natgillin/translations-raw huggingface dataset:
It is available in a pack with one vial.
Na voljo je v škatli z eno vialo.
Additionally, for each vial the packs contain
Dodatno vsebuje škatla še:
Manufacturer
Izdelovalec Baxter Oncology GmbH, Kantstrasse 2, D- 33790 Halle, Nemčija
Baxter Oncology GmBH, Kantstrasse 2, D-33790 Halle, Germany. For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Č eská republika Serono Austria GmbH Floridsdorfer Hauptstraße 1 A-1210 Vídeň Rakousko Tel: + 43 1 6047690
38 Česká republika Serono Austria GmbH Floridsdorfer Hauptstraße 1 A- 1210 Vídeň Rakousko Tel: + 43 1 6047690
Ísland Gróco ehf.
39 Ísland Gróco ehf.
What is CHAMPIX?
Kaj je zdravilo CHAMPIX?
CHAMPIX is a tablet containing the active substance varenicline.
Zdravilo CHAMPIX so tablete, ki vsebujejo zdravilno učinkovino vareniklin.
Tablets containing 0.5 mg varenicline are white, those that contain 1.0 mg are pale blue.
Tablete, ki vsebujejo 0, 5 mg vareniklina so bele; tablete, ki vsebujejo 1, 0 mg vareniklina so svetlo modre.
What is CHAMPIX used for?
Za kaj se zdravilo CHAMPIX uporablja?
CHAMPIX is used in adults to help them stop smoking.
Zdravilo CHAMPIX se uporablja kot pomoč pri prenehanju kajenja za odrasle.
How is CHAMPIX used?
Kako se zdravilo CHAMPIX uporablja?
CHAMPIX should be used by smokers who are motivated to stop smoking, and who are also receiving additional advice and support.
Zdravilo CHAMPIX je namenjeno kadilcem, ki so za prenehanje kajenja motivirani in so deležni dodatnega svetovanja in podpore.
Patients should first set a date when they will stop.
Bolniki si morajo najprej postaviti datum, ko bodo prenehali kaditi.
Then they begin treatment with CHAMPIX 1 to 2 weeks before that date.
Nato začnejo jemati zdravilo CHAMPIX 1 do 2 tedna pred tem datumom.
Treatment starts with one 0.5 mg tablet daily for 3 days, this is followed by a further 4 days where the patient takes one 0.5 mg tablet twice daily.
Zdravljenje se začne tako, da prve 3 dni jemljejo eno tableto 0, 5 mg dnevno, nato pa 4 dni eno tableto 0, 5 mg dvakrat dnevno.
From then on, the patient takes one 1 mg tablet twice daily until the end of treatment (12 weeks).
Zatem bolnik jemlje eno tableto 1 mg dvakrat dnevno do konca zdravljenja (12 tednov).
A special pack with the correct quantities of both strengths of tablets is available when initiating treatment.
Za začetek zdravljenja je na voljo posebno pakiranje s pravilnimi količinami obeh jakosti tablet.
The dose may be reduced to 0.5 mg twice a day in patients who do not tolerate the 1 mg twice daily dose.
Če bolnik ne prenaša odmerka 1 mg dvakrat dnevno, se lahko odmerek zniža na 0, 5 mg dvakrat dnevno.
Patients who have severe problems with their kidneys should take CHAMPIX as 1 mg once daily.
Bolniki s hudimi težavami z ledvicami smejo jemati zdravila CHAMPIX v odmerku 1 mg enkrat dnevno.
At the end of the 12 weeks, in patients who stopped smoking, doctors may choose to carry on treatment for another 12 weeks.
Po koncu 12- tedenskega obdobja se lahko zdravniki za bolnike, ki so opustili kajenje, odločijo opraviti še dodatno 12- tedensko zdravljenje.
They may also decide to stop the medicine progressively (‘ tapering’).
Lahko se odločijo tudi za progresivno prekinitev zdravljenja (postopno zmanjševanje odmerka).
The tablets are swallowed whole with water.
Tablete CHAMPIX je treba pogoltniti cele z vodo.
They can be taken with or without food.
Bolnik jih lahko vzame s hrano ali brez nje.
How does CHAMPIX work?
