FrancophonIA/ELRC3.0 huggingface dataset:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation)
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: Number of Study Participants
Danish: Antal deltagere i undersøgelsen
English: Additional experience has occurred with marketed use of this vaccine.
Danish: Der er samlet yderligere erfaring med brug af denne vaccine efter markedsføring.
English: In studies of adults in which a high percentage of individuals had underlying chronic medical conditions, the safety profile of FLUENZ was comparable to the safety profile observed in individuals without these conditions.
Danish: I studier af voksne, hvor en stor procentdel af personerne havde underliggende kroniske medicinske sygdomme, var sikkerhedsprofilen af FLUENZ sammenlignelig med den observerede sikkerhedsprofil hos personer uden disse sygdomme.
English: Do not use Fluenz after the expiry date which is stated on the applicator label after the letters EXP.
Danish: Brug ikke Fluenz efter den udløbsdato, der står på applikatoretiketten efter bogstaverne EXP.
English: (24.6, 70.5)d fewer cases than injectable
Danish: (24,6; 70,5)d færre tilfælde end for injicerbar
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 January 2011
Danish: Dato for første markedsføringstilladelse: 27. januar 2011
English: Fluenz is a trademark of MedImmune, LLC.
Danish: Fluenz er et varemærke for MedImmune, LLC.
English: The following information is intended for medical or healthcare professionals only: Fluenz is for nasal use only.
Danish: Vejledning for sundhedspersonale Følgende oplysninger er tiltænkt læger og sundhedspersonale: Fluenz er kun til nasal anvendelse.
English: The vaccine is unlikely to have an effect on the ability to drive and use machines.
Danish: Det er ikke sandsynligt, at vaccinen har en virkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: Influenza Season
Danish: Influenza-sæson
English: Before use, the vaccine may be taken out of the refrigerator, without being replaced, for a maximum period of 12 hours at a temperature not above 25°C.
Danish: Vaccinen kan tages ud af køleskabet højst 12 timer før brug og opbevares ved en temperatur, der ikke overstiger 25 °C.
English: ………………………………………...…………………………per 0.2 ml dose
Danish: .......................................................................................................pr. 0,2 ml dosis
English: Influenza vaccine
Danish: Influenzavaccine
English: • Refer to the FLUENZ administration diagram (Figure 1) for step-by-step administration instructions.
Danish: • Se indgivelsesdiagrammet for FLUENZ (figur 1) for trinvis instruktion i indgivelse.
English: It is not known whether FLUENZ is excreted in human milk.
Danish: Det er ukendt, om FLUENZ udskilles i human mælk.
English: Fluenz will be administered under the supervision of a doctor, nurse or pharmacist.
Danish: Fluenz vil blive indgivet under overvågning af en læge, sygeplejerske eller apoteket.
English: Please read the package leaflet for disposal of medicines no longer required.
Danish: Læs indlægssedlen for bortskaffelse af medicin, der ikke længere behøves.
English: FLUENZ should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies.
Danish: FLUENZ bør ikke administreres til børn og unge med svær astma eller aktiv hvæsen, da personer med disse tilstande ikke er blevet undersøgt tilstrækkeligt i kliniske studier.
English: Your doctor, nurse or pharmacist will decide if Fluenz can be given at the same time as other vaccines.
Danish: Lægen, sundhedspersonalet eller apoteket vil afgøre om Fluenz kan gives på samme tidspunkt som andre vacciner.
English: Fluenz is a vaccine to prevent influenza (flu).
Danish: Fluenz er en vaccine til at forebygge influenza.
English: • if you are allergic to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of Fluenz (listed in section 6 “Contents of the pack and other information”).
Danish: • hvis du er allergisk over for æg, æggeprotein, gentamicin eller gelatine eller et af de øvrige indholdsstoffer (angivet i punkt 6 ”Pakningsstørrelser og yderligere oplysninger”).
English: Pregnancy There are limited data from the use of FLUENZ in pregnant women.
Danish: Graviditet Der er utilstrækkelige data fra anvendelse af FLUENZ til gravide kvinder.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/661/002 < - 10 sprayers>
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/661/002 < 10 sprayflasker >
English: While animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, FLUENZ is not recommended during pregnancy.
