natgillin/translations-raw huggingface dataset:
Hos patienter med moderat nedsat nyrefunktion (anslået kreatininclearance ≥30 ml/ min og ≤50 ml/ min) var vareniclinniveauet øget 1, 5 gange sammenlignet med patienter med normal nyrefunktion (anslået kreatininclearance > 80 ml/ min).
In patients with moderate renal impairment (estimated creatinine clearance ≥ 30 ml/ min and ≤ 50 ml/ min), varenicline exposure increased 1.5-fold compared with subjects with normal renal function (estimated creatinine clearance > 80 ml/ min).
Hos patienter med alvorligt nedsat nyrefunktion (anslået kreatininclearance < 30 ml/ min) er vareniclinniveauet øget 2, 1 gange.
In subjects with severe renal impairment (estimated creatinine clearance < 30 ml/ min), varenicline exposure was increased 2.1-fold.
4. 2).
In subjects with end-stage-renal disease (ESRD), varenicline was efficiently removed by haemodialysis (see section 4.2).
Vareniclins farmakokinetik hos ældre patienter med normal nyrefunktion (i alderen 65– 75 år) svarer til den for yngre voksne patienter (se pkt.
The pharmacokinetics of varenicline in elderly patients with normal renal function (aged 65- 75 years) is similar to that of younger adult subjects (see section 4.2).
4. 2.
For elderly patients with reduced renal function please refer to section 4.2.
Når 22 unge i alderen 12- 17 år (begge inklusive) fik en enkeltdosis på 0, 5 mg og 1 mg vareniclin er farmakokinetikken dosis- proportional mellem 0, 5 mg og 1 mg doserne.
When 22 adolescents aged 12 to 17 years (inclusive) received a single 0.5 mg and 1 mg dose of varenicline the pharmacokinetics of varenicline was approximately dose proportional between the 0.5 mg and 1 mg doses.
Det systemiske niveau, som er vurderet ved AUC( 0- inf), og den renale clearance er sammenligneligt med det, der ses hosvoksne.
Systemic exposure, as assessed by AUC (0-inf), and renal clearance of varenicline were comparable to adults.
4. 2).
An increase of 30% in Cmax and a shorter elimination half-life (10.9 hr) were observed in adolescents compared with adults (see section 4.2).
In vitro- forsøg viser, at vareniclin ikke hæmmer cytochrom P450- enzymer (IC50 > 6. 400 ng/ ml).
In vitro studies demonstrate that varenicline does not inhibit cytochrome P450 enzymes (IC50 > 6,400 ng/ ml).
P450 - enzymerne er undersøgt for hæmning:
The P450 enzymes tested for inhibition were:
1A2, 2A6, 2B6, 2C8, 2C19, 2D6, 2E1 og 3A4/ 5.
1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/ 5.
In vitro inducerede vareniclin desuden ikke aktiviteten af cytochrom P450- enzymerne 1A2 og 3A4 i humane hepatocytter.
Also, in human hepatocytes in vitro, varenicline was shown to not induce the activity of cytochrome P450 enzymes 1A2 and 3A4.
Det er derfor usandsynligt, at vareniclin ændrer farmakokinetikken af stoffer, der primært metaboliseres af cytochrom P450- enzymer.
Therefore, varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
5. 3 Prækliniske sikkerhedsdata
9 5.3 Preclinical safety data
De prækliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet og toksicitet i forbindelse med 9 reproduktion.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, fertility and embryo-foetal development.
Afkom fra rotter, der får vareniclin, mens de er drægtige, udviser nedsat fertilitet og øget ” auditory startle response ” (se pkt.
In the offspring of pregnant rats treated with varenicline there were decreases in fertility and increases in the auditory startle response (see section 4.6).
Ikke- kliniske data peger på, at vareniclin har afhængighedsskabende egenskaber, om end i lavere grad end nicotin.
Nonclinical data indicate varenicline has reinforcing properties albeit with lower potency than nicotine.
I forsøg med mennesker viste vareniclin et lavt misbrugspotentiale.
In clinical studies in humans, varenicline showed low abuse potential.
Tabletkerne
Core Tablet
Filmovertræk Hypromellose Titandioxid (E171) Macrogoler Triacetin
Hypromellose Titanium Dioxide (E171) Macrogols Triacetin
Dette lægemiddel kræver ingen særlige forholdsregler vedr. opbevaring.
This medicinal product does not require any special storage conditions
Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0, 5 mg filmovertrukne tabletter og 1 gennemsigtig blister med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
Treatment initiation packs Aclar / PVC / blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg film- coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0, 5 mg filmovertrukne tabletter og 1 gennemsigtig blister med 14 x 1 mg filmovertrukne tabletter i en karton.
Aclar / PVC / blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg film- coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0, 5 mg og 14 x 1 mg filmovertrukne tabletter og yderligere 1 gennemsigtig blister med 28 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
10 Aclar / PVC / blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and a second clear blister of 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 28 x 0, 5 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
Maintenance packs Aclar / PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
10 Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 56 x 0, 5 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
Aclar / PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
HDPE blåhvid tabletbeholder med polypropylen børnesikret lukning og aluminiumsfolie/ polyethylen forsegling, indeholdende 56 x 0, 5 mg filmovertrukne tabletter.
High-density polyethylene (HDPE) blue white tablet container with polypropylene child resistant closure and an aluminium foil / polyethylene induction seal containing 56 x 0.5 mg film-coated tablets
6. 6 Særlige forholdsregler ved bortskaffelse og håndtering
6.6 Special precautions for disposal and other handling
Pfizer Limited, Ramsgate Road, Sandwich Kent CT13 9NJ Storbritannien
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
29/ 09/ 2006
26/ 09/ 2006
1 filmovertrukken tablet indeholder 1 mg vareniclin (som tartrat).
Each film-coated tablet contains 1 mg of varenicline (as tartrate).
1 mg filmovertrukne tabletter:
1 mg film-coated tablets:
Lyseblå, kapselformede, bikonvekse tabletter præget ” Pfizer ” på den ene side og ” CHX 1. 0 ” på den anden side.
Light blue, capsular-shaped, biconvex tablets debossed with “ Pfizer ” on one side and “ CHX 1.0” on the other side.
Rygeophør har større sandsynlighed for at lykkes hos patienter, der er motiverede for at stoppe med at ryge og som modtager yderligere rådgivning og støtte.
Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.
12 Risikoen for at begynde at ryge igen efter behandling er højest i perioden umiddelbart efter, at behandlingen er slut.
12 In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.
Da ældre patienter ofte har nedsat nyrefunktion, bør der hos sådanne patienter tages hensyn til nyrestatus.
Because elderly patients are more likely to have decreased renal function, prescribers should consider the renal status of an elderly patient.
Effekent af at holde op med at ryge:
Effect of smoking cessation:
Ikke alle patienter var holdt op med at ryge, da symptomerne debuterede og ikke alle patienter havde kendt forudgående psykiatrisk lidelse.
Not all patients had stopped smoking at the time of onset of symptoms and not all patients had known pre-existing psychiatric illness.
Nedtrykthed, dog sjældent med selvmordstanker og selvmordsforsøg kan være en følge af nikotinophør.
Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nictotine withdrawal.
Desuden kan rygeophør, hvad enten det gennemføres med eller uden farmakoterapi, resultere i en exacerbation af en underliggende psykiatrisk lidelse (f. eks. depression).
In addition, smoking cessation, with or without pharmacotherapy, has been associated with the exacerbation of underlying psychiatric illness (e. g. depression).
Virkning og sikkerhed af Champix hos patienter med alvorlige psykiatriske lidelser, f. eks. skizofreni, bipolar lidelse og alvorlig depression, er ikke blevet fastslået.
13 The safety and efficacy of Champix in patients with serious psychiatric illness such as schizophrenia, bipolar disorder and major depressive disorder has not been established.
13 Der er ingen klinisk erfaring med behandling af patienter med epilepsi med CHAMPIX.
There is no clinical experience with CHAMPIX in patients with epilepsy.
Der foreligger kun begrænset klinisk data for den potentielle interaktion mellem alkohol og vareniclin.
There is limited clinical data on any potential interaction between alcohol and varenicline.
