natgillin/translations-raw huggingface dataset:
How to store Clopidogrel/Acetylsalicylic acid Teva
Shranjevanje zdravila Klopidogrel/acetilsalicilna kislina Teva
What Clopidogrel/Acetylsalicylic acid Teva contains
Kaj vsebuje zdravilo Klopidogrel/acetilsalicilna kislina Teva
System Organ
Organski sistem Pogosti
Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Klopidogrel/acetilsalicilna kislina Teva 75 mg/75 mg filmsko obložene tablete klopidogrel/acetilsalicilna kislina
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki hidrogensulfata) in 100 mg acetilsalicilne kisline.
• stomach ulcer
• Okvara jeter
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki hidrogensulfata) in 75 mg acetilsalicilne kisline.
Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Klopidogrel/acetilsalicilna kislina Teva 75 mg/100 mg filmsko obložene tablete klopidogrel/acetilsalicilna kislina
You should stop other clopidogrel treatment while you are taking Clopidogrel/Acetylsalicylic acid Teva.
Če se pojavi podaljšanje krvavitve v času jemanja zdravila Klopidogrel/acetilsalicilna kislina Teva
• fever
• plod:
• burning in stomach and/or oesophagus
• pekoč občutek v želodcu in/ali požiralniku,
The combination of clopidogrel/acetylsalicylic acid must not be used in patients with severe renal impairment (see section 4.3).
Kombinacije klopidogrela/acetilsalicilne kisline se ne sme uporabljati pri bolnikih s hudo okvarjenim delovanjem ledvic (glejte poglavje 4.3).Terapevtske izkušnje pri bolnikih z blago do zmerno okvarjenim delovanjem ledvic so omejene (glejte poglavje 4.4).
Possible side effects
Pomožne snovi
Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets Clopidogrel/Acetylsalicylic acid
Klopidogrel/acetilsalicilna kislina Teva 75 mg/100 mg tablete klopidogrel/acetilsalicilna kislina
Contact your doctor immediately if you experience: • fever, signs of infection or extreme tiredness.
• zvišana telesna temperatura, znaki okužbe ali huda utrujenost.
• dizziness
• izpuščaji,
• constipation
Vrtoglavica
NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg tablets Clopidogrel/Acetylsalicylic acid
Klopidogrel/acetilsalicilna kislina Teva 75 mg/75 mg tablete klopidogrel/acetilsalicilna kislina
2 capsules
2 kapsuli
1 capsule (125 mg) + 2 capsules (80 mg)
1 kapsula (125 mg) + 2 kapsuli (80 mg)
1 sachet + 2 dispensers + 1 cap + 1 mixing cup
kapsula, trda peroralna uporaba pretisni omot (PVC/alu) 1 kapsula kapsula, trda peroralna uporaba pretisni omot (PVC/alu) 6 x 1 kapsula prašek za peroralno suspenzijo peroralna uporaba vrečka (PET/Alu/LLDPE) 1 vrečka + 2 odmernika + 1 zaporka + 1 čaša za mešanje
The marketing authorisation holders should provide convincing and robust data to identify a patient population in which the clinical benefits of ketoconazole-containing products for oral use clearly outweigh the risks.
Imetniki dovoljenja za promet z zdravilom morajo predložiti prepričljive in zanesljive podatke, ki bi omogočili določanje specifične populacije bolnikov, pri kateri klinične koristi zdravil za peroralno uporabo, ki vsebujejo ketokonazol, jasno odtehtajo z njimi povezana tveganja.
National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic bodo zagotovili, kadar je to primerno, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
Annex III Conditions for lifting the suspension of the Marketing Authorisation(s)
Priloga III Pogoji za preklic začasnega umika dovoljenj za promet z zdravili
Conditions for lifting the suspension of the Marketing Authorisation(s)
Pogoji za preklic začasnega umika dovoljenj za promet z zdravili
The company had not yet responded to the last round of questions at the time of the withdrawal.
Družba v času umika še ni odgovorila na zadnja vprašanja.
The company also provided results of a mathematical (modelling and simulation) exercise to predict the levels of the active substances and the medicine's effectiveness in clearing the virus from the blood in different circumstances.
Družba je priskrbela tudi rezultate matematičnih (modelnih in simulacijskih) operacij, da bi predvideli ravni zdravilnih učinkovin in učinkovitost zdravila pri odstranjevanju virusa iz krvi v različnih okoliščinah.
What is Cokiera?
Kaj je zdravilo Cokiera?
The active substances in Cokiera work in different ways.
