natgillin/translations-raw huggingface dataset:
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA(OV) GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Therefore, fentanyl should not be used within 14 days after discontinuation of treatment with MAO-inhibitors.
Zato fentanila ne uporabljajte 14 dni po ukinitvi zdravljenja z zaviralci monoaminooksidaze.
4.6 Pregnancy and lactation
Nosečnost in dojenje
Fentanyl is metabolized primarily in the liver via CYP3A4.
Fentanil se presnavlja predvsem v jetrih z encimom CYP3A4.
Like all medicines, Fentanyl-ratiopharm can cause side effects, although not everybody gets them.
MOŽNI NEŽELENI UČINKI Kot vsa zdravila imajo lahko tudi obliži Fentanyl-ratiopharm neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If this should occur - remove the patches and contact a doctor immediately.
V tem primeru je treba obliž takoj odstraniti in o tem obvestiti zdravnika.
Patients with hepatic or renal impairment should be observed carefully and the dose reduced if necessary (see section 4.4).
Bolnike z okvaro jeter ali ledvic je treba skrbno opazovati in odmerek po potrebi zmanjšati (glejte poglavje 4.4).
If traces of the transdermal patch remain on the skin after its removal, these can be cleaned off using copious amounts of soap and water.
Ostanke obliža na koži po odstranitvi lahko odstranimo s pomočjo zadostne količine vode in mila.
This applies, for example, to: - medicines used for treating anxiety (tranquillisers) - medicines used for treating depression (antidepressants) - medicines used for treating psychological disorders (neuroleptics) - anaesthetics, if you think you are going to have an anaesthetic, tell the doctor or dentist that you are using Fentanyl-ratiopharm - medicines used for treating sleep disorders (hypnotics, sedatives) - medicines used for treating allergies or travel sickness (antihistamines/antiemetics) - other strong-acting painkillers (opioids) - alcohol
Med ta zdravila sodijo: - zdravila za zdravljenje anksioznosti (pomirjevala) - zdravila za zdravljenje depresije (antidepresivi) - zdravila za zdravljenje psiholoških bolezni (nevroleptiki) - anestetiki, če boste podvrženi posegu za katerega bo potrebna anestezija, svojemu zdravniku ali zobozdravniku povejte, da uporabljate obliže Fentanyl-ratiopharm - zdravila proti nespečnosti (hipnotiki, pomirjevala) - zdravila proti alergijam ali potovalni bolezni (antihistaminiki/antiemetiki) - močna zdravila proti bolečinam (opioidi) - in alkoholne pijače
No alcohol or other solvents must be used for cleaning, as these may penetrate the skin due to the effect of the patch.
Alkohola in drugih topil zato ne smemo uporabiti, ker lahko zaradi prejšnjega delovanja obliža le ta prehajata v kožo.
Prolonged use of Fentanyl-ratiopharm can cause physical dependence.
Pri dolgotrajni uporabi obližev Fentanyl-ratiopharm se lahko pojavi psihična odvisnost.
The first of these are transient and their cause should be investigated if symptoms persist.
Prvi le teh so prehodni, v kolikor pa ne izzvenijo je potrebno raziskati druge morebitne vzroke njihovega nastanka.
The concomitant use of other CNS depressants may produce additive depressant effects and hypoventilation, hypotension as well as profound sedation or coma may occur.
Sočasna uporaba drugih zaviralcev osrednjega živčnega sistema ima lahko dodaten depresiven učinek in lahko povzroči hipoventilacijo, hipotenzijo in močno sedacijo ali komo.
If you get pregnant during treatment with Fentanyl-ratiopharm, consult your doctor.
Če med uporabo obližev Fentanyl-ratiopharm zanosite, se o tem posvetujte s svojim zdravnikom.
Fentanyl-ratiopharm is a medicinal product that could be life-threatening to children.
Obliži Fentanyl-ratiopharm so zdravilo, ki v primeru zaužitja lahko ogrozijo življenje otrok.
Following administration of Fentanyl-ratiopharm, fentanyl is continuously absorbed through the skin over a period of 72 hours.
Po pritrditvi obliža Fentanyl-ratiopharm se fentanil 72 ur absorbira skozi kožo.
The safety of fentanyl in pregnancy has not been established.
Varnost uporabe transdermalnih obližev s fentanilom v nosečnosti ni bila potrjena.
Irregular heartbeat, dilated blood vessels, hiccup, water retention in the tissues, feeling cold.
neredno bitje srca, razširjene krvni žile, kolcanje, zadrževanje vode v tkivih, občutek mraza.
If you forget, then change your patch as soon as you remember.
Če ste pozabili zamenjati obliž, to storite takoj, ko se na to spomnite.
Breakthrough pain
“Preboj bolečine”
If you take concomitantly medicines that affect brain function it is more likely that you'll have side effects especially difficulty in breathing.
Če sočasno uporabljate druga zdravila z delovanjem na osrednji živčni sistem je verjetneje, da se bodo pri vas pojavili neželeni učinki, predvsem težave z dihanjem.
Pay special attention to see that the patch sticks properly at the edges.
Posebej bodite pozorni na robove obliža, ki morajo biti dobro prilepljeni.
Pack containing 3, 5, 10 or 20 transdermal patches
Škatle s 3, 5, 10, ali 20 transdermalnimi obliži
Duration of administration
Trajanje odmerjanja
If you have been using the same dose of Fentanyl-ratiopharm for a longer period of time, your doctor may decide that you are permitted to drive and use dangerous machines.
Če ste uporabljali transdermalne obliže Fentanyl-ratiopharm že dlje časa, vam vaš zdravnik lahko dovoli vožnjo ali upravljanje strojev.
Other symptoms may be hypothermia, decreased muscle tonus, bradycardia, hypotension.
Drugi možni znaki so hipotermija, izguba mišične tenzije, bradikardija in hipotenzija.
Data obtained with intravenous fentanyl in patients with renal failure suggest that the volume of distribution of fentanyl may be changed by dialysis.
Podatki, pridobljeni pri bolnikih z ledvično okvaro, ki so fentanil prejemali intravensko, kažejo, da dializa lahko spremeni volumen porazdelitve fentanila.
As a general rule, the discontinuation of opioid analgesia should be gradual, in order to prevent withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety and muscular tremor).
Po splošnih pravilih moramo zdravljenje z opioidi ukinjati postopoma, da tako preprečimo pojav odtegnitvenih simptomov (kot so slabost, bruhanje, driska, tesnoba in mišični tremor).
Please fill in date and time when you put your patch on.
Prosimo zabeležite datum in uro aplikacije obliža.
Patients stabilized on a specific dosage will not necessarily be restricted.
Bolnikom, ki so stabilizirani na določenem odmerku, ni nujno prepovedati vožnje ali upravljanja strojev.
Eye disorders Very rare:
Očesne bolezni Zelo redki:
Significant increases in body temperature can potentially increase fentanyl absorption rate.
Ob znatnem zvišanju telesne temperature se lahko poveča hitrost absorbcije fentanila.
Uncommon: euphoria, amnesia, insomnia, hallucinations, agitation.
evforija, amnezija, nespečnost, halucinacije, razdražljivost
Any unused medicinal product should be discarded or returned to the pharmacy.
Neuporabljene obliže je treba zavreči ali vrniti v lekarno.
If patients with renal impairment receive transdermal fentanyl they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Če bolniki z okvarjenim delovanjem ledvic prejemajo transdermalne obliže fentanila, je treba pozorno spremljati znake toksičnosti fentanila in po potrebi zmanjšati odmerek.
The skin area to which the patch is applied should be free of microlesions (e.g. due to irradiation or shaving) and skin irritation.
Predel kože kamor se namesti obliž ne sme biti poškodovan (mikrolezije zaradi npr. obsevanja ali britja) ali razdražen.
All dosages given in the table are equivalent in analgesic effect to 10 mg parenteral morphine.
Preglednica 1: Ustrezni analgetični učinek zdravil Vsi, v tabeli navedeni odmerki ustrezajo analgetičnemu učinku 10 mg parenteralnega odmerka morfina.
Fentanyl should only be used during pregnancy when clearly necessary.
Zato fentanila ne smete uporabljati med nosečnostjo razen, če je nujno potrebno.
headache, visual disturbances), changes in your state of consciousness or loss of consciousness or coma - slow irregular heartbeat (bradyarrhythmias) - myasthenia gravis (a disease causing tiredness and weakness of the muscles)
(npr. glavobol, motnje vida), motnje stanja zavesti ali izgubo zavesti ali komo - počasen in nepravilen utrip srca - miastenija gravis (bolezen, ki povzroča šibkost mišic in utrujenost)
The dose should be titrated individually until analgesic efficacy is attained.
Odmerek titrirajte za vsakega posameznega bolnika, dokler ne dosežete analgetičnega učinka.
Absorption
Absorpcija:
Generalised acute allergic reactions with a fall in the blood pressure and/or difficulty in breathing (anaphylactic reactions), delusional ideas, states of excitement, loss of physical strength, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms, coordination disturbances, seizures (including clonic and grand mal seizures), diminished visual acuity, impaired respiration (respiratory depression), respiratory arrest (apnoea), painful bloating, block of the digestion channel, urinary bladder pain, passing water less than normal (reduced urine excretion).
generalizirane alergične reakcije s padcem krvnega tlaka in/ali težko dihanje (anafilaktične reakcije), privide, stanje vzdraženosti, izguba fizične moči, depresija, tesnoba, zmedenost, motnje spolnih funkcij, odtegnitveni znaki, motnje koordinacije, epileptični napadi (klonični in grand mal napadi), zmanjšana ostrina vida, motnje dihanja (depresija dihanja), zastoj dihanja (apnena), boleče napenjanje, zapora prebavnega trakta, bolečine v mehurju, zmanjšano izločanje urina.
Due to limited experience in children under 12 years of age, Fentanyl-ratiopharm should be used in this age group only after careful consideration has been given to the benefit versus risk ratio.
Zaradi omejenih izkušenj uporabe Fentanyl-ratiopharm pri otrocih mlajših od 12 let ne priporočamo, razen v primerih pazljivega ovrednotenja razmerja med koristmi in tveganji zdravljenja.
It is not recommended to use those together with Fentanyl-ratiopharm.
Uporaba teh zdravil skupaj z obliži Fentanyl-ratiopharm ni priporočena.
delusional ideas, states of excitement, asthenia, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms.
deluzije, stanja vzburjenosti, astenija, depresija, anksioznost, zmedenost, seksualna funkcionalna motnja, simptomi odtegnitve
3 transdermal patches 5 transdermal patches 10 transdermal patches 20 transdermal patches
3 transdermalni obliži 5 transdermalnih obližev 10 transdermalnih obližev 20 transdermalnih obližev
Due to the polymer matrix and the diffusion of fentanyl through the skin layers, the release rate remains relatively constant.
Polimerni matriks in difuzija fentanila skozi kožo omogoča sproščanje z razmeroma enakomerno hitrostjo.
Combined use of ritonavir or other potent CYP3A4-inhibitors with transdermal fentanyl is not recommended, unless the patient is carefully observed.
Sočasna uporaba močnih zaviralcev encima CYP3A4 in transdermalnega fentanila zato ni priporočena razen, če pri bolniku pozorno spremljate znake neželenih učinkov.
CNS active substances may worsen the respiratory depression (see section 4.5).
Sočasna uporaba fentanila in zdravil, ki delujejo na osrednje živčevje, lahko respiratorno depresijo poslabša (glejte poglavje 4.5).
If you use more Fentanyl-ratiopharm than you should If you have stuck on more patches than prescribed, remove the patches and contact your doctor or hospital on their opinion of the risk.
Če ste vzeli več obližev kot je predpisano, obliže odstranite in se nemudoma posvetujte z zdravnikom ali bolnišnico glede tveganja.
Elderly or cachectic patients should be observed carefully and the dose reduced if necessary.
Starejše ali oslabljene bolnike je treba pozorno nadzorovati in jim po potrebi zmanjšati odmerek.
All of these effects can be expected and should, therefore, be anticipated in order to optimise treatment, especially constipation.
Vse neželene učinke, posebej zaprtje, je potrebno pričakovati in zdravljenje optimizirati.
Your first patch will start to work slowly, this may take as long as one day, so your doctor may give you extra painkillers until your fentanyl transdermal patch starts working completely.
To lahko traja tudi cel dan tako, da vam vaš zdravnik lahko predpiše dodatna zdravila proti bolečinam dokler transdermalni obliž fentanila na začne popolnoma delovati.
Active substance Parenteral (im) Oral
Učinkovina parenteralno (i.m.)
Fentanyl-ratiopharm should be administered with caution to patients with bradyarrhythmias.
Fentanyl-ratiopharm utegne povzročiti bradikardijo, zato bodite pazljivi pri zdravljenju bolnikov, ki imajo bradiaritmijo.
In patients with chronic obstructive or other pulmonary diseases fentanyl may have more severe adverse reactions, in such patients opioids may decrease respiratory drive and increase airway resistance.
Pri bolnikih s kronično obstruktivno pljučno boleznijo ali drugo boleznijo dihal lahko zdravljenje s fentanilom povzroči resnejše neželene učinke, kot sta zmanjšanje frekvence dihanja in povečanje upora v zračnih poteh.
According to your reaction the strength of the patch or the number of patches may need to be adjusted.
Glede na vaš odziv na zdravljenje bo prilagodil odmerek ali število obližev.
It is advised not to use Fentanyl-ratiopharm during labour and delivery (including caesarean section) because fentanyl may cause breathing problems in the newborn child.
Uporaba obližev Fentanyl-ratiopharm med popadki in porodom (vključno s carskim rezom) ni priporočena, ker fentanil lahko pri plodu/novorojencu povzroči težave z dihanjem.
Concomitant use of potent CYP3A4-inhibitors (e.g. ritonavir) with transdermally administered fentanyl may result in increased plasma concentrations of fentanyl.
Močni zaviralci citokroma CYP3A4, kot npr. ritonavir, dani sočasno s transdermalnim fentanilom, lahko povečajo koncentracijo fentanila v plazmi.
The corresponding fentanyl dosage should be determined as follows: a) using Table 2 for patients who have a need for opioid rotation (conversion ratio of oral morphine to transdermal fentanyl equal to150:1) b) using Table 3 for patients on stable and well tolerated opioid therapy (conversion ratio of oral morphine to transdermal fentanyl equal to 100:1)
Odmerek fentanil določite na naslednji način: a) s preglednico 2 za bolnike s potrebo menjavanja zdravljenja z opioidi (delež pretvorbe peroralnega morfina v transdermalni fentanil je enak 150:1) b) s preglednico 3. za stabilne bolnike, ki dobro prenašajo zdravljenje z opioidi (delež pretvorbe peroralnega morfina v transdermalni fentanil je enak 100:1)
The patch application site should not be exposed to heat from external heat sources, e.g. sauna.
Bolnikom je treba svetovati, naj mesto aplikacije obliža ne izpostavljajo neposrednim zunanjim virom toplote, kot npr.savna.
Manufacturer Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
Ludwig-Merckle-Str. 3 89143 Blaubeuren Nemčija
Uncommon: Unnatural feeling of happiness, memory loss, difficulties in sleeping, hallucinations, agitation, tremor, sensitivity disturbances, speech disorders, fall or rise in the blood pressure and heart rate, difficulties in breathing, diarrhoea, difficulty in passing urine, skin rash, skin reddening (erythema).
nenavadno občutje sreče, izguba spomina, težave s spanjem, prividi, razdraženost, tresenje, motnje zaznavanja, motnje govora, padec ali dvig krvnega tlaka in utripa srca, težave z dihanjem, driska, težave pri odvajanju vode, kožni izpuščaj, rdečica kože (eritem).
Uncommon: hypertension, hypotension.
hipertenzija, hipotenzija
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and Address}
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte dodatek I - Izpolni država članica] {Ime in naslov}
After exhibiting a serious adverse reaction a patient should be monitored for 24 hours following removal of a transdermal patch due to the half life of fentanyl (see section 5.2).