14 4. 6 Graviditet og amning
14 4.6 Pregnancy and lactation
Når der træffes beslutning om, hvorvidt amning skal fortsættes/ standses, eller hvorvidt behandling med CHAMPIX skal fortsættes/ standses, skal der tages højde for fordele for barnet ved amning in henhold til fordele for CHAMPIX- behandlingen af kvinden.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with CHAMPIX should be made taking into account the benefit of breast-feeding to the child and the benefit of CHAMPIX therapy to the woman.
Rygeophør er, hvad enten det gennemføres med eller uden behandling er forbundet med forskellige symptomer.
Smoking cessation with or without treatment is associated with various symptoms.
Eksempelvis er følgende symptomer set hos patienter, der prøvede at holde op med at ryge: dysfori og nedtrykt sindstilstand; søvnløshed, irritabilitet, frustration eller vrede; angst; koncentrationsbesvær; rastløshed; nedsat hjerterytme; øget appetit eller vægtøgning.
For example, dysphoric or depressed mood; insomnia, irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; decreased heart rate; increased appetite or weight gain have been reported in patients attempting to stop smoking.
Stofskiftesygdomme og ernæringsbetingede sygdomme Almindelig Usædvanlig
Metabolism and nutrition disorders Common Uncommon
Systemorganklasser Psykiske lidelser
System Organ Class
Meget almindelig Usædvanlig
Psychiatric disorders Very common Uncommon
Drømmeforstyrrelser, søvnløshed Panik- anfald, bradyfreni, abnorm tankegang, humørsvingninger
Abnormal dreams, insomnia Panic reaction, bradyphrenia, thinking abnormal, mood swings
Sygdomme i nervesystemet Meget almindelig Almindelig Usædvanlig Hjertesygdomme
Nervous system disorders Very common Common Uncommon Cardiac disorders
Her virker det som en partiel agonist, det vil sige en forbindelse, der både viser agonist- virkning, men som har mindre virkningsfuld end nicotin, og antagonist- virkning ved tilstedeværelse af nicotin.
Varenicline binds with high affinity and selectivity at the α 4β 2 neuronal nicotinic acetylcholine receptors, where it acts as a partial agonist - a compound that has both agonist activity, with lower intrinsic efficacy than nicotine, and antagonist activities in the presence of nicotine.
Dette sker dog ved et signifikant lavere niveau end hos nicotin.
Electrophysiology studies in vitro and neurochemical studies in vivo have shown that varenicline binds to the α 4β 2 neuronal nicotinic acetylcholine receptors and stimulates receptor-mediated activity, but at a significantly lower level than nicotine.
I disse forsøg, der forløb over 52 uger, fik patienter behandling i 12 uger efterfulgt af 40 uger uden behandling.
In these 52-week duration studies, patients received treatment for 12 weeks, followed by a 40-week non- treatment phase.
Efter 40 uger uden behandling er det vigtigste sekundære endepunkt for begge kliniske forsøg den vedvarende afholdenhedsrate (Continuous Abstinence Rate, CA) ved uge 52.
CA was defined as the proportion of all subjects treated who did
CA blev defineret som den del af alle deltagere, som ikke røg (end ikke ét enkelt sug af en cigaret) fra uge 9 til og med uge 52, og som ikke havde en udåndingsmåling af CO > 10 ppm.
17 not smoke (not even a puff of a cigarette) from Week 9 through Week 52 and did not have an exhaled CO measurement of > 10 ppm.
Sammenlignet med placebo har CHAMPIX desuden en signifikant reducerende effekt på de forstærkende virkninger af rygningen, der kan føre til, at de patienter, der ryger under behandlingen, ikke kan komme af med deres rygevaner Vareniclins virkning på trangen til at ryge, på rygeophøret og på den forstærkede virkning af rygning blev ikke målt i perioden uden behandling.
CHAMPIX also significantly reduced reinforcing effects of smoking that can perpetuate smoking behaviour in patients who smoke during treatment compared with placebo.
Fastholdelse af afholdenhed
The effect of varenicline on craving, withdrawal and reinforcing effects of smoking were not measured during the non-treatment long-term follow-up phase.
Det tredje forsøg vurderer den gavnlige virkning af yderligere 12 ugers behandling med CHAMPIX for at fastholderygeophør.
Maintenance of Abstinence Study The third study assessed the benefit of an additional 12 weeks of CHAMPIX therapy on the maintenance of abstinence.
