natgillin/translations-raw huggingface dataset:
In either case it should be confirmed by a blood test that Arava has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
V obeh primerih je treba s krvno preiskavo potrditi, da se je zdravilo Arava dovolj odstranilo iz telesa,
For further information on the laboratory testing please contact the Marketing Authorisation Holder or its representative.
Za dodatne informacije o laboratorijskem testiranju se obrnite na imetnika dovoljenja za promet z zdravilom ali njegovega predstavnika.
74 If you suspect that you are pregnant while taking Arava or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Če med jemanjem zdravila Arava ali v dveh letih po koncu zdravljenja posumite, da ste zanosili, morate o tem nemudoma obvestiti zdravnika in opraviti nosečnostni test.
If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to speed up the removal of Arava from the body, as this may decrease the risk to your baby.
Če test potrdi, da ste noseči, vam bo zdravnik morda predlagal zdravljenje z določenimi zdravili, ki lahko pospešijo odstranjevanje zdravila Arava iz telesa, ker to lahko zmanjša tveganje za otroka.
If you are affected, do not drive, or use machines.
Če čutite vplive zdravila ne vozite oziromane upravljajte s stroji.
75 Tell your doctor immediately and stop taking Arava:
75 alergijske reakcije,
- an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the
- zvečanje števila krvnih celic imenovanih eozinofilci (eozinofilija), blago zmanjšanje števila
number of white blood cells (leucopenia); decrease in the number of all blood cells (pancytopenia),
belih krvnih celic (levkopenija); izmanjšanje števila vseh krvnih celic (pancitopenija).
- sever liver injury such as liver failure or necrosis which may be fatal,
- resne poškodbe, kot sta odpoved jeter ali nekroza, ki sta lahko usodni,
One film-coated tablet contains 20 mg of leflunomide
Vsaka filmsko obložena tableta vsebuje 20 mg
colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 8000 and yellow ferric oxide (E172) in the film-coating.
silicijev dioksid, magnezijev stearat (E470b) in laktoza monohidrat v jedru tablete ter smukec (E553b), hipromeloza (E464), titanov dioksid (E171), makrogol 8000 in rumeni železov oksid (E172) v filmski oblogi.
What Arava looks like and contents of the pack Arava 20 mg film-coated tablets are yellowish to ochre and triangular.
Arava 20 mg filmsko obložene tablete so rumenkaste do okraste barve in trikotne oblike.
77 Not all pack size may be marketed.
Na trgu ni vseh navedenih pakiranj.
Manufacturer Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex, France
77 Izdelovalec Sanofi Winthrop Industrie 56, Route de Choisy au Bac F- 60205 Compiegne Cedex, Francija
Italia sanofi-aventis S. p. A.
78 Italia sanofi- aventis S. p. A.
- if you have any liver problems,
- če imate kakršnekoli težave z jetri,
- if you have severely low numbers of proteins in your blood (hypoproteinaemia),
- če imate znižano število beljakovin v krvi (hipoproteinemija),
Take special care with Arava
Bodite posebno pozorni pri jemanju zdravila Arava
- -
- če ste kdaj imeli tuberkulozo (pljučna bolezen),
if you have ever suffered from tuberculosis (a lung disease), if you are male and wish to father a child, as Arava can cause birth defects in new born infants.
- če ste moški in želite zaploditi otroka, saj zdravilo Arava lahko povzroči okvare pri
80 To minimise any possible risk, men wishing to father a child should contact their doctor who may advise you to stop taking Arava and take certain medicines to speed up the removal of Arava from your body.
80 zdravnikom, ki vam bo morda svetoval, da nehate jemati zdravilo Arava in vzamete določena zdravila za pospešitev izločanja zdravila Arava iz telesa.
Arava can occasionally cause some problems with your blood, liver or lungs.
Občasno lahko zdravilo Arava povzroči nekatere krvne, jetrne ali plučne težave.
Pregnancy and breast-feeding Do not take Arava if you are, or think you may be pregnant.
Nosečnost in dojenje Ne jemljite zdravila Arava, če ste ali mislite, da ste noseči.
81 For further information on the laboratory testing please contact the Marketing Authorisation Holder or its representative.
Za dodatne informacije o laboratorijskem testiranju se obrnite na imetnika dovoljenja za promet z zdravilom ali njegovega predstavnika.
If you suspect that you are pregnant while taking Arava or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Če test potrdi, da ste
If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to speed up the removal of Arava from the body, as this may decrease the risk to your baby.
81 noseči, vam bo zdravnik morda predlagal zdravljenje z določenimi zdravili, ki pospešijo odstranjevanje zdravila Arava iz telesa, ker to lahko zmanjša tveganje za otroka.
Always take Arava exactly as your doctor has told you.
Pri jemanju zdravilaArava Natančno upoštevajte zdravnikova navodila.
Arava is not recommended for use in children and adolescents below18 years of age.
Uporaba zdravila Arava ni priporočljiva pri otrocih in mladostnikih, ki so mlajši od 18 let.
82 Tell your doctor immediately and stop taking Arava:
Nemudoma obvestite svojega zdravnika in prenehajte jemati zdravilo Arava:
life-threatening reactions (e. g.
reakcij, (npr.
- tiredness (asthenia),
- utrujenost (astenija),
- an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the
- zvečanje števila krvnih celic imenovanih eozinofilcev (eozinofilija), blago zmanjšanje števila
- inflammation of the lung (interstitial lung disease),
- vnetje pljuč (intersticijska bolezen pljuč,
Very rare side effects (may occur in less than 1 in 10,000 patients)
Zelo redki neželeni učinki (lahko se pojavijo pri manj kot 1 od 10. 000 bolnikov)
- sever liver injury such as liver failure or necrosis which may be fatal,
- resne poškodbe jeter, kot je odpoved jeter ali nekroza, ki sta lahko usodni,
necrolysis, erythema multiforme).
83 nekroliza, multiformni eritem).
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, and male infertility (which is reversible once treatment with Arava is stopped) may also occur with a not known frequency.
Z neznano pogostnostjo se lahko pojavijo neželeni učinki, kot je ledvična odpoved, zmanjšana koncentracija sečne kisline v krvi, in neplodnost pri moških (izgine po prenehanju uporabe zdravila Arava
One film-coated tablet contains 100 mg of leflunomide.
Vsaka filmsko obložena tableta vsebuje 100 mg
- The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), talc (E553b),
- Pomožne snovi so: koruzni škrob, povidon (E1201), krospovidon (E1202), smukec (E553b),
silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the film-coating.
brezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) in laktoza monohidrat v jedru tablete ter smukec (E553b), hipromeloza (E464), titanov dioksid (E171) in makrogol 8000 v filmski oblogi.
Arava 100 mg film-coated tablets are white to almost white and round with a diameter of about 1 cm.
Arava 100 mg filmsko obložene tablete so bele do skoraj bele, okrogle in imajo premer približno 1 cm.
84 Marketing Authorisation Holder Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany
Imetnik dovoljenja za promet Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, Nemčija
Manufacturer Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex, France
Izdelovalec Sanofi Winthrop Industrie 56, Route de Choisy au Bac F- 60205 Compiegne Cedex, Francija
België/ Belgique/ Belgien sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00
84 België/ Belgique/ Belgien sanofi- aventis Belgium Tél/ Tel: +32 (0) 2 710 54 00
Lietuva UAB sanofi-aventis Lietuva Tel: +370 5 2755224
85 Lietuva UAB sanofi- aventis Lietuva Tel: +370 5 2755224
Ariclaim is a medicine containing the active substance duloxetine.
Ariclaim je zdravilo, ki vsebuje zdravilno učinkovino duloksetin.
It is available as gastroresistant capsules (20 mg: blue; 30 mg: white and blue; 40 mg: orange; 60 mg: green and blue). ‘ Gastroresistant ’ means that the capsules ’ contents pass through the stomach without being broken down until they reach the intestine.
Na voljo je v obliki gastrorezistentnih kapsul (20 mg: modre kapsule; 30 mg: bele in modre kapsule; 40 mg: oranžne kapsule; 60 mg: zelene in modre kapsule).
This prevents the active substance being destroyed by the acid in the stomach.
„ Gastrorezistentne “ pomeni, da vsebina kapsul potuje skozi želodec, ne da bi se v njem razgradila, dokler ne doseže črevesa.
Ariclaim is used to treat: • moderate to severe stress urinary incontinence (SUI) in women.
Zdravilo Ariclaim se uporablja za zdravljenje: • zmerne do hude stresne urinske inkontinence (SUI) pri ženskah.
SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising. • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Stresna urinska inkontinenca je nenamerno uhajanje urina med telesnim naporom, kašljanjem, smejanjem, kihanjem, dviganjem ali telesno vadbo; • bolečin zaradi diabetične periferne nevropatije (poškodb živcev v okončinah, ki se pojavljajo pri bolnikih s sladkorno boleznijo).
