natgillin/translations-raw huggingface dataset:
Levemir Penfill 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure 
3 ml raztopine v vložku (steklo tipa I) z batom (brombutil) in gumijasto zaporko (brombutil/poliizopren).
5 x 3 ml pre-filled pens 2 x (5 x 3 ml) pre-filled pens 1 x 3 ml pre-filled pen + 7 NovoFine needles 1 x 3 ml pre-filled pen + 7 NovoTwist needles 
1 x 3 ml napolnjen injekcijski peresnik 5 x 3 ml napolnjeni injekcijski peresniki 2 x (5 x 3 ml) napolnjeni injekcijski peresniki 1 x 3 ml napolnjen injekcijski peresnik + 7 igel NovoFine 1 x 3 ml napolnjen injekcijski peresnik + 7 igel NovoTwist
Instructions on how to use Levemir 100 units/ml solution for injection in pre-filled pen (FlexTouch) 
Navodila za uporabo zdravila Levemir 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku (FlexTouch)
In elderly patients, glucose monitoring should be intensified and the Levemir dose adjusted on an individual basis. 
Pri starejših bolnikih je treba koncentracijo glukoze v krvi spremljati pozorneje ter odmerek zdravila Levemir prilagoditi posamezniku.
*Self-Monitored Plasma Glucose Adult type 2 diabetes simple self-titration guideline: Average pre-breakfast SMPG* 
Preproste smernice za samotitriranje pri odraslih bolnikih s sladkorno boleznijo tipa 2 Povprečna SIGP* pred zajtrkom Prilagoditev odmerka zdravila Levemir
Use the dose selector on your Levemir FlexTouch pen to select your dose. 
Uporabite izbirnik odmerka na injekcijskem peresniku Levemir FlexTouch, da si zagotovite natančno in enostavno izbiro odmerka.
Instructions on how to use LEVEMIR solution for injection in InnoLet 
Navodila za uporabo zdravila Levemir raztopina za injiciranje v injekcijskem peresniku InnoLet
In clinical trials using basal bolus insulin therapy, the overall rates of hypoglycaemia with Levemir and NPH insulin were similar. 
Klinična preskušanja, v katerih so uporabljali bazalno-bolusno zdravljenje z insulinom, so pokazala, da je celotna pogostnost hipoglikemije podobna pri zdravljenju z zdravilom Levemir ali insulinom NPH.
0-26 weeks -0.16 0-52 weeks -0.05 
0-26 tednov -0,16 0-52 tednov -0,05
-4 units 
- 4 enote
0-26 weeks -0.51 0-52 weeks -0.50 
0-26 tednov -0,51 0-52 tednov -0,50
► Inject the insulin under your skin. 
Kako injicirati zdravilo Levemir ► Insulin injicirajte pod kožo.
C. Take a new disposable needle and tear off the paper tab. 
• Vzemite novo iglo in z nje odstranite papirno nalepko.
There are no clinically relevant differences between genders in pharmacokinetic properties of Levemir. 
Spol Farmakokinetične lastnosti zdravila Levemir se med spoloma klinično pomembno ne razlikujejo.
Making the injection 
Injiciranje odmerka
FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen in use is lost or damaged. 
Injekcijski peresnik FlexPen je namenjen za uporabo z iglami NovoFine ali NovoTwist za enkratno uporabo, dolžine do 8 mm. Vedno nosite s seboj rezervni injekcijski peresnik za injiciranje insulina, za primer, da injekcijski peresnik FlexPen izgubite ali se poškoduje.
Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 x 5 (without needles) pre-filled pens of 3 ml. 
Pakiranja z 1 (z iglami ali brez), s 5 (brez igel) in skupno pakiranje z 2 x 5 (brez igel) napolnjenimi injekcijskimi peresniki po 3 ml. Na trgu morda ni vseh navedenih pakiranj.
K. Remove the needle from the skin. 
K. Izvlecite iglo.
► Needles and Levemir InnoLet must not be shared. 
► Igel in zdravila Levemir InnoLet si ne delite z drugimi.
As the pharmacokinetics of Levemir has not been studied extensively in these populations, it is advised to monitor plasma glucose closely in these populations. 
Zaželeno je natančno nadziranje glukoze v plazmi, saj pri teh bolnikih farmakokinetika zdravila Levemir ni bila podrobno raziskana.
Dose of Levemir should be adjusted individually. 
Odmerek zdravila Levemir je treba prilagoditi posamezno.
1 x 3 ml pre-filled pen 
5 x 3 ml vložki
-3 units 
- 3 enote
Levemir FlexTouch is designed to be used with NovoFine or NovoTwist single-use disposable needles up to a length of 8 mm. 
Injekcijski peresnik je namenjen za uporabo z injekcijskimi iglami NovoFine ali NovoTwist za enkratno uporabo, dolžine do 8 mm.
How to use Levemir 
Kako uporabljati zdravilo Levemir
Levemir is a soluble, long-acting insulin analogue with a prolonged duration of effect used as a basal insulin. 
Mehanizem delovanja in farmakodinamični učinki Zdravilo Levemir je topen dolgodelujoči insulinski analog s podaljšanim delovanjem, ki se uporablja kot bazalni insulin.
For individual dose adjustments, the following two titration guidelines are recommended for adults: Adult type 2 diabetes titration guideline: Average pre-breakfast SMPG* Levemir dose adjustment >10.0 mmol/l (180 mg/dl) 
Smernice za titriranje pri odraslih bolnikih s sladkorno boleznijo tipa 2 Povprečna SIGP* pred zajtrkom Prilagoditev odmerka zdravila Levemir
EU/1/04/278/004 1 pen of 3 ml EU/1/04/278/005 5 pens of 3 ml EU/1/04/278/006 10 pens of 3 ml EU/1/04/278/010 1 pen of 3 ml and 7 NovoFine needles EU/1/04/278/011 1 pen of 3 ml and 7 NovoTwist needles 
EU/1/04/278/004 1 injekcijski peresnik s 3 ml EU/1/04/278/005 5 injekcijskih peresnikov s 3 ml EU/1/04/278/006 10 injekcijskih peresnikov s 3 ml EU/1/04/278/010 1 injekcijski peresnik s 3 ml in 7 igel NovoFine EU/1/04/278/011 1 injekcijskih peresnik s 3 ml in 7 igel NovoTwist
Levemir InnoLet is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. InnoLet delivers 1-50 units in increments of 1 unit. 
Zdravilo Levemir InnoLet je napolnjen injekcijski peresnik, namenjen za uporabo z iglami NovoFine ali NovoTwist za enkratno uporabo, dolžine do 8 mm. Injekcijski peresnik InnoLet omogoča aplikacijo od 1 do 50 enot v korakih po 1 enoto.
Antibody development has been observed with the use of Levemir. 
Med uporabo zdravila Levemir so opažali pojav protiteles.
• your doctor has added another medicine for the treatment of diabetes, in addition to your 
• k zdravljenju z zdravilom Levemir doda še drugo zdravilo za zdravljenje sladkorne bolezni.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen. 
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v vložku Penfill 1 x 3 ml vložek
► Needles and Levemir Penfill must not be shared. 
► Igel in zdravila Levemir Penfill si ne delite z drugimi.
INFORMATION IN BRAILLE Levemir FlexTouch 
PODATKI V BRAILLOVI PISAVI Levemir FlexTouch
Levemir FlexPen is a pre-filled, colour-coded, disposable pen containing insulin detemir. 
Kako ravnati z injekcijskim peresnikom Levemir FlexPen Levemir FlexPen je napolnjen, barvno-kodirani injekcijski peresnik za enkratno uporabo, ki vsebuje insulin detemir.
Check the name and coloured label of your pen to make sure that it contains the correct type of insulin. 
Preverite ime in barvno nalepko injekcijskega peresnika in se tako prepričajte, da res vsebuje pravo vrsto insulina.
If you get any side effects, talk to your doctor, pharmacist or nurse. 
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, z medicinsko sestro ali s farmacevtom.
Levemir FlexTouch is a pre-filled, colour-coded, disposable pen containing insulin detemir. 
Kako ravnati z injekcijskim peresnikom Levemir FlexTouch Levemir FlexTouch je napolnjen, barvno-kodirani injekcijski peresnik za enkratno uporabo, ki vsebuje insulin detemir.
SAS, 45 Avenue d'Orléans, F-28000 Chartres, France. 
- Če sta drugi in tretji znak H7 ali T6, je izdelovalec Novo Nordisk Production SAS, 45 Avenue d'Orleans, F-28000 Chartres, Francija.
A drop of insulin should appear at the needle tip. 
Na igli se mora pojaviti kapljica insulina.
Levemir 100 units/ml Solution for injection Insulin detemir SC use 
Levemir 100 enot/ml raztopina za injiciranje insulin detemir za s.c. uporabo
At the beginning of the insulin treatment, refraction anomalies and oedema may occur; these reactions are usually of transitory nature. 
Po začetku zdravljenja z insulinom se lahko pojavijo refrakcijske anomalije in edemi.
Levemir Penfill and FlexPen 
Levemir Penfill in FlexPen
L. Lead the needle tip into the outer needle cap on a flat surface. 
L. Konico igle (na ravni površini) vstavite v zunanji pokrovček igle, ne da bi se dotaknili igle ali zunanjega pokrovčka igle.
Very rare - Anaphylactic reactions* 
Zelo redko - anafilaktične reakcije* Presnovne in prehranske motnje Zelo pogosto - hipoglikemija* Bolezni živčevja
Levemir FlexTouch is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexTouch delivers 1-80 units in increments of 1 unit. 
Zdravilo Levemir FlexTouch je napolnjen injekcijski peresnik (barvno kodiran), namenjen za uporabo z iglami NovoFine ali NovoTwist za enkratno uporabo, dolžine do 8 mm. Injekcijski peresnik FlexTouch omogoča aplikacijo od 1 do 80 enot v korakih po 1 enoto.
Levemir FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit. 
Zdravilo Levemir FlexPen je napolnjen injekcijski peresnik (barvno kodiran), namenjen za uporabo z iglami NovoFine ali NovoTwist za enkratno uporabo, dolžine do 8 mm. Injekcijski peresnik FlexPen omogoča aplikacijo od 1 do 60 enot v korakih po 1 enoto.
Levemir InnoLet is a pre-filled disposable pen containing insulin detemir. 
Kako ravnati z injekcijskim peresnikom Levemir InnoLet Levemir InnoLet je napolnjen injekcijski peresnik za enkratno uporabo, ki vsebuje insulin detemir.
Levemir InnoLet is only suitable for injecting under the skin. 
Zdravilo Levemir InnoLet je primerno samo za injiciranje pod kožo.
► Levemir Penfill is only suitable for injecting under the skin using a reusable pen. 
► Zdravilo Levemir Penfill je primerno samo za injiciranje pod kožo z injekcijskim peresnikom za večkratno uporabo.
• Dial the number of units required by turning the dose selector clockwise (picture C). 
• Nastavite potrebno število enot tako, da izbirnik odmerka zavrtite v smeri urinega kazalca
Instructions on how to use LEVEMIR solution for injection in a FlexPen 
Navodila za uporabo zdravila Levemir raztopina za injiciranje v injekcijskem peresniku FlexPen
► Levemir InnoLet is only suitable for injecting under the skin. 
► Zdravilo Levemir InnoLet je primerno samo za injiciranje pod kožo.
Press the dose button until the dose counter returns to 0. 
Pritisnite in držite potisni gumb, da se števec odmerka vrne na 0.
INFORMATION IN BRAILLE Levemir InnoLet 
PODATKI V BRAILLOVI PISAVI
Levemir InnoLet is only suitable for subcutaneous injections. 
Zdravilo Levemir InnoLet je primerno samo za podkožno injiciranje.
Now turn over for information on how to use your FlexTouch. 
Zdaj na hrbtni strani preberite, kako uporabljati injekcijski peresnik FlexTouch.
Lower day-to-day variability in FPG was demonstrated during treatment with Levemir compared to NPH in long-term clinical trials. 
V dolgoročnih kliničnih preskušanjih so med zdravljenjem z zdravilom Levemir od dne do dne ugotovili manjšo variabilnost glukoze v plazmi na tešče (GPT) kot z insulinom NPH.
► After each injection be sure to remove and discard the needle and store Levemir without the needle attached. 
