natgillin/translations-raw huggingface dataset:
Hos opioidnaive patienter ligger den lavest effektive serumkoncentration af fentanyl til opnåelse af smertelindring i området 0, 3 til 1, 2 ng/ ml, mens blodkoncentrationer på 10- 20 ng/ ml fremkalder kirurgisk anæstesi og udtalt respirationsdepression.
The analgesic effects of fentanyl are related to the blood level of the active substance; in opioid-naïve patients, minimum effective analgesic serum concentrations of fentanyl range from 0.3-1.2 ng/ ml, while blood levels of 10-20 ng/ ml produce surgical anaesthesia and profound respiratory depression.
Som alle µ- opioidreceptoragonister fremkalder fentanyl dosisafhængig respirationsdepression.
Fentanyl, in common with all µ-opioid receptor agonists, produces dose dependent respiratory depression.
24 Mens opioider generelt øger muskeltonus i urinrørets glatte muskulatur, har nettovirkningen tendens til at være variabel og fremkalder i visse tilfælde imperiøs vandladningstrang og hos andre vandladningsbesvær.
24 While opioids generally increase the tone of urinary tract smooth muscle, the net effect tends to be variable, in some cases producing urinary urgency, in others, difficulty in urination.
Opioider øger tonus og nedsætter de propulsive kontraktioner i den glatte muskulatur i mave - tarmkanalen, der medfører en forlængelse i gastrointestinal gennemløbstid, hvilket kan være ansvarlig for fentanyls obstiperende virkning.
Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract leading to a prolongation in gastrointestinal transit time, which may be responsible for the constipating effect of fentanyl.
Fentanyl er et særdeles lipofilt lægemiddel, der absorberes meget hurtigt via den orale mukosa og langsommere via mave- tarmkanalen.
Fentanyl is a highly lipophilic drug absorbed very rapidly through the oral mucosa and more slowly through the gastrointestinal tract.
Peroralt administreret fentanyl undergår udtalte hepatiske og intestinale førstepassage- virkninger.
Orally administered fentanyl undergoes pronounced hepatic and intestinal first pass effects.
30 minutter efter administration af Rapinyl.
Rapid absorption of fentanyl occurs over about 30 minutes following administration of Rapinyl.
70%.
The bioavailability of Rapinyl has not been studied but is estimated to be about 70%.
Gennemsnitlige, maksimale plasmakoncentrationer af fentanyl spænder fra 0, 2 til 1, 3 ng/ ml (efter administration af 100 til 800 µg Rapinyl) og nås inden for 22, 5 til 240 minutter.
Mean maximal plasma concentrations of fentanyl range from 0.2 to 1.3 ng/ ml (after administration of 100 to 800 µg Rapinyl) and are reached within 22.5 to 240 minutes.
80- 85% fenatyl bindes af plasmaproteiner, hovedsageligt α1- glycoprotein og i mindre grad albumin og lipoprotein.
About 80-85% of fentanyl is bound by plasma proteins, mainly α 1-glycoprotein and to a lesser extent albumin and lipoprotein.
3- 6 l/ kg.
The volume of distribution of fentanyl at steady state is about 3-6 l/ kg.
75% af dosis gennem urinen, mest som metabolitter med mindre end 10% som uomdannet lægemiddel.
Within 72 hours of intravenous fentanyl administration around 75% of the dose is excreted into the urine, mostly as metabolites, with less than 10% as unchanged drug.
9% af dosis genfindes i fæces primært som metabolitter.
About 9% of the dose is recovered in the faeces, primarily as metabolites.
0, 5 l/ t/ kg.
Total plasma clearance of fentanyl is about 0.5 l/ h/ kg.
20 timer (interval 11, 5- 25 timer).
After Rapinyl administration, the main elimination half-life of fentanyl is about 7 hours (range 3-12.5 hours) and the terminal half-life is about 20 hours (range 11.5-25 hours).
Rapinyls farmakokinetik har vist sig at være dosisproportional i dosisområdet 100- 800 µg.
The pharmacokinetics of Rapinyl have been shown to be dose proportional over the dose range of 100 to 800 µg.
