natgillin/translations-raw huggingface dataset:
EU/1/08/450/003 2 x 5 pre-filled syringes 
ŠTEVILKA (E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/450/003 2 x 5 napolnjenih injekcijskih brizg
During intermittent dosing with 30 MIU (300 μg)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time. 
(300 μg)/dan, so čez čas lahko opazna velika nihanja v absolutnem številu nevtrofilcev.
Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below. 
Če ni razredčen v skladu s spodnjimi navodili, se razredčen filgrastim lahko adsorbira na steklene in plastične materiale.
Special precautions in sickle cell disease 
Posebni previdnostni ukrepi pri bolnikih s srpasto anemijo
EXP After dilution use within 24 hours. 
Po redčenju je zdravilo uporabno še 24 ur.
Hold the syringe and gently take the cover from the needle without twisting. 
Pred injiciranjem zdravila Biograstim morate narediti naslednje: Primite injekcijsko brizgo ter nežno in brez sukanja potegnite pokrovček z igle.
Special precautions in cancer patients Leukocytosis 
Posebni previdnostni ukrepi pri bolnikih z rakom
EXPIRY DATE 
Pogosti diareja
Initial dose adjustment to alternate day dosing with 30 MIU (300 μg)/day by subcutaneous injection is recommended. 
Priporoča se prilagoditev dnevnega odmerka v vrednosti 30 x 106i.e.
Your doctor will test your blood daily to see how well the treatment is working and to find the dose that is best for you. 
Zato da bi ugotovil, kako dobro deluje zdravljenje in kakšen odmerek je najbolj primeren za vas, bo vaš zdravnik vsak dan analiziral vašo kri.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
In patients with severe chronic neutropenia (SCN) Congenital neutropenia 
Posebni previdnostni ukrepi pri bolnikih s hudo kronično nevtropenijo
Neutrophil count 
Število nevtrofilcev
Do not attempt to self-administer without this training. 
Brez napotkov zdravnika ali sestre si ne poskušajte zdravila odmeriti sami.
Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i.e. platelets consistently < 100,000/mm 
Pri bolnikih, pri katerih pride do trombocitopenije, kar pomeni, da je število trombocitov stalno < 100.000/mm3, je potrebno razmisliti o začasni prekinitvi zdravljenja ali o zmanjšanju odmerka filgrastima.
The recommendation of a minimum yield of 2.0 x 10 
Priporočen začetni odmerek je 1,2 x 106i.e.
Water for injections 
Napolnjena injekcijska brizga
Urinary abnormalities 
Kongenitalna nevtropenija
9/L during the treatment period the dose of filgrastim should be reescalated according to the above steps 
Če se med zdravljenjem absolutno število nevtrofilcev zmanjša, tako da je vrednost < 1,0 x 109/l, je treba odmerek filgrastima povečati, kot je opisano zgoraj.
Filgrastim should be administered daily by subcutaneous injection until the neutrophil count has 
Filgrastim je potrebno odmerjati dnevno v obliki subkutanih injekcij, dokler število nevtrofilcev ne doseže in ostane večje od 1,5 x 109/l.
Meta-analysis a 
1986-2001a
Transient thrombocytopenia (platelets < 100 x 10 leukapheresis was observed in 35 % of subjects studied. 
Levkocitozo (število belih krvničk > 50 x 109/l) so opazili pri 41 % darovalcev, prehodno trombocitopenijo (število trombocitov < 100 x 109/l) pa pri 35 % darovalcev po odmerjanju filgrastima in po levkaferezi.
Vascular disorders 
Navodila za samoinjiciranje
Transformation to leukaemia or myelodysplastic syndrome 
Neželeni učinek anemija, splenomegalija trombocitopenija
9/L to > 5.0 x 10 
Zmanjšajte na 0,5 x 106i.e.
Your doctor will decide how many days treatment is needed. 
Zdravnik bo odločil koliko dni zdravljenja potrebujete.
An updated RMP should be submitted: 
Posodobljen RMP je treba predloţ iti:
Resistant (R >) 
Odporen (R >)
• If you are a child or growing adolescent below 18 years of age. 
• Če ste otrok ali mladostnik, mlajši od 18 let.
There is limited experience in patients aged > 75 years. 
Izkušnje pri bolnikih, starih> 75 let, so omejene.
• Feeling tired 
• občutek utrujenosti
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Zdravila se ne sme mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
• Change in taste 
• spremembe v okusu
The total duration of treatment is 5 to 14 days. 
Celotno trajanje zdravljenja je od 5 do 14 dni.
Clinical efficacy against specific pathogens 
Klinična učinkovitost proti specifičnim patogenim organizmom
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). 
Pogostnosti so opredeljene 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).
(Any unused portion of the reconstituted solution should be discarded). 
(Neuporabljen del rekonstituirane razopine je potrebno zavreči).
Each infusion will last about an hour. 
Vsaka aplikacija infuzije bo trajala pribliţ no eno uro.
• Blood in urine 
• kri v urinu
If less than 8 hours remain before the next dose, wait until the next scheduled dose. 
Če je manj kot 8 ur do naslednjega odmerka, počakajte do naslednjega odmerka.
• Ringing or buzzing in the ears (tinnitus) 
• zvenenje ali piskanje v ušesih (tinitus)
• You have diabetes. 
• imate sladkorno bolezen.
The requirements for submission of PSURs 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. 
Zahteve glede predloţ itve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
These may be signs and symptoms of a hypersensitivity (allergic) reaction and may be life-threatening. 
To so lahko znaki in simptomi preobčutljivostne (alergijske) reakcije in so lahko smrtno nevarni.
The following information is intended for healthcare professionals only: For single use only. 
Naslednje informacije so namenjene samo zdravstvenemu osebju:
• If you are pregnant, might become pregnant, or think you might be pregnant. 
• Če ste noseči, načrtujete zanositev ali menite, da bi lahko bili noseči.
In those cases your doctor will consider if this treatment is the best option for you. 
V teh primerih bo zdravnik presodil, ali je to zdravljenje za vas najboljša moţ nost.
Children or growing adolescents below 18 years of age (see section 4.2). 
Otroci ali mladostniki, mlajši od 18 let (glejte poglavje 4.2).
This medicine must not be used in children and adolescents, as it has not been studied enough in these groups. 
Tega zdravila se ne sme uporabljati pri otrocih in mladostnikih, ker pri tej populaciji ni bilo dovolj raziskano.
Via Sette Santi 3, 50131 Florence, Italy 
Via Sette Santi 3, 50131 Florence, Italija
• Hearing things that do not exist (auditory hallucination) 
• slišimo stvari, ki jih v resničnem svetu ni (slušne halucinacije)
Clinical response to treatment and renal function should be closely monitored in these patients. 
Klinični odziv na zdravljenje in delovanje ledvic je pri teh bolnikih potrebno natančno spremljati.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
O neţ elenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neţ elenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila
• You have a myasthenia gravis (a type of muscle weakness), because symptoms can become worse. 
• imate miastenijo gravis (vrsta mišične oslabelosti), saj se simptomi lahko poslabšajo.
Other side effects may include: 
Drugi neţ eleni učinki lahko vključujejo:
It works by blocking bacteria enzymes needed to copy and to repair their DNA. 
Deluje z blokiranjem encimov bakterij, potrebnih za kopiranje in popravilo njihovih DNK.
Treatment of overdose with delafloxacin should consist of observation and general supportive measures. 
Zdravljenje prevelikega odmerka delafloksacina mora vključevati opazovanje in splošne podporne ukrepe.
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for delafloxacin are as follows: 
Mejne vrednosti minimalne inhibitorne koncentracije (MIK), kot jih je ugotovil Evropski odbor za testiranje protimikrobne občutljivosti (EUCAST - European Committee on Antimicrobial Susceptibility Testing), so kot sledi:
Therefore, concomitant use of corticosteroids should be avoided. 
Sočasni uporabi kortikosteroidov se je zato potrebno izogibati.
From a microbiological point of view, the product should be used immediately after reconstitution and dilution. 
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji in razredčenju.
It belongs to a group of medicines called fluoroquinolones. 
Spada v skupino zdravil, imenovanih fluorokinoloni.
Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Quofenix affects you. 
Ne vozite, ne upravljajte s stroji in ne izvajajte drugih dejavnosti, ki zahtevajo mentalno pozornost ali koordinacijo, dokler ne veste, kakšen vpliv ima na vas zdravilo Quofenix.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. 
Poročanje o domnevnih neţ elenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
See the end of section 4 for how to report side effects. 
Glejte na koncu poglavja 4, kako poročati o neţ elenih učinkih.
Hyperhidrosis Cold sweat Night sweat 
Hiperhidroza Hladen znoj Nočno znojenje
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloţ enem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
• The vial should be vigorously shaken until contents are completely dissolved. 
• Vialo je treba močno stresati, dokler se vsebina popolnoma ne raztopi.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi to zdravilo neţ elene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Pack-size: 10 vials. 
Velikost pakiranja: 10 vial.
Do not take any medicine to treat your diarrhoea without first checking with your doctor. 
Ne jemljite nobenega zdravila za zdravljenje diareje, ne da bi se prej posvetovali z zdravnikom.
SX Via Morolense 5 03013 Ferentino (FR) Italy or 
SX Via Morolense 5 03013 Ferentino (FR) Italija ali
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil doseţ en pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Delafloxacin is a probable substrate of BCRP. 
Delafloksacin je verjetno substrat BCRP.
Excipient(s) with known effect: 
Pomoţ na(e) snov(i) z znanim učinkom:
• You are suffering from diarrhoea, or have previously suffered from diarrhoea while taking antibiotics or up to 2 months afterwards. 
• imate diarejo ali ste imeli diarejo med jemanjem antibiotikov ali do 2 meseca po jemanju.
Chemical and physical in-use stability has been demonstrated for 24 hours at 20 to 25ºC or at 2 to 8°C. 
Kemično in fizikalno stabilnost med uporabo so dokazovali 24 ur pri temperaturah 20 do 25 °C ali pri 2 do 8 °C.
• Dizziness or loss of balance (vertigo) 
• omotičnost ali izguba ravnoteţja (vrtoglavica)
Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake »EXP«.
Delafloxacin pharmacokinetic is comparable in patients with ABSSSI and healthy volunteers. 
Farmakokinetika delafloksacina je primerljiva pri bolnikih z ABSSSI in zdravimi prostovoljci.
• Cloudy urine because of the presence of solid component 
• moten urin zaradi prisotnosti trdih delcev
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 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions. 
Če se ne uporabi takoj, so čas in pogoji shranjevanja pred uporabo odgovornost uporabnika in običajno ne smejo biti daljši od 24 ur pri 2 do 8 °C, razen če je bila rekonstitucija in redčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population. 
V epidemioloških študijah so poročali o povečanem tveganju za aortno anevrizmo in disekcijo po vnosu fluorokinolonov, zlasti pri starejši populaciji.
• You had sometimes long treatment with antibiotics; it can mean that you get another infection caused by other bacteria (superinfection) which cannot be treated by the antibiotic. 
• ste prejeli dolgotrajno zdravljenje z antibiotiki, saj to lahko pomeni, da se bo pojavila še druga okuţ ba, ki jo povzroča bakterija, ki je ta antibiotik ne bo ozdravil (superinfekcija).
If this happens, stop taking Quofenix and inform your doctor immediately in order to prevent the development of potentially irreversible condition. 
Če se to zgodi, prenehajte z jemanjem zdravila Quofenix in o tem takoj obvestite svojega zdravnika, da preprečite razvoj potencialno nepovratnega stanja.
• Swollen, red, irritated veins 
• otečene, rdeče, razdraţene vene
The pharmacokinetics of delafloxacin is not significantly altered with age; therefore, dose adjustment is not necessary based on age. 
Farmakokinetika delafloksacina se ne spreminja pomembno glede na starost, zato prilagoditve odmerjanja glede na starost niso potrebne.
Administration of oral delafloxacin in patients with severe renal impairment and low body weight may lead to increased systemic exposures. 
Apliciranje peroralnega delafloksacina pri bolnikih s hudo okvaro ledvic in nizko telesno maso lahko povzroči povečano sistemsko izpostavljenost.
Quofenix tablets should be taken at least 2 hours before or 6 hours after: 
Quefenix tablete je treba vzeti najmanj 2 uri pred oziroma 6 ur po zauţ itju:
• Staphylococcus aureus (including methicillin-resistant [MRSA]) 
• Staphylococcus aureus (vključno z odpornim na meticilin [MRSA])
Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. 
Tveganje se poveča, če ste starejši (stari več kot 60 let), imate presajen organ, imate teţ ave z ledvicami ali se zdravite s kortikosteroidi.
Delafloxacin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk. 
Delafloksacin se lahko daje takim bolnikom le, če pričakujemo, da klinična korist odtehta potencialno tveganje.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovino ali katero koli pomoţ no snov, navedeno v poglavju 6.1.
There are no data available on severe cases of hypoglycaemia resulting in coma or death after delafloxacin use. 
Podatkov o hudih primerih hipoglikemije, ki je povzročila komo ali smrt po uporabi delafloksacina, ni.
The vial should be vigorously shaked until contents are completely dissolved. 
Vialo je treba močno stresati, dokler se vsebina popolnoma ne raztopi.
Fluoroquinolones have been associated with an increased risk of central nervous system (CNS) reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) and toxic psychosis. 
Fluorokinoloni so bili povezani s povečanim tveganjem za reakcije centralnega ţ ivčnega sistema (CNS - Central Nervous system), vključno s konvulzijami in zvišanim intrakranialnim tlakom (vključno s psevdotumor cerebri) in toksično psihozo.
• Feeling lightheaded or faint, usually because of a drop in blood pressure 
• občutek vrtoglavosti ali izgube zavesti, največkrat zaradi padca krvnega tlaka
Dyspnoea Cough Dry throat 
Dispneja Kašelj Suho grlo
If you might become pregnant you have to use effective contraception during treatment with Quofenix. 
Če bi lahko zanosili, morate med zdravljenjem z zdravilom Quofenix uporabljati učinkovito kontracepcijo.
Accumulation of the intravenous vehicle sulfobutylbetadex sodiumoccurs in patients with moderate to severe renal impairment; therefore serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to switch to Quofenix 450 mg tablet every 12 hours. 
Kopičenje intravenskega nosilca natrijevega sulfobutilbetaciklodekstrina se pojavi pri zmernih do hudih ledvičnih okvarah, zato je treba pri teh bolnikih skrbno spremljati ravni kreatinina v serumu, in če pride do zvišanja, je treba razmisliti o prehodu na zdravilo Quofenix 450 mg tablete vsakih 12 ur.
The effects of delafloxacin on fertility in humans have not been studied. 
Učinkov delafloksacina na plodnost pri ljudeh niso raziskali.
• If you have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic'. 
• Če ste ţe kdaj imeli teţave s tetivami, na primer tendonitisom, ki je bil povezan z zdravljenjem s kinolonskim antibiotikom.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo
Pack sizes of 10 x1, 20 x1, 30 x1, 50 x1, 60 x1 or 100 x1 tablets. 
Velikosti pakiranj po 10 x1, 20 x1, 30 x1, 50 x1, 60 x1 ali 100 x1 tablet.
Gastritis erosive 
Erozivni gastritis
Patients with glucose-6-phosphate dehydrogenase deficiency 
Bolniki s pomanjkanjem glukoza-6-fosfat dehidrogenaze
• an antacid, multivitamin, or other product that has magnesium, aluminium, iron, or zinc 
• antacidov, multivinaminov ali drugih izdelkov, ki vsebujejo magnezij, aluminij, ţelezo ali cink
If you have diabetes, you should monitor your blood glucose levels carefully. 
Če ste sladkorni bolnik, morate natančno spremljati svoje ravni glukoze v krvi.
• You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. 
• Redko se pojavijo simptomi poškodbe ţivcev (nevropatija), kot so bolečina, ţarenje, mravljinčenje, otrplost in/ali šibkost, zlasti v stopalih in nogah, dlaneh in rokah.
You will be given one infusion of Quofenix, containing 300 mg of the medicine, twice a day between 5 and 14 days at the discretion of your doctor. 
Prejeli boste eno infuzijo zdravila Quofenix, ki vsebuje 300 mg zdravila, dvakrat na dan med 5 in 14 dni, po presoji vašega zdravnika.
• didanosine buffered tablets for oral suspension or the paediatric powder for oral solution 
• didanozinijevih puferskih tablet za peroralno suspenzijo ali pediatričnega praška za peroralno raztopino
See section 4.8 for how to report adverse reactions. 
Glejte poglavje 4.8, kako poročati o neţ elenih učinkih.
Gram-positive micro-organisms: 
Grampozitivni mikroorganizmi:
It is used to treat adults with serious short-term infections of the skin and tissues under the skin caused by certain bacteria when usual antibiotics cannot be used or have not worked. 
Uporablja se za zdravljenje odraslih za kratkotrajno zdravljenje hudih okuţ b koţ e in tkiv pod koţ o, ki jih povzročajo nekatere bakterije, kadar običajnih antibiotikov ni mogoče uporabiti ali ne delujejo.
The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. 
Tveganje za tendinitis in rupturo tetive je povečano pri starejših bolnikih, bolnikih z okvaro ledvic, bolnikih s presajenimi organi in pri tistih, ki se sočasno zdravijo s kortikosteroidi.
Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones, ATC code: J01MA23 Mechanism of action 
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje bakterijskih infekcij, fluorokinoloni, Oznaka ATC: J01MA23
Aortic dissection and aneurysm 
Disekcija aorte in anevrizma
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden boste prejeli to zdravilo.
The European Medicines Agency has waived the obligation to submit the results of studies with Quofenix in all subsets of the paediatric population in the treatment of local infections of skin and subcutaneous tissues (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odloţ ila zahtevo za predloţ itev rezultatov študij z zdravilom Quofenix za vse podskupine pediatrične populacije za zdravljenje lokalne okuţ be koţ e in koţ nih struktur (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In diabetic patients, careful monitoring of blood glucose is recommended. 
Pri sladkornih bolnikih se priporoča skrbno spremljanje vrednosti glukoze v krvi.
Treatment of these patients with delafloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3). 
Zdravljenje teh bolnikov z delafloksacinom se sme uvesti le, če ni drugih moţ nosti zdravljenja in po natančni oceni koristi/tveganja (glejte tudi poglavje 4.3).
Dosing in patients with severe renal impairment (CrCl of <30 mL/min) should be decreased to 200 mg intravenously every 12 hours; alternatively patients should receive 450 mg delafloxacin orally every 12 hours (see section 4.4 and 5.2). 
Odmerek pri bolnikih s hudo ledvično okvaro (CrCl < 30 ml/min) je treba zniţ ati na 200 mg intravensko vsakih 12 ur, alternativno lahko bolniki prejemajo 450 mg delafloksacina peroralno vsakih 12 ur (glejte poglavji 4.4 in 5.2).
Clostridioides difficile-associated disease 
Bolezen povezana s Clostridioides difficile
Long-term carcinogenicity studies have not been conducted with delafloxacin. 
Dolgoročnih študij karcinogenosti z delafloksacinom niso opravili.
Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping Quofenix therapy. 
Vnetje in pretrganje tetiv se lahko pojavijo ţ e v prvih 48 urah zdravljenja, lahko pa tudi več mesecev po prenehanju zdravljenja z zdravilom Quofenix.
Please, inform your doctor or nurse immediately if you get any of these symptoms, as the medicine should be stopped and you may need urgent medical attention: 
Če opazite katerega koli od teh simptomov, nemudoma obvestite zdravnika ali medicinsko sestro, saj je treba zdravljenje prekiniti in boste morda potrebovali nujno medicinsko pomoč: