natgillin/translations-raw huggingface dataset:
Emdocam alone will not provide adequate pain relief during the dehorning procedure. 
Samo zdravilo Emdocam ne zagotavlja ustreznega lajšanja bolečine med postopkom odstranjevanja rogov.
Name and address of the manufacturer responsible for batch release Produlab Pharma bv 
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Produlab Pharma bv
In horses, a transient swelling at the injection site can occur but resolves without intervention. 
Pri konjih se lahko na mestu injiciranja pojavi prehodna oteklina, ki mine brez intervencije.
MANUFACTURER´S BATCH NUMBER 
IZDELOVALČEVA ŠTEVILKA SERIJE
DD.MM.YYYY 
DD.MM.LLLL
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable 
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
Overdose (symptoms, emergency procedures, antidotes): In case of overdose, symptomatic treatment should be initiated. 
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Pri prevelikem odmerjanju uvedite simptomatsko zdravljenje.
People with known hypersensitivity to Non-Steroidal AntiInflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. 
Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
Meloxicam is predominantly found in plasma. 
Presnavljanje Meloksikam se pretežno nahaja v plazmi.
Meloxicam in Emdocam 20 mg/ml solution for injection for cattle, pigs and horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Meloksikam v zdravilu Emdocam 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje, kot je navedeno v tabeli 1( dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010, je dovoljena učinkovina:
Clear yellow solution. 
Prozorna rumena raztopina.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals, including isolated reports treated). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).>
To a minor extent it also inhibits collagen-induced thrombocyte aggregation. 
V manjši meri zavira agregacijo trombocitov, ki jo povzroča kolagen.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. 
Za zmanjšanje kliničnih znakov driske, v kombinaciji s peroralnim rehidracijskim zdravljenjem, pri teletih, starejših od enega tedna, in mladem govedu, ki ni v obdobju laktacije.
Not authorised for use in horses producing milk for human consumption. 
5 dni Ni dovoljena uporaba pri konjih, katerih mleko je namenjeno prehrani ljudi.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE 
B. POGOJI DOVOLJENJA TER OMEJITVE GLEDE OSKRBE IN UPORABE
Meloxicam 20 mg/ml 
meloksikam 20 mg/ml
Marketing authorisation holder Emdoka bvba 
Imetnik dovoljenja za promet z zdravilom Emdoka bvba
Any unused medicines should not be disposed of via wastewater or household waste. 
Ne odvrzite zdravila v odpadno vodo ali <med gospodinjske odpadke.
Shelf-life after first opening of the container: 28 days. 
Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. 
Za zmanjšanje simptomov šepavosti in vnetja pri neinfekcijskih lokomotornih motnjah.
Cattle, pigs and horses 
govedo, prašiči in konji
After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 µg/ml was reached after 1 hour in pigs. 
Po dveh intramuskularnih odmerkih meloksikama po 0,4 mg/kg je znašala Cmax pri prašičih po 1 uri 1,9 µg/ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON - 50, 100 or 250 ml vials 
ZUNANJA KARTONSKA ŠKATLA - viale s 50, 100 ali 250 ml
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively. 
Po enkratnem subkutanem odmerku meloksikama po 0,5 mg/kg je znašala Cmax pri mladem govedu in kravah v obdobju laktacije 2,1 µg/ml in 2,7 µg/ml po 7,7 ure in 4 urah.
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively. 
Razpolovna doba izločanja meloksikama je po subkutani injekciji pri mladem govedu in kravah v obdobju laktacije 26 in 17,5 ure.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant medicinal products. 
Zdravila ne smete dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulantnimi zdravili.
NL-4941 SJ Raamsdonksveer The Netherlands 
Produlab Pharma bv NL-4941 SJ Raamsdonksveer Nizozemska
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-skeletal disorders, a suitable oral therapy containing meloxicam, administered in accordance with label recommendations, may be used for continuation of treatment. 
