FrancophonIA/ELRC3.0 huggingface dataset:
English: Somavert is available as powder and solvent that are mixed together to make up a solution for injection under the skin.
Danish: Somavert leveres som et pulver og en solvens, der blandes sammen til en opløsning, som gives ved injektion under huden.
English: Somavert is a medicine used to treat adults with acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults and is caused by the pituitary gland producing excess growth hormone.
Danish: Somavert er et lægemiddel til behandling af voksne med akromegali, en sjælden hormonsygdom, der sædvanligvis forekommer hos midaldrende voksne, og som skyldes, at hypofysen producerer for meget væksthormon.
English: For the full list of side effects and restrictions with Somavert, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Somavert fremgår af indlægssedlen.
English: How is Somavert used?
Danish: Hvordan anvendes Somavert?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Somavert have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Somavert.
English: What benefits of Somavert have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Somavert?
English: Acromegaly occurs when the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non-cancerous) tumour.
Danish: Akromegali forekommer, når hypofysen, som sidder nederst i hjernen, producerer for meget væksthormon, som regel på grund af en godartet tumor.
English: In adults, rather than gaining height, overproduction of growth hormone leads to acromegaly, with overgrowth of bone, swelling of soft tissue (such as the hands and feet),
Danish: akromegali, med overvækst af knoglevæv, hævelser i blødt væv (såsom hænder og fødder), hjertesygdomme og andre lidelser.
English: How does Somavert work?
Danish: Hvordan virker Somavert?
English: 2nd injection: after 3 weeks.
Danish: Anden injektion: efter 3 uger.
English: ATCvet code: QI04AA02.
Danish: ATCvet-kode: QI04AA02
English: 1st injection: from 1.5 months of age.
Danish: Første injektion: fra 1,5 måneders-alderen.
English: The level of efficacy for other species may differ from that observed in sheep.
Danish: Effekten hos andre dyrearter kan variere fra den, der er observeret hos får.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af markedsføringstilladelsen skal informere Europa Kommisionen om planerne for markedsføring af det lægemiddel, der er godkendt under denne procedure.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/03/2011.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 14/03/2011
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Danish: *Relativ styrke bestemt ved en styrketest i mus, som blev sammenlignet med en referencevaccine, der blev påvist at være effektiv hos får.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated .
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares og transporteres nedkølet.
English: a) the administration of the product to animals will interfere with the implementation of national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) at behandling af dyr med veterinærlægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret,
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Danish: For at undgå kontaminering af vaccinen under brug anbefales det at anvende et multiinjektionsvaccinationssystem, når der anvendes store doser.
English: Off-white or pink liquid.
Danish: Råhvid eller lyserød væske.
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Danish: *(cyklusværdi (Ct) ≥ 36 bestemt med en valideret RT-PCR-metode, som ikke indikerede tilstedeværelse af viralt genom)
English: The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Danish: Hjælpestofferne (inklusive adjuvanter) som er anført i punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Date of last renewal: 07/01/2016
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 07/01/2016
English: High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.
Danish: Høj densitet polyethylen (HDPE) hætteglas 20, 100 eller 240 ml med chlorobutyl elastomer prop og aluminiumshætte indeholdende 10, 50 eller 120 doser vaccine.
English: A transient increase in rectal temperature, not exceeding 0.6 °C, may occur during the 24 hours following administration of a two-fold overdose.
Danish: En forbigående stigning i rektaltemperaturen på højst 0,6 °C kan forekomme i løbet af de første 24 timer efter administration af en dobbelt overdosis.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue virus (BTV).
Danish: Anvend derfor kun vaccinen til denne kategori af dyr i henhold til en benefit/risk-vurdering foretaget af den ansvarlige dyrlæge og/eller de nationale myndigheder, der er ansvarlige for den foreliggende vaccinationspolitik for bluetongue virus (BTV).
English: A transient increase in rectal temperature, not exceeding 1.2 °C, may occur commonly during the 24 hours following vaccination.
Danish: En forbigående stigning i rektaltemperaturen på højst 1,2°C kan almendeligt forekomme i løbet af de første 24 timer efter vaccination.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml of vaccine contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosis på 2 ml vaccine indeholder:
English: Incompatibilities: Do not mix with any other veterinary medicinal products.
Danish: Uforligeligheder: Må ikke blandes med andre lægemidler til dyr.
English: Pharmacotherapeutic group: Inactivated viral vaccines for sheep, Bluetongue virus.
Danish: Farmakoterapeutisk gruppe: Inaktiverede virale vacciner til får, mod Bluetonguevirus.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Preprinted carton box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Fortrykt kartonæske med 1 x 20 ml, 1 x 100 ml og 1 x 240 ml
English: PACKAGE LEAFLET: Zulvac 1+8 Ovis suspension for injection for sheep
Danish: INDLÆGSSEDDEL: Zulvac 1+8 Ovis suspension til injektion til får
English: Lactation: No data is available on safety in lactating animals.
Danish: Laktation: Der foreligger ingen oplysninger om sikkerheden hos diegivende dyr.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Danish: En beslutning om at anvende denne vaccine før eller efter et andet lægemiddel til dyr skal derfor tages fra gang til gang.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: To stimulate active immunity against Bluetongue virus, serotypes 1 and 8 in sheep.
Danish: Til stimulation af aktiv immunitet mod Bluetonguevirus, serotype 1 og 8 hos får.
English: Avoid multiple vial broaching.
Danish: Undgå anbrud gentagne gange.
English: Special precautions for use in animals: Only use in healthy animals.
Danish: Særlige forsigtighedsregler vedrørende brugen: Kun raske dyr må vaccineres.
English: Duration of immunity: 12 months after completion of the primary vaccination scheme.
Danish: Varighed af immunitet: 12 måneder efter afslutning af basisvaccinationsprogrammet.
English: Primary vaccination: Administer one dose of 2 ml according to the following vaccination scheme:
Danish: Basisvaccination: Indgiv en dosis på 2 ml i henhold til følgende vaccinationsprogram:
English: Once broached use immediately.
Danish: Efter anbrud anvendes straks.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER
English: WITHDRAWAL PERIOD(S) Zero days.
Danish: 10. TILBAGEHOLDELSESTID(ER) 0 dage.
English: Onset of immunity: 21 days after completion of the primary vaccination scheme.
Danish: Indtræden af immunitet: 21 dage efter afslutning af basisvaccinationsprogrammet.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 20 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas 20 ml
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstillerne ansvarlig for batchfrigivelse
English: WITHDRAWAL PERIOD(S) Withdrawal period(s): Zero days.
Danish: TILBAGEHOLDELSESTID(ER) Tilbageholdelsestid(er): 0 dage
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1+8 Ovis suspension for injection for sheep
Danish: VETERINÆRLÆGEMIDLETS NAVN Zulvac 1+8 Ovis injektionsvæske, suspension, til får
English: EXPIRY DATE EXP {month/year} Once broached use immediately.
Danish: 10. UDLØBSDATO EXP {måneder/år} Efter anbrud anvendes straks.
English: OTHER INFORMATION Pack sizes:
Danish: ANDRE OPLYSNINGER Pakningsstørrelser
English: 4.2 Indications for use, specifying the target species Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by Bluetongue virus, serotypes 1 and 8.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Aktiv immunisering af får fra 1,5 måneders-alderen til forebyggelse* af viræmi, som er forårsaget af Bluetonguevirus, serotype 1 og 8.
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 63 days).
Danish: Reaktionen er som oftest generel hævelse omkring injektionsstedet (varer højst 9 dage) eller mærkbare små knuder (subkutan granulom som kan vare i mere end 63 dage).
English: Administration of a two-fold overdose may be followed in most animals by a local reaction at the injection site.
Danish: De fleste dyr kan få en lokal reaktion på administrationsstedet efter en dobbelt overdosis.
English: Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by Bluetongue virus, serotypes 1 and 8.
Danish: Aktiv immunisering af får fra 1,5 måneders-alderen til forebyggelse* af viræmi, som er forårsaget af Bluetonguevirus, serotype 1 og 8.
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma possibly persisting for more than 48 days).
Danish: Reaktionen er som oftest generel hævelse omkring injektionsstedet (varer højst 7 dage) eller mærkbare små knuder (subkutan granulom som kan vare i mere end 48 dage).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Per dose of 2 ml:
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Pr. dosis på 2 ml:
English: INDICATION(S)
Danish: INDGIVELSESVEJ( E)
English: Vaccination may be followed in most animals by a local reaction at the injection site.
Danish: De fleste dyr får en lokal reaktion på administrationsstedet efter vaccination.
English: No data are available on safety in lactating animals.
Danish: Der foreligger ingen oplysninger om sikkerheden hos diegivende dyr.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml and 240 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas med 100 ml og 240 ml
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstilleren af de(t) biologisk aktive stof(fer)
English: Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 1 år Opbevaringstid efter første åbning af den indre emballage: anvendes umiddelbart efter anbrud.
English: Inactivated Bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Danish: Inaktiveret Bluetonguevirus, serotype 8, stamme BTV-8/BEL2006/02
English: Disodium hydrogen phosphate dodecahydrate Sodium chloride
Danish: Kaliumdihydrogenphosphat Dinatriumhydrogenphosphatdodecahydrat Natriumchlorid
English: Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1
Danish: Inaktiveret Bluetonguevirus, serotype 1, stamme BTV-1/ALG2006/01 E1
English: Aluminium hydroxide Saponin
Danish: Aluminiumhydroxid, saponin, thiomersal
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/120/001-003
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/120/001-003
English: Pregnancy: Can be used during pregnancy.
Danish: Drægtighed: Veterinærlægemidlet kan anvendes under drægtighed.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/120/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/120/001
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/120/002
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/120/002
English: Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 Inactivated Bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Danish: Inaktiveret Bluetonguevirus, serotype 1, stamme BTV-1/ALG2006/01 E1 Inaktiveret Bluetonguevirus, serotype 8, stamme BTV-8/BEL2006/02
English: Excipients: Thiomersal
Danish: Hjælpestof: Thiomersal
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Danish: Vær forsigtig ved anvendelse af vaccinen til andre husdyr eller vilde dyrearter tilhørende drøvtyggere, som skønnes at være i risikogruppe for infektion.
English: Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 Inactivated Bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1
Danish: Inaktiveret Bluetonguevirus, serotype 1, stamme BTV-1/ALG2006/01 E1 RP*≥ 1 Inaktiveret Bluetonguevirus, serotype 8, stamme BTV-8/BEL2006/02 RP*≥ 1 *Relativ styrke bestemt ved en styrketest i mus, som blev sammenlignet med en referencevaccine, der blev påvist at være effektiv hos får.
English: Each dose of 2 ml of vaccine contains:
Danish: Pr. dosis på 2 ml:
English: Date of first authorisation: 17 October 2003 Date of latest renewal: 17 October 2008
Danish: Dato for første markedsføringstilladelse: 17. oktober 2003 Dato for seneste fornyelse: 17. oktober 2008
English: Stalevo may be taken with or without food.
Danish: Stalevo kan tages med eller uden mad.
English: Stalevo with food and drink
Danish: Brug af Stalevo sammen med mad og drikke
English: Therefore, do not take Stalevo and iron supplements at the same time.
Danish: Tag derfor ikke Stalevo og jerntilskud samtidig.
English: The starting dose of Stalevo should provide either the same amount of levodopa or slightly (5-10%) more.
Danish: Startdosis af Stalevo bør indeholde enten den samme mængde af levodopa eller en anelse (5-10%) mere.
English: Stalevo should not be used during pregnancy unless the benefits for the mother outweigh the possible risks to the foetus.
Danish: Stalevo bør ikke anvendes under graviditet, med mindre fordelene for moderen opvejer mulige risici for fosteret.
English: The effects of Stalevo may be weakened by certain medicines.
Danish: Virkningen af Stalevo kan svækkes af visse lægemidler.
English: Stalevo is used for the treatment of Parkinson's disease.
Danish: Stalevo bruges til behandling af Parkinsons sygdom.
English: You should be aware that Stalevo may make these reactions worse.
Danish: Du skal være opmærksom på, at Stalevo kan forværre denne virkning.
English: If you must undergo surgery, please tell your doctor that you are using Stalevo.
Danish: Hvis du skal opereres, skal du fortælle lægen, at du bruger Stalevo.
English: When used with Stalevo, the daily dose of selegiline should not exceed 10 mg.
Danish: Indtaget sammen med Stalevo bør den daglige dosis af selegilin ikke overstige 10 mg.
English: Therefore, Stalevo and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Danish: Stalevo og jernpræparater bør derfor tages med mindst 2-3 timers mellemrum (se pkt.
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 1126%].
Danish: I et interaktionsstudie hos raske, frivillige forsøgspersoner ændrede entacapon imidlertid ikke plasmaniveauerne for S-warfarin, mens AUC for R-warfarin øgedes i gennemsnit med 18% [CI90 1126%].
English: Experience with Stalevo in patients under 18 years is limited.
Danish: Der er kun begrænset erfaring med Stalevo til patienter under 18 år.
English: - All patients treated with Stalevo should be monitored carefully for the development of mental changes, depression with suicidal tendencies, and other serious antisocial behaviour.
Danish: - Alle patienter, der behandles med Stalevo, bør overvåges omhyggeligt med hensyn til udvikling af mentale forandringer, depression med suicidale tendenser og anden alvorligt ændret social adfærd.
English: Paediatric population: The safety and efficacy of Stalevo in children aged below 18 years have not been established.
Danish: Pædiatrisk population: Stalevos sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Therefore Stalevo should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
Danish: Stalevo bør derfor gives med forsigtighed til patienter, der anvender andre lægemidler, som kan forårsage ortostatisk hypotension.
English: Stalevo may increase the effects and side effects of certain medicines.
Danish: Stalevo kan øge virkningen og bivirkningerne af visse lægemidler.
English: Daily ON time with and without entacapone was recorded in home-diaries by patients.
Danish: Daglig ”on-tid” (timer) med eller uden entacapon blev registreret i dagbøger af patienterne.
English: Therefore, the use of Stalevo in children or adolescents is not recommended.
Danish: Derfor frarådes det at anvende Stalevo til børn eller unge.
English: Stalevo may have a major influence on the ability to drive and use machines.
Danish: Stalevo kan i væsentlig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på tabletbeholderen og æsken.
English: Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy.
Danish: Stalevo kan sænke blodtrykket, og du kan føle dig ør og svimmel.
English: - Stalevo may induce orthostatic hypotension.
Danish: - Stalevo kan inducere ortostatisk hypotension.
English: In the pharmacokinetic studies with Stalevo the bioavailability of levodopa is higher in women than in men, primarily due to the difference in body weight, while there is no gender difference with carbidopa and entacapone.
Danish: I farmakokinetiske studier med Stalevo var biotilgængeligheden af levodopa højere for kvinder end for mænd, hovedsageligt pga. forskellen i kropsvægt, mens der ikke sås kønsforskelle med carbidopa og entacapon.
English: Pyridoxine, however, is not effective in reversing the actions of Stalevo.
Danish: Pyridoxin har imidlertid ingen effekt på virkningerne af Stalevo.
English: For some patients, Stalevo may not be well absorbed if it is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and nuts).
Danish: Hos nogle patienter optages Stalevo dårligt, hvis tabletten tages sammen med eller kort tid efter proteinrig mad (såsom kød, fisk, mælkeprodukter, kerner og nødder).
English: Entacapone is a reversible, specific and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa.
Danish: Entacapon er en reversibel, specifik og hovedsagelig perifert virkende COMT-hæmmer, beregnet til samtidig administrering med levodopa.
English: Do not take Stalevo if you are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
Danish: Tag ikke Stalevo, hvis du tager visse lægemidler mod depression (kombinationer af selektive MAO-A og MAO-B-hæmmere eller ikke-selektive MAO-hæmmere).
English: The possibility that the patient has taken other active substances in addition to Stalevo should be taken into consideration.
Danish: Muligheden for at patienten har taget andre lægemidler samtidig med Stalevo, skal overvejes.
English: It may therefore be necessary, particularly in patients with dyskinesia, to reduce levodopa dose by 10-30% within the first days to first weeks after initiating Stalevo treatment.
Danish: Det kan derfor være nødvendigt at reducere levodopadosis med 10-30% i løbet af de første dage eller uger efter behandlingsstart med Stalevo, specielt hos patienter med dyskinesier.
English: Elderly: No dose adjustment of Stalevo is required for elderly.
Danish: Ældre: Det er ikke nødvendigt med dosisjusteringer hos ældre.
English: Other antiparkinsonian medicinal products: To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Stalevo therapy.
Danish: Andre antiparkinsonmidler: Indtil nu har der ikke været tegn på interaktioner, der vil udelukke samtidig brug af standard-antiparkinson-lægemidler med Stalevobehandling.
English: Patients taking these medicinal products with Stalevo should be carefully observed for loss of therapeutic response.
Danish: Patienter, der anvender disse lægemidler samtidig med Stalevo, bør nøje overvåges med henblik på reduceret terapeutisk respons.
English: At the initiation, Stalevo should be adjusted to correspond as closely as possible to the total daily dose of levodopa currently used.
Danish: Ved start skal doseringen af Stalevo tilpasses, så den ligger så tæt som muligt på den daglige dosis af levodopa, der hidtil er anvendt.
English: - Stalevo is not recommended for the treatment of drug-induced extrapyramidal reactions.
Danish: - Stalevo er ikke egnet til behandling af lægemiddelinducerede ekstrapyramidale reaktioner.