natgillin/translations-raw huggingface dataset:
4. 5).
Reduction in the dose of alfentanil and other short acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e. g. alfentanyl and sufentanil) should be considered when co-administered with voriconazole (see section 4.5).
Ritonavir (potent CYP450- induktor; CYP3A4- hæmmer og - substrat):
Ritonavir (Potent CYP450 inducer; CYP3A4 inhibitor and substrate):
VFEND oral suspension indeholder saccharose og bør ikke gives til patienter med sjældne arvelige problemer med fructoseintolerans, sucrase- isomaltasemangel eller glucose- galactosemalabsorption.
VFEND oral suspension contains sucrose and should not be given to patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption.
Dette afsnit omfatter andre lægemidlers virkning på voriconazol, virkninger af voriconazol på andre lægemidler og to- vejs interaktioner.
68 This section addresses the effects of other medicinal products on voriconazole, the effects of voriconazole on other medicinal products and two-way interactions.
Kontraindikationer, interaktioner der kræver dosisjustering og omhyggelig klinisk og/ eller 68 biologisk monitorering, og til sidst dem der ingen signifikant farmakokinetisk interaktion har, men som har klinisk interesse for det terapeutiske område.
The interactions for the first two sections are presented in the following order: contraindications, those requiring dosage adjustment and careful clinical and/ or biological monitoring and finally those that have no significant pharmacokinetic interaction but may be of clinical interest in this therapeutic field.
Rifampicin (600 mg én gang dagligt) nedsætter Cmax (maksimal plasmakoncentration) og AUCτ (arealet under plasmakoncentrationstidskurven inden for et dosisinterval) af voriconazol med henholdsvis 93% og 96%.
Rifampicin (600 mg once daily) decreased the Cmax (maximum plasma concentration) and AUCτ (area under the plasma concentration time curve within a dose interval) of voriconazole by 9 3% and 96%, respectively.
Administration af voriconazol har ingen signifikant effekt på middel Cmax og AUCτ af ritonavir i højdosis- studiet, men ses en lille nedsættelse af steady state Cmax og AUCτ af ritonavir med gennemsnitlig henholdsvis 25% og 13% i lavdosis ritonavir interaktionsstudiet.
Administration of voriconazole did not have a significant effect on mean Cmax and AUCτ of ritonavir in the high dose study, although a minor decrease in steady state Cmax and AUCτ of ritonavir with an average of 25% and 13% respectively was observed in the low dose ritonavir interaction study.
Samtidig administration af voriconazol og høje doser ritonavir (400 mg og derover 2 gange dagligt) er kontraindiceret.
One outlier subject with raised voriconazole levels was identified in each of the ritonavir interaction studies. Coadministration of voriconazole and ritonavir (400 mg and above twice daily) is contraindicated.
Skønt det ikke er undersøgt, er det sandsynligt, at carbamazepin eller phenobarbital vil nedsætte voriconazol- plasmakoncentrationerne signifikant.
Although not studied, carbamazepine or phenobarbital is likely to significantly decrease plasma voriconazole concentrations.
Virkninger af voriconazol på andre lægemidler
69 Effects of voriconazole on other medicinal products
69 Voriconazol bør anvendes med forsigtighed hos patienter, der samtidig tager medicin, som er kendt for at forlænge QT- intervallet.
Voriconazole should be administered with caution in patients with concomitant medication that is known to prolong QT interval.
4. 4).
Reduction in the dose of alfentanil and other short acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e. g. fentanyl and sufentanil) should be considered when coadministered with voriconazole (see section 4.4).
Orale antikoagulantia:
70 Oral anticoagulants:
70 Andre orale antikoagulantia, f. eks. phenprocoumon, acenocoumarol (CYP2C9, CYP3A4- substrater):
Other oral anticoagulants e. g. phenprocoumon, acenocoumarol (CYP2C9, CYP3A4 substrates):
Samtidig behandling med voriconazol og phenytoin bør undgås, medmindre fordelen opvejer risikoen.