Pri umirjanju vnetja in lajšanju bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih lahko za nadaljevanje zdravljenja uporabimo ustrezno peroralno zdravljenje, ki vsebuje meloksikam in se daje v skladu z navodili za uporabo.
Ethanol (96%) Poloxamer 188 
etanol (96 %)
4.7 Use during pregnancy, lactation or lay Cattle and pigs: 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. 
Za zmanjšanje kliničnih znakov pri akutnih okužbah dihal pri govedu ob ustreznem antibiotičnem zdravljenju.
Shelf-life after first opening the container: 28 days. 
EXP {mesec/leto} Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy. 
Za pomožno zdravljenje pri zdravljenju puerperalne septikemije in toksemije (sindroma mastitisa,
A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies. 
NEŽELENI UČINKI V kliničnih raziskavah so zasledili blago in prehodno oteklino na mestu injiciranja po subkutanem dajanju, in sicer pri manj kot 10 % goveda.
Emdocam 20 mg/ml solution for injection for cattle, pigs and horses 
Emdocam 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje
THE WORDS "KEEP OUT OF SIGHT AND REACH OF CHILDREN" 
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM”
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS 
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E)
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and vial after EXP. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in viali za EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
Ethanol (96%) 150 mg Clear yellow solution for injection. 
150 mg Prozorna rumena raztopina za injiciranje.
Meloxicam Meloxicam Bovine, caprine, porcine, rabbit, 
Terapevtske indikacije meloksikam meloksikam govedo, koze,
Do not use in pregnant and lactating mares. 
Ne uporabite pri kobilah v obdobju brejosti in laktacije.
Emdocam 20 mg/ml solution for injection for cattle, pigs and horses meloxicam 
Emdocam 20 mg/ml, raztopina za injiciranje za govedo, prašiče in konje meloksikam
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate. 
Govedo Enkratna subkutana ali intravenska injekcija odmerka po 0,5 mg meloksikama na kilogram telesne mase (to je 2,5 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
Once broached, use by… 
Načeto zdravilo uporabite do …
QUANITITY OF THE ACTIVE SUBSTANCE(S) 
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E)
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 28 days 
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06 
Oznaka ATCvet: QM01AC06
Single intramuscular injection at a dose of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate. 
Enkratna intramuskularna injekcija odmerka po 0,4 mg meloksikama na kilogram telesne mase (to je 2 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem.
Bovine, caprine 
kunci, kopitarji
Cattle: Meat and offal: 
Govedo: Meso in organi:
Cattle: meat and offal: 15 days; milk: 5 days 
Karenca: Govedo: meso in organi: 15 dni; mleko: 5 dni
meat and offal: 5 days 
meso in organi: 5 dni
Withdrawal periods: Cattle: meat and offal: 15 days; milk: 5 days. 
Karenca: Govedo: meso in organi: 15 dni; mleko: 5 dni.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label for 100 ml and 250 ml 
Etiketa viale s 100 ml in 250 ml
Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 3 ml/100 kg body weight). 
Enkratna intravenska injekcija odmerka po 0,6 mg meloksikama na kilogram telesne mase (to je 3 ml/100 kg telesne mase).
Pack size of 1 colourless Type I glass vial containing 50 ml, 100 ml or 250 ml. 
Velikost pakiranja 1 viala iz brezbarvnega stekla tipa I po 50 ml, 100 ml ali 250 ml. Viale so zaprte z brombutilnimi gumijastimi zamaški in zapečatene z aluminijastimi zaporkami.
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS , IF ANY 
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
Once broached, use by _____ 
UPORABE, če je smiselno
Do not use in pregnant or lactating mares. 
Ne uporabite pri brejih kobilah ali kobilah v obdobju laktacije.
Excipient: 
Karenca:
Pharmacologically active substance 
Farmakološko aktivna snov(i)
Can be used during pregnancy and lactation. 
