natgillin/translations-raw huggingface dataset:
Under normal seksuel stimulering produceres der cGMP i penis, hvor det får musklen i svulmelegemet i penis (corpora cavernosa) til at slappe af. 
During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Sildenafil Actavis er af sammenlignelig kvalitet og er bioækvivalent med Viagra. 
The CHMP concluded that, in accordance with EU requirements, Sildenafil Actavis has been shown to have comparable quality and to be bioequivalent to Viagra.
Det virker ved at blokere phosphodiesteraseenzymet, som normalt nedbryder et stof kaldet cyklisk guanosinmonophosphat (cGMP). 
It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Dosis kan øges til maksimalt 100 mg eller nedsættes til 25 
The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Viagra. 
Therefore, the CHMP's view was that, as for Viagra, the benefit outweighs the identified risk.
Det aktive indholdsstof i Sildenafil Actavis, sildenafil, tilhører en gruppe af lægemidler kaldet phosphodiesterase type 5- (PDE5)-hæmmere. 
The active ingredient in Sildenafil Actavis, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Sildenafil Actavis. 
The Committee recommended that Sildenafil Actavis be given marketing authorisation.
Det betyder, at Sildenafil Actavis er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, nemlig Viagra. 
This means that Sildenafil Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Sildenafil Actavis er et ‘generisk lægemiddel'. 
Sildenafil Actavis is a ‘generic medicine'.
Hvilke fordele og risici er der forbundet med Sildenafil Actavis? 
What are the benefits and risks of Sildenafil Actavis?
Da Sildenafil Actavis er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet. 
Because Sildenafil Actavis 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.
Sildenafil Actavis er et lægemiddel, der indeholder det aktive stof sildenafil. 
Sildenafil Actavis is a medicine that contains the active substance sildenafil.
Hvis Sildenafil Actavis tages sammen med et måltid, kan virkningens indtræden forsinkes i forhold til, hvis det tages uden et måltid. 
If Sildenafil Actavis is taken with food, the onset of activity may be delayed compared with taking Sildenafil Actavis without food.
Da Sildenafil Actavis er et generisk lægemiddel, har undersøgelserne af mennesker været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Viagra. 
Because Sildenafil Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Andre oplysninger om Sildenafil Actavis 
Other information about Sildenafil Actavis
Hvorfor blev Sildenafil Actavis godkendt? 
Why has Sildenafil Actavis been approved?
Hvad er Sildenafil Actavis? 
What is Sildenafil Actavis?
Hvordan blev Sildenafil Actavis undersøgt? 
How has Sildenafil Actavis been studied?
Hvad anvendes Sildenafil Actavis til? 
What is Sildenafil Actavis used for?
Hvordan anvendes Sildenafil Actavis? 
How is Sildenafil Actavis used?
Hvordan virker Sildenafil Actavis? 
How does Sildenafil Actavis work?
Haes-Steril Hes Natriumchlorid 9 g/1.000 ml, hydroxyethylstivelse 200/0,5 
Haes-Steril Hes Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 200/0.5
Natriumchlorid 9 g/1.000 ml, poly(O-2-hydroxyethyl)-stivelse 130/0,4 (Ph.Eur.) 
Sodium Chloride 9g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.)