Farmakokinetik hos særlige patientgrupper Nedsat lever - eller nyrefunktion kan forårsage øgede serumkoncentrationer.
Renal/ hepatic impairment Impaired hepatic or renal function could cause increased serum concentrations.
4. 2 og 4. 4).
Elderly, cachectic or generally impaired patients may have a lower fentanyl clearance, which could cause a longer terminal half-life for the compound (see sections 4.2 and 4.4).
Der er ikke foretaget langtids- carciogenicitetsundersøgelser.
Long-term carcinogenicity studies have not been performed.
Mannitol (E421) Silificeret mikrokrystallinsk cellulose Croscarmellosenatrium
Mannitol (E421) Silicified microcrystalline cellulose Croscarmellose sodium
25 Magnesiumstearat
25 Magnesium stearate
Skal opbevares i den originale blisterpakning for at beskytte mod fugt.
Store in the original blister package in order to protect from moisture.
Rapinyl sublinguale resoribletter er pakket i OPA/ PVC/ aluminium/ aluminiumblistre, der er anbragt i en papæske.
Rapinyl sublingual tablets are packaged in OPA/ PVC/ aluminium/ aluminium blisters contained in a cardboard outer carton.
Pakninger med 10 eller 30 sublinguale resoribletter.
Packs of 10 or 30 sublingual tablets.
Ikke anvendt lægemiddel samt affald heraf skal altid destrueres på en sikker måde.
Waste material should be disposed of safely.
Patienter/ plejere skal opfordres til at returnere evt. ubrugte produkter til apoteket, hvor det vil blive destrueret i henhold til nationale og lokale retningslinier.
Patients/ carers should be encouraged to return any unused product to the Pharmacy, where it should be disposed of in accordance with national and local requirements.
[Se bilag I – udfyldes nationalt] (Navn og adresse) < {tlf} > < {fax} > < {e- mail} >
[See Annex I - To be completed nationally] {Name and address }< {tel }> < {fax }> < {e-mail }>
26 ETIKETTERING
26 LABELLING
27 MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Æske
Carton Label
Rapinyl og tilhørende navne (se bilag I) 50 mikrogram sublinguale resoribletter [Se bilag I – udfyldes nationalt] Rapinyl 100 mikrogram sublinguale resoribletter Rapinyl 200 mikrogram sublinguale resoribletter Rapinyl 300 mikrogram sublinguale resoribletter Rapinyl 400 mikrogram sublinguale resoribletter Rapinyl 600 mikrogram sublinguale resoribletter Rapinyl 800 mikrogram sublinguale resoribletter
Rapinyl and associated names (see Annex I) 50 microgram sublingual tablets [See Annex I - To be completed nationally] Rapinyl 100 microgram sublingual tablets Rapinyl 200 microgram sublingual tablets Rapinyl 300 microgram sublingual tablets Rapinyl 400 microgram sublingual tablets Rapinyl 600 microgram sublingual tablets Rapinyl 800 microgram sublingual tablets
Hver sublinguale resoribet indeholder 50 mikrogram fentanyl (som citrat) 100 mikrogram fentanyl (som citrat) 200 mikrogram fentanyl (som citrat) 300 mikrogram fentanyl (som citrat) 400 mikrogram fentanyl (som citrat) 600 mikrogram fentanyl (som citrat) 800 mikrogram fentanyl (som citrat)
Each sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate) 200 micrograms fentanyl (as citrate) 300 micrograms fentanyl (as citrate) 400 micrograms fentanyl (as citrate) 600 micrograms fentanyl (as citrate) 800 micrograms fentanyl (as citrate)
LÆGEMIDDELFORM OG INHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
PHARMACEUTICAL FORM AND CONTENTS
10 sublinguale resoribletter 30 sublinguale resoribletter
10 tablets 30 tablets
Sublingual anvendelse Skal opløses under tungen.
Sublingual use.
Må ikke synkes.
To be dissolved under the tongue.
Læs indlægssedlen inden brug.
Do not swallow Read the package leaflet before use.
Dette produkt må KUN anvendes som ordineret.
This product should ONLY be used as prescribed.
Opbevares i den originale blisterpakning for at beskytte mod fugt.