Zaradi razpolovnega časa fentanila morate bolnika po pojavu resnega neželenega učinka nadzorovati še 24 ur po odstranitvi transdermalnega obliža (glejte poglavje 5.2).
Withdrawal symptoms have been reported when changing from long-term treatment with morphine to transdermal fentanyl despite adequate analgesic efficacy.
Pri prehodih z dolgotrajnega zdravljenja z morfinom na zdravljenje s transdermalnimi obliži fentanila so kljub ustrezni analgetični učinkovitosti poročali o znakih in simptomih odtegnitve.
Cardiac disease
Srčne bolezni
- low blood pressure - impaired liver function - impaired kidney function - if you have had a head injury, a brain tumour, signs of increased intracranial pressure (e.g.
- astma, depresija dihanja ali katero koli bolezen pljuč - nizek krvni tlak - okvarjeno delovanje jeter - okvarjeno delovanje ledvic - če ste imeli poškodovano glavo, možganski tumor ali znake povišanega intrakranialnega tlaka
After this, the Fentanyl-ratiopharm should help to relieve pain continuously and you should be able to stop taking these extra painkillers.
Ko začne obliž Fentanyl-ratiopharm delovati bo kontinuirano pomagal blažiti bolečino in ostala dodatna zdravila proti bolečinam niso več potrebna.
METHOD AND ROUTE(S) OF ADMINISTRATION Transdermal use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Transdermalna uporaba.
Respiratory depression may persist beyond the removal of the patch.
Respiratorna depresija lahko ostaja tudi po odstranitvi obliža.
The most common adverse reactions following administration at usual doses are drowsiness, confusion, nausea, vomiting and constipation.
Najpogostejši neželeni učinki po običajnih odmerkih so zaspanost, zmedenost, slabost, bruhanje in zaprtje.
Fentanyl-ratiopharm is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers.
Obliži Fentanyl-ratiopharm se uporabljajo pri hudih kroničnih bolečinah, ki jih je treba zdraviti z močnimi zdravili proti bolečinam.
Feeling unusually drowsy or tired (depressant effect on brain function), nervousness, loss of appetite, dry mouth, stomach pain, skin reactions at the attachment site.
občutek zaspanosti, omotičnosti ali utrujenosti (depresija centralnega živčnega sistema), živčnost, izguba apetita, suha usta, bolečine v trebuhu, kožne reakcije na mestu aplikacije obliža.
As fentanyl is excreted into breast milk, lactation should be discontinued under the treatment with fentanyl (see also section 4.6)
Z ozirom na dejstvo, da se fentanil izloča v materino mleko, je treba dojenje pri zdravljenju s fentanilom prekiniti (glejte tudi poglavje 4.6).
Combination with barbituric acid derivatives, buprenorphine, nalbuphine and pentazocine should in general be avoided (see section 4.5).
Sočasna uporaba barbituratov, buprenorfina, nalbufina ali pentazocina ni priporočljiva in se ji na splošno izogibamo (glejte poglavje 4.5).
Table 3: Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients on stable and well tolerated opioid therapy)
Preglednica 3: Priporočeni začetni odmerek transdermalnih obližev fentanila na osnovi dnevnega peroralnega odmerka morfina (za stabilne bolnike, ki dobro prenašajo zdravljenje z opioidi)
Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Fentanil je zdravilo z visokim očistkom, ki ga encim CYP3A4 večinoma hitro in močno presnavlja.
The serum fentanyl concentrations attained are dependant on the fentanyl transdermal patch size.
Koncentracija, ki jo fentanil doseže v serumu, je odvisna od velikosti transdermalnega obliža.
The transdermal patches are equipped with a blue imprint with the strength.
Na transdermalne obliže je z modrim črnilom natisnjena jakost zdravila.
The product is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Zdravilo je indicirano za hude kronične bolečine, ki zahtevajo zdravljenje z opioidnimi analgetiki.
How to change the transdermal patch - Remove the patch after the period your doctor has told you.
- Obliž odstranite po obdobju, ki ga je določil zdravnik.
Very common: headache, dizziness.
Zelo pogosti: glavobol, omotica Občasni:
Less than 10 % of fentanyl is excreted unchanged by the kidneys, and unlike morphine, there are no known active metabolites eliminated by the kidneys.
Pri fentanilu (za razliko od morfina) ni znanih aktivnih presnovkov, ki bi se izločali skozi ledvice.
Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
Pri starejših in oslabelih bolnikih je očistek fentanila lahko zmanjšan; zdravilo ima zato daljšo razpolovno dobo.
Constipation, on the other hand, does not stop if treatment continues.
Zaprtje pa tekom zdravljenja ne izzveni.
The dosing is individual and based on the patient's opioid history and takes into account:
Odmerjanje je individualno in osnovano na podlagi bolnikovega prejšnjega zdravljenja z opioidnim analgetiki.
Adhesive layer: Polyacrylate adhesive layer Backing film: Polypropylene foil, blue printing ink Release liner: Polyethylene terephthalate foil (siliconised)
Lepljiva površina: poliakrilatni adheziv Zaščitna obloga: polipropilenska folija, modro črnilo za tisk Membrana za sproščanje zdravila: tetraftalatna folija
Polyacrylate adhesive layer
Adhezivna površina poliakrilatni adheziv
It is advised not to use fentanyl during labour and delivery (including caesarean section) since fentanyl passes the placenta and may cause respiratory depression in the new born infant.
Uporaba fentanila med popadki in porodom (vključno s carskim rezom) ni priporočena, ker fentanil prehaja v placento in lahko pri plodu/novorojencu povzroči respiratorno depresijo.
Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed infant.
Fentanil prehaja v materino mleko, kar lahko pri dojenčku povzroči sedacijo in respiratorno depresijo.
Fentanyl passes into the breast-milk and may cause side effects in the breast-fed infant as sedation and respiratory depression.
Fentanil prehaja v materino mleko, kar lahko pri dojenčku povzroči neželene učinke kot npr. sedacijo in respiratorno depresijo.
This is because fentanyl levels fall gradually after the patch is removed; it takes at least 17 hours for the fentanyl serum concentration to decrease by 50 %.
Vsaj 17 ur po odstranitvi obliža traja, da se koncentracija fentanila v serumu zmanjša za 50 odstotkov.
- Hypersensitivity to the active substance or to any of the excipients.
- Preobčutljivost za fentanil ali katerokoli pomožno snov.
If you stop using Fentanyl-ratiopharm
Če prenehate uporabljati obliže Fentanyl-ratiopharm
MARKETING AUTHORISATION NUMBERS [To be completed nationally]
ŠTEVILKA DOVOLJENJA ZA PROMET [Izpolni država članica]
Caution should be exercised when treating patients with myasthenia gravis.
Pri zdravljenju bolnikov z miastenijo gravis morate biti previdni.
Very common: Somnolence, headache, dizziness, nausea, vomiting, constipation, sweating, itching.
Zelo pogosti: zaspanost, glavobol, omotica, slabost, bruhanje, zaprtost, potenje, srbenje.
Lactation should therefore be discontinued during treatment and for at least 72 hours after the removal of Fentanyl-ratiopharm (see also section 4.4)
Zato se mora dojenje med zdravljenjem z obliži Fentanyl-ratiopharm prekiniti in se ne sme začeti prej kot 72 ur po zadnji uporabi fentanila (glejte poglavje 4.4).
You should not take the medicines listed below at the same time as you are using Fentanylratiopharm, unless you are closely monitored by your doctor.
Bolniki med zdravljenjem z obliži Fentanyl-ratiopharm ne smejo jemati spodaj naštetih zdravil, razen, če so pod strogim nadzorom zdravnika.
Lactation
vazodilatacija
As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
Ker fentanil prehaja v materino mleko je potrebno dojenje med zdravljenjem z obliži Fentanylratiopharm prekiniti (glejte poglavje 4.6).
Symptoms
Kontraindikacije