For SUI, the recommended dose of Ariclaim is 40 mg twice a day.
Pri bolnicah s stresno urinsko inkontinenco znaša priporočeni odmerek zdravila Ariclaim 40 mg dvakrat na dan.
Combining Ariclaim with pelvic floor muscle training may provide additional benefit.
Dodatne koristi prinese kombiniranje jemanja zdravila Ariclaim s programom treninga mišic medeničnega dna.
For diabetic neuropathic pain, the recommended dose is 60 mg once a day, but some patients may need a higher dose of 120 mg per day.
Pri bolnikih z bolečino diabetične nevropatije znaša priporočeni odmerek 60 mg enkrat dnevno, nekateri bolniki pa bodo morda potrebovali višji odmerek 120 mg dnevno.
The benefit of treatment should be re-assessed at regular intervals.
Koristi zdravljenja je treba v rednih intervalih ponovno oceniti.
Ariclaim should be used with caution in elderly patients.
Pri starejših bolnikih je zdravilo Ariclaim treba uporabljati previdno.
It should not be used in patients who have certain problems with their liver or severe kidney problems.
Ne sme se uporabljati pri bolnikih, ki imajo določene težave z jetri ali hude težave z ledvicami.
The dose should be reduced gradually when stopping treatment.
Ob prenehanju zdravljenja je odmerek treba zmanjševati postopoma.
Reproduction is authorised provided the source is acknowledged. that allow nerve cells to communicate with one another.
Kako zdravilo Ariclaim deluje?
By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Zdravilna učinkovina zdravila Ariclaim je duloksetin, zaviralec ponovnega prevzema serotonina in noradrenalina.
How duloxetine works in SUI is not clear but it is thought that, by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
Živčni prenašalci so kemične snovi, ki omogočajo komunikacijo med celicami.
By closing the urethra more powerfully, Ariclaim prevents the unwanted loss of urine during physical stress such as coughing or laughing.
Duloksetin s tem, ko zavira njihov ponovni prevzem, poveča količino teh živčnih prenašalcev v prostorih med temi živčnimi celicami in s tem poveča stopnjo komunikacije med celicami.
Since these neurotransmitters are also involved in reducing the sensation of pain, blocking their re-uptake into nerve cells may also improve the symptoms of neuropathic pain.
Kako duloksetin deluje pri stresni urinski inkontinenci ni povsem jasno, vendar se domneva, da duloksetin s povečevanjem ravni 5 - hidroksitripamina in noradrenalina na raven v živcih, ki nadzorujejo mišice sečnice (izvodilo iz sečnega mehurja navzven), okrepi stisk mišic zapiralk sečnice med shranjevanjem urina.
For the treatment of SUI, Ariclaim has been studied in a total of 2,850 women.
Pri zdravljenju stresne urinske inkontinence so zdravilo Ariclaim preučevali pri skupno 2850 ženskah.
The four main studies involved 1,913 women and lasted 12 weeks, comparing Ariclaim (mostly as 40 mg twice a day) with placebo (a dummy treatment).
V štirih glavnih študijah, ki so vključevale 1913 žensk in so trajale 12 tednov, so zdravilo Ariclaim (večinoma v odmerku 40 mg dvakrat dnevno) primerjali s placebom (zdravilom brez zdravilne učinkovine).
The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients’ scores on an incontinence-specific quality-of-life questionnaire (I-QOL).
Glavni merili učinkovitosti sta bili pogostnost inkontinenčnih epizod (IEF), tj. število inkontinenčnih epizod na teden, razvidno iz dnevnikov zdravljenja, ter število točk po vprašalniku o kakovosti življenja, specifičnem za inkontinenco (I- QOL).
For the treatment of diabetic neuropathic pain, Ariclaim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Pri zdravljenju bolečine diabetične nevropatije so zdravilo Ariclaim preučevali v dveh 12- tedenskih študijah pri 809 bolnikih s sladkorno boleznijo, ki so imeli vsakodnevne bolečine v trajanju najmanj šest mesecev.
The effectiveness of three different doses of Ariclaim was compared with that of placebo.
Učinkovitost treh različnih odmerkov zdravila Ariclaim so primerjali z učinkovitostjo placeba.
The main measure of effectiveness was the change in the severity of pain each week, as recorded by the patients on an 11-point scale in daily diaries.
Glavno merilo učinkovitosti je bila vsakotedenska sprememba resnosti bolečine, kot so jo vsakodnevno v svojih dnevnikih zabeležili bolniki na podlagi 11- točkovne lestvice.
In all four studies of SUI, the patients treated with Ariclaim had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study.
V vseh štirih študijah zdravljenja stresne urinske inkontinence so imele bolnice, ki so prejemale zdravilo Ariclaim, manj inkontinenčnih epizod po 12 tednih, in sicer približno štiri ali pet inkontinenčnih epizod manj na teden v primerjavi z obdobjem pred študijo).
The IEF decreased by 52% in the Ariclaim group, compared with a decrease of 33% in the placebo-treated group.
Pogostnost inkontinenčnih epizod se je v skupini bolnic, ki so prejemale zdravilo Ariclaim, zmanjšala za 52% v primerjavi s 33- odstotnim zmanjšanjem v skupini bolnic, ki so prejemale placebo.
The I-QOL questionnaire scores were also improved in the Ariclaim group compared with the placebo group.
V skupini bolnic, ki so prejemale zdravilo Ariclaim, se je izboljšal tudi rezultat po vprašalniku I- QOL v primerjavi s skupino bolnic, ki so prejemale placebo.
Ariclaim was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Zdravilo Ariclaim je bilo učinkovitejše od placeba le pri bolnicah, ki so imele več kot 14 inkontinenčnih epizod na teden (zmerna do huda stresna urinska inkontinenca) ob začetku študije.
For the treatment of diabetic neuropathic pain, Ariclaim at doses of 60 mg once or twice a day was more effective at reducing pain than placebo.
Pri zdravljenju bolečine diabetične nevropatije je bilo zdravilo Ariclaim v odmerku 60 mg enkrat ali dvakrat dnevno učinkovitejše pri zmanjševanju bolečine kot placebo.
In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks, with patients taking Ariclaim having pain scores between 1.17 and 1.45 points lower than those taking placebo.
V obeh študijah so zmanjšanje bolečine opazili od prvega tedna zdravljenja dalje vse do 12. tedna zdravljenja, pri čemer so bili rezultati glede bolečine pri bolnikih, ki so prejemali zdravilo Ariclaim, za 1, 17 do 1, 45 točke nižji od rezultatov, zabeleženih pri bolnikih, ki so jemali placebo.
The most common side effects with Ariclaim when used to treat SUI (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Ariclaim pri zdravljenju stresne urinske inkontinence (opaženi pri več kot 1 bolnici izmed 10) so navzeja, suha usta, zaprtje in utrujenost.
Most of these were mild or moderate, starting early in treatment and getting milder as treatment continued.
Večina teh učinkov je bila blagih do zmernih, pojavili pa so se že v zgodnjem obdobju zdravljenja in z nadaljevanjem zdravljenja postajali čedalje blažji.
The most common side effects when used to treat diabetic neuropathic pain (seen in more than 1 patient 10) are headache, somnolence (sleepiness), nausea and dry mouth.
Najpogostejši neželeni učinki pri zdravljenju bolečine diabetične nevropatije (opaženi pri več kot 1 bolniku izmed 10) so bili glavobol, somnolenca (zaspanost), navzeja in suha usta.
For the full list of all side effects reported with Ariclaim, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ariclaim, glejte navodilo za uporabo.
Ariclaim should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Zdravila Ariclaim ne sme uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) duloksetin ali katero koli drugo sestavino zdravila.
Ariclaim should not be used in patients with certain types of liver disease or with severe kidney disease.
Zdravila Ariclaim ne sme uporabljati bolnikih z določenimi obolenji jeter ali s hudim obolenjem ledvic.
Ariclaim should not be used with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Zdravilo Ariclaim se ne sme uporabljati sočasno z zaviralci monoamin- oksidaze (skupino zdravil proti depresiji), fluvoksaminom (drugo vrsto zdravila proti depresiji) ali ciprofloksacinom ali enoksacinom 2/ 3 (vrstama antibiotikov).
Treatment should not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Zdravljenje z zdravilom Ariclaim se ne sme uvesti pri bolnicah z nenadzorovanim visokim krvnim tlakom zaradi tveganja za hipertenzivno krizo (nenadno nevarno povišanje krvnega tlaka).
The Committee for Medicinal Products for Human Use (CHMP) decided that Ariclaim’ s benefits are greater than its risks for the treatment of moderate to severe SUI and of diabetic peripheral neuropathic pain in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ariclaim pri zdravljenju zmerne do hude stresne urinske inkontinence in bolečine diabetične nevropatije pri odraslih večje od z njim povezanih tveganj.
The Committee recommended that Ariclaim be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Ariclaim odobri dovoljenje za promet.
2/ 3 Other information about Ariclaim:
Druge informacije o zdravilu Ariclaim:
The marketing authorisation holder is Eli Lilly Nederland BV.
Imetnik dovoljenja za promet z zdravilom je družba Eli Lilly Nederland B. V.
This summary was last updated in 05-2008.
Povzetek je bil nazadnje posodobljen 05- 2008.
ARICLAIM 40 mg hard gastro-resistant capsules.
ARICLAIM 40 mg trde gastrorezistentne kapsule
Each capsule contains 40 mg of duloxetine (as hydrochloride).
Vsaka kapsula vsebuje 40 mg duloksetina (v obliki klorida).
Excipients: sucrose 11.5 mg.
Pomožne snovi: saharoza 11, 5 mg.
Opaque orange body, imprinted with ’ 40mg’ and an opaque blue cap, imprinted with ‘ 9545’.
Neprozorno oranžno telo z vtisnjenim napisom ‘ 40 mg ’ ter neprozoren moder pokrovček z vtisnjeno oznako ‘ 9545 ’.
ARICLAIM is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI), (see section 5.1).
4. 1 Terapevtske indikacije
Stress Urinary Incontinence:
Stresna urinska inkontinenca:
The recommended dose of ARICLAIM is 40 mg twice daily without regard to meals.
Priporočeni odmerek zdravila ARICLAIM je 40 mg dvakrat dnevno ne glede na obroke.
After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy.
Po 2- 4 tednih zdravljenja je treba bolnice ponovno pregledati, da ovrednotimo učinkovitost in prenosljivost zdravljenja.
However, limited data are available to support the efficacy of ARICLAIM 20 mg twice daily.
Vendar pa so na voljo le omejeni podatki, ki potrjujejo učinkovitost zdravila ARICLAIM 20 mg dvakrat dnevno.
The efficacy of ARICLAIM has not been evaluated for longer than 3 months in placebo-controlled studies.
Učinkovitosti zdravila ARICLAIM v študijah, kontroliranih s placebom, niso vrednotili dlje kot 3 mesece.
Combining ARICLAIM with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Kombiniranje jemanja zdravila ARICLAIM s programom treninga mišic medeničnega dna (pelvic floor muscle training, PFMT) je lahko bolj učinkovito, kot če metodi zdravljenja uporabljamo posamezno.
Diabetic Peripheral Neuropathic Pain:
Bolečina diabetične periferne nevropatije:
The plasma concentration of duloxetine displays large inter-individual variability (see 5.2).
Plazemska koncentracija duloksetina izkazuje veliko različnost med posamezniki (glejte poglavje 5. 2).
The medicinal product response should be evaluated after 2 months’ of treatment.
Odziv na zdravilo je treba ovrednotiti po 2 mesecih zdravljenja.
Additional response after this time is unlikely (see 5.1).
Dodatni odziv po preteku tega obdobja ni verjeten (glejte poglavje 5. 1).
2 Hepatic insufficiency:
2 Terapevtsko korist redno (vsaj enkrat na vsake tri mesece) ocenjujemo.
ARICLAIM should not be used in patients with liver disease resulting in hepatic impairment (see section 4.3).
Okvarjeno delovanje jeter Zdravila ARICLAIM ne smemo uporabljati pri bolnikih z obolenjem jeter, katerega posledica je okvarjeno delovanje jeter (glejte poglavje 4. 3).
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
Okvarjeno delovanje ledvic Pri bolnikih z blago do zmerno okvarjenim delovanjem ledvic (očistek kreatinina 30 do 80 ml/ min) odmerka ni treba prilagajati.
ARICLAIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3).
Zdravila ARICLAIM ne smemo uporabljati pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/ min; glejte poglavje 4. 3).
Elderly No dosage adjustment is recommended for elderly patients solely on the basis of age.
Starejši Samo na podlagi starosti pri starejših bolnikih prilagajanje odmerka ni potrebno.
Caution should be exercised when treating the elderly
Otroci in mladostniki Izkušenj pri otrocih ni (glejte poglavje 4. 4).
Abrupt discontinuation should be avoided.
Prekinitev zdravljenja Izogibati se moramo nenadni prekinitvi zdravljenja.
When stopping treatment with ARICLAIM the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Ob prenehanju zdravljenja z zdravilom ARICLAIM je treba odmerek zdravila v obdobju najmanj enega do dveh tednov postopoma zmanjševati, da zmanjšamo tveganje za pojav odtegnitvenih reakcij (glejte poglavji 4. 4 in 4. 8).