3,27 g/1.000 ml, L-maleinsyre 0,67 g/1.000 ml 
3.27g/1000ml, L-Malic Acid 0.67g/1000ml
Hes Hipertónico Natriumchlorid 72 g/1.000 ml, hydroxyethylstivelse 200/0,5 
Hes Hipertónico Sodium Chloride 72g/1000ml, Hydroxyethyl Starch 200/0.5
Natriumchlorid 4,5 g/500 ml, hydroxyethylstivelse 130/0,4 30 g/500 ml 
Sodium Chloride 4.5g/500ml, Hydroxyethyl Starch 130/0.4 30g/500ml
Natriumchlorid 9 g/1.000 ml, poly(O-2-hydroxyethyl)-stivelse 60 g/1.000 ml 
Sodium Chloride 9g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000ml
Natriumchlorid 9 g/1.000 ml, hydroxyethylstivelse 200/0,5 100 g/1.000 ml 
Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 200/0.5 100g/1000ml
Natriumchlorid 9 g/1.000 ml, hydroxyethylstivelse 130/0,4 100 g/1.000 ml 
Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0.4 100g/1000ml
Natriumchlorid 9 g/1.000 ml, hydroxyethylstivelse 130/0,4 60 g/1.000 ml 
Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0.4 60g/1000ml
Natriumchlorid 9 g/1.000 ml, hydroxyethylstivelse (hetastarch) 60 g/1.000 ml 
Sodium Chloride 9g/1000ml, Hetastarch 60g/1000ml
Natriumchlorid 9 g/l, poly(O-2hydroxyethyl)-stivelse 100 g/l 
Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 100gl
Natriumchlorid 9 g/l, poly(O-2hydroxyethyl)-stivelse 60 g/l 
Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 60gl
Magnesiumchloridhexahydrat 0,3 g/l, kaliumchlorid 0,3 g/l, natriumchlorid 6,02 g/l, natriumacetattrihydrat 4,63 g/l, hydroxyethylstivelse 130/0,4 60 g/l 
Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl
Magnesiumchloridhexahydrat 0,3 g/1.000 ml, kaliumchlorid 0,3 g/l, natriumchlorid 6,02 g/1.000 ml, natriumacetattrihydrat 4,63 g/1.000 ml, poly(O-2hydroxyethyl)-stivelse 130/0,4 (Ph.Eur.) 
Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3gl, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (O-2Hydroxyethyl) Starch 130/0.4 (Ph.Eur.)
Magnesiumchloridhexahydrat 0,2 g/1.000 ml, kaliumchlorid 0,4 g/1.000 ml, natriumchlorid 6 g/1.000 ml, kalciumchloriddihydrat 0,134 g/1.000 ml, hydroxyethylstivelse (hetastarch) 60 g/1.000 ml, natriumacetattrihydrat 3,7 g/1.000 ml 
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.4g/1000ml, Sodium Chloride 6g/1000ml, Calcium Chloride Dihydrate 0.134g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate 3.7g/1000ml
Magnesiumchloridhexahydrat 0,3 g/1.000 ml, kaliumchlorid 0,3 g/1.000 ml, natriumchlorid 6,02 g/1.000 ml, natriumacetattrihydrat 4,63 g/1.000 ml, poly(O-2hydroxyethyl)-stivelse 130/0,4 (Ph.Eur.) 
Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.)
Magnesiumchloridhexahydrat 0,3 g/1.000 ml, kaliumchlorid 0,3 g/1.000 ml, natriumchlorid 6,02 g/1.000 ml, natriumacetattrihydrat 4,63 g/1.000 ml, hydroxyethylstivelse 130/0,4 60 g/1.000 ml 
Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Hydroxyethyl Starch 130/0.4 60g/1000ml
Magnesiumchloridhexahydrat 0,2 g/1.000 ml, kaliumchlorid 0,4 g/1.000 ml, natriumchlorid 6 g/1.000 ml, kalciumchloriddihydrat 0,134 g/1.000 ml, natriumacetattrihydrat 3,7 g/1.000 ml, poly(O-2hydroxyethyl)-stivelse 100 g/1.000 ml 
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.4g/1000ml, Sodium Chloride 6g/1000ml, Calcium Chloride Dihydrate 0.134g/1000ml, Sodium Acetate Trihydrate 3.7g/1000ml, Poly (0 2
Magnesiumchloridhexahydrat 0,3 g/1.000 ml, kaliumchlorid 0,3 g/1.000 ml, natriumchlorid 6,02 g/1.000 ml, natriumacetattrihydrat 4,63 g/1.000 ml, poly(O-2hydroxyethyl)-stivelse 60 g/1.000 ml 
Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000ml
Magnesiumchloridhexahydrat 0,2 g/1.000 ml, kaliumchlorid 0,3 g/1.000 ml, natriumchlorid 6,25 g/1.000 ml, kalciumchloriddihydrat 0,37 g/1.000 ml, hydroxyethylstivelse (hetastarch) 100 g/1.000 ml, natriumacetattrihydrat 3,27 g/1.000 ml 
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Hetastarch 100g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml
0,37 g/1.000 ml, hydroxyethylstivelse (hetastarch) 60 g/1.000 ml, natriumacetattrihydrat 
0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate
Magnesiumchloridhexahydrat 0,2 g/1.000 ml, kaliumchlorid 0,3 g/1.000 ml, natriumchlorid 6,25 g/1.000 ml, kalciumchloriddihydrat 0,37 g/1.000 ml, hydroxyethylstivelse (hetastarch) 100 g/1.000 ml, natriumacetattrihydrat 3,27 g/1.000 ml, L-maleinsyre 0,67 g/1.000 ml 
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Hetastarch 100g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml, L-Malic Acid 0.67g/1000ml
Magnesiumchloridhexahydrat 0,2 g/1.000 ml, kaliumchlorid 0,3 g/1.000 ml, natriumchlorid 6,25 g/1.000 ml, kalciumchloriddihydrat 0,37 g/1.000 ml, hydroxyethylstivelse (hetastarch) 60 g/1.000 ml, natriumacetattrihydrat 3,27 g/1.000 ml, L-maleinsyre 0,67 g/1.000 ml 
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml, L-Malic Acid 0.67g/1000ml
Magnesiumchloridhexahydrat 0,2 g/1.000 ml, kaliumchlorid 0,3 g/1.000 ml, natriumchlorid 6,25 g/1.000 ml, kalciumchloriddihydrat 0,37 g/1.000 ml, hydroxyethylstivelse (hetastarch) 100 g/1.000 ml, maleinsyre 0,67 g/1.000 ml, natriumacetattrihydrat 3,27 g/1.000 ml 
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Hetastarch 100g/1000ml, Malic Acid 0.67g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml
Magnesiumchloridhexahydrat 0,2 g/1.000 ml, kaliumchlorid 0,3 g/1.000 ml, natriumchlorid 6,25 g/1.000 ml, kalciumchloriddihydrat 0,37 g/1.000 ml, natriumacetattrihydrat 3,27 g/1.000 ml, L-maleinsyre 0,67 g/1.000 ml 
Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml, L-Malic Acid 0.67g/1000ml
Her er 4 måder at få besvaret dine spørgsmål: 
Here are 4 ways to get your questions answered:
Lægen vil fortælle dig, hvor meget du skal tage hver dag. 
Your doctor will tell you how much you should take each day.
Jeg prøver at trykke på den, men jeg kan kun trykke den delvist ned. 
I'm trying to push it, but I can only partially push it down.
30. juni 2023 
30 June 2023
Hver pen må kun bruges af én patient. 
Each pen must be used by only one patient.
Du har muligvis brugt alle doser i din pen. 
You may have used all the doses in your pen.
I alt 49 patienter blev inkluderet i studiet. 
A total of 49 patients were enrolled in the study.
Det bekræfter, at din pen ikke er blevet primet endnu. 
This confirms that your pen has not been primed yet.
• Henvis til følgende ofte stillede spørgsmål. 
• Refer to the following Frequently Asked Questions.
Monitorering af patienterne under behandlingen 
Monitoring of patients during treatment
Hvorfor vil den blå knap ikke gå hele vejen ned? 
Why won't the blue button go all the way down?
E. Ofte stillede spørgsmål 
E. Frequently Asked Questions
Vigtigt - Læs disse oplysninger, inden du starter: 
Important - Read this information before getting started:
Hvad er Natpar? 