Zdravilne učinkovine v zdravilu Cokiera različno delujejo.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogo so umaknili po tem, ko je odbor CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
Ritonavir itself does not have an antiviral effect on hepatitis C virus.
Ritonavir sam po sebi nima protivirusnega učinka na virus hepatitisa C.
The active substances in Cokiera are effective against hepatitis C virus genotypes 1a and 1b.
Zdravilne učinkovine v zdravilu Cokiera so učinkovite proti virusu hepatitisa C genotipov 1a in 1b.
On 3 August 2016, AbbVie Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cokiera, for the treatment of chronic hepatitis C.
Družba AbbVie Ltd je 3. avgusta 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Cokiera, namenjenim zdravljenju kroničnega hepatitisa C.
Because all the active substances in Cokiera were already included in authorised medicines, the company presented the results of studies to see whether the active substances from Cokiera were ‘bioequivalent' to the authorised medicines.
Ker so bile vse zdravilne učinkovine v zdravilu Cokiera že vključene v odobrena zdravila, je družba predstavila rezultate študij, da bi ugotovili, ali so zdravilne učinkovine v zdravilu Cokiera biološko enakovredne odobrenim zdravilom.
Cokiera is an antiviral medicine containing the active substances dasabuvir, ombitasvir, paritaprevir and ritonavir.
Zdravilo Cokiera je protivirusno zdravilo, ki vsebuje zdravilne učinkovine dasabuvir, ombitasvir, paritaprevir in ritonavir.
Cokiera was expected to be used for treating adults with chronic (long-term) hepatitis C. Hepatitis C is an infection of the liver caused by the hepatitis C virus.
Zdravilo Cokiera naj bi se uporabljalo za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C. Hepatitis C je okužba jeter, ki jo povzroča virus hepatitisa C.
The CHMP considered that the data provided did not properly show how the size of meals affect absorption of the active substances from Cokiera and therefore how well Cokiera works.
Presodil je, da predloženi podatki ne kažejo ustrezno, kako velikost obroka vpliva na absorpcijo zdravilnih učinkovin v zdravilu Cokiera in posledično učinkovitost zdravila Cokiera.
All four active substances in Cokiera are already available in authorised medicines for treating chronic hepatitis C. It was expected that combining the substances in a single tablet would make it simpler for patients to take their medicine.
Vse štiri zdravilne učinkovine v zdravilu Cokiera se že uporabljajo v odobrenih zdravilih za zdravljenje kroničnega hepatitisa C. Kombiniranje učinkovin v eni tableti naj bi bolnikom olajšalo jemanje zdravila.
What was Cokiera expected to be used for?
Za kaj naj bi se zdravilo Cokiera uporabljalo?
In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal is based on strategic business reasons for this specific product.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da je vlogo umaknila zaradi strateških poslovnih razlogov v zvezi z zdravilom Cokiera.
Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cokiera could not have been approved for the treatment of chronic hepatitis C in adults.
Na podlagi pregleda podatkov je odbor v času umika izrazil določene zadržke in začasno menil, da zdravila Cokiera ni mogoče odobriti za zdravljenje kroničnega hepatitisa C pri odraslih.
The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this specific product.
Družba je odbor CHMP obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe zdravila Cokiera.
Dasabuvir blocks the action of an enzyme in the hepatitis C virus, called ‘NS5B RNA-dependent polymerase', which the virus needs to multiply.
Dasabuvir zavira delovanje encima v virusu hepatitisa C, imenovanega „RNK-polimeraza NS5B, odvisna od RNK“, ki ga virus potrebuje za razmnoževanje.
Ombitasvir blocks the action of a protein in the hepatitis C virus called ‘NS5A' and paritaprevir blocks the action of another protein called ‘NS3/4A', both of which the virus needs to multiply.
Ombitasvir zavira delovanje beljakovine v virusu hepatitisa C, imenovane „NS5A“, paritaprevir pa zavira delovanje druge beljakovine, imenovane „NS3/4A“.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Cokiera.
Zato je v času umika menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Cokiera.
How is Cokiera expected to work?
Kako naj bi zdravilo Cokiera delovalo?
Ritonavir, the fourth active substance, slows down the removal of paritaprevir from the body by blocking an enzyme called CYP3A that breaks down paritaprevir.
telesa, tako da zavira encim CYP3A, ki razgrajuje paritaprevir.
Generally, these reactions were mild or moderate.
Te reakcije so bile na splošno rečeno blage ali zmerne.
Cmax was not significantly changed.
Cmax se ni signifikantno spremenila.
Do not give this medicine to children and adolescents under the age of 18 because the potential risks and benefits are not known.