Danish: Selvom dyrestudier hverken indikerer direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet, bør FLUENZ ikke anvendes under graviditeten.
English: FLUENZ has been administered to over 30,000 individuals in controlled clinical studies over multiple years, in various regions and using different vaccine strains.
Danish: FLUENZ er blevet indgivet til over 30.000 personer i kontrollerede kliniske studier i løbet af flere år, i forskellige regioner og med forskellige vaccinestammer.
English: • If you are pregnant, think you may be pregnant, plan to become pregnant soon or are breast feeding, tell your doctor, nurse or pharmacist before receiving this vaccine.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger snart at blive gravid, eller hvis du ammer, skal du spørge din læge, sundhedspersonalet eller apoteket til råds, før du får denne vaccine.
English: No data exist regarding the safety of intranasal administration of FLUENZ in children with unrepaired craniofacial malformations.
Danish: Der foreligger ingen data angående sikkerheden af intranasal administration af FLUENZ til børn med ikke-opererede kraniofaciale misdannelser.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: However, a conclusion on clinical benefit of this vaccine in adults could not be made given that results observed in some studies versus injectable influenza vaccines were suggestive of a lower efficacy of FLUENZ.
Danish: Der kunne dog ikke drages en konklusion om de kliniske fordele af denne vaccine hos voksne, da de observerede resultater i nogle studier sammenlignet med injicerbar vaccine kunne tyde på en svagere virkning af FLUENZ.
English: Fluenz vaccine viruses are grown in chicken eggs.
Danish: Fluenz-vaccinens virus er dyrket i hønseæg.
English: B/Massachusetts/2/2012-like strain (B/Massachusetts/2/2012, MEDI 237751)
Danish: B/Massachusetts/2/2012-lignende stamme (B/Massachusetts/2/2012, MEDI 237751)
English: • The recommended dose for children and adolescents is 0.2 ml Fluenz, administered as 0.1 ml in each nostril.
Danish: • Den anbefalede dosis for børn og unge er 0,2 ml Fluenz, indgivet som 0,1 ml i hvert næsebor.
English: If influenza antiviral agents and FLUENZ are administered concomitantly, revaccination should be considered when appropriate.
Danish: Hvis antivirale stoffer mod influenza og FLUENZ administreres samtidigt, skal re-vaccination overvejes, hvis det er hensigtsmæssigt.
English: There have been occasional reports of administration of twice the recommended dose of FLUENZ in the post-marketing setting.
Danish: Der foreligger enkelte rapporter om indgivelse af det dobbelte af den anbefalede dosis af FLUENZ efter markedsføring.
English: • Children who have not previously had an influenza vaccine will receive a second, follow-up dose after an interval of at least 4 weeks.
Danish: • Børn, som ikke tidligere har fået en influenzavaccine, vil få en 2, opfølgende dosis efter en periode på mindst 4 uger.
English: The influenza virus strains in FLUENZ are (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
Danish: Influenzavirus-stammerne i FLUENZ er (a) koldadapterede (ca, cold-adapted), (b) temperaturfølsomme (ts, temperature-sensitive) og (c) svækkede (att, attenuated).
English: Vaccine recipients should be informed that FLUENZ is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts.
Danish: Modtagere af vaccinen skal informeres om, at FLUENZ er en vaccination med svækket levende virus, og at den derfor potentielt kan overføres ved kontakt med immunkompromitterede personer.
English: *** fluorescent focus units
Danish: *** fluorescent focus units (FFU)
English: Therefore, as some viruses are excreted in human milk, FLUENZ should not be used during breastfeeding.
Danish: Da nogle vira udskilles i human mælk, bør FLUENZ ikke anvendes under amning.
English: Fertility No data exist regarding the possible effects of FLUENZ on male and female fertility.
Danish: Der eksisterer ingen data angående de mulige virkninger af FLUENZ på mandlig og kvindelig fertilitet.
English: Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Fluenz.
Danish: Spørg lægen, sundhedspersonalet eller apoteket, hvis du ønsker at få yderligere oplysninger om bivirkninger fra Fluenz.
English: Check expiry date Product must be used before date on applicator label.
Danish: Kontroller udløbsdatoen Produktet skal anvendes før datoen på
English: FLUENZ's efficacy data in the paediatric population consist of 9 controlled studies comprising over 20,000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons.
Danish: FLUENZ's data angående virkning består af 9 kontrollerede studier, som omfattede over 20.000 spædbørn, småbørn, børn og unge, udført i løbet af 7 influenzasæsoner.
English: The concurrent use of FLUENZ with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.
Danish: Samtidig anvendelse af FLUENZ og antivirale stoffer aktivet mod influenza A- og/eller B-vira er ikke blevet evalueret.
English: The co-administration of FLUENZ with inactivated vaccines has not been studied.
Danish: Samtidig indgivelse af FLUENZ og inaktiverede vacciner er ikke blevet undersøgt.
English: Other possible side effects of Fluenz
Danish: Andre bivirkninger ved Fluenz
English: Fluenz is not recommended for women who are pregnant or are breast-feeding.
Danish: Fluenz frarådes til kvinder, som er gravide eller ammer.
English: Region Age Range a
Danish: Undersøgelsesnummer Region Aldersinterval a
English: METHOD AND ROUTE(S) OF ADMINISTRATION For nasal use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun til nasal anvendelse.
English: Table 1 FLUENZ Efficacy in Placebo Controlled Paediatric Studies
Danish: Tabel 1 Virkning af FLUENZ i placebokontrollerede pædiatriske studier
English: e The primary circulating strain was antigenically dissimilar from the H3N2 strain represented in the vaccine; efficacy against the mismatched A/H3N2 strain was 85.9% (95% CI: 75.3, 91.9).
Danish: e Den primære cirkulerende stamme var på antigenniveau forskellig fra H3N2-stammen, som repræsenteres i vaccinen; virkning over for den ikke-matchede A/H3N2-stamme var 85,9 % (95 % CI: 75,3; 91,9).
English: Safety data regarding use of FLUENZ have been compiled from over 28,500 children and adolescents 2 to 17 years of age from clinical studies and over 52,500 children and adolescents from post-authorisation safety studies.
Danish: Sikkerhedsdata angående brugen af FLUENZ er blevet indsamlet i kliniske studier med over 28.500 børn og unge i alderen 2 til 17 år, og fra sikkerhedsstudier efter markedsføring med over 52.500 børn og unge.
English: Non-clinical data with FLUENZ reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance, and neurovirulence.
Danish: De prækliniske data med FLUENZ gav ingen grund til at mistænke særlig risiko for mennesker, vurderet ud fra prækliniske konventionel studie af toksicitet efter gentagne doser, reproduktions- og udviklingstoksicitet, lokal tolerance eller neurovirulens.
English: • Fluenz is administered as a divided dose in both nostrils as described below.
Danish: • Fluenz indgives som en delt dosis i begge næsebor, som beskrevet nedenfor.
English: Fluenz will be given as a spray in each nostril.
Danish: Fluenz gives som spray i hvert næsebor.
English: When the submission of a PSUR and the update of a RMP coincide, they should be submitted at the same time.
Danish: Når tidsfristen for fremsendelse af en periodisk, opdateret sikkerhedsindberetning (PSUR) er sammenfaldende med tidsfristen for opdatering af en RMP, skal de fremsendes samtidig.
English: Manufacturer: MedImmune, UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke, Liverpool, L24 9JW, UK
Danish: Fremstiller: MedImmune, UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke, Liverpool, L24 9JW, Storbritannien
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FLUENZ
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) FLUENZ
English: Talk to your doctor, nurse or pharmacist before vaccination:
Danish: Kontakt lægen, sundhedspersonalet eller apoteket før vaccinationen:
English: Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
Danish: Børn og unge med klinisk betydende immundefekt, som skyldes sygdomme eller immunsupprimerende behandling, såsom: akut eller kronisk leukæmi; lymfom; symptomatisk HIV-infektion; cellulær immundefekt eller behandling med højdosis kortikosteroider.
English: Matched strains
Danish: Matchede stammer
English: fewer cases than injectable
Danish: færre tilfælde end for injicerbar
English: This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 10.
Danish: Denne vaccine foreligger som en næsespray-suspension, i en nasal applikator til engangsbrug (0,2 ml) i en pakningsstørrelse på 10.
English: FLUENZ should under no circumstances be injected.
Danish: FLUENZ må under ingen omstændigheder injiceres.
English: Figure 1 FLUENZ Administration
Danish: Figur 1 Indgivelse af FLUENZ
English: • The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff.
Danish: • Patienten kan trække vejret normalt mens vaccinen indgives - der er ikke grund til at
English: For children who have not previously been vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.
Danish: Børn, som ikke tidligere er blevet vaccineret mod sæsonbestemt influenza, bør have en 2. dosis efter mindst 4 uger.
English: Efficacy (95% CI)
Danish: Virkning (95 % CI)
English: b Reduction in culture-confirmed influenza illness relative to injectable influenza vaccine.
Danish: b Reduktion i influenzasygdom bekræftet ved dyrkning i forhold til injicerbar influenzavaccine.
English: The adverse reactions reported were similar to those seen with the recommended single dose of FLUENZ.
Danish: De rapporterede bivirkninger var sammenlignelige med bivirkninger observeret efter den anbefalede enkeltdosis af FLUENZ.
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for bortskaffelse og anden håndtering Indgivelse
English: The co-administration of FLUENZ with the live attenuated vaccines: measles, mumps, rubella, varicella, and orally-administered poliovirus has been studied.
Danish: Samtidig administration af FLUENZ med levende, svækkede vacciner: mæslinger, fåresyge, rubella, varicella og oralt indgivet poliovirus er blevet undersøgt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: FLUENZ IS FOR NASAL USE ONLY.
Danish: FLUENZ ER KUN TIL NASAL ANVENDELSE.
English: As with most vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of FLUENZ.
Danish: Relevant medicinsk behandling og overvågning skal altid være umiddelbart tilgængelig i tilfælde af en anafylaktisk hændelse efter administration af FLUENZ.
English: In an active-controlled clinical study (MI-CP111), an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants and toddlers 6-11 months of age (6.1% FLUENZ versus 2.6% injectable influenza vaccine).
Danish: I et klinisk studie med aktiv kontrol (MI-CP111) blev der observeret en forøget hyppighed af indlæggelser (af alle årsager) i en periode på 180 dage efter den sidste vaccinationsdosis hos spædbørn og små børn i alderen 6-11 måneder (6,1 % FLUENZ versus 2,6 % injicerbar influenzavaccine).
English: A/Victoria/361/2011 (H3N2)-like strain (A/Texas/50/2012, MEDI 237514)
Danish: A/Victoria/361/2011 (H3N2)-lignende stamme (A/Texas/50/2012, MEDI 237514)
English: MedImmune, LLC Lagelandseweg 78 6545 CG Nijmegen Netherlands
Danish: MedImmune, LLC Lagelandseweg 78 6545 CG Nijmegen Holland
English: However, based upon the potential for influenza antiviral agents to reduce the effectiveness of FLUENZ, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy.
Danish: Baseret på muligheden for, at antivirale stoffer mod influenza potentielt kan reducere FLUENZ's virkning, frarådes det imidlertid at give vaccinen i de første 48 timer, efter ophør af behandling med antivirale stoffer mod influenza.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Fluenz på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Do not use salicylates in children and adolescents younger than 18 years of age for 4 weeks after vaccination unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection.
Danish: Salicylater må ikke anvendes til børn og unge under 18 år i 4 uger efter vaccinationen, med mindre det er medicinsk indiceret, da tilfælde af Reyes syndrom er blevet rapporteret efter brug af salicylater ved infektioner med vildtype-influenza.
English: Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
Danish: Børn og unge under 18 år, som modtager salicylatbehandling på grund af forbindelsen mellem Reyes syndrom og salicylater og vildtype-influenzainfektion.
English: No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or FLUENZ have been observed.
Danish: Der blev ikke observeret klinisk betydende ændringer i immunresponset over for mæslinger, fåresyge, varicella, oralt indgivet poliovirus eller FLUENZ.
English: Table 2 FLUENZ Relative Efficacy in Active-controlled Paediatric Studies with Injectable
Danish: Tabel 2 Relativ virkning af FLUENZ i aktivt kontrollerede pædiatriske studier med
English: 5 single-use nasal applicators (0.2 ml each) Store in a refrigerator.
Danish: 5 nasale applikatorer til engangsbrug (0,2 ml applikator) Opbevares i køleskab.
English: FLUENZ is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
Danish: FLUENZ er derimod ikke kontraindiceret til personer med asymptomatisk HIV-infektion, til personer, som modtager topikale/inhalerede kortikosteroider eller systemiske lavdosis-kortikosteroider, eller til personer, som er i substitutionssbehandling med kortikosteroider som, f.eks. ved binyrebarkinsufficiens.
English: It is not recommended to administer FLUENZ to infants and toddlers 12-23 months of age.
Danish: Det frarådes at give FLUENZ til spædbørn og småbørn i alderen 12-23 måneder.
English: • FLUENZ is administered as a divided dose in both nostrils.
Danish: • FLUENZ indgives som en delt dosis i begge næsebor.
English: FLUENZ is supplied as a 0.2 ml suspension in a single-use nasal applicator (Type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector cap (synthetic rubber), plunger rod, plunger-stopper (butyl rubber), and a dose-divider clip.
Danish: FLUENZ leveres som en 0,2 ml suspension i en nasal applikator (type 1 glas) til engangsbrug, med studs (polypropylen med overførselsventil af polyethylen), beskyttelseslåg til studsen (syntetisk gummi), stempelstang, stempelprop (butylgummi) og en klips til dosisfordeling.
English: In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers 6-23 months of age (5.9% FLUENZ versus 3.8% injectable influenza vaccine).
Danish: I det samme studie blev der observeret en forøget hyppighed af hvæsen gennem 42 dage hos spædbørn og små børn i alderen 6-23 måneder (5,9 % FLUENZ versus 3,8 % injicerbar influenzavaccine).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE PÅ 5 NASALE APPLIKATORER TIL ENGANGSBRUG
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (2 X 5 NASAL APPLICATORS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE PÅ 10 NASALE APPLIKATORER TIL ENGANGSBRUG (2 X 5 NASALE APPLIKATORER)
English: M = months b Reduction in culture-confirmed influenza illness relative to placebo.
Danish: e a b Reduktion i influenzasygdom bekræftet ved dyrkning i forhold til placebo.
English: • It is recommended that Fluenz is not given at the same time as influenza-specific antiviral medicines.
Danish: • Det anbefales, at Fluenz ikke gives på samme tidspunkt som influenzaspecifik antiviral medicin, da vaccinen kan blive mindre effektiv.
English: The rate of wheezing was not increased in FLUENZ recipients 24 months and older.
Danish: Hyppigheden af hvæsen var ikke forøget hos modtagere af FLUENZ i alderen 24 måneder og derover.
English: fewer cases than injectable c fewer cases than injectable
Danish: færre tilfælde end for injicerbar c færre tilfælde end for injicerbar
English: Fluenz must only be used as a nasal spray.
Danish: Fluenz må kun anvendes som en næsespray.
English: Improved Efficacy (95% CI)
Danish: Forbedring i beskyttelsesgrad (95 % CI)
English: D153-P514 Europe 6 to 71 M 2,085 2002-2003
Danish: D153-P514 Europa 6 til 71 M 2.085 2002-2003
English: Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure Fluenz is delivered into the nose.
Danish: Placer applikatoren Mens patienten er i en opretstående stilling, placeres spidsen lige indenfor næseboret for at sikre, at Fluenz indgives i næsen.
English: The suspension is colourless to pale yellow, clear to opalescent.
Danish: Suspensionen er farveløs til svag gullig, klar til opaliserende.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SINGLE-USE NASAL APPLICATOR
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER NASAL APPLIKATOR TIL ENGANGSBRUG