What is Natpar?
• søvnproblemer (være søvnig i løbet af dagen eller have besvær med at falde i søvn om aftenen)* 
• sleep problems (feeling sleepy during the day or having trouble sleeping at night)*
• Ellers skal du fortsætte med trin 2 nedenfor. 
• Otherwise, continue with Step 2 below.
• Ellers skal du gå til “Daglig injektion” (afsnit C). 
• Otherwise, go to “Daily Injection” (Section C).
Det vil være samme ugedag 2 uger senere (se figur B). 
This will be the same day of the week, 2 weeks later (See Figure B).
Gennemsnitsalderen var 47,3 år (19-74 år), og 79 % var kvinder. 
The mean age was 47.3 years (range 19 to 74 years); 79% were females.
Den kalcæmiske respons opretholdes i mere end 24 timer efter administration. 
The calcaemic response is sustained for more than 24 hours after administration.
Hvem skal jeg kontakte, hvis jeg tror, at jeg ikke har modtaget en fuld dosis, eller hvis jeg har symptomer af enhver slags? 
Who should I contact if I am concerned about not having received a full dose or if I have symptoms of any kind?
Se punkt 5.2. 
See section 5.2.
Øvrige indholdsstoffer i medicinen (for alle styrker): 
The other ingredients in the medicine (for all strengths) are:
• Medicinen må ikke anvendes, hvis den ikke har været opbevaret korrekt. 
• Do not use this medicine if it has not been stored correctly.
Du skal kun gøre dette én gang for hver ny pen. 
You only need to do this one time for each new pen.
Patienterne havde haft hypoparatyroidisme i gennemsnitligt 13,6 år. 
Patients had hypoparathyroidism for an average of 13.6 years.
Dette lægemiddel må ikke blandes med andre lægemidler. 
This medicinal product must not be mixed with other medicinal products.
Nålen er muligvis ikke sat korrekt på. 
The needle may not be attached correctly.
Det betyder, at det er næsten "natriumfrit". 
This means that it is essentially “sodium-free”.
Tag den næste Natpar-dosis på det sædvanlige tidspunkt næste dag. 
Take your next dose of Natpar at the usual time the next day.
• Bekræft, at serummagnesium er inden for referenceområdet. 
• Confirm serum magnesium is within the reference range.
Hvis symptomerne er alvorlige, kan din læge give dig yderligere behandling. 
If your symptoms are severe, your doctor may give you additional medical treatment.
Hyppigheden defineres som Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), and not known (cannot be estimated from the available data).
• Lad injektionsstedet lufttørre. 
• Let the injection site air dry.
Du må ikke rengøre den med nogen andre væsker som f.eks. alkohol. 
Do not clean it with any other liquids, such as alcohol.
Lægen vil tjekke dit kalciumniveau. 
Your doctor will check your calcium levels.
Natpar bør ikke anvendes til børn og unge under 18 år. 
Natpar should not be used in children or adolescents under 18 years old.
Hvis du for eksempel giver din første injektion på en tirsdag, skal du kassere din pen 2 uger senere på en tirsdag. 
For example, if you give your first injection on a Tuesday, you will need to discard your pen 2 weeks later on a Tuesday.
Denne indlægsseddel blev senest ændret 07/2019. 
This leaflet was last revised in 07/2019.
Hvorfor viser dosistælleren ”14”, efter jeg har givet en injektion med en nyblandet pen? 
Why does the dose counter show “14” after I have given an injection using a newly mixed pen?
Hypoparatyroidisme kan dog i sig selv påvirke din evne til at koncentrere dig. 
However, hypoparathyroidism itself may affect your ability to concentrate.
• Du skal klargøre en ny pen hver 14. dag. 
• Prepare a new pen every 14 days.
Hvordan rengør jeg min pen? 
How do I clean my pen?
Vigtigt: Læs trin 10 til og med trin 14 omhyggeligt, inden du injicerer. 
Important: Carefully read Step 10 through Step 14 before injecting.
Lægen vil kontrollere, hvordan du reagerer på behandlingen: - i de første 7 dage efter, behandlingen er startet, og - hvis din dosis ændres. 
Your doctor will check how you respond to the treatment: - during the first 7 days of starting treatment and - if your dose is changed.
Ingen ændring 
No change
• Slip den blå knap. 
• Let go of the blue button.
Du må ikke injicere en dobbeltdosis som erstatning for den glemte dosis. 
Do not inject a double dose to make up for a forgotten dose.
Du må ikke dele din pen eller dine penkanyler med andre. 
Do not share your pen or pen needles with anyone else.
Afbrydelse eller seponering af behandling 
Interruption or discontinuation of treatment
• Du må IKKE bruge en pen, der har været frosset. 
• Do NOT use a pen that has been frozen.
C. Daglig injektion 
C. Daily Injection
Overvej at øge dosis efter mindst 2-4 uger på en stabil dosis 
Consider increase after at least 2-4 weeks at a stable dose
Hvis udløbsdatoen er før den aktuelle dato eller inden for de næste to uger, skal du kassere pennen og bruge en ny pen. 
If the expiration date is before today's date or is in the next two weeks, discard the pen and use a new pen.
Disse oplysninger erstatter ikke rådgivning fra din læge eller sygeplejerske vedrørende din tilstand eller behandling. 
This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.
Ring til din læge. 
Call your doctor.
• Vask dine hænder med vand og sæbe og tør dem med et rent håndklæde. 
• Wash your hands with soap and water and dry them with a clean towel.
Det kan betyde, at du ikke holdt nålen i låret i hele 10 sekunder. 
This may mean that you did not hold the needle in your thigh for the full 10 seconds.
Hvis du stadig ikke kan skrue den helt ned, skal du bruge en ny nål. 
If you still cannot screw it down all the way, use a new needle.
• Kontakt din læge eller sygeplejerske. 
• Call your doctor or nurse.
Du må ikke puste på det eller vifte med din hånd. 
Do not blow on it or fan it with your hand.
Hvis du tror, at du ikke har fået hele din dosis, må du ikke tage en anden dosis. 
If you do not think you received your full dose, do not take another dose.
Hvad skal jeg gøre, hvis medicinen i pennen har været frosset? 
What should I do if the medicine in the pen is frozen?
Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) 
Not known (cannot be estimated from the available data)
Absorption Natpar administreret subkutant havde en absolut biotilgængelighed på 53 %. 
Absorption Natpar administered subcutaneously had an absolute bioavailability of 53%.
Du skal bruge følgende redskaber til din injektion: 
You will need the following supplies for your injection:
I effektanalysen blev forsøgspersoner, der opfyldte tre komponenter af det tredelte responskriterie, betragtet som respondere. 
For the efficacy analysis, subjects that fulfilled three components of a three-part response criterion were considered responders.
Natpar er ikke proteinbundet og har et lille fordelingsvolumen. 
Natpar is not protein bound and has a low volume of distribution.
Din pen skal bruges dagligt i 14 dage og skal derefter smides væk (kasseres) 14 dage efter blanding, også selv om der er resterende medicin i pennen. 
Your pen is to be used daily for 14 days and should be thrown away (discarded) 14 days after mixing, even if medicine remains in the pen.
Hvad skal jeg gøre, hvis jeg hørte et klik, da jeg trykkede den blå knap ned for at give injektionen, men den blå knap ikke forblev nede? 
What should I do if I heard a click when I pushed the blue button to give the injection, but the blue button did not stay down?
Hvis du glemmer at tage Natpar (eller ikke kan injicere det på det sædvanlige tidspunkt), skal du tage injektionen, så snart du kan, men du må ikke injicere mere end én dosis på samme dag. 
If you forget to use Natpar (or cannot inject it at your usual time), use your injection as soon as you can but do not inject more than one dose in the same day.
