natgillin/translations-raw huggingface dataset:
Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42% of the total plasma concentration.
Izsledki študije, v kateri so sodelovali bolniki s preveliko telesno maso, so pokazali, da v majhnem deležu sistemsko absorbirane količine zdravila dva poglavitna presnovka zasedata približno 42% skupne koncentracije v plazmi, M1 (hidrolizirani 4- členski laktonski obroč) in M3 (M1 z N- formillevcinskim ostankom).
M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1000 and 2500 fold less than orlistat respectively).
M1 in M3 imata odprt betalaktonski obroč in skrajno šibak zaviralni učinek na lipazo (1000 - oziroma 2500- krat šibkejši od orlistata).
In view of this low inhibitory activity and the low plasma levels at therapeutic doses (average of 26 ng/ ml and 108 ng/ ml respectively), these metabolites are considered to be pharmacologically inconsequential.
Zaradi šibkega zaviralnega učinka in majhne koncentracije v plazmi po vnosu terapevtskih odmerkov (povprečno 26 ng/ ml oziroma 108 ng/ ml), veljata oba presnovka za farmakološko nepomembna.
Elimination Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed drug was the major route of elimination.
Izločanje Študije, v katerih so sodelovale osebe z normalno in preveliko telesno maso, so pokazale, da se neabsorbirano zdravilo izloča pretežno z blatom.
Orlistat, M1 and M3 are all subject to biliary excretion.
Orlistat, M1 in M3 se izločajo tudi z žolčem.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost za razmnoževanje ne kažejo posebnega tveganja za človeka.
Capsule filling: microcrystalline cellulose (E460) sodium starch glycollate povidone (E1201)
Vsebina kapsule: mikrokristalna celuloza (E460), natrijev karboksimetilškrob, povidon (E1201), natrijev lavrilsulfat,
8 sodium lauryl sulphate talc
8 smukec.
Capsule shell: gelatine indigo carmine (E132) titanium dioxide (E171) edible printing ink (black iron oxide, ammonium hydroxide, potassium hydroxide, shellac)
Ovojnica kapsule: želatina, indigotin (E132), titanov dioksid (E171), barvila za potiskanje (črni železov oksid, amonijev hidroksid, kalijev hidroksid, šelak).
Do not store above 25 °C.
Pretisni omoti: shranjujte pri temperaturi do 25 °C.
Store in original package in order to protect from moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
Do not store above 30 °C.
Stekleničke: shranjujte pri temperaturi do 30 °C.
PVC/ PE/ PVDC blisters containing 21, 42 and 84 hard capsules.
PVC/ PE/ PVDC pretisni omoti, ki vsebujejo 21, 42 in 84 trdih kapsul.
Roche Pharma AG Emil-Barrell-Str.
Roche Pharma AG Emil- Barell- Str.
1 D-79639 – Grenzach-Wyhlen Germany
1 D- 79639 Grenzach- Wyhlen Nemčija
OUTER CARTON FOR BLISTER PACKS
ZUNANJA OVOJNINA ZA PRETISNE OMOTE
21 hard capsules 42 hard capsules 84 hard capsules
21 trdih kapsul 42 trdih kapsul 84 trdih kapsul
Do not store above 25 °C Store in the original package in order to protect from moisture.
Shranjujte pri temperaturi do 25 °C Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago
EU/ 1/ 98/ 071/ 001 21 capsules EU/ 1/ 98/ 071/ 002 42 capsules EU/ 1/ 98/ 071/ 003 84 capsules
EU/ 1/ 98/ 071/ 001 21 kapsul EU/ 1/ 98/ 071/ 002 42 kapsul EU/ 1/ 98/ 071/ 003 84 kapsul
Xenical 120 mg hard capsules Orlistat
Xenical 120 mg trde kapsule Orlistat
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI
Do not store above 30 °C Keep the container tightly closed in order to protect from moisture
Shranjujte pri temperaturi do 30 °C Vsebnik shranjujte tesno zaprt za zagotovitev zaščite pred vlago
EU/ 1/ 98/ 071/ 004 21 capsules EU/ 1/ 98/ 071/ 005 42 capsules EU/ 1/ 98/ 071/ 006 84 capsules
EU/ 1/ 98/ 071/ 004 21 kapsul EU/ 1/ 98/ 071/ 005 42 kapsul EU/ 1/ 98/ 071/ 006 84 kapsul
Xenical 120mg hard capsules Orlistat
Xenical 120 mg trde kapsule orlistat
What Xenical is and what it is used for 2.
Kaj je zdravilo Xenical in za kaj ga uporabljamo 2.
Before you take Xenical 3.
Kaj morate vedeti, preden boste vzeli zdravilo Xenical 3.
How to take Xenical 4.
Kako jemati zdravilo Xenical 4.
How to store Xenical 6.
Možni neželeni učinki 5 Shranjevanje zdravila Xenical 6.
WHAT XENICAL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO XENICAL IN ZA KAJ GA UPORABLJAMO
The undigested fat cannot be absorbed and is eliminated by your body.
Neprebavljena maščoba se ne more vsrkati in se iz telesa izloči.
BEFORE YOU TAKE XENICAL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO XENICAL
Do not take XENICAL
Ne jemljite zdravila XENICAL
- if you are allergic (hypersensitive) to orlistat or to any of the other ingredients of Xenical,
- če ste alergični na (preobčutljivi za) orlistat ali katerokoli sestavino zdravila Xenical,
- if you have chronic malabsorption syndrome (insufficient absorption of nutrients from
- če imate kronični malabsorpcijski sindrom (nezadostna absorpcija hranil iz prebavil),
- if you have cholestasis (liver disorder)
- če imate holestazo (motnjo jetrnega delovanja),
- if you have breast-feeding
- če dojite.
Take special care with XENICAL Weight loss may also affect the dose of medicines taken for other conditions (e. g. high cholesterol or diabetes).
Bodite posebno pozorni pri jemanju zdravila XENICAL Zaradi hujšanja je včasih treba prilagoditi odmerek zdravila, ki ga jemljete, za zdravljenje drugih bolezenskih stanj (na primer zvišanega holesterola ali sladkorne bolezni).
As with any weight-control program, over-consumption of fat and calories may reduce any weight loss effect.
Tako kot pri vseh shujševalnih programih, lahko tudi pri tovrstnem čezmerno uživanje maščob in kalorij učinek zdravila izniči.
In addition your daily intake of fat should be distributed evenly over
Dnevno količino zaužitih maščob je treba porazdeliti
21 three main meals because if Xenical is taken with a meal very high in fat, the possibility of gastrointestinal effects may increase.
Če jemljemo zdravilo Xenical z obrokom, ki vsebuje veliko maščob, se možnost neželenih učinkov v prebavilih lahko poveča.
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.
Za preprečitev morebitne neuspešnosti peroralnih kontracepcijskih sredstev, ki se lahko pojavi ob hudi driski, se priporoča uporaba dodatne kontracepcijske metode.
Use in Children Xenical is not intended to be used in children.
Uporaba pri otrocih Zdravilo Xenical ni namenjen zdravljenju otrok.
Your doctor may need to monitor your blood coagulation.
• zdravil, ki zavirajo strjevanje krvi (na primer varfarina), zato bo zdravnik presodil, ali potrebujete med zdravljenjem kontrolne preiskave strjevanja krvi;
• Iodine salts and/ or levothyroxine.
• jodovih soli in/ ali levotiroksina.
Cases of hypothyroidism and/ or reduced control of hypothyroidism may occur.
Pojavi se lahko hipotiroidizem in/ ali poslabša nadzor nad njim.
You may ask your doctor for advice.
Za nasvet povprašajte zdravnika.
Xenical reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E.
Zdravilo Xenical zmanjša absorpcijo pripravkov nekaterih v maščobi topnih hranil, zlasti beta karotena in vitamina E, zato morate upoštevati zdravnikov nasvet o uravnovešeni prehrani z veliko sadja in zelenjave.
You should therefore follow your doctor’ s advice in taking a well balanced diet rich in fruit and vegetables.
Včasih zdravnik med zdravljenjem predpiše multivitaminski pripravek.
Orlistat may unbalance an anticonvulsivant treatment, by decreasing the absorption of antiepileptic drugs, thus leading to convulsions.
Orlistat lahko deluje na antikonvulzivno zdravljenje tako, da zmanjša absorpcijo antiepileptikov, kar lahko vodi do konvulzij.
Please contact your doctor if you think that the frequency and/ or severity of the convulsions have changed when taking Xenical together with antiepileptic drugs.
Prosimo, obrnite se na svojega zdravnika, če menite, da se je pogostost in/ ali resnost konvulzij spremenila, ko ste sočasno jemali zdravilo Xenical in antiepileptike.
Pregnancy and breast-feeding Taking Xenical during pregnancy is not recommended.
Nosečnost in dojenje Jemanje zdravila Xenical med nosečnostjo ni priporočljivo.
Driving and using machines Xenical has no known effect on your ability to drive a car or operate machinery.
Vpliv na sposobnost upravljanja vozil in strojev Ni znano, da bi zdravilo Xenical vplivalo na vašo sposobnost za vožnjo avtomobila ali upravljanje strojev.
HOW TO TAKE XENICAL
KAKO JEMATI ZDRAVILO XENICAL
The usual dose of Xenical is one 120 mg capsule taken with each of the three main meals per day.
Običajen odmerek zdravila Xenical je ena 120- mg kapsula ob vsakem od treh glavnih dnevnih obrokov hrane.
22 Xenical should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30% of the calories from fat.
22 Med zdravljenjem z zdravilom Xenical morate uživati uravnovešeno hrano z veliko sadja in zelenjave ter nadzorovati vnos kalorij.
Therefore, if you miss a main meal or if you have a meal containing no fat, Xenical need not be taken.
Zdravilo Xenical deluje samo ob maščobah, ki jih vsebuje zaužita hrana, zato kapsule ni treba vzeti, če obrok izpustite ali zaužijete živila brez maščob.
Your doctor will discontinue the treatment with Xenical after 12 weeks if you have not lost at least 5% of your body weight as measured at the start of treatment with Xenical.
Če se vaša telesna masa po 12 tednih zdravljenja z zdravilom Xenical ne bo zmanjšala vsaj za pet odstotkov, vam bo zdravnik zdravljenje z zdravilom Xenical ukinil.
If you take more XENICAL than you should If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital as you may need medical attention.
Če ste vzeli večji odmerek zdravila XENICAL, kot bi smeli Če ste vzeli več kapsul, kot vam je predpisal zdravnik, ali je kapsule nenamerno zaužila tretja oseba, se posvetujte z zdravnikom, farmacevtom ali pokličite v bolnišnico, ker boste morda potrebovali medicinsko pomoč.
If you forget to take XENICAL If you forget to take your medicine at any time, take it as soon as you remember provided this is within one hour of your last meal, then continue to take it at the usual times.
Naslednje odmerke jemljite kot običajno.
Like all medicines, Xenical can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Xenical neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Headache, abdominal pain/ discomfort, urgent or increased need to open the bowels, flatulence (wind) with discharge, oily discharge, oily or fatty stools, liquid stools, low blood sugar levels (experienced by some people with type 2 diabetes).
Glavobol, bolečina/ neudobje v trebuhu, nujna ali povečana potreba po odvajanju, vetrovi z izcedkom, oljnat izcedek, oljnato ali mastno blato, tekoče blato, nizka raven sladkorja v krvi (pri nekaterih osebah s sladkorno boleznijo tipa 2).
Rectal pain/ discomfort, soft stools, incontinence (stools), bloating (experienced by some people with type 2 diabetes), tooth/ gum disorder, irregularity of menstrual cycle, tiredness.
Bolečina/ neudobje v danki, mehko blato, inkontinenca (blato), napenjanje (pri nekaterih osebah s sladkorno boleznijo tipa 2), motnje zob/ dlesni, neredna menstruacija, utrujenost.
23 feeling unwell.
23 Poročali so tudi o naslednjih neželenih učinkih, vendar iz razpoložljivih podatkov ni mogoče določiti njihove pogostnosti:
Increases in the levels of some liver enzymes may be found in blood tests, diverticulitis, gallstones, hepatitis (inflammation of the liver), pancreatitis (inflammation of the pancreas), skin blistering (including blisters that burst), effects on clotting with anti-coagulants.
Zvišana raven nekaterih jetrnih encimov pri krvnih testih, divertikulitis, žolčni kamni, hepatitis (vnetje jeter), pankreatitis (vnetje trebušne slinavke), kožni mehurji (vključno z mehurji, ki pokajo), učinki na strjevanje krvi med zdravljenjem z zdravili, ki zavirajo strjevanje krvi.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE XENICAL
SHRANJEVANJE ZDRAVILA XENICAL
Blister packs Do not use Xenical after the expiry date stated on the carton.
Pretisni omoti Zdravila Xenical ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici.
Glass bottles Do not use Xenical after the expiry date stated on the bottle.
Stekleničke Zdravila Xenical ne smete uporabljati po izteku roka uporabnosti, ki je naveden na steklenički.
What XENICAL contains
Kaj vsebuje zdravilo XENICAL
- The active substance is orlistat.
- Zdravilna učinkovina je orlistat (120 mg).