Govedo in prašiči: Lahko se uporablja v obdobju brejosti in laktacije.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label for 50 ml 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Sodium hydroxide Hydrochloric acid Meglumine Water for injections 
- etanol (96 %) - poloksamer 188 - makrogol 300 - glicin - natrijev hidroksid - klorovodikova kislina - meglumin - voda za injekcije
The European Commission granted a marketing authorisation valid throughout the European Union for DepoCyte on 11 July 2001. 
Evropska komisija je dovoljenje za promet z zdravilom DepoCyte, veljavno po vsej Evropski uniji, odobrila dne 11. julija 2001.
Other information about DepoCyte: 
Druge informacije o zdravilu DepoCyte:
DepoCyte cytarabine 
Depocyte citarabin
A patient was classified as a ‘responder' if they had no cancer cells in the spinal fluid after treatment and if their symptoms had not got worse after four weeks. 
Bolnik je bil označen kot „odziven“, če po zdravljenju v spinalni tekočini ni imel rakavih celic in če se njihovi simptomi po štirih tednih niso poslabšali.
The marketing authorisation holder is Pacira Limited. 
Imetnik dovoljenja za promet je družba Pacira Limited.
This document is a summary of the European Public Assessment Report (EPAR) for DepoCyte. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo DepoCyte.
In the main study, 72% of the patients who received DepoCyte responded to treatment (13 out of 18), compared with 18% of those who received the standard formulation of cytarabine (3 out of 17). 
V glavni študiji se je 72 % (13 od 18) bolnikov, ki so prejemali zdravilo DepoCyte odzvalo na zdravljenje, v primerjavi z 18 % (3 od 17) tistih, ki so prejemali standardno obliko citarabina.
For more information about treatment with DepoCyte, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom DepoCyte preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The study also looked at how long the patients lived without their nerve disease getting worse. 
V študiji so opazovali tudi, kako dolgo so bolniki živeli, ne da bi se obolenje živcev poslabšalo.
What benefit has DepoCyte shown during the studies? 
Kakšne koristi je zdravilo DepoCyte izkazalo med študijami?
As a result, cytarabine slows down the growth of tumour cells and eventually kills them. 
Posledično citarabin upočasni rast tumorskih celic in jih sčasoma tudi ubije.
However, there was no difference between the two medicines in how long the patients lived without their nerve disease getting worse. 
Vendar pa ni bilo med zdraviloma nobenih razlik glede tega, koliko časa so bolniki živeli, ne da bi se jim obolenje živcev poslabšalo.
These symptoms mainly affect the nerves, and include pain, fits, headache, problems walking, memory problems, incontinence and unusual sensations. 
Ti simptomi največkrat prizadenejo živce in vključujejo bolečino, krče, glavobol, težave pri hoji, težave s spominom, inkontinenco in nenavadne občutke.
DepoCyte should only be given by a doctor who has experience in the use of anticancer medicines. 
Zdravilo DepoCyte lahko predpiše le zdravnik, ki ima izkušnje z zdravili proti raku.
The Committee decided that DepoCyte's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor je zaključil, da so koristi zdravila DepoCyte večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
DepoCyte helps to control the symptoms of the disease. 
Zdravilo DepoCyte pomaga obvladovati simptome bolezni.
What is the risk associated with DepoCyte? 
Kakšna tveganja so povezana z zdravilom DepoCyte?
DepoCyte is a ‘depot' injection (a type of injection where the medicine is prepared so that it is absorbed by the body very slowly). 
DepoCyte je injekcija „na zalogo“ (vrsta injekcije, v kateri je zdravilo pripravljeno tako, da ga telo vsrkava zelo počasi).
The active substance in DepoCyte, cytarabine (also known as ara-C), is an anticancer medicine that has been used since the 1970s. 
Zdravilna učinkovina v zdravilu DepoCyte, citarabin (znan tudi kot ara-C), je učinkovina proti raku, ki se uporablja že od sedemdesetih let prejšnjega stoletja.
It must not be used in patients who have an active infection in the meninges. 