• højt blodtryk* 
• high blood pressure*
Ikke kendt (hyppigheden kan ikke beregnes ud fra tilgængelige data): 
Not known (frequency cannot be estimated from the available data):
Disse 17 patienter havde lave titre af anti-PTH-antistoffer, og 3 af dem blev efterfølgende antistofnegative. 
These 17 patients had low titre anti-PTH antibodies and, of these, 3 subsequently became antibody negative.
• øget mængde kalcium i urinen* 
• increased level of calcium in your urine*
Vigtigt: Små luftbobler i væsken vil muligvis ikke stige til vejrs. 
Important: Small air bubbles in the liquid may not rise to the top.
19 Sådan bortskaffer du dine tomme penne 
19 How to discard your empty pens
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 24. april 2017 Dato for seneste fornyelse: 29. april 2019 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 April 2017
90 % af de randomiserede patienter gennemførte det 24 uger lange behandlingsforløb. 
Ninety percent of patients who were randomised completed 24 weeks of treatment.
• Opbevar din pen væk fra varme og lys. 
• Store your pen away from heat and light.
• smerter i arme eller ben 
• pain in your arms and legs
Kan jeg bruge andre kanyler? 
Can I use different needles?
Når du tager din næste planlagte injektion, skal du sørge for at holde nålen i låret i mindst 10 sekunder. 
When you give your next scheduled injection, be sure that you hold the needle in your thigh for at least 10 seconds.
PTH (1-84) er den primære regulator af plasmacalcium-homøostasen. 
PTH (1-84) is the principal regulator of plasma calcium homeostasis.
• Sæt pennen ned og vent, indtil pulveret er opløst og væsken er farveløs, eller indtil der er gået 5 minutter. 
• Set your pen down and wait until the powder is dissolved and the liquid is colourless, or until 5 minutes have passed.
• Gem hætten til senere brug. 
• Save the cap for later use.
Samtidig brug af Natpar og bisfosfonater anbefales ikke. 
Concomitant use of Natpar with bisphosphonates is not recommended.
Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler. 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis. 
This medicinal product contains less than 1 mmol (23 mg) sodium per dose.
En risiko for den gravide kvinde eller fosteret kan ikke udelukkes. 
A risk to the pregnant woman or developing foetus cannot be excluded.
• nervøsitet eller angst 
• feeling nervous or anxious
Det er normalt at se små bobler. 
It is common to see small bubbles.
Pulveret er hvidt, og solvensen er en klar, farveløs opløsning. 
The powder is white and the solvent is a clear, colourless solution.
Tre af disse patienter havde antistoffer med neutraliserende aktivitet; disse patienter opretholdt den kliniske respons uden evidens for immun-relaterede bivirkninger. 
Three of these patients had antibodies with neutralising activity; these patients maintained a clinical response with no evidence of immune-related adverse reactions.
Vigtigt: Det er normalt, at der kommer 1 eller 2 dråber medicin ud af huden eller kanylespidsen efter dette trin. 
Important: It is normal to see 1 or 2 drops of medicine leaking out of the skin or from the needle tip after this step.
Symptomer relateret til forhøjet eller nedsat kalciumniveau er anført i listen nedenfor. 
Symptoms related to high or low calcium levels are included in the list below.
1 • Hvis du lige har gennemført “Klargøring og blanding af ny pen” (afsnit B), skal du gå til trin 8 nedenfor. 
1 • If you just completed “New Pen Setup & Mixing” (Section B), go to Step 8 below.
Vigtigt: For at gøre det lettere at sætte hætten på, kan du anbringe kanylehæten mod en genstand eller overflade. 
Important: To make capping easier, place the needle cap against an object or surface.
2 • Tag din pen ud af køleskabet og anbring den på en ren, flad overflade. 
2 • Remove your pen from your refrigerator and set it on a clean, flat surface.