Store in the original blister package in order to protect from moisture
Det anbefales at opbevare Rapinyl på et aflåst sted.
It is recommended to keep Rapinyl in a locked storage space
(Navn og adresse) < {tlf} > < {fax} > < {email} >
{Name and address }< {tel }> < {fax }> < {e-mail }>
[Udfyldes nationalt]
29 [To be completed nationally]
29 15.
15.
30 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
30 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Rapinyl og tilhørende navne (se bilag I) 50 µg sublinguale resoribletter [Se bilag I – udfyldes nationalt] Rapinyl 100 µg sublinguale resoribletter Rapinyl 200 µg sublinguale resoribletter Rapinyl 300 µg sublinguale resoribletter Rapinyl 400 µg sublinguale resoribletter Rapinyl 600 µg sublinguale resoribletter Rapinyl 800 µg sublinguale resoribletter
Rapinyl and associated names (see Annex I) 50 µg sublingual tablets [See Annex I - To be completed nationally] Rapinyl 100 µg sublingual tablets Rapinyl 200 µg sublingual tablets Rapinyl 300 µg sublingual tablets Rapinyl 400 µg sublingual tablets Rapinyl 600 µg sublingual tablets Rapinyl 800 µg sublingual tablets
31 INDLÆGSSEDDEL
31 PACKAGE LEAFLET
Rapinyl og tilhørendetilhørende navne (Se bilag I) 50 mikrogram sublinguale resoribletter [Se bilag I – udfyldes nationalt] Rapinyl 100 mikrogram sublinguale resoribletter Rapinyl 200 mikrogram sublinguale resoribletter Rapinyl 300 mikrogram sublinguale resoribletter Rapinyl 400 mikrogram sublinguale resoribletter Rapinyl 600 mikrogram sublinguale resoribletter Rapinyl 800 mikrogram sublinguale resoribletter
Rapinyl and associated names (see Annex I) 50 microgram sublingual tablets [See Annex I - To be completed nationally] Rapinyl 100 microgram sublingual tablets Rapinyl 200 microgram sublingual tablets Rapinyl 300 microgram sublingual tablets Rapinyl 400 microgram sublingual tablets Rapinyl 600 microgram sublingual tablets Rapinyl 800 microgram sublingual tablets
Læs denne indlægsseddel grundigt, inden De begynder at tage medicinen • Gem indlægssedlen.
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
De kan få brug for at læse den igen. • Spørg lægen eller på apoteket, hvis der er mere, De vil vide. • Lægen har ordineret Rapinyl til Dem personligt.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
Rapinyls virkning, og hvad De skal bruge det til 2.
What Rapinyl is and what it is used for 2.
Det skal De vide, før De begynder at tage Rapinyl 3.
Before you take Rapinyl 3.
Sådan skal De tage Rapinyl 4.
How to take Rapinyl 4.
Sådan opbevarer De Rapinyl 6.
How to store Rapinyl 6.
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE RAPINYL
BEFORE YOU TAKE RAPINYL
Tag ikke Rapinyl
Do not take Rapinyl
• hvis De er overfølsom (allergisk) over for fentanyl eller et af de øvrige indholdsstoffer • hvis De har alvorlige vejrtrækningsproblemer
• if you are allergic (hypersensitive) to fentanyl or any of the other ingredients of Rapinyl • if you have severe breathing problems
Inden De påbegynder behandlingen med Rapinyl, skal De regelmæssigt have taget eller brugt et ordineret, stærkt smertestillende lægemiddel, som kaldes et opioid, til at kontrollere Deres vedvarende smerter.
Before you start treatment with Rapinyl, you must have been regularly taking or using a prescribed strong pain-relieving medicine, called an opioid, to control your persistent pain.
4 – Bivirkninger).
If you have not, this medicine could cause severe breathing difficulties (see section 4 – Possible side effects).