Tega zdravila ne dajajte otrokom in mladostnikom, ki so mlajši od 18 let, saj možna tveganja in koristi niso znani.
The majority of patients had a primary diagnosis of back pain.
Večina bolnikov je imelo primarno diagnozo bolečine v hrbtu.
Important notes:
Pomembne opombe:
Studies have been conducted in juvenile rats and dogs.
Študije so bile opravljene na mladičih podgan in psov.
How often this happens is not known from the data that is available.
Ni znano, kako pogosto se je to zgodilo, saj podatki niso na voljo.
If it is not, do not use the solution.
Če ni taka, je ne smete uporabiti.
Are you mobile enough to reach the toilet, or do you have a caregiver looking after you who can help?
Ste dovolj pokretni, da lahko sami pridete do stranišča, oziroma imate negovalca, ki vam lahko pri tem pomaga?
This section is divided into the following subsections:
To poglavje je razdeljeno v naslednja podpoglavja:
Has it been 48 hours or longer since your last bowel movement?
Je od vašega zadnjega iztrebljanja minilo 48 ur ali več?
The injection volume for these patients should be calculated as follows:
Injekcijski volumen za te bolnike izračunamo kot sledi:
Treatment should be initiated as appropriate.
Z zdravljenjem je treba začeti, če je potrebno.
The following packs are available:
Na voljo so naslednja pakiranja:
Wash your hands thoroughly with soap and warm water.
Roke si temeljito umijte z milom in toplo vodo.
Date of first authorisation: 02 July 2008 Date of latest renewal: 27 May 2013
Datum prve odobritve: 2. julij 2008 Datum zadnjega podaljšanja: 27. maj 2013
Please read and follow them step by step.
Preberite jih in se korak za korakom ravnajte po njih.
Opioids are prescribed by your doctor.
Opioide vam predpisuje vaš zdravnik.
There is no need to worry about this as it will not affect the accuracy of the dose or pose any risk to your health.
Zaradi tega se ne vznemirjajte, saj to ne vpliva na natančnost odmerka in ne predstavlja tveganja za vaše zdravje.
This medicine is for use in adults (aged 18 and over).
To zdravilo je namenjeno za uporabo pri odraslih (starih 18 let in več).
The terminal disposition half-life (t1/2) is approximately 8 hours.
Končni razpolovni čas odstranjevanja (t1/2) je približno 8 ur.
Always have the outer carton of the medicine with you, even if it is empty.
Vedno imejte pri sebi škatlo zdravila, tudi če je prazna.
Your doctor may allow you to take other medicines, including those used for constipation.
Mogoče vam bo zdravnik dovolil jemati še druga zdravila, tudi taka, ki se uporabljajo za zaprtje.
You may have a bowel movement within a few minutes to a few hours of the injection; therefore, it is recommended to have a toilet facility or bedpan near you.
Mogoče boste šli na blato v nekaj minutah do nekaj urah po injekciji; zato je priporočljivo, da imate stranišče ali nočno posodo v bližini.
When you hear a click sound that means the entire contents were injected.
Potem ko zaslišite klik, to pomeni, da ste vbrizgali vso vsebino.
The following side effects are very common and may affect more than 1 in 10 people.
Naslednji neželeni učinki so zelo pogosti in se lahko pojavijo pri več kot 1 od 10 bolnikov.
Please read the instructions carefully and follow them step by step.
Navodila natančno preberite in se korak za korakom ravnajte po njih.
Avoid repeated injections at the exact same spot previously used.
Izogibajte se ponovnim injekcijam na točno istem mestu, ki ste ga uporabili že prej.
If you receive only the vial, you will need to obtain alcohol swabs and an injection syringe.
Če ste prejeli samo vialo, si boste morali nabaviti alkoholne zložence in injekcijsko brizgo.
In the event of an overdose, signs and symptoms of orthostatic hypotension should be monitored and reported to a physician.
V primeru prevelikega odmerka je treba spremljati znake in simptome ortostatske hipotenzije in o njih poročati zdravniku.
The steady-state volume of distribution (Vss) is approximately 1.1 L/kg.
Volumen porazdelitve v stanju ravnovesja (Vss) je približno 1,1 l/kg.
In both studies, there was no evidence to suggest differential effects of age or gender on safety or efficacy.
V nobeni od teh dveh študij ni bilo znakov, ki bi kazali na razlikovalne učinke starosti ali spola na varnost ali učinkovitost.
You may receive either a pack containing an inner carton with everything needed for the injection, or a single vial only.
Na voljo imate bodisi škatlo z notranjo škatlo, ki vsebuje vse, kar potrebujete za injiciranje, ali samo eno vialo.
However, this resulted in a small reduction in total clearance (from 107 L/h to 95 L/h).
Vendar je to le malo zmanjšalo celotni očistek (s 107 l/uro na 95 l/uro).
This will mean that the safety mechanism has been activated, and the needle will disappear into the syringe.
To bo pomenilo, da se je aktiviral varnostni mehanizem in igla se bo potegnila v injekcijsko brizgo.
Hold the syringe in one hand like a pencil.
Držite brizgo v eni roki, kot bi držali svinčnik.
Therefore, no dose adjustment is recommended based on age.
Zato na podlagi starosti ne priporočajo nikakršnega prilagajanja odmerjanja.
In these studies, the median age was 68 years (range 21-100); 51 % were females.
V teh študijah je bila mediana starost 68 let (razpon 21-100); 51 % je bilo žensk.
Pharmacotherapeutic group: Laxatives, Peripheral opioid receptor antagonists, ATC code: A06AH01
Farmakoterapevtska skupina: Odvajala, antagonisti perifernih opioidnih receptorjev, oznaka ATC: A06AH01
Throughout both study periods, patients maintained their usual laxative regimen.
Med obema obdobjema študije so se bolniki držali svojega običajnega predpisanega programa odvajanja.
• If you are receiving supportive care for your advanced illness, this medicine will only be used for a limited period of time, which will usually be less than 4 months.
• Če prejemate podporno nego zaradi napredovale bolezni, se lahko to zdravilo uporablja le v omejenem časovnem obdobju, ki običajno ni daljše od 4 mesecev.
This may have an effect on your ability to drive and use machines.
To lahko vpliva na vašo sposobnost vožnje in upravljanja strojev.
Dose (mL) = patient weight (kg) x 0.0075
odmerek (ml) = bolnikova telesna teža (kg) x 0,0075
A total of 136, 21, and 82 patients received at least one open-label dose in studies 301, 301EXT, and 302EXT, respectively.
Vsega skupaj 136, 21 in 82 bolnikov je v študijah 301, 301EXT oziroma 302EXT prejelo vsaj po en odprt odmerek.
This should be taken into account when prescribing methylnaltrexone bromide for such patients.
To je treba upoštevati pri predpisovanju metilnaltreksonijevega bromida takšnim bolnikom.
You may use a sharps container (such as a yellow biohazard container).
Uporabite lahko vsebnik za ostre odpadke (na primer rumeni vsebnik za biološko nevarne odpadke).
Effect on cardiac repolarisation
Vpliv na repolarizacijo srca
Remove the protective plastic cap from the vial.
Odstranite plastično zaščitno zaporko z viale.
Relistor was administered every 3.2 days (median dosing interval, with a range of 1-39 days).
Zdravilo Relistor so dajali na 3,2 dneva (mediani interval odmerjanja, z razponom 1-39 dni).
In both studies, patients had advanced terminal illness and limited life expectancy, with the majority having a primary diagnosis of incurable cancer; other primary diagnoses included end-stage COPD/emphysema, cardiovascular disease/heart failure, Alzheimer's disease/dementia, HIV/AIDS, or other advanced illnesses.
V obeh študijah so imeli bolniki napredovalo terminalno bolezen in krajšo pričakovano življenjsko dobo, večina jih je imela primarno diagnozo neozdravljivega raka; med drugimi primarnimi diagnozami so bili še končni stadij KOPB/emfizema, kardiovaskularne bolezni/popuščanja srca, Alzheimerjeve bolezni/demence, HIV/AIDS in drugih napredovalih bolezni.
In this study, the median patient age was 49 years (range 23-83); 60% were females.
V tej študiji je bila mediana starost bolnikov 49 let (razpon 23-83); 60 % je bilo žensk.
Your doctor will tell you whether you should stop or continue taking your usual laxatives when you start using this medicine.
Zdravnik vam bo povedal, ali naj z običajnim laksativnim zdravljenjem prenehate ali nadaljujete, ko začnete uporabljati to zdravilo.
This section contains important questions that you will need to answer before you take Relistor, and during treatment with Relistor.
To poglavje vsebuje pomembna vprašanja, na katera boste morali odgovoriti, preden vzamete zdravilo Relistor ali med zdravljenjem z zdravilom Relistor.
It is used for patients when other medicines for constipation, called laxatives, have not worked well enough.
Uporablja se pri bolnikih, če druga zdravila proti zaprtju, imenovana laksativi, niso bila dovolj učinkovita.
The mechanism of this effect is unknown; however, the human cardiac potassium ion channel (hERG) appears not to be involved.