Concomitant use of voricoazole and phenytoin should be avoided unless the benefit outweighs the risk.
4. 2.
71 increased to 5 mg / kg intravenously twice daily or from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see section 4.2.
71 Rifabutin (300 mg én gang dagligt) nedsatte Cmax og AUCτ af voriconazol 200 mg 2 gange dagligt med henholdsvis 69% og 78%.
Rifabutin (300 mg once daily) decreased the Cmax and AUCτ of voriconazole at 200 mg twice daily by 69% and 78%, respectively.
Hvis samtidig behandling med rifabutin og voriconazol er berettiget, kan vedligeholdelsesdosis af voriconazol øges til 5 mg/ kg intravenøst 2 gange dagligt eller oralt fra 200 mg til 350 mg 2 gange dagligt (100 mg til 200 mg oralt 2 gange dagligt hos patienter med en legemsvægt under 40 kg) (se pkt.
If rifabutin coadministration with voriconazole is justified then the maintenance dose of voriconazole may be increased to 5 mg/ kg intravenously twice daily or from 200 mg to 350 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg) (see section 4.2).
Omhyggelig monitorering af fuldt blodbillede og bivirkninger til rifabutin (f. eks. uveitis) anbefales, hvis rifabutin gives samtidig med voriconazol.
Careful monitoring of full blood counts and adverse reactions to rifabutin (e. g. uveitis) is recommended when rifabutin is coadministered with voriconazole.
Orale kontraceptiva, som indeholder større doser end 1 mg norethisteron og 0, 035 mg ehtinylestradiol, er ikke undersøgte.
Oral contraceptives containing doses other than 1 mg norethisterone and 0.035 mg ethinylestradiol have not been studied.
Steady state efavirenz (400 mg oralt 1 gang dagligt) nedsatte steady state Cmax og AUCτ af voriconazol med et gennemsnit på henholdsvis 61% og 77% hos raske forsøgspersoner.
In the
Voriconazol øgede ved steady state i det samme studie steady state efavirenz Cmax og AUCτ med et gennemsnit på henholdsvis 38% og 44% hos raske forsøgspersoner.
72 same study voriconazole at steady state increased the steady state Cmax and AUCτ of efavirenz by an average of 38% and 44% respectively, in healthy subjects.
72 I et separat forsøg med raske forsøgspersoner gav samtidig administration af 300 mg voriconazol 2 gange dagligt og lavdosis efavirenz (300 mg 1 gang dagligt) ikke tilstrækkelig eksponering af voriconazol.
In a separate study in healthy subjects, voriconazole dose of 300 mg BID in combination with low dose efavirenz (300 mg once daily) did not lead to sufficient voriconzole exposure.
Når voriconazol anvendes samtidigt med efavirenz, bør voriconazols vedligeholdelsesdosis øges til 400 mg 2 gange dagligt, og efavirenz- dosis bør nedsættes med 50%, dvs. til 300 mg 1 gang dagligt (se pkt.
When voriconazole is coadministered with efavirenz, voriconazole maintenance dose should be increased to 400 mg twice daily and the efavirenz dose should be reduced by 50%, i. e. to 300 mg once daily (See section 4.2).
Databasen repræsenterer en heterogen population indeholdende patienter med maligne hæmatologiske sygdomme, HIV- inficerede patienter med øsofageal candidiasis og refraktære svampeinfektioner, non- neutropene patienter med candidæmi eller aspergillosis og raske forsøgspersoner.
This represents a heterogeneous population, containing patients with haematological malignancy, HIV infected patients with oesophageal candidiasis and refractory 73 fungal infections, non-neutropenic patients with candidaemia or aspergillosis and healthy volunteers.
73 Da størstedelen af studierne var åbne, er alle kausale bivirkninger, hvor der er en mulig årsagssammenhæng, anført efter systemorganklasse og frekvens (meget almindelig > 1/ 10, almindelig > 1/ 100 og < 1/ 10, ikke almindelig > 1/ 1000 og < 1/ 100, sjælden < 1/ 1000 og meget sjælden < 1/ 10. 000) i tabellen nedenfor.
In the table below, since the majority of the studies were of an open nature all causality adverse events, by system organ class and frequency (very common ≥ 1/ 10, common ≥ 1/ 100 and < 1/ 10, uncommon ≥ 1/ 1000 and < 1/ 100, rare, ≥ 1/ 10 000 and < 1/ 1000 and very rare, < 1/ 10 000) if possibly causally related are listed.
Hypoacusis, tinnitus
74 Ear and labyrinth disorders Rare Hypoacusis, tinnitus
74 Mave- tarmkanalen Meget almindelig Almindelig
Gastrointestinal disorders Very common Uncommon
Almindelig Ikke almindelig
75 Immune system disorders Common Uncommon
Lever og galdeveje Meget almindelig Almindelig Sjælden
Hepato-biliary disorders Common Uncommon
75 Psykiske forstyrrelser Almindelig Sjælden Ændret smagsopfattelse
Psychiatric disorders
De samlede data fra 3 bioækvivalensstudier, hvor formuleringen pulver til oral suspension blev anvendt, sås behandlingsrelateret smagsændring hos 12 (14%) af forsøgspersonerne.
Altered taste perception In the combined data from three bioequivalence studies using the powder for oral suspension formulation, treatment related taste perversion was recorded in 12 (14%) of subjects.
I disse studier, såvel korttids - som langtidsbehandling, oplevede ca.
Visual disturbances In clinical trials, voriconazole treatment-related visual disturbances were very common.
Brug hos børn Sikkerheden af voriconazol er undersøgt hos 245 pædiatriske patienter i alderen 2 til < 12 år, som blev behandlet med voriconazol i farmakokinetiske studier (87 pædiatriske patienter) og i ” compassionate use ” programmer (158 pædiatriske patienter).
76 Paediatric Use The safety of voriconazole was investigated in 245 paediatric patients aged 2 to < 12 years who were treated with voriconazole in pharmacokinetic studies (87 paediatric patients) and in compassionate use programs (158 paediatric patients).
76 4. 9 Overdosering
4.9 Overdose
Klinisk effekt (med delvist eller fuldstændigt respons, se neden for under Klinisk erfaring) er vist over for Aspergillus spp. herunder A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., herunder C. albicans C. glabrata, C. krusei, C. parapsilosis, C. tropicalis samt et begrænset antal af C. dubliniensis, C. inconspicua og C. guilliermondii, Scedosporium spp., herunder S. apiospermum, S. prolificans og Fusarium spp.
Microbiology Clinical efficacy (with partial or complete response, see below under Clinical Experience) has been demonstrated for Aspergillus spp. including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans and Fusarium spp.
Andre behandlede svampeinfektioner (med hyppigt delvist eller fuldstændigt respons) omfatter isolerede tilfælde af Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserholium rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. herunder P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis og Trichosporon spp. herunder T. beigelii infektioner.
77 Other treated fungal infections (with often partial or complete response) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and Trichosporon spp. including T. beigelii infections.
77 Artsbestemmelse af svampekultur og andre relevante laboratorieundersøgelser (serologi, histopatologi) bør foretages før behandling for at isolere og identificere de sygdomsfremkaldende mikroorganismer.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms.
Aspergillus- infektioner – effekt hos aspergillose patienter med dårlig prognose Voriconazol har in- vitro fungicid aktivitet over for Aspergillus spp.
Aspergillus infections – efficacy in aspergillosis patients with poor prognosis Voriconazole has in vitro fungicidal activity against Aspergillus spp.
Der sås tilfredstillende globalt respons (fuldstændigt eller delvis resolution af alle tilhørende symptomer, radiografiske/ bronkoskopiske abnormaliteter ved baseline) hos 53% af de voriconazolbehandlede patienter sammenlignet med 31% af patienterne behandlet med komparatoren.
A satisfactory global response (complete or partial resolution of all attributable symptoms/ signs, radiographic/ bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole-treated patients compared to 31% of patients treated with comparator.
I den primære analyse var succesfuld respons, i følge en ” Data Review Committee ” (DRC), der var blindet over for studiemedicinen, defineret som resolution/ forbedring i alle kliniske tegn og symptomer på infektion med eradikation af Candida fra blodet og infektion i dybtliggende vævssteder 12 uger efter endt behandling (EOT).
In the primary analysis, successful response as assessed by a Data Review Committee (DRC) blinded to study medication was defined as resolution/ improvement in all clinical signs and symptoms of infection with eradication of Candida from blood and infected deep tissue sites at 12 weeks after the
78
78 end of therapy (EOT).
Tidspunkt
Timepoint _
Erfaring med pædiatriske patienter 61 pædiatriske patienter i alderen 9 måneder til 15 år, som havde fået diagnosticeret eller sandsynligvis havde invasiv svampeinfektion, blev behandlet med voriconazol.
Experience in paediatric patients Sixty-one paediatric patients aged 9 months up to 15 years who had definite or probable invasive fungal infections, were treated with voriconazole.
Hovedparten (57/ 61) havde ikke haft succes med tidligere svampebehandling.
79 The majority (57/ 61) had failed previous antifungal therapies.
Kliniske studier, der undersøger QT- intervallet 1 placebokontrolleret, randomiseret, enkeltdosis, crossover studie, der undersøgte effekten på QT - intervallet hos raske frivillige forsøgspersoner, blev udført med 3 orale doser af voriconazol og ketoconazol.
Clinical Studies Examining QT Interval A placebo-controlled, randomized, single-dose, crossover study to evaluate the effect on the QT interval of healthy volunteers was conducted with three oral doses of voriconazole and ketoconazole.
79 7, 0 msek. for ketoconazol 800 mg.
The placebo-adjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg.
Der er påvist bioækvivalens mellem 200 mg tabletter og 40 mg/ ml oral suspension ved administration af en 200 mg dosis.
Bioequivalence was established between the 200mg tablet and the 40 mg/ ml oral suspension when administered as a 200 mg dose.
Hvis flere doser voriconazol oral suspension indtages sammen med meget fede måltider, vil Cmax og AUCτ blive reduceret med henholdsvis 58% og 37%.
When multiple doses of voriconazole oral suspension are administered with high fat meals, Cmax and AUCτ are reduced by 58% and 37% respectively.
In vivo forsøg antyder, at CYP2C19 er signifikant involveret i voriconazols metabolisme.
80 In vivo studies indicated that CYP2C19 is significantly involved in the metabolism of voriconazole.
80 Udskillelse Voriconazol udskilles ved levermetabolisme, hvor mindre end 2% af dosis udskilles uforandret i urinen.
Excretion Voriconazole is eliminated via hepatic metabolism with less than 2% of the dose excreted unchanged in the urine.
I de kliniske studier blev der ikke foretaget dosisjusteringer på baggrund af alder.
81 In the therapeutic studies no dosage adjustment was made on the basis of age.
4. 2).
A relationship between plasma concentrations and age was observed. The safety profile of voriconazole in young and elderly patients was similar and, therefore, no dosage adjustment is necessary for the elderly (see section 4.2).
En initialdosis er ikke indiceret til 81 pædiatriske patienter.
A loading dose is not indicated in paediatric patients.
6.
82 6.
Saccharose Silica, kolloid Titandioxid (E171) Xanthangummi Natriumcitrat Natriumbenzoat (E211) Citronsyre Naturlig appelsinsmag (indeholder appelsinolie, maltodextrin og tocopherol).
Sucrose Silica, Colloidal Titanium Dioxide (E171) Xanthan Gum Sodium Citrate Sodium Benzoate (E211) Citric Acid Natural Orange Flavour (containing orange oil, maltodextrin and tocopherol)
82 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 6.
This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6.
Det er ikke meningen, at suspensionen skal yderligere fortyndes med vand eller andre midler.
It is not intended that the suspension be further diluted with water or other vehicles.
Opbevaringstid for pulver til oral suspension er 2 år.