Kako zdravilo CHAMPIX deluje?
People who smoke become addicted to nicotine, a chemical in tobacco.
Kadilci postanejo zasvojeni z nikotinom, ki je kemična snov v tobaku.
Nicotine acts in the nervous system, where it binds to receptors and triggers the release of a chemical messenger, dopamine, which plays a part in the pleasure derived from smoking.
Nikotin deluje v živčevju, kjer se veže na receptorje in sproži sproščanje sporočilne spojine dopamin, ki je delno odgovorna za užitek pri kajenju.
The active substance in CHAMPIX, varenicline, can bind to some of these receptors, the α 4β 2 nicotinic acetylcholine receptors.
Zdravilna učinkovina v zdravilu CHAMPIX je vareniklin, ki se veže na nekatere od teh receptorjev – tj. α4β2 nikotinske acetilholinske receptorje.
When binding to these receptors, varenicline acts in two ways: it acts like nicotine (partial agonist) and this helps to relieve craving symptoms, but it also acts against nicotine (antagonist), by taking its place, and this helps to reduce the pleasurable effects of smoking.
Vareniklin z vezavo na receptorje deluje na dva načina: deluje kot nikotin (delni agonist) in s tem blaži simptome hlepenja; deluje pa tudi proti nikotinu (antagonist), saj preprečuje vezavo nikotina in s tem zmanjšuje s kajenjem povezane občutke ugodja.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has CHAMPIX been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo CHAMPIX raziskano?
The effects of CHAMPIX were first tested in experimental models before being studied in humans.
Učinki zdravila CHAMPIX so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
The two mains studies of the effectiveness of CHAMPIX in smoking cessation involved 2,052 patients (average age:
V dveh glavnih raziskavah o učinkovitosti zdravila CHAMPIX za prenehanje kajenja je sodelovalo 2052 bolnikov (povprečna starost:
CHAMPIX, bupropion (another non-nicotine medicine used in smoking cessation) or placebo (a dummy treatment).
43 let), ki so 12 tednov prejemali enega od treh možnih zdravljenj: zdravilo CHAMPIX, bupropion (drugo zdravilo brez nikotina za opuščanje kajenja) ali placebo (zdravilo brez zdravilne učinkovine).
Patients were then followed for a further 40 weeks to see if they started smoking again.
Bolnike so spremljali še dodatnih 40 tednov, da bi videli, ali so znova začeli kaditi.
The main measure of effectiveness was the number of patients who had completely stopped smoking for 4 weeks (between week 9 and week 12 of the study), confirmed by laboratory testing of the patients ’ breath for signs of smoking.
Glavni merilo učinkovitosti je bilo število bolnikov, ki so popolnoma opustili kajenje za 4 tedne (med 9. in 12. tednom raziskave), kar so preverjali z laboratorijskimi preiskavami izdihanega zraka bolnikov, v katerem so iskali znake kajenja.
What benefit has CHAMPIX shown during the studies?
Kakšne koristi je zdravilo CHAMPIX izkazalo med raziskavami?
In both studies, CHAMPIX was more effective than bupropion or placebo in helping patients to stop smoking.
V obeh raziskavah je zdravilo CHAMPIX v primerjavi z bupropionom oz. placebom učinkoviteje pripomoglo k prenehanju kajenja.
The percentage of patients who had not smoked at all during weeks 9-12 was 44% with CHAMPIX, 30% with bupropion, and 18% with placebo.
Odstotek bolnikov, ki so popolnoma prenehali kaditi v obdobju od 9. do 12. tedna, je bil za zdravilo CHAMPIX 44%, za bupropion 30% in za placebo 18%.
More patients remained non-smokers after treatment with CHAMPIX than after placebo:
Več bolnikov, ki so jemali zdravilo CHAMPIX, je ostalo nekadilcev v primerjavi z bolniki, ki so jemali placebo:
40 weeks after the end of the treatment period, the percentage of patients who were still non-smokers was 23% among those who had taken CHAMPIX, and 9% among those who had taken a placebo.
40 tednov po koncu obdobju zdravljenja je bil odstotek bolnikov, ki so še vedno bili nekadilci, 23% za bolnike, ki so jemali CHAMPIX, in 9% za bolnike, ki so jemali placebo.