Mehanizem tega učinka ni znan; zdi pa se, da kalijevi kanalčki (hERG) v človeškem srcu niso vpleteni.
Approximately half of the dose is excreted in the urine and somewhat less in faeces.
Približno pol odmerka se izloči z urinom in nekaj manj z blatom.
Select a flat, clean, well-lit working surface where you can lay out the contents of your Relistor carton.
Pripravite si ravno, čisto in dobro osvetljeno delovno površino, kamor boste zložili vsebino škatle zdravila Relistor.
Patients were required to discontinue all previous laxative therapy.
Od bolnikov se je zahtevalo, da so se prenehali zdraviti z vsemi predhodnimi odvajalnimi zdravili.
Gender No meaningful gender differences have been observed.
Pomembnih razlik zaradi spola niso opazili.
Dizziness may occur, and this may have an effect on the ability to drive and use machines (see section 4.8).
Lahko se pojavi vrtoglavost, ki lahko vpliva na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
Your doctor will decide if you can use Relistor if you are pregnant.
Vaš zdravnik se bo odločil, ali lahko med nosečnostjo uporabljate zdravilo Relistor.
This injection should not be mixed in the same syringe with any other medicine.
Te raztopine za injiciranje ne smete zmešati v isti brizgi z nobenim drugim zdravilom.
Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia.
Pri bolnikih, ki imajo motnje hematoencefalne bariere, se lahko poveča tveganje za opioidni odtegnitveni sindrom in/ali zmanjšano analgezijo.
Due to light sensitivity, the solution for injection should be used within 24 hours.
Zaradi občutljivosti za svetlobo morate raztopino za injiciranje uporabiti v 24 urah.
• If you are allergic to methylnaltrexone bromide or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na metilnaltreksonijev bromid ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Constipation not related to opioid use
Konstipacija, ki ni povezana z uporabo opioidov
• This medicine should not be used for treatment of patients with constipation which is not related to opioid use.
• Tega zdravila se ne sme uporabljati za zdravljenje bolnikov s konstipacijo, ki ni povezana z uporabo opioidov.
The effect on race could not be analysed because the study population was predominantly Caucasian (88 %).
Vpliva rase ni bilo mogoče analizirati, ker so v populaciji študije prevladovali pripadniki bele rase (88 %).
Do you have a contact number for your community nurse or the health centre?
Imate telefonsko številko medicinske sestre vašega zdravnika ali zdravstvenega doma?
If severe or persistent diarrhoea occurs during treatment, patients should be advised not to continue therapy with methylnaltrexone bromide and consult their physician.
Če se med zdravljenjem pojavi huda ali trdovratna driska, moramo bolnikom svetovati, naj ne nadaljujejo zdravljenja z metilnaltreksonijevim bromidom in naj se posvetujejo s svojim zdravnikom.
If this happens, discard the product and start again using another vial and syringe.
Če se to zgodi, zdravilo zavrzite in začnite znova z drugo vialo in injekcijsko brizgo.
Methylnaltrexone sulphate is an inactive metabolite and present in plasma at a level of approximately 25 % of drug related materials.
Metilnaltreksonijev sulfat je neaktiven presnovek in je prisoten v plazmi na ravni približno 25 % snovi, povezanih z zdravilom.
For storage conditions of the medicinal product in the syringe, see section 6.3.
Za pogoje shranjevanje zdravila v injekcijski brizgi glejte poglavje 6.3.
The 8 mg pre-filled syringe will only be used to treat these patients if the dose needs to be decreased because of another medical problem.
8-mg napolnjena injekcijska igla se za te bolnike uporablja samo, če je treba zaradi druge zdravstvene težave odmerek zmanjšati.
PATIENT CHECKLIST
KONTROLNA KARTICA ZA BOLNIKA
Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/kg.
Bolniki, katerih telesna teža je zunaj navedenih meja, naj prejmejo po 0,15 mg/kg.
The safety and efficacy of methylnaltrexone bromide in children less than 18 years has not been established.
Varnosti in učinkovitost metilnaltreksonijevega bromida pri otrocih, mlajših od 18 let, nista bili dokazani.
At any time, the patient's assigned dose could be reduced based on tolerability.
Bolniku dodeljeni odmerek se je lahko kadarkoli zmanjšal na podlagi slabega prenašanja zdravila.
Women using this medicine should not breast-feed, since it is not known if methylnaltrexone bromide passes into human breast milk.
Ženske, ki uporabljajo to zdravilo, ne smejo dojiti, saj ni znano, ali se metilnaltreksonijev bromid izloča v materino mleko.