33 Vær ekstra forsigtig med at tage Rapinyl
33 Take special care with Rapinyl
Fortæl det til lægen inden behandlingen, hvis De har eller for nylig har oplevet noget af følgende, fordi lægen er nødt til at tage hensyn hertil, når han/ hun ordinerer Deres dosis: • et kranietraume, fordi Rapinyl kan skjule omfanget af traumet • vejrtrækningsproblemer eller myasthenia gravis (en tilstand der er karakteriseret ved muskelsvaghed) • langsom hjertefrekvens eller lavt blodtryk • lever - eller nyresygdom, fordi det kan kræve at lægen skal justere dosis mere forsigtigt • en hjernesvulst og/ eller forhøjet intrakranielt tryk (en stigning i trykket inde i hjernen, som giver svær hovedpine, følelse af at være syg og tågesyn) • sår i munden eller mucositis (hævelse og rødme inde i munden)
Tell your doctor before treatment if you have or have recently had any of the following, as your doctor will need to take account of these when prescribing your dose: • a head injury, because Rapinyl may cover up the extent of the injury • breathing problems or suffer from myasthenia gravis (a condition characterised by muscle weakness) • a slow heart rate or low blood pressure • liver or kidney disease, as this may require your doctor to more carefully adjust your dose • a brain tumour and/ or raised intracranial pressure (an increase of pressure in the brain which causes severe headache, a feeling of sickness and blurred vision) • mouth wounds or mucositis (swelling and redness of the inside of the mouth)
Dette gælder også medicin, som ikke er købt på recept.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines (other than your regular opioid pain-relieving medicine), including medicines obtained without a prescription.
Følgende medicin kan øge virkningen af Rapinyl: • Visse typer svampedræbende medicin, der indeholder ketoconazol eller itraconazol (bruges til at behandle svampeinfektioner). • Visse typer antibiotika, der bruges til at behandle betændelser (såkaldte makrolidantibiotika f. eks. erythromycin). • Visse typer medicin mod virus, der bruges til at behandle infektioner, der er forårsaget af vira (såkaldte proteasehæmmere, f. eks. ritonavir). • Medicin, der indeholder alkohol • Medicin, der kaldes monoaminooxidase (MAO) - hæmmere, som bruges mod svær depression og Parkinsons sygdom.
The following medicines may increase the effects of Rapinyl: • Certain types of antifungal medicines containing e. g. ketoconazole or itraconazole (used to treat fungal infections). • Certain types of antibiotic medicines used to treat infections (called macrolides, containing e. g. erythromycin). • Certain types of antiviral medicines used to treat infections caused by viruses (called protease inhibitors, containing e. g. ritonavir). • Medicines containing alcohol • Medicines called monoamine-oxidase (MAO) inhibitors, which are used for severe depression and Parkinson’ s disease.
Følgende medicin kan nedsætte virkningen af Rapinyl: • Visse typer stærke smertestillende lægemidler, der f. eks. indeholder buprenorphin eller pentazocin
The following medicines may reduce the effects of Rapinyl: • Certain types of strong pain killers containing e. g. buprenorphine or pentazocine
Rapinyl kan øge virkningen af medicin, der gør Dem søvnig, herunder: • andre stærkt smertestillende lægemidler (medicin af opioidtypen f. eks. mod smerter og hoste) • bedøvelsesmidler til fuld narkose (bruges til at få Dem til at sove under operationer) • muskelafslappende midler • sovetabletter • medicin til behandling af
Rapinyl may add to the effect of medicines that make you feel sleepy, including: • other strong pain-relieving medicines (opioid-type medicines e. g. for pain and cough) • general anaesthetics (used to make you sleep during operations) • muscle relaxants • sleeping tablets • medicines used to treat
depression allergier angst og psykose
depression allergies anxiety and psychosis
34 Graviditet og amning
34 Pregnancy and breast-feeding
Rapinyl kan nedsætte Deres mentale og fysiske evne til at udføre potentielt farlige opgaver såsom at føre motorkøretøj eller betjene maskiner.
Rapinyl may impair your mental and/ or physical ability to perform potentially hazardous tasks such as driving or operating machinery.
Dette produkt må KUN bruges i overensstemmelse med lægens instrukser.
This product should ONLY be used by you according to your doctor’ s instructions.
Indledende fase – at finde den mest passende dosis
Initial Phase – Finding the most appropriate dose
De skal altid bruge den dosis Rapinyl, som lægen har ordineret – dette kan være en anderledes dosis, end den De har taget med anden medicin mod gennembrudssmerter.