- The other ingredients are microcrystalline cellulose (E460), sodium starch glycollate, povidone
- Pomožne snovi so mikrokristalna celuloza (E460), natrijev karboksimetilškrob, povidon
(E1201), sodium lauryl sulphate and talc.
(E1201), natrijev lavrilsulfat in smukec.
What XENICAL looks like and contents of the pack
Izgled zdravila XENICAL in vsebina pakiranja
Xenical capsules are turquoise with the imprint “ ROCHE XENICAL 120” and are supplied in blister packs and glass bottles, containing 21, 42 and 84 capsules.
Kapsule zdravila Xenical so turkizne barve z napisom ROCHE XENICAL 120, na voljo so v pretisnih omotih in stekleničkah, ki vsebujejo po 21, 42 in 84 kapsul.
Manufacturer Roche Pharma AG Emil-Barrell-Str.
24 Izdelovalec Roche Pharma AG Emil- Barell- Str.
Kύπρος Γ .Α .Σταμάτης & Σια Λτδ.
25 Kύπρος Γ. Α. Σταµάτης & Σια Λτδ.
blister (PVC/ PE/ PCTFE/ alu)
Pretisni omoti (PVC/ PE/ PCTFE Alu)
XERISTAR 30 mg hard gastro-resistant capsules
XERISTAR 30 mg trde gastrorezistentne kapsule
The XERISTAR 30 mg capsule has an Opaque white body, imprinted with ‘ 30 mg’ and an opaque blue cap, imprinted with ‘ 9543’.
Kapsula zdravila XERISTAR 30 mg ima neprozorno belo telo z vtisnjenim napisom ‘ 30 mg ’ ter neprozoren moder pokrovček z vtisnjeno oznako ‘ 9543 ’.
2 Diabetic Peripheral Neuropathic Pain:
2 Bolečina diabetične periferne nevropatije:
However, as with any medicine, caution should be exercised when treating the elderly, especially with XERISTAR 120 mg per day for which data are limited (see sections 4.4 and 5.2).
Vendar pa je, kot pri vseh zdravilih, pri zdravljenju starejših potrebna previdnost, posebno z zdravilom XERISTAR 120 mg na dan, pri kateri so na voljo omejeni podatki (glejte poglavji 4. 4 in 5. 2).
Therefore, administration of XERISTAR to children and adolescents is not recommended (see section 4.4).
Zato dajanja zdravila XERISTAR otrokom in mladostnikom ne priporočamo (glejte poglavje 4. 4).
Hepatic impairment XERISTAR should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Okvarjeno delovanje jeter Zdravila XERISTAR pri bolnikih z obolenjem jeter, ki ima za posledico okvarjeno delovanje jeter, ne smemo uporabljati (glejte poglavji 4. 3 in 5. 2).
When stopping treatment with XERISTAR 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 XERISTAR 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).
Concomitant use of XERISTAR with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
Zdravila XERISTAR ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4. 5).
XERISTAR should not be used in combination with fluvoxamine, ciprofloxacin or enoxacine (i. e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Zdravila XERISTAR ne smemo uporabljati v kombinaciji s fluvoksaminom, ciprofloksacinom ali enoksacinom (tj. močnimi zaviralci CYP1A2), saj kombinacija povzroči povišane plazemske koncentracije duloksetina (glejte poglavje 4. 5).
The initiation of treatment with XERISTAR is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
3 Uvedba zdravljenja z zdravilom XERISTAR je kontraindicirana pri bolnikih z nenadzorovano hipertenzijo, ki lahko izpostavi bolnike možnemu tveganju za hipertenzivno krizo (glejte poglavje 4. 4 in 4. 8).
Mania and seizures XERISTAR should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija in epileptični napadi Zdravilo XERISTAR je treba pri bolnikih z manijo v anamnezi ali z diagnozo bipolarne motnje in/ ali epileptičnimi napadi uporabljati previdno.
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing XERISTAR to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Midriaza V povezavi z duloksetinom so poročali o midriazi, zato je pri predpisovanju zdravila XERISTAR bolnikom s povišanim intraokularnim tlakom ali s tveganjem za akutni glavkom z zaprtim zakotjem potrebna previdnost.
Use with antidepressants Caution should be exercised when using XERISTAR in combination with antidepressants.
Sočasna uporaba z antidepresivi Pri uporabi zdravila XERISTAR v kombinaciji z antidepresivi je potrebna previdnost.
St John’ s wort Undesirable effects may be more common during concomitant use of XERISTAR and herbal preparations containing St John’ s wort (Hypericum perforatum).
Šentjanževka Ob sočasni uporabi zdravila XERISTAR in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
Other psychiatric conditions for which XERISTAR is prescribed can also be associated with an increased risk of suicide-related events.
Druga psihiatrična stanja, za katera predpisujemo zdravilo XERISTAR so tudi lahko povezana z večjim tveganjem za pojav dogodkov povezanih s samomorom.
A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
4 pokazala, da pri bolnikih, mlajših od 25 let, pri uporabi antidepresivov obstaja večje tveganje za pojav samomorilnega vedenja kot pri uporabi placeba.
4 Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.
Še posebej skrbno je treba nadzirati bolnike z velikim tveganjem.
XERISTAR should not be used in the treatment of children and adolescents under the age of 18 years.
Zdravila XERISTAR pri zdravljenju otrok in mladostnikov, mlajših od 18 let, ne smemo uporabljati.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering XERISTAR.
Hiponatremija Ob dajanju zdravila XERISTAR so redko poročali o hiponatremiji, zlasti pri starejših.
In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with XERISTAR and 23% of patients taking placebo.
V kliničnih preskušanjih so se neželeni učinki ob nenadni prekinitvi zdravljenja pojavili pri približno 45% bolnikov, ki so jemali zdravilo XERISTAR in pri 23% bolnikov, ki so dobivali placebo.
Data on the use of XERISTAR 120mg in elderly patients with major depressive disorders are limited.
Podatki o uporabi zdravila XERISTAR 120 mg pri starejših bolnikih z velikimi depresivnimi motnjami so omejeni.
Data on the use of XERISTAR in elderly patients with generalised anxiety disorder are limited.
Podatki o uporabi zdravila XERISTAR pri starejših bolnikih z generalizirano anksiozno motnjo so pomanjkljivi.
Sucrose XERISTAR hard gastro-resistant capsules contain sucrose.
Saharoza XERISTAR trde gastrorezistentne kapsule vsebujejo saharozo.
Consequently, caution is advised when XERISTAR is taken in combination with other centrally acting medicinal products and substances including alcohol and sedative medicinal products (e. g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Zato je pri jemanju zdravila XERISTAR v kombinaciji z drugimi osrednje delujočimi zdravili in snovmi, ki vključujejo alkohol in pomirjevala (denimo benzodiazepini, morfinomimetiki, antipsihotiki, fenobarbital, sedirajoči antihistaminiki), potrebna previdnost.
Monoamine Oxidase Inhibitors (MAOIs): due to the risk of serotonin syndrome, XERISTAR should not be used in combination with nonselective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Zaviralci monoaminooksidaze (MAOI): zaradi nevarnosti za serotoninski sindrom zdravila XERISTAR ne smemo uporabljati v kombinaciji z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze (MAOI) ali v 14 dneh po prenehanju zdravljenja z MAOI.
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping XERISTAR before starting an MAOI (see section 4.3).
Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila XERISTAR preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4. 3).
However, the concomitant use of XERISTAR with selective, reversible MAOIs is not recommended (see section 4.4).
Vendar pa sočasno uporabo zdravila XERISTAR s selektivnimi reverzibilnimi MAOI odsvetujemo (glejte poglavje 4. 4).
Caution is advisable if XERISTAR is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John’ s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
Če zdravilo XERISTAR uporabljamo sočasno s serotoninergičnimi antidepresivi, kot so SSRI, tricikličnimi antidepresivi, denimo, klomipraminom ali amitriptilinom, šentjanževko (Hypericum perforatum), venlafaksinom ali triptani, tramadolom, petidinom in triptofanom, priporočamo previdnost.
Caution is advised if XERISTAR is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as 6 nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Če zdravilo XERISTAR dajemo sočasno z zdravili, ki jih presnavlja predvsem CYP2D6 (risperidon, triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin) in zlasti če imajo ozek terapevtski indeks (kot na primer s flekainidom, propafenonom in metoprololom), svetujemo previdnost.
Therefore XERISTAR should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Zato zdravila XERISTAR ne smemo dajati skupaj z močnimi zaviralci CYP1A2, denimo s fluvoksaminom (glejte poglavje 4. 3).
XERISTAR should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Zdravilo XERISTAR naj se v nosečnostu uporablja le, če možna korist upravičuje možno tveganje za plod.
As the safety of duloxetine in infants is not known, the use of XERISTAR while breast-feeding is not recommended.
Ker varnost uporabe duloksetina pri dojenčkih ni znana, odsvetujemo uporabo zdravila XERISTAR med dojenjem.