The shelf-life of the powder for oral suspension is 2 years.
Opbevaringstid efter færdigblanding er 14 dage.
The shelf-life of the constituted suspension is 14 days.
Færdigblandet suspension:
Constituted suspension:
Må ikke opbevares over 30°C, må ikke opbevares i køleskab eller nedfryses.
Do not store above 30°C, do not refrigerate or freeze.
Opbevares ved 2°C – 8°C (i køleskab) før færdigblanding.
Store at 2°C -8°C (in a refrigerator) before constitution.
Opbevaringsbetingelser for færdigblandet suspension se pkt. 6. 3.
For storage conditions of the constituted suspension see section 6.3.
6. 6 Emballage og pakningsstørrelser
6.5 Nature and contents of container
Én 100 ml high density polyethylenflaske (HDPE) (med et børnesikret polypropylenlåg) indeholder 45 g pulver til oral suspension.
One 100 ml high-density polyethylene (HDPE) bottle (with a polypropylene child resistant closure) contains 45 g of powder for oral suspension.
Efter færdigblanding er volumen af suspensionen 75 ml, der giver et brugbart volumen på 70 ml.
Following constitution, the volume of the suspension is 75 ml, providing a usable volume of 70 ml.
Eventuelle rester af den færdigblandede suspension skal kasseres efter 14 dage.
Any unused product or waste material should be disposed of in accordance with local requirements.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
Any remaining suspension should be discarded 14 days after constitution.
Afmål 23 ml vand ved at fylde målebægeret helt op til markeringen.
Measure 23 ml of water by filling the measuring cup to the top of the marked line.
Hæld vandet i flasken.
Add the water to the bottle.
Afmål yderligere 23 ml vand i målebægeret og hæld dette i flasken.
Using the cup measure another 23 ml of water and add this to the bottle.
1 minut.
Shake the closed bottle vigorously for about 1 minute.
Brugsanvisning
83 Instructions for use:
10 sek. før hver brug.
Shake the closed bottle of constituted suspension for approximately 10 seconds before each use.
21. marts 2002 Dato for seneste fornyelse:
21 March 2002 Date of last renewal:
84 BILAG II
84 ANNEX II
FREMSTILLER( E) ANSVARLIGE FOR BATCHFRIGIVELSE
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
85 A.
85 A.
Navn og adresse på fremstillerne ansvarlige for batchfrigivelse
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
Tabletter Pfizer Manufacturing Deutschland GmbH Heinrich- Mack- Str.
Tablets Pfizer Manufacturing Deutschland GmbH Heinrich-Mack-Str.
35 D- 89257 Illertissen Tyskland
35 D-89257 Illertissen Germany
Pulver til infusionsvæske, opløsning og pulver til oral suspension Pfizer PGM Zone Industrielle 29 route des Industries 37530 Pocé- sur- Cisse Frankrig
Pfizer PGM Zone Industrielle 29 Route des Industries 37530 Pocé-Sur-Cisse France
Indehaveren af markedsføringstilladelsen vil fortsætte med at indsende årlige PSUR, medmindre andet er fastlagt af CHMP.
The Marketing Authorisation Holder will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
86 BILAG III
86 ANNEX III LABELLING AND PACKAGE LEAFLET
88 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Blisterpakning for 50 mg filmovertrukne tabletter - pakning med 2, 10, 14, 20, 28, 30, 50, 56, 100 stk.
Blister pack for 50 mg film-coated tablets – Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100
Indeholder lactosemonohydrat.
Includes lactose monohydrate.
2, 10, 14, 20, 28, 30, 50 56 eller 100 filmovertrukne tabletter
2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets
Forseglet pakning Må ikke bruges, hvis pakningen har været åbnet
Sealed Pack Do not use if box has been opened
89 11.
89 10.
Pfizer Limited, Sandwich, Kent, CT13 9NJ, Storbritannien
Pfizer Limited Sandwich Kent, CT13 9NJ, United Kingdom
2 tabletter:
2 tabs:
EU/ 1/ 02/ 212/ 001 10 tabletter:
EU/ I/ 02/ 212/ 001 10 tabs:
EU/ 1/ 02/ 212/ 002 14 tabletter:
EU/ I/ 02/ 212/ 002 14 tabs:
EU/ 1/ 02/ 212/ 003 20 tabletter:
EU/ I/ 02/ 212/ 003 20 tabs:
EU/ 1/ 02/ 212/ 004 28 tabletter:
EU/ I/ 02/ 212/ 004 28 tabs:
EU/ 1/ 02/ 212/ 005 30 tabletter:
EU/ I/ 02/ 212/ 005 30 tabs:
EU/ 1/ 02/ 212/ 006 50 tabletter:
EU/ I/ 02/ 212/ 006 50 tabs:
EU/ 1/ 02/ 212/ 007 56 tabletter:
EU/ I/ 02/ 212/ 007 56 tabs:
EU/ 1/ 02/ 212/ 008 100 tabletter:
EU/ I/ 02/ 212/ 008 100 tabs:
90 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
90 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
91 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
91 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre emballage for beholdere med 50 mg filmovertrukne tabletter – pakning med 2, 30, 100 stk.
Bottle outer pack for 50 mg film-coated tablets – Pack of 2, 30, 100
Indeholder lactosemonohydrat.
Includes lactose monohydrate
2, 30 eller 100 filmovertrukne tabletter
2, 30 or 100 film-coated tablets
Læs indlægssedlen før brug.
Oral use Read enclosed leaflet before use.
EU/ 1/ 02/ 212/ 010 30 tabletter:
EU/ I/ 02/ 212/ 010 30 tabs:
EU/ 1/ 02/ 212/ 011 100 tabletter:
EU/ I/ 02/ 212/ 011 100 tabs:
EU/ 1/ 02/ 212/ 012
EU/ I/ 02/ 212/ 012
93 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
93 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Etiket til beholder med 50 mg filmovertrukne tabletter – pakning med 2, 30, 100 stk.
Bottle label for 50 mg film-coated tablets – Pack of 2, 30, 100
1. LÆGEMIDLETS NAVN, STYRKE OG/ ELLER INDGIVELSESVEJ( E)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
VFEND 50 mg filmovertrukne tabletter Voriconazol Oral anvendelse
VFEND 50 mg film-coated tablets Voriconazole Oral use
2 (30, 100) filmovertrukne tabletter Hver tablet indeholder 50 mg voriconazol
2 (30, 100) film-coated tablets Each tablet contains 50 mg voriconazole
Opbevares utilgængeligt for børn.
Medicinal product subject to medical prescription Keep out of the reach and sight of children.
Læs vedlagte indlægsseddel før brug.
Read enclosed leaflet before use.
Pfizer Limited, Sandwich, Kent, CT13 9NJ, Storbritannien
Pfizer Limited Sandwich Kent, CT13 9NJ, UK
(EU/ 1/ 02/ 212/ 012 100 tabl.)
EU/ I/ 02/ 212/ 010 (EU/ I/ 02/ 212/ 011 30 tabs) (EU/ I/ 02/ 212/ 012 100 tabs)
94 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Blister pakning for 200 mg filmovertrukne tabletter – pakning med 2, 10, 14, 20, 28, 30, 50, 56, 100 stk.
Blister pack for 200 mg film-coated tablets – Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100
2, 10, 14, 20, 28, 30, 50, 56 eller 100 filmovertrukne tabletter
2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets
EU/ 1 // 02/ 212/ 013 10 tabletter:
EU/ I/ 02/ 212/ 013 10 tabs:
EU/ 1 // 02/ 212/ 014 14 tabletter:
EU/ I/ 02/ 212/ 014 14 tabs:
EU/ 1 // 02/ 212/ 015 20 tabletter:
EU/ I/ 02/ 212/ 015 20 tabs:
EU/ 1 // 02/ 212/ 016 28 tabletter:
EU/ I/ 02/ 212/ 016 28 tabs: