natgillin/translations-raw huggingface dataset:
- Sygdomme i lever - og galdeveje: Alvorlig hepatitis og leversvigt (se pkt.
Pancreatitis, -Hepato-biliary disorders:
4. 4).
Severe hepatitis and liver failure (see section 4.4)
- Sygdomme i nervesystemet:
ris -Nervous system disorders:
Tilfælde af hurtigt indsættende eksacerbation af myastenia gravis
Cases of rapid onset of exacerbation of myasthenia gravis have been reported (see sections 4.3 and 4.4).
ise er rapporteret (se pkt.
tho 4.9 Overdose
tor I tilfælde af akut overdosering skal mavens indhold tømmes.
In the event of acute overdose the stomach should be emptied.
Blodelektrolytter (specielt kalium) skal kontrolleres og
au Blood electrolytes (especially potassium) must be controlled.
au grundet risikoen for forlængelse af Qtinterval og øget risiko for arytmier skal EKG måling finde sted.
Due to the potential for the prolongation of the QT interval and increased risk of arrhythmia, ECG monitoring must take place
FARMAKOLOGISKE EGENSKABER re 5. 1 Farmakodynamiske egenskaber ge
PHARMACOLOGICAL PROPERTIES
Macrolider, lincosamider og streptogramin, ATC- kode:
5.1 Pharmacodynamic properties lon Pharmacotherapeutic group: macrolides, lincosamides and streptogramins, ATC Code:
J01FA15 æn
J01FA15.
Telithromycin er et semisyntetisk derivat af erythromycin A, og tilhører gruppen af ketolider, en ny gruppe af antibakterielle midler beslægtet med macrolider.
Telithromycin is a semisynthetic derivative of erythromycin A belonging to the ketolides, a class of antibacterial agents related to macrolides. no
Virkningsmekanisme l
Mode of action
Telithromycin hæmmer proteinsyntesen ved at virke på ribosom- niveauet. ke
Telithromycin inhibits protein synthesis by acting at the ribosome level. t uc
Telithromycins affinitet til den bakterielle 50S ribosom subunit er 10 gange højere end for erythromycin A, hvis stammerne er følsomme over for erythromycin A.
The affinity of telithromycin for the 50S bacterial subunit of ribosome is 10 fold higher than that of erythromycin A when the strain is susceptible to erythromycin A.
Over for erythromycin A r ik
Against erythromycin A resistant rod
resistente stammer udviser telithromycin på grund af en MLSB resistensmekanisme i den bakterielle 50S subunit en 20 gange så høj affinitet sammenlignet med erythromycin A. te
strains, due to an MLSB mechanism of resistance, telithromycin shows a more than 20 fold affinity compared to erythromycin A in the 50S bacterial subunit.
Telithromycin påvirker ribosomoversættelsen på det 23S ribosomale RNA- niveau. hvor det interagerer med område V og II.
Telithromycin interferes with the ribosome translation at the 23S ribosomal RNA level, where it lP
Desuden er telithromycin i stand til at blokere dannelsen af de 50S og 30S ribosomale subunits. dle
Furthermore, telithromycin is able to block the formation of the 50S and 30S ribosomal subunits. na
Det anbefalede MIC breakpoint for telithromycin, hvor følsomme bakterier adskilles fra intermediært mi
The recommended MIC breakpoints for telithromycin, separating susceptible organisms from i
følsomme bakterier og intermediært følsomme bakterier fra resistente bakterier, er:
intermediately susceptible organisms and intermediately susceptible organisms from resistant dic
Følsomme ≤ 0, 5 mg/ l, resistente > 2 mg/ l ge
organisms, are: susceptible ≤ 0.5 mg/ l, resistant > 2mg/ l.
Antibakterielt spektrum
Antibacterial spectrum Me
Forekomsten af resistens kan variere geografiskt og over tid for udvalgte arter, og lokal information Læ
The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
8 Denne information giver kun en tilnærmet vejledning over sandsynligheden for om en mikroorganisme vil være følsom over for telithromycin
This information provides only an approximate guidance on probabilities as to whether microorganisms will be susceptible to telithromycin.
sa Aerobe Gram- positive bakterier Staphylococcus aureus methicillin følsomme (MSSA) * Lancefield gruppe C og G streptococci (β hæmolytisk)
8 Commonly susceptible species Aerobic Gram-positive bacteria Staphylococcus aureus methicillin susceptible (MSSA)* Lancefield group C and G (ß haemolytic) streptococci
til Streptococcus agalactiae Streptococcus pneumoniae * Viridans gruppe streptococci
ed Streptococcus agalactiae Streptococcus pneumoniae * Viridans group streptococci
ret Aerobe Gram- negative bakterier Legionella pneumophila Moraxella catarrhalis *
Legionella pneumophila
ise Andre Chlamydophila pneumoniae * Chlamydia psittaci Mycoplasma pneumoniae *
au Chlamydia psittaci Mycoplasma pneumoniae*
tor Arter, for hvilke erhvervet resistens kan udgøre et problem Aerobe Gram- positive bakterier Staphylococcus aureus methicillin følsomme (MSSA) *
r Species for which acquired resistance may be a problem
au Streptococcus pyogenes * Aerobe Gram- negative bakterier Haemophilus influenzae * Haemophilus parainfluenzae re Arveligt betingede resistente organismer Aerobe Gram- negative bakterier ge
ge Aerobic Gram-positive bacteria Staphylococcus aureus methicillin resistant (MRSA)+ Streptococcus pyogenes* lon Aerobic Gram- negative bacteria Haemophilus influenzae$* Haemophilus parainfluenzae$ Inherantly resistant organisms no
Acinetobacter Enterobacteriaceae Pseudomonas æn
Aerobic Gram- negative bacteria Acinetobacter Enterobacteriaceae Pseudomonas t uc
* Klinisk effekt er blevet vist ved følsomme isolater til godkendte indikationer. $Naturlig intermediate følsomhed + ** Blandt MRSA er raten af MLSB resistente stammer mere end 80%, telithromycin er ikke aktiv overfor MLSBc.
∗ Clinical efficacy has been demonstrated for susceptible isolates in the approved clinical indications. $natural intermediate susceptibility +Among MRSA the rate of MLSBc resistant strains is more than 80%, telithromycin is not active rod
Resistens l ke
Resistance lP
Hovedparten af MRSA r ik
The majority of MRSA are na
er resistente overfor erythromycinA ved en konstitutiv MLSB mekanisme.
resistant to erythromycin A by a constitutive MLSB mechanism.
Mens ekspositionen af te
In vitro results have shown that telithromycin is affected by the erythromycin ermB or mefA related i dic
telithromycin bevirkede pneumokok mutanter med forhøjede MICværdier, forblev MICværdierne indenfor forselåede følsomhedsinterval. dle
Me
For Streptococcus pneumoniae er der ikke kryds - eller co- resistens mellem telithromycin og andre antibakterielle klasser inklusive erythromycin A og/ eller penicillinresistens. mi
For Streptococcus pneumoniae, there is no cross- or co-resistance between telithromycin and other antibacterial classes including erythromycin A and/ or penicillin resistance.
For Streptococcus pyogenes forekommer krydsresistens for high- level erythromycin A resistente stammer. ge
For Streptococcus pyogenes, cross-resistance occurs for high-level erythromycin A resistant strains.
Effekt på oral og fækal flora
9 Effect on oral and faecal flora
clarithromycin 500 mg to gange daglig i 10 dage lignende og reversibel reduktion af oral og fækal flora.
In a comparative study in healthy human volunteers, telithromycin 800 mg daily and clarithromycin 500 mg twice daily for 10 days showed a similar and reversible reduction of oral and faecal flora.
9 5. 2 Farmakokinetiske egenskaber
ed 5.2 Pharmacokinetic properties
lg Absorption
ris Absorption
sa Efter peroral administration absorberes telithromycin ganske hurtigt.
Following oral administration, telithromycin is fairly rapidly absorbed.
En gennemsnitlig maksimal plasmakoncentration på 2 mg/ l opnås indenfor 1- 3 timer efter en gang daglig dosering af 800 mg
A mean maximum plasma
til telithromycin.
tho concentration of about 2 mg/ l is reached within 1-3 hour after dose with once-daily dosing of telithromycin 800 mg.
Absorptionsraten og – udbredelsen påvirkes ikke af fødeindtagelse, hvorfor Levviax tabletter kan gives uden hensyn til fødeindtagelse.
The rate and extent of absorption is unaffected by food intake, and thus Levviax tablets can be given without regard to food.
ret Gennemsnitlig minimum plasmakoncentration ved steady state på 0, 04 og 0, 07 mg/ l nås indenfor 3- 4 dage ved dosering én gang daglig af 800 mg telithromycin.
au Mean steady-state trough plasma concentrations of between 0.04 and 0.07 mg/ l are reached within 3 to 4 days with once-daily dosing of telithromycin 800 mg.
1, 5 gange
At steady-state AUC is approximately 1.5 fold
ise højere end ved enkeltdosering.
r increased compared to the single dose.
tor 800 mg daglig dosis regime.
ge Mean peak and trough plasma concentrations at steady state in patients were 2.9±1.6 mg/ l (range 0.02- 7.6 mg/ l) and 0.2±0.2 mg/ l (range 0.010 to 1.29 mg/ l), during a therapeutic 800 mg once-daily dose lon regimen.
De maksimale totale re vævskoncentrationer i epitelomkranset væske, alveolære makrofager, bronchial mucosa,, tonsiller og sinusvæv var henholdsvis 14, 9 ± 11, 4 mg/ l, 318, 1 ± 231 mg/ l, 3, 88 ± 1, 87 mg/ kg, 3, 95 ± 0, 53 mg/ kg ge
bronchial mucosa, tonsils and sinus tissue were 14.9±11.4 mg/ l, 318.1±231 mg/ l, 3.88±1.87 mg/ kg, uc
og 6, 96 ± 1, 58 mg/ kg.
3.95±0.53 mg/ kg and 6.96±1.58 mg/ kg, respectively.
Den genemsnitlig maksimum æn
The total tissue concentration 24 h after dose in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 0.84±0.65 mg/ l, 162±96 mg/ l, 0.78±0.39 mg/ kg, 0.72±0.29 mg/ kg and 1.58±1.68 mg/ kg, respectively. rod
telithromycin koncentration i hvide blodlegemer var 83 ± 25 mg/ l.
The mean maximum white blood cell concentration of telithromycin was 83±25 mg/ l.
Metabolisme l
Metabolism lP
13% af telithromycin AUC, og har ringe antimikrobiel virkning sammenlignet med modersubstansen.
Its principal circulating metabolite represents approximately 13% of telithromycin na
Andre metaboliter blev påvist i plasma, urin og fæces og udgør mindre end eller er lig med 3% af plasma AUC. r ik
Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3% of plasma AUC. i dic
Hoved CYP450 enzymet involveret i telithromycin metaboliseringen er CYP3A4Telithromycin er CYP3A4 og te
The major CYP450 enzyme involved in the metabolism of telithromycin is CYP3A4.
CYP2D6 hæmmer men har ingen ellerbegrænset effekt på CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 og 2E1. dle
Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9, Me
1/ 3 af telithromycin udskilles uomdannet, 20% i fæces og 12% i urin. mi
Approximately one-third of telithromycin was eliminated unchanged; 20% in faeces and 12% in urine.
58±5 L/ time efter intravenøs hvoraf den renale clearance er på 22%.
The total clearance (mean ±SD) is 10 approximately 58±5 l/ h after an intravenous administration with renal clearance accounting for about 22% of this.
Telithromycin viser en trieksponentiel fjernelse fra plasma med en hurtig distributionshalveringstid på ge
Telithromycin displays a tri-exponential decay from plasma, with a rapid distribution half-life of 0.17 h.
Læ
The main elimination half-life of telithromycin is 2-3 h and the terminal, less important, half-life is about 10 h at the dose 800 mg once daily.
10 Specielle grupper
Special populations
lg - Nedsat nyrefunktion I en multi dosis undersøgelse med36 patienter med forskellige grader af nedsat nyrefunktion, blev en
ed -Renal impairment In a multiple-dose study, 36 subjects with varying degrees of renal impairment, a 1.4-fold increase in
Baseret på observerede data er en daglig dosis på
ris Cmax, ss, and a 2-fold increase in AUC (0-24)ss at 800 mg multiple doses in the severe renally impaired group (CLCR < 30 mL/ min) compared to healthy volunteers were observed and a reduced dosage of Levviax is recommended (See Section 4.2.).
til 600 mg nogenlunde ækvivalent med den påvirkning som var målet observeret hos de raske frivillige.
Based on observed data, a 600 mg daily dose is
Baseret på simulations data, kan et alternativ dagligt dosis regime på 800 mg og 400 mg til patienter med alvorlig nedsat nyrefunktion nærme sig AUC (0- 48 t) hos raske individer, som får 800 mg en
Based on simulation data, an alternating daily dosing regimen of 800 mg and 400 mg in patients with severe renal impairment can approximate the AUC (0-48h) in healthy subjects receiving 800 mg once daily.
Dialyse effekt på telithromycins elimination blev ikke vurderet.
au The effect of dialysis on the elimination of telithromycin has not been assessed.
I
r In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with
tor begge forsøg blev observeret højere nyre elimination hos patienter med nedsat leverfunktion.
In both studies, higher renal elimination was observed in the hepatically impaired patients.
4. 4).
Due to limited lon experience in patients with decreased metabolic capacity of the liver, Levviax should be used with caution in patients with hepatic impairment (see also section 4.4).
au - Ældre forsøgspersoner Hos forsøgspersoner over 65 (median 75 år) var den maksimale plasmakoncentration og AUC for telithromycin øget 2 gange i forhold til unge raske voksne.
-Elderly subjects In subjects over 65 (median 75 years), the maximum plasma concentration and AUC of telithromycin no
Disse ændringer i farmakokinetikken førte re ikke til dosisjustering. ge
These changes in pharmacokinetics do not necessitate dosage adjustment.
- Børn Telithromycins farmakokinetik hos børn under 12 år er endnu ikke undersøgt.
The pharmacokinetics of telithromycin in paediatric population less than 12 years old have not yet been studied.
alderen 13- 17 år, hvilket viser at koncentrationen af telithromycin i denne aldersgruppe svarer til koncentrationer på patienter i alderen 18- 40 år.
Limited data, obtained in paediatric patients 13 to 17 years of age, showed that telithromycin concentrations in this age group were similar to the concentrations in patients 18 to 40 rod
- Køn l
years of age.
Telithromycins farmakokinetik er ens for mænd og kvinder. ke
-Gender The pharmacokinetics of telithromycin are similar between males and females. lP
5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data na
Gentagen dosis toksicitetsforsøg af 1, 3 og 6 måneders varighed med telithromycin udført på rotter, r ik
These effects showed a tendency to regress after i
Disse virkninger viste en tendens til regression efter behandlingsophør.
cessation of treatment.
Plasma ekspositioner baseret på frie fraktioner af det aktive stof, ved koncentrationer med ingen te
Plasma exposures based on free fraction of active substance, at the no observed dic
observerede bivirkninger, nås i interval på 1, 6 til 13 gange den forventede kliniske eksposition.
adverse effect levels ranged from 1.6 to 13 times the expected clinical exposure.
Fosfolipidosis (intracellulær fosfolipid akkumulation), som påvirker flere organer og væv (f. eks. lever, dle
Phospholipidosis (intracellular phospholipid accumulation) affecting a number of organs and tissues Me
nyre, lunger, tymus, milt, galdeblære, mesenteriale lymfekirtler, GI tragt) er observeret hos rotter og hunde som fik telithromycin i gentagne doser på 150 mg/ kg/ dag eller mere i en måned og 20 mg/ kg/ dag i 3- 6 måneder.
(e. g., liver, kidney, lung, thymus, spleen, gall bladder, mesenteric lymph nodes, GI-tract) has been observed in rats and dogs administered telithromycin at repeated doses of 150 mg/ kg/ day or more for 1 month and 20 mg/ kg/ day or more for 3-6 months.
Denne administration svarer til et systemisk påvirkningsniveau af det frie aktive stof på henholdsvis mindst 9 gange det forventede niveau hos mennesker efter 1 måned og mi
This administration corresponds to free active substance systemic exposure levels of at least 9 times the expected levels in human after 1 month and less than the expected level in humans after 6 months, respectively.
Disse observationers betydning for mennesker er ukendt. ge
The significance of these findings for humans is unknown.
Virkningerne var åbenbare ved Læ
11 In similarity to some macrolides, telithromycin caused a prolongation of Qtc interval in dogs and on action potential duration in rabbit Purkinje fibers in vitro.
plasmakoncentrationer af det frie lægemiddel på 8 til 13 gange det forventede kliniske niveau..
Effects were evident at plasma levels of free drug 8 to 13 times the expected clinical level.
11 Hypokaliæmi og kinidin havde additiv / supraadditiv virkninger in- vitro mens forstærkningen var åbenbar med sotalol.
Hypokalaemia and quinidine had additive/ supra-additive effects in vitro while potentiation was evident with sotalol.
Telithromycin men ikke dets humane hovedmetabolitter havde inhibitorisk
Telithromycin, but not its major human metabolites, had inhibitory activity on HERG and Kv1.5 channels.
sa Reproduktive toksicitetsforsøg viste nedsat cellemodning hos rotter og bivirkninger på befrugtningen.
ed Reproduction toxicity studies showed reduced gamete maturation in rat and adverse effects on fertilization.
Forsøg på rotter og kaniner var inklusiv med hensyn til potentiale for teratogenicitet.
Studies in rats and rabbits were inconclusive with respect to potential
til Der er usikre tegn på bivirkninger på føtaludvikling ved høje doser.
ris for teratogenicity, there was equivocal evidence of adverse effects on foetal development at high doses.
Telithromycin og dets humane hovedmetabolitter var negative i forsøg på genotoksisk potentiale in -
tho Telithromycin, and its principal human metabolites, were negative in tests on genotoxic potential in vitro and in vivo.
ise 6.
au 6.
tor Tabletkerne:
r ge Tablet core:
Mikrokrystallinsk cellulose
Microcrystalline cellulose lon Povidone K25 Croscarmellose sodium Magnesium stearate no
au Povidon K25 Croscarmellosenatrium Magnesiumstearat re Filmovertræk: ge
Tablet coating:
Talkum Macrogol 8000 Hypromellose 6 cp æn
Talc Macrogol 8000 t
Titandioxid (E171) Gul jernoxid (E172) Rød jernoxid (E172) l
Titanium dioxide E171 Yellow iron oxide E172 Red iron oxide E172 rod
6. 2 Uforligeligheder ke
6.2 Incompatibilities
Ikke relevant.
Not applicable. lP
6. 3 Opbevaringstid r ik
6.3 Shelf life na
3 år. te
3 years.
6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage i dic
Ingen særlige forholdsregler vedrørende opbevaringen. dle
No special precautions for storage.
6. 5 Emballage (art og indhold)
6.5 Nature and contents of container Me
Hvert blisterhul indeholder 2 tabletter. mi
Two tablets are contained in each blister cavity.
10, 14, 20 og 100 tabletter Uigennemsigtig PVC/ aluminiumsblisterpakning ge
Available as packs of 10, 14, 20 and 100 tablets.
Pakning på 5 x 2 tabletter Uigennemsigtig PVC/ aluminiumsblisterpakning, som perforeret ” Unit dose ” pakning Læ
Opaque PVC/ Aluminium blisters
Muligvis vil ikke alle pakninger blive markedsført
Available as pack of 5 x 2 tablets.
12 6. 6 Særlige forholdsregler ved bortskaffelse
12 Opaque PVC/ Aluminium perforated unit dose blisters.
lg Ingen særlige forholdsregler.
Not all pack sizes may be marketed.
sa 7.
ris 7.
til Aventis Pharma S: A 20, Avenue Raymond Aron F- 92160 ANTONY
Aventis Pharma S. A.
ret Frankrig
tho 20, Avenue Raymond Aron F-92160 ANTONY France
ise 8.
au 8.
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
9. ge DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION lon Date of first authorisation:
Dato for første markedsføringstilladelse:
9 July 2001 Date of first renewal:
9. juli 2001
9 July 2006 no
9. juli 2006 10.
10.
DATO FOR ÆNDRING AF TEKSTEN l æn ke r ik te dle mi ge Læ
DATE OF REVISION OF THE TEXT t uc rod lP i na dic Me
13 lg sa til ret ise tor BILAG II au re
13 ed ris tho r au ge lon ANNEX II
ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE no
mi
B.
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN l æn ke r ik te
CONDITIONS OF THE MARKETING AUTHORISATION t uc rod lP nai dic Me
INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
14 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
lg Navn og adresse på fremstilleren ansvarlig for batchfrigivelse:
Name and address of the manufacturer responsible for batch release:
sa Aventis Pharma S. p. A.
Aventis Pharma S. p. A.
til 67019 Scoppito (L’ Aquila) Italien
ed Strada Statale No 17, km22 67019 Scoppito (L’ Aquila) Italy
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
ris B CONDITIONS OF THE MARKETING AUTHORISATION
BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
tho • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Lægemidlet må kun udleveres efter recept.
au Medicinal product subject to medical prescription
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
au Ikke relevant.
r EFFECTIVE USE OF THE MEDICINAL PRODUCT
• ANDRE BETINGELSER re Indehaveren af denne markedsføringstilladelse skal indsende PSUR hver 6. måned. ge
ge Not applicable lon • OTHER CONDITIONS
mi
The holder of this marketing Authorisation will have to submit PSURs every 6 months.
r ik
rod
ke
uc
l
t
æn
no
ge Læ
Me
15 Læ ge mi dle te r ik ke l
15 ed ris tho r au ge lon ANNEX III
16 æn BILAG III ge re ETIKETTERING OG INDLÆGSSEDDEL au tor ise ret til sa lg Læ ge mi dle te r ik ke l
16 Me dic ina lP rod uc t
17 æn ge A.
17 no A.
ETIKETTERING re au tor ise ret til sa lg OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
LABELLING lon ge PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
lg Karton
tho
sa 1.
ris
til Levviax 400 mg filmovertrukne tabletter Telithromycin
ed Levviax 400 mg film-coated tablets Telithromycin
ret 2.
ris 2.
ise Hver filmovertrukken tablet indeholder 400 mg telithromycin
tho Each film-coated tablet contains 400 mg of telithromycin
tor 3.
au 3.
au 4.
r 4.
10 filmovertrukne tabletter 14 filmovertrukne tabletter re 20 filmovertrukne tabletter 100 filmovertrukne tabletter ge
ge 10 film-coated tablets 14 film-coated tablets lon 20 film-coated tablets 100 film-coated tablets 5 x 2 film-coated tablets no
Læs indlægssedlen inden brug l
Read the package leaflet before use t uc
Oral anvendelse ke
Oral use rod
Opbevares utilgængeligt for børn. te
Keep out of the reach and sight of children lP
EVENTUELLE ANDRE SÆRLIGE ADVARSLER dle
OTHER SPECIAL WARNING(S), IF NECESSARY i na
UDLØBSDATO
EXPIRY DATE dic
EXP {MM/ ÅÅÅÅ} mi
EXP {month/ year} Me
SÆRLIGE OPBEVARINGSBETINGELSER ge
SPECIAL STORAGE CONDITIONS
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF Læ
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
lg Aventis Pharma A/ S 20.
20, Avenue Raymond Aron
sa F- 92160 ANTONY Frankrig
ed F-92160 ANTONY France
til 12.
ris 12.
ret EU/ 1/ 01/ 192/ 001 10 tabletter EU/ 1/ 01/ 192/ 002 14 tabletter EU/ 1/ 01/ 192/ 003 20 tabletter
tho EU/ 1/ 01/ 192/ 001 10 tablets EU/ 1/ 01/ 192/ 002 14 tablets EU/ 1/ 01/ 192/ 003 20 tablets
ise EU/ 1/ 01/ 192/ 004 100 tabletter EU/ 1/ 01/ 192/ 005 5x2 tabletter
au EU/ 1/ 01/ 192/ 004 100 tablets EU/ 1/ 01/ 192/ 005 5x2 tablets
tor 13.
r 13.
Lot {nummer}
Batch {number} ge lon 14.
14. au GENEREL KLASSIFIKATION FOR UDLEVERING re Receptpligtigt lægemiddel. ge
Medicinal product subject to medical prescription no
INSTRUKTIONER VEDRØRENDE ANVENDELSEN æn
INSTRUCTIONS ON USE t uc
INFORMATION I BRAILLE- SKRIFT
INFORMATION IN BRAILLE rod
Levviax l ke r ik te dle mi ge Læ
Levviax lP i na dic Me
19 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
19 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
lg sa 1.
1.
Levviax 400 mg filmovertrukne tabletter
ed Levviax 400 mg film-coated tablets Telithromycin
Aventis Pharma S. A.
tho Aventis Pharma S. A.
ise 3.
3.
tor EXP {MM/ ÅÅÅÅ}
au EXP {month/ year}
au 4.
r ge 4.
ANDET ge
Batch {number} lon t no uc rod lP i na dic Me
20 Læ ge mi dle te r ik ke l
20 Me dic ina lP rod uc t
21 æn ge B.
21 no B.
INDLÆGSSEDDEL re au tor ise ret til sa lg INDLÆGSSEDDEL
PACKAGE LEAFLET lon ge
lg Levviax 400 mg filmovertrukne tabletter Telithromycin
Levviax 400 mg film-coated tablets Telithromycin
sa Læs hele denne indlægsseddel omhyggeligt, inden De begynder at tage dette lægemiddel.
Read all of this leaflet carefully before you start taking this medicine.