natgillin/translations-raw huggingface dataset:
Hver pakning indeholder en flaske, en flaskeadapter (BIPA), en doseringssprøjte i plast og to doseringsbægre med børnesikre låg. 
When the bottle is delivered, there is a plastic covered foil seal which is on the top of the bottle, underneath the cap. Each pack contains one bottle, a press-in-bottle-adaptor (PIBA), a plastic measuring syringe and two dosing cups with child-resistant caps.
GBH har ikke forårsaget negative virkninger relateret til fertilitet i studier med han- og hunrotter ved doser på op til 1.000 mg/kg/dag. 
Studies in male and female rats at doses up to 1,000 mg/kg/day GHB have shown no evidence of an adverse effect on fertility.
Det skal De vide, før De begynder at tage Xyrem Sådan skal De tage Xyrem Bivirkninger 
What Xyrem is and what it is used for What you need to know before you take Xyrem How to take Xyrem
Efter fortynding skal opløsningen indtages inden for 24 timer; hvis opløsningen ikke anvendes inden for 24 timer, skal den kasseres. 
Doses should be taken within 24 hours after preparation, or else discarded.
4.5) bør dosis af natriumoxybat reduceres med 20 %. 
If sodium oxybate and valproate are used concomitantly (see section 4.5), a decrease in sodium oxybate dose by 20% is recommended.
Hvis De har taget for meget Xyrem 
If you take more Xyrem than you should
Mave-tarm-kanalen 
Cataplexy Attacks
- Lægen har ordineret Xyrem til Dem personligt. 
- This medicine has been prescribed for you only.
Antal patienter 
Number of Subjects
Almindelig: natlig enurese, urininkontinens Ikke kendt: pollakisuri/imperiøs vandladning, nykturi 
Renal and urinary disorders Common: enuresis nocturna, urinary incontinence
Det gives hver tredje uge ved en infusion over 10 minutter. 
It is given once every three weeks as an infusion lasting 10 minutes.
Yderligere information vedrørende Pemetrexed Krka findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Further information on Pemetrexed Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det kan desuden anvendes som vedligeholdelsesbehandling hos patienter, der har fået platinbaseret kemoterapi. 
It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.
Den anbefalede dosis Pemetrexed Krka er 500 mg pr. kvadratmeter kropsoverflade (beregnet ud fra patientens højde og vægt). 
The recommended dose of Permetrexed Krka is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Pemetrexed Krka. 
As for every medicine, the company provided studies on the quality of Pemetrexed Krka.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed Krka? 
What measures are being taken to ensure the safe and effective use of Pemetrexed Krka?
For mere information om brugen af Pemetrexed Krka, se indlægssedlen, eller kontakt lægen eller apotekspersonalet. 
For more information about using Pemetrexed Krka, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pemetrexed Krka kan sammenlignes med Alimta. 
The European Medicines Agency concluded that, in accordance with EU requirements, Pemetrexed Krka has been shown to be comparable to Alimta.
Bivirkninger rapporteret for Pemetrexed Krka vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Pemetrexed Krka are carefully evaluated and any necessary action taken to protect patients.
Da Pemetrexed Krka er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet. 
Because Pemetrexed Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Alimta, og de behøver ikke at blive gentaget for Pemetrexed Krka. 
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed Krka.
Hvilke fordele og risici er der forbundet med Pemetrexed Krka? 
What are the benefits and risks of Pemetrexed Krka?
Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Pemetrexed Krka optages identisk med referencelægemidlet for at give det samme niveau af det aktive stof i blodet. 
There was no need for ‘bioequivalence' studies to investigate whether Pemetrexed Krka is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Pemetrexed Krka er et kræftlægemiddel til behandling af to typer af lungekræft: 
Pemetrexed Krka is a cancer medicine used to treat two types of lung cancer:
Det betyder, at Pemetrexed Krka indeholder det samme aktive stof og virket på samme måde som et "referencelægemidlet", som allerede er godkendt i EU, og som hedder Alimta. 
This means that Pemetrexed Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Alimta.
Andre oplysninger om Pemetrexed Krka 
Other information about Pemetrexed Krka
Oversigt over Pemetrexed Krka, og hvorfor det er godkendt i EU 
An overview of Pemetrexed Krka and why it is authorised in the EU
• fremskreden ikkesmåcellet lungekræft af typen ikke-pladecellekarcinom, hvor det anvendes enten i kombination med cisplatin hos tidligere ubehandlede patienter eller som enkeltstofbehandling hos patienter, der tidligere har fået kræftbehandling. 
• advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Hvad er Pemetrexed Krka, og hvad anvendes det til? 
What is Pemetrexed Krka and what is it used for?
Hvorfor er Pemetrexed Krka godkendt i EU? 
Why is Pemetrexed Krka authorised in the EU?
I kroppen omdannes pemetrexed til en aktiv form, der blokerer de enzymer, der medvirker ved dannelsen af nukleotider (byggestenene i DNA og RNA, cellernes genetiske materiale). 
In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes involved in producing nucleotides (the building blocks of DNA and RNA, the genetic material of cells).
Det var derfor agenturets opfattelse, at fordelene af Pemetrexed Krka opvejer de identificerede risici, som for Alimta, og at det kan godkendes til anvendelse i EU. 
Therefore, the Agency's view was that, as for Alimta, the benefit of Pemetrexed Krka outweighs the identified risk and it can be authorised for use in the EU.
• malignt pleuramesoteliom (kræft i lungehinderne, der sædvanligvis skyldes udsættelse for asbest), hvor det anvendes sammen med cisplatin hos patienter, der ikke tidligere har fået kemoterapi, og hos hvem kræften ikke kan fjernes ved operation 
• malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Som for alle lægemidler bliver data vedrørende brugen af Pemetrexed Krka løbende overvåget. 
As for all medicines, data on the use of Pemetrexed Krka are continuously monitored.
Pemetrexed Krka indeholder det aktive stof pemetrexed. 
Pemetrexed Krka contains the active substance pemetrexed.
Det får kræftcellerne til at dele sig langsommere, men har kun ringe virkning på normale celler. 
This slows down the division of cancer cells, while normal cells are only slightly affected.
Dette skyldes, at Pemetrexed Krka gives som infusion i en vene, så det aktive stof leveres direkte ind i blodbanen. 
This is because Pemetrexed Krka is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Det aktive stof i Pemetrexed Krka, pemetrexed, er et vævsgiftigt (cytotoksisk) lægemiddel (dvs. det dræber celler, der deler sig, såsom kræftceller) i gruppen "antimetabolitter". 
The active substance in Pemetrexed Krka, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Når Pemetrexed Krka gives sammen med cisplatin, bør der desuden før og efter cisplatindosen gives medicin mod kvalme (for at forhindre opkastning) samt væsketilskud (for at forhindre dehydrering). 
When Pemetrexed Krka is given with cisplatin, an antiemetic medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
For at mindske bivirkningerne ved bør patienten under behandlingen med Pemetrexed Krka få binyrebarkhormon (en type lægemiddel, der mindsker inflammation), folsyre (en type vitamin) og indsprøjtninger med B12vitamin. 
To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Krka.
Hvordan er Pemetrexed Krka blevet undersøgt? 
How has Pemetrexed Krka been studied?
Hvis patienten får lave blodtal, eller der opstår visse andre bivirkninger, bør behandlingen udsættes eller standses, eller dosis nedsættes. 
Treatment should be delayed or stopped, or the dose reduced, in patients whose blood cell counts are low or who have certain other side effects.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pemetrexed Krka. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Krka have been included in the summary of product characteristics and the package leaflet.
Pemetrexed Krka fås som et pulver, der efter opløsning indgives ved infusion (drop) i en blodåre. 
Pemetrexed Krka is available as a powder that is made up into a solution for infusion (drip) into a vein.
I kræftceller omdannes pemetrexed hurtigere til den aktive form end i normale celler. 
Pemetrexed is converted into its active form more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Dannelsen af DNA og RNA bremses derved af den aktive form af pemetrexed. 
As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing.
Hvordan virker Pemetrexed Krka? 
How does Pemetrexed Krka work?
Hvordan anvendes Pemetrexed Krka? 
How is Permetrexed Krka used?
Proceduren indledtes den 17. oktober 2002. 
The procedure started on 17 October 2002.
CPMP vedtog derfor en positiv udtalelse den 20. februar 2003. 
The CPMP adopted a positive opinion on 20 February 2003.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 25. juni 
The final opinion was converted into a decision by the European Commission on 25 June 2003.
London, 20 August 2003 EMEA/CPMP/4260/03/da 
London, 20 August 2003 EMEA/CPMP/4260/03/en
Referencemedlemsstaten under den gensidige anerkendelsesprocedure er Irland med Østrig, Belgien, Danmark, Tyskland, Grækenland, Island, Italien, Luxembourg, Norge, Portugal, Spanien og Sverige som berørte medlemsstater. 
The Reference Member State for this MRP was Ireland with Austria, Belgium, Denmark, Germany, Greece, Finland, Iceland, Italy, Luxembourg, Norway, Portugal, Spain, and Sweden as Concerned Member States.
Indehaveren af markedsføringstilladelsen fremsendte yderligere oplysninger den 11. november 2002 og fremsendte yderligere skriftlige redegørelser den 5. februar 2003. 
Supplementary information was provided by the Marketing Authorisation Holder on 11 November 2002 and further written explanations on 5 February 2003.
De faglige konklusioner og begrundelserne for ændringen af produktresuméet fremgår af bilag II. 
The scientific conclusions and the grounds for the amendment of the Summary of Product Characteristics are set out in Annex II.
Primær hyperhydrosis er en kronisk idiopatisk sygdom med kraftig og ukontrollerbar sveden. 
Primary hyperhydrosis is a chronic idiopathic disorder of excessive and uncontrolled sweating.
I juni 2002 ansøgte Allergan Pharmaceuticals (Irland) Ltd, indehaveren af markedsføringstilladelsen, om en ny indikation under proceduren for gensidig anerkendelse af markedsføringstilladelserne for Botox vedrørende behandling af aksillær hyperhidrosis. 
In June 2002, the Marketing Authorisation Holder, Allergan Pharmaceuticals (Ireland) Ltd applied for a new indication through Mutual Recognition Procedure (MRP), for Botox for the treatment of axillary hyperhidrosis.
Den 3. september 2002 blev der i henhold til artikel 29 i direktiv 2001/83/EF indbragt en sag med henblik på voldgift af Tyskland og Italien, som berørte væsentlige indsigelser vedrørende virkning og klinisk sikkerhed af lægemidlet Botox til den nye indikation. 
On September 3rd 2002 a referral for arbitration according to article 29 of Directive 2001/83/EC was triggered by Germany and Italy regarding the major objections on the clinical safety and efficacy of this new indication for the medicinal product Botox.
Botox blev godkendt første gang i Den Europæiske Union i 1994 til intramuskulær behandling af neuromuskulære lidelser. 
Botox was first licensed in the European Union in 1994 for neuromuscular disorders via intramuscular route.
Efter at CPMP har behandlet de punkter, hvorom der er uenighed, og de svar, der er afgivet af indehaveren af markedsføringstilladelsen, er CPMP af den opfattelse, at de af Tyskland og Italien rejste indsigelser ikke bør forhindre udstedelse af en markedsføringstilladelse for den nye indikation, forudsat at en række vigtige betingelser til sikring af en sikker og effektiv anvendelse af lægemidlet er opfyldt. 
The CPMP, having considered the points of disagreement and the responses provided by the Marketing Authorisation Holder, was of the opinion that the objections raised by Germany and Italy should not prevent the granting of a Marketing Authorisation for the new indication “persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment” subject to certain essential conditions for the safe and effective use of the medicinal product.
Virkemåden for Botox ved hyperhidrosis anses for at være hæmning af kolinergt induceret heftig sveden ved at blokere de autonome sympatiske nervefibre, som innerverer svedkirtlerne. 
The mechanism of action of Botox in hyperhidrosis is thought to be the inhibition of cholinergically-induced excessive sweating by blockage of autonomic sympathetic nerve fibres innervating sweat glands.
Botox [Clostridium botulinum toksin type A neurotoksinkompleks] hæmmer frigivelse af acetylkolin ved præsynaptisk membran på kolinerge neuroner. 
Botox [Clostridium botulinum toxin type A neurotoxin complex] inhibits the release of acetylcholine at the presynaptic membrane on cholinergic neurons.
UDVALGET FOR FARMACEUTISKE SPECIALITETER (CPMP) SAMMENFATTENDE OPLYSNINGER OM UDTALELSEN OM DEN INDBRAGTE SAG EFTER VOLDGIFTEN I HENHOLD TIL ARTIKEL 29 I DIREKTIV 2001/83/EF BOTOX Aktivt stof: Clostridium botulinum type A neurotoksinkompleks 
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) SUMMARY INFORMATION ON REFERRAL OPINION FOLLOWING ARBITRATION PURSUANT TO ARTICLE 29 OF COUNCIL DIRECTIVE 2001/83/EC FOR
Yderligere oplysninger). 
Further information).
Desuden skal der fremsendes en opdateret RMP: 
In addition, an updated RMP should be submitted:
Risikostyringsprogram (RPM) 
Risk Management plan (RMP)
Se venligst produktinformationen for: 
Please consult the Product Information of:
Loc. Bellaria - 53018 Rosia - Sovicille (SI) Italien 
Loc. Bellaria - 53018 Rosia - Sovicille (SI) Italy
Influenzavaccine, ATC-kode: J07BB02 
Influenza vaccine, ATC Code: J07BB02
De rapporterede bivirkninger er opstillet efter følgende hyppighed: Meget almindelig (1/10), 
Adverse reactions reported are listed according to the following frequency: Very common (1/10),
Fortæl det til lægen, hvis du har nogen kendte allergier. 
Tell your doctor if you have any known allergies.
Ingen af ingredienserne i vaccinen kan give influenza. 
None of the ingredient in the vaccine can cause flu.
Immunisering bør udskydes hos patienter med alvorlig febril sygdom eller akut infektion. 
Immunisation should be postponed in patients with severe febrile illness or acute infection.
I sådanne tilfælde skal du være klar over, at bivirkningerne kan være mere intense. 
In such cases, you should be aware that the side effects may be more intense.
Lægerne er opmærksomme på denne mulighed og har nødbehandling til rådighed i disse tilfælde. 
Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Co-administration blev ikke associeret med højere forekomster af lokale eller systemiske reaktioner sammenlignet med administration af Focetria alene. 
Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Focetria alone.
Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger. 
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Der blev udført et klinisk studie hos børn med den samme vaccine. 
A clinical study was conducted with the same vaccine in children.
- hvis du har en alvorlig infektion og feber (temperatur over 38 °C). 
• if you have a severe infection with a high temperature (over 38°C).
I disse tilfælde vil Western Blot-teknikken give et negativt resultat. 
In such cases, the Western Blot method is negative.
Induration var en almindelig reaktion hos børn, men mindre almindelig hos spædbørn. 
Induration was a common reaction in toddlers but was less common in infants.
CHMP er enig i PRAC's videnskabelige konklusioner. 
The CHMP agrees with the scientific conclusions made by the PRAC.
• Når der modtages nye oplysninger, der kan have indflydelse på den gældende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter 
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Der var færre bivirkninger efter den anden vaccination end efter den første. 
There were fewer reactions after the second vaccination compared with the first.
I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil. 
• Official batch release In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
De almindelige reaktioner forsvinder som regel inden for 1-2 dage uden behandling. 
The common reactions usually disappear within 1-2 days without treatment.
Immunresponset over for sæsonbetingede antigener var tilfredsstillende. 
The immune response to the seasonal antigens was satisfactory.
Der findes sikkerhedsdata for gravide kvinder, som er blevet eksponeret for Focetria, især under andet og tredje trimester. 
Safety data are available in pregnant women exposed to Focetria in particular during second and third trimesters.
Vaccinen indeholder et ‘adjuvans' (MF59C.1), der skal stimulere en bedre reaktion. 
The vaccine contains an ‘adjuvant' (MF59C.1) to stimulate a better response.
Farmakoterapeutisk klassifikation: Vacciner. 
Pharmacotherapeutic group: Vaccines.
Dette er en flerdosisbeholder. 
This is a multidose container.
Det er almindeligt accepteret, at adjuvanseffekten, som medfører øget immunogenicitet, er forbundet med en let forøget hyppighed af lokale reaktioner (især lette smerter) sammenlignet med konventionelle, ikke-adjuverede influenzavacciner. 
It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
Vaccinen vil blive sprøjtet ind i en muskel (normalt i overarmen). 
The vaccine will be injected into a muscle (usually in the upper arm).
Disse bivirkninger forsvinder normalt i løbet af 1-2 dage uden behandling. 
These side effects usually disappear within 1-2 days without treatment.
Disse bivirkninger kan opstå i forbindelse med Focetria. 
These side effects may occur with Focetria.
Pakninger med 1 og 10. 
Packs of 1 and 10.
Lægemidlets PSUR-cyklus skal følge en halvårlig cyklus, indtil andet aftales med CHMP. 
The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP
Focetria bør anvendes i overensstemmelse med officielle retningslinjer. 
Focetria should be used in accordance with Official Guidance.
Under hensyntagen til PRAC's vurderingsrapport om PSUR'erne for Focetria er PRAC nået frem til følgende videnskabelige konklusioner: 
Taking into account the PRAC Assessment Report on the PSUR for Focetria, the scientific conclusions of PRAC are as follows:
Herudover er bivirkningerne i listen nedenfor er opstået i dagene eller ugerne efter vaccinationen med adjuverede og ikke-adjuverede vacciner, som gives rutinemæssigt en gang om året for at forebygge influenza. 
In addition, the side effects listed below have occurred in the days or weeks after vaccination with adjuvanted and non-adjuvanted vaccines given routinely every year to prevent flu.
• Senest 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering) 
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Systemisk 
Systemic
Disse forbigående falsk-positive reaktioner kan skyldes produktion af IgM som respons på vaccinen. 
These transitory false positive results may be due to IgM production in response to the vaccine.
Som med alle injicerbare vacciner skal relevant medicinsk behandling samt mulighed for overvågning altid være let tilgængelig i tilfælde af en sjælden anafylaktisk reaktion efter indgift af vaccinen. 
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Feber ≥ 40° C 
Fever ≥ 40° C
I de kliniske studier med vaccinen var de fleste bivirkninger milde og kortvarige. 
In the clinical studies with the vaccine, most side effects were mild in nature and short term.
Adjuvans MF59C.1, som indeholder: squalen 
Adjuvant MF59C.1 containing: squalene
9,75 milligram polysorbat 80 
9.75 milligrams polysorbate 80
Vasculitis med forbigående nyrepåvirkning og ekssudativ erythema multiforme. 
Vasculitis with transient renal involvement and exudative erythema multiforme.
I lyset af de tilgængelige data vedrørende anvendelse af Focetria under graviditet vurderede PRAC derfor, at ændringerne i produktresumeet var berettigede. 
Therefore, in view of available data regarding the use of Focetria during pregnancy, the PRAC considered that changes to the product information were warranted.
Bivirkninger under kliniske studier med børn 
Side effects from clinical studies in children
De fleste reaktioner var milde, kortvarige og kvalitativt på samme niveau som dem, der blev induceret af konventionelle sæson-influenzavacciner. 
Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.