FrancophonIA/ELRC3.0 huggingface dataset:
English: Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Danish: Twinrix Pædiatrisk er indiceret til brug hos ikke-immuniserede spædbørn, børn og unge fra 1 år op til og inkluderende 15 år, som har risiko for både hepatitis A- og hepatitis B-infektion.
English: Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the adult formulation
Danish: Unormale leverfunktionstest * henviser til bivirkninger set i kliniske studier udført med vaccinen til brug for voksne.
English: In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 89% of the subjects one month after the first dose and in 100% one month after the third dose (i.e. month 7).
Danish: I kliniske studier påvistes specifikke humorale antistoffer mod hepatitis A hos ca. 89 % af de personer en måned efter den første vaccination, og hos 100 % en måned efter den tredje dosis (dvs. måned 7).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin, eller har gjort det for nylig.
English: Twinrix Paediatric can be given concomitantly with Human Papillomavirus (HPV) vaccine.
Danish: Twinrix Pædiatrisk kan gives samtidigt med human papillomvirus (HPV)-vaccine.
English: Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines.
Danish: Hypersensitivitet efter forudgående indgift af hepatitis A- og/eller hepatitis B-vacciner.
English: Only the concomitant administration of Twinrix Paediatric with Cervarix has been specifically studied.
Danish: Kun samtidig administration af Twinrix Pædiatrisk og Cervarix er specifikt undersøgt.
English: 0.2 milligrams Al3+
Danish: 0,2 milligram Al3+
English: • Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
Danish: • Rød-violette knopper på huden (lichen planus), alvorlig hududslæt (erythema multiforme)
English: Twinrix Paediatric should under no circumstances be administered intravascularly.
Danish: Twinrix Pædiatrisk må under ingen omstændigheder administreres intravaskulært.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: Tegn på en allergisk reaktion kan være kløende hududslæt, stakåndethed og opsvulming af ansigtet eller tungen.
English: Twinrix Paediatric is for intramuscular injection, preferably in the deltoid region in adolescents and children or in the anterolateral thigh in infants.
Danish: Twinrix Pædiatrisk er til intramuskulær injektion, fortrinsvis i deltoidea-regionen hos unge og børn eller i det anterolaterale lår hos spædbørn.
English: • Aching muscles
Danish: • Ømme muskler
English: • Numbness or weakness of the arms and legs (neuropathy), paralysis
Danish: • Sovende fornemmelse i arme og ben (neuropati), lammelse
English: Twinrix Paediatric confers immunity against HAV and HBV infection by inducing specific anti-HA and anti-HBs antibodies.
Danish: Twinrix Pædiatrisk giver immunitet mod HAV- og HBV-infektion ved at inducere specifikke antiHAV- og anti-HB-antistoffer.
English: In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given.
Danish: I situationer, hvor der skal gives en booster-dosis af hepatitis A og/eller hepatitis B, kan der anvendes en monovalent vaccine eller en kombineret vaccine.
English: It is not known whether Twinrix Paediatric will prevent HA and HB in such cases.
Danish: Det vides ikke, om Twinrix Pædiatrisk vil forhindre hepatitis A og hepatitis B i sådanne tilfælde.
English: Appetite lost
Danish: Almindelig Nedsat appetit
English: The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.
Danish: De kinetiske forhold vedrørende nedgangen i anti-HAV- og anti-HB-antistoffer blev påvist at være lig de monovalente vacciners kinetiske forhold.
English: Twinrix Paediatric contains neomycin Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
Danish: Twinrix Pædiatrisk indeholder neomycin Fortæl lægen, hvis du er overfølsom over for neomycin (et antibiotikum).
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Twinrix Paediatric should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Paediatric therapy to the woman.
Danish: Det skal besluttes, om amningen skal forsættes eller stoppes, eller om behandlingen med Twinrix Pædiatrisk skal forsættes eller stoppes, idet der tages højde for fordelene ved amning for barnet i forhold til den terapeutiske fordel for moderen.
