestre.
English: When the response has been obtained, the minimal effective dose to maintain this level should be established.
Slovenian: Ko je ta odziv dosežen, je treba določiti najmanjši učinkoviti odmerek za vzdrževanje te ravni.
English: cell numbers vary depending on the precise methodology used and therefore, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Slovenian: s pretočno citometrijo se razlikujejo glede na dejansko uporabljeno metodologijo, zato je treba priporočila o številu, ki temeljijo na študijah v drugih laboratorijih, razlagati previdno.
English: It is advisable to wait and see how you feel after receiving Grastofil and before driving or operating machinery.
Slovenian: Priporočljivo je počakati, da vidite, kako se boste po prejemu zdravila Grastofil počutili, preden začnete voziti ali upravljati stroje.
English: The timing of leukapheresis: one or two leukaphereses on days 5 and 6 which is often sufficient.
Slovenian: Časovni razpored levkafereze: eno do dve levkaferezi 5. in 6. dan, kar pogosto zadošča.
English: Your treatment with Grastofil will usually last for about 14 days.
Slovenian: Vaše zdravljenje z zdravilom Grastofil bo običajno trajalo približno 14 dni.
English: After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Slovenian: Po enem do dveh tednih zdravljenja je mogoče začetni odmerek podvojiti ali prepoloviti, odvisno od bolnikovega odziva.
English: Do not take a double dose to make up for a forgotten injection.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeno injiciranje.
English: Date of first authorisation: 18 October 2013 Date of latest renewal: 4 October 2018
Slovenian: Datum zadnjega podaljšanja: 4. oktober 2018
English: If you are a stem cell donor, you must be aged between16 and 60 years.
Slovenian: Če ste darovalec matičnih celic, morate biti stari med 16 in 60 leti.
English: Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Slovenian: Rastni faktorji so beljakovine, ki naravno nastajajo v telesu, mogoče pa jih je izdelati tudi s pomočjo biotehnologije in jih uporabiti kot zdravilo.
English: Before you inject Grastofil you must do the following:
Slovenian: Preden boste injicirali zdravilo Grastofil morate narediti naslednje:
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 10
Slovenian: Z levkaferezo je treba začeti 5. dan in jo, če je potrebno, nadaljevati do 6. dne, da se zbere 4 x 10
English: Your healthcare professional should always record the exact medicine you are using.
Slovenian: Vaš zdravstveni delavec mora vedno natančno zabeležiti, katero zdravilo uporabljate.
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Slovenian: Vezavna protitelesa sicer nastajajo, kot je pričakovano pri vseh bioloških zdravilih, vendar jih do zdaj še niso povezali z nevtralizacijsko aktivnostjo.
English: Contact your doctor to discuss when you should inject the next dose.
Slovenian: S svojim zdravnikom se posvetujte o tem, kdaj morate injicirati naslednji odmerek.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Slovenian: Zato je treba natančno spremljati velikost vranice (npr. s kliničnim pregledom, ultrazvokom).
English: This should be considered when interpreting boneimaging results.
Slovenian: To je treba upoštevati pri razlagi rezultatov slikanja kosti.
English: Clinical studies with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific posology recommendations cannot be made.
Slovenian: V klinične študije s filgrastimom je bilo vključeno majhno število starejših bolnikov, vendar posebne študije v tej skupini niso bile izvedene in zato ni na voljo posebnih priporočil za odmerjanje.
English: Once the number of white cells in your blood has returned to normal it may be possible to reduce the dose frequency to less than once per day.
Slovenian: Ko se število belih krvničk v vaši krvi vrne na običajno, je možno pogostnost uporabe zdravila zmanjšati na manj kot enkrat dnevno.
English: The choice of route should depend on the individual clinical circumstance.
Slovenian: Izbira načina dajanja zdravila bi morala biti odvisna od posameznih kliničnih okoliščin.
English: Thereafter, it is recommended that the ANC is measured at least twice weekly for the first two weeks and subsequently once per week or once every other week during maintenance therapy.
Slovenian: Pozneje pa je priporočljivo ANC določati vsaj dvakrat na teden prva dva tedna, nato pa enkrat na teden ali enkrat na dva tedna med vzdrževalnim zdravljenjem.
English: Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.
Slovenian: Potisnite bat s počasnim in stalnim pritiskom in pri tem konstantno držite kožo, dokler ni brizga prazna.
English: The only consistently reported adverse event was musculoskeletal pain which is no different from the experience in the adult population.
Slovenian: Edini neželeni učinek, o katerem so dosledno poročali, je bila mišično-skeletna bolečina‚ ki se ne razlikuje od izkušenj v odrasli populaciji.
English: In other circumstances, additional leukaphereses may be necessary.
Slovenian: V drugih okoliščinah utegnejo biti potrebne dodatne levkafereze.
English: Remove the needle and let go of your skin.
Slovenian: Odstranite iglo in spustite kožo.
English: If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections.
Slovenian: Če zdravilo prejemate v obliki subkutane injekcije, vam bo zdravnik morda predlagal, da se naučite, kako si injekcijo date sami.
English: See section 2 “What you need to know before you use Grastofil”.
Slovenian: Glejte poglavje 2 "Kaj morate vedeti, preden boste uporabili zdravilo Grastofil".
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Tega zdravila se ne sme mešati z drugimi zdravili, razen s tistimi, navedenimi v poglavju 6.6. 6.3 Rok uporabnosti
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljeno takoj, je za čas shranjevanja med uporabo in razmere pred uporabo odgovoren uporabnik, ta čas pa običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je redčenje potekalo v nadzorovanih in validiranih aseptičnih pogojih.
English: These collected cells are given back to you after you receive very high doses of treatment for cancer to make your blood counts get back to normal more quickly.
Slovenian: Tako odvzete celice vam bodo vrnjene po tem, ko boste prejeli zelo velike odmerke zdravila za raka, da bi se število krvnih celic hitreje vrnilo na normalne vrednosti.
English: Subcutaneous and intravenous use.
Slovenian: za subkutano in intravensko uporabo
English: Do not remove the needle cover until you are ready to inject.
Slovenian: Ne odstranite pokrovčka igle, dokler niste pripravljeni za injiciranje.
English: These changes all reversed after discontinuation of treatment.
Slovenian: Po prenehanju zdravljenja so vse spremembe izginile.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical studies.
Slovenian: Možnih medsebojnih delovanj z drugimi hematopoetskimi rastnimi faktorji in citokini v kliničnih študijah še niso raziskovali.
English: How long will I have to take Grastofil?
Slovenian: Kako dolgo bom moral uporabljati zdravilo Grastofil?
English: Diluted filgrastim may be adsorbed to glass and plastic materials.
Slovenian: Razredčeni filgrastim se lahko adsorbira na steklene in plastične materiale.
English: The clinical relevance of this finding to multiple dose administration is not clear.
Slovenian: Klinična pomembnost tega izsledka v zvezi z večkratnimi odmerki ni jasna.
English: Leave the syringe at room temperature (15ºC to 25 ºC) for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes.
Slovenian: Pustite brizgo na sobni temperaturi (15 ºC do 25 ºC) približno 30 minut ali nežno držite napolnjeno brizgo v roki za nekaj minut.
English: Rates of generation of antibodies against filgrastim is generally low.
Slovenian: Stopnje nastanka protiteles proti filgrastimu so na splošno nizke.
English: cells/kg) or acceleration of platelet recovery to the same degree.
Slovenian: +/kg) ali za pospešitev obnove trombocitov na enako raven.
English: Push the plunger up slowly to the number (given in mL) that matches the dose of Grastofil which your doctor has prescribed.
Slovenian: Bat potisnite počasi navzgor do številke (v ml), ki ustreza odmerku zdravila Grastofil, ki vam ga je predpisal zdravnik.
English: Grastofil can be used:
Slovenian: Zdravilo Grastofil se lahko uporablja:
English: In some cases, your body may make enough neutrophils, but as a part of your treatment for cancer, your doctor may want to increase the number of certain blood cells (CD34 cells) and collect them.
Slovenian: V nekaterih primerih telo morda tvori dovolj nevtrofilcev, vendar želi zdravnik kot del zdravljenja raka povečati število določenih krvnih celic (celice CD34) zaradi odvzema.
English: Yields in excess of this minimum yield appear to correlate with more rapid recovery; those below with slower recovery.
Slovenian: Zdi se, da deleži, večji od tega najmanjšega deleža, korelirajo s hitrejšo obnovo, manjši deleži pa s počasnejšo obnovo.
English: The subcutaneous route is preferred in most cases.
Slovenian: V večini primerov ima prednost subkutana uporaba.
English: • osteoporosis (bone disease),
Slovenian: • osteoporozo (bolezen kosti),
English: • increase of certain enzymes in the blood
Slovenian: • zvišane ravni nekaterih encimov v krvi
English: Some cases of splenic rupture were fatal.
Slovenian: Nekateri primeri raztrganja vranice so bili usodni.
English: This section contains information on how to give yourself an injection of Grastofil.
Slovenian: To poglavje vsebuje informacije o tem, kako si dati injekcijo zdravila Grastofil.
English: To give yourself a subcutaneous injection you will need:
Slovenian: Za samoinjiciranje subkutane injekcije boste potrebovali:
English: What should I do before I give myself a subcutaneous injection of Grastofil?
Slovenian: Kaj moram narediti, preden si dam podkožno injekcijo Grastofil?
English: Analysis includes studies involving BM transplant during this period; some studies used GM-CSF
Slovenian: Analiza vključuje študije v zvezi s presaditvijo kostnega mozga v tem časovnem obdobju; v nekaterih študijah je bila uporabljena GM-CSF
English: Remember: if you have any problems, please ask your doctor or nurse for help and advice.
Slovenian: Ne pozabite: če imate kakršne koli težave, prosite zdravnika ali medicinsko sestro za pomoč in nasvet.
English: • in patients with advanced HIV infection which will help reduce the risk of infections;
Slovenian: • pri bolnikih z napredovalo okužbo s HIV za pomoč pri zmanjšanju tveganja za okužbe;
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02
Slovenian: Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, kolonije spodbujajoči faktorji, oznaka ATC: L03AA02.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHT AND REACH OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 vloge dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
English: Only clear solutions without particles should be used.
Slovenian: Uporabljate lahko samo bistre raztopine brez delcev.
English: This leaflet was last revised in MM/YYYY
Slovenian: Navodilo je bilo nazadnje revidirano dne: MM/LLLL
English: It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Slovenian: Priporoča se, da center za odvzem krvi sistematično beleži in spremlja darovalce matičnih celic vsaj še deset let ter darovalcem tako zagotovi dolgoročno varnost.
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Slovenian: Iz študije o dajanju enkratnega odmerka obstajajo dokazi, da lahko intravenski način dajanja zdravila skrajša trajanje učinka.
English: The data in the tables below describe adverse reactions reported from clinical studies and spontaneous reporting.
Slovenian: Podatki v spodnjih preglednicah opisujejo neželene učinke, o katerih so poročali v kliničnih študijah in v spontanem poročanju.
English: • before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment.
Slovenian: • pred velikimi odmerki kemoterapije, da lahko kostni mozeg proizvaja več matičnih celic, ki jih je možno odvzeti in vam jih vrniti po zdravljenju.
English: • if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section
Slovenian: • če ste alergični na filgrastim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: If someone else is injecting you, they can also use the back of your arms.
Slovenian: Če vam nekdo drug pomaga z injiciranjem, lahko injicira tudi v zadnji del roke.
English: If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Slovenian: Če deleži celic po zgoraj navedenih merilih niso zadostni, je treba razmisliti o drugih oblikah zdravljenja, ki ne zahtevajo predhodne podpore matičnih celic.
English: Regular blood tests will be taken to monitor the number of white blood cells in your body.
Slovenian: Z rednimi krvnimi preiskavami bodo spremljali število belih krvnih celic v telesu.
English: There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Slovenian: Ni nobenih dokazov za to, da bi pri bolnikih, okuženih s HIV, zdravljenje s filgrastimom povzročilo povečanje replikacije HIV.
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Slovenian: V nekaterih primerih so se simptomi med ponovno uporabo ponovili, kar nakazuje vzročno povezavo.
English: Κορίνθου 12, Ν. Ψυχικό, 15451, Αθήνα Telephone +30/2106776550
Slovenian: Κορίνθου 12, Ν. Ψυχικό, 15451, Αθήνα Τηλ:+30/2106776550
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Slovenian: Izbira metode izplavljanja je odvisna od splošnih ciljev zdravljenja pri posameznem bolniku.
English: The recommendation of a minimum yield of ≥ 2.0 x 10
Slovenian: Najmanjši priporočeni delež ≥ 2,0 x 10
English: Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).
Slovenian: Zdravnik bo morda redno opravljal preiskave urina, če se pri vas pojavlja ta neželeni učinek ali če v urinu odkrije beljakovine (proteinurija).
English: The best places to inject are the top of the thighs and the abdomen.
Slovenian: Najboljši mesti za injiciranje sta zgornji del stegen in trebuh.
English: The degree of variation between individual patients and between laboratory assays of CD34
Slovenian: Delež odstopanja med posameznimi bolniki in med laboratorijskimi testi za celice CD34
English: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Shranjujte v hladilniku (2 ºC-8 ºC).
English: Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemias, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Slovenian: Po uveljavljeni kemoterapiji za trdne tumorje, limfome in pri limfoidni levkemiji se pričakuje, da bo trajanje zdravljenja, če želimo doseči zahtevane kriterije, do 14 dni.
English: Do not rub the injection site.
Slovenian: Ne drgnite na mestu injiciranja.
English: In clinical studies in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Slovenian: V kliničnih študijah z bolniki z rakom je bila mišično-skeletna bolečina blaga ali zmerna pri 10 % in huda pri 3 % bolnikov.
English: Filgrastim should be discontinued and appropriate treatment given.
Slovenian: Z uporabo filgrastima je treba prenehati in uvesti ustrezno zdravljenje.
English: Absolute neutrophil count (ANC)
Slovenian: Absolutno število nevtrofilcev (ANC)
English: A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection.
Slovenian: Število belih krvnih celic se lahko zmanjša (nevtropenija) iz več razlogov, povzroči pa manjšo sposobnost telesa za boj proti okužbam.
English: For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
Slovenian: Pri bolnikih, pri katerih se ni izvajala obsežna kemoterapija, pogosto zadošča ena levkafereza.
English: If you develop or are likely to develop cancers of the blood, you should not use Grastofil, unless instructed by your doctor.
Slovenian: Če se pri vas razvije krvni rak ali je verjetno, da se bo, zdravila Grastofil ne smete uporabljati, razen če vam tako naroči vaš zdravnik.