You must always use the dose of Rapinyl as prescribed by your doctor – this may be a different dose from that which you have used with other medicines for breakthrough pain.
Vedligeholdelsesfase – efter De har fundet den mest passende dosis
Maintenance Phase - Once you have found the most appropriate dose
Hvis De mener, at den dosis Rapinyl, De tager, ikke kontrollerer Deres gennembrudssmerter tilfredsstillende, så fortæl det til lægen, da det kan være nødvendigt at han/ hun justerer dosis.
If you think that the dose of Rapinyl that you are using is not controlling your breakthrough pain satisfactorily tell your doctor, as he may need to adjust your dose.
35 Indtagelse af medicinen
35 Taking the medicine
• Hvis De er tør i munden, så tag en slurk vand for at væde den.
• If your mouth is dry, take a sip of water to moisten it.
Spyt vandet ud eller synk det.
Spit out or swallow the water.
• fjern evt. tilbageværende resoribletter fra munden • fortæl Deres plejer eller en anden person i hjemmet, hvad der er sket • De eller Deres plejer skal straks kontakte lægen, apoteket eller det lokale hospital og drøfte, hvad der skal gøres • mens der ventes på lægen, skal personen holdes vågen ved at snakke med denne eller ryste hende/ ham en gang imellem
If you take more Rapinyl than you should • remove any remaining tablets from your mouth • tell your carer or another person in your house what has happened • you or your carer should immediately contact your doctor, pharmacist or local hospital and discuss what action to take • while waiting for the doctor, keep the person awake by talking to or shaking her/ him now and then
Symptomer på overdosering omfatter: • ekstrem sløvhed • langsom, overfladisk vejrtrækning Hvis dette forekommer, så tilkald akut lægehjælp.
Symptoms of overdose include: • extreme drowsiness • slow, shallow breathing If these occur, seek emergency medical help immediately.
De må kun holde op med at tage Rapinyl sublinguale resoribletter efter lægens råd.
If you stop taking Rapinyl You should only stop taking Rapinyl sublingual tablets on the advice of your doctor.
De skal fortsætte med at tage Deres sædvanlige opioide smertelindrende medicin mod vedvarende smerter som anvist af lægen.
You must continue to take/ use your regular opioid pain relieving medicine for persistent pain as advised by your doctor.
Rapinyl kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Rapinyl can cause side-effects, although not everybody gets them.
3 ” Hvis De har taget for mange Rapinyl sublinguale resoribletter ”).
36 If you start to feel unusually or extremely sleepy or your breathing becomes slow or shallow, you or your carer should immediately contact your doctor or local hospital for emergency help (see also section 3 “ If you take more Rapinyl than you should”).
Meget almindelige bivirkninger (påvirker mere end 1 ud af 10 brugere) omfatter: • kvalme, hovedpine, søvnighed/ træthed, svimmelhed
Very common side effects (affects more than 1 user in 10) include: • nausea, headache, sleepiness/ tiredness, dizziness.
Almindelige bivirkninger (påvirker mellem 1 og 10 ud af 100 brugere) omfatter: • opkastning, diaré, forstoppelse, mavepine, oppustet fornemmelse, fordøjelsesbesvær, appetitløshed • depression, koncentrationsvanskeligheder, ekstrem høj fornemmelse af velvære • øget følsomhed over for lyd og støj, sløret syn eller dobbeltsyn • lavt blodtryk, blussen/ varmefølelse, langsom overfladisk vejrtrækning, svaghed, fornemmelse af at være ved at besvime, nedsat følsomhed over for berøring, følelsesløshed eller snurren • snue eller tilstoppet næse, mundtørhed, ondt i halsen, hudkløe, hududslæt, irritation under tungen
Common side effects (affects 1 to 10 users in 100) include: • vomiting, diarrhoea, constipation, stomach ache, bloated feeling, indigestion, loss of appetite • depression, difficulty in concentrating, excessive feeling of well being • increased sensitivity to sound and noise, blurred or double vision • low blood pressure, flushing/ feeling hot, slow shallow breathing, feeling weak, feeling faint, reduced sensitivity to touch, numbness or tingling • runny or blocked nose, dry mouth, sore throat, itching of the skin, skin rash, irritation under the tongue
Uregelmæssig hjertebanken, vejrtrækningsstop, blod i spyt, nedsat urinmængde, smertefuld sammentrækning af blæren
Other known side effects associated with fentanyl products include: • Very common side effects (affects more than 1 user in 10 people): excessive sweating • Common side effects (affects 1 to 10 users in 100): feeling confused, feeling anxious or nervous, hallucinations, abnormal thinking, muscle twitching, difficulty sleeping, strange dreams, tongue or taste problems, flushing, mouth ulcers/ blisters, blockage of the gut, difficulty swallowing, being accident-prone • Uncommon side effects (affects 1 to 10 users in 1,000): feeling restless, feeling detached, moodswings, trembling, difficulty speaking, being forgetful, loss of coordination, vertigo, slow or fast heartbeat, high blood pressure, difficulty breathing, slow or shallow breathing, asthma, bloating, wind, thirst, difficulty going to the toilet, change in frequency of going to the toilet, feeling unwell • Rare side effects (affects 1 to 10 users in 10,000): hiccups • Very rare side effects (affects less than 1 user in 10,000): irregular heartbeat, stopping breathing, blood in the saliva, decrease in amount of urine, painful contraction of the bladder
Den smertelindrende medicin i Rapinyl er meget stærk og kan være livstruende, hvis den ved et uheld tages af et barn.
The pain-relieving medicine in Rapinyl is very strong and could be life-threatening if taken accidentally by a child.
Rapinyl skal opbevares utilgængeligt for børn.
Rapinyl must be kept out of the reach and sight of children.
Skal opbevares i den originale blisterpakning for at beskytte mod fugt.
Store in the original blister in order to protect from moisture.
37 Spørg på apoteket, hvordan De skal aflevere medicinrester.
37 6.
Fentanyl.
The active substance is fentanyl.
50 mikrogram fentanyl (som citrat) 100 mikrogram fentanyl (som citrat) 200 mikrogram fentanyl (som citrat) 300 mikrogram fentanyl (som citrat) 400 mikrogram fentanyl (som citrat) 600 mikrogram fentanyl (som citrat) 800 mikrogram fentanyl (som citrat)
One sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate) 200 micrograms fentanyl (as citrate) 300 micrograms fentanyl (as citrate) 400 micrograms fentanyl (as citrate) 600 micrograms fentanyl (as citrate) 800 micrograms fentanyl (as citrate)
Mannitol (E421), silificeret mikrokrystallinsk cellulose, croscarmellose - natrium og magnesiumstearat.
The other ingredients are mannitol (E421), silicified microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
Lægen vil ordinere den styrke (facon) og det antal resoribletter, der er passende for Dem.
Your doctor will prescribe the strength (shape) and number of tablets suitable for you.
50 mikrogram resoribletten er en hvid, femkantet tablet 100 mikrogram resoribletten er en hvid, rund tablet 200 mikrogram resoribletten er en hvid, oval tablet 300 mikrogram resoribletten er en hvid, trekantet tablet 400 mikrogram resoribletten er en hvid, diamantformet tablet 600 mikrogram resoribletten er en hvid, ” D ” - formet tablet 800 mikrogram resoribletten er en hvid, kapselformet tablet
The 100 microgram tablet is a white round tablet The 200 microgram tablet is a white oval-shaped tablet The 300 microgram tablet is a white triangle-shaped tablet The 400 microgram tablet is a white diamond-shaped tablet The 600 microgram tablet is a white “ D” -shaped tablet The 800 microgram tablet is a white capsule-shaped tablet
Recip AB Lagervägen 7 136 50 Haninge Sverige Tlf.: +46 8 6025200
Recip AB Lagervägen 7 136 50 Haninge Sweden Tel. +46 8 6025200
38 BILAG IV
38 ANNEX IV
39 De nationale kompetente myndigheder koordineret af referencemedlemsstaten skal sikre, at følgende betingelser er opfyldt af indehaverne af markedsføringstilladelsen:
39 The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders: