FrancophonIA/ELRC3.0 huggingface dataset:
English: TachoSil can be cut to the correct size and shaped if too large.
Danish: TachoSil kan klippes/formes til en passende størrelse og facon.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (jf. bilag I: Produktresume, pkt.
English: How to use TachoSil
Danish: Sådan skal du bruge TachoSil
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ
English: The numbers of subjects experiencing an efficacy outcome event were 25 (6.9%) and 30 (8.2%) for TachoSil and current practice treated patients, respectively, providing an Odds Ratio of 0.82 (95% CI: 0.47, 1.43).
Danish: TachoSil og efter normal praksis, hvilket giver en oddsratio på 0,82% (95% CI: 0,47; 1,43).
English: 5.2 Pharmacokinetic properties
Danish: 5.2 Farmakokinetiskeegenskaber
English: This procedure enables an easy adhesion of TachoSil to the wound surface.
Danish: Dette medfører, at TachoSil let klæber til sårets overflade.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Danish: Det drejer sig om udvælgelse af donorer, screening af de individuelle donationer og plasmareserver for specifikke tegn på infektion samt valg af effektive fremstillingstrin til inaktivering/fjernelse af virus.
English: • to use TachoSil immediately after opening the inner sterile package.
Danish: • at TachoSil tages i brug straks efter åbningen af den indre, sterile blisterpakning.
English: TachoSil, sealant matrix human fibrinogen/human thrombin
Danish: TachoSil, vævsklæbermatrix human fibrinogen/human thrombin
English: TachoSil is an off-white sealant matrix.
Danish: TachoSil er en råhvid vævsklæbermatrix.
English: • to have a non-sterile person open the outer aluminium cover
Danish: • at den ydre alufoliepakning åbnes af en ikke-steril person
English: Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development.
Danish: For virkningerne på reproduktion, svangerskabets forløb, den embryonale og føtale udvikling samt peri- og postnatal udvikling er erfaringsgrundlaget fra dyrestudier utilstrækkeligt.
English: Sealant matrix.
Danish: Vævsklæbermatrix.
English: Sealant matrix
Danish: Vævsklæbermatrix
English: Do not store above 25 ºC
Danish: Må ikke opbevares ved temperaturer over 25°C
English: The yellow, active side of the matrix is applied to the bleeding/leaking surface and held against it with a gentle pressure for 3-5 minutes.
Danish: Den gule, aktive side vendes ned mod den sivende såroverflade, og matrixen trykkes let mod overfladen i 3-5 minutter.
English: TachoSil, sealant matrix human fibrinogen/human thrombin For epilesional use
Danish: TachoSil, vævsklæbermatrix human fibrinogen/human thrombin Til anvendelse på læsioner
English: • to have a sterile person open the inner sterile package
Danish: • at den sterile indre blisterpakning åbnes af en steril person
English: The efficacy of TachoSil was tested in a randomised controlled study in 726 patients (362 treated with TachoSil and 364 controls) undergoing skull base surgery as an adjunct to suture for sealing the dura mater, in which the efficacy outcome was measured post-operatively as verified cerebrospinal fluid (CSF) leaks or pseudomeningocoele, or treatment failure during surgery.
Danish: Virkningen af TachoSil som tillæg til sutur i forbindelse med forsegling af dura mater blev undersøgt i et randomiseret, kontrolleret studie med 726 patienter (362 blev behandlet med TachoSil, og 364 var kontrolpersoner), som skulle opereres i basis cranii.
English: While unrolling the matrix the yellow, active side of the matrix is applied to the bleeding/leaking surface using e.g. a pair of cleansed forceps and held against it with a moist pad under gentle pressure for 3-5 minutes.
Danish: Mens matrixen rulles ud, appliceres matrixens gule, aktive side på den sivende såroverflade ved hjælp af for eksempel et par rengjorte tænger.
English: What TachoSil contains
Danish: TachoSil indeholder pr. cm
English: TachoSil is intended for epilesional use only.
Danish: TachoSil er udelukkende beregnet til anvendelse på læsioner.
English: The product is available in different sizes and comes in packages with up to 5 units: Package with 1 matrix of 9.5 cm x 4.8 cm Package with 2 matrices of 4.8 cm x 4.8 cm Package with 1 matrix of 3.0 cm x 2.5 cm Package with 5 matrices of 3.0 cm x 2.5 cm Package with 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Danish: Præparatet fås i forskellige størrelser og findes i pakninger med op til 5 enheder: Pakning med 1 matrix på 9,5 cm x 4,8 cm Sampakning med 2 matrixer på 4,8 cm x 4,8 cm Pakning med 1 matrix på 3,0 cm x 2,5 cm Sampakning med 5 matrixer på 3,0 cm x 2,5 cm Pakning med 1 prærullet matrix på 4,8 cm x 4,8 cm
English: Read this before you open the package: TachoSil comes in sterile packages and therefore it is important:
Danish: TachoSil leveres i en steril pakning og det er derfor vigtigt:
English: Parvovirus B19 infection may be serious for pregnant woman (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia, (e.g. sickle cell disease or haemolytic anaemia).
Danish: Infektioner med denne virus kan være alvorlige for gravide kvinder og for personer med svækket immunforsvar eller bestemtetyper anæmi (blodmangel), for eksempel seglcelleanæmi og hæmolytisk anæmi.
English: 1 matrix of 3.0 cm x 2.5 cm
Danish: 1 matrix på 3,0 cm x 2,5 cm
English: TachoSil can be cut to the appropriate size and shaped to fit the wound.
Danish: Hvis TachoSil er for stor i forhold til såret, kan den formes og/eller klippes til en passende størrelse.
English: Cleanse surgical instruments, gloves and adjacent tissues, if necessary.
Danish: Rengør de kirurgiske instrumenter, handskerne og det tilstødende væv, hvis det er nødvendigt, da TachoSil klæber til disse, hvis de er dækket af blod.
English: 1 matrix of 9.5 cm x 4.8 cm 2 matrices of 4.8 cm x 4.8 cm 1 matrix of 3.0 cm x 2.5 cm 5 matrices of 3.0 cm x 2.5 cm 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Danish: 1 matrix på 9,5 cm x 4,8 cm 2 matrixer på 4,8 cm x 4,8 cm 1 matrix på 3,0 cm x 2,5 cm 5 matrixer på 3,0 cm x 2,5 cm 1 prærullet matrix på 4,8 cm x 4,8 cm
English: Pre-moisten the flat TachoSil matrix in saline solution and place it on the wound immediately (if the wound is completely wetted by blood and other fluids, there is no need to moisten the matrix before application).
Danish: Hvis såret er fuldstændig vædet med blod og andre væsker, er der ingen grund til at fugte matrixen før anvendelse.
English: Takeda Austria GmbH St. Peter Strasse 25
Danish: GmbH St. Peter
English: The blister is packed in an aluminium-bonded foil sachet with a desiccant bag included and packed in a folding carton.
Danish: Denne blister er pakket i et brev bestående af en to-lags aluminiumsfolie sammen med en tørrekapsel.
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.
Danish: Forholdsreglerne er vurderet effektive for kappeklædte vira som HIV, HBV samt HCV og for den ikkekappeklædte virus HAV. Forholdsreglerne kan være af begrænset værdi for ikke-kappeklædte vira af typen parvovirus B19.
English: Adhesions
Danish: Adhæsion
English: The active side of the matrix, which is coated with fibrinogen and thrombin, is marked by a yellow colour.
Danish: Den aktive side af matrixen er gul og coatet med fibrinogen og thrombin.
English: TachoSil sealant matrix.
Danish: TachoSil, vævsklæbermatrix
English: Package with 1 matrix of 9.5 cm x 4.8 cm Package with 2 matrices of 4.8 cm x 4.8 cm Package with 1 matrix of 3.0 cm x 2.5 cm Package with 5 matrices of 3.0 cm x 2.5 cm Package with 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Danish: Pakning med 1 matrix på 9,5 cm x 4,8 cm Sampakning med 2 matrixer på 4,8 cm x 4,8 cm Pakning med 1 matrix på 3,0 cm x 2,5 cm Sampakning med 5 matrixer på 3,0 cm x 2,5 cm Pakning med 1 prærullet matrix på 4,8 cm x 4,8 cm
English: For smaller wounds, e.g. in minimally invasive surgery the smaller size matrices (4.8 cm x 4.8 cm or 3.0 cm x 2.5 cm) or the pre-rolled matrix (based on a matrix of 4.8 cm x 4.8 cm) is recommended.
Danish: De små matrixer (4,8 cm x 4,8 cm eller 3,0 cm x 2,5 cm) og den prærullede matrix (baseret på en matrix på 4,8 cm x 4,8 cm) anbefales i forbindelse med mindre sår, f.eks. ved minimal invasiv kirurgi.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Danish: På trods af dette kan muligheden for at overføre smitsomme stoffer ikke udelukkes totalt, når der anvendes et medicinsk præparat udvundet af menneskeblod eller plasma.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Danish: På trods af alle disse forholdsregler kan risikoen for overførsel af en infektion ikke fuldstændig udelukkes, når man bruger lægemidler, der er fremstillet ud fra blod og plasma fra mennesker.
English: For epilesional use.
Danish: Til anvendelse på læsioner.
English: 1 matrix of 4.8 cm x 4.8 cm
Danish: 1 matrix på 4,8 cm x 4,8 cm
English: This means that the TachoSil sticks to the tissue surface, the blood coagulates (local haemostasis) and the tissue is sealed.
Danish: Dette gør, at TachoSil kan klæbe til såroverfladen (vævet).
English: ALUMINIUM-BONDED FOIL SACHET
Danish: BREV AF ALUMINIUMSFOLIE
English: Alternatively, e.g. in case of stronger bleeding, TachoSil may be applied without pre-moistening, while also pressing gently to the wound for 3-5 minutes.
Danish: I tilfælde af stærkere blødninger fra såret kan TachoSil tages i brug uden forudgående fugtning.
English: 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Danish: 1 prærullet matrix på 4,8 cm x 4,8 cm
English: 1 matrix of 9.5 cm x 4.8 cm
Danish: 1 matrix på 9,5 cm x 4,8 cm
English: Application of TachoSil must be individualised by the treating surgeon.
Danish: Den behandlende kirurg afgør, hvordan TachoSil skal appliceres hos den enkelte patient.
English: Life threatening thromboembolic complications may occur if the preparation is applied intravascularly.
Danish: Intravaskulær anvendelse af TachoSil kan medføre livstruende tromboemboliske komplikationer.
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaver af markedsføringstilladelsen og fremstiller Takeda Austria
English: Once the package is opened, post-sterilisation is not possible.
Danish: Åbne pakninger kan ikke resteriliseres.
English: Blood clots may occur if TachoSil is unintentionally applied inside a blood vessel.
Danish: Hvis TachoSil ved et uheld påføres inden i et blodkar, kan der opstå blodpropper.
English: For viral safety see section 4.4.
Danish: Virussikkerhed se pkt.
English: 18 October 2013
Danish: Den 18. oktober 2013
English: The final opinion was converted into a Decision by the European Commission on 18 October 2013.
Danish: Den endelige udtalelse blev den 18. oktober 2013 omarbejdet til en beslutning af EuropaKommissionen.
English: International non-proprietary name (INN): dexamethasone
Danish: Internationalt fællesnavn (INN): dexamethason
English: The Committee appointed Dr C. Ibrahim as rapporteur and Dr D. Murphy as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis dr. C. Ibrahim og dr. D. Murphy.
English: The referral started on 12 September 2012.
Danish: Indbringelsesproceduren blev indledt den 12. september 2012.
English: Written explanations were provided by the marketing authorisation holders on 10 December 2012and 21 May 2013.
Danish: Indehaveren af markedsføringstilladelsen afgav skriftlige redegørelser den 10. december 2012 og den 21. maj 2013.
English: The CVMP was requested to evaluate the adequacy and consumer safety of the withdrawal periods for meat in cattle and horses and the withdrawal periods for milk in cattle for the concerned products.
Danish: CVMP blev anmodet om at vurdere tilstrækkeligheden og forbrugersikkerheden af tilbageholdelsestiderne for kød fra kvæg og heste og tilbageholdelsestiderne for komælk for de pågældende produkter.
English: Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, antiallergic and gluconeogenetic agent for administration to agricultural and domestic animals.
Danish: Dexamethason er et langtidsvirkende syntetisk glukokortikoid, der anvendes som antiinflammatorisk, antiallergisk og glukoneogenetisk middel til landdyr og andre husdyr.
English: Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to changes of the product information related to harmonisation of the withdrawal periods.
Danish: På grundlag af de foreliggende data fandt CVMP, at det overordnede forhold mellem fordele og risici for disse produkter fortsat er positivt, forudsat at der foretages ændringer i produktinformationen med henblik på harmonisering af tilbageholdelsestiderne.
English: The veterinary medicinal products Dexadreson 2 mg/ml and its associated names and generic products thereof are solutions for injection which contain 2 mg dexamethasone per ml.
Danish: Veterinærlægemidlerne Dexadreson, 2 mg/ml, og relaterede navne samt tilsvarende generiske produkter er injektionsvæsker, opløsning, der indeholder dexamethason, 2 mg/ml.
English: On 22 August 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Dexadreson 2 mg/ml and associated names, and generic products thereof.
Danish: Den 22. august 2012 foretog Tyskland en indbringelse for agenturet i henhold til artikel 35 i direktiv 2011/82/EF for Dexadreson, 2 mg/ml, og relaterede navne samt tilsvarende generiske produkter.
English: Therefore, the Committee adopted a positive opinion on 18 July 2013, recommending variations to the terms of the marketing authorisations for Dexadreson 2 mg/ml and its associated names and generic products thereof.
Danish: Den 18. juli 2013 vedtog udvalget derfor en positiv udtalelse og anbefalede udstedelse af markedsføringstilladelse for Dexadreson, 2 mg/ml, og relaterede navne samt tilsvarende generiske produkter.
English: Opinion following an Article 351 referral for Dexadreson 2 mg/ml and associated names, and generic products thereof
Danish: Udtalelse efter en artikel 351-indbringelse for Dexadreson, 2 mg/ml, og relaterede navne samt tilsvarende generiske produkter
English: Opinion following an Article 350F referral for Dexadreson 2 mg/ml and associated names, and generic products thereof
Danish: Udtalelse efter en artikel 350F-indbringelse for Dexadreson, 2 mg/ml, og relaterede navne samt tilsvarende generiske produkter EMA/539466/2013
English: In Phase I the calculation of the initial PEC in soil is performed when more than a “small number of animals” are treated.
Danish: I fase I udføres beregningen af den indledende PEC i jord, hvis mere end ”et mindre antal dyr” behandles.
English: When such specific information is not available the default values given in the guideline are applied.
Danish: Hvis sådanne specifikke oplysninger ikke er tilgængelige anvendes standardværdierne i retningslinjen.
English: In the first phase the extent of environmental exposure is determined based on the intended use of the veterinary medicinal product.
Danish: I den første fase afgøres omfanget af påvirkningen af miljøet på baggrund af den tilsigtede anvendelse af veterinærlægemidlet.
English: = Conversion factor [1000 μg.mg-1]
Danish: = Omregningsfaktor [1000 μg.mg-1]
English: = Housing factor either 1 for animals housed throughout the year or 0.5 for animals housed for only 6 months (see Table 3 of the guideline.)
Danish: = Bygningsfaktor, enten 1 for dyr, der huses hele året, eller 0,5 for dyr, der huses seks måneder om året (se tabel 3 i retningslinjerne.)
English: During the mutual recognition procedure concerns were raised that Shotaflor 300 mg/ml solution for injection for cattle may present a potential serious risk to the environment.
Danish: Under den gensidige anerkendelsesprocedure blev der ytret betænkeligheder med hensyn til, om Shotaflor 300 mg/ml injektionsvæske, opløsning, til kvæg kan udgøre en potentielt alvorlig miljørisiko.
English: Shotaflor contains florfenicol, which is a broad-spectrum primarily bacteriostatic, antibiotic with a range of activity, including many Gram-negative and Gram-positive organisms.
Danish: Shotaflor indeholder florfenicol, som er et bredspektret primært bakteriostatisk antibiotikum med en række virkeområder, herunder mange gramnegative og grampositive organismer.
English: Because Shotaflor 300 mg/ml solution for injection for cattle is indicated for treatment only (i.e. it is indicated only for use in clinically ill animals not for preventative use) it was considered that, in this case, it was appropriate to use the disease incidence within the herd as the proportion of animals treated.
Danish: Da Shotaflor 300 mg/ml injektionsvæske, opløsning, til kvæg kun er indiceret til behandling (dvs., at det kun er indiceret til klinisk syge dyr og ikke til forebyggende brug), blev det vurderet, at det i dette tilfælde var passende at anvende sygdomsforekomsten i en besætning som andelen af behandlede dyr.
English: place-1.y-1] (see Table 3 of the guideline.)
Danish: place-1.y-1] (se tabel 3 i retningslinjerne)
English: The dossier as submitted in the referral procedure is considered to fulfil the necessary requirements with regards to the environmental risk assessment (as established in Article 12(3)(j) of Directive 2001/82/EC, as amended by Directive 2004/28/EC), provided that the product is used only for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Danish: Det dossier, som blev indsendt under indbringelsesproceduren, anses for at opfylde de nødvendige krav med hensyn til miljørisikovurderingen (som fastsat i artikel 12, stk. 3, litra j, i direktiv 2001/82/EF, som ændret ved direktiv 2004/28/EF), forudsat at produktet kun bruges til terapeutisk behandling af luftvejsinfektioner hos kvæg forårsaget af Mannheimia haemolytica, Pasteurella multocida og Histophilus somni.
English: = EU nitrogen spreading limit [kg N.ha-1]
Danish: = EU's grænse for spredning af kvælstof [kg N.ha-1]
English: = Fraction of herd treated [value between 0 and 1] (see Table 2 of the guideline.)
Danish: = Del af besætningen, der er behandlet [værdi mellem nul og en] (se tabel 2 i retningslinjerne.)
English: The Marketing Authorisation Holder provided data with the aim of demonstrating that the percentage of herd animals that will be treated for Bovine Respiratory Disease (BRD) is less than the default value of 50% given in the CVMP guideline mentioned above (EMEA/CVMP/ERA/418282/2005Rev.1)).
Danish: Indehaveren af markedsføringstilladelsen fremlagde data med det formål at vise, at den procentvise andel af dyr i en besætning, der vil blive behandlet for bovin luftvejssygdom, er mindre end standardværdien på 50 %, som fremgår af den ovennævnte CVMP-retningslinje (EMEA/CVMP/ERA/418282/2005-Rev.1).
English: = Animal turnover rate per place per year [place-1.y-1] (see Table 3 of the guideline.)
Danish: = Omsætningsrate per sted per år [place-1.y1] (se tabel 3 i retningslinjerne.)
English: When such specific information is not available then the default values given in Table 2 of the CVMP guideline in support of VICH guidelines (Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005Rev.1 - also known as the Technical Guidance Document - TGD) should be used.
Danish: Hvis sådanne specifikke oplysninger ikke er tilgængelige, bør standardværdierne i tabel 2 i CVMP's retningslinje ("Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38" - EMEA/CVMP/ERA/418282/2005-Rev.1 - også kendt som det teknisk vejledende dokument - TGD) anvendes.
English: • Commercial farms (several breeds and age): France - 15.7%, Germany - 20.3%, Italy - 15.2%,
Danish: • Kommercielle gårde (flere racer og aldersklasser): Frankrig - 15,7 %, Tyskland - 20,3 %, Italien15,2 %, Spanien - 17,1 % (Godinho et al, 20055).
English: 6 Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. and Cavirani S. (2008) Field
Danish: 6 Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. and Cavirani S. (2008) Field Efficacy of Combination Vaccines Against Bovine Respiratory Pathogens in Calves.
English: In particular, concerns were raised over the adequacy of the data provided by the Marketing Authorisation Holder on the incidence of bovine respiratory disease (BRD) within an infected herd and as a consequence objections were raised over the proposal to deviate from the default value of 50% specified in CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - (EMEA/CVMP/ERA/418282/2005-Rev.1) as the value for the proportion of infected animals for use in calculation of the Predicted Environmental Concentration in soil (PECsoil).
Danish: Som følge heraf blev der gjort indsigelser mod forslaget om at afvige fra standardværdien på 50 % som angivet i CVMP's "Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38" (EMEA/CVMP/ERA/418282/2005-Rev.1) som værdien for andelen af inficerede dyr til brug i beregningen af PECsoil (PEC-værdier i jord (Predicted Environmental Concentration)).
English: This summary was last updated in 11-2008.
Danish: Dette sammendrag blev sidst ajourført i 11-2008.
English: If treatment is stopped for any reason, the dose should be decreased gradually.
Danish: Hvis behandlingen af en eller anden årsag indstilles, skal dosis nedtrappes gradvis.
English: The maximum daily dose is 1.1 mg three times per day.
Danish: Den daglige maksimumsdosis er 1,1 mg tre gange dagligt.
English: It is available as white, round tablets (0.088, 0.18, 0.35 and 0.7 mg).
Danish: Det fås som hvide, runde tabletter (0,088, 0,18, 0,35 og 0,7 mg).
English: The starting dose is 0.088 mg three times per day.
Danish: Startdosis er 0,088 mg tre gange dagligt.
English: This means that Pramipexole Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sifrol.
Danish: Det betyder, at Pramipexol Teva er identisk med et ”referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Sifrol.
English: Pramipexole Teva must be given less frequently in patients who have problems with their kidneys.
Danish: Pramipexol Teva skal gives mindre hyppigt til patienter, som har problemer med deres nyrer.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PRAMIPEXOLE TEVA EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PRAMIPEXOL TEVA EPAR - sammendrag for offentligheden
English: Pramipexole Teva tablets should be swallowed with water, with or without food.
Danish: Pramipexol Teva-tabletter sluges med vand med eller uden et måltid.
English: Pramipexole Teva can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective.
Danish: Pramipexol Teva kan enten anvendes alene eller i kombination med levodopa (et andet lægemiddel til behandling af Parkinsons sygdom) på ethvert stadium af sygdommen, herunder de senere stadier, når levodopa begynder at blive mindre effektivt.