natgillin/translations-raw huggingface dataset:
Behandling med desirudin fortsættes derefter 2 gange daglig efter operationen i 9 til højst 12 dage, eller til patienten er helt oppegående, alt efter hvilken situation, der først opstår.
Treatment with desirudin is then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully mobile, whichever occurs first.
Informer hurtigst muligt lægen eller sygeplejersken, hvis en af nedenstående bivirkninger opstår.
Tell the doctor or nurse as soon as possible if any of the following side effects occur, some of which may be confused with side effects of surgery:
Dog er stabilitet under anvendelse demonstreret i 24 timer ved temperaturer mellem 2 °C og 8 °C (i køleskab).
However, the in-use stability has been demonstrated for 24 hours between 2°C and 8°C (in a refrigerator).
Om nødvendigt bør behandlingen med desirudin afbrydes, indtil aPTT vender tilbage til mindre end 2 gange kontrolværdien, hvor behandling med desirudin kan genoptages med reduceret dosis (se også pkt.
If necessary, therapy with desirudin should be interrupted until aPTT falls to less than twice the control at which time treatment with desirudin can be resumed at a reduced dose (see also section 4.5).
Stigning af leverenzymer, svimmelhed, søvnløshed, konfusion, følelse af at være forpustet, opkastning (med eller uden blod), forstoppelse, blod i urinen, vandladningsbesvær, udslæt, kløe (urtikaria), lavt indhold af kalium i blodet, brændende fornemmelse ved vandladning sammen med en øget vandladningshyppighed, langsom sårheling, næseblod, højt blodtryk, smerter (herunder smerter i benene, maven og/eller brystet).
Increase in liver enzymes, dizziness, sleeplessness, confusion, feeling breathless, vomiting (with or without blood), constipation, blood in your urine, difficulty in urinating, rash, itching (urticaria), low levels of potassium in the blood, burning feeling when passing urine with also an increased frequency of urination, slow healing of wounds, nose bleeds, high blood pressure, pain (including pain in legs,
Allergiske reaktioner er i kliniske undersøgelser rapporteret hos samme mængde (1,6 %) patienter, der blev behandlet med desirudin (N=2.367) eller ufraktioneret
Allergic reactions have been reported in the same proportion (1.6%) of patients treated with desirudin (N=2,367) or with unfractionated heparin (N=1,1 34) in clinical trials, regardless of causality.
Af den administrerede dosis udskilles 40-50 % uforandret i urinen.
The total urinary excretion of unchanged desirudin amounts to 40-50 % of the administered dose.
Patienter med nedsat nyrefunktion
Patients with liver impairment
Dog er stabilitet under anvendelse demonstreret i 24 timer ved temperaturer mellem 2 og 8 °C (i køleskab).
However, the in-use stability has been demonstrated for 24 hours between 2ºC and 8ºC (in a refrigerator).
Desirudin er kontraindiceret til patienter med: - overfølsomhed over for det aktive eller over for et eller flere af hjælpestofferne, - aktiv blødning og/eller irreversible koagulationsforstyrrelser, - svær nedsat lever- og nyrefunktion, - under graviditet (se pkt.
Desirudin is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients - with active bleeding and/or irreversible coagulation disorders - with severe renal and hepatic impairment
De fleste af de bivirkninger, der er rapporteret i kontrollerede kliniske undersøgelser af desirudin 15 mg to gange daglig og en standarddosis af ufraktioneret heparin, kan tilskrives selve hofteoperationen og virkningsmekanismen for de to produkter, der er undersøgt.
In controlled clinical trials investigating desirudin 15 mg twice daily and a standard dose of unfractionated heparin, the nature of the hip surgery operation and the mode of action of the two drugs studied account for most of the adverse experiences reported.
Opbevar hætteglas og ampul i den ydre karton for at beskytte mod lys.
Keep the vial and ampoule in the outer carton in order to protect from light.
Imidlertid bør det frarådes at amme, eller der bør anvendes alternativ lægemidler.
However, lactating mothers should be advised to avoid breast feeding or alternative
LÆGEMIDLETS NAVN Revasc 15 mg/0,5 ml pulver og solvens til injektionsvæske, opløsning
NAME OF THE MEDICINAL PRODUCT Revasc 15mg/0.5ml powder and solvent for solution for injection
En gennemsnitlig forlængelse af maksimum aPTT på ca. 1,4 gange basisværdien er observeret efter subkutan (s.c.) injektion af 15 mg desirudin 2 gange daglig.
