natgillin/translations-raw huggingface dataset:
6 Desuden er følgende bivirkninger blevet associeret med lapatinib i kombination med capecitabine, men sås med samme hyppighed i gruppen, der kun fik capecitabine.
6 In addition, the following adverse reactions were reported to be associated with lapatinib in combination with capecitabine but were seen at a similar frequency in the capecitabine alone arm.
Nervesystemet Almindelig Mave- tarmkanalen
Nervous system disorders Common
Meget almindelig Hud og subkutane væv
Gastrointestinal disorders Very common Skin and subcutaneous Very common
Stomatitis, forstoppelse, abdominalsmerter
Stomatitis, constipation, abdominal pain tissue disorders Palmar-plantar erythrodysaesthesia
Meget almindelig
Musculoskeletal and connective tissue disorders Very common General disorders and Very common Psychiatric disorders
Almene symptomer og reaktioner på administrationsstedet Meget almindelig
Pain in extremity, back pain administrative site conditions Mucosal inflammation
Psykiske forstyrrelser Meget almindelig
Very common
1% af de patienter, der har fået lapatinib, og var asymptomatisk i mere end 90% af tilfældene.
Decreased left ventricular ejection fraction Left ventricular ejection fraction (LVEF) decreases have been reported in approximately 1% of patients receiving lapatinib and were asymptomatic in more than 90% of cases.
Reduktion i LVEF kunne ikke genfindes eller blev bedre i mere end 60% af tilfældene ved ophør af behandlingen med lapatinib.
LVEF decreases resolved or improved in more than 60% of cases on discontinuation of treatment with lapatinib.
0, 1% af patienter, som alene fik lapatinib.
Symptomatic LVEF decreases were observed in approximately 0.1% of patients who received lapatinib monotherapy.
De observerede symptomer omfatter dyspnø, hjertesvigt og palpitationer.
Observed symptoms included dyspnoea, cardiac failure and palpitations.
Alle hændelser forsvandt med det samme med ophør med lapatinib.
All events resolved promptly on discontinuation of lapatinib.
LVEF- fald blev rapporteret hos 2, 5% af de patienter, der fik lapatinib i kombination med capecitabine sammenlignet med 1, 0% ved capecitabine alene.
LVEF decreases were reported in 2.5% of patients who received lapatinib in combination with capecitabine, as compared to 1.0% with capecitabine alone.
65% af de patienter, der blev behandlet med lapatinib i kombination med capecitabine.
Diarrhoea Diarrhoea occurred in approximately 65% of patients who received lapatinib in combination with capecitabine.
De fleste tilfælde af diarre var grad 1 eller 2, og medførte ikke afbrydelse af behandlingen med lapatinib.
Most cases of diarrhoea were grade 1 or 2 and did not result in discontinuation of treatment with lapatinib.
4. 4).
Diarrhoea responds well to proactive management (see section 4.4).
28% af patienterne, der blev behandlet med lapatinib i kombination med capecitabine.
Rash Rash occurred in approximately 28% of patients who received lapatinib in combination with capecitabine.
Udslæt var generelt milde og resulterede ikke i afbrydelse af behandlingen med lapatinib.
Rash was generally low grade and did not result in discontinuation of treatment with lapatinib.
Der findes ingen specifik antidot til hæmning af EGFR - (ErbB1) og/ eller ErbB2 - (HER2) tyrosin - phosphorylering.
There is no specific antidote for the inhibition of EGFR (ErbB1) and/ or ErbB2 (HER2) tyrosine phosphorylation.
Den maksimale orale dosis lapatinib, der er administreret i kliniske forsøg, er 1800 mg en gang daglig.
The maximum oral dose of lapatinib that has been administered in clinical trials is 1800 mg once daily.
Patienten fik en grad 3- diarre og kastede op på dag 10.
There has been a report of one patient who took an overdose of 3000 mg of lapatinib for 10 days and suffered grade 3 diarrhoea and vomiting on day 10.
Efter intravenøs hydrering og afbrydelse af behandlingen med lapatinib og letrozol forsvandt symptomerne.
The symptoms resolved following intravenous hydration and interruption of treatment with lapatinib and letrozole.
Det kan derfor ikke forventes, at hæmodialyse vil være en effektiv måde at øge udskillelsen af lapatinib.
Lapatinib is not significantly renally excreted and is highly bound to plasma proteins, therefore haemodialysis would not be expected to be an effective method to enhance the elimination of lapatinib.
7 Dette lægemiddel har fået en betinget godkendelse.
L01XE07
Det betyder, at der afventes yderligere evidens for lægemidlet.
This means that furrther evidence on this medicinal product is awaited.
Det europæiske lægemiddelagentur (EMEA) vil vurdere ny information om produktet hvert år, og denne produktinformation vil om nødvendigt blive opdateret.
The European Medicines Agency (EMEA) will review new information on the product every year and this SPC will be updated as necessary.
3 nM og 13 nM) med en langsom udfasningshastighed fra disse receptorer (halveringstiden er større end eller lig med 300 minutter).
Lapatinib a 4-anilinoquinazoline, is an inhibitor of the intracellular tyrosine kinase domains of both EGFR (ErbB1) and of ErbB2 (HER2) receptors (estimated Kiapp values of 3nM and 13nM, respectively) with a slow off-rate from these receptors (half-life greater than or equal to 300 minutes).
Lapatinib hæmmer ErbB- drevet tumorcellevækst in vitro og i forskellige dyremodeller.
Lapatinib inhibits ErbB-driven tumour cell growth in vitro and in various animal models.
Den væksthæmmende effekt af lapatinib blev vurderet i trastuzumab- konditionerede cellelinjer.
The growth inhibitory effects of lapatinib were evaluated in trastuzumab-conditioned cell lines.
Lapatinib bevarede betydelig aktivitet over for brystcancercellelinjer selekteret for langtidsvækst i trastuzumab- holdigt medium in vitro.
Lapatinib retained significant activity against breast cancer cell lines selected for long-term growth in trastuzumab-containing medium in vitro.
Effekten og sikkerheden ved lapatinib i kombination med capecitabine til brystcancerpatienter med god performance status blev evalueret i et randomiseret fase III- forsøg.
The efficacy and safety of lapatinib in combination with capecitabine in breast cancer patients with good performance status was evaluated in a randomized, phase III trial.
Patienter egnede til inklusion havde lokalt fremskreden eller metastatisk brystcancer med overekspression af ErbB2 - (HER2 -), progredierende efter tidligere behandling, der inkluderede taxan, antracyklin og trastuzumab.
Patients eligible for enrolment had ErbB2 (HER2)-over-expressing, locally advanced or metastatic breast cancer, progressing after prior treatment that included taxanes, anthracyclines and trastuzumab.
LVEF blev evalueret hos alle patienter (vha. ekkokardiogram eller MUGA), før initiering af behandling med lapatinib for at sikre, at baseline- LVEF lå inden for institutionens normale grænser.
LVEF was evaluated in all patients (using echocardiogram or MUGA) prior to initiation of treatment with lapatinib to ensure baseline LVEF was within the institutions normal limits.
8 ugers intervaller under behandling med lapatinib for at sikre, det ikke faldt til under institutionens nedre normalgrænse.
In clinical trials LVEF was monitored at approximately eight week intervals during treatment with lapatinib to ensure it did not decline to below the institutions lower limit of normal.
De fleste fald i LVEF (mere end 60%) sås i løbet af de første 9 ugers behandling, imidlertid fandtes der begrænsede data på langtidsanvendelse.
The majority of LVEF decreases (greater than 60%) were observed during the first nine weeks of treatment, however limited data was available for long term exposure.
Patienterne blev randomiseret til enten lapatinib 1250 mg en gang om dagen (kontinuerligt) plus capecitabine (2000 mg/ m2/ døgn på dag 1- 14 hver 21. dag) eller til capecitabine alene (2500 mg/ m2/ døgn på dag 1- 14 hver 21. dag).
Patients were randomized to receive either lapatinib 1250 mg once daily (continuously) plus capecitabine (2000 mg/ m2/ day on days 1-14 every 21 days), or to receive capecitabine alone (2500 mg/ m2/ day on days 1-14 every 21 days).
Evalueringerne blev foretaget af forsøgets investigatorer og af et uafhængigt panel, der var blindet over for behandlingen.
Assessments were undertaken by the study investigators and by an independent review panel, blinded to treatment.
Forsøget blev standset på grund af resultaterne af en planlagt interim- analyse, der viste en forbedring i TTP hos de patienter, der fik lapatinib plus capecitabine.
The study was halted based on the results of a pre-specified interim analysis that showed an improvement in TTP for patients receiving lapatinib plus capecitabine.
I tiden fra interim - analysen og til inklusionen standsede blev der inkluderet yderligere 75 patienter i forsøget.
An additional 75 patients were enrolled in the study between the time of the interim analysis and the end of the enrolment.
Nedenstående tabel viser investigators analyse af data på det tidspunkt, hvor inklusionen standsede.
Investigator analysis on data at the stop of enrolment is presented in the following table.
Lapatinib (1250 mg/ dag) +
Lapatinib (1,250 mg/ day)+
Capecitabine (2500 mg / m2/ dag)
Capecitabine (2,500 mg/ m2/ day)
capecitabine (2000 mg / m2/ dag)
capecitabine (2,000 mg/ m2/ day) Number of TTP events
= 198) 121
= 198) 121
= 201) 126
= 201) 126
Median TTP, uger Hazard Ratio
Median TTP, weeks Hazard Ratio
23, 9
23.9
(95% CI) p- værdi
(95% CI) p value
Den uafhængige vurdering af data viste også, at når lapatinib blev givet sammen med capecitabine, blev tiden til progression øget signifikant (hazard ratio 0, 57 [95% CI 0, 43; 0, 77] p = 0, 0001) sammenlignet med capecitabine alene.
The independent assessment of the data also demonstrated that lapatinib when given in combination with capecitabine significantly increased time to progression (Hazard Ratio 0.57 [95% Cl 0.43, 0.77] p=0.0001) compared to capecitabine alone.
Nedenstående tabel viser en opdateret analyse af de samlede overlevelsesdata frem til den 28. september 2007.
8 Results of an updated analysis of the overall survival data to 28 September 2007 are presented in the table below.
capecitabine (2000 mg / m2/ dag)
capecitabine (2,000 mg/ m2/ day) Number of subjects who died
Medianoverlevelse, uger Hazard Ratio
Median overall survival, weeks
0, 9
65.9
65, 9
0.9
I kombinationsgruppen var der 4 tilfælde (2%) af progression i centralnervesystemet sammenlignet med 13 tilfælde (6%) af progression i gruppen med capecitabine alene.
On the combination arm, there were 4 (2%) progressions in the central nervous system as compared with the 13 (6%) progressions on the capecitabine alone arm.
70% variationskoefficient i AUC).
The absolute bioavailability following oral administration of lapatinib is unknown, but it is incomplete and variable (approximately 70% coefficient of variation in AUC).
Der forekommer serumkoncentrationer efter en median forsinkelse (lag time) på 0, 25 timer (interval 0 – 1, 5 timer).
Serum concentrations appear after a median lag time of 0.25 hours (range 0 to 1.5 hours).
En daglig dosering på 1250 mg medfører geometriske middel - (variationskoefficient) Cmax- værdier ved steady state på 2, 43 (76%) µg/ ml og AUC- værdier på 36, 2 (79%) µg* time/ ml.
Daily dosing of 1250 mg produces steady state geometric mean (coefficient of variation) Cmax values of 2.43 (76%) µg/ ml and AUC values of 36.2 (79%) µg*hr/ ml.
Systemisk eksponering for lapatinib øges, når lapatinib indtages sammen med mad.
Systemic exposure to lapatinib is increased when administered with food.
2, 5 og 3 gange højere), når lapatinib blev administreret sammen med henholdsvis et måltid med lavt fedtindhold (5% fedt [500 kalorier]) og et måltid med højt fedtindhold (50% fedt [1000 kalorier]).
Lapatinib AUC values were approximately 3- and 4-fold higher (Cmax approximately 2.5 and 3– fold higher) when administered with a low fat (5% fat [500 calories]) or with a high fat (50% fat [1,000 calories]) meal, respectively.
Lapatinib er stærkt bundet (mere end 99%) til albumin og alfa- 1- syre- glykoprotein.
Lapatinib is highly bound (greater than 99%) to albumin and alpha-1 acid glycoprotein.
In vitro- forsøg indikerer, at lapatinib er et substrat for transportørerne BCRP (ABCG1) og p- glykoprotein (ABCB1).
In vitro studies indicate that lapatinib is a substrate for the transporters BCRP (ABCG1) and p-glycoprotein (ABCB1).
Lapatinib er også in vitro fundet at hæmme disse effluxtransportører samt leveroptagelsestransportøren OATP 1B1 ved klinisk relevante koncentrationer (IC50- værdier svarede til 2, 3 µg/ ml).
Lapatinib has also been shown in vitro to inhibit these efflux transporters, as well as the hepatic uptake transporter OATP 1B1, at clinically relevant concentrations (IC50 values were equal to 2.3 µg/ ml).
Den kliniske signifikans ved disse virkninger på farmakokinetikken af andre lægemidler eller den farmakologiske aktivitet ved andre kræftlægemidler kendes ikke.
The clinical significance of these effects on the pharmacokinetics of other medicinal products or the pharmacological activity of other anti-cancer agents is not known.
Lapatinib gennemgår omfattende metabolisme, primært via CYP3A4 og CYP3A5 med mindre bidrag fra CYP2C19 og CYP2C8, til en række oxiderede metabolitter, hvor ingen af dem udgør mere end 14% af den dosis, der fandtes i fæces eller 10% af lapatinib- koncentrationen i plasma.
Lapatinib undergoes extensive metabolism, primarily by CYP3A4 and CYP3A5, with minor contributions from CYP2C19 and CYP2C8 to a variety of oxidated metabolites, none of which account for more than 14% of the dose recovered in the faeces or 10% of lapatinib concentration in plasma.
Lapatinib hæmmer CYP3A (Ki 0, 6- 2, 3 µg/ ml) og CYP2C8 (0, 3 µg/ ml) in vitro ved klinisk relevante koncentrationer.
Lapatinib inhibits CYP3A (Ki 0.6 to 2.3 µg/ ml) and CYP2C8 (0.3 µg/ ml) in vitro at clinically relevant concentrations.
Lapatinib hæmmede ikke i signifikant grad følgende enzymer i humane levermikrosomer:
Lapatinib did not significantly inhibit the following enzymes in human liver microsomes:
CYP1A2, CYP2C9, CYP2C19 og CYP2D6 eller UGT- enzymer (in vitro- IC50 - værdierne var højere end eller lig med 6, 9 µg/ ml).
CYP1A2, CYP2C9, CYP2C19, and CYP2D6 or UGT enzymes (in vitro IC50 values were greater than or equal to 6.9 µg/ ml).
Men daglig dosis af lapatinib resulterer i steady state i løbet af 6- 7 dage, hvilket indikerer en effektiv halveringstid på 24 timer.
However, daily dosing of lapatinib results in achievement of steady state within 6 to 7 days, indicating an effective half-life of 24 hours.
Lapatinib udskilles overvejende gennem metabolisering af CYP3A4/ 5.
Lapatinib is predominantly eliminated through metabolism by CYP3A4/ 5.
Fund af lapatinib i fæces udgør median 27% (interval 3- 67%) af en peroral dosis.
Recovery of unchanged lapatinib in faeces accounts for a median 27% (range 3 to 67%) of an oral dose.
Mindre end 2% af den indgivne perorale dosis (som lapatinib og metabolitter) blev udskilt med urinen.
Less than 2% of the administered oral dose (as lapatinib and metabolites) excreted in urine.
Farmakokinetikken for lapatinib er ikke undersøgt specifikt for patienter med nedsat nyrefunktion eller patienter, der får hæmodialyse.
9 Lapatinib pharmacokinetics have not been specifically studied in patients with renal impairment or in patients undergoing haemodialysis.
7- 9 eller højere end 9) og hos 8 raske kontrolpersoner.
The pharmacokinetics of lapatinib were examined in subjects with moderate (n = 8) or severe (n = 4) hepatic impairment (Child-Pugh scores of 7-9, or greater than 9, respectively) and in 8 healthy control subjects.
56% og 85% hos forsøgspersoner med moderat og svært nedsat leverfunktion.
Systemic exposure (AUC) to lapatinib after a single oral 100 mg dose increased approximately 56% and 85% in subjects with moderate and severe hepatic impairment, respectively.
4. 2 og 4. 4).
Administration of lapatinib in patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 4.4).
Lapatinib blev undersøgt hos gravide rotter og kaniner, der fik orale doser på 30, 60 og 120 mg/ kg/ døgn.
Lapatinib was studied in pregnant rats and rabbits given oral doses of 30, 60, and 120 mg/ kg/ day.
Men der var mindre anomalier (venstresidig umbilicus - arterie, cervikalt ribben og tidlig knogledannelse) hos rotter ved ≥ 60 mg/ kg/ døgn (4 gange den forventede, kliniske optagelse hos mennesker).
There were no teratogenic effects; however, minor anomalies (left-sided umbilical artery, cervical rib and precocious ossification) occurred in rats at ≥ 60 mg/ kg/ day (4 times the expected human clinical exposure).
8% og 23% af den forventede, kliniske optagelse hos mennesker) og aborter ved 120 mg/ kg/ døgn.
In rabbits, lapatinib was associated with maternal toxicity at 60 and 120 mg/ kg/ day (8% and 23% of the expected human clinical exposure, respectively) and abortions at 120 mg/ kg/ day.
Ved ≥ 60 mg/ dag sås lavere fostervægt og mindre skeletvariationer.
At ≥ 60 mg/ kg/ day there were decreased foetal body weights, and minor skeletal variations.
Ved udviklingsforsøg med rotter før og efter fødslen sås et fald i overlevelse hos afkommet mellem fødsel og dag 21 efter doser på 60 mg/ kg/ døgn eller højere (5 gange den forventede, kliniske optagelse hos mennesker).
In the rat pre- and postnatal development study, a decrease in pup survival occurred between birth and postnatal day 21 at doses of 60 mg/ kg/ day or higher (5 times the expected human clinical exposure).
Den højeste dosis uden effekt i dette forsøg var 20 mg/ kg/ døgn.
The highest no- effect dose for this study was 20 mg/ kg/ day.
8 og 3 gange den forventede, kliniske optagelse hos mennesker).
There were no effects on male or female rat gonadal function, mating, or fertility at doses up to 120 mg/ kg/ day (females) and up to 180 mg/ kg/ day (males) (8 and 3 times the expected human clinical exposure, respectively).
Lapatinib var ikke klastogent eller mutagent i en række analyser inkl. kromosomafvigelser hos kinesiske hamstre, Ames ’ test, kromosomafvigelser i humane lymfocytter og in vivo - kromosomafvigelser i knoglemarv hos rotter.
Lapatinib was not clastogenic or mutagenic in a battery of assays including the Chinese hamster chromosome aberration assay, the Ames assay, human lymphocyte chromosome aberration assay and an in vivo rat bone marrow chromosome aberration assay.
Tabletkerne Mikrokrystallinsk cellulose Povidon (K30) Natriumstivelsesglycolat (type A) Magnesiumstearat
Tablet core Microcrystalline cellulose Povidone (K30) Sodium starch glycolate (Type A) Magnesium stearate
Tabletovertræk Hypromellose Titandioxid (E171) Macrogol 400 Polysorbat 80 Jernoxid, gul (E172) Jernoxid, rød (E172)
Tablet coating Hypromellose Titanium dioxide (E171) Macrogol 400 Polysorbate 80 Iron oxide yellow (E172) Iron oxide red (E172)
10 6. 5 Emballagetype og pakningsstørrelser
10 6.4 Special precautions for storage
Hver pakning med Tyverb indeholder 70 tabletter.
Do not store above 30ºC.
Tabletterne er pakket i blisterpakninger (polyamid / aluminium/ polyvinylchorid/ aluminium) a 10 stk.
Each pack of Tyverb contains 70 tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 10 tablets each.
Hver blisterkort er perforeret på midten og kan deles i daglige doser med 5 tabletter.
Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 5 tablets.
Multipakningen består af 2 pakninger, der hver indeholder 70 tabletter og er pakket i en stor ydre emballage.
Multipacks contain 140 film-coated tablets consisting of 2 x 70 tablet packs in a large outer carton.
Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UK
Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.
Yderligere information om dette lægemiddel er tilgængelig på det europæiske lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu. / >
Glaxo Operations UK Limited Priory Street Ware Hertfordshire SG12 0DG Storbritannien
Glaxo Operations UK Limited Priory Street Ware Hertfordshire SG12 0DG United Kingdom
Lægemiddelovervågningssystem Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet, som beskrevet i version 3 af Modul 1. 8. 1 af ansøgningen om markedsføringstilladelsen, er på plads og fungerer før markedsføring, og så længe produktet er markedsført.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Risikohåndteringsplan Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de studier og yderligere lægemiddelovervågningsaktiviteter, der er beskrevet i lægemiddelovervågningsplanen, som aftalt i version 4a af Risikohåndteringsplanen (RMP) anført i Modul 1. 8. 2 i ansøgningen om markedsføringstilladelsen, og i efterfølgende CHMP- krav til opdateringer af RMP.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4a of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Som angivet i CHMP' s retningslinjer for risikohåndteringssystemer i forbindelse med humane lægemidler, skal den opdaterede RMP indsendes samtidig med den næste periodiske sikkerhedopdatering (Periodic Safety Update Report, PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Yderligere skal der indsendes en opdateret RMP: • når der modtages ny information, der kan have indflydelse på nuværende sikkerhedsspecifikation, lægemiddelovervågningsplan eller risikominimeringsaktiviteter. • inden for 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering) • efter anmodning fra EMEA
In addition, an updated RMP should be submitted • 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
At udføre og indsende opdaterede analyser for overlevelsesdata fra forsøg EGF100151.
To perform and submit an updated analysis of survival data for study EGF100151.
Tidspunkt for data cut- off er august 2008, og resultaterne fra analyserne skal indsendes i december 2008.
A data cut-off date of August 2008 will be applied, with the results of the analysis to be submitted by December 2008.
At udføre et randomiseret, kontrolleret klinisk fase III- forsøg for at undersøge forekomsten af hjernemetastaser ved tidspunktet for recidiv hos personer i behandling med lapatinib sammenlignet med en passende kontrolgruppe i behandling med trastuzumab.
To conduct a Phase III randomised, controlled clinical study to evaluate the incidence of brain metastases as the site of relapse with a lapatinib-containing therapy compared with an appropriate, trastuzumab-containing control arm.
Forsøgets protokol skal afsluttes og indsendes til EMEA i juli 2008.
The study protocol will be finalised and submitted to the EMEA by July 2008.
Den endelige forsøgsrapport skal indsendes i maj 2013.
The final study report for the trial will by submitted by May 2013.
ETIKETTERING
15 A. LABELLING
YDRE KARTON (ENKELT 14- DAGS- PAKNING)
OUTER CARTON (14 DAY, SINGLE PACK)
Må ikke opbevares over 30 °C.
Do not store above 30ºC.
17 11.
17 11.
Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UK
Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom
YDRE KARTON (28- DAGS- MULTIPAKNING)
OUTER CARTON (28-DAY, MULTIPACK)
140 filmovertrukne tabletter Multipakning bestående af 2 pakninger, der hver indeholder 70 filmovertrukne tabletter
140 film-coated tablets Multipack comprising 2 packs, each containing 70 film-coated tablets