Patienter der var stoppet med at ryge ved uge 12 blev derefter randomiseret til at få enten CHAMPIX (1 mg 2 gange dagligt) eller placebo i yderligere 12 uger i en total forsøgsperiode på 52 uger.
Patients who stopped smoking by Week 12 were then randomized to receive either CHAMPIX (1 mg twice daily) or placebo for an additional 12 weeks for a total study duration of 52 weeks.
På nuværende tidspunkt er den kliniske erfaring med anvendelse af CHAMPIX til sorte ikke tilstrækkelig til at klinisk effekt kan afgøres.
There is currently limited clinical experience with the use of CHAMPIX among black people to determine clincial efficacy.
Efter oral administration af vareniclin opnås maksimal plasmakoncentration efter 3- 4 timer.
Maximum plasma concentrations of varenicline occur typically within 3-4 hours after oral administration.
Efter administration af flere orale doser hos frivillige, raske forsøgspersoner blev steady state opnået indenfor 4 dage.
Following administration of multiple oral doses to healthy volunteers, steady-
Absorptionen er stort set total efter oral administration og den systemiske tilgængelighed er høj.
Absorption is virtually complete after oral administration and systemic availability is high.
Vareniclins orale biotilgængelighed bliver hverken påvirket af fødeindtag eller tidspunkt for dosering.
Oral bioavailability of varenicline is unaffected by food or time-of- day dosing.
18 Fordeling:
Distribution:
Det systemiske niveau, som er vurderet ved AUC( 0- inf), og den renale clearance er sammenligneligt med det, der ses hos voksne.
Systemic exposure, as assessed by AUC (0-inf), and renal clearance of varenicline were comparable to adults.
5. 3 Prækliniske sikkerhedsdata
19 5.3 Preclinical safety data
Afkom fra rotter, der får vareniclin, mens de er drægtige, 19 udviser nedsat fertilitet og øget ” auditory startle response ” (se pkt.
In the offspring of pregnant rats treated with varenicline there were decreases in fertility and increases in the auditory startle response (see section 4.6).
Filmovertræk Hypromellose Titandioxid (E171) Macrogoler Indigotin I (E132) Triacetin
Hypromellose Titanium Dioxide (E171) Macrogols Indigo Carmine Aluminium Lake E132 Triacetin
Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0, 5 mg og 14 x 1 mg filmovertrukne tabletter og yderligere 1 gennemsigtig blister med 28 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
20 Aclar / PVC / blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and a second clear blister of 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 28 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
Maintenance packs Aclar / PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
20 Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 56 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
Aclar / PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 28 x 1 mg filmovertrukne tabletter i en karton.
Aclar / PVC / blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 56 x 1 mg filmovertrukne tabletter i en karton.
Aclar / PVC / blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
Aclar/ PVC/ blister med aluminiumsfolie, indeholdende 112 x 1 mg filmovertrukne tabletter i en karton.
Aclar / PVC / blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
HDPE blåhvid tabletbeholder med polypropylen børnesikret lukning og aluminiumsfolie/ polyethylen forsegling, indeholdende 56 x 1 mg filmovertrukne tabletter.
High-density polyethylene (HDPE) blue white tablet container with polypropylene child resistant closure and an aluminium foil / polyethylene induction seal containing 56 x 1 mg film-coated tablets
21 BILAG II
21 ANNEX II
INDEHAVER( E) AF VIRKSOMHEDSGODKENDELSE( R) ANSVARLIG( E) FOR BATCHFRIGIVELSE
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
INDEHAVER( E) AF VIRKSOMHEDSGODKENDELSE( R) ANSVARLIG( E) FOR BATCHFRIGIVELSE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Pfizer Manufacturing Deutschland GmbH Heinrich- Mack- Strasse 35 D- 89257 Illertissen Tyskland
Pfizer Manufacturing Deutschland GmbH Heinrich-Mack-Strasse 35 D-89257 Illertissen Germany
Pharmacovigilance- systemet Indehaveren af markedsføringstilladelsen skal sikre, at Pharmacovigilance- systemet, som beskrevet i version 1. 1 præsenteret i Modul 1. 8. 1 Ansøgning om Markedsføringstilladelsen, er på plads og fungerer før, og mens produktet er på markedet.
The MAH must ensure that the system of pharmacovigilance, as described in Version 1.1 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Risk management- plan Indehaveren af markedsføringstilladelsen forpligter sig til at udføre studier og yderligere pharmacovigilanceaktiviteter, som er beskrevet i pharmacovigilanceplanen, version 3. 0, 25. juni 2008, af Risk Management- planen (RMP), som præsenteret i Modul 1. 8. 2 af ansøgningen om markedsføringstilladelsen og enhver følgende opdatering af RMP som vedtaget af CHMP.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 (25 June 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Enhver opdatering til RMP skal indsendes sammen med den følgende periodiske sikkerhedsopdatering (PSUR) i henhold til CHMPs vejledning om Risk Management- systemer for lægemidler til humant brug.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Opdateret RMP skal desuden indsendes:
In addition, an updated RMP should be submitted
• Når ny information modtages, som kan influere den nuværende sikkerhedsspecifikation, pharmacovigilanceplan eller risikominimeringsaktiviteter • Indenfor 60 dage efter at en vigtig (pharmacovigilance eller risikominimerings) milepæl bliver nået • På anmodning fra EMEA
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
23 BILAG III
23 ANNEX III
25 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
2- ugers startpakning Varmeforseglet kortpakning, indeholdende 1 blisterpakning med 11 x 0, 5 mg vareniclin filmovertrukne tabletter og 1 blisterpakning med 14 x 1 mg vareniclin filmovertrukne tabletter – indre og ydre mærkning
2-week treatment initiation pack Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg varenicline film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets – inner and outer labelling
CHAMPIX 0, 5 mg og 1 mg filmovertrukne tabletter Vareniclin
CHAMPIX 0.5 mg and 1 mg film-coated tablets Varenicline
Hver tablet indeholder 0, 5 mg eller 1 mg vareniclin (som tartrat).
Each tablet contains 0.5 mg or 1 mg varenicline (as tartrate).
Filmovertrukne tabletter 11 x 0, 5 mg og 14 x 1 mg
Film-coated tablets 11 x 0.5 mg and 14 x 1 mg
Må ikke anvendes, hvis forseglingen er brudt.
Do not use if box has been opened
Pakningen skal forblive hel.
KEEP THE PACKAGE INTACT
Udløbsdato:
MM/ YYYY
Pfizer Limited Sandwich Kent CT13 9NJ Storbritannien
Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom
EU/ 1/ 06/ 360/ 03
EU/ 1/ 06/ 360/ 003
START PÅ DAG 1 Den dag jeg vil stoppe med at ryge, skal være mellem dag 8 og dag 14.
START AT DAY 1 The day I stop smoking should be between day 8 and day 14.
Den dag jeg vil stoppe med at ryge er:
The day I stop smoking will be ______________.
Nummereret 1 – 14 Sol som symbol Måne som symbol
Numbers 1 to 14 sun as symbol moon as symbol
27 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
27 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blisterpakning med 11 x 0, 5 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
Blister Pack of 11 x 0.5 mg varenicline film-coated tablets, Heat Sealed Card
CHAMPIX 0, 5 mg Vareniclin
CHAMPIX 0.5 mg Varenicline
28 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
28 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
CHAMPIX 1 mg Vareniclin
CHAMPIX 1 mg Varenicline
29 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
4- ugers startpakning Varmeforseglet kortpakning, indeholdende 1 blisterpakning med 11 x 0, 5 mg and 14 x 1 mg vareniclin filmovertrukne tabletter og 1 blisterpakning med 28 x 1 mg vareniclin filmovertrukne tabletter – indre og ydre mærkning
4-week treatment initiation pack Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 x 1 mg varenicline film-coated tablets – inner and outer labelling
CHAMPIX 0, 5 mg CHAMPIX 1 mg FILMOVERTRUKNE TABLETTER Vareniclin
CHAMPIX 0.5 mg CHAMPIX 1 mg FILM-COATED TABLETS Varenicline
Indeholder:
4-week treatment initiation pack containing:
11 x 0, 5 mg filmovertrukne tabletter og 42 x 1 mg filmovertrukne tabletter
11 x 0.5 mg Film-coated tablets and 42 x 1 mg Film-coated tablets
Nummereret 1 – 28 Sol som symbol Måne som symbol
Numbers 1 to 28 sun as symbol moon as symbol
31 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
31 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS