natgillin/translations-raw huggingface dataset:
The CHMP concluded that, in accordance with EU requirements, Irbesartan/Hydrochlorothiazide Teva has been shown to have comparable quality and to be bioequivalent to CoAprovel.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Irbesartan/Hydrochlorothiazide Teva primerljivo raven kakovosti kot zdravilo CoAprovel ter da mu je biološko enakovredno.
This means that Irbesartan/Hydrochlorothiazide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called CoAprovel.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu CoAprovel.
Irbesartan/Hydrochlorothiazide Teva is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Zdravilo Irbesartan/Hydrochlorothiazide Teva se uporablja pri odraslih z esencialno hipertenzijo (visokim krvnim tlakom), ki ni ustrezno uravnana z uporabo samo irbesartana ali samo hidroklorotiazida.
Because Irbesartan/Hydrochlorothiazide Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, CoAprovel.
Ker je zdravilo Irbesartan/Hydrochlorothiazide Teva generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu CoAprovel.
Irbesartan/Hydrochlorothiazide Teva is a ‘generic medicine'.
Irbesartan/Hydrochlorothiazide Teva je „generično zdravilo“.
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 Irbesartan/Hydrochlorothiazide Teva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The dose of Irbesartan/Hydrochlorothiazide Teva to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking
Odmerek zdravila Irbesartan/Hydrochlorothiazide Teva, ki naj ga bolnik uporabi, je odvisen od odmerka irbesartana ali hidroklorotiazida, ki ga je bolnik jemal pred tem.
Irbesartan/Hydrochlorothiazide Teva irbesartan and hydrochlorothiazide
Irbesartan/Hydrochlorothiazide Teva irbesartan in hidroklorotiazid
Other information about Irbesartan/Hydrochlorothiazide Teva
Druge informacije o zdravilu Irbesartan/Hydrochlorothiazide Teva
Irbesartan/Hydrochlorothiazide Teva may be added to other treatments for hypertension.
Zdravilo Irbesartan/Hydrochlorothiazide Teva se lahko uvede sočasno z drugimi načini zdravljenja hipertenzije.
What are the benefits and risks of Irbesartan/Hydrochlorothiazide Teva?
Kakšne so koristi in tveganja, povezani z zdravilom Irbesartan/Hydrochlorothiazide Teva?
The Committee recommended that Irbesartan/Hydrochlorothiazide Teva be given marketing authorisation.
Priporočil je, da se za zdravilo Irbesartan/Hydrochlorothiazide Teva izda dovoljenje za promet.
Irbesartan/Hydrochlorothiazide Teva is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Teva je zdravilo, ki vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
Irbesartan/Hydrochlorothiazide Teva contains two active substances, irbesartan and hydrochlorothiazide.
Zdravilo Irbesartan/Hydrochlorothiazide Teva vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
Why has Irbesartan/Hydrochlorothiazide Teva been approved?
Zakaj je bilo zdravilo Irbesartan/Hydrochlorothiazide Teva odobreno?
How has Irbesartan/Hydrochlorothiazide Teva been studied?
Kako je bilo zdravilo Irbesartan/Hydrochlorothiazide Teva raziskano?
What is Irbesartan/Hydrochlorothiazide Teva?
Kaj je zdravilo Irbesartan/Hydrochlorothiazide Teva?
How is Irbesartan/Hydrochlorothiazide Teva used?
Kako se zdravilo Irbesartan/Hydrochlorothiazide Teva uporablja?
What is Irbesartan/Hydrochlorothiazide Teva used for?
Za kaj se zdravilo Irbesartan/Hydrochlorothiazide Teva uporablja?
How does Irbesartan/Hydrochlorothiazide Teva work?
Kako zdravilo Irbesartan/Hydrochlorothiazide Teva deluje?
Irbesartan/Hydrochlorothiazide Teva is taken by mouth.
Zdravo Irbesartan/Hydrochlorothiazide Teva se jemlje peroralno.
Your doctor will do regular blood tests to check for any changes in:
Vaš zdravnik bo izvajal redne preiskave krvi, da bo preverjal spremembe v:
Date of latest renewal: 13 March 2006
Datum zadnjega podaljšanja: 13. marec 2006
Step 2 a.
Korak 2 a.
Children (aged 2 to 18 years)
Otroci (stari od 2 do 18 let)
Allow it to dry in the air before using it again.
Pustite, da se posuši na zraku, preden ga boste naslednjič uporabljali.
Your treatment will then continue at the normal times.
Vaše zdravljenje se bo nadaljevalo po normalnem urniku.
There are limited safety and efficacy data in children below the age of 2 years.
O varnosti in učinkovitosti pri otrocih, mlajših od dveh let, je na voljo premalo podatkov.
Your baby may be affected by one or more of these.
Vašega otroka bi lahko prizadela ena ali več od navedenih nepravilnosti.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 1996
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 14. februar 1996
Add the rest of the water.
Dodajte preostalo količino vode.
Your doctor or nurse will make up the medicine and give it to you.
Zdravnik ali medicinska sestra bosta pripravila zdravilo in vam ga dala.
Cellcept is usually given by a doctor or nurse in hospital.
Zdravilo CellCept ponavadi daje zdravnik ali medicinska sestra v bolnišnici.
Your doctor will have to advise you on which vaccines you can have.
Vaš zdravnik vam bo svetoval, katera cepiva lahko prejmete.
You will have the medicine for at least 4 days.
• Zdravilo boste prejemali vsaj 4 dni.
The educational materials shall contain the following key elements:
Izobraževalna gradiva naj vsebujejo naslednje ključne elemente:
Do not take a double dose to make up for a missed dose.
Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
If you are planning to have a child, talk to your doctor about the potential risks and alternative therapies.
Če nameravate imeti otroka, se pogovorite z zdravnikom o možnih tveganjih in drugih možnih zdravljenjih.
• Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)
• vaši jajčniki ne delujejo več (prezgodnja okvara jajčnikov, ki jo je potrdil specialist ginekolog);
Talk to your doctor about the most suitable contraception for you.
Z zdravnikom se pogovorite o izbiri kontracepcije, ki je za vas najbolj primerna.
taken twice a day.
2 g na dan.
It is available in packs of 4 vials.
• Na voljo je v pakiranju po 4 viale.
Turn the whole thing upside down (bottle and dispenser - see picture below).
Oboje skupaj obrnite na glavo (steklenico in razdelilnik - glejte spodnjo sliko).
This includes medicines obtained without a prescription, such as herbal medicines.
To vključuje zdravila, ki ste jih dobili brez recepta, kot so rastlinski pripravki.
This will be given as 1 g in the morning and then 1 g in the evening.
• Dobili boste 1 g zjutraj in 1 g zvečer.
If you feel drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines until you feel better.
Če ste zaspani, omotični ali zmedeni, se pogovorite z zdravnikom ali medicinsko sestro; ne vozite in ne uporabljate nobenega orodja ali strojev, dokler se ne počutite bolje.
If you need to do it yourself, see Section 7 “Making up the medicine”
Če ga morate pripraviti sami, glejte poglavje 7 »Priprava zdravila«.
You are a woman who is not capable of becoming pregnant if any of the following applies to you:
Med ženske, ki ne morejo zanositi, sodite, če kar koli izmed naslednjega velja za vas:
• Immediately after use - take the dispenser to pieces and rinse it under running tap water.
• Takoj po uporabi - razdelilnik razstavite in ga sperite pod tekočo vodo.
• You are a child or teenager who has not started having periods.
• ste otrok ali najstnica, ki še ni dobila prve menstruacije.
Do not use the suspension past this expiry date.
Po tem datumu suspenzije ne uporabljajte.
They will follow the instructions under Section 7 “Making up the medicine”.
Sledila bosta navodilom, ki so zapisana v poglavju 7 »Priprava zdravila«.
In addition, there have been isolated reports of the following malformations:
Dodatno so zabeležili posamezna poročila o naslednjih malformacijah:
Pull the plunger out slowly.
Počasi izvlecite bat.
Swallow your tablets whole with a glass of water.
• Pogoltnite cele tablete s kozarcem vode.
There have also been reports of bronchiectasis in children and adults.
Poročali so o primerih bronhiektazije pri otrocih in odraslih.
Preparation of suspension
Priprava suspenzije:
The amount you take depends on the type of transplant you have had.
Količina, ki jo vzamete, je odvisna od tipa presadka, ki ga imate.
the number of your blood cells or signs of infections.
• številu krvnih celic ali znake okužb.
Put the end of the dispenser directly into your mouth and swallow the medicine.
Konec razdelilnika dajte neposredno v usta in pogoltnite zdravilo.
The bottle adapter should stay in the bottle.
Nastavek za steklenico mora ostati na steklenici.
• pneumonia, bronchitis,
• pljučnica, bronhitis,
Patients in all study arms also received cyclosporine and corticosteroids.
Bolniki v vseh študijskih skupinah so prejemali tudi ciklosporin in kortikosteroide.
This needs mixing with glucose before using.
Pred uporabo se mora zmešati z glukozo.
(50 tablets)
(50 tablet)
Additional risk minimisation measures
• Dodatni ukrepi za zmanjševanje tveganj
• telmisartan - used to treat high blood pressure
• telmisartan - uporablja se za zdravljenje visokega krvnega tlaka.
• rifampicin - an antibiotic used to prevent and treat infections such as tuberculosis (TB)
• rifampicin - antibiotik, ki se uporablja za preprečevanje in zdravljenje okužb, kot je tuberkuloza,
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pred začetkom uporabe natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
You may get general side effects affecting your body as a whole.
Pojavijo se lahko splošni neželeni učinki, ki se nanašajo na telo kot celoto.
• antibiotics - used to treat bacterial infections
• antibiotiki - uporabljajo se za zdravljenje bakterijskih okužb,
It is given as a slow drip (infusion) into a vein.
Daje se kot počasna infuzija v žilo.
It is recommended, however, to administer CellCept at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Vseeno je priporočljivo, da dajemo zdravilo CellCept vsaj eno uro pred ali tri ure po dajanju sevelamerja, zato da zmanjšamo vpliv na absorpcijo mikofenolne kisline.
In this leaflet the shorter name CellCept is used.
• V tem navodilu se uporablja skrajšano ime CellCept.
Also other medicines can affect the way CellCept works.
Prav tako lahko druga zdravila vplivajo na delovanje zdravila CellCept.
Component of a multipack, can't be sold separately.
Sestavnih delov skupnega pakiranja ni mogoče prodajati posebej.
This needs mixing with purified water before using.
Pred uporabo ga je treba zmešati s prečiščeno vodo.
If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate.
Če teh navodil ne boste popolnoma razumeli, se posvetujte z zdravnikom, da vam jih bo ponovno razložil, preden boste vzeli mofetilmikofenolat.
However, at high MPAG plasma concentrations (> 100µg/mL), small amounts of MPAG are removed.
Pri visokih koncentracijah mikofenolglukuronida v plazmi (> 100 μg/ml) se majhne količine mikofenolglukuronida vendarle odstranijo.
Like all medicines, CellCept can cause side effects, although not everybody gets them.
Kot vsa zdravila lahko tudi zdravilo CellCept povzroča neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Cellcept may cause somnolence, confusion, dizziness, tremor or hypotension, and therefore patients are advised to use caution when driving or using machines.
Zdravilo CellCept lahko povzroči zaspanost, zmedenost, omotico, tremor ali hipotenzijo, zato bolnikom priporočamo previdnost pri vožnji ali upravljanju strojev.
Paediatric population aged 2 to 18 years
Pediatrični bolniki, stari od 2 do 18 let
Also try not to get it on your skin, inside your mouth or nose.
Prav tako pazite, da ne zaide na vašo kožo, v usta ali nos.
It is recommended that the second test should be performed 8 - 10 days after the first test. For transplants from deceased donors, if it is not possible to perform two tests 8-10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8-10 days later.
Če pri presaditvah od umrlih darovalcev pred začetkom zdravljenja ni mogoče opraviti dveh testov v razmiku 8-10 dni (zaradi časovnih omejitev pri razpoložljivosti organov za presaditev), je treba test nosečnosti opraviti neposredno pred začetkom zdravljenja, naslednji test pa 8-10 dni po prvem.
• Your doctor will decide the most appropriate dose based on your child's height and weight (body surface area - measured as square metres or “m2”).
• Zdravnik bo določil najbolj ustrezen odmerek glede na višino in telesno maso otroka (telesna površina, izmerjena v kvadratnih metrih oziroma »m2«).
Patients taking CellCept should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year.
Med zdravljenjem z zdravilom CellCept moramo napraviti preiskave celotne krvne slike enkrat na teden prvi mesec, dvakrat mesečno v drugem in tretjem mesecu in nato enkrat mesečno v prvem letu.
Keep pulling it out until the desired amount of medicine is in the dispenser.
• Vlecite, dokler v razdelilnik ne zajamete želene količine zdravila.
This is because CellCept can affect the way some other medicines work.
Zdravilo CellCept namreč lahko vpliva na delovanje nekaterih drugih zdravil.
In some of these cases switching CellCept to another immunosuppressant resulted in improvement in respiratory symptoms.
V nekaj od teh primerov je zamenjava zdravila CellCept za drugi imunosupresiv povzročila izboljšanje respiratornih simptomov.
Important information about some of the ingredients of CellCept
Pomembne informacije o nekaterih sestavinah zdravila CellCept
CellCept should be used together with other medicines: Ciclosporin and corticosteroids.
Zdravilo CellCept je treba uporabljati skupaj z drugimi zdravili, kot so: • ciklosporin in kortikosteroidi.
Shake the closed bottle well for about 5 seconds before each use.
Pred vsako uporabo zaprto steklenico dobro stresajte približno 5 sekund.
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
Skupine pogostnosti neželenih učinkov so opredeljene po naslednjem dogovoru: 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) in zelo redki (< 1/10.000).
ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
CellCept reduces your body's defences.
Zdravilo CellCept zmanjša obrambno sposobnost vašega organizma.
PHARMACEUTICAL FORM Powder for oral suspension.
FARMACEVTSKA OBLIKA prašek za peroralno suspenzijo
Physicians should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult their physician if there is a possibility of pregnancy.
Zdravniki morajo zagotoviti, da bolnice, ki jemljejo mofetilmikofenolat, razumejo tveganje za škodo otroku, nujnost uporabe učinkovite kontracepcije in nujnost, da se nemudoma posvetujejo z zdravnikom, če obstaja možnost, da je prišlo do zanositve.
Skin problems such as:
Težave s kožo, kot so:
Do not take CellCept:
Ne jemljite zdravila CellCept:
Treatment with CellCept should be initiated and maintained by appropriately qualified transplant specialists.
Zdravljenje z zdravilom CellCept mora vpeljati in voditi ustrezen specialist za presaditve.
Tap the closed bottle several times to loosen the powder.
Zaprto steklenico večkrat rahlo pretresite, da se prašek razrahlja.
• azathioprine or other medicines which suppress your immune system - given after a transplant operation
• azatioprin ali druga zdravila, ki zavirajo imunski sistem - uporabljajo se po presaditveni operaciji,
Do not use cloths or wipes for drying.
Za sušenje ne uporabljajte krp ali robčkov.
(150 (3x50) tablets multipack)
(150 (3×50) tablet v skupnem pakiranju)
The educational programme is aimed at ensuring that the health professionals and patients are aware of the teratogenicity and mutagenicity, the need for pregnancy tests before starting therapy with Cellcept, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Cellcept.
Namen izobraževalnega programa je zagotoviti, da bi se zdravstveni delavci in bolniki zavedali teratogenosti in mutagenosti, potrebe po testih nosečnosti pred začetkom zdravljenja z zdravilom CellCept, zahteve po kontracepciji za bolnike in bolnice ter da bi vedeli, kaj storiti v primeru zanositve med zdravljenjem z zdravilom CellCept.
It is recommended to monitor MPA exposure levels and to adjust CellCept doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Priporočljivo je spremljanje ravni izpostavljenosti mikofenolni kislini in prilagoditev odmerkov zdravila CellCept za ohranitev klinične učinkovitosti, kadar sočasno dajemo rifampicin.
• If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
• če ne uporabljate učinkovite kontracepcije (glejte Nosečnost, kontracepcija in dojenje),
If a dose of CellCept is missed, this will be given to you as soon as possible.
Če je bil odmerek zdravila CellCept izpuščen, vam ga bodo dali čimprej, ko bo to mogoče.
You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
• vam je ali menite, da bi vam lahko izostala menstruacija, imate neobičajno menstrualno krvavitev ali sumite, da ste noseči;
These changes may suggest a ‘left shift' in the maturity of neutrophils in haematological investigations, which may be mistakenly interpreted as a sign of infection in immunosuppressed patients such as those that receive CellCept.
Te spremembe lahko pri preiskavah krvi predstavljajo ‘premik v levo' pri zorenju nevtrofilcev, kar se lahko pri imunosupresiranih bolnikih, kot so ti, ki prejemajo zdravilo CellCept, napačno razlaga kot znak okužbe.
• cholestyramine - used to treat high cholesterol
• holestiramin - uporablja se za zdravljenje visokega holesterola,
Do not take any capsules that have broken open or split.
• Ne zaužijte kapsul, ki so odprte ali poškodovane.
If you stop your treatment you may increase the chance of rejection of your transplant organ.
Če prenehate z zdravljenjem, lahko povečate možnost zavrnitve vašega presadka.
The recommended dose is 600 mg/ m2
Priporočeni odmerek je 600 mg/m2
Try not to inhale the dry powder.
Izogibajte se vdihavanju suhega praška.
(100 capsules)
(100 kapsul)
Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, oznaka ATC: L04AA06
The Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme and a follow-up pregnancy questionnaire, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Imetnik dovoljenja za promet se mora z nacionalnim organom, pristojnim za zdravila, dogovoriti o vsebini in obliki izobraževalnega programa in vprašalnika o spremljanju nosečnosti, vključno z načinom obveščanja, načinom distribucije in vsemi drugimi vidiki programa.
Do not use solvent-containing wipes for cleaning.
Za čiščenje ne uporabljajte robčkov, ki vsebujejo topila.
An introduction in each guide will inform the reader that the purpose of the guide is to tell them that a foetal exposure must be avoided and how to minimize the risk of birth defects and miscarriage associated with mycophenolate mofetil.
• uvod v obeh vodnikih bo informiral bralca, da je namen vodnika pojasniti, da se je treba izogibati izpostavljenosti ploda in kako kar najbolj zmanjšati tveganje za prirojene okvare in spontani splav, povezane z uporabo mofetilmikofenolata.
In patients not also taking ciclosporin, concomitant administration of CellCept and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Pri bolnikih, ki ne jemljejo tudi ciklosporina, je sočasno dajanje zdravila CellCept in rifampicina povzročilo zmanjšanje izpostavljenosti mikofenolni kislini (AUC0-12h) za 18 do 70 %.
• Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
• so vam z operacijo odstranili jajcevoda in oba jajčnika (bilateralna salpingo-ooforektomija);
Sodium less than 1 mmol (23 mg) per dose
Natrij: manj kot 1 mmol (23 mg) na odmerek
CellCept capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Kapsule CellCept lahko predpišemo samo bolnikom, katerih telesna površina je najmanj 1,25 m2.
The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not considered clinically significant.
Spremembe v farmakokinetiki mikofenolglukuronida (fenolnega glukuronida mikofenolne kisline) (ki ga je bilo za 8 % več) so bile minimalne in jih ne smatramo za klinično pomembne.
Your pharmacist will normally make up the medicine for you.
Zdravilo vam običajno pripravi farmacevt.
These include diarrhoea, infections, fewer white cells and fewer red cells in the blood.
Ti vključujejo drisko, okužbe ter zmanjšano število belih in rdečih krvnih celic.
Note: If required, CellCept 1 g/5 ml powder for oral suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
Opomba: Če je treba, lahko zdravilo CellCept 1 g/5 ml prašek za peroralno suspenzijo bolniku damo z nazogastrično sondo z velikostjo najmanj 8 French (najmanj 1,7 mm notranjega premera).
If neutropenia develops, dosing with CellCept should be interrupted or the dose reduced (see section 4.4).
Če se pojavi nevtropenija, je treba odmerjanje zdravila CellCept prekiniti ali odmerek zmanjšati (glejte poglavje 4.4).
CellCept contains aspartame.
• Zdravilo CellCept vsebuje aspartam.
For 6 weeks after you stop taking CellCept.
• 6 tednov po prenehanju jemanja zdravila CellCept.
The medicine comes as a powder.
Zdravilo je v obliki praška.
The risk increases with total immunosuppressive load (see section 4.4).
Nevarnost narašča z zvečano stopnjo imunosupresije (glejte poglavje 4.4).
• antacids or proton pump inhibitors - used for acid problems in your stomach such as indigestion
• antacidi ali zaviralci protonske črpalke - uporabljajo se pri težavah s kislino v želodcu, kot je dispepsija,
(300 capsules)
(300 kapsul)
Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept itself, concomitant medications, viral infections, or some combination of these causes.
Bolnike, ki prejemajo zdravilo CellCept, je treba skrbno nadzorovati zaradi nevtropenije, ki je lahko posledica jemanja zdravila CellCept, sočasno uporabljenih zdravil, virusnih okužb ali nekaterih kombinacij teh vzrokov.