The percentage in the patients who had taken bupropion was 16%.
Takih je bilo 16% bolnikov, ki so jemali bupropion.
What is the risk associated with CHAMPIX?
Kakšna tveganja so povezana z zdravilom CHAMPIX?
The most common side-effects (seen in more than 1 patient in 10) are nausea (feeling sick), insomnia (difficulty sleeping), abnormal dreams and headache.
Najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) so bili slabost, nespečnost, neobičajne sanje in glavobol.
For the full list of all side effects reported with CHAMPIX, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila CHAMPIX, najdete v Navodilih za uporabo.
CHAMPIX should not be used in people who may be hypersensitive (allergic) to varenicline or any of the other ingredients.
Zdravila CHAMPIX ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) vareniklin ali katerokoli drugo sestavino zdravila.
Why has CHAMPIX been approved?
Zakaj je bilo zdravilo CHAMPIX odobreno?
The Committee for Medicinal products for Human Use (CHMP) concluded that CHAMPIX has shown its effectiveness in helping patients stop smoking, and that the risks of smoking outweigh the risks of the medicine.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je učinkovitost zdravila CHAMPIX kot pomoč pri prenehanju kajenja dokazana in da so tveganja, povezana s kajenjem, večja od tveganj, povezanih z zdravilom.
Hence they recommended that CHAMPIX be given marketing authorisation.
Zato je Odbor priporočil odobritev dovoljenja za promet z zdravilom CHAMPIX.
Which measures are being taken to ensure the safe use of CHAMPIX?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila CHAMPIX?
Because the studies carried out with CHAMPIX did not include some groups of patients (such as older people, patients with heart or lung disease and other conditions), the company will carry out extra studies as well as monitor the use in these patients, to ensure that the side effects in such patients are well identified.
Ker v raziskave, opravljene z zdravilom CHAMPIX, niso bile vključene določene skupine bolnikov (starostniki, bolniki s srčnimi in pljučnimi oz. drugimi boleznimi), bo podjetje opravilo dodatne raziskave ter spremljalo uporabo zdravila pri teh bolnikih, da se zagotovi dobro poznavanje neželenih učinkov pri njih.
Other information about CHAMPIX:
Druge informacije o zdravilu CHAMPIX:
The European Commission granted a marketing authorisation valid throughout the European Union for CHAMPIX to Pfizer Limited on 26th September 2006.
Evropska Komisija je dovoljenje za promet z zdravilom CHAMPIX, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Limited dne 26. septembra 2006.
The full EPAR for CHAMPIX can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo CHAMPIX je na voljo tukaj.
This summary was last updated in 08-2006.
Ta povzetek je bil nazadnje posodobljen 08- 2006.
EU Number
Številka EU EU/ 1/ 06/ 360/ 001
Invented name
Jakost 0, 5 mg
Strength
Champix
Pharmaceutical Form
filmsko obložena tableta
Route of Administration
peroralna uporaba
Packaging
plastenka (HDPE)
Package size
56 tablet
0.5 mg 1.0 mg 0.5 mg and 1.0 mg
filmsko obložena tableta
Oral use Oral use Oral use
filmsko obložena tableta
bottle (HDPE) bottle (HDPE) blister (Aclar/ PVC/ alu) in a card
pretisni omot (Aclar/ PVC/ alu) v zavarjenem kartonskem pakiranju
56 tablets 56 tablets 11 x 0.5 mg + 14 x 1 mg tablets
filmsko obložena tableta
1.0 mg 1.0 mg 0.5 mg 0.5 mg 0.5 mg and 1.0 mg
filmsko obložena tableta
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
pretisni omot (Aclar/ PVC/ alu) v zavarjenem kartonskem pakiranju
Oral use Oral use Oral use Oral use Oral use
filmsko obložena tableta
blister (Aclar/ PVC/ alu) in a card blister (Aclar/ PVC/ alu) in a card blister (Aclar/ PVC/ alu) in a card blister (Aclar/ PVC/ alu) in a card blister (Aclar/ PVC/ alu) in a carton
pretisni omot (Aclar/ PVC/ alu) v škatli
28 tablets 56 tablets 28 tablets 56 tablets 11 x 0.5 mg + 14 x 1 mg tablets
11 x 0. 5 mg + 14 x 1mg tablet
1.0 mg 1.0 mg 1.0 mg 0.5 mg and 1.0 mg
filmsko obložena tableta
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
filmsko obložena tableta
Oral use Oral use Oral use Oral use
filmsko obložena tableta
blister (Aclar/ PVC/ alu) in a carton blister (Aclar/ PVC/ alu) in a carton blister (Aclar/ PVC/ alu) in a carton blister (Aclar/ PVC/ alu) in a card
pretisni omot (Aclar/ PVC/ alu) v zavarjenem kartonskem pakiranju
28 tablets 56 tablets 112 tablets 11 x 0.5 mg + 14 x 1 mg tablets plus 28 x 1mg tablets
11 x 0. 5 mg + 14 x 1mg tablet plus 28 x 1 mg tablet
CHAMPIX 0.5 mg film-coated tablets
CHAMPIX 0, 5 mg filmsko obložene tablete
Each film-coated tablet contains 0.5 mg of varenicline (as tartrate).
Ena filmsko obložena tableta vsebuje 0, 5 mg vareniklina (v obliki vareniklinijevega tartrata).
White, capsular-shaped, biconvex tablets debossed with “ Pfizer ” on one side and “ CHX 0.5” on the other side.
0, 5- mg filmsko obložene tablete: bele, bikonveksne tablete kapsulaste oblike z oznako "Pfizer" na eni strani in "CHX 0. 5" na drugi strani.
CHAMPIX is for oral use.
Zdravilo CHAMPIX je namenjeno za peroralno uporabo.
The recommended dose is 1 mg varenicline twice daily following a 1- week titration as follows:
Priporočeni odmerek je 1 mg vareniklina dvakrat na dan, in sicer po naslednji 1- tedenski titraciji:
0.5 mg once daily 0.5 mg twice daily 1 mg twice daily
0, 5 mg enkrat na dan 0, 5 mg dvakrat na dan 1 mg dvakrat na dan
CHAMPIX dosing should start 1-2 weeks before this date.
Zdravilo CHAMPIX naj začne uporabljati 1 do 2 tedna pred tem datumom.
Patients who cannot tolerate adverse effects of CHAMPIX may have the dose lowered temporarily or permanently to 0.5 mg twice daily.
Bolnikom, ki ne morejo prenašati neželenih učinkov zdravila CHAMPIX, lahko začasno ali za stalno znižamo odmerek na 0, 5 mg dvakrat na dan.
CHAMPIX tablets should be swallowed whole with water.
Tablete CHAMPIX je treba pogoltniti cele z vodo.
CHAMPIX can be taken with or without food.
Zdravilo CHAMPIX lahko bolnik vzame s hrano ali brez nje.
For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHAMPIX at 1 mg twice daily may be considered (see section 5.1).
Pri bolnikih, ki po 12 tednih uspešno opustijo kajenje, se lahko odločimo za nadaljnji 12- tedenski ciklus zdravljenja z zdravilom CHAMPIX v odmerku 1 mg dvakrat na dan (glejte poglavje 5. 1).
No data are available on the efficacy of an additional 12 weeks course of treatment for patients who do not succeed in stopping smoking during initial therapy or who relapse after treatment.
O učinkovitosti nadaljnjega 12- tedenskega ciklusa zdravljenja pri bolnikih, ki po uvodnem zdravljenju ne opustijo kajenja ali ki po končanem zdravljenju ponovno začnejo kaditi, ni podatkov.
2 In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.
2 Pri odvajanju od kajenja s pomočjo zdravil nastopi takoj po koncu zdravljenja povišano tveganje za ponoven začetek kajenja.
In patients with a high risk of relapse, dose tapering may be considered (see section 4.4).
Pri bolnikih z visokim tveganjem za ponoven začetek kajenja lahko razmislimo o postopnem zmanjševanju odmerka (glejte poglavje 4. 4).
Patients with renal insufficiency No dosage adjustment is necessary for patients with mild (estimated creatinine clearance > 50 ml/ min and ≤ 80 ml/ min) to moderate (estimated creatinine clearance ≥ 30 ml/ min and ≤ 50 ml/ min) renal impairment.
Bolniki z ledvično insuficienco Bolnikom z blago (ocenjeni očistek kreatinina > 50 ml/ min in ≤ 80 ml/ min) ter zmerno (ocenjeni očistek kreatinina ≥ 30 ml/ min in ≤ 50 ml/ min) okvaro ledvic odmerka ni treba prilagoditi.
For patients with moderate renal impairment who experience adverse events that are not tolerable, dosing may be reduced to 1 mg once daily.
Bolnikom z zmerno okvaro ledvic lahko odmerek zmanjšamo na 1 mg enkrat na dan, če se pri njih pojavijo neželeni učinki, ki jih ne prenesejo.
For patients with severe renal impairment (estimated creatinine clearance < 30 ml/ min), the recommended dose of CHAMPIX is 1 mg once daily.
Priporočeni odmerek zdravila CHAMPIX pri bolnikih s hudo okvaro ledvic (ocenjeni očistek kreatinina < 30 ml/ min) je 1 mg enkrat na dan.
Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily.
Odmerjanje je treba začeti z 0, 5 mg enkrat na dan prve 3 dni in nato povečati do 1 mg enkrat na dan.
Based on insufficient clinical experience with CHAMPIX in patients with end stage renal disease, treatment is not recommended in this patient population (see section 5.2).
Pri bolnikih s končno odpovedjo ledvic ni zadostnih izkušenj z zdravilom CHAMPIX, zato ga v tej populaciji bolnikov ni priporočljivo uporabljati (glejte poglavje 5. 2).
Patients with hepatic impairment No dosage adjustment is necessary for patients with hepatic impairment (see section 5.2).
Bolniki z okvaro jeter Bolnikom z okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5. 2).
Dosing in elderly patients No dosage adjustment is necessary for elderly patients (see section 5.2).
Odmerjanje pri starejših bolnikih Prilagoditev odmerka pri starejših bolnikih ni potrebna (glejte poglavje 5. 2).
Paediatric patients CHAMPIX is not recommended for use in children or adolescents below 18 years of age due to insufficient data on safety and efficacy (see section 5.2).
Pediatrični bolniki Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila CHAMPIX pri otrocih in mladostnikih, starih manj kot 18 let, ni priporočljiva (glejte poglavje 5. 2).
Effect of smoking cessation:
Učinek prenehanja kajenja:
Depression, suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with Champix in the post-marketing experience.
V obdobju trženja pri bolnikih, ki so poskušali opustiti kajenje z zdravilom Champix, poročajo o depresiji, samomorilnih mislih in poskusih samomora.
Not all patients had stopped smoking at the time of onset of symptoms and not all patients had known pre-existing psychiatric illnesss.
V času nastopa simptomov niso vsi bolniki prenehali s kajenjem; prav tako niso imeli vsi bolniki že prej znane obstoječe psihiatrične bolezni.
Clinicians should be aware of the possible emergence of significant depressive symptomatology in patients undergoing a smoking cessation attempt, and should advise patients accordingly.
Zdravniki se morajo zavedati, da se lahko pri bolnikih, ki poskušajo opustiti kajenje, pojavi izrazita depresivna simptomatika, in morajo bolnikom ustrezno svetovati.
Champix should be discontinued immediately if agitation, depressed mood or changes in behaviour that are of concern for the doctor, the patient, family or caregivers are observed, or if the patient develops suicidal ideation or suicidal behaviour.
Z jemanjem zdravila Champix je potrebno takoj prenehati, če opazimo razdražljivost, depresivno razpoloženje ali spremembe v obnašanju, ki bi lahko vzbujale skrb zdravniku, bolniku, družini ali skrbniku, ali če se pri bolniku pokažejo samomorilne misli ali samomorilno obnašanje.
In addition, smoking cessation, with or without pharmacotherapy, has been associated with exacerbation of underlying psychiatric illness (e. g. depression).
Prenehanje kajenja, z zdravljenjem ali brez njega, poleg tega povezujejo s poslabšanjem že obstoječih psihiatričnih bolezni (npr. depresije).
3 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.
Varnost in učinkovitost zdravila Champix pri bolnikih z resnimi psihiatričnimi boleznimi, kot so shizofrenija, bipolarna motnja in huda depresivna motnja, nista bili dokazani.
There is no clinical experience with CHAMPIX in patients with epilepsy.
3 Pri bolnikih z epilepsijo kliničnih izkušenj z zdravilom CHAMPIX ni.
At the end of treatment, discontinuation of CHAMPIX was associated with an increase in irritability, urge to smoke, depression, and/ or insomnia in up to 3% of patients.
Na koncu zdravljenja je bila prekinitev jemanja zdravila CHAMPIX pri do 3% bolnikov povezana s povečano razdražljivostjo, slo po kajenju, depresijo in/ ali nespečnostjo.
Furthermore since metabolism of varenicline represents less than 10% of its clearance, active substances known to affect the cytochrome P450 system are unlikely to alter the pharmacokinetics of varenicline (see section 5.2) and therefore a dose adjustment of CHAMPIX would not be required.
Poleg tega presnova vareniklina predstavlja manj kot 10% njegovega očistka, zato ni verjetno, da bi farmakokinetiko vareniklina spremenila zdravilne učinkovine, ki vplivajo na sistem citokroma P450 (glejte poglavje 5. 2); prilagoditev odmerka zdravila CHAMPIX torej ni potrebna.
Therefore, active substances that are cleared by renal secretion (e. g. metformin - see below) are unlikely to be affected by varenicline.
Zato ni verjetno, da bi vareniklin vplival na zdravilne učinkovine, ki se iz telesa odstranijo z ledvično sekrecijo (npr. metformin – glejte spodaj).
Metformin had no effect on varenicline pharmacokinetics.
Vareniklin ni vplival na farmakokinetiko metformina, metformin pa ni vplival na farmakokinetiko vareniklina.
Cimetidine:
Cimetidin:
Co-administration of cimetidine, with varenicline increased the systemic exposure of varenicline by 29% due to a reduction in varenicline renal clearance.
Sočasna uporaba cimetidina z vareniklinom je zaradi zmanjšanja ledvičnega očistka vareniklina povečala sistemsko izpostavljenost vareniklinu za 29%.
Smoking cessation itself may result in changes to warfarin pharmacokinetics (see section 4.4).
Prenehanje kajenja lahko samo po sebi spremeni farmakokinetiko varfarina (glejte poglavje 4. 4).
There is limited clinical data on any potential interaction between alcohol and varenicline.
Kliničnih podatkov o možni interakciji med alkoholom in vareniklinom je malo.
Nicotine replacement therapy (NRT):
Nadomestno zdravljenje z nikotinom:
When varenicline and transdermal NRT were co-administered to smokers for 12 days, there was a statistically significant decrease in average systolic blood pressure (mean 2.6 mmHg) measured on the final day of the study.
Ko so kadilcem 12 dni sočasno dajali vareniklin in transdermalno nadomestno zdravljenje z nikotinom, so ugotovili statistično pomembno znižanje povprečnega sistoličnega krvnega tlaka (povprečno 2, 6 mmHg), izmerjenega zadnji dan študije.
In this study, the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue was greater for the combination than for NRT alone.
V tej študiji je bila pojavnost navzee, glavobola, bruhanja, omotice, dispepsije in utrujenosti večja pri uporabi kombiniranega zdravljenja kot samega nadomestnega zdravljenja z nikotinom.
There are no adequate data from the use of CHAMPIX in pregnant women.
Ni zadostnih podatkov o uporabi zdravila CHAMPIX pri nosečnicah.
CHAMPIX should not be used during pregnancy.
Zdravila CHAMPIX ne smemo uporabljati med nosečnostjo.
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.
Pri odločitvi za nadaljevanje/ prekinitev dojenja oz. za nadaljevanje/ prekinitev zdravljenja z zdravilom CHAMPIX je treba upoštevati korist dojenja za otroka in korist zdravljenja z zdravilom CHAMPIX za žensko.
CHAMPIX may have minor or moderate influence on the ability to drive and use machines.
Zdravilo CHAMPIX ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
CHAMPIX may cause dizziness and somnolence and therefore may influence the ability to drive and use machines.
Povzroči lahko omotico in zaspanost in tako lahko vpliva na sposobnost vožnje in upravljanja s stroji.