Ne sme se uporabljati pri osebah, ki imajo aktivno vnetje mening.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for DepoCyte. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo DepoCyte, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
DepoCyte is first given as a 50-mg injection every two weeks for the first five doses, followed by a further 50 mg four weeks later. 
Prvih pet odmerkov zdravila DepoCyte se na začetku daje kot 50-miligramska injekcija vsake dva tedna, ki jim štiri tedne kasneje sledi še nadaljnji 50-miligramski odmerek.
DepoCyte should not be given to people who may be hypersensitive (allergic) to cytarabine or any of the other ingredients. 
Zdravila DepoCyte ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) citarabin ali katero koli drugo sestavino zdravila.
The patient should also receive dexamethasone (a steroid) to help control some of the medicine's side effects. 
Bolnik mora prejeti tudi deksametazon (steroid), ki pomagajo pri nadzoru nekaterih neželenih učinkov.
DepoCyte is used to treat lymphomatous meningitis. 
Zdravilo DepoCyte se uporablja za zdravljenje limfomatoznega meningitisa.
Cytarabine is an analogue of pyrimidine. 
Citarabin je analog pirimidina.
The dose can be decreased to 25 mg if the patient shows signs of damage to the nerves (such as headache, abnormal vision, muscle weakness or pain). 
Odmerek se nato lahko zmanjša na 25 mg, čebolnik kaže znake poškodbe živcev (kot so glavobol, neobičajen vid ali šibkost oziroma bolečine v mišicah).
The medicine must be injected ‘intrathecally' (directly into the spinal fluid in the space that surrounds the spinal cord and the brain). 
Zdravilo mora biti injicirano „intratekalno“ (neposredno v spinalno tekočino v prostor, ki obkroža hrbtenjačo in možgane).
DepoCyte has been compared with a standard formulation of cytarabine in one main study involving 35 patients with lymphomatous meningitis. 
Zdravilo DepoCyte je bilo primerjano s standardno obliko citarabina v eni glavni študiji z 35 bolniki z limfomatoznim meningitisom.
The CHMP noted that DepoCyte had shown effectiveness in lymphomatous meningitis when compared with the standard formulation of cytarabine, and that it could improve patients' quality of life because fewer intrathecal injections are needed. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo DepoCyte izkazalo učinkovitost pri limfomatoznem meningitisu v primerjavi s standardno obliko citarabina ter da lahko prispeva k izboljšanju kakovosti bolnikovega življenja, saj je potrebnih manj intratekalnih injekcij.
In the body, cytarabine takes the place of pyrimidine and interferes with the enzymes involved in the production of new DNA. 
Citarabin v telesu zavzame mesto pirimidina in ovira encime, ki sodelujejo pri izdelavi nove DNK.
For the full list of all side effects reported with DepoCyte, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila DepoCyte, glejte navodilo za uporabo.
In DepoCyte, cytarabine is contained in liposomes (small fatty particles), from which the medicine is released slowly. 
V zdravilu DepoCryte je citarabin vsebovan v liposomih (majhni maščobni delci), iz katerih se zdravilo počasi sprošča.
It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the ‘anti-metabolite' group. 
Je citotoksin (zdravilo, ki ubija deleče se celice, kot so rakaste celice), ki spada v skupino antimetabolitov.
Why has DepoCyte been approved? 
Zakaj je bilo zdravilo DepoCyte odobreno?
DepoCyte is a suspension for injection that contains 50 mg of the active substance, cytarabine. 
Zdravilo DepoCyte je suspenzija za injiciranje, ki vsebuje 50 mg zdravilne učinkovine citarabin.
This is a condition in which cells from a lymphoma (a tumour in the lymphatic system) have spread to the spinal fluid and the meninges (the membranes that surround the brain and spinal cord). 
To je obolenje, pri katerem so se tumorske celice limfoma (tumorja v limfnem sistemu) razširile v spinalno tekočino in na meninge (membrane, ki obdajajo možgane in hrbtenjačo).
The most common side effects with DepoCyte (seen in more than 1 treatment cycle in 10) are headache, arachnoiditis (inflammation of one of the membranes protecting the spine and the brain), confusion, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), weakness and thrombocytopenia (low blood platelet counts).To minimise the symptoms of arachnoiditis, patients should receive dexamethasone by mouth or by injection at the same time as DepoCyte and must be closely monitored. 
Najpogostejši neželeni učinki zdravila DepoCyte (opaženi v več kot enem ciklu zdravljenja od 10) so glavobol, arahnoiditis (vnetje ene od membrane, ki varujejo hrbtenjačo in možgane), zmedenost, slabost, bruhanje, driska, preksija (povišana telesna temperatura), šibkost in trombocitopenija (nizke ravni trombocitov v krvi).
The full EPAR for DepoCyte can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo DepoCyte je na voljo tukaj.
This is then followed by maintenance doses of 50 mg every four weeks for a further four doses. 
miligramski vzdrževalni odmerki vsake štiri tedne.
What is DepoCyte used for? 
Za kaj se zdravilo DepoCyte uporablja ?
How has DepoCyte been studied? 
Kako je bilo zdravilo DepoCyte raziskano?
How is DepoCyte used? 
Kako se zdravilo DepoCyte uporablja?
What is DepoCyte? 
Kaj je zdravilo DepoCyte?
How does DepoCyte work? 
Kako zdravilo DepoCyte deluje?
28 x 1 tablets 
98 tablets
Invented name Strength 
Izmišljeni ime Jakost
Pharmaceutical Form Route of Administration Packaging 
Farmacevtska oblika Pot uporabe
Dose adjustments might be necessary in these patients. 
Pri teh bolnikih bo morda potrebna prilagoditev odmerka.
Gabapentin has been associated with severe respiratory depression. 
Gabapentin je bil povezan s hudo respiratorno depresijo.
Gabapentin - Respiratory depression without concomitant opioid use (EPITT no 18814) 
Gabapentin - respiratorna depresija brez sočasne uporabe opioidov (EPITT št. 18814)
Adopted at the 6-9 June 2017 PRAC 
Sprejeto na seji odbora PRAC med 6. in 9. junijem 2017
What you need to know before you take <brand name> Warnings and precautions 
Kaj morate vedeti, preden boste vzeli zdravilo <lastniško ime> Opozorila in previdnostni ukrepi
- if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen 
− če imate bolezni živčnega sistema, bolezni dihal ali ste stari več kot 65 let, vam bo zdravnik morda predpisal drugačno shemo odmerjanja
Respiratory depression 
Dihalna depresija
In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems. 
Zlasti obvestite zdravnika (ali farmacevta), če jemljete ali ste pred kratkim jemali zdravila proti epileptičnim krčem (konvulzijam), motnjam spanja, depresiji, tesnobi ali kateri koli drugi nevrološki ali duševni motnji.
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious: 
Takoj obvestite zdravnika, če po jemanju zdravila opazite katerega koli od naslednjih simptomov, saj lahko predstavljajo resno stanje:
Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction. 
Bolniki z zmanjšano respiratorno funkcijo, boleznimi dihal ali nevrološkimi boleznimi, okvaro ledvic, sočasno uporabo zaviralcev osrednjega živčevja in starejši ljudje so lahko izpostavljeni večjemu tveganju za pojav tega hudega neželenega učinka.
New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/337624/2017 
Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih EMA/PRAC/388994/2017
Undesirable effects Respiratory, thoracic and mediastinal disorders Frequency ‘rare': Respiratory depression 
Bolezni dihal, prsnega koša in mediastinalnega prostora Pogostnost: „redki“: Respiratorna depresija
- breathing problems, which if severe you may need emergency and intensive care to continue breathing normally 
− težave z dihanjem, pri katerih boste morda v primeru, da se pojavijo v hudi obliki, za vzpostavitev normalnega dihanja potrebovali nujno zdravniško pomoč in intenzivno nego
Summary of product characteristics 4.4. 
Povzetek glavnih značilnosti zdravila