natgillin/translations-raw huggingface dataset:
Ingen dosisjusteringer, baseret på andre kendte co- varianter (køn, proteinuri, race og alder), er nødvendige for patienter efter allogen nyretransplantation.
No dosage adjustments based on other identified covariates (gender, proteinuria, race and age) are required for renal allograft patients.
Farmakokinetiske og farmakodynamiske egenskaber blev vurderet på 61 pædiatriske patienter behandlet med en dosis Zenapax på 1 mg/ kg i. v. hver 14. dag til ialt 5 doser.
Pharmacokinetic and pharmacodynamic properties were evaluated in 61 paediatric patients treated with 1 mg/ kg IV dose of Zenapax every 14 days for a total of 5 doses.
a lg Peak serum koncentrationer (peak ± SD) øgedes mellem den første dose (16 ± 12 µg/ ml) og den femte dose (21 ± 14 µg/ ml).
Peak serum concentrations (peak + SD) rose between the first dose (16 + 12 µg/ ml) and the fifth dose (21 + 14 µg/ ml).
Middel trough serum koncentrationen var 5, 0 ± 2, 7 µg/ ml før den femte dose.
The mean trough serum concentration before the fifth dose was 5.0 + 2.7 µg/ ml.
Tac- delen af IL- 2 receptoren blev mættet umiddelbart efter første dosis på 1, 0 mg/ kg daclizumab og
The Tac
ls forblev mættet i mindst 3 måneder efter transplantationen.
7 subunit of the IL-2 receptor was saturated immediately after the first dose of 1.0 mg/ kg of daclizumab and remained saturated for at least the first three months post-transplant.
Mætningen af Tac- delen af IL- 2 receptoren var den samme som observeredes hos voksne patienter som fik samme dosis.
Saturation of the Tac subunit of the IL-2 receptor was similar to that observed in adult patients receiving the same dose regimen.
t ti Der er ingen farmakokinetisk interaktion mellem Zenapax og mycophenolsyre, mycophenolatmofetils
There is no pharmacokinetic interaction between Zenapax and mycophenolic acid, the active metabolite of mycophenolate mofetil (CellCept).
to subkutant, i doser fra 50 til 125 mg/ kg og efter 28 dages administration af 15 mg/ kg til aber.
ed Daclizumab was well tolerated after single bolus intravenous or subcutaneous doses ranging from 50 to 125 mg/ kg in mice, rats, and rabbits and after 28 days administration of 15 mg/ kg to monkeys.
Der opretholdtes acceptable au daclizumabkoncentrationer hos alle 18 aber bortset fra 2 som udviklede anti- daclizumabantistoffer.
There was
I de undersøgte ere
ori no cross reactivity in-vitro between daclizumab and human cryosections (28 organs) at concentrations up to 56 mg/ ml, demonstrating the absence of non-specific binding.
standard tests var daclizumab ikke genotoksisk.
Daclizumab was not genotoxic in standard tests.
Et præklinisk reproduktionstoxicitetsstudie med daclizumab har vist en øget risiko for tidlig prænatal ng
However, the data show considerable
Det totale antal af læ
ra inter-animal variation and were within the historical control range for this species.
prænatale dødsfald for hele drægtighedsperioden varierede fra 20% til 45%.
The overall prenatal losses for the entire gestational period ranged from 20% to 45%.
I det samme prækliniske reproduktionstoxicitetsstudie med daclizumab, hvor cynomolgusaberne fik doser, der svarer til 5- 10 gange normal human dosis (10 mg / kg), udskilte fire ud af syv aber meget r ik
The incidence of stillbirth, caesarean section and breech delivery were comparable between the control and treatment groups. ge In the same non-clinical reproduction toxicity study with daclizumab, four out of seven lactating lon cynomolgus monkeys given a 5 – 10 fold multiple (10 mg/ kg) of the normal human dose were found to secrete very low levels of daclizumab (0.17 – 0.28% of maternal serum levels) in breast milk. no
FARMACEUTISKE OPLYSNINGER dle
PHARMACEUTICAL PARTICULARS
6. 1 Fortegnelse over hjælpestoffer mi
6.1 List of excipients t uc
Polysorbat 80 Natriumchlorid Natriumdihydrogenphosphat, vandfri ge
Polysorbate 80 Sodium chloride rod
Dinatriumphosphat, vandfri Saltsyre, koncentreret Læ
Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous Hydrochloric acid, concentrated Sodium hydroxide lp
Natriumhydroxid Vand til injektionsvæsker
Water for injections na
Der er ikke set uforligelighed mellem Zenapax og polyvinylchloridposer eller infusionssæt.
No incompatibility between Zenapax and polyvinyl chloride bags or infusion sets has been observed. i dic
6. 3 Opbevaringstid
6.3 Shelf life Me
8 3 år
3 years
Der er påvist kemisk og fysisk stabilitet under anvendelsen i 24 timer ved 2 °C- 8 °C eller i 4 timer ved 25 °C.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C - 8 °C or for 4 hours at 25 °C.
a lg 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
ls
8
- Opbevares i køleskab (2 °C - 8 °C).
- Store in a refrigerator (2 °C – 8 °C).
ere 6. 5 Emballage (art og indhold)
6.5 Nature and contents of container
ris Ikke alle pakningsstørrelser er nødvendigvis markedsført.
Not all pack sizes may be marketed.
to 6. 6 Særlige forholdsregler ved bortskaffelse au Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i overenstemmelse med lokale krav. ere
s Any unused product or waste material should be disposed of in accordance with local requirements.
Instruktioner for brug og håndtering
ori Instructions for use and handling
Zenapax må IKKE injiceres direkte.
uth Zenapax is NOT for direct injection.
Det skal fortyndes med 50 ml steril 0, 9% natriumkloridopløsning ng
It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before intravenous administration to the patients.
Opløsningen må ikke rystes.
For mixing the solution, do not shake, gently invert the bag in order to avoid foaming.
Pas på at bevare opløsningen steril da den ikke indeholder læ
Care must be taken to assure sterility of prepared
antimikrobielle konserveringsmidler eller bakteriostatiske stoffer.
ra solution, since the drug product does not contain any antimicrobial preservative or bacteriostatic agents.
Når infusionsopløsningen er tilberedt skal den straks indgives ke
Once the infusion ge is prepared it should be administered intravenously immediately.
Hvis fortyndingen er sket aseptisk kan infusionsvæsken opbevares i 24 timer i køleskab ved 2 °C - 8 °C eller i 4 timer ved 25 °C. r ik
If diluted aseptically it may be stored for 24 hours when refrigerated between 2 °C - 8 °C or for 4 hours at 25 °C. lon Other drug/ substances should not be added or infused simultaneously through the same intravenous line. no
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN dle
MARKETING AUTHORISATION HOLDER t
Roche Registration Limited mi
Roche Registration Limited uc
6 Falcon Way Shire Park Welwyn Garden City ge
6 Falcon Way Shire Park rod
AL7 1TW Storbritannien Læ
Welwyn Garden City AL7 1TW United Kingdom lp
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
MARKETING AUTHORISATION NUMBER(S) na
EU/ 1/ 99/ 098/ 001 (pakning med 1 hætteglas) EU/ 1/ 99/ 098/ 002 (pakning med 3 hætteglas)
EU/ 1/ 99/ 098/ 001 (single vial pack) EU/ 1/ 99/ 098/ 002 (3 vial pack) i dic
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Me
9 Dato for første tilladelse:
Date of first authorisation:
26 februar 1999 Dato for genregistrering:
26 February 1999 Date of renewal:
10 a lg ls t ti ere ris to BILAG II au ere
9 s ed ori uth ra ANNEX II ge lon A.
FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE ng
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE no
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN læ ke r ik te dle mi ge Læ
CONDITIONS OF THE MARKETING AUTHORISATION t uc rod lp ina dic Me
FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
10 A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
340 Kingsland Street Nutley
340 Kingsland Street Nutley
a lg New Jersey USA
ed New Jersey USA
ls Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
s Name and address of the manufacturer responsible for batch release
t ti Roche Pharma AG Emil- Barell- Str.
ori Roche Pharma AG Emil-Barell-Str.
ere D- 79639 Grenzach- Wyhlen TYSKLAND
uth D-79639 Grenzach-Wyhlen GERMANY
ris B.
ra B.
to • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF au MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
● THE MARKETING AUTHORISATION HOLDER ge CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON lon Medicinal product subject to restricted medical prescription (see Annex I:
Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I:
Summary of Product Characteristics, section 4.2). no
• BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET ng
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT t
Ikke relevant. læ
Not applicable. uc
• ANDRE BETINGELSER ke r ik te dle mi ge Læ
● OTHER CONDITIONS rod lp i na dic Me
12 Læ ge mi dle te r ik ke læ
12 Me dic ina lp rod uc t
13 ng BILAG III ere au ETIKETTERING OG INDLÆGSSEDDEL
LABELLING lon ge ra uth ori sed PARTICULARS TO APPEAR ON THE OUTER PACKAGING
mi dle te
OUTER CARTON
to
1.
ETIKETTERING au
NAME OF THE MEDICINAL PRODUCT
to
ed Zenapax 5 mg/ ml concentrate for solution for infusion Daclizumab
ris ere
s ori 2.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
STATEMENT OF ACTIVE SUBSTANCE(S)
LÆGEMIDLETS NAVN
uth Daclizumab*………… 5 mg per 1 ml infusion
1 hætteglas á 5 ml indeholder 25 mg daclizumab * (5 mg/ ml).
One vial of 5 ml contains 25 mg of daclizumab* (5 mg/ ml).
LISTE OVER HJÆLPESTOFFER ere
ra * Recombinant humanized IgG1 anti-Tac antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology.
Polysorbat 80; natriumchlorid; natriumdihydrogenphosphat, vandfri; dinatriumphosphat, vandfri; saltsyre, koncentreret; natriumhydroxid; vand til injektionsvæsker. ng læ
LIST OF EXCIPIENTS ge lon Polysorbate 80, sodium chloride, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injection. no
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
PHARMACEUTICAL FORM AND CONTENTS t uc
1 hætteglas á 5 ml ke r ik
1 vial of 5 ml rod
Intravenøs infusion efter fortynding te
Intravenous use, for infusion after dilution lp
Læs indlægssedlen inden brug dle
Read the package leaflet before use na
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN mi
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN i dic
Opbevares utilgængeligt for børn ge Læ
Keep out of the reach and sight of children Me
15 Opbevares i køleskab (2 °C - 8 °C) Må ikke nedfryses Opbevares i den originale yderpakning for at beskytte mod lys
14 Store in a refrigerator (2 °C – 8 °C) Do not freeze Store in the original package in order to protect from light
a lg 11.
ed 11.
ls Roche Registration Limited
s ori Roche Registration Limited 6 Falcon Way
ere Welwyn Garden City AL7 1TW Storbritannien
uth Shire Park Welwyn Garden City AL7 1TW United Kingdom
ris
ra 12.
EU/ 1/ 99/ 098/ 001
EU/ 1/ 99/ 098/ 001 ge lon
ere
13.
au
Batch t uc
FREMSTILLERENS BATCHNUMMER
GENERAL CLASSIFICATION FOR SUPPLY
Batch ng læ
Medicinal product subject to medical prescription rod
GENEREL KLASSIFIKATION FOR UDLEVERING
INSTRUCTIONS ON USE lp na
Receptpligtigt lægemiddel ke r ik
INFORMATION IN BRAILLE i dic Me
INSTRUKTIONER VEDRØRENDE ANVENDELSEN te
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
a lg Zenapax 5 mg/ ml koncentrat til infusionsvæske, opløsning Daclizumab
ed Zenapax 5 mg/ ml concentrate for solution for infusion Daclizumab
ls t ti 2.
s ori 2.
1 ml infusionsvæske -
uth Daclizumab*………… 5 mg per 1 ml infusion
3 hætteglas á 5 ml ke r ik
3 vials of 5 ml each rod
17 Opbevares i køleskab (2 °C - 8 °C) Må ikke nedfryses Opbevares i den originale yderpakning for at beskytte mod lys
16 Store in a refrigerator (2 °C – 8 °C) Do not freeze Store in the original package in order to protect from light
EU/ 1/ 99/ 098/ 002
EU/ 1/ 99/ 098/ 002 ge lon
FREMSTILLERENS BATCHNUMMER
BATCH NUMBER no
Batch ng læ
Batch t uc
Receptpligtigt lægemiddel ke r ik
Medicinal product subject to medical prescription rod
INSTRUKTIONER VEDRØRENDE ANVENDELSEN te
INSTRUCTIONS ON USE lp na
INFORMATIONER I BRAILLE- SKRIFT dle mi ge Læ
INFORMATION IN BRAILLE i dic Me
a lg Zenapax 5 mg/ ml koncentrat til infusionsvæske, opløsning Daclizumab
Zenapax 5 mg/ ml concentrate for solution for infusion
ls t ti 2.
s 2.
ere Til intravenøs anvendelse efter fortynding Læs indlægssedlen inden brug
uth Read the package leaflet before use
to EXP au 4.
EXP
Batch ng
BATCH NUMBER ge lon Batch no
5 ml ke
5 ml uc rod
19 Læ ge mi dle te r ik ke læ
19 no lon B.
INDLÆGSSEDDEL au
PACKAGE LEAFLET ge ra uth ori sed PACKAGE LEAFLET:
Zenapax 5 mg/ ml koncentrat til infusionsvæske, opløsning Daclizumab
Zenapax 5 mg/ ml concentrate for solution for infusion Daclizumab
kunne skade dem, selv om deres symptomer er de samme som Deres egne.
ed if their symptoms are the same as yours.
ls nævnt i denne indlægsseddel, bør de fortælle det til Deres læge eller apotek.
please tell your doctor or pharmacist.
t ti Denne indlægsseddel fortæller:
What Zenapax is and what it is used for
ere 1.
uth 2.
Hvad Zenapax er, og hvad det anvendes til 2.
Before you use Zenapax 3.
Hvad De skal gøre, før De begynder at anvende Zenapax 3.
How to use Zenapax 4.
Hvordan De anvender Zenapax
Possible side effects
ris 4.
ra 5.
Hvordan De opbevarer Zenapax 6.
How to store Zenapax 6.
to au 1.
ge lon 1.
HVAD ZENAPAX ER, OG HVAD DET ANVENDES TIL ere
WHAT ZENAPAX IS AND WHAT IT IS USED FOR
Disse lægemidler hjælper med at undertrykke din krops naturlige reaktion til at afstøde dit transplanterede organ. ng
These medicines help to suppress your body’ s natural response to reject your transplanted organ. no
Daclizumab er et humaniseret monoklonalt antistof fremstilles i en murin NSO myelom cellelinje under anvendelse af glutamin synthetase (GS) ekspressions system (NS_ GSO) ved rekombinant DNA læ
Daclizumab is a humanised monoclonal antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology. t
teknologi.
called antigens.
Monoklonale antistoffer er proteiner som specifikt genkender og bindes til andre unikke proteiner i organismen som kaldes antigener.
Daclizumab binds to an antigen found on the surface of specific white blood cells called T lymphocytes.
Daclizumab bindes til et antigen som ligger på ke
This activity suppresses the body ’ s natural immune response which otherwise rod
overfladen af specielle hvide blodlegemer, T- lymfocytter.
might cause transplant rejection.
Zenapax anvendes sammen med andre immunosuppressive lægemidler, inklusive ciclosporin og kortikosteroider. te
Zenapax is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids. lp na
HVAD DE SKAL GØRE, FØR DE BEGYNDER AT ANVENDE ZENAPAX dle
BEFORE YOU USE ZENAPAX
De bør ikke anvende Zenapax anvendes:
Do not use Zenapax i dic
- hvis De er allergisk (overfølsom) over for daclizumab eller et af de øvrige indholdsstoffer i
- if you are allergic (hypersensitive) to daclizumab or to any of the other ingredients of Zenapax.
Zenapax.
- if you are breast-feeding.
ge
Me
Læ
Please read the section below on breast-feeding.
Vær særlig forsigtig med at anvende Zenapax:
Take special care with Zenapax
- hvis De nogensinde har haft en overfølsomhedsreaktion over for et andet immunosuppressivt
- if you have ever had an allergic reaction to other immunosuppressive medicines, which help to
lægemiddel som hjælper med at undertrykke kroppens naturlige forsvarsmekanismer.
suppress the body’ s natural defence mechanisms.
Behandling med lægemidler som hjælper med at undertrykke kroppens naturlige forsvarsmekanismer kan øge risikoen for alvorlige sygdomme eller infektioner.
Therapy with medicines which help to suppress the body’ s natural defence mechanisms can increase the risk for developing malignancies or infections.
Zenapax øger ikke denne risiko,, når det anvendes sammen med andre immunosuppresive lægemidler, inklusive ciclosporin og corticosteroider.
Zenapax does not increase this risk when it is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
21 Alvorlige allergiske reaktioner kan forekomme efter indgift af proteiner.
20 Serious allergic reactions may occur following the administration of proteins.
Anvendelse af anden medicin Hvis De tager eller for nylig har taget andre lægemidler, bør De oplyse Deres læge eller apotek herom, også hvis der er tale om ikke- receptpligtige lægemidler.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
a lg af mere end et lægemiddel på samme tid eventuelt kan styrke eller svække effekten af de lægemidler, De tager.
This is extremely important because using more than one medicine at the same time may strengthen or weaken the effect of the medicines you are taking.
Derfor bør Zenapax ikke anvendes sammen med andre lægemidler uden lægens samtykke.
Therefore, Zenapax should not be used with other drugs without your doctor’ s consent.
ls Graviditet og amning De må ikke anvende denne medicin, hvis De ammer.
ed Pregnancy and breast-feeding You must not use this medicine if you are breast-feeding.
t ti De bør ikke anvende denne medicin, hvis De er gravid, med mindre Deres læge beslutter, at det er
s ori You should not use this medicine if you are pregnant unless your doctor decides that it is necessary for you.
Fortæl lægen med det samme, hvis De er gravid,
uth Zenapax may cause damage to your unborn or breast-feeding baby.
Deres læge bør informere Dem om at bruge prævention, før behandlingen med Zenapax starter, under
Tell your doctor straightaway if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.
to behandlingen med Zenapax og i yderligere 4 måneder efter den sidste dosis af Zenapax.
ra Your doctor should advise you about using contraception before treatment with Zenapax is started, during treatment with Zenapax, and for an additional 4 months following the last dose of Zenapax.
Bilkørsel og betjening af maskiner au Der er ingen holdepunkter for at antage, at Zenapax påvirker evnen til at føre motorkøretøj eller ere
ge
betjene maskiner. ng
There is no evidence to indicate that Zenapax has an effect on your ability to drive a car or operate lon machinery.
HVORDAN DE ANVENDER ZENAPAX
HOW TO USE ZENAPAX no
Det skal fortyndes med 50 ml steril natriumchlorid læ
It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before administration to patients. t uc
En læge/ sygeplejerske vil give en passende dosis (normalt 1 mg/ kg legemsvægt) i form af en intravenøs infusion, der varer ca.. 15 minutter.
A health care professional will give you a suitable dose (normally 1 mg/ kg of body weight) in the form of an intravenous infusion over a 15- minute period.
Den første dosis gives 24 timer før transplantationen.
The first dose is given within 24 hours rod
I alt får De 5 doser svarende til en komplet r ik
You will receive 4 subsequent doses which are spaced 14 days apart from each other.
behandling.
In total you should receive 5 doses of Zenapax for a complete treatment course.
Hele behandlingen varer almindeligvis 8 uger. te
A course of treatment usually lasts for 8 weeks. lp
De efterfølgende infusioner får De måske en dag før eller senere end planlagt.
You may receive subsequent infusions within a day before or after the scheduled administration. na
Spørg Deres læge eller apotek, hvis De har yderligere spørgsmål. dle
If you have any further questions on the use of this product, ask your doctor or pharmacist. i dic
HVILKE MULIGE BIVIRKNINGER ZENAPAX HAR mi
POSSIBLE SIDE EFFECTS
Som alle andre lægemidler kan Zenapax have bivirkninger, selvom ikke alle får bivirkninger. ge
Like all medicines, Zenapax can cause side effects, although not everybody gets them.
Hoste og åndenød, Læ
Me
også hvis De ligger ned, opkastning, forvirring og mindre urinafgang end normalt.
Tell your doctor immediately if you notice any of the following side effects occur: cough and shortness of breath, including when laying flat, vomiting, confusion or passing less urine then normal.
- rysten (tremor)
- shaking (tremor)
- forhøjet blodtryk (hypertension)
- high blood pressure (hypertension)
- vejrtrækningsproblemer
- difficulty breathing
- forstoppelse; diarré; opkastning; kvalme; eller halsbrand
- constipation; diarrhoea; vomiting; nausea; or heartburn
- smerter i led og muskler
- pain in joints and muscles
- overskud af væske i kroppen (ødem); opsvulmede arme og ben (perifere ødemer);
- excess fluid in the body (oedema); swelling of the arms and legs (peripheral oedema)
- problemer med sårheling
- problems with wound healing
Almindelige bivirkninger (som forekommer hos mellem 1 og 10 ud af 100) er: betændelse i struben (pharyngitis); løbende næse (rhinitis); diabetes mellitus; højt blodsukker (hyperglykæmi); for meget
Common side effects (occurring in between 1 and 10 patients out of 100) are inflammation of the throat (pharyngitis); runny nose (rhinitis); diabetes mellitus; high blood sugar (hyperglycaemia); fluid overload; dehydration; anxiety; depression; dizziness; sensation of pins and needles; blurred vision;
a lg væske i kroppen; dehydrering,; ængstelse; depression; svimmelhed; prikkende fornemmelse; sløret syn; hjertebanken (tachycardi); blødning (hæmorragi); blodet koagulerer (thrombose); lavt blodtryk (hypotension); ophobning af væske i lymfesystemet i en del af kroppen (lymfocele); alvorlig
ed fast heart rate (tachycardia); bleeding (haemorrhage); blood clot (thrombosis); low blood pressure (hypotension); accumulation of lymph fluid in one part of the body (lymphocele); severe shortness of breath, including when laying flat at night (pulmonary oedema); fluid on the lungs (pleural effusion);
ls kortåndethed, også i liggende stilling (lungeødem), væske på lungerne (pleural effusion), sammenklappende lunger (atelectase); mangel på ilt i kroppen (hypoxi); forstoppelse; hoste; larmende
s collapsed lung (atelectasis); lack of oxygen in the body (hypoxia); congestion; cough; noisy or
t ti eller abnorme vejrtrækningslyde, inklusive rallen; udspilet mave; mavesmerter eller ubehag; luft i tarmen; hæmoroider; udslæt; kløen; acne; nattesved; øget svedtendens; øget hårvækst (hirsutisme);
ori abnormal breath sounds, including crackling breath sounds (rales); bloated stomach; stomach pain or discomfort; flatulence; haemorrhoids; rash; itchy skin; acne; night sweats; increased sweating; excessive hair growth (hirsutism); back pain; muscle cramps, particularly in the legs; pain in the joints
ere rygsmerter; muskelkramper, særlig i benene; smerter i led (artralgi); muskelsmerter (myalgi); brystsmerter; generelle smerter; træthed; hudirritation på injektionsstedet; feber; kulderystelser; generel svaghed; smerter i lænden og ændringer eller besvær med urinafgang (hydronephrosis); blod i
uth (arthralgia); pain in the muscles (myalgia); chest pain; pain in general; tiredness; skin irritation at the site of injection; fever; chills; general weakness; pain in the loins and changes or difficulty in passing urine (hydronephrosis); blood in the urine; pain on passing urine (dysuria); reduced urine output
ris urinen; smerter ved urinafgang (dysuria); mindre mængde urin (oliguria); smerter efter operation.
ra (oliguria); pain following surgery.
Sjældent forekommer allergiske reaktioner (overfølsomhedsreaktioner) overfor Zenapax.
Rarely, allergic reactions (hypersensitivity) to Zenapax may occur. ge Some side effects are more likely to occur in children than in adults, these include diarrhoea, pain lon following surgery, fever, vomiting, high blood pressure, itchy skin, infections of the nose and throat and infections in the urine.