English: Twinrix Paediatric is a white, slightly milky liquid presented in a glass pre-filled syringe (0.5 ml).
Danish: Twinrix Pædiatrisk er en hvid, næsten mælkeagtig væske i en fyldt injektionssprøjte af glas (0,5 ml).
English: • Swelling or bruising at the injection site
Danish: • Hævelse eller blå mærker ved injektionsstedet
English: The safety and immunogenicity of Twinrix Paediatric administered as a booster dose following a three dose primary course have not been evaluated.
Danish: Sikkerheden og immunogeniciteten af Twinrix Pædiatrisk givet som en booster-dosis efter et tre-dosis primært vaccinationsprogram er ikke undersøgt.
English: Alternatively, subjects primed with Twinrix Paediatric may be administered a booster dose of either of the monovalent vaccines.
Danish: Alternativ kan individer, som er påbegyndt Twinrix Pædiatrisk, gives en booster-dosis af en af de monovalente vacciner.
English: Arthralgia*
Danish: Artralgi *
English: Twinrix Paediatric is available in packs of 1, 10 and 50 with or without needles.
Danish: Twinrix Pædiatrisk findes i pakninger med 1, 10 og 50 fyldte injektionssprøjter med og uden nåle.
English: The effect of Twinrix Paediatrict on embryo-fetal, peri-natal and post-natal survival and development has been assessed in rats.
Danish: Virkningen af Twinrix Pædiatrisk på fostrets, den perinatale og postnatale overlevelse og udvikling er undersøgt på rotter.
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
Danish: 0,5 ml suspension i fyldt injektionssprøjte (type I glas) med stempelprop (butylgummi).
English: • Inflammation of nerves (neuritis)
Danish: • Betændelse i nervesystemet (neuritis)
English: EU/1/97/029/009 - pack of 1 with 2 needles EU/1/97/029/010 - pack of 10 with 20 needles
Danish: EU/1/97/029/009 - pakning med 1 med 2 kanyler EU/1/97/029/010 - pakning med 10 med 20 kanyler
English: Twinrix Paediatric is not recommended for postexposure prophylaxis (e.g. needle stick injury).
Danish: Twinrix Pædiatrisk anbefales ikke til post-ekspositionsprofylakse (f.eks. stikuheld med kanyle).
English: • Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness).
Danish: • Alvorlige overfølsomhedsreaktioner (anafylaksi, anafalaktiske reaktioner og serumsyge lignende symptomer).
English: It is possible that subjects may be in the incubation period of a HA or HB infection at the time of vaccination.
Danish: Nogle personer kan være i inkubationsfasen af en hepatitis A- eller hepatitis B-infektion på tidspunktet for vaccination.
English: • A disease of the nerves of the eye (optic neuritis)
Danish: • Sygdom i øjets nervesystem (optisk neuritis)
English: Hypoaesthesia*, paraesthesia*, dizziness
Danish: Hypæstesi*, paræstesi*, svimmelhed
English: Influenza like illness*, chills*
Danish: Influenza-lignende symptomer*, kulderystelser *
English: The excretion of Twinrix Paediatric in milk has not been studied in animals.
Danish: Udskillelsen af Twinrix Pædiatrisk i mælk hos dyr er ikke undersøgt.
English: The effect of Twinrix Paediatric on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials.
Danish: Virkningen af Twinrix Pædiatrisk på fostrets, den perinatale og postnatale overlevelse og udvikling er ikke undersøgt prospektivt i kliniske studier.
English: EU/1/97/029/001 - pack of 1 without needle EU/1/97/029/002 - pack of 10 without needle EU/1/97/029/008 - pack of 50 without needle EU/1/97/029/006 - pack of 1 with 1 needle EU/1/97/029/007 - pack of 10 with 10 needles
Danish: EU/1/97/029/001 - pakning med 1 uden kanyle EU/1/97/029/002 - pakning med 10 uden kanyler EU/1/97/029/008 - pakning med 50 uden kanyler EU/1/97/029/006 - pakning med 1 med 1 kanyle EU/1/97/029/007 - pakning med 10 med 10 kanyler
English: No data on concomitant administration of Twinrix Paediatric with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Danish: Der foreligger ikke data for samtidig administration af Twinrix Pædiatrisk og specifik hepatitis Aimmunoglobulin eller hepatitis B-immunoglobulin.
English: • Diarrhoea, vomiting, stomach pain
Danish: • Diarré, opkastning, mavesmerter
English: However, exceptionally Twinrix Paediatric can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects (see section 4.2).
Danish: Hos individer med thrombocytopeni eller blødnings-forstyrrelser kan Twinrix Pædiatrisk dog administreres subkutant, da blødning kan forekomme efter en intramuskulær adminstration hos sådanne individer (se pkt.
English: It is unknown whether Twinrix Paediatric is excreted in human breast milk.
Danish: Det er ukendt, om Twinrix Pædiatrisk udskilles i human mælk.
English: • Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills
Danish: • Influenzalignende symptomer, herunder høj feber, ondt i halsen, løbende næse, hoste og kuldegysninger.
English: • Multiple sclerosis, swelling of the spinal cord (myelitis)
Danish: • Multipel sklerose, rygmarvsbetændelse (myelitis)
English: • Irritability
Danish: • Irritabilitet.
English: Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix.
Danish: Følgende bivirkninger er set i afprøvninger på patienter, ved rutinemæssig brug af vaccinen, ved brug af hepatitis A- eller hepatitis B-vaccine eller ved brug af Twinrix Voksen:
English: LIST OF EXCIPIENTS Sodium chloride Water for injections
Danish: - Øvrige indholdstoffer: natriumchlorid, vand til injektionsvæsker.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (0.5 ml):
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 dosis (0,5 ml):
English: • Swollen glands in the neck armpit or groin (lymphadenopathy)
Danish: • Hævede kirtler i halsen, armhulen eller lysken (lymfadenopati)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 February 1997
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Your doctor will advise on the possible need for extra doses, and future booster dosing.
Danish: • Tredje dosis: 6 måneder efter den første dosis Din læge vil rådgive vedrørende behov for ekstra doser og fremtidige boosterdoser.
English: Uncommon Upper respiratory tract infection*
Danish: Infektion i øvre luftveje *
English: Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens.
Danish: Samtidig administration af Twinrix Pædiatrisk og Cervarix (HPV-vaccine) har ikke vist nogen klinisk relevant påvirkning af antistofresponset for HPV- og hepatitis A-antigener.
English: • A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome)
Danish: • Smerte, svaghed og lammelse i ben og arme, samt i visse tilfælde bryst og ansigt, som skyldes kortvarig betændelse i nervesystemet (Guillain-Barré syndrom)
English: 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Danish: 10 mikrogram produceret på human diploid (MRC-5) -celler adsorberet til aluminiumhydroxidhydrat
English: Contents of the pack and other information What Twinrix Paediatric contains - The active substances are: Hepatitis A virus (inactivated)1,2
Danish: Pakningsstørrelser og yderligere oplysninger Twinrix Pædiatrisk indeholder: - Aktive stoffer: Hepatitis A-virus (inaktiveret)
English: Twinrix Paediatric is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Danish: Twinrix Pædiatrisk er en kombineret vaccine formuleret ved pooling af bulk fremstillinger af det oprensede inaktiverede hepatitis A (HA)-virus og oprensede hepatitis B-overfladeantigen (HBsAg), separat adsorberede til aluminiumhydroxidhydrat og aluminiumphosphat.
English: Irritability
Danish: Almindelig Irritabilitet
English: What Twinrix Paediatric is and what it is used for What you need to know before you receive Twinrix Paediatric How Twinrix Paediatric is given Possible side effects
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Twinrix Pædiatrisk Sådan får du Twinrix Pædiatrisk Bivirkninger
English: • Swelling or infection of the brain (encephalitis)
Danish: • Hjernebetændelse (encephalitis)
English: Gastrointestinal symptoms, nausea Uncommon Diarrhoea, vomiting, abdominal pain
Danish: Almindelig Gastrointestinale symptomer, kvalme Ikke almindelig
English: It is advised that vaccines other than Cervarix should not be administered at the same time as Twinrix Paediatric.
Danish: Det frarådes derfor at vaccinere på samme tidspunkt med andre vacciner end Cervarix.
English: • Drowsiness, headache
Danish: • Døsighed, hovedpine
English: 0.025 milligrams Al3+ Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Danish: 0,025 milligram Al3+ produceret på gærceller (Saccharomyces cerevisiae) ved rekombinant DNA-teknologi adsorberet til aluminiumphosphat
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Twinrix Paediatric, suspension for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Twinrix Pædiatrisk
English: • Degenerative disease of the brain (encephalopathy)
Danish: • Ændring af hjernens celler (encephalopati)
English: How Twinrix Paediatric is given
Danish: Sådan får du Twinrix Pædiatrisk
English: • Joint swelling, muscular weakness
Danish: • Hævelse i led, muskelsvaghed
English: The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines:
Danish: Overvågning efter markedsføring Følgende bivirkninger er set ved enten Twinrix eller ved GlaxoSmithKlines monovalente hepatitis A- og B-vacciner: Infektioner og parasitære sygdomme
English: 50 x 1 dose (0.5 ml)
Danish: 50 x 1 dosis (0,5 ml)
English: 12-15 years, all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 85% had anti-HBs antibody ≥10 mIU/ml.
Danish: Efter et vaccinationsprogram ved 0, 1 og 6 måneder med Twinrix Pædiatrisk hos børn fra 12 til 15 år havde alle de personer, som man fulgte op på, efter 10 år anti-HAV-antistoffer ≥ 15 mIE/ml, og 85 % havde anti-HB-antistoffer ≥ 10 mIE/ml.
English: However, if you get any of these symptoms you should contact a doctor urgently.
Danish: Hvis de forekommer, skal du øjeblikkeligt søge lægehjælp
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING
English: Twinrix Paediatric can be given with a Human Papillomavirus (HPV) vaccine at a separate injection site (another part of your body, e.g. the other arm) during the same visit.
Danish: Brug af anden medicin sammen med Twinrix Pædiatrisk Twinrix Pædiatrisk kan gives samtidig med en human papillomvirus (HPV)-vaccine, når blot vaccinerne gives på hver sit injektionssted (f.eks. i hver sin arm).
English: In haemodialysis patients, patients receiving immunosuppressive treatment or patients with an impaired immune system, the anticipated immune response may not be achieved after the primary immunisation course.
Danish: Hos hæmodialysepatienter og personer med svækket immunsystem opnås ikke altid adækvat anti-HAV og anti-HBs antistoftiter efter det primære immuniseringsprogram, hvorfor sådanne patienter kan have behov for yderligere doser af vaccinen.
English: years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 97% had anti-HBs antibody ≥10 mIU/ml.
Danish: Efter et vaccinationsprogram ved 0, 1 og 6 måneder med Twinrix Pædiatrisk hos børn fra 1 til 11 år havde alle de personer, som man fulgte op på, efter 5 år anti-HAV-antistoffer ≥ 15 mIE/ml, og 97 % havde anti-HB-antistoffer ≥10 mIE/ml.
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Danish: Meget sjældne (kan forekomme ved op til 1 ud af 10.000 vaccinedoser):
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Danish: Sjældne (kan forekomme ved op til 1 ud af 1.000 vaccinedoser):
English: • Generally feeling unwell, tiredness
Danish: • Utilpashed, træthed
English: • Feeling of pins and needles (paraesthesia)
Danish: • Fornemmelse af prikken og stikken (parestesi)
English: • Infection around the brain which may give severe headache with stiff neck and sensitivity to light
Danish: • Svær hovedpine med nakkestivhed og øget følsomhed over for lys, forårsaget af betændelse rundt om hjernen (meningitis)
English: Common (these may occur with up to 1 in 10 doses of the vaccine)
Danish: Almindelige (kan forekomme ved op til 1 ud af 10 vaccinedoser):
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Danish: Ikke almindelige (kan forekomme ved op til 1 ud af 100 vaccinedoser):
English: GlaxoSmithKline, S.A. Tel: + 34 902 202 700 es-ci@gsk.com
Danish: Tel: + 34 902 202 700 es-ci@gsk.com
English: Twinrix Paediatric, Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Danish: Twinrix Pædiatrisk injektionsvæske, suspension i fyldt injektionssprøjte Hepatitis A (inaktiveret)- og hepatitis B (rDNA) (HAB)-vaccine (adsorberet)
English: - neomycin.
Danish: 6.1 eller neomycin.
English: - If you get / your child gets any side effects, talk to your doctor or pharmacist.
Danish: - Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre eller du/dit barn får bivirkninger, som ikke er nævnt her.
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Danish: 0,025 milligram Al3 produceret på gærceller (Saccharomyces cerevisiae) ved rekombinant DNA-teknologi adsorberet til aluminumphosphat
English: NAME OF THE MEDICINAL PRODUCT Twinrix Paediatric, suspension for injection Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Danish: Twinrix Pædiatrisk, injektion, suspension, Hepatitis A (inaktiveret)- og hepatitis B (rDNA) (HAB)-vaccine (adsorberet).
English: What you need to know before you receive Twinrix Paediatric
Danish: Det skal du vide, før du får Twinrix Pædiatrisk Du må ikke få Twinrix Pædiatrisk, hvis
English: • Fits or seizures
Danish: • Nældefeber, kløe
English: Very common Pain and redness at the injection site Common
Danish: Smerte og rødme ved administrationsstedet
English: România GlaxoSmithKline (GSK) SRL
Danish: España GlaxoSmithKline, S.A.
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Danish: GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208
English: 1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
Danish: 10 x 1 dosis (0,5 ml) 1 fyldt injektionssprøjte + 2 kanyler 1 dosis (0,5 ml)
English: I.M.
Danish: HAB-vaccine i.m.
English: It is not recommended for patients with severe kidney problems.
Danish: Det anbefales ikke til patienter med svære nyreproblemer.
English: The full EPAR for Zoledronic acid Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zoledronic acid Actavis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Actavis on 20 April 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zoledronic acid Actavis den 20. april 2012.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Actavis.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Zoledronic acid Actavis.
English: This means that Zoledronic acid Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Danish: Det betyder, at Zoledronic acid Actavis er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zometa.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Actavis has been shown to be comparable to Zometa.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Zoledronic acid Actavis er sammenlignelig med Zometa.
English: A risk management plan has been developed to ensure that Zoledronic acid Actavis is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Zoledronic acid Actavis anvendes så sikkert som muligt.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Actavis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zoledronic acid Actavis.
English: For more information about treatment with Zoledronic acid Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zoledronic acid Actavis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In addition, the company that markets Zoledronic acid Actavis will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
Danish: Virksomheden, som markedsfører Zoledronic acid Actavis, vil desuden udarbejde et patientkort med oplysninger om risikoen for osteonekrose i kæben (beskadigelse af kæbebenene, der kan medføre smerter, sår i munden eller løse tænder) og en instruks til patienter om at kontakte deres læge, hvis de oplever symptomer.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Actavis, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zoledronic acid Actavis, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The usual dose of Zoledronic acid Actavis is one infusion of 4 mg over at least 15 minutes.
Danish: Den normale dosis Zoledronic acid Actavis er én infusion på 4 mg, der varer mindst 15 minutter.