FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelgraz .
Slovenian: Ob uporabi zdravila Pelgraz so poročali o hudih kožnih reakcijah (Stevens-Johnsonov sindrom).
English: Pelgraz is a clear colourless solution for injection in a pre-filled injector with an injection needle.
Slovenian: Zdravilo Pelgraz je bistra, brezbarvna raztopina za injiciranje v napolnjenem injektorju z injekcijsko iglo.
English: • Lift straight up: The yellow band indicates that the needle guard is locked.
Slovenian: Rumen krog označuje, da je ščitnik za iglo zaklenjen.
English: Allow the pre-filled injector to reach room temperature before injecting.
Slovenian: Pred injiciranjem pustite napolnjen injektor, da doseže sobno temperaturo.
English: Pulmonary adverse reactions
Slovenian: Neželene reakcije na pljučih
English: Keep hands away from needle guard after cap is removed.
Slovenian: Po odstranitvi zamaška roke umaknite od ščitnika za iglo.
English: The overall rate of febrile neutropenia was 9% of patients treated with pegfilgrastim and 18% of patients treated with filgrastim (difference 9%, 95% CI of -16.8%,-1.1%).
Slovenian: Celotna pogostost febrilne nevtropenije je bila pri bolnikih, zdravljenih s pegfilgrastimom, 9 %, pri bolnikih, zdravljenih s filgrastimom, pa 18 % (razlika 9 %, 95 % IZ je
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Pelgraz Vsebina pakiranja in dodatne informacije
English: Aortitis has been reported after filgrastim or pegfilgrastim administration in healthy subjects and in cancer patients.
Slovenian: Pri zdravih posameznikih in bolnikih z rakom so po dajanju filgrastima ali pegfilgrastima poročali o aortitisu.
English: • Gather an alcohol swab and a sharps container
Slovenian: • Pripravite alkoholni zloženec in zbiralnik za ostre predmete.
English: Pelgraz is a clear colourless solution for injection in a pre-filled syringe with an injection needle.
Slovenian: Zdravilo Pelgraz je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi z injekcijsko iglo.
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and WBC count).
Slovenian: Simptomi, ki so se pojavili, so vključevali povišano telesno temperaturo, bolečine v trebuhu, splošno slabo počutje, bolečine v hrbtu in povišane vrednosti vnetnih označevalcev (npr. Creaktivnega proteina in števila belih krvničk).
English: Pelgraz is available in a pack containing 1 pre-filled injector in a monocarton and one alcohol swab.
Slovenian: Zdravilo Pelgraz je na voljo v pakiranju s po 1 napolnjenim injektorjem v škatli in enim alkoholnim zložencem.
English: For all questions about storage, ask your doctor, nurse or pharmacist.
Slovenian: Če imate kakršna koli vprašanja glede shranjevanja, se obrnite na zdravnika, medicinsko sestro ali farmacevta.
English: Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Slovenian: Pri bolnikih z rakom in zdravih darovalcih so redko poročali o vnetju aorte (velike krvne žile, ki prenaša kri od srca po telesu).
English: Using the pre-filled syringe with needle safety guard
Slovenian: Uporaba napolnjene injekcijske brizge s ščitnikom igle
English: Pack size of one pre-filled injector with one alcohol swab, in a blistered packaging.
Slovenian: Pakiranje z enim napolnjenim injektorjem in enim alkoholnim zložencem v pretisnem omotu.
English: Talk to your doctor, pharmacist or nurse before using Pelgraz if you:
Slovenian: Pred začetkom uporabe zdravila Pelgraz se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
English: • a pre-filled syringe of Pelgraz;
Slovenian: • napolnjeno injekcijsko brizgo zdravila Pelgraz;
English: There is insufficient information on the excretion of pegfilgrastim/metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Slovenian: Dojenje Ni dovolj podatkov o izločanju pegfilgrastima/presnovkov v materino mleko.
English: Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously.
Slovenian: da subkutano dajanje pegfilgrastima ne vpliva na sposobnost razmnoževanja, plodnost, obdobje estrusa, dneve med parjenjem in koitusom ter intrauterino preživetje.
English: Capillary leak syndrome1
Slovenian: Žilne bolezni sindrom kapilarne prepustnosti1
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 mcg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg·hr/mL and 29.3 ± 23.2 mcg·hr/mL, respectively) (see section 5.1).
Slovenian: (47,9 ± 22,5 µg·h/ml) kot med otroci, starimi od 6 do 11 (22,0 ± 13,1 µg·h/ml) in od 12 do 21 let (29,3 ± 23,2 µg·h/ml) (glejte poglavje 5.1).
English: How do I inject Pelgraz myself?
Slovenian: Kako si injiciram zdravilo Pelgraz?
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon
Slovenian: Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije preobčutljivostne vrste, vključno z izpuščajem na koži, urtikarijo, angioedemom, dispnejo, eritemom, zardevanjem in hipotenzijo (občasno [≥ 1/1.000 do < 1/100]).
English: Sickle cell crisis2; Splenomegaly2;
Slovenian: srpastocelična kriza2, splenomegalija2, ruptura vranice2
English: Glomerulonephrit is2
Slovenian: Bolezni sečil glomerulonefritis2
English: Check with your doctor or pharmacist for proper disposal instructions.
Slovenian: Glede ustreznih navodil za odstranjevanje se posvetujte z zdravnikom ali farmacevtom.
English: A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo AML compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
Slovenian: faze pri bolnikih, ki so dobivali kemoterapijo zaradi de novo AML, je primerjala pegfilgrastim (enkraten odmerek 6 mg) s filgrastimom ob aplikaciji med indukcijsko kemoterapijo.
English: Pelgraz 6 mg solution for injection in pre-filled syringe Pre-filled syringe (type I glass) with a permanently attached stainless steel injection needle, with a needle safety guard.
Slovenian: Pelgraz 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga (iz stekla tipa I) s trajno pritrjeno nerjavečo jekleno injekcijsko iglo in ščitnikom igle.
English: If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Slovenian: Če imate kakšna vprašanja o injiciranju zdravila, se za pomoč obrnite na svojega zdravnika ali medicinsko sestro.
English: Tell your doctor if you experience these symptoms.
Slovenian: Če se vam pojavijo ti simptomi,
English: Always keeping your skin pinched, depress the plunger slowly and evenly while grasping the finger flange until the entire dose has been given and the plunger cannot be depressed any further.
Slovenian: Kožo še najprej držite s palcem in kazalcem in bat počasi in enakomerno potisnite navzdol,
English: - The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.
Slovenian: - Pomožne snovi so natrijev acetat, sorbitol (E420), polisorbat 20 in voda za injekcije (glejte poglavje 2).
English: Musculoskelet al and connective tissue disorders
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva bolečina v kosteh mišično-skeletna bolečina
English: Pelgraz is for subcutaneous use.The injections should be given subcutaneously into the thigh, abdomen or upper arm.
Slovenian: Injekcije se morajo dati subkutano v stegno, trebuh ali zgornji del roke.
English: Pack size of one pre-filled syringe with one alcohol swab, in a blistered packaging.
Slovenian: Pakiranje z eno napolnjeno injekcijsko brizgo in enim alkoholnim zložencem v pretisnem omotu.
English: Package leaflet: Information for the user Pelgraz 6 mg solution for injection in pre-filled injector pegfilgrastim This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Pelgraz 6 mg raztopina za injiciranje v napolnjenem injektorju pegfilgrastim Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Pelgraz 6 mg solution for injection in pre-filled syringe Pelgraz 6 mg solution for injection in pre-filled injector
Slovenian: Pelgraz 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Pelgraz 6 mg raztopina za injiciranje v napolnjenem injektorju
English: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1% of patients receiving pegfilgrastim.
Slovenian: Pri manj kot 1 % bolnikov, ki dobivajo pegfilgrastim, so opazili število belih krvničk, ki je enako 100 x 109/l ali večje.
English: Pelgraz 6 mg solution for injection in pre-filled injector Each pre-filled injector contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection.
Slovenian: Pelgraz 6 mg raztopina za injiciranje v napolnjenem injektorju En napolnjen injektor vsebuje 6 mg pegfilgrastima* v 0,6 ml raztopine za injiciranje.
English: The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled injector and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Slovenian: (podkožna injekcija) z napolnjeno injekcijsko brizgo, ki jo morate prejeti vsaj 24 ur po zadnjem odmerku kemoterapije na koncu vsakega cikla kemoterapije.
English: Pelgraz 6 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection.
Slovenian: Pelgraz 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima* v 0,6 ml raztopine za injiciranje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (PRE-FILLED INJECTOR)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (NAPOLNJEN INJEKTOR)
English: Sickle cell anaemia
Slovenian: Srpastocelična anemija
English: Each pre-filled injector contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection.
Slovenian: En napolnjen injektor vsebuje 6 mg pegfilgrastima v 0,6 ml (10 mg/ml) raztopine za injiciranje.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom
English: The incidence of hospitalisations and intravenous antiinfective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p < 0.001; and 2% versus 10%, p < 0.001).
Slovenian: kot med prejemnicami placeba (1 % v primerjavi s 14 %, p < 0,001, ter 2 % v primerjavi z 10 %, p < 0,001).
English: Package leaflet: Information for the user Pelgraz 6 mg solution for injection in pre-filled syringe pegfilgrastim This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Pelgraz 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Pelgraz 6 mg solution for injection in pre-filled injector Before use, Pelgraz solution should be inspected visually for particulate matter.
Slovenian: Pelgraz 6 mg raztopina za injiciranje v napolnjenem injektorju Pred uporabo morate raztopino zdravila Pelgraz pregledati glede vidnih delcev.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v 0,6 ml (10 mg/ml) raztopine za injiciranje.
English: Elevations in lactate dehydrogenase and alkaline phosphatase1;
Slovenian: Preiskave zvišanje laktatdehidrogenaze in alkalne fosfataze1, prehodno zvišanje jetrnih funkcijskih testov za ALT ali AST1
English: Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 years (75%) compared to older children aged 6-11 years and 12-21 years (70% and 33%, respectively) and adults (see sections 4.8 and 5.2).
Slovenian: (70 %) in 12 do 21 let (33 %) ter pri odraslih (glejte poglavji 4.8 in 5.2).
English: Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain (common events) have occurred on initial or subsequent treatment with pegfilgrastim.
Slovenian: Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije na mestu injiciranja, vključno z eritemom na mestu injiciranja (občasni) kot tudi bolečino na mestu injiciranja
English: How to store Pelgraz
Slovenian: Shranjevanje zdravila Pelgraz
English: Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment.
Slovenian: V povezavi z zdravljenjem s pegfilgrastimom so redko poročali o Stevens-Johnsonovem sindromu
English: Pre-filled injector containing a pre-filled syringe (type I glass) with a permanently attached stainless steel injection needle.
Slovenian: Pelgraz 6 mg raztopina za injiciranje v napolnjenem injektorju Napolnjen injektor, ki vsebuje napolnjeno injekcijsko brizgo (iz stekla tipa I) s trajno pritrjeno nerjavečo jekleno injekcijsko iglo.
English: Pelgraz 6 mg solution for injection in pre-filled syringe Before use, Pelgraz solution should be inspected visually for particulate matter.
Slovenian: Pelgraz 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Pred uporabo morate raztopino zdravila Pelgraz pregledati glede vidnih delcev.
English: Pre-Injection
Slovenian: Pred injiciranjem
English: Each pre-filled syringe contains 0.6 mL of solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 0,6 ml raztopine za injiciranje.
English: Each pre-filled injector contains 6 mg of pegfilgrastim in 0.6 mL of solution.
Slovenian: En napolnjen injektor vsebuje 6 mg pegfilgrastima v 0,6 ml raztopine.
English: Keep the pre-filled injector in the outer carton in order to protect from light.
Slovenian: Napolnjen injektor shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Each pre-filled syringe injector contains 0.6 mL of solution for injection.
Slovenian: En napolnjen injektor z injekcijsko brizgo vsebuje 0,6 ml raztopine za injiciranje.
English: Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora sindrom dihalne stiske pri odraslem2, pljučne neželene reakcije (intersticijska pljučnica, pljučni edem, pljučni infiltrati in pljučna fibroza), hemoptiza pljučna krvavitev
English: Pelgraz 6 mg solution for injection in pre-filled injector pegfilgrastim
Slovenian: Pelgraz 6 mg raztopina za injiciranje v napolnjenem injektorju pegfilgrastim
English: The safety and efficacy of Pelgraz have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g. nitrosoureas.
Slovenian: Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, varnosti in učinkovitosti zdravila Pelgraz niso ovrednotili.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (PRE-FILLED SYRINGE)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (NAPOLNJENA INJEKCIJSKA BRIZGA)
English: Rare to
Slovenian: Redki 0 do
English: Keep the pre-filled injector in the carton in order to protect from light.
Slovenian: Napolnjen injektor shranjujte v škatli za zagotovitev zaščite pred svetlobo.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Pelgraz.
Slovenian: Če uporabljate zdravilo Pelgraz, morate prenehati dojiti, razen če vam zdravnik ne naroči drugače.
English: • bleeding from the lung (pulmonary haemorrhage)
Slovenian: • krvavitev iz pljuč.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija1 levkocitoza1
English: Haemoptysis
Slovenian: OVOJNINAH
English: Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further.
Slovenian: dokler ni injiciran celoten odmerek in dokler bat ni pritisnjen do konca.
English: Each pre-filled injector contains 0.6 mL of solution.
Slovenian: En napolnjen injektor vsebuje 0,6 ml raztopine.
English: • Push the handle straight down: The medicine will be injected as you push.
Slovenian: Zdravilo se bo injiciralo, medtem ko potiskate ročaj.
English: Pelgraz 6 mg solution for injection in pre-filled syringe pegfilgrastim
Slovenian: Pelgraz 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
English: • Clean injection site: use an alcohol swab to wipe site clean.
Slovenian: Za čiščenje uporabite alkoholni zloženec.
English: Keep the syringe in the outer carton in order to protect from light.
Slovenian: Injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: • Remove bottom cap: Twist and pull bottom cap to remove.
Slovenian: Da zamašek odstranite, ga obrnite in povlecite.
English: Mobilisation of PBPC
Slovenian: pegfilgrastima ANC
English: Stop using Pelgraz and seek medical attention immediately if you notice any of the symptoms described in section 4.
Slovenian: prenehajte uporabljati zdravilo Pelgraz in se nemudoma posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: Injection site reactions2
Slovenian: ki ne izvira od srca reakcije na mestu injiciranja2
English: Injecting Pelgraz yourself
Slovenian: Samoinjiciranje zdravila Pelgraz
English: • Dispose of the used Pelgraz pre-filled injector: Place injector in an approved sharps container.
Slovenian: • Odstranite uporabljen napolnjen injektor zdravila Pelgraz.
English: Allow to air dry.
Slovenian: Počakajte, da se mesto injiciranja posuši na zraku.
English: Sodium acetate* Sorbitol (E420) Polysorbate 20
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev acetat* sorbitol (E420) polisorbat 20 voda za injekcije
English: - Keep this leaflet.
Slovenian: • Odstranite spodnji zamašek.
English: Do not try to inject yourself unless you have received special training from your doctor or nurse.
Slovenian: Če vas zdravnik ali medicinska sestra o tem nista posebej poučila, si ne poskušajte sami dajati injekcij.
English: Do not use if expiration date has passed.
Slovenian: Če je rok uporabnosti potekel, zdravila ne uporabljajte.
English: Keep the pre-filled syringe in the carton in order to protect from light.
Slovenian: Napolnjeno injekcijsko brizgo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
English: Hypersensitivity reactions;
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije, anafilaksija
English: Lay the patient on their back.
Slovenian: Položite bolnika na hrbet.
English: 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: • If you use buprenorphine.
Slovenian: • Če uporabljate buprenorfin.
English: In some cases, further doses may be necessary.
Slovenian: V nekaterih primerih bodo potrebni dodatni odmerki.
English: Check for a response, to see if the person is conscious.
Slovenian: Preverite, ali se oseba odziva, da ugotovite stanje zavesti.
English: 3832 RC Leusden Netherlands
Slovenian: 3832 RC Leusden Nizozemska
English: • If you take opioids to control pain.
Slovenian: • Če opioide jemljete za obvladovanje bolečine.
English: Can you feel breath on the cheek?
Slovenian: Ali na licu čutite sapo?
English: For 10 seconds check for breathing - is the chest moving?
Slovenian: 10 sekund namenite preverjanju dihanja - ali se prsni koš dviga?
English: • Difficulty in sleeping.
Slovenian: • težave s spanjem
English: • Information about Nyxoid and the fact that it cannot replace provision of basic life support
Slovenian: • informacijo o zdravilu Nyxoid in dejstvu, da ne more nadomestiti nudenja osnovnih postopkov oživljanja
English: Tell your doctor if you have damage to the inside of your nose as this could affect how Nyxoid works.
Slovenian: Zdravniku povejte, če imate v nosu poškodbe, saj lahko to vpliva na delovanje zdravila Nyxoid.
English: In view of the indication and the broad therapeutic margin, overdose is not to be expected.
Slovenian: Glede na indikacijo in širok terapevtski razpon preveliko odmerjanje ni pričakovano.
English: The Patient Information Card should include:
Slovenian: Informacijska kartica za bolnika naj vključuje:
English: • High blood pressure, low blood pressure
Slovenian: • visok krvni tlak, nizek krvni tlak
English: This should be performed in accordance with the educational guidance for Nyxoid.
Slovenian: To je treba izvesti skladno s smernicami za izobraževanje o uporabi zdravila Nyxoid.
English: • not responding to a loud noise or touch.
Slovenian: • neodzivnost na hrup ali dotik.
English: Nyxoid should be administered as soon as possible to avoid damage to the central nervous system or death.
Slovenian: Zdravilo Nyxoid je treba dati čim hitreje, da se preprečijo poškodbe centralnega živčnega sistema ali smrt.
English: Genotoxicity and carcinogenicity
Slovenian: Genotoksičnost in karcinogenost
English: restlessness or irritability
Slovenian: nemirnost ali razdražljivost
English: Check airways and breathing.
Slovenian: Preverite dihalne poti in dihanje.
English: Call for an ambulance.
Slovenian: Pokličite rešilca.
English: In addition, training is provided via a video and a Patient Information Card.
Slovenian: Poleg tega je na voljo videoposnetek za usposabljanje in kartica z informacijami za bolnika.
English: Nyxoid is intended for use by appropriately trained individuals.
Slovenian: Zdravilo Nyxoid je namenjeno za uporabo ustrezno usposobljenim posameznikom.
English: Always tell your friends and family that you carry Nyxoid with you.
Slovenian: Svojim prijateljem in družinskim članom vedno povejte, da imate zdravilo Nyxoid pri sebi.
English: Pharmacotherapeutic group: Antidotes, ATC code: V03AB15
Slovenian: Farmakoterapevtska skupina: antidoti; oznaka ATC: V03AB15
English: Monitoring of the patient for a response
Slovenian: Spremljanje odziva bolnika na zdravilo
English: Like all medicines, this medicine can cause side effects although not everyone gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: Instructing patients / users on the proper use of Nyxoid
Slovenian: Svetovanje bolnikom/uporabnikom glede pravilne uporabe zdravila Nyxoid
English: Frequency categories are assigned to those adverse reactions considered to be at least possibly causally related to naloxone and are defined as very common: (≥ 1/10); common: (≥ 1/100, < 1/10); uncommon: (≥ 1/1,000, < 1/100); rare: (≥ 1/10,000, < 1/1,000) very rare: (< 1/10,000); not known
Slovenian: Kategorije pogostnosti so dodeljene tistim neželenim učinkom, za katere obstaja vsaj možna vzročna povezava z naloksonom, in so razvrščeni kot zelo pogosti: (≥ 1/10); pogosti: (≥ 1/100 do < 1/10); občasni: (≥ 1/1.000 do < 1/100); redki: (≥ 1/10.000 do < 1/1.000) zelo redki: (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Naloxone has not been shown to produce tolerance or cause physical or mental dependence.
Slovenian: Ni dokazano, da bi nalokson povzročal toleranco ali telesno ali psihično odvisnost.
English: Immune system disorders Very rare:
Slovenian: Bolezni imunskega sistema Zelo redki: