natgillin/translations-raw huggingface dataset:
- hvis du er overfølsom (allergisk) over for mycophenolatmofetil, mycophenolsyre eller et af de
- If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the
Vær ekstra forsigtig med at anvende CellCept:
Take special care with CellCept:
- Hvis du oplever nogen form for tegn på infektion (f. eks. feber, ondt i halsen), uventede blå
- In case of any evidence of infection (e. g. fever, sore throat), unexpected bruising and/ or
- Hvis du har eller nogensinde har haft problemer med dit fordøjelsessystem, f. eks. mavesår.
- If you have or ever have had any problems with your digestive system, e. g. stomach ulcers.
- Hvis du lider af phenylketonuri (en sjælden arvelig stofskiftesygdom).
- If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism).
84 Brug af anden medicin:
83 Taking other medicines:
- Tager du nogen form for medicin som indeholder: azatioprin eller andre immunosuppressive
- Are you taking any medicines containing: azathioprine or other immunosuppressive agents
Brug af CellCept sammen med mad og drikkevarer:
Taking CellCept with food and drink:
Din læge bør rådgive dig om at anvende antikonception før du begynder at indtage CellCept, mens du indtager CellCept og i 6 uger efter du er ophørt med at tage CellCept.
Your doctor should advise you about using contraception before taking CellCept, whilst taking CellCept, and for six weeks after you have stopped taking CellCept.
Du skal straks fortælle din læge, hvis du er blevet gravid, ammer, eller hvis du bliver eller påtænker at blive gravid.
Tell your doctor straight away if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.
Vigtig information om nogle af de øvrige indholdsstoffer i CellCept 1 g/ 5 ml:
Important information about some of the ingredients of CellCept 1 g/ 5 ml powder for oral suspension:
Hvis du lider af phenylketonuri (en sjælden arvelig stofskiftesygdom) skal du tale med din læge, før du begynder at tage denne medicin.
If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism), talk to your doctor before you start to take this medicine.
Denne medicin indeholder også sorbitol, som er en sukkerart.
This medicine also contains sorbitol which is a sugar.
Kontakt lægen før du tager denne medicin, hvis din læge har fortalt dig, at du ikke tåler visse sukkerarter, såsom sorbitol.
If you have been told by your doctor that you have an intolerance to some sugars, such as sorbitol, contact your doctor before taking this medicinal product.
Den sædvanlige dosis er:
The usual way to take CellCept oral suspension is as follows:
Første dosis gives inden for 72 timer efter transplantationen.
The first dose will be given within 72 hours after the transplant operation.
Den anbefalede daglige dosis er 10 ml suspension (2 g af den aktive bestanddel) indtaget som to separate doser.
The recommended daily dose is 10 ml suspension (2 g of the active ingredient) taken as 2 separate doses.
Det vil sige, at man skal tage 5 ml suspension om morgenen og 5 ml suspension om aftenen.
This means taking 5 ml suspension in the morning and then 5 ml suspension in the evening.
Dosis afhænger af barnets størrelse.
84 The dose given will vary depending on the size of the child.
Den anbefalede dosis er 600 mg/ m2 to gange daglig.
The recommended dose is 600 mg/ m² taken twice a day.
85 Voksne:
Adults:
Første dosis gives inden for 5 dage efter transplantationen.
The first dose will be given within 5 days following the transplant operation.
Den anbefalede daglige dosis er 15 ml suspension (3 g af den aktive bestanddel) indtaget som to separate doser.
The recommended daily dose is 15 ml suspension (3 g of the active ingredient) taken as 2 separate doses.
Det vil sige, at man skal tage 7, 5 ml suspension om morgenen og 7, 5 ml suspension om aftenen.
This means taking 7.5 ml suspension in the morning then 7.5 ml suspension in the evening.
Det anbefales at apoteket rekonstituerer CellCept Oral Suspension for dig før udleveringen.
It is recommended that the pharmacist reconstitutes CellCept oral suspension for you prior to dispensing.
For at rekonstituere suspensionen vil apoteket gøre følgende:
To reconstitute the suspension the pharmacist will proceed as follows:
Fremstilling af suspension
Preparation of suspension
Knipse flere gange på den aflukkede flaske for at løsne pulveret.
Tap the closed bottle several times to loosen the powder.
Måle 94 ml renset vand af i et målebæger.
Measure 94 ml of purified water in a graduated cylinder.
Fjerne børnesikringslåget og skubbe flaskeadaptoren ned i flaskehalsen.
Remove child-resistant cap and push bottle adapter into neck of bottle.
Lukke flasken godt med det børnesikrede låg.
Close bottle with child-resistant cap tightly.
Skrive udløbsdatoen for den rekonstituerede suspension på flaskens etiket (holdbarheden af den rekonstituerede suspension er 2 måneder
(The shelf-life of the reconstituted suspension is 2 months.)
Undgå at det tørre pulver indåndes eller kommer i direkte kontakt med hud eller slimhinder og undgå, at den rekonstituerede suspension kommer i direkte kontakt med huden.
Avoid inhalation or direct contact with skin or mucous membranes of the dry powder as well as direct contact of the reconstituted suspension with the skin.
Skyl øjnene med almindeligt vand.
If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Suspensionen udtages med dispenseren på følgende måde:
85 To withdraw the suspension with the oral dispenser proceed as follows:
86 1.
1.
5 sek. før brugen.
Shake closed bottle well for about 5 seconds before each use.
Før spidsen af dispenseren sættes i flaskeadaptoren skal stemplet trykkes helt ned mod dispenserens spids.
Before inserting the tip of the dispenser into bottle adapter, push the plunger completely down toward the tip of the dispenser.
Sæt spidsen fast i flaskeadaptorens åbning.
Insert tip firmly into opening of the bottle adapter.
Vend flaske og adaptor med bunden i vejret.
Turn the entire unit (bottle and dispenser) upside down.
Træk langsomt stemplet tilbage til den ønskede medicinmængde er kommet ned i dispenseren (se figuren).
Pull the plunger out slowly until the desired amount of medication is withdrawn into the dispenser (see figure).
Vend flaske og adaptor opad igen og fjern langsomt dispenseren fra flasken.
Turn the entire unit right side up and remove the dispenser slowly from the bottle.
Tag medicinen direkte i munden og slug den.
Dispense directly into mouth and swallow.
Lad være med at blande den med væske før indtagelsen.
Do not mix with any liquid prior to dispensing.
Luk flasken med det børnesikrede låg hver gang efter brugen.
Close bottle with child-resistant cap after each use.
Umiddelbart efter indtagelsen:
Immediately after administration:
Skil dispenseren ad, rens den under rindende vand og lad den tørre i luften før den skal bruges næste gang.
Disassemble dispenser, rinse under running tap water and air dry prior to next use.
Undgå at suspensionen kommer i kontakt med huden.
Care should be taken to avoid contact of the skin with the suspension.
Hvis det sker så vask huden omhyggeligt med vand og sæbe.
If such contact occurs, wash thoroughly with soap and water.
Hvis du har tager for meget CellCept- oralsuspension:
If you take more CellCept than you should:
Hvis du indtager mere af suspensionen end du har fået besked på, eller hvis en anden ved et uheld har indtaget din medicin, skal du straks tage til læge eller sygehusets skadestue.
If you take more suspension than you have been told to take, or if someone else accidentally takes your medicine, immediately see a doctor or go to a hospital straight away.
Hvis du holder op med at tage CellCept:
86 If you stop taking CellCept:
Stop ikke med at tage din medicin medmindre lægen har bedt dig om det.
Do not stop taking your medicine unless your doctor tells you to.
Spørg lægen eller på apoteket, hvis der er noget du er tvivl om.
If you have any further questions on the use of this product, ask your doctor.
87 CellCept nedsætter kroppens egne forsvarsmekanismer for at bremse afstødning af den transplanterede nyre, hjerte eller lever.
CellCept reduces your body’ s own defence mechanisms to stop you rejecting your transplanted kidney, heart or liver.
Bivirkninger, som kan påvirke hele organismen, kan være overfølsomhed (så som anafylaksi, angioødem), feber, træthedsfornemmelse, søvnbesvær, smerter (som f. eks. smerter i maven, brystkassen, muskler/ led og smerter ved vandladning), hovedpine, influenzasymptomer og opsvulmen.
General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioeodema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/ muscle, pain on passing urine), headache, flu symptoms and swelling.
Hudlidelser som f. eks. acne, forkølelsessår, helvedesild (herpes zoster), øget hudvækst, hårtab udslæt og kløe.
Disorders of the skin such as acne, cold sores, shingles, skin growth, hair loss, rash, itching.
Lidelser i mave/ tarmkanalen og i munden som f. eks. forstoppelse, kvalme, sure opstød, betændelse i bugspytkirtlen, maveproblemer inklusive blødning, betændelse i maven, leverproblemer, betændelse i tyktarmen appetitløshed, luft i maven, og sår i mundhulen.
Disorders of the digestive system and mouth such as constipation, nausea, indigestion, pancreas inflammation, intestinal disorders including bleeding, inflammation of the stomach, liver problems, inflammation of the colon, loss of appetite, flatulence and mouth ulcers.
Lidelser i nervesystemet og sanseorganerne som f. eks. kramper, rysten, svimmelhed, depression, omtågethed, følelsesløshed, muskelkramper, angst, og ændringer af tankegang eller humør.
Disorders of the nerves and senses such as convulsions, tremor, dizziness, depression, drowsiness, numbness, muscle spasms, anxiety, changes in thinking or mood.
Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
Do not use after the expiry date stated on the carton and bottle label (EXP).
Den rekonstituerede opløsning er holdbar i to måneder.
87 The shelf-life of the reconstituted suspension is two months.
Apoteket vil skrive udløbsdatoen på flaskens etiket i den sorte rubrik “ Anv. senest ”.
The pharmacist will write the date of expiration on the bottle label in the black box next to "Use before".
Pulver til oral suspension må ikke opbevares ved temperaturer over 30 °C.
Powder for oral suspension: do not store above 30°C.
Den rekonstituerede opløsning må ikke opbevares ved temperaturer over 30 °C.
Reconstituted suspension: do not store above 30°C.
- Aktivt stof: mycophenolatmofetil
- The active substance is mycophenolate mofetil
CellCept 1 g/ 5 ml pulver til oral suspension: sorbitol silica, kolloid, vandfri natriumcitrat sojabønne lecitin blandet frugtsmag xanthangummi aspartam * (E 951) methylparahydroxybenzoat (E 218) citronsyre, vandfri
CellCept 1 g/ 5 ml powder for oral suspension: sorbitol silica, colloidal anhydrous sodium citrate soybean lecithin mixed fruit flavour xanthan gum aspartame* (E951) methyl parahydroxybenzoate (E218) citric acid anhydrous
* indeholder phenylalanin svarende til 2, 78 mg/ 5 ml suspension
* contains phenylalanine equivalent to 2.78 mg/ 5 ml of suspension.
CellCept 1 g/ 5 ml pulver til oral suspension:
CellCept 1 g/ 5 ml powder for oral suspension:
Efter opløsning er volumenet af suspensionen 175 ml, hvilket giver et brugbart volumen på 160- 165 ml.
When reconstituted, the volume of the suspension is 175 ml, providing a usable volume of 160 – 165 ml.
89 Danmark Roche a/ s Tlf: +45 - 36 39 99 99
Danmark Roche a/ s Tlf: +45 - 36 39 99 99
Latvija Roche Latvija SIATel: +371 - 7 039831
89 Latvija Roche Latvija SIA Tel: +371 - 7 039831
Denne indlægsseddel blev senest godkendt den {MM/ ÅÅÅÅ}
This leaflet was last approved on {MM/ YYYY}
90 INDLÆGSSEDDEL:
90 PACKAGE LEAFLET:
CellCept 500 mg tabletter mycophenolatmofetil
CellCept 500 mg tablets mycophenolate mofetil
CellCept tabletter anvendes til at forhindre kroppen i at afstøde en transplanteret nyre, hjerte eller lever.
CellCept tablets are used to prevent your body rejecting a transplanted kidney, heart or liver.
Tag ikke Cellcept:
Do not take CellCept:
- Hvis du har, eller nogensinde har haft problemer med dit fordøjelsessystem, f. eks. mavesår.
- If you have or ever have had any problems with your digestive system, e. g., stomach ulcers.
91 Hvis du kan svare ja til nogen af de følgende spørgsmål, skal du tale med din læge før du begynder at tage CellCept:
91 If you answer yes to any of the following questions talk to your doctor before you start to take CellCept:
- Tager du nogen form for medicin, som indeholder: azatioprin eller andre immunosuppressive
- Are you taking any medicines containing: azathioprine or other immunosuppressive agents
stoffer (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 andre lægemidler (inklusive håndkøbsmedicin), som din læge ikke er bekendt med?
(which are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic renal 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?
Din læge bør rådgive dig om at anvende antikonception, før du begynder at indtage CellCept, mens du indtager CellCept, og i 6 uger efter du er ophørt med at tage CellCept.
Your doctor should advise you about using contraception before taking CellCept, whilst taking CellCept, and for six weeks after you have stopped taking CellCept.
Det er ikke påvist, at Cellcept påvirker evnen til at føre bil eller betjene maskiner.
CellCept has not been shown to impair your ability to drive or operate machinery.
Den anbefalede daglige dosis er 4 tabletter (2 g af den aktive bestanddel) indtaget som to separate doser.
The recommended daily dose is 4 tablets (2 g of the active ingredient) taken as 2 separate doses.
Det vil sige, at man skal tage 2 tabletter om morgenen og 2 tabletter om aftenen.
This means taking 2 tablets in the morning then 2 tablets in the evening.
Den anbefalede daglige dosis er 6 tabletter (3 g af den aktive bestanddel) indtaget som 2 separate doser.
The recommended daily dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses.
Det vil sige, at man skal tage 3 tabletter om morgenen og 3 tabletter om aftenen.
This means taking 3 tablets in the morning then 3 tablets in the evening.
92 Levertransplantation
92 Liver Transplant
Den første dosis CellCept til indtagelse gennem munden gives tidligts 4 dage efter transplantationen, og når du er i stand til at indtage medicin gennem munden.
The first dose of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications.
Den anbefalede daglige dosis er 6 tabletter (3 g af den aktive bestanddel) indtaget som to separate doser.
The recommended daily dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses.
Det vil sige, at man skal tage 3 tabletter om morgenen og 3 tabletter om aftenen.
This means taking 3 tablets in the morning and then 3 tablets in the evening.
Hvis du har taget for mange CellCept- tabletter:
If you take more CellCept than you should:
Hvis du indtager flere tabletter end du har fået besked på, eller hvis en anden ved et uheld har indtaget din medicin, skal du straks tage til læge eller sygehusets skadestue.
If you take more tablets than you have been told to take, or if someone else accidentally takes your medicine, immediately see a doctor or go to a hospital straight away.
Hvis behandlingen med CellCept stoppes kan chancerne for afstødning af det transplanterede organ øges.
Stopping your treatment with CellCept may increase the chance of rejection of your transplanted organ.
CellCept nedsætter kroppens egne forsvarsmekanismer for at bremse afstødning af den transplanterede nyre, hjerte - eller lever.
CellCept reduces your body’ s own defence mechanisms to stop you rejecting your transplanted kidney, heart or liver.
Bivirkninger, som kan påvirke hele organismen, kan være overfølsomhed (så som anafylaksi, angioødem), feber, træthedsfornemmelse, søvnbesvær, smerter (som f. eks. smerter i maven, brystkassen, muskler/ led og smerter ved vandladning), hovedpine, influenzasymptomer og opsvulmen
General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioeodema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/ muscle, pain on passing urine), headache, flu symptoms and swelling.
Andre bivirkninger omfatter:
93 Other unwanted effects may include:
Hudlidelser som f. eks. acne, forkølelsessår, hudsår, helvedesild (herpes zoster), øget hudvækst, hårtab, udslæt og kløe.
Disorders of the skin such as acne, cold sores, shingles, skin growth, hair loss, rash, itching.
93 Urinvejslidelser som f. eks. nyreproblemer eller hyppig vandladningstrang.
Urinary disorders such as kidney problems or the urgent need to pass urine.
Lidelser i mave/ tarmkanalen og i munden som f. eks. forstoppelse, kvalme, sure opstød, betændelse i bugspytkirtlen, maveproblemer inklusive blødning, betændelse i maven, leverproblemer, tyktarmabetændelse, appetitløshed, luft i maven og sår i mundhulen.
Disorders of the digestive system and mouth such as constipation, nausea, indigestion, pancreas inflammation, intestinal disorders including bleeding, inflammation of the stomach, liver problems, inflammation of the colon, loss of appetite, flatulence and mouth ulcers.
Lidelser i nervesystemet og sanseorganerne som f. eks. kramper, rysten og svimmelhed, depression, omtågethed, følelsesløshed, muskelkramper, angst og ændringer af tanker eller humør.
Disorders of the nerves and senses such as convulsions, tremor, dizziness, depression, drowsiness, numbness, muscle spasms, anxiety, changes in thinking or mood.
Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
Do not use the tablets after the expiry date stated on the carton (EXP).
Opbevares i den ydre karton for at beskytte mod lys.
Keep in outer carton in order to protect from light.
- Aktivt stof: mycophenolamofetil
- The active substance is mycophenolate mofetil.
Tabletovertrækket: hydroxypropylmethylcellulose hydroxypropylcellulose titandioxid (E 171) polyethylenglycol 400 indigocarminaluminiumlak (E 132) rød jernoxid (E 172)
Tablet coating: hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide (E171) polyethylene glycol 400 indigo carmine aluminium lake (E132) red iron oxide (E172)
94 Udseende og pakningsstørrelser
94 What CellCept looks like and contents of the pack
CellCept 500 mg tabletter:
CellCept 500 mg tablets:
1 karton indeholder 50 tabletter (i blisterkort á 10 stk.) 1 karton indeholder 150 tabletter (i blisterkort á 10 stk.)
1 carton contains 50 tablets (in blister packs of 10) 1 carton contains 150 tablets (in blister packs of 10)
CellCept tabletter: lavendelfarvede kappeformede tabletter, mærket med ” CellCept 500 ” på den ene side og ” Firmalogo ” på en anden.
CellCept tablets: lavender coloured caplet-shaped tablet, engraved with "CellCept 500" on one side and "Company logo" on the other.
95 France Roche Tél: +33 (0) 1 46 40 50 00
France Roche Tél: +33 (0) 1 46 40 50 00
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Hvad er CELSENTRI?
What is CELSENTRI?
CELSENTRI er et lægemiddel, der indeholder det aktive stof maraviroc.
CELSENTRI is a medicine containing the active substance maraviroc.
Det leveres som blå, ovale tabletter (150 og 300 mg).
It is available as blue, oval tablets (150 or 300 mg).
Hvad anvendes CELSENTRI til?
What is CELSENTRI used for?
CELSENTRI er et antiviralt lægemiddel.
CELSENTRI is an antiviral medicine.
Dette virus er årsag til aids (erhvervet immundefektsyndrom).
It is used in combination with other antiviral medicines to treat adults who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Dette afgøres ved en blodprøve.
CELSENTRI is only used in patients who have been treated for HIV infection before and only when the HIV-1 they are infected with is ‘ CCR5-tropic’, which is determined by a blood test.
Med "CCR5 - tropisk" menes, at når viruset inficerer en celle, bindes det til et bestemt protein, der kaldes CCR5, på cellens overflade.
This means that the virus, when infecting a cell, attaches to a specific protein called CCR5 on the surface of the cell.
Hvordan anvendes CELSENTRI?
How is CELSENTRI used?
Påbegyndelse af behandlingen med CELSENTRI bør foretages af en læge med erfaring i behandling af hiv- infektion.
Treatment with CELSENTRI should be initiated by a doctor who has experience in the management of HIV infection.
Dette gøres ved at udføre en pålidelig "tropismetest" på en frisk blodprøve.
Before treatment, the doctor must check that the patient ’ s blood only shows infection with CCR5-tropic virus, using a newly drawn blood sample and a reliable ‘ tropism test’.
Den anbefalede dosis er 150, 300 eller 600 mg to gange dagligt, afhængigt af den øvrige medicin, patienten får.
The recommended dose is 150, 300 or 600 mg twice a day, depending on the other medicines that the patient is taking.
Lægemidlet kan tages i forbindelse med et måltid eller mellem måltiderne.
It can be taken with or without food.
Hos patienter over 65 år og hos patienter med leversygdom bør CELSENTRI anvendes med forsigtighed.
CELSENTRI should be used with caution in patients aged over 65 years and in patients who have problems with their liver.
Hos sådanne patienter bør behandlingens virkning overvåges nøje.
Patients who have kidney problems may need to take CELSENTRI less frequently if they are taking other medicines that are broken down in the body (metabolised) in the same way as CELSENTRI, and their response to treatment should be closely monitored.
Der vides intet om skift fra anden hiv- medicin til CELSENTRI hos patienter, hos hvem hiv- behandlingen virker godt, og som ikke har måleligt virusindhold i blodet.
There is no information on switching to CELSENTRI from another type of medicine for HIV infection in patients whose HIV is being treated successfully, when no virus can be detected in their blood.
Der foreligger heller ingen oplysninger om fornyet anvendelse af CELSENTRI hos patienter, der har fået lægemidlet tidligere, men hos hvem det er holdt op med at virke.
There is also no information on the re-use of CELSENTRI in patients who have taken it in the past, but in whom it stopped working.
I sådanne tilfælde bør anden behandling derfor overvejes.
Other treatments should be considered in these cases.
Det aktive stof i CELSENTRI, maraviroc, er en "CCR5- antagonist".
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged uses this protein to enter the cells.
Det CCR5- tropiske hiv behøver dette protein for at trænge ind i cellerne.
By attaching itself to the protein, maraviroc prevents it from entering the cells.
Maraviroc virker derimod ikke, når viruset i en blodprøve bindes til et andet protein, der kaldes CXCR4, eller når det kan bindes både til CCR5 og CXCR4.
Maraviroc cannot work when the virus in a blood sample attaches to another protein called CXCR4, or when it can attach to both CCR5 and CXCR4.