natgillin/translations-raw huggingface dataset:
6.1 eller over for andre sulfonamidderivater (hydrochlorthiazid er et sulfonamidderivat) Graviditet i 2. eller 3. trimester (se pkt.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance <30 ml/min) Refractory hypokalaemia, hypercalcaemia
Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret effekten og sikkerheden af Irbesartan Hydrochlorothiazide Zentiva som inital behandling ved svær hypertension (defineret som SeDBT ≥ 110 mmHg).
Efficacy and safety of Irbesartan Hydrochlorothiazide Zentiva as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, doubleblind, active-controlled, 8-week, parallel-arm study.
Lactosemonohydrat Hypromellose Titaniumdioxid (E 171) Macrogol 3000
Titanium dioxide Macrogol 3000
Croscarmellosenatrium Hypromellose Silica
Lactose monohydrate Hypromellose
Hver tablet af Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg tabletter indeholder 300 mg irbesartan og 25 mg hydrochlorthiazid.
Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmovertrukne tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets.
Dosisjustering er ikke nødvendig hos ældre patienter.
No dosage adjustment is necessary inolder people.
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter leveres i blisterpakninger af 14, 28, 56 eller 98 tabletter.
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Dog skal denne faste dosis-kombination gives med forsigtighed til patienter med mild til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min, men < 60 ml/min).
However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but <60 ml/min) this fixed dose combination should be administered with caution.
Zentiva må ikke anvendes til patienter med alvorlig nyrefunktionsnedsættelse (kreatininclearance < 30 ml/min) (se pkt.
Irbesartan Hydrochlorothiazide Zentiva should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Irbesartan Hydrochlorothiazide Zentiva skal tages gennem munden.
Irbesartan Hydrochlorothiazide Zentiva is for oral use.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg tabletter irbesartan/hydrochlorthiazid NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Zentiva k.s.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Hver tablet af Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid.
Each tablet of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter leveres i blisterpakninger á 14, 28, 56 eller 98 tabletter.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Hver filmovertrukken tablet indeholder 38,5 mg lactose (som lactosemonohydrat).
Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
Der er hverken observeret rebound-hypertension for irbesartan eller hydrochlorthiazid.
Although not specifically studied with the Irbesartan Hydrochlorothiazide Zentiva, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Zentiva k.s.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Dog skal denne faste dosis-kombination gives med forsigtighed til patienter med mildt til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min, men < 60 ml/min).
However, in patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min but <60 ml/min) this fixed dose combination should be administered with caution.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Zentiva k.s.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmovertrukne tabletter er lyserød, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2788 på den anden side.
What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets are pink, biconvex, ovalshaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Hyperkalæmi
cardiac arrhythmias
Hver tablet af Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid.
Each tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Det skal du vide, før du begynder at tage Irbesartan Hydrochlorothiazide Zentiva Sådan skal du tage Irbesartan Hydrochlorothiazide Zentiva Bivirkninger
What Irbesartan Hydrochlorothiazide Zentiva is and what it is used for What you need to know before you take Irbesartan Hydrochlorothiazide Zentiva How to take Irbesartan Hydrochlorothiazide Zentiva Possible side effects
Dosisjustering er ikke nødvendig til patienter med nedsat nyrefunktion, hvis den renale kreatinin-clearance er  30 ml/min (se pkt.
No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥30 ml/min.
EU/1/06/377/001 - 14 tabletter EU/1/06/377/002 - 28 tabletter EU/1/06/377/003 - 56 tabletter EU/1/06/377/004 - 56 x 1 tabletter EU/1/06/377/005 - 98 tabletter
EU/1/06/377/001 - 14 tablets EU/1/06/377/002 - 28 tablets EU/1/06/377/003 - 56 tablets EU/1/06/377/004 - 56 x 1 tablets EU/1/06/377/005 - 98 tablets
EU/1/06/377/006 - 14 tabletter EU/1/06/377/007 - 28 tabletter EU/1/06/377/008 - 56 tabletter EU/1/06/377/009 - 56 x 1 tabletter EU/1/06/377/010 - 98 tabletter
EU/1/06/377/006 - 14 tablets EU/1/06/377/007 - 28 tablets EU/1/06/377/008 - 56 tablets EU/1/06/377/009 - 56 x 1 tablets EU/1/06/377/010 - 98 tablets
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmovertrukne tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets.
EU/1/06/377/017 - 14 tabletter EU/1/06/377/018 - 28 tabletter EU/1/06/377/031 - 30 tabletter EU/1/06/377/019 - 56 tabletter EU/1/06/377/020 - 56 x 1 tabletter EU/1/06/377/021 - 84 tabletter EU/1/06/377/032 - 90 tabletter EU/1/06/377/022 - 98 tabletter
EU/1/06/377/017 - 14 tablets EU/1/06/377/018 - 28 tablets EU/1/06/377/031 - 30 tablets EU/1/06/377/019 - 56 tablets EU/1/06/377/020 - 56 x 1 tablets EU/1/06/377/021 - 84 tablets EU/1/06/377/032 - 90 tablets EU/1/06/377/022 - 98 tablets
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
EU/1/06/377/011 - 14 tabletter EU/1/06/377/012 - 28 tabletter EU/1/06/377/029 - 30 tabletter EU/1/06/377/013 - 56 tabletter EU/1/06/377/014 - 56 x 1 tabletter EU/1/06/377/015 - 84 tabletter EU/1/06/377/030 - 90 tabletter EU/1/06/377/016 - 98 tabletter
EU/1/06/377/011 - 14 tablets EU/1/06/377/012 - 28 tablets EU/1/06/377/029 - 30 tablets EU/1/06/377/013 - 56 tablets EU/1/06/377/014 - 56 x 1 tablets EU/1/06/377/015 - 84 tablets EU/1/06/377/030 - 90 tablets EU/1/06/377/016 - 98 tablets
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmovertrukne tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets.
Indlægsseddel: Information til brugeren Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
EU/1/06/377/023 - 14 tabletter EU/1/06/377/024 - 28 tabletter EU/1/06/377/033 - 30 tabletter EU/1/06/377/025 - 56 tabletter EU/1/06/377/026 - 56 x 1 tabletter EU/1/06/377/027 - 84 tabletter EU/1/06/377/034 - 90 tabletter EU/1/06/377/028 - 98 tabletter
EU/1/06/377/023 - 14 tablets EU/1/06/377/024 - 28 tablets EU/1/06/377/033 - 30 tablets EU/1/06/377/025 - 56 tablets EU/1/06/377/026 - 56 x 1 tablets EU/1/06/377/027 - 84 tablets EU/1/06/377/034 - 90 tablets EU/1/06/377/028 - 98 tablets
Sverige Zentiva, k.s.
Lietuva Zentiva, k.s.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Følgende ændringer, observeret hos rotter og makakaber, der fik en kombination af irbesartan/hydrochlorthiazid på 10/10 og 90/90 mg/kg/dag, blev også set ved anvendelse af de individuelle stoffer og/eller var sekundære til blodtryksnedsættelse (der blev ikke observeret signifikante toksikologiske interaktioner):  nyreforandringer karakteriseret ved let øgning af serum-urea og kreatinin samt hyperplasi/hypertrofi af det juxtaglomerulære apparat, hvilket er en direkte konsekvens af interaktion mellem irbesartan og renin angiotensin systemet; let fald i erytrocytparametre (erytrocytter, hæmoglobin, hæmatokrit);
The following changes, observed in rats and macaques receiving the irbesartan/hydrochlorothiazide combination at 10/10 and 90/90 mg/kg/day, were also seen with one of the two medicinal products alone and/or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed):
Forholdet mellem den laveste og den maksimale effekt af Irbesartan Hydrochlorothiazide Zentiva 150 mg /12,5 mg var 100%, når blodtrykket blev monitoreret ambulant.
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg were 100%.
Om nødvendigt kan Irbesartan Hydrochlorothiazide Zentiva kombineres med andre antihypertensiva (se pkt.
When necessary, Irbesartan Hydrochlorothiazide Zentiva may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmovertrukne tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2875 på den anden side.
What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets are peach, biconvex, ovalshaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmovertrukne tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2876 på den anden side.
What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets are peach, biconvex, ovalshaped, with a heart debossed on one side and the number 2876 engraved on the other side.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2775 på den anden side.
What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2776 på den anden side.
What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets.
Indlægsseddel: Information til brugeren Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Zentiva 150 mg/12,5 mg.  Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg kan gives til patienter, der er utilstrækkeligt regulerede med Irbesartan Hydrochlorothiazide Zentiva 300 mg /12,5 mg.
• Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
Indlægsseddel: Information til brugeren Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets.
Indlægsseddel: Information til brugeren Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Advarsler og forsigtighedsregler Kontakt lægen, før du tager Irbesartan Hydrochlorothiazide Zentiva, hvis du oplever følgende:
Talk to your doctor before taking Irbesartan Hydrochlorothiazide Zentiva and if any of the following apply to you:
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Zentiva 150 mg/12,5 mg.  Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg kan gives til patienter, der er utilstrækkeligt regulerede med Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg.
• Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide
Det er især tilfældet ved nyrefunktionsnedsættelse og/eller hjertesygdom og diabetes mellitus.
Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide Zentiva hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Når en direkte ændring fra monoterapi til de faste kombinationer påtænkes, bør følgende retningslinjer overvejes:  Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg kan gives til patienter, hvis blodtryk ikke kan reguleres tilstrækkeligt med hydrochlorthiazid eller irbesartan 150 mg alene;  Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg kan gives til patienter, der er utilstrækkeligt regulerede med irbesartan 300 mg eller med Irbesartan Hydrochlorothiazide
• Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
120 (60 x 2) kapsler (multipakning)
120 (60 x 2) capsules (multipack)
Hvis dette sker, vil det med størst sandsynlighed ske ved den første dosis.
If this does occur, it is most likely to occur at the first dose.
Dette kan endda være livstruende.
This can even be life threatening.
4866 Unterach am Attersee Østrig
4866 Unterach am Attersee Austria
I nogle tilfælde kan du få brug for en blodtransfusion.
In some cases you may need a blood transfusion.
Denne behandling gentages normalt hver 3. uge.
This pattern of treatment will normally be repeated every three weeks.
Dato for første markedsføringstilladelse: 22. august 2007 Dato for seneste fornyelse: 16. juni 2017
Date of first authorisation: 22 August 2007 Date of latest renewal: 16 June 2017
Disse patienter skal behandles med forsigtighed.
These patients should be treated with caution.
Effekt og sikkerhed var den samme for begge doseringer.
Efficacy and safety were similar for both regimens.
• Tegn på en infektion.
• Signs of infection.
Dette omfatter spontane bivirkningsindberetninger såvel som alvorlige hændelser fra igangværende studier.
This includes spontaneous case reports as well as serious adverse events from ongoing studies.
På grund af små patientpopulationer i dette sygdomsstadie er oplysningerne til støtte for indikationerne baseret på begrænsede data.
Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Følgende yderligere bivirkninger er observeret:
The following additional adverse reactions were seen:
Familieplanlægning bør diskuteres med patienterne efter behov.
Family planning should be discussed with patients as appropriate.
Forklaringen på dette er ikke kendt.
There is no known reason for this.
21 år.
21 days.
Nelarabin bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
Nelarabine should not be used during pregnancy unless clearly necessary.
Atriance anvendes til behandling af patienter med:
Atriance is used to treat patients with:
Dette er en godkendelse under særlige vilkår, og i henhold til artikel 14, stk. 8 i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
This being an approval under exceptional circumstance and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Se indlægssedlen for yderligere information.
See the leaflet for further information.
Lægen vil beslutte, hvor mange behandlingsforløb der kræves.
Your doctor will decide how many treatment cycles are required.
Det unormalt høje antal hvide blodceller kan forekomme i blodet og andre dele af kroppen.
The abnormal high number of white blood cells can appear in the blood and other parts of the body.
(36 %) i pædiatriske patienter] på dag 1.
(36 %) in paediatric patients] on day 1.
Det kan ikke udelukkes, at der er risiko for påvirkning af nyfødte/spædbørn.
A risk to the newborn/infant cannot be excluded.
Dette resulterer i celledød.
This results in cell death.
Mandlige patienter, som ønsker at blive fædre, skal spørge lægen til råds om familieplanlægning eller behandling.
Male patients, who may wish to father a child, should ask their doctor for family planning advice or treatment.
Følgende termer er anvendt til klassifikation af frekvenser: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The following convention has been utilised for the classification of frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Da tidsforløbet for intracellulær ara-GTP var forlænget, kunne dets halveringstid ikke fastsættes nøjagtigt.
Because the timecourse of intracellular ara-GTP was prolonged, its elimination half-life could not be accurately estimated.
Den potentielle risiko for mennesker kendes ikke, men eksponering under graviditet vil sandsynligvis føre til abnormiteter og misdannelser hos fosteret.
The potential risk in humans is unknown, however, exposure during pregnancy will likely lead to anomalies and malformations of the foetus.
Der foreligger ingen eller begrænset data fra anvendelse af nelarabin til gravide kvinder.
There are no or limited amount of data from the use of nelarabine in pregnant women.
Atriance bør ikke anvendes til gravide kvinder.
Atriance is not recommended for pregnant women.
Behandlingen kan variere afhængigt af resultaterne af de regelmæssige blodprøver.
This treatment may vary, depending on the results of regular blood tests.
Atriance kan nedsætte antallet af hvide blodceller og nedsætte din modstandskraft over for en infektion (herunder lungebetændelse).
Atriance may reduce the number of white blood cells and lower your resistance to infection (including pneumonia).
Blodprøver under behandling
Blood tests during treatment
Dette lægemiddel indeholder mindst 23 mg natrium pr. dosis.
This medicine contains at least 23 mg sodium per dose.
Nelarabin er kun til intravenøs anvendelse og må ikke fortyndes før administration.
Nelarabine is for intravenous use only and must not be diluted prior to administration.
Dette kan føre til alvorlig blødning fra forholdsvis små skader, som f.eks små rifter.
This can lead to severe bleeding from relatively small injuries such as a small cut.
Dosis af Atriance skal muligvis justeres.
Your dose of Atriance may need to be adjusted.
Tid til komplet respons i begge responsgrupper varierede mellem 2,9 og 11,7 uger.
Time to complete response in both classifications of response ranged from 2.9 to 11.7 weeks.
• Nedsat blodtryk.
• Lowered blood pressure.