natgillin/translations-raw huggingface dataset:
Proportion of patients achieving < 50 copies/ ml at Week 48 by subgroup (pooled Studies MOTIVATE 1 and MOTIVATE 2, ITT)
Delež bolnikov, ki so po 48 tednih dosegli < 50 kopij/ ml po podskupinah (kumulativno za študiji MOTIVATE 1 in MOTIVATE 2, ZNZ – z namenom zdravljenja, ang.
Metabolism: studies in humans and in vitro studies using human liver microsomes and expressed enzymes have demonstrated that maraviroc is principally metabolized by the cytochrome P450 system
Študije pri človeku ter in vitro študije s človeškimi jetrnimi mikrosomi in eksprimiranimi encimi so pokazale, da se maravirok presnavlja predvsem s sistemom citokroma P450 v presnovke, ki so v bistvu neaktivni proti HIV- 1.
31 Repeated dose toxicity studies in rats identified the liver as the primary target organ for toxicity (increases in transaminases, bile duct hyperplasia, necrosis).
Študije toksičnosti pri ponavljajočih se odmerkih pri podganah so pokazale, da so jetra primarni tarčni organ za toksičnost (zvišanje transaminaz, hiperplazija žolčevodov, nekroza).
Other developmental parameters of these offspring, including fertility and reproductive performance, were not affected by the maternal administration of maraviroc.
35 6.
Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous Sodium starch glycolate Magnesium stearate
Mikrokristalna celuloza, Brezvodni kalcijev hidrogenfosfat Natrijev karboksimetilškrob Magnezijev stearat
32 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
33 ANNEX II
37 DODATEK II
Gödecke GmbH Mooswaldallee 1 79090 Freiburg Germany
Gödecke GmbH Mooswaldallee 1 79090 Freiburg Nemčija
The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora pred prihodom zdravila na trg in dokler bo zdravilo na trgu in v uporabi zagotoviti vzpostavitev in delovanje sistema farmakovigilance, kot je opisan v verziji 1. 1v Modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom.
Risk Management plan
Načrt obvladovanja tveganja
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne dejavnosti, ki so opisane v Farmakovigilančnem načrtu, kot je predložen v verziji 1. 4 Načrta obvladovanj tveganja v Modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom ter skladno s kasnejšimi dopolnitvami ki jih je potrdil Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s Smernicami za sisteme obvladovanja tveganja pri zdravilih za uporabo v humani medicini Odbora za zdravila za uporabo v humani medicini (CHMP) je treba dopolnjen Načrt obvladovanja tveganja predložiti hkrati z naslednjim Periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Dodatno je treba dopolnjen Načrt obvladovanja tveganja predložiti • kadar so na voljo novi podatki, ki vplivajo na trenutno Specifikacijo varnosti, Farmakovigilančni načrt ali dejavnosti za zmanjševanje tveganja • v roku 60 dni od pomembne prelomnice (v zvezi s farmakovigilanco ali z zmanjševanjem tveganja) • na zahtevo EMEA
35 ANNEX III
39 DODATEK III
37 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
41 PODATKI NA ZUNANJI OVOJNINI
Bottle label - 150 mg film-coated tablets
Nalepka za plastenko – 150 mg filmsko obložene tablete
Contains soya lecithin: see the package leaflet for further information.
Vsebuje sojin lecitin: za dodatne informacije glejte navodilo za uporabo.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF REACH AND SITE OF CHILDREN
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
EXP {MM-YYYY}
{MM/ LLLL}
Pfizer Limited Ramsgate Road Sandwich CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Velika Britanija
39 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
43 PODATKI NA ZUNANJI OVOJNINI
Bottle label - 300 mg film-coated tablets
Nalepka za plastenko – 300 mg filmsko obložene tablete
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
45 PODATKI NA ZUNANJI OVOJNINI
30 film-coated tablets 60 film-coated tablets 90 film-coated tablets Multipack containing 180 (2 packs of 90) film-coated tablets
30 filmsko obloženih tablet 60 filmsko obloženih tablet 90 filmsko obloženih tablet Dvojno pakiranje s 180 (2 pakiranji po 90) filmsko obloženimi tabletami
Sealed pack Do not use if box has been opened
Če so vidni znaki odprtja, zdravila ne smete uporabiti.
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 PODATKI NA ZUNANJI OVOJNINI
45 PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON Multipacks of 180 (2 packs of 90 film-coated tablets) - without blue box - 150 mg film-coated tablets
49 PODATKI NA SEKUNDARNI OVOJNINI Dvojno pakiranje po 180 filmsko obloženih tablet (2 škatlici z 90 filmsko obloženimi tabletami) - brez blue box- a - 150 mg filmsko obložene tablete
Celsentri 150 mg film-coated tablets maraviroc
CELSENTRI 150 mg filmsko obložene tablete maravirok
Component of a multipack comprising 2 packs, each containing 90 film-coated tablets
Sestavni del dvojnega pakiranja iz 2 škatlic po 90 filmsko obloženih tablet
47 PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON Multipacks of 180 (2 packs of 90 film-coated tablets) - without blue box - 300 mg film-coated tablets
Dvojno pakiranje po 180 filmsko obloženih tablet (2 škatlici z 90 filmsko obloženimi tabletami) - brez blue box- a - 300 mg filmsko obložene tablete
Celsentri 300 mg film-coated tablets maraviroc
CELSENTRI 300 mg filmsko obložene tablete maravirok
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 150 mg film-coated tablets
Nalepka na zunanjem ovoju dvojnega pakiranja po 180 filmsko obloženih tablet (2 škatlici z 90 filmsko obloženimi tabletami), ki je ovito v prozorno folijo - vključno z blue box- om - 150 mg filmsko obložene tablete
Multipack comprising 2 packs, each containing 90 film-coated tablets
Dvojno pakiranje iz 2 škatlic po 90 filmsko obloženih tablet
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 300 mg film-coated tablets
Nalepka na zunanjem ovoju dvojnega pakiranja po 180 filmsko obloženih tablet (2 škatlici z 90 filmsko obloženimi tabletami), ki je ovito v prozorno folijo - vključno z blue box- om - 300 mg filmsko obložene tablete
53 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
57 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Blister Pack of 10 x 150 mg maraviroc film-coated tablets
Pretisni omot za 10 filmsko obloženih tablet po 150 mg
Pfizer (logo)
Pfizer (kot logo imetnika dovoljenja za promet)
54 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
58 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Blister Pack of 10 x 300 mg maraviroc film-coated tablets
Pretisni omot za 10 filmsko obloženih tablet po 300 mg
INFORMATION FOR THE USER
60 NAVODILO ZA UPORABO
please tell your doctor or your pharmacist.
omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What CELSENTRI is and what it is used for 2.
Kaj je zdravilo CELSENTRI in za kaj ga uporabljamo 2.
Before you take CELSENTRI 3.
Kaj morate vedeti, preden boste vzeli zdravilo CELSENTRI 3.
How to take CELSENTRI 4.
Kako jemati zdravilo CELSENTRI 4.
How to store CELSENTRI 6.
Shranjevanje zdravila CELSENTRI 6.
WHAT CELSENTRI IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CELSENTRI IN ZA KAJ GA UPORABLJAMO
CELSENTRI is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus type-1 (HIV-1) infection.
Zdravilo CELSENTRI je protiretrovirusno zdravilo, ki ga uporabljamo za zdravljenje okužbe z virusom humane imunske pomanjkljivosti tipa 1 (HIV- 1).
Its active ingredient, maraviroc, belongs to a group of medicines called CCR5 antagonists.
Zdravilna učinkovina, maravirok, sodi v skupino zdravil, imenovanih antagonisti CCR5.
CELSENTRI prevents the entry of HIV-1 into the cells in your blood that are attacked by HIV (called CD4 or T-cells).
Zdravilo CELSENTRI prepreči vstop virusa HIV- 1 v krvne celice, ki jih je napadel virus HIV (t. i. celice CD4 ali celice T).
CELSENTRI works by blocking a receptor called CCR5 that HIV use to gain entry into these cells.
Zdravilo CELSENTRI deluje tako, da blokira receptor CCR5, ki ga virus HIV uporablja za vstopanje v te celice.
CELSENTRI reduces the amount of HIV in your body and enhances your immune system.
Zdravilo CELSENTRI zmanjša količino virusa HIV v telesu in okrepi imunski sistem.
2 BEFORE YOU TAKE CELSENTRI
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO CELSENTRI
Do not take CELSENTRI if you are allergic (hypersensitive) to maraviroc or to peanut or soya or to any of the other ingredients of CELSENTRI (see section 2, Important information about some of the ingredients of CELSENTRI).
Ne jemljite zdravila CELSENTRI če ste alergični na (preobčutljivi za) maravirok ali arašide ali sojo oziroma katerokoli sestavino zdravila CELSENTRI (glejte poglavje 2, Pomembne informacije o nekaterih sestavinah zdravila CELSENTRI).
Take special care with CELSENTRI:
Bodite posebno pozorni pri uporabi zdravila CELSENTRI:
Your doctor must take blood samples to test whether CELSENTRI is an appropriate treatment for you.
Zdravnik vam bo morda vzel kri za preiskave, s katerimi bo ugotovil, ali je CELSENTRI za vas primerno zdravilo.
Before taking this medicine, make sure that your doctor knows if you:
Preden začnete uporabljati to zdravilo, morate zdravniku povedati, če:
• have problems with your liver including chronic hepatitis B or C as there is only limited experience in patients with liver problems.
• imate težave z jetri, vkjučno s kroničnim hepatitisom B ali C, saj so izkušnje z uporabo pri bolnikih z okvarami jeter omejene.
If you notice symptoms of hepatitis (loss of appetite, fever, feeling sick/ being sick and/ or yellowing of skin or eyes), rash and/ or itching, you should stop taking CELSENTRI and inform your doctor immediately.
Če opazite simptome hepatitisa (izguba apetita, povišana telesna temperatura, slabost s siljenjem na
57 • have or previously had low blood pressure and/ or if you are taking any medicines to lower blood pressure
• imate ali ste kdaj imeli nizek krvni tlak in/ ali jemljete kakšna zdravila za zniževanje krvnega tlaka
• have tuberculosis or serious fungal infections as due to the way CELSENTRI works on certain immune cells, CELSENTRI could potentially increase the risk of developing infections.
• imate tuberkulozo ali hudo glivično okužbo, saj lahko zdravilo CELSENTRI zaradi svojega delovanja na določene celice imunskega sistema poveča tveganje za razvoj okužb.
• have or previously had any kidney problems particularly if you are taking certain antibiotics (clarithromycin, telithromycin, antifungal medicines (ketoconazole, itraconazole) and/ or protease inhibitors (except for tipranavir/ ritonavir)
• če imate ali ste kdaj imeli težave z ledvicami, še posebej če jemljete določene antibiotike (klaritromicin, telitromicin), protiglivična zdravila (ketokonazol, itrakonazol) in/ ali zaviralce proteaz (razen tipranavirja/ ritonavirja)
• have problems with your heart or circulatory system as there is only limited experience in patients with serious problems of this type.
• če imate težave s srcem ali obtočili, saj so izkušnje z uporabo pri bolnikih s takšnimi težavami omejene
It is not known if CELSENTRI works in children.
Ni znano, če zdravilo CELSENTRI deluje pri otrocih.
Therefore CELSENTRI is not recommended for use in children.
Uporaba zdravila CELSENTRI pri otrocih torej ni priporočljiva.
CELSENTRI is not a cure for HIV infection or AIDS (advanced HIV infection).
Zdravilo CELSENTRI ne ozdravi okužbe s HIV ali aidsa (napredovale okužbe s HIV).
CELSENTRI does not reduce the risk of passing HIV to others through sexual contact, sharing needles or exposure to your blood.
Zdravilo CELSENTRI tudi ne zmanjša tveganja za prenos HIV na druge s spolnim stikom, souporabo injekcijskih igel ali z izpostavljenostjo vaši krvi.
It is important to continue to take appropriate precautions to prevent passing HIV to others.
Pomembno je, da nadaljujete z ustreznimi previdnostnimi ukrepi, da bi preprečili prenos HIV na druge.
In some patients with AIDS and a history of opportunistic infection (an infection that can occur when your immune system is impaired), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Nekaterim bolnikom z aidsom, ki so v preteklosti imeli kakšno oportunistično okužbo (okužbo, ki se pojavi, če je imunski sistem prizadet), se lahko kmalu po začetku zdravljenja proti HIV pojavijo znaki in simptomi vnetja zaradi prejšnjih okužb.
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Domnevno so ti simptomi posledica izboljšanja telesnega imunskega sistema; to izboljšanje telesu omogoči, da se spopade z okužbami, ki so bile dotlej morda prisotne brez očitnih simptomov.
If you notice any symptoms of infection, please inform your doctor immediately.
Če opazite kakršnekoli simptome okužbe, o tem nemudoma obvestite svojega zdravnika.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Pri nekaterih bolnikih, ki prejemajo kombinirano protiretrovirusno zdravljenje, se lahko pojavi bolezen kosti, imenovana osteonekroza (odmrtje kostnega tkiva zaradi prekinjene oskrbe kosti s krvjo).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Med mnogimi dejavniki tveganja za razvoj te bolezni so med drugim tudi dolžina trajanja kombiniranega protiretrovirusnega zdravljenja, uporaba kortikosteroidov, uživanje alkohola, hudo zavrtje imunskega sistema ter višji indeks telesne mase.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Znaki osteonekroze so togost sklepov, bolečine (posebej v kolkih, kolenih in ramenih) in težave pri gibanju.
If you notice any of these symptoms please inform your doctor.
Če opazite kakšnega od teh simptomov, obvestite svojega zdravnika.
Please tell your doctor and your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.
Some medicines may affect the levels of CELSENTRI in the body when they are taken at the same time as CELSENTRI.
Nekatera zdravila lahko vplivajo na količino zdravila CELSENTRI v telesu, če jih vzamete sočasno.
Therefore the dose of CELSENTRI may need to be adjusted.
Torej bo odmerek zdravila CELSENTRI morda treba prilagoditi.
Tell your doctor if you are taking any medicines including other medicines to treat HIV infection (e. g. efavirenz, lopinavir, saquinavir, darunavir, atazanavir, nelfinavir, indinavir), antibiotics (clarithromycin, telithromycin, rifampicin) and antifungal medicines (ketoconazole, itraconazole).
Svojemu zdravniku povejte, če jemljete katerakoli zdravila, vključno z drugimi zdravili za zdravljenje okužbe s HIV (npr. efavirenz, lopinavir, sakvinavir, darunavir, atazanavir, nelfinavir, indinavir), antibiotike (klaritromicin, telitromicin, rifampicin) in protiglivična zdravila (ketokonazol, itrakonazol).
This will allow your doctor to prescribe the most appropriate dose of CELSENTRI for you.
Tako vam bo lahko zdravnik predpisal odmerek zdravila CELSENTRI, ki bo za vas najprimernejši.
John’ s wort (Hypericum perforatum) are likely to prevent CELSENTRI from working properly and should not be taken together with CELSENTRI.
Zdravila, ki vsebujejo šentjanževko (Hypericum perforatum), lahko vplivajo na učinek zdravila CELSENTRI in se jih ne sme jemati sočasno z zdravilom CELSENTRI.
58 Taking CELSENTRI with food and drink
62 Jemanje zdravila CELSENTRI skupaj s hrano in pijačo
CELSENTRI can be taken with or without food.
Zdravilo CELSENTRI lahko vzamete s hrano ali brez nje.
Tell your doctor if you are pregnant, planning to become pregnant or become pregnant whilst taking this medicine.
Zdravniku morate povedati, če ste noseči, če nameravate zanositi ali če zanosite med jemanjem tega zdravila.
If you are pregnant, CELSENTRI should only be taken after careful discussion with your doctor.
Če ste noseči, smete zdravilo CELSENTRI jemati le po natančnem pogovoru z vašim zdravnikom.
The safe use of CELSENTRI in pregnancy has not been established.
Varnost uporabe zdravila CELSENTRI med nosečnostjo ni ugotovljena.
It is not known whether the active ingredient in CELSENTRI can pass into your breast milk.
Ni znano, ali učinkovina zdravila CELSENTRI prehaja v materino mleko.
Therefore, mothers should not breast-feed during treatment with CELSENTRI.
Zato ženske med zdravljenjem z zdravilom CELSENTRI ne smejo dojiti.
In general, women infected with HIV should not breast-feed because the virus may be transmitted through the breast milk.
Na splošno je priporočljivo, da ženske, okužene s HIV, ne dojijo, ker se virus lahko prenese z materinim mlekom.
Important information about some of the ingredients of CELSENTRI
Pomembne informacije o nekaterih sestavinah zdravila CELSENTRI
HOW TO TAKE CELSENTRI
KAKO JEMATI ZDRAVILO CELSENTRI
Always take CELSENTRI exactly as your doctor has instructed.
Natančno upoštevajte zdravnikova navodila.
You should check with your doctor or pharmacist if you are not sure how to take CELSENTRI.
Če ste negotovi glede uporabe zdravila CELSENTRI, se posvetujte z zdravnikom ali s farmacevtom.
You should continue to take CELSENTRI for as long as instructed by your doctor.
Zdravilo CELSENTRI jemljite toliko časa, kot vam je naročil zdravnik.
If you accidentally take more than the prescribed dose of CELSENTRI, contact your doctor or the nearest hospital right away.
Če pomotoma vzamete odmerek zdravila CELSENTRI, večji od predpisanega, se nemudoma posvetujte s svojim zdravnikom ali najbližjo bolnišnico.
When you get up, do so as slowly as possible.
Ko boste vstali, to storite karseda počasi.
59 If you forget to take CELSENTRI
Če ste pozabili vzeti zdravilo CELSENTRI
If it is almost time for your next dose, do not take the missed dose.
Če pa je že skoraj čas za naslednji odmerek, ne
It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your antiretroviral medicines.
Dokazano je, da lahko redno jemanje zdravila, brez izpuščanja odmerkov, ter jemanje ob pravem času močno izboljša učinkovitost kombinacije protiretrovirusnih zdravil, ki jo uporabljate.
Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking CELSENTRI correctly, as described above.
Zato je pomembno, da zdravilo CELSENTRI jemljete pravilno, tako kot je opisano zgoraj, razen če vam zdravnik naroči, da morate zdravljenje prekiniti.
If you have any further questions on the use of this product, ask your doctor or your pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
Like all medicines, CELSENTRI can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo CELSENTRI neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
When treating HIV infection, it is not always easy to identify what side effects are caused by CELSENTRI, by the other medicines you are taking, or by the HIV infection itself.
Pri zdravljenju okužbe s HIV ni vedno lahko ugotoviti, katere neželene učinke povzročajo zdravilo CELSENTRI ali druga zdravila, ki jih jemljete, in katere povzroča okužba s HIV sama.
A very common side-effect (likely to occur in more than 1 in 10 patients) is feeling sick.
Zelo pogost neželeni učinek (ki se lahko pojavi pri več kot 1 od 10 bolnikov) je slabost.
Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Pogosti neželeni učinki (ki se lahko pojavijo pri manj kot 1 od 10 bolnikov) so:
• diarrhoea, being sick (vomiting), stomach ache, feeling bloated, indigestion, constipation, weight loss • headache, dizziness, abnormal sense of taste, sleepiness, problems sleeping, abnormal sensations in the body such as pins and needles • rash, itching, muscle spasms, back pain, feeling weak, cough • increased levels of substances that measure the function of the liver and pancreas.
• driska, bruhanje, bolečine v želodcu, občutek napihnjenosti, prebavne težave, zaprtje, izguba telesne mase • glavobol, omotica, moteno okušanje, zaspanost, težave s spanjem, nenormalni občutki po telesu, kot npr. mravljinčenje • izpuščaj, srbenje, mišični krči, bolečina v hrbtu, občutek slabotnosti, kašelj • zvišane ravni snovi, ki so merila delovanja jeter in trebušne slinavke.
These can be seen in the results of blood tests and can be a sign of reduced function or damage of these organs.
To se vidi v rezultatih preiskav krvi in je lahko znak zmanjšanega delovanja ali okvare teh organov.
If you experience symptoms, such as loss of appetite, feeling sick/ being sick and/ or yellowing of skin or eyes, you should inform your doctor.
Če se vam pojavijo simptomi, kot so izguba apetita, slabost ali bruhanje in/ ali porumenelost kože ali očesnih beločnic, morate obvestiti svojega zdravnika.
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
Občasni neželeni učinki (ki se lahko pojavijo pri manj kot 1 od 100 bolnikov) so:
• reduction in number of white and red blood cells, enlarged lymph glands, heart attack, reduced blood flow to the heart • inflammation of the pancreas, rectal bleeding, liver disease, muscle aches and pains • fainting, epilepsy, fits, inability to move the muscles in the face, tingling or burning sensation in the hands or feet, loss of reflexes, hallucination • kidney failure, producing more urine than normal • pneumonia, breathing difficulties such as shortness of breath.
• zmanjšanje števila belih in rdečih krvnih celic, povečanje bezgavk, srčni infarkt, zmanjšan pretok krvi skozi srčno mišico • vnetje trebušne slinavke, krvavitev iz danke, bolezen jeter, bolečine v mišicah • omedlevica, epilepsija, napadi krčev, nezmožnost za gibanje mišic obraza, mravljinčenje ali pekoč občutek v rokah ali stopalih, izguba refleksov, halucinacije • odpoved ledvic, izločanje več urina kot ponavadi • pljučnica, težave z dihanjem, npr. kratka sapa
HOW TO STORE CELSENTRI
SHRANJEVANJE ZDRAVILA CELSENTRI
• Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label.
• Zdravila CELSENTRI ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu ali nalepki plastenke.
60 • This medicine does not require any special storage conditions.
64 • Za shranjevanje zdravila niso potrebna posebna navodila.
Medicines should not be disposed of via wastewater or household waste.
• Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What CELSENTRI contains
Kaj vsebuje zdravilo CELSENTRI