► Po vsakem injiciranju morate iglo odstraniti in zavreči, zdravilo Levemir pa shraniti brez nameščene igle.
► If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common side effects in section 4. 
6, Vsebina pakiranja in dodatne informacije), ► če sumite, da se začenja hipoglikemija (nizek krvni sladkor) (glejte poglavje 4, podpoglavje a)
EU/1/04/278/010 EU/1/04/278/011 
EU/1/04/278/007 EU/1/04/278/008 EU/1/04/278/009
Levemir InnoLet and FlexTouch 
Levemir InnoLet in FlexTouch
MARKETING AUTHORISATION NUMBERS EU/1/04/278/001 1 cartridge of 3 ml EU/1/04/278/002 5 cartridges of 3 ml EU/1/04/278/003 10 cartridges of 3 ml 
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/04/278/001 1 vložek s 3 ml EU/1/04/278/002 5 vložkov s 3 ml EU/1/04/278/003 10 vložkov s 3 ml
Levemir dose adjustment 
Shranjevanje zdravila Levemir
The dose of Levemir should be adjusted individually. 
Odmerek zdravila Levemir je treba prilagoditi posamezniku.
The best places to give yourself an injection are: the front of your thighs, the front of your waist (abdomen), or the upper arm. You should always measure your blood sugar regularly. 
Najprimernejša mesta za injiciranje so: sprednji del stegen, sprednji del trebuha ali nadlakti.
E. Pull off the outer needle cap and save it. You will need it after the injection, to correctly remove the needle from the pen. 
Potrebovali ga boste po injiciranju, da pravilno odstranite iglo z injekcijskega peresnika.
Levemir FlexPen is only suitable for subcutaneous injections. 
Zdravilo Levemir FlexPen je primerno samo za podkožno injiciranje.
Always dispose of the needle after each injection. 
Iglo po vsakem injiciranju zavrzite.
Levemir Penfill is only suitable for subcutaneous injections from a reusable pen. 
Zdravilo Levemir Penfill je primerno samo za podkožno injiciranje z injekcijskim peresnikom za večkratno uporabo.
Levemir Penfill is only suitable for injecting under the skin using a reusable pen. 
Zdravilo Levemir Penfill je primerno samo za injiciranje pod kožo z injekcijskim peresnikom za večkratno uporabo.
► Needles and Levemir FlexTouch must not be shared. 
► Igel in zdravila Levemir FlexTouch si ne delite z drugimi.
Start by checking your pen to make sure that it contains Levemir 100 units/ml, then look at the illustrations to the right to get to know the different parts of your pen and needle. 
Začnite tako, da preverite injekcijski peresnik in se tako prepričate, da vsebuje zdravilo Levemir 100 enot/ml.
Always keep the cartridge in the outer carton when you are not using it in order to protect it from light. 
Kadar vložka ne uporabljate, ga vedno shranjujte v zunanji ovojnini, za zagotovitev zaščite pred svetlobo.
Levemir FlexTouch is only suitable for subcutaneous injections. 
Zdravilo Levemir FlexTouch je primerno samo za podkožno injiciranje.
MARKETING AUTHORISATION NUMBERS EU/1/04/278/007 1 pen of 3 ml EU/1/04/278/008 5 pens of 3 ml EU/1/04/278/009 10 pens of 3 ml 
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/04/278/007 1 injekcijski peresnik s 3 ml EU/1/04/278/008 5 injekcijskih peresnikov s 3 ml EU/1/04/278/009 10 injekcijskih peresnikov s 3 ml
Gender 
Francija
HbA1c ≤6% targets at both GW 24 and GW 
TN dosegle ciljno vrednost HbA1c ≤ 6 % (%)
PHARMACOLOGICAL PROPERTIES 
Farmakodinamična primerjava
► Needles and Levemir FlexPen must not be shared. 
► Igel in zdravila Levemir FlexPen si ne delite z drugimi.
Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breastfeeding. 
Če ste noseči ali če dojite, se posvetujte z zdravnikom, medicinsko sestro ali s farmacevtom, preden uporabite katero koli zdravilo.
Maternal glycaemic control Levemir NPH Difference/ Odds Ratio/ Rate Ratio 95% CI 
Razlika/razmerje obetov/ razmerje deležev pri 95 % IZ
Preparing your Levemir FlexTouch pen Check the name and coloured label on your Levemir FlexTouch pen to make sure that it contains the type of insulin you need. 
Preverite ime in barvno nalepko in se tako prepričajte, da vaš injekcijski peresnik Levemir FlexTouch vsebuje pravo vrsto insulina.
Levemir 100 units/ml solution for injection in cartridge Insulin detemir 
Levemir 100 enot/ml raztopina za injiciranje v vložku insulin detemir
There is no experience with the use of Levemir in children below the age of 1 year. 
Pri otrocih do 1. leta starosti ni izkušenj pri zdravljenju z zdravilom Levemir.
► Levemir FlexPen is only suitable for injecting under the skin. 
► Zdravilo Levemir FlexPen je primerno samo za injiciranje pod kožo.
Always use a new needle for each injection.Always remove and discard the needle after each injection and store your InnoLet without the needle attached. 
Po vsakem injiciranju morate iglo odstraniti in zavreči, injekcijski peresnik InnoLet pa shraniti brez nameščene igle.
Levemir FlexPen is only suitable for injecting under the skin. 
Zdravilo Levemir FlexPen je primerno samo za injiciranje pod kožo.
Solution for injection in pre-filled pen. 
raztopina za injiciranje v napolnjenem injekcijskem peresniku FlexPen
Mean FPG at GW 36 (mmol/l) 
TN (mmol/l)
► Levemir FlexTouch is only suitable for injecting under the skin. 
► Zdravilo Levemir FlexTouch je primerno samo za injiciranje pod kožo.
Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi glicerol fenol metakrezol cinkov acetat natrijev hidrogenfosfat dihidrat natrijev klorid klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
Do not use this medicine after the expiry date which is stated on the InnoLet label and carton after ‘EXP'. 
Zdravila ne uporabljajte po preteku roka uporabnosti, ki je naveden na nalepki injekcijskega peresnika InnoLet in škatli, za "Uporabno do".
Levemir FlexTouch is only suitable for injecting under the skin. 
Zdravilo Levemir FlexTouch je primerno samo za injiciranje pod kožo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (FlexTouch) 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (NAPOLNJEN INJEKCIJSKI PERESNIK FlexTouch)
Levemir 100 units/ml solution for injection in pre-filled pen Insulin detemir 
Levemir 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin detemir
Before opening: Levemir InnoLet that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. 
Pred odprtjem: zdravilo Levemir InnoLet, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
Read carefully the instructions for use included in this package leaflet. 
Natančno preberite navodila za uporabo injekcijskega peresnika Levemir InnoLet, ki jih vključuje to navodilo za uporabo.
Do not use this medicine after the expiry date which is stated on the FlexTouch label and carton after ‘EXP'. 
Zdravila ne uporabljajte po preteku roka uporabnosti, ki je naveden na nalepki injekcijskega peresnika FlexPen in škatli, za "Uporabno do".
1 x 3 ml pre-filled pen 5 x 3 ml pre-filled pens 10 x 3 ml pre-filled pens 
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjenem injekcijskem peresniku InnoLet 1 x 3 ml napolnjen injekcijski peresnik 5 x 3 ml napolnjeni injekcijski peresniki 10 x 3 ml napolnjeni injekcijski peresniki
Before opening: Levemir Penfill that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. 
Pred odprtjem: zdravilo Levemir Penfill, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
Pharmacotherapeutic group: Drugs used in diabetes. 
Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, insulini in analogi za injiciranje z dolgotrajnim delovanjem.
• Caregivers must be very careful when handling used needles -to reduce the risk of needle injury and cross-infection. 
• Osebe, ki skrbijo za bolnika, morajo biti pri ravnanju z uporabljenimi iglami zelo pazljive,
Before opening: Levemir FlexPen that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. 
Pred odprtjem: zdravilo Levemir FlexPen, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark 
- Če sta drugi in tretji znak S6, P5, K7, R7, VG, FG ali ZF, je izdelovalec Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danska.
Before opening: Levemir FlexTouch that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. 
Pred odprtjem: zdravilo Levemir FlexTouch, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
D. Screw the needle straight onto the pen. 
D. Iglo naravnost in trdno privijte na injekcijski peresnik.
SC use 
Način uporabe
EU/1/04/278/015 1 pen of 3 ml and 7 NovoFine needles EU/1/04/278/016 1 pen of 3 ml and 7 NovoTwist needles 
To je del skupnega pakiranja 10 injekcijskih peresnikov in ni namenjeno za izdajanje posameznih injekcijskih peresnikov EU/1/04/278/015 1 injekcijski peresnik s 3 ml in 7 igel NovoFine EU/1/04/278/016 1 injekcijski peresnik s 3 ml in 7 igel NovoTwist
► Do not refill the cartridge. 
► Vložkov se ne sme znova polniti.
Solution for injection in cartridge. 
raztopina za injiciranje v napolnjenem injekcijskem peresniku FlexTouch
PHARMACEUTICAL FORM Solution for injection. 
raztopina za injiciranje
Levemir 100 units/ml Solution for injection in pre-filled pen Insulin detemir 
Levemir 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin detemir za subkutano uporabo
Always keep the pen cap on your FlexTouch when you are not using it in order to protect it from light. 
Kadar injekcijskega peresnika FlexTouch ne uporabljate, naj bo vedno pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
• If you are under 18 years of age 
• če ste mlajši od 18 let,
Patients should be closely monitored. 
Bolnike je treba natančno spremljati.
• Alcohol abuse 
• Zloraba alkohola
Practically all the drug is eliminated within 6 days. 
Praktično ves odmerek zdravila se izloči v 6 dneh.
Take the next tablet at your regular time on the next day. 
Naslednjo tableto vzemite ob običajni uri naslednji dan.
Reduced function of transport proteins 
Zmanjšana funkcija transportnih proteinov
In this case, symptomatic and supportive measures should be adopted. 
V takšnem primeru je treba uvesti simptomatske in podporne ukrepe.
The exact mechanism of interaction is not known. 
Natančen mehanizem medsebojnega delovanja ni znan.
• you drink large amounts of alcohol (more than 21 units (210 mL) a week of pure alcohol) 
• pijete velike količine alkohola (več kot 21 enot (210 ml) čistega alkohola na teden),
Additional tests and medicines may be needed to diagnose and treat this. 
Za diagnozo in zdravljenje bodo morda potrebne dodatne preiskave in zdravila.
Your doctor will determine the appropriate strength for you, depending on your condition, your current treatment and your personal risk status. 
Vaš zdravnik bo določil primerno jakost zdravila, odvisno od vaše bolezni, trenutnega zdravljenja in osebnih tveganj.
Date of first authorisation: 26 August 2013 Date of latest renewal: 16 May 2018 
Datum prve odobritve: 26. avgust 2013 Datum zadnjega podaljšanja: 16. maja 2018
Measures to reduce the risk of myopathy caused by medicinal product interactions 
Ukrepi za zmanjšanje tveganja miopatije, ki jo povzroči medsebojno delovanje zdravil
The C allele has a frequency of 18% in the European population. 
V populaciji Evropejcev ima alel C pogostnost 18 %.
The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known): 
Obstajajo tudi poročila o naslednjih neželenih učinkih, vendar pogostnosti ni mogoče oceniti iz razpoložljivih podatkov (pogostnost neznana):
The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown. 
Mehanizem tega medsebojnega delovanja (ali gre za farmakodinamiko, farmakokinetiko ali oboje) še ni znan.
Safety in pregnant women has not been established. 
Varnosti pri nosečnicah še niso ugotovili.
The liver is the primary site of action of the active form. 
Jetra so primarno mesto delovanja aktivne oblike.
Concomitant food intake does not affect the absorption. 
Sočasni vnos hrane ne vpliva na absorpcijo.
These changes are specific to rodents and have not been observed in other species at comparable dose levels. 
Te spremembe so specifične za glodavce in jih niso odkrili pri drugih živalskih vrstah pri primerljivih odmerkih.
Supportive study 
Podporna študija
The usual dose is one tablet per day. 
Običajni odmerek je ena tableta na dan.
Biotransformation and Elimination 
Biotransformacija in izločanje