natgillin/translations-raw huggingface dataset:
Den anbefalede dosis cisplatin er 75 mg/ m2 legemsoverflade infunderet over 2 timer cirka 30 minutter efter afsluttet infusion af pemetrexed på den første dag i hver 21- dages- cyklus.
The recommended dose of cisplatin is 75 mg/ m2 BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
(Se også produktresuméet for cisplatin for at få specifikke oplysninger om dosering).
Patients must receive adequate anti-emetic treatment and appropriate hydration prior to and/ or after receiving cisplatin (See also cisplatin Summary of Product Characteristics for specific dosing advice).
2 ALIMTA givet alene:
2 ALIMTA as single agent:
Til patienter, der behandles for ikke- småcellet lungecancer efter tidligere behandling med kemoterapi, er den anbefalede dosis af ALIMTA 500 mg/ m2 legemesoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21- dages- cyklus.
In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of ALIMTA is 500 mg/ m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Præmedicineringsregime:
Premedication regimen:
For at reducere incidensen og sværhedsgraden af hudreaktioner bør der indgives et kortikosteroid - præparat dagen før, på dagen for og dagen efter indgift af pemetrexed.
To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration.
Dette kortikosteroidpræparat skal svare til 4 mg dexamethason indgivet oralt 2 gange dagligt (se pkt 4. 4).
The corticosteroid should be equivalent to 4 mg of dexamethasone administered orally twice a day (see section 4.4).
4. 4).
To reduce toxicity, patients treated with pemetrexed must also receive vitamin supplementation (see section 4.4).
Patienter skal dagligt tage et oralt folsyretilskud eller en multivitamin indeholdende folsyre (350- 1. 000 mikrogram).
Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1000 micrograms) on a daily basis.
Patienter skal også have en intramuskulær injektion af B12- vitamin (1. 000 mikrogram) i ugen op til indgift af den første dosis pemetrexed og herefter én gang hver tredje cyklus.
Patients must also receive an intramuscular injection of vitamin B12 (1000 micrograms) in the week preceding the first dose of pemetrexed and once every three cycles thereafter.
De efterfølgende injektioner af B12- vitamin kan indgives samme dag som pemetrexed.
Subsequent vitamin B12 injections may be given on the same day as pemetrexed.
Inden hver administration af kemoterapi skal der indsamles laboratorieanalyser af blodet til evaluering af nyre - og leverfunktion.
Prior to each chemotherapy administration blood chemistry tests should be collected to evaluate renal and hepatic function.
Før påbegyndelse af en kemoterapicyklus skal patienter opfylde følgende parametre:
Before the start of any cycle of chemotherapy, patients are required to have the following:
Det absolutte neutrofiltal (ANC) skal være ≥ 1. 500 celler/ mm3, og trombocyttallet skal være ≥ 100. 000 celler/ mm3.
Absolute Neutrophil Count (ANC) should be ≥ 1500 cells/ mm3 and platelets should be ≥ 100,000 cells/ mm3.
Kreatinin- clearance skal være ≥ 45 ml/ min.
Creatinine clearance should be ≥ 45 ml/ min.
Total bilirubin skal være ≤ 1, 5 gange den normale øvre grænseværdi.
The total bilirubin should be ≤ 1.5 times upper limit of normal.
Alkalisk fosfatase (AP), aspartataminotransferase (ASAT eller SGOT) og alaninaminotransferase (ALAT eller SGPT) skal være ≤ 3 gange den normale øvre grænseværdi.
Alkaline phosphatase (AP), aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) should be ≤ 3 times upper limit of normal.
Dosisjusteringer:
Dose Adjustments:
Dosisjusteringer i begyndelsen af en efterfølgende cyklus skal baseres på hæmatologisk nadir eller den maksimale ikke- hæmatologiske toksicitet fra den foregående behandlingscyklus.
Dose adjustments at the start of a subsequent cycle should be based on nadir haematologic counts or maximum non-haematologic toxicity from the preceding cycle of therapy.
Tabel 1 – Dosisjustering for ALIMTA (som enkeltstof eller i kombination) OG cisplatin – hæmatologisk toksicitet ANC- nadir < 500 / mm3 og nadir for trombocytter ≥ 50. 000 / mm3
Table 1 - Dose Modification Table for ALIMTA (as single agent or in combination) AND Cisplatin – Haematologic Toxicities
3
Nadir ANC < 500 / mm3 and nadir platelets ≥ 50,000 / mm3 Nadir platelets < 50,000 / mm3 regardless of nadir ANC Nadir platelets < 50,000/ mm3 with bleedinga, regardless of nadir ANC. a
75% af tidligere dosis (både ALIMTA og cisplatin).
75% of previous dose (both ALIMTA and cisplatin).
50% af tidligere dosis (begge stoffer)
50% of previous dose (both drugs).
Disse kriterier opfylder National Cancer Institute Common Toxicity Criteria (CTC v2. 0; NCI 1998) definition på ≥CTC grad 2 blødning.
These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition of ≥ CTC Grade 2 bleeding
Hvis patienter udvikler ikke- hæmatologisk toksicitet ≥ grad 3 (undtagen neurotoksicitet), skal behandlingen med ALIMTA seponeres, indtil patientens værdier er nået ned på eller under niveauet fra før behandlingen.
If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), ALIMTA should be withheld until resolution to less than or equal to the patient’ s pre-therapy value.
3 Tabel 2 – Dosisjustering for ALIMTA (som enkeltstof eller i kombination) OG cisplatin – ikke- hæmatologisk toksicitet a, b
3 Table 2 - Dose Modification Table for ALIMTA (as single agent or in combination) and Cisplatin– Non-haematologic Toxicities a, b
Dosis af ALIMTA 2 (mg/ m)
of ALIMTA 2 (mg/ m)
Dosis af cisplatin (mg/ m2)
Dose for cisplatin (mg/ m2)
75% af tidligere dosis
75% of previous dose
Mucositis af grad 3 eller 4 a
Grade 3 or 4 mucositis a
50% af tidligere dosis
50% of previous dose
100% af tidligere dosis
100% of previous dose b
National Cancer Institute Common Toxicity Criteria (CTC v 2. 0; NCI 1998) b Undtagen neurotoksicitet
National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
I tilfælde af neurotoksicitet er den anbefalede dosisjustering for ALIMTA og cisplatin angivet i tabel 3.
In the event of neurotoxicity, the recommended dose adjustment for ALIMTA and cisplatin is documented in Table 3.
Tabel 3 – Dosisjustering for ALIMTA (som enkeltstof eller i kombination) OG cisplatin – neurotoksicitet CTCa- grad
Table 3 - Dose Modification for ALIMTA (as single agent or in combination) and Cisplatin – Neurotoxicity
Dosis af ALIMTA (mg/ m2)
Dose of ALIMTA (mg/ m2)
0- 1
0– 1
100% af tidligere dosis
100% of previous dose
2
2 a
National Cancer Institute Common Toxicity Criteria (CTC v 2. 0; NCI 1998)
National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Behandlingen med ALIMTA skal afbrydes, hvis patienten efter to dosisreduktioner oplever hæmatologisk eller ikke- hæmatologisk toksicitet af grad 3 eller 4 eller omgående, hvis der observeres neurotoksicitet af grad 3 eller 4.
Treatment with ALIMTA should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 doses reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Der er i kliniske forsøg ikke fundet tegn på, at patienter på 65 år eller ældre har forøget risiko for bivirkninger sammenlignet med patienter under 65 år.
In clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
ALIMTA anbefales ikke til børn under 18 år, pga. utilstrækkelige data vedrørende sikkerhed og effekt.
ALIMTA is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy.
Patienter med nedsat nyrefunktion (standardformel, der er udviklet af Cockcroft og Gault, eller glomerulær filtrationshastighed baseret på Tc99m- DPTA- serum- clearancemetoden):
Patients with Renal Impairment (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA serum clearance method):
I kliniske forsøg krævede patienter med en kreatinin - clearance på ≥ 45 ml/ min ingen særlige dosisjusteringer ud over de, der anbefales til alle patienter.
In clinical studies, patients with creatinine clearance of ≥ 45 ml/ min required no dose adjustments other than those recommended for all patients.
4. 4).
There are insufficient data on the use of pemetrexed in patients with creatinine clearance below 45 ml/ min; therefore the use of pemetrexed is not recommended (see section 4.4).
Patienter med nedsat leverfunktion:
Patients with Hepatic Impairment:
Der er ikke fundet nogen sammenhæng mellem ASAT (SGOT), ALAT (SGPT) eller total bilirubin og pemetrexeds farmakokinetik.
No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified.
Der er dog ikke foretaget specifikke forsøg med patienter med nedsat leverfunktion såsom bilirubin > 1, 5 gange den normale øvre grænseværdi og/ eller transferase > 3, 0 gange den normale øvre grænseværdi (uden forekomst af levermetastaser) eller > 5, 0 gange den normale øvre grænseværdi (med forekomst af levermetastaser).
However patients with hepatic impairment such as bilirubin > 1.5 times the upper limit of normal and/ or transaminase > 3.0 times the upper limit of normal (hepatic metastases absent) or > 5.0 times the upper limit of normal (hepatic metastases present) have not been specifically studied.
4. 6).
4 Breast-feeding must be discontinued during pemetrexed therapy (see section 4.6).
4. 5).
Concomitant yellow fever vaccine (see section 4.5).
4. 8).
Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia and anaemia (or pancytopenia) (see section 4.8).
Under behandlingen skal patienten monitoreres for myelosuppression, og pemetrexed må ikke gives til patienter, før det absolutte neutrofiltal (ANC) igen er ≥ 1. 500 celler/ mm3, og trombocyt - tallet igen er ≥ 100. 000 celler/ mm3.
Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1500 cells/ mm3 and platelet count returns to ≥ 100,000 cells/ mm3.
4. 2).
Dose reductions for subsequent cycles are based on nadir ANC, platelet count and maximum non-haematologic toxicity seen from the previous cycle (see section 4.2).
Der blev observeret en mindre toksicitet og en reduktion i antallet af hæmatologiske og ikke - hæmatologiske toksiciteter af grad 3/ 4 såsom neutropeni, febril neutropeni og infektion med neutropeni af grad 3/ 4, når patienterne var i forbehandling med folsyre og B12- vitamin.
Less toxicity and reduction in Grade 3/ 4 haematologic and non-haematologic toxicities such as neutropenia, febrile neutropenia and infection with Grade 3/ 4 neutropenia were reported when pre-treatment with folic acid and vitamin B12 was administered.
4. 2).
Therefore, all patients treated with pemetrexed must be instructed to take folic acid and vitamin B12 as a prophylactic measure to reduce treatment-related toxicity (see section 4.2).
4. 2).
Pre-treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions (see section 4.2).
Der er ikke foretaget forsøg med tilstrækkeligt mange patienter med en kreatinin- clearance på under 45 ml/ min.
An insufficient number of patients has been studied with creatinine clearance of below 45 ml/ min.
4. 2).
Therefore, the use of pemetrexed in patients with creatinine clearance of < 45 ml/ min is not recommended (see section 4.2).
Patienter med mild til moderat nyreinsufficiens (kreatinin- clearance på 45- 79 ml/ min) skal undgå at tage non- steroide anti- inflammatoriske lægemidler (NSAID- præparater) såsom ibuprofen og acetyl - salicylsyre (> 1, 3 g daglig) i mindst 2 dage inden, på dagen for og i mindst 2 dage efter indgift af pemetrexed (se pkt.
Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/ min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) as ibuprofen, and aspirin (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
4. 5).
All patients eligible for pemetrexed therapy should avoid taking NSAIDs with long elimination half- lives for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.5).
Mange af de patienter, der oplevede disse bivirkninger, havde underliggende risikofaktorer for udviklingen af nyrepåvirkninger inklusive dehydrering, tidligere hypertension eller diabetes.
Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Effekten af ekstracellulær væske, såsom pleuraekssudater eller ascites, på pemetrexed kendes ikke.
The effect of third space fluid, such as pleural effusion or ascites, on pemetrexed is unknown.
Hos patienter med en klinisk signifikant mængde ekstracellulær væske bør det overvejes at dræne ekssudatet inden indgift af pemetrexed.
In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to pemetrexed administration.
Patienter skal derfor have modtaget passende anti - emetisk behandling og relevant hydrering inden og/ eller efter behandlingen.
Therefore, patients should receive adequate antiemetic treatment and appropriate hydration prior to and/ or after receiving treatment.
Under kliniske forsøg med pemetrexed er der ikke almindeligt rapporteret om svære kardiovaskulære hændelser herunder myokardieinfarkt og cerebrovaskulære hændelser sædvanligvis når pemetrexed gives i kombination med et andet cytotoksisk lægemiddelstof.
Serious cardiovascular events, including myocardial infarction and cerebrovascular events have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
4. 8).
Most of the patients in whom these events have been observed had pre- existing cardiovascular risk factors (see section 4.8).
4. 3 og 4. 5).
As a result, concomitant use of live attenuated vaccines (except yellow fever which is contraindicated) is not recommended (see section 4.3 and 4.5).
5 Pemetrexed kan have skadelige genetiske virkninger.
5 Pemetrexed can have genetically damaging effects.
4. 6).
Women of childbearing potential must use effective contraception during treatment with pemetrexed (see section 4.6).
Samtidig behandling med nefrotoksiske lægemidler (f. eks. aminoglycosid, loop - diuretika, platinforbindelser, cyclosporin) kan resultere i forsinket clearance af pemetrexed.
Concomitant administration of nephrotoxic drugs (e. g. aminoglycoside, loop diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of pemetrexed.
Patientens kreatinin- clearance skal om nødvendigt monitoreres nøje.
If necessary, creatinine clearance should be closely monitored.
Samtidig indgivelse af præparater, som også udskilles tubulært (f. eks. probenecid, penicillin), kan resultere i en forsinket clearance af pemetrexed.
Concomitant administration of substances that are also tubularly secreted (e. g. probenecid, penicillin) could potentially result in delayed clearance of pemetrexed.
Hos patienter med en normal nyrefunktion (kreatinin- clearance ≥ 80 ml/ min) kan høje doser af non - steroide anti- inflammatoriske lægemidler (NSAID- præparater såsom ibuprofen > 1600 mg/ dag) og acetylsalicylsyre i høje doser (≥ 1, 3 g daglig) nedsætte udskillelsen af pemetrexed, og dermed øge forekomsten af bivirkninger relateret til pemetrexed.
In patients with normal renal function (creatinine clearance > 80 ml/ min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/ day) and aspirin at higher dosage (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Der skal derfor udvises forsigtighed ved indgift af højere doser af NSAID- præparater eller acetylsalicylsyre samtidig med pemetrexed hos patienter med normal nyrefunktion (kreatinin- clearance ≥ 80 ml/ min).
Therefore, caution should be made when administering higher doses of NSAIDs or aspirin at higher dosage, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 ml/ min).
Hos patienter med let til moderat nyreinsufficiens (kreatinin- clearance 45- 79 ml/ min) bør samtidig administration af pemetrexed og NSAID- præparater (for eksempel ibuprofen) eller acetylsalicylsyre i højere doser undgås 2 dage inden, på behandlingsdagen og i mindst 2 dage efter indgift af pemetrexed (se pkt.
In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/ min), the concomitant administration of pemetrexed with NSAIDs (e. g. ibuprofen) or aspirin at higher dosage should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
4. 4).
In the absence of data regarding potential interaction with NSAIDs having longer half-lives as piroxicam or rofecoxib, the concomitant administration with pemetrexed should be avoided for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Resultaterne af in vitro- forsøg med humane levermikrosomer tyder på, at pemetrexed ikke burde forårsage en klinisk signifikant inhibition af den metaboliske clearance af lægemidler, der metaboliseres af CYP3A, CYP2D6, CYP2C9 og CYP1A2.
Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of drugs metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
På grund af den forøgede risiko for trombotiske komplikationer hos cancerpatienter anvendes anti - koagulationsbehandling ofte til disse patienter.
Due to the increased thrombotic risk in patients with cancer, the use of anticoagulation treatment is frequent.
Den høje intra- individuelle variation i koagulations - status under sygdomsforløb og risikoen for interaktion mellem orale antikoagulantia og kemoterapi mod cancer kræver hyppigere monitorering af INR (International Normalised Ratio), hvis der træffes beslutning om at behandle patienten med orale antikoagulantia.
The high intra-individual variability of the coagulation status during diseases and the possibility of interaction between oral anticoagulants and anticancer chemotherapy require increased frequency of INR (International Normalised Ratio) monitoring, if it is decided to treat the patient with oral anticoagulants.
Følgende samtidig brug er kontraindiceret:
Concomitant use contraindicated:
4. 3).
Yellow fever vaccine: risk of fatal generalised vaccinale disease (see section 4.3).
6 Følgende samtidig brug frarådes:
Concomitant use not recommended:
Levende svækkede vacciner (med undtagelse af gul feber, for hvilken samtidig brug er kontraindiceret): risiko for systemisk sygdom med mulig dødelig udgang.
The risk is increased in
Risikoen øges hos patienter, som i forvejen har et svækket immunforsvar på grund af deres tilgrundliggende sygdom.
6 subjects who are already immunosuppressed by their underlying disease.
4. 4).
Use an inactivated vaccine where it exists (poliomyelitis) (see section 4.4).
Der foreligger ingen data om brugen af pemetrexed til gravide kvinder, men ligesom andre anti- meta - bolitter formodes pemetrexed at kunne forårsage alvorlige fødselsdefekter, hvis det indgives under graviditeten.
There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other anti-metabolites, is suspected to cause serious birth defects when administered during pregnancy.
4. 4).
Pemetrexed should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus (see section 4.4).
Kvinder i den fødedygtige alder skal anvende effektive svangerskabsforebyggende midler under behandlingen med pemetrexed.
Women of childbearing potential must use effective contraception during treatment with pemetrexed.
Pemetrexed kan have genetisk skadende effekt.
Pemetrexed can have genetically damaging effects.
Det frarådes, at køns - modne mænd gør en kvinde gravid under behandlingen og i op til 6 måneder efter behandlingen.
Sexually mature males are advised not to father a child during the treatment and up to 6 months thereafter.
Det vides ikke, om pemetrexed udskilles i modermælken hos mennesker, og det kan ikke udelukkes, at det kan have bivirkninger for spædbarnet.
It is not known whether pemetrexed is excreted in human milk and adverse reactions on the suckling child cannot be excluded.
4. 3).
Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
Patienten skal derfor advares mod at køre bil eller betjene maskiner, hvis han/ hun oplever træthed.
Therefore patients should be cautioned against driving or operating machines if this event occurs.
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev rapporteret hos > 5% af 168 patienter med mesotheliom, som var randomiseret til behandling med cisplatin og pemetrexed, og 163 patienter med mesotheliom, som var randomiseret til enkeltstofbehandling med cisplatin.
The table below provides the frequency and severity of undesirable effects that have been reported in > 5% of 168 patients with mesothelioma who were randomised to receive cisplatin and pemetrexed and 163 patients with mesothelioma randomised to receive single agent cisplatin.
I begge behandlingsarme fik disse patienter, som ikke tidligere havde været i kemoterapi, fuldt tilskud af folsyre og B12- vitamin.
In both treatment arms, these chemonaive patients were fully supplemented with folic acid and vitamin B12.
Bivirkninger Hyppighed:
Adverse reactions Frequency estimate:
Meget almindelig (≥1/ 10), almindelig (≥1/ 100 og < 1/ 10), usædvanlig (≥1/ 1000 og < 1/ 100), sjælden (≥1/ 10. 000 og < 1/ 1000), meget sjælden (< 1/ 10. 000) og ukendt (kan ikke vurderes ud fra tilgængelige data/ spontane rapporter).
Very common (≥ 1/ 10), Common (≥ 1/ 100 and < 1/ 10), Uncommon (≥ 1/ 1000 and < 1/ 100), Rare (≥ 1/ 10,000 and < 1/ 1000), Very Rare (<  1/ 10,000) and Not known (cannot be estimated from available data-spontaneous reports)
7 Organsystem - klasse
7 System Organ
Bivirkning *
Event*
Pemetrexed/ cisplatin (n = 168)
Pemetrexed/ cisplatin (N = 168)
Cisplatin (n = 163)
Cisplatin (N = 163)
Toksicitet i Toksicitet i alle grader grad 3- 4 (%) (%)
Toxicity Toxicity (%) (%)
Toksicitet i Toksicitet alle grader i grad 3- 4 (%) (%)
Toxicity Toxicity (%) (%)
Blod og lymfesystem
Blood and Lymphatic System
Nedsat neutrofiler / granulocyter
Neutrophils/ Granulocytes decreased
Nedsat leukocytter
Disorders
53, 0 14, 9
Leukocytes decreased
16, 6
53.0 14.9
0, 6
16.6 0.6
0, 0
10.4 0.0
Øjne
Eye Disorders
Mave - tarmkanalen
Gastrointestinal Disorders
Diarré Opkastning Stomatitis / pharyngitis
Diarrhoea Vomiting Stomatitis/ Pharyngitis
0, 0 4, 3 0, 0
8.0 0.0 49.7 4.3 6.1 0.0
Kvalme Anoreksi Forstoppelse
Nausea Anorexia Constipation
5, 5 0, 6 0, 6
76.7 5.5 14.1 0.6 7.4 0.6
Almene symptomer og reaktioner på administra - tionsstedet
General Disorders
42, 3
42.3
Sensorisk neuropati
Neuropathy- Sensory
Smagsforstyr - relser
Taste disturbance
Nedsat kreatinin - clearance **
Creatinine clearance decreased**
Hud og
Skin and Subcutaneous
subkutane væv
Tissue Disorders