A mean peak aPTT prolongation of around 1.4 times baseline value is observed following a subcutaneous (SC) b.i.d.
I kliniske forsøg var bivirkninger, der blev rapporteret uanset forbindelse til forsøgslægemidlet, blødningsepisoder, oliguri, hyperpyrexi og luksation af led.
Adverse reactions irrespective of trial drug relationship reported during clinical trials were bleeding episodes, oliguria, hyperpyrexia and joint dislocation.
Disse lægemidler omfatter acetylsalicylsyre og NSAID præparater ticlopidin og clopidogrel, glycoprotein IIb/IIIa-antagonister (abciximab, eptifibatid, tirofiban) og iloprost.
As with other anticoagulants desirudin should be used with caution in conjunction with medicinal products which affect platelet function these medicinal products include: acetylsalicylic acid and NSAIDs, ticlopidine and clopidogrel, glycoprotein IIb/IIIa antagonists (abciximab, eptifibatide,
I to kontrollerede dobbeltblinde kliniske undersøgelser var den totale hyppighed af tromboemboliske hændelser hos patienter behandlet med desirudin 15 mg s.c. 2 gange daglig (N=370) det halve i forhold til patienter behandlet med en standarddosis af ikke-fraktioneret heparin (N=396) (p < 0,0001); hyppigheden af proksimal dyb venetrombose var kun en femtedel af den ved heparin (p < 0,0001) observerede.
(N=370) was half that in patients treated with a standard dose of unfractionated heparin (N=396) (p<0.0001); the rate of proximal deep venous thrombosis was only one fifth that observed with the heparin (p<0.0001).
For at tilberede den færdige opløsning tilsættes 0,5 ml af den medfølgende mannitol solvens under aseptiske forhold til hætteglasset med pulveret til injektionsvæske.
6.6 Special precautions for disposal and other handling To prepare the reconstituted aqueous solution, 0.5ml of the accompanying mannitol solvent is added under aseptic conditions to the vial containing the powder for solution for injection.
Revasc består af et hætteglas, der indeholder et hvidt pulver og en ampul, der indeholder et klart, farveløst solvens til injektionsvæske, opløsning.
What Revasc looks like and contents of the pack Revasc consists of a vial containing a white powder and an ampoule containing clear, colourless
«Mean residence time» er 1,7- 2 timer og 6-7 timer efter henholdsvis i.v.
A slower terminal elimination phase follows with a dose-independent mean terminal elimination half life of 2 to 3 h. The mean residence times are 1.7-2 h and 6-7 h after IV and SC administration, respectively.
Patienter, som tidligere har været behandlet med hirudin eller hirudinanaloger, kan have forøget risiko, da disse reaktioner er immunmedierede.
As these reactions are immune-mediated, patients with previous exposure to hirudin or hirudin analogue may be at an increased risk.
Indehaveren af markedsføringstilladelsen og fremstiller
SUBSTANCE AND MANUFACTURING AUTHORISATION
Immunsystemet Almindelig:
Nervous system disorders Uncommon:
Opbevar hætteglas og ampul i den ydre karton.
Keep the vial and ampoule in the outer carton.
Absorptionen er fuldstændig og vurderet på areal under kurve- (AUC) værdierne.
Absorption is complete based on mean area under
Sjælden:
Investigations Uncommon:
- Spørg lægen, sygeplejersken eller på apoteket, hvis der er mere, De vil vide.
- If you have any further questions, ask your doctor, nurse or your pharmacist.
ATC-kode: B01AE01
PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anticoagulant, ATC code: B01AE01
Desirudin er kontraindiceret til patienter med svært nedsat leverfunktion (se pkt.
Desirudin is contraindicated in severe hepatic impairment (see section 4.3).
