natgillin/translations-raw huggingface dataset:
5. 2).
Cholestyramine: following single dose administration 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g three times a day (TID) of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4, and section 5.2).
30% forventes, hvis samtidig ciclosporinbehandling seponeres.
17 In contrast, if concomitant ciclosporin treatment is stopped, an increase in MPA AUC of around 30% should be expected.
Hos
No substantial alteration of MPA pharmacokinetics is anticipated and Myfenax dose adjustment is not required.
16 patienter med nedsat nyrefunktion, som får Myfenax og ganciclovir, eller deres prodrugs, f. eks. valganciclovir, samtidig bør dosisanbefalingerne for ganciclovir følges og patienterne monitoreres omhyggeligt.
In patients with renal impairment in which mycophenolate mofetil and ganciclovir or its prodrugs, e. g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
5. 2).
Oral contraceptives: the pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co administration of mycophenolate (see also section 5.2).
Hos patienter, som ikke fik ciclosporin, sås ved samtidig administration af mycophenolatmofetil og rifampicin et fald på 18- 70% i MPA- eksponeringen (AUC 0- 12 timer).
Rifampicin: in patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Når mycophenolatmofetil blev administreret samtidig med sevelamer, faldt MPA - Cmax og AUC 0- 12 timer med henholdsvis 30% og 25%, dog uden at dette havde kliniske konsekvenser (f. eks. i form af transplantatafstødning).
Sevelamer: decrease in MPA Cmax and AUC0-12 by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection).
4. 4).
However, in hepatic transplant patients, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5 g taken twice a day, morning and evening[BID) were administered to patients taking tacrolimus (see also section 4.4).
Det anbefales, at behandling med Myfenax ikke initieres før en negativ graviditetstest foreligger.
18 It is recommended that Myfenax therapy should not be initiated until a negative pregnancy test has been obtained.
Myfenax bør kun anvendes til gravide kvinder, hvis den
Myfenax should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus.
Imidlertid var følgende behandlingsrelaterede bivirkninger hyppigere i den pædiatriske population, især hos børn under 6 år, sammenlignet med voksne: diarré, sepsis, leukopeni, anæmi og infektion.
However, the following treatment-related adverse events were more frequent in the paediatric population, 19 particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leucopenia, anaemia and infection.
Ældre patientersom får Myfenax som led i et kombinations immunsuppressivt regi, kan have større risiko for visse infektioner (inklusive vævsinvasiv sygdom forårsaget af
Elderly patients receiving Myfenax as part of a combination immunosuppressive regimen, may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger individuals.
Uønskede hændelser, som var ” sandsynligt relateret ” eller ” muligt relateret ” til mycophenolatmofetil, og som rapporteredes hos de patienter, der blev behandlet med mycophenolatmofetil i de kontrollerede studier med nyre - (2 g data), hjerte - og levertransplanterede patienter er anført i den følgende tabel.
Adverse reactions, probably or possibly related to mycophenolate, reported in ≥ 1/ 10 and in ≥ 1/ 100 to < 1/ 10 of patients treated with mycophenolate in the controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients are listed in the following table.
reaktioner på administrations - stedet
Hepatobiliary disorders Psychiatric disorders
Der har været indberetninger om aplastisk anæmi og knoglemarvsdepression hos patienter behandlet med mycophenolatmofetil, hvor nogle har været fatale.
Agranulocytosis (uncommon) and neutropenia have been reported; therefore regular monitoring of patients taking Myfenax is advised (see section 4.4). There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate, some of which have been fatal.
Hypersensitive reaktioner, herunder angioneurotisk ødem og anafylaktiske reaktioner, er blevet rapporteret.
Hypersensitivity: hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
4. 6
22 Congenital disorders: see further details in section 4.6.
4. 4).
It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 4.4). If neutropenia develops, dosing with Myfenax should be interrupted or the dose reduced (see section 4.4).
93% af den administrerede dosis genfundet i urinen og 6% genfundet i fæces.
Orally administered radiolabelled mycophenolate mofetil results in complete recovery of the administered dose; with 93%
Det meste (ca.
23 of the administered dose recovered in the urine and 6% recovered in the faeces.
Ved høje MPAG - koncentrationer (> 100 µg/ ml) fjernes dog mindre mængder MPAG.
However, at high MPAG plasma concentrations (> 100μ g/ ml), small amounts of PAG are removed.
40% lavere sammenlignet med den sene posttransplantationsperiode (3 – 6 måneder efter transplantationen).
In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplants patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 – 6 months post-transplant).
I en enkelt- dosis undersøgelse (6 personer per gruppe) blev middel plasma MPA AUC hos personer med svær, kronisk nyreinsufficiens (glomerulær filtrationsrate < 25 ml min- 1 1, 73 m- 2) observeret til 28- 75% højere i forhold til middelværdierne hos normale, sunde personer eller personer med mindre grad af nyreinsufficiens.
In a single dose study (6 subjects/ group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 ml min-1 1.73 m-2) were 28 – 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Virkningen af hepatisk sygdom på denne proces
Effects of hepatic disease on this process probably depend on the particular disease.
I forsøgsmodeller var mycophenolatmofetil ikke tumordannende.
24 In experimental models, mycophenolate mofetil was not tumourigenic.
2 - 3 gange den systemiske eksponering (AUC eller Cmax) der er observeret hos nyre transplantationspatienter der fik den anbefalede kliniske dosis på 2 g daglig og 1, 3 - 2 gange den systemiske eksponering (AUC eller Cmax) observeret hos hjerte transplantationspatienter der fik den anbefalede kliniske dosis på 3 g daglig.
The highest dose tested in the animal carcinogenicity studies resulted in approximately 2 – 3 times the systemic exposure (AUC or Cmax) observed in renal transplant patients as the recommended clinical dose of 2 g/ day and 1.3 – 2 times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the recommended clinical dose of 3 g/ day.
Ved teratologiske undersøgelser på rotter og kaniner forekom der føtal resorption og misdannelser hos rotter ved 6 mg kg- 1 dag- 1 (inkl. anophthalmi, agnathi og hydrocephalus) og hos kaniner ved 90 mg kg - 1 dag- 1 (inkl. kardiovaskulære og nyre anomalier, såsom cordis ectopia og ectopiske nyrer og diafragma og umbilical brok) med fravær af maternel toksicitet.
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg kg1 day-1 (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg kg-1 day-1 (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
Hypromellose (HPMC 2910) Titandioxid (E171) Macrogol (PEG 400) Talcum Indigocarmin (E 132) Jernoxid, sort (E172) Jernoxid, rød (E172)
25 Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
Da mycophenolatmofetil har demonstreret fosterbeskadigende virkning på rotter og kaniner, må Myfenax filmovertrukne tabletter ikke knuses.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbit, Myfenax film- coated tablets should not be crushed.
EU/ 1/ 07/ 438/ 003 (50 tabletter) EU/ 1/ 07/ 438/ 004 (150 tabletter)
EU/ 1/ 07/ 438/ 003 (50 tablets) EU/ 1/ 07/ 438/ 004 (150 tablets)
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu 26 ANNEX II
FREMSTILLER( E) ANSVARLIGE FOR BATCHFRIGIVELSE
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
TEVA Pharmaceutical Works Private Limited Company H- 2100 Gödöllő Táncsics Mihály út 82 Hungary
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő Táncsics Mihály út 82 Hungary
28 BILAG III
28 Risk Management Plan No description of Risk Management Plan has been provided by the applicant.
ETIKETTERING OG INDLÆGSSEDDEL
PSURs The PSUR submission schedule for both strengths should follow the PSUR schedule for the reference products.
29 A.
29 ANNEX III
30 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
30 A. LABELLING
32 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
33 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
35 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
36 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
37 INDLÆGSSEDDEL:
37 B. PACKAGE LEAFLET
Myfenax 250 mg kapsler, hårde Mycophenolatmofetil
Myfenax 250 mg hard capsules Mycophenolate mofetil
- Lægen har ordineret Myfenax til dig personligt.
- This medicine has been prescribed for you.
Myfenaxs virkning og hvad du skal bruge det til 2.
What Myfenax is and what it is used for 2.
Det skal du vide, før du begynder at tage Myfenax 3.
Before you take Myfenax 3.
Sådan skal du tage Myfenax 4.
How to take Myfenax 4.
Sådan opbevarer du Myfenax 6.
How to store Myfenax 6.
MYFENAXS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT MYFENAX IS AND WHAT IT IS USED FOR
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE MYFENAX
BEFORE YOU TAKE MYFENAX
Tag ikke Myfenax:
Do not take Myfenax
de øvrige indholdsstoffer i Myfenax.
other ingredients of Myfenax.
Du bør straks informere din læge:
Take special care with Myfenax You should inform your doctor immediately:
Myfenax nedsætter din organismes forsvarsmekanismer.
Myfenax reduces your body’ s defence mechanism.
38 Hvis du kan svare ja til nogen af de følgende spørgsmål, skal du tale med din læge, før du begynder at tage Myfenax:
If you answer yes to any of the following questions talk to your doctor before you start to take Myfenax:
nedsætter immunforsvaret (som undertiden gives til patienter efter en transplantationsoperation), colestyramin (som bruges til behandling af patienter med for højt kolesteroltal), rifampicin (antibiotika), mavesårsmedicin, phosphatbindere (bruges til patienter med kronisk nyresvigt for at reducere absorptionen af phosphat) eller anden medicin (inklusive håndkøbsmedicin), som din læge ikke er bekendt med?
are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients 39 with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic renal kidney failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
Indtagelse af mad og drikkevarer har ingen indflydelse på din behandling med Myfenax.
Taking Myfenax with food and drink Taking food and drink has no influence on your treatment with Myfenax.
Tag ikke Myfenax, hvis du ammer.
Pregnancy and breast-feeding Do not take Myfenax if you are breast feeding.
Din læge bør rådgive dig om at bruge prævention.
Your doctor should advise you about using contraception before taking Myfenax, whilst taking Myfenax, and for 6 weeks after you have stopped taking Myfenax.
Du skal bruge prævention før, mens og i 6 uger efter at du er ophørt med at tage Myfenax.
Myfenax may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Det er ikke påvist, at Myfenax påvirker evnen til at føre bil eller betjene maskiner.
Driving and using machines Myfenax has not been shown to impair your ability to drive or operate machines.
SÅDAN SKAL DU TAGE MYFENAX
HOW TO TAKE MYFENAX
Myfenax bør ikke anvendes til hjertetransplanterede børn og unge, da der ikke er tilgængelig data til at anbefale dette.
No data are available to recommend the use of Myfenax in children and adolescents who have received a heart transplant.
39 Voksne:
Adults:
Den første dosis Myfenax til indtagelse gennem munden gives tidligst 4 dage efter transplantationen, og når du er i stand til at indtage medicin gennem munden.
The recommended daily dose is 12 capsules (3 g of the
Den anbefalede daglige dosis er 12 kapsler (3 g aktivt stof) indtaget som to separate doser.
40 active ingredient) taken as 2 separate doses.
Myfenax bør ikke anvendes til levertransplanterede børn og unge, da der ikke er tilgængelig data til at anbefale dette.
No data are available to recommend the use of Myfenax in children and adolescents who have received a liver transplant.
Det er vigtigt ikke at indtage for mange kapsler.
If you take more Myfenax than you should It is important not to take too many capsules.
Hvis du på noget tidspunkt glemmer at tage medicinen, skal du tage den, så snart du kommer i tanke om det.
If you forget to take Myfenax If you forget to take your medicine at any time, take it as soon as you remember, then continue to take it at the usual times.
Fortsæt derefter med at tage den til de sædvanlige tider.
Do not take a double dose to make up for a forgotten dose.
Stop ikke med at tage Myfenax, bare fordi du måtte få det bedre.
If you stop taking Myfenax Do not stop taking Myfenax because you feel better.
Myfenax kan som al medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Myfenax can have side effects, although not everybody gets them.
Meget almindelige bivirkninger (det forekommer hos flere end l ud af 10 behandlede): • Diarre, opkastning, føle sig syg. • Fald i det normale indhold af forskellige blodceller, hvilket kan resultere i en øget risiko for infektioner, blå mærker, blødninger, kortåndethed og svaghed. • Bakterie -, svampe - og virusinfektioner i fordøjelseskanalen og urinrøret, forkølelsessår og helvedesild.
Very common side effects likely to affect more than 1 in 10 people: • Diarrhoea, vomiting, feeling sick • Decrease in normal amounts of different blood cells, which can result in increased risk of infections, bruising, bleeding, breathlessness and weakness • Bacterial, fungal and viral infections of the digestive and urinary tract, cold sores and shingles
Almindelige bivirkninger (det forekommer hos mellem 1 og 10 ud af 100 behandlede): • Ændringer i de forskellige laboratorieparametre, herunder øget leverenzymer; nyreparametre såsom kreatinin, kalium, blodsukker, fedtstoffer i blodet, kolesterol, fosfater, magnesium, kalcium og urinsyre. • Nyreproblemer med forhøjet urinstof. • Lidelser i fordøjelsessystemet såsom forstoppelse, fordøjelsesbesvær, luft i maven, bøvsen, betændelse i munden, spiserøret, maven, tarme, lever eller bugspytkirtel og blødning fra mave- tarmkanalen. • Kramper, øget muskelspændinger, rysten og muskelsvaghed, ledsmerter
Common side effects likely to affect less than 1 in 10, but more than 1 in 100 people: • Changes in different laboratory parameters, including increase in liver enzymes, renal parameters such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid • Kidney problems with increased levels of urea • Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding • Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain • Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss • Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose
40 • Søvnløshed, svimmelhed og hovedpine, snurren og følelsesløshed, ændringer i smagssansen, appetitløshed, vægttab. • Betændelse og infektion i luftvejene og i mave- tarmkanalen, ondt i halsen, bihulebetændelse, løbende og kløende næse. • Hudkræft eller godartet vækster på huden og svampeinfektioner på huden og i skeden. • Ændringer i blodtrykket, hurtigere hjerteslag, blodkarudvidelse. • Væskeophobning i kroppen, feber, ubehag, sløvhed og svaghed. • Leverbetændelse, gulfarvning af huden og det hvide i øjnene.
41 • Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina • Changes in blood pressure, faster heart beat, dilation of blood vessels • Fluid retention in the body, fever, discomfort, lethargy and weakness • Inflammation of the liver, yellowing of the skin and whites of the eyes
Ikke almindelig bivirkninger (det forekommer hos mellem 1 og 10 ud af 1. 000 behandlede): • Spredning af lymfevæv, herunder kræftsvulster. • Betændelse eller infektion i hjertet og dets klapper samt i den membran der dækker hjernen og rygraden.
Uncommon side effects likely to affect less than 1 in 100 but more than 1 in 1000 people • Proliferation of the lymphatic tissue, including malignant tumours • Inflammation or infections of the heart and its valves and of the membrane that covers the brain and spinal cord
Andre bivirkninger der er rapporteret hvor hyppigheden ikke er fastlagt: • Overfølsomhedsreaktioner (allergiske reaktioner).
Other side effects that have been reported where frequency has not been established • Hypersensitivity (allergic) reactions
SÅDAN OPBEVARER DE MYFENAX
HOW TO STORE MYFENAX
Myfenax indeholder
What Myfenax contains:
Indigo carmin (E132) Titandioxid (E 171) Gelatine Krop:
Indigo carmine (E132) Titanium dioxide (E171) Gelatin Body:
Rød jernoxid (E172) Gul jernoxid (E172)
Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) 42 Gelatin Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide
41 Titandioxid (E 171) Gelatine Sort blæk indeholder:
What Myfenax looks like and contents of the pack
Myfenaxs udseende og pakningsstørrelse Kapsler, hårde:
Hard capsules:
Krop: er uigennemsigtig karamelfarvet printet ” 250 ” aksialt med sort blæk.
Body: caramel opaque, printed ‘ 250 ’ axially in black ink.
Hoved: er uigennemsigtig lyseblå printet ” M ” aksialt med sort blæk.
Cap: light blue opaque printed ‘ M ’ axially in black ink.
Myfenax 250 mg kapsler, hårde fås i PVC/ PVdC- aluminium blister i Pakkestørrelser på 100 eller 300 kapsler pr. karton.
Myfenax 250 mg hard capsules are available in PVC/ PVdC – aluminium blisters in pack sizes of 100 or 300 capsules per carton.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) hhtp: / /www. emea. europa. eu
42 INDLÆGSSEDDEL:
43 PACKAGE LEAFLET:
Myfenax 500 filmovertrukne tabletter Mycophenolatmofetil
Myfenax 500mg film-coated tablets Mycophenolate mofetil
de øvrige indholdsstoffer i Myfenax.
other ingredients of Myfenax. if you are breast-feeding.
- Hvis du oplever nogen form for tegn på infektion (f. eks. feber, ondt i halsen), uventede blå
- if you experience any evidence of infection (e. g. fever, sore throat), unexpected bruising
mærker og/ eller blødning.
and/ or bleeding
43 Hvis du kan svare ja til nogen af de følgende spørgsmål, skal du tale med din læge, før du begynder at tage Myfenax:
If you answer yes to any of the following questions talk to your doctor before you start to take Myfenax:
Det er ikke påvist, at Myfenax påvirker evnen til at føre bil eller betjene maskiner
Driving and using machines Myfenax has not been shown to impair your ability to drive or operate machines.
44 Den første dosis Myfenax til indtagelse gennem munden gives tidligst 4 dage efter transplantationen, og når du er i stand til at indtage medicin gennem munden.
The first dose of oral Myfenax will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
Den anbefalede daglige dosis er 6 tabletter (3 g aktivt stof) indtaget som to separate doser.
The recommended daily dose is 6 tablets (3 g of the 45 active ingredient) taken as 2 separate doses.
Det er vigtigt ikke at indtage for mange tabletter.
If you take more Myfenax than you should It is important not to take too many tablets.
Almindelige bivirkninger (det forekommer hos mellem 1 og 10 ud af 100 behandlede): • Ændringer i de forskellige laboratorieparametre, herunder øget leverenzymer; nyreparametre såsom kreatinin, kalium, blodsukker, fedtstoffer i blodet, kolesterol, fosfater, magnesium, kalcium og urinsyre. • Nyreproblemer med forhøjet urinstof. • Lidelser i fordøjelsessystemet såsom forstoppelse, fordøjelsesbesvær, luft i maven, betændelse i munden, spiserøret, maven, tarme, lever eller bugspytkirtel og blødning fra mave - tarmkanalen. • Kramper, øget muskelspændinger, rysten og muskelsvaghed, ledsmerter. • Søvnløshed, svimmelhed og hovedpine, snurren og følelsesløshed, ændringer i smagssansen, appetitløshed, vægttab. • Betændelse og infektion i luftvejene og i mave- tarmkanalen, ondt i halsen, bihulebetændelse, løbende og kløende næse. • Hudkræft eller godartet vækster på huden og svampeinfektioner på huden og i skeden.
Common side effects likely to affect less than 1 in 10, but more than 1 in 100 people: • Changes in different laboratory parameters, including increase in liver enzymes, renal parameters such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid • Kidney problems with increased levels of urea • Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding • Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain • Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss • Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose • Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina • Changes in blood pressure, faster heart beat, dilation of blood vessels • Fluid retention in the body, fever, discomfort, lethargy and weakness
45 • Ændringer i blodtrykket, hurtigere hjerteslag, blodkarudvidelse. • Væskeophobning i kroppen, feber, ubehag, sløvhed og svaghed. • Leverbetændelse, gulfarvning af huden og det hvide i øjnene.
46 • Inflammation of the liver, yellowing of the skin and whites of the eyes
SÅDAN OPBEVARER DU MYFENAX
HOW TO STORE MYFENAX
Myfenax indeholder Det aktive stof er mycophenolatmofetil.
What Myfenax contains:
Hver tablet indeholder 500 mg mycophenolatmofetil.
The active substance is 500 mg mycophenolate mofetil.