natgillin/translations-raw huggingface dataset:
Derfor frarådes kombination af lithium og Irbesartan Hydrochlorothiazide BMS (se pkt.
Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide BMS is not recommended (see section 4.4).
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/369/017-022
MARKETING AUTHORISATION NUMBERS EU/1/06/369/017-022
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/369/001-005
MARKETING AUTHORISATION NUMBERS EU/1/06/369/001-005
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/369/006-010
MARKETING AUTHORISATION NUMBERS EU/1/06/369/006-010
Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret effekten og sikkerheden af Irbesartan Hydrochlorothiazide BMS som inital behandling ved svær hypertension (defineret som SeDBT ≥ 110 mmHg).
Efficacy and safety of Irbesartan Hydrochlorothiazide BMS as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double-blind, active controlled, 8-week, parallel-arm study.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/369/023-028
MARKETING AUTHORISATION NUMBERS EU/1/06/369/023-028
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/369/011-016
MARKETING AUTHORISATION NUMBERS EU/1/06/369/011-016
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder: irbesartan 150 mg og hydrochlorthiazid 12,5 mg
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains: irbesartan 150 mg and hydrochlorothiazide 12.5 mg
Det skal du vide, før du begynder at bruge Irbesartan Hydrochlorothiazide BMS Sådan skal du bruge Irbesartan Hydrochlorothiazide BMS Bivirkninger
What Irbesartan Hydrochlorothiazide BMS is and what it is used for Before you take Irbesartan Hydrochlorothiazide BMS How to take Irbesartan Hydrochlorothiazide BMS Possible side effects
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder: irbesartan 300 mg og hydrochlorthiazid 25 mg
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 25 mg
INFORMATION I BRAILLE-SKRIFT Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg
INFORMATION IN BRAILLE Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg
genfindes ca. 20% radioaktivitet i urinen og resten i afføringen.
After either oral or intravenous administration of 14C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Hver tablet af Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg tabletter indeholder 300 mg irbesartan og 25 mg hydrochlorthiazid.
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder: irbesartan 300 mg og hydrochlorthiazid 12,5 mg
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 12.5 mg
INFORMATION I BRAILLE-SKRIFT Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg
INFORMATION IN BRAILLE Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg
Der er hverken observeret rebound-hypertension for irbesartan eller hydrochlorthiazid.
Although not specifically studied with the Irbesartan Hydrochlorothiazide BMS, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmovertrukne tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets.
Kartoner med 56 tabletter; 4 blisterkort med 14 tabletter i PVC/PVDC/aluminiumblistere
Cartons of 56 tablets; 4 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Hver tablet af Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tabletter indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid.
Each tablet of Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kartoner med 14 tabletter; 1 blisterkort med 14 tabletter i PVC/PVDC/aluminiumblistere
Cartons of 14 tablets; 1 blister card of 14 tablets in PVC/PVDC/Aluminium blisters.
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tabletter leveres i blisterpakninger á 14, 28, 56 eller 98 tabletter.
Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Hyperkalæmi
hyperkalaemia
DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE IRBESARTAN HYDROCHLOROTHIAZIDE BMS
BEFORE YOU TAKE IRBESARTAN HYDROCHLOROTHIAZIDE BMS
Kartoner med 98 tabletter; 7 blisterkort med 14 tabletter i PVC/PVDC/aluminiumblistere
Cartons of 98 tablets; 7 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Kartoner med 28 tabletter; 2 blisterkort med 14 tabletter i PVC/PVDC/aluminiumblistere
Cartons of 28 tablets; 2 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tabletter leveres i blisterpakninger á 14, 28, 56 eller 98 tabletter.
Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Svimmelhed
dizziness
LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmovertrukne tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets.
De aktive stoffer er irbesartan og hydrochlorthiazid.
What Irbesartan Hydrochlorothiazide BMS contains The active substances are irbesartan and hydrochlorothiazide.
Hver tablet af Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tabletter indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid.
Each tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide BMS 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 BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 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.
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmovertrukne tabletter leveres i blisterpakninger á 14, 28, 56, 84 eller 98 filmovertrukne tabletter.
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
EU/1/06/369/017 - 14 tabletter EU/1/06/369/018 - 28 tabletter EU/1/06/369/019 - 56 tabletter EU/1/06/369/020 - 56 x 1 tabletter EU/1/06/369/021 - 84 tabletter EU/1/06/369/022 - 98 tabletter
EU/1/06/369/017 - 14 tablets EU/1/06/369/018 - 28 tablets EU/1/06/369/019 - 56 tablets EU/1/06/369/020 - 56 x 1 tablets EU/1/06/369/021 - 84 tablets EU/1/06/369/022 - 98 tablets
Amning:
Excipient:
EU/1/06/369/011 - 14 tabletter EU/1/06/369/012 - 28 tabletter EU/1/06/369/013 - 56 tabletter EU/1/06/369/014 - 56 x 1 tabletter EU/1/06/369/015 - 84 tabletter EU/1/06/369/016 - 98 tabletter
EU/1/06/369/011 - 14 tablets EU/1/06/369/012 - 28 tablets EU/1/06/369/013 - 56 tablets EU/1/06/369/014 - 56 x 1 tablets EU/1/06/369/015 - 84 tablets EU/1/06/369/016 - 98 tablets
EU/1/06/369/023 - 14 tabletter EU/1/06/369/024 - 28 tabletter EU/1/06/369/025 - 56 tabletter EU/1/06/369/026 - 56 x 1 tabletter EU/1/06/369/027 - 84 tabletter EU/1/06/369/028 - 98 tabletter
EU/1/06/369/023 - 14 tablets EU/1/06/369/024 - 28 tablets EU/1/06/369/025 - 56 tablets EU/1/06/369/026 - 56 x 1 tablets EU/1/06/369/027 - 84 tablets EU/1/06/369/028 - 98 tablets
LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmovertrukne tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets.
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmovertrukne tabletter leveres i blisterpakninger á 14, 28, 56, 84 eller 98 filmovertrukne tabletter.
Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Hvis du vil have yderligere oplysninger om Irbesartan Hydrochlorothiazide BMS, skal du henvende dig til den lokale repræsentant:
Take special care with Irbesartan Hydrochlorothiazide BMS Tell your doctor if any of the following apply to you:
Dosis:
Lactation:
EU/1/06/369/001 - 14 tabletter EU/1/06/369/002 - 28 tabletter EU/1/06/369/003 - 56 tabletter EU/1/06/369/004 - 56 x 1 tabletter EU/1/06/369/005 - 98 tabletter
EU/1/06/369/001 - 14 tablets EU/1/06/369/002 - 28 tablets EU/1/06/369/003 - 56 tablets EU/1/06/369/004 - 56 x 1 tablets EU/1/06/369/005 - 98 tablets
EU/1/06/369/006 - 14 tabletter EU/1/06/369/007 - 28 tabletter EU/1/06/369/008 - 56 tabletter EU/1/06/369/009 - 56 x 1 tabletter EU/1/06/369/010 - 98 tabletter
EU/1/06/369/006 - 14 tablets EU/1/06/369/007 - 28 tablets EU/1/06/369/008 - 56 tablets EU/1/06/369/009 - 56 x 1 tablets EU/1/06/369/010 - 98 tablets
Kartoner med 84 tabletter; 6 blisterkort med 14 tabletter i PVC/PVDC/aluminiumblistere
Cartons of 84 film-coated tablets; 6 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmovertrukne tabletter leveres i blisterpakninger á 14, 28, 56, 84 eller 98 filmovertrukne tabletter.
Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Irbesartan Hydrochlorothiazide BMS 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 BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 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 BMS 300 mg/25 mg tabletter irbesartan/hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg tablets irbesartan/hydrochlorothiazide
Forholdet mellem den laveste og den maksimale effekt af Irbesartan Hydrochlorothiazide BMS 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 BMS 150 mg/12.5 mg were 100%.
Irbesartan Hydrochlorothiazide BMS 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 BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 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.
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg kan gives til patienter, hvis blodtryk ikke kan reguleres tilstrækkeligt med hydrochlorthiazid eller irbesartan 150 mg alene; Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg kan gives til patienter, der er utilstrækkeligt regulerede med irbesartan 300 mg eller med Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg.
Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
Irbesartan Hydrochlorothiazide BMS 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 BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 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 BMS 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 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 BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 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.
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Hypromellose Silikondioxid
Lactose monohydrate Hypromellose
Lægemidlet må kun udleveres efter recept.
This medicine has been prescribed for you.
LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tabletter
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets.
Irbesartan Hydrochlorothiazide BMS indeholder:
WHAT IRBESARTAN HYDROCHLOROTHIAZIDE BMS IS AND WHAT IT IS USED FOR
Omvendt kan der opstå hyperkaliæmi på grund af irbesartankomponenten i Irbesartan Hydrochlorothiazide BMS.
Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide BMS hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Biograstim til CT Arzneimittel GmbH den 15. september 2008.
The European Commission granted a marketing authorisation valid throughout the EU for Biograstim to CT Arzneimittel GmbH on 15 September 2008.
Andre oplysninger om Biograstim:
Other information about Biograstim:
Det betyder, at Biograstim svarer til et biologisk lægemiddel, som allerede er godkendt i Den Europæiske Union (EU), og som indeholder det samme aktive stof (også kendt som "referencelægemidlet").
This means that Biograstim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Udvalget anbefalede udstedelse af markedsføringstilladelse for Biograstim.
The Committee recommended that Biograstim be given marketing authorisation.
Biograstim kan også anvendes til patienter, der skal donere blodstamceller til transplantation, for at bidrage til at frigøre disse celler fra knoglemarven.
Biograstim can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Biograstim anvendes til at stimulere dannelsen af hvide blodlegemer i følgende tilfælde:
Biograstim is used to stimulate the production of white blood cells in the following situations:
Andre bivirkninger kan optræde hos flere end 1 ud af 10 patienter, afhængig af den tilstand, som Biograstim anvendes til behandling af.
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Biograstim is being used for.
Det aktive stof i Biograstim, filgrastim, svarer i høj grad til et humant protein kaldet granulocyt kolonistimulerende faktor (G-CSF).
The active substance in Biograstim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) BIOGRASTIM EPAR - Sammendrag for offentligheden
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BIOGRASTIM EPAR summary for the public
Den hyppigste bivirkning ved Biograstim (som ses hos mere end 1 ud af hver 10 patienter) er muskelsmerter (smerter i muskler og knogler).
The most common side effect with Biograstim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Den fuldstændige EPAR for Biograstim findes her.
The full EPAR for Biograstim can be found here.
Biograstim bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for filgrastim eller andre af indholdsstofferne.
Biograstim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Biograstim er et ‘biosimilært' lægemiddel.
Biograstim is a ‘biosimilar' medicine.
Biograstim blev sammenlignet med Neupogen og placebo (en virkningsløs behandling) i en hovedundersøgelse af 348 patienter med brystcancer.
Biograstim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
For at undersøge sikkerheden af Biograstim blev der gennemført to undersøgelser af patienter med lungecancer og non-Hodgkin's lymfom (en form for lymfekræft).
To study the safety of Biograstim, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
I løbet af deres første kemoterapicyklus på 21 dage havde patienter behandlet med Biograstim eller Neupogen svær neutropeni i gennemsnitligt 1,1 dag sammenlignet med 3,8 dage hos dem, der fik placebo.
During the first 21-day chemotherapy cycle, patients treated with either Biograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at Biograstim i overensstemmelse med EU's krav har en profil med hensyn til kvalitet, sikkerhed og virkning, som svarer til Neupogen.
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Biograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Den fuldstændige liste over alle de indberettede bivirkninger ved Biograstim fremgår af indlægssedlen.
For the full list of all side effects reported with Biograstim, see the Package Leaflet.
Hvilken risiko er der forbundet med Biograstim?
What is the risk associated with Biograstim?
Referencelægemidlet for Biograstim er Neupogen.
The reference medicine for Biograstim is Neupogen.
Biograstim gives ved injektion under huden eller ved infusion i en vene.
Biograstim is given by injection under the skin or infusion into a vein.
Biograstim gives sædvanligvis på et specialiseret behandlingscenter, selvom de patienter, der får lægemidlet gennem injektion under huden,
Biograstim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Biograstim er en opløsning til injektion eller infusion (drop i en vene).
Biograstim is a solution for injection or for infusion (drip into a vein).
Biograstim blev undersøgt for at påvise, at det er sammenligneligt med referencelægemidlet Neupogen.
Biograstim was studied to show that it is comparable to the reference medicine, Neupogen.
Hvorfor blev Biograstim godkendt?
Why has Biograstim been approved?
Virkningen af Biograstim viste sig derfor at svare til virkningen af Neupogen.
Therefore, the effectiveness of Biograstim was shown to be equivalent to that of Neupogen.
Behandling med Biograstim mindskede varigheden af svær neutropeni på tilsvarende måde som Neupogen.
Treatment with Biograstim and Neupogen brought about similar reductions in duration of severe neutropenia.
Hvad anvendes Biograstim til?
What is Biograstim used for?
Hvilke fordele viser undersøgelserne, at der er ved Biograstim?
What benefit has Biograstim shown during the studies?
Hvordan blev Biograstim undersøgt?
How has Biograstim been studied?
Hvad er Biograstim?
What is Biograstim?
Hvordan anvendes Biograstim?
How is Biograstim used?
Hvordan virker Biograstim?
How does Biograstim work?
Dato for første markedsføringstilladelse: 15. maj 2002 Dato for seneste fornyelse: 20. april 2012
Date of first authorisation: 15 May 2002 Date of latest renewal: 20 April 2012
Sammenligning af formuleringer
Comparison between formulations
Deres Navn: _____________________________________________ Ordinerende læge: ______________________________________ Spørg Deres læge, hvis De har nogen spørgsmål vedrørende Tracleer.
Your name: __________________________________________________ Prescribing doctor: ________________________________________ If you have questions about Tracleer ask your doctor.
Brug nok vand til at dække hele tabletten.
Use enough water to cover the whole tablet.
Tryk lægemidlet gennem folien.
Push the pharmaceutical product through the foil.
Vigtige sikkerhedsadvarsler for patienter, der tager Tracleer (bosentan)
Important Safety Alerts for Patients taking Tracleer (bosentan)
Den PAH, som Tracleer er indiceret for, kan være:
The PAH for which Tracleer is indicated can be:
56 dispergible tabletter (14 x 4)
56 dispersible tablets (14 x 4)
Tracleer behandling bør kun påbegyndes, hvis det systemiske systoliske blodtryk er over 85 mmHg.
Tracleer should only be initiated if the systemic systolic blood pressure is higher than 85 mmHg.
Nogle af disse patienter, som ikke udviser nogen reaktion efter 8 ugers behandling med Tracleer, kan dog reagere positivt efter yderligere 4 til 8 ugers behandling.
However, some patients who show no response after 8 weeks of treatment with Tracleer may respond favourably after an additional 4 to 8 weeks of treatment.
Dette kort indeholder vigtige oplysninger om Tracleer.
This card contains important information about Tracleer.
Tracleer anvendes til at behandle:
Tracleer is used to treat:
Det er vigtigt, at De får foretaget disse blodundersøgelser regelmæssigt, så længe De tager Tracleer.
It is important that you have these regular blood tests as long as you are taking Tracleer.
De bivirkninger, der er indberettet for børn og unge, der er blevet behandlet med Tracleer, er de samme som for voksne.
The side effects that have been reported in children treated with Tracleer are the same as those in adults.
CL = konfidensgrænse; PVR = pulmonal vaskulær modstand; SD = standardafvigelse.
CL = confidence limit; PVR = pulmonary vascular resistance; SD = standard deviation.
• andre lægemidler til behandling af pulmonal hypertension: sildenafil og tadalafil;
• other medications for the treatment of pulmonary hypertension: sildenafil and tadalafil;
Dette lægemiddel indeholder 3,7 mg aspartam i hver dispergibel tablet.
This medicine contains 3.7 mg of aspartame in each dispersible tablet.