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON: TIL 1 HÆTTEGLAS (15 mg/hætteglas) OG 1 AMPUL
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 1 VIAL (15mg/vial) AND 1 AMPOULE
Hvis De har glemt at få Revasc
If a dose is missed
Luftveje, thorax og mediastinum Ikke almindelig: Dyspnø
Dizziness, insomnia, confusion Respiratory, thoracic and mediastinal disorders Uncommon:
Feber, hævelse på injektionsstedet, hæmatom, ødem af benene, Ikke almindelig: Smerter i benene, smerter, abdominal- og brystsmerter
General disorders and administration site conditions Fever, injection site mass, haematomas, oedema in legs Pain in legs, pain, abdominal and chest pain
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON: 10 HÆTTEGLAS (15 mg/hætteglas) OG 10 AMPULLER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 10 VIALS (15mg/vial) AND 10 AMPOULES
- hvis De er overfor naturlig eller syntetisk hirudin, inklusive desirudin eller et af de øvrige
- if you are hypersensitive (allergic) to natural or synthetic hirudin, including desirudin or any of the - if you are bleeding a lot or have any serious bleeding disorder (e.g. haemophilia) - if you have serious kidney or liver disease
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON: 2 HÆTTEGLAS (15 mg hætteglas) OG 2 AMPULLER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 2 VIALS (15mg/vial) AND 2 AMPOULES
Aktiveret partiel tromboplastintid (aPTT) skal monitoreres hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance mellem 31 og 90 ml/min; se pkt.
In patients with mild or moderate renal impairment (creatinine clearance between 31 and 90 ml/min; see section 4.4) activated partial thromboplastin time (aPTT) should be monitored.
Desirudin bør anvendes med forsigtighed under omstændigheder med øget risiko for blødninger, som ved store operationer, biopsi eller punktur af et ikke kompressibelt blodkar indenfor de seneste måneder; tidligere tilfælde af hjerneblødning, intrakraniel eller intraokulær blødning inkl.
Desirudin should be used with caution in conditions with increased risks of haemorrhage such as major surgery, biopsy or puncture of a non-compressible vessel within the last month; a history of haemorrhagic stroke, intracranial or intraocular bleeding including diabetic (haemorrhagic) retinopathy; a cerebral ischaemic attack within the last 6 months, a known haemostatic disorder (congenital or acquired, e.g. haemophilia, liver disease) or a history of gastrointestinal or pulmonary
Revasc 15 mg /0,5 ml Pulver til injektionsvæske Desirudin
injection of 15mg desirudin.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver og solvens til injektionsvæske, opløsning 15 mg pulver i et hætteglas og 0,5 ml solvens i en ampul
Powder and solvent for solution for injection 15mg of powder in a vial and 0.5ml of solvent in an ampoule
administration (ca. 1,95-2,20 ml/min/kg) og var uafhængig af dosis.
Total clearance of desirudin has been found to be in the same range following either SC or IV administration (ca 1.95-2.20ml/min/kg) and was dose-independent.
Solvens:
In the solvent the
Hvis De har fået for meget Revasc
If you are given more than you should
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Revasc 15 mg/0,5 ml pulver og solvens til injektionsvæske, opløsning Desirudin
PACKAGE LEAFLET: INFORMATION FOR THE USER Revasc 15mg/0.5ml powder and solvent for solution for injection Desirudin Read all of this leaflet carefully before you start using this medicine.
Tag altid Revasc nøjagtig som Deres læge har fortalt Dem. Spørg lægen eller apoteket, hvis der er noget De er i tvivl om..
Always take Revasc exactly as your doctor has instructed you.
- en nylig operation (inklusive tandkirurgi) eller biopsi eller hul på blodkar indenfor for den seneste måned - en nylig kortvarig mangel af blodforsyningen til dele af hjernen indenfor de seneste 6 måneder - tilfælde af blødning i tarmen eller lungerne indenfor de seneste tre måneder
Make sure you tell your doctor if you are likely to have an increased risk of bleeding, which may be the case if you have, or have had: - bleeding disorders or a family history of bleeding disorder - stomach ulcers or any other bleeding disease of the gut - history of a stroke, or bleeding within the brain or eye - a recent operation (including dental surgery) or biopsy or pricking of a blood vessel within the last month - recently a brief shortage of blood supply to a part of the brain within the last six months
MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL: 15mg
Ampul etiket: 0,5 ml solvens
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE LABEL: 0.5ml SOLVENT
• ANDRE BETINGELSER
FURTHER INFORMATION
Oversigt over indlægssedlen:
Powder for injection
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (jfr.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
LÆGEMIDLETS NAVN
The dose
Hud og subkutane væv Ikke almindelig: Udslæt, urtikaria
Skin and subcutaneous tissue disorders
INFORMATION I BRAILLE-SKRIFT
What Revasc contains
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 15 mg desirudin
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
25 mg/ml Pulver til injektionsvæske, suspension
Powder for suspension for injection
Hætteglas 100 mg
Subcutaneous use vial (glass) 100 mg
Gennemførelse af aftalen i medlemsstaterne (indsendelse af ændringsansøgningen fra indehaveren af markedsføringstilladelsen):
Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder):
24. juli 2013
24 July 2013
1. oktober 2013
01 October 2013
CMDh's møde i juni 2013
June 2013 CMDh meeting
Virksomheden ønskede godkendelsen anerkendt i Belgien, Bulgarien, Cypern, Tyrkiet, Danmark, Estland, Grækenland, Frankrig, Ungarn, Irland, Island, Litauen, Luxembourg, Letland, Malta, Nederlandene, Norge, Polen, Rumænien, Slovenien, Slovakiet og Det Forenede Kongerige ("de berørte medlemsstater").
The company wanted the authorisation to be recognised in Belgium, Bulgaria, Cyprus, Czech, Denmark, Estonia, Greece, France, Hungary, Ireland, Iceland, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Romania, Slovenia, Slovakia and the United Kingdom (the ‘concerned Member States').
Hvad er Priligy?
What is Priligy?
Resultatet af en procedure i henhold til artikel 29 i direktiv 2001/83/EF, med senere ændringer
Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Hvorfor blev Priligy revurderet?
Why was Priligy reviewed?
Priligy er et lægemiddel, der anvendes til behandling af for tidlig sædafgang hos mænd i alderen 18 til 64 år.
Priligy is a medicine used to treat premature ejaculation in men aged 18 to 64 years old.
CHMP konkluderede desuden, at den potentielle øgede risiko for synkope er påvist at være kontrollerbar.
The CHMP also concluded that the potential increased risk for syncope has been proven to be manageable.
Priligy antages at forøge tiden til sædafgang ved at øge mængden af en neurotransmitter mellem nervecellerne.
Priligy is believed to increase the time it takes to ejaculate by increasing the amount of a neurotransmitter between the nerve cells.
Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den svenske lægemiddelstyrelse henviste sagen til CHMP med henblik på voldgift den 24. februar 2011.
However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 24 February 2011.
Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af Priligy tabletter.
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Priligy tablets.
Patienterne bør ikke sættes i behandling med 60 mg tabletter og må kun overgå til 60 mg, hvis de ikke har responderet tilfredsstillende på 30 mg tabletterne og ikke har haft moderate eller svære bivirkninger eller symptomer, der kan være tegn på synkope.
Patients should not start treatment with 60 mg tablets, and may only be switched to 60 mg if they have not responded sufficiently to the 30 mg tablets and have not experienced moderate or severe adverse reactions or symptoms suggestive of syncope.
Virksomheden, der markedsfører Priligy i Sverige, Janssen-Cilag AB, indgav en ansøgning om markedsføringstilladelse for Priligy (30 mg og 60 mg tabletter) via den gensidige anerkendelsesprocedure på grundlag af den indledende godkendelse, der var udstedt af Sverige den 6. februar 2009.
The company that markets Priligy in Sweden, Janssen-Cilag AB, submitted an application to market Priligy (30 mg and 60 mg tablets) through the mutual recognition procedure based on the initial authorisation granted by Sweden on 6 February 2009.
Spørgsmål og svar om Priligy (dapoxetin, tabletter, 30 mg og 60 mg)
Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets)
Den virker ved at forhindre genoptagelse af neurotransmitteren 5-hydroxytryptamin (der også kaldes serotonin) i nervecellerne i hjernen og rygmarven, og øger derved mængden af serotonin mellem cellerne.
The active substance, dapoxetine, is a selective serotonin re-uptake inhibitor (SSRI) and it works by preventing the neurotransmitter 5-hydroxytryptamine (also called serotonin) from being taken back up into nerve cells in the brain and spinal cord, thereby increasing the amount of serotonin between nerve cells.
Efter vurderingen af de aktuelt foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved Priligy 60 mg opvejer risiciene, og at der bør udstedes markedsføringstilladelse for Priligy (30 mg og 60 mg) i alle berørte medlemsstater.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Priligy 60 mg outweigh its risks, and that therefore the marketing authorisation for Priligy (30 mg and 60 mg) should be granted in all concerned Member States.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved 60 mg tabletten (som der var uenighed om) faktisk opvejer risiciene, og at den markedsføringstilladelse for Priligy, der er udstedt i Sverige, kan anerkendes i andre EUmedlemsstater.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the 60 mg tablet (over which there was disagreement) do outweigh its risks and that the marketing authorisation for Priligy granted in Sweden can be recognised in other Member States of the EU.
Begrundelsen for henvisningen var betænkeligheder ved benefit/risk-forholdet for 60 mg tabletten hos nogle medlemsstater, som anså dens ekstra fordel i forhold til 30 mg tabletter for at være for beskeden i forhold til den øgede risiko for svære tilfælde af synkope (besvimelse), der er set i undersøgelserne med lægemidlet.
The grounds for the referral were concerns over the benefit-risk balance of the 60 mg tablet by some Member States, who considered its additional benefit compared with the 30 mg tablet to be too modest when weighed against the increased risk of severe cases of syncope (fainting) seen in studies with the medicine.
Spørgsmål og svar om Priligy (dapoxetin, tabletter, 30 mg og 60 mg) EMA/106788/2012
Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets) EMA/59013/2012
Markedsføringstilladelsen blev fornyet den 3. maj 2001 og den 3. maj 2006.
The marketing authorisation was renewed on 3 May 2001 and on 3 May 2006.
Det produceres af en celle, der har fået indsat et gen (DNA), som sætter den i stand til at producere humant FSH.
It is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Dosis og indgivelseshyppighed af Puregon afhænger af brugen (se ovenfor) og patientens reaktion på behandlingen.
The dose and frequency of administration of Puregon depend on its use (see above) and the patient's response to treatment.
De hyppigst indberettede bivirkninger er en reaktion eller smerter på injektionsstedet.
The most common side effects reported are a reaction and pain at the injection site.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Puregon den 3. maj 1996.
The European Commission granted a marketing authorisation valid throughout the European Union, for Puregon on 3 May 1996.
Andre oplysninger om Puregon:
Other information about Puregon:
Indehaveren af markedsføringstilladelsen er N.V.
The marketing authorisation holder is N.V. Organon.
Den fuldstændige EPAR for Puregon findes her.
The full EPAR for Puregon is available here.
I kroppen regulerer FSH forplantningsfunktionen: Hos kvinder stimulerer det produktionen af æg, og hos mænd stimulerer det produktionen af sæd i testiklerne.
In the body, FSH regulates the reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles.
Puregon gives som en “subkutan” injektion (under huden) eller i en muskel.
Puregon is given as a ‘subcutaneous' injection (under the skin) or into a muscle.
Behandling med Puregon skal foretages af en læge med erfaring i behandling af fertilitetsproblemer.
Treatment with Puregon should be carried out by a doctor who has experience in the treatment of fertility problems.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Puregon.
The Committee recommended that Puregon be given marketing authorisation.
Puregon blev undersøgt hos 172 anovulatoriske kvinder, hvor man målte, hvor mange behandlingscyklusser der skulle til, for at disse kvinder fik ægløsning.
Puregon was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate.
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PUREGON EPAR - sammendrag for offentligheden
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREGON EPAR summary for the public
Anvendelsen af Puregon til kvinder i fertilitetsbehandling er blevet undersøgt hos 981 patienter.
Puregon's use in women undergoing fertility treatment has been studied in 981 patients.
Puregon anvendes til behandling af kvindelig infertilitet i følgende situationer:
Puregon is used to treat infertility in women in the following situations:
• Kvinder, der er anovulatoriske (ikke producerer æg) og ikke reagerer på behandling med clomifencitrat (et andet lægemiddel, der stimulerer ægløsning).
• women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation).
Pulveret skal blandes med den medfølgende solvens umiddelbart før brug.
The powder should be mixed with the solvent provided just before use.
Puregon indgives for at stimulere æggestokkene til at producere mere end ét æg ad gangen.
Puregon is administered to stimulate the ovaries to produce more than one egg at a time
Puregon indeholder det aktive stof follitropin beta.
Puregon contains the active substance follitropin beta.
Follitropin beta i Puregon produceres ved hjælp af en metode kaldet "rekombinant DNA-teknologi".
The follitropin beta in Puregon is produced by a method known as ‘recombinant DNA technology'.
Puregon bør kun gives af personer, som er blevet instrueret af en læge og har adgang til ekspertrådgivning.
Puregon should only be administered by people who have been trained by the doctor and have access to expert advice.