natgillin/translations-raw huggingface dataset:
This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free' 
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 6 mg, tj. zanemarive količine natrija.
What you need to know before you use Pelgraz Do not use Pelgraz 
Što morate znati prije nego počnete primjenjivati lijek Pelgraz
A higher frequency of serious adverse reactions in younger children aged 0-5 years (92%) has been observed compared to older children aged 6-11 and 12-21 years respectively (80% and 67%) and adults. 
Primijećena je veća učestalost ozbiljnih nuspojava u mlađe djece, u dobi 0-5 godina (92 %) u odnosu na stariju djecu, u dobi 6-11 godina (80 %) i 12-21 godina (67 %),
The pre-filled syringe is externally equipped with the device for selfadministration (pre-filled injector). 
S vanjske strane napunjene štrcaljke nalazi se uređaj za samostalnu primjenu (napunjeni injektor).
If you use more Pelgraz than you should contact your doctor, pharmacist or nurse. 
Ako primijenite više Pelgraza nego što ste trebali, obratite se liječniku, ljekarniku ili medicinskoj sestri.
Solution for injection 1 pre-filled syringe + 1 alcohol swab 
Otopina za injekciju 1 napunjena štrcaljka + 1 jastučić natopljen alkoholom
Pelgraz is a clear colourless solution for injection in a pre-filled injector with an injection needle. 
Pelgraz je bistra bezbojna otopina za injekciju u napunjenom injektoru s iglom za injekciju.
The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and WBC count). 
Simptomi koji su se javljali su vrućica, bol u trbuhu, malaksalost, bol u leđima i povišeni upalni markeri (npr. C-reaktivni protein i broj bijelih krvnih stanica).
• alcohol swab. 
• jastučić natopljen alkoholom.
Check the expiry date on the pre-filled syringe label (EXP). 
3. Provjerite rok valjanosti na naljepnici napunjene štrcaljke (EXP).
Sickle cell crisis2; Splenomegaly2; 
Kriza srpastih stanica2,
Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled injector label after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici napunjenog injektora iza oznake „Rok valjanosti“/„EXP“.
For all questions about storage, ask your doctor, nurse or pharmacist. 
Za sva pitanja o čuvanju lijeka obratite se liječniku, medicinskoj sestri ili ljekarniku.
Dispose of the syringe as instructed by your doctor, pharmacist or nurse. 
Štrcaljku zbrinite prema uputama liječnika, ljekarnika ili medicinske sestre.
Pelgraz is available in a pack containing 1 pre-filled injector in a monocarton and one alcohol swab. 
Pelgraz je dostupan kao jednostruko pakiranje koje sadrži 1 napunjeni injektor u jednoj kutiji i s jednim jastučićem natopljenim alkoholom.
Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) 
(intersticijska upala pluća, plućni edem, plućni infiltrati i plućna fibroza)
Pelgraz is a clear colourless solution for injection in a pre-filled syringe with an injection needle. 
Pelgraz je bistra bezbojna otopina za injekciju u napunjenoj štrcaljki s iglom za injekciju.
• have sickle cell anaemia. 
• bolujete od anemije srpastih stanica.
One 6 mg dose (a single pre-filled syringe or pre-filled injector) of Pelgraz is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. 
Doziranje Jednokratna doza lijeka Pelgraz od 6 mg (jedna napunjena štrcaljka ili napunjeni injektor) preporučuje se uz svaki kemoterapijski ciklus, najmanje 24 sata nakon primjene citotoksične kemoterapije.
• Clean injection site: use an alcohol swab to wipe site clean. 
• Očistite mjesto za primjenu injekcije: jastučićem ili maramicom natopljenom alkoholom prebrišite mjesto.
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. 
Uobičajena doza je 6 mg primijenjena jednom potkožnom injekcijom (injekcija pod kožu) pomoću napunjenog injektora, koja se mora dati najmanje 24 sata nakon posljednje doze kemoterapije na kraju svakog kemoterapijskog ciklusa.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder 
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet
The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle. 
Uobičajena doza je 6 mg primijenjena jednom potkožnom injekcijom (injekcija pod kožu) pomoću napunjene štrcaljke, koja se mora dati najmanje 24 sata nakon posljednje doze kemoterapije na kraju svakog kemoterapijskog ciklusa.
• Gather an alcohol swab and a sharps container 
• Uzmite jastučić natopljen alkoholom i spremnik za odlaganje oštrih predmeta
How to use Pelgraz 
Kako primjenjivati lijek Pelgraz
Read the package leaflet for further information. 
Za dodatne informacije pročitajte uputu o lijeku.
Pack size of one pre-filled injector with one alcohol swab, in a blistered packaging. 
Veličina pakiranja: jedan napunjeni injektor s jastučićem natopljenim alkoholom, u blister pakiranju.
Pack size of one pre-filled syringe with one alcohol swab, in a blistered packaging. 
Veličina pakiranja: jedna napunjena štrcaljka s jastučićem natopljenim alkoholom, u blister pakiranju.
Elevations in lactate dehydrogenase and alkaline phosphatase1; 
Povišena razina laktat-dehidrogenaze i alkalne fosfataze1; Prolazno povišenje vrijednosti testova jetrene funkcije za ALT ili AST1
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (PRE-FILLED INJECTOR) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (NAPUNJENI INJEKTOR)
The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17%, p < 0.001). 
Incidencija febrilne neutropenije bila je niža u bolesnica randomiziranih u grupu koja je dobivala pegfilgrastima u usporedbi s bolesnicama koje su dobivale placebo (1 % prema
Pelgraz is for subcutaneous use.The injections should be given subcutaneously into the thigh, abdomen or upper arm. 
Injekcije je potrebno primijeniti supkutanim putem u bedro, abdomen ili nadlakticu.
• Remove bottom cap: Twist and pull bottom cap to remove. 
• Skinite poklopac na dnu injektora: odvrnite i povucite poklopac na dnu injektora kako biste ga skinuli.
Solution for injection 1 pre-filled injector + 1 alcohol swab 
1 napunjeni injektor + 1 jastučić natopljen alkoholom
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (PRE-FILLED INJECTOR) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (NAPUNJENI INJEKTOR)
Allow the pre-filled injector to reach room temperature before injecting. 
Prije injiciranja pričekajte da napunjeni injektor dosegne sobnu temperaturu.
Musculoskelet al and connective tissue disorders 
Poremećaji mišićno koštanog sustava i vezivnog tkiva
• experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch. 
• imate alergijsku reakciju koja uključuje slabost, pad krvnog tlaka, otežano disanje, oticanje lica
Find a comfortable, well-lit place and put everything you need where you can reach them (the pre-filled syringe and alcohol swab). 
Pronađite udobno, dobro osvijetljeno mjesto i stavite sve što trebate tako da Vam je pri ruci
How to store Pelgraz 
Kako čuvati lijek Pelgraz
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (PRE-FILLED SYRINGE) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (NAPUNJENA ŠTRCALJKA)
• get left upper abdominal pain or pain at the tip of your shoulder. 
Pogledajte dio 4. • osjetite bol u gornjem lijevom dijelu trbuha ili u vrhu ramena.
The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 mcg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy. 
Pedijatrijska populacija Farmakokinetika pegfilgrastima ispitivana je u 37 pedijatrijskih bolesnika sa sarkomom koji su primali
Check for any changes in colour, cloudiness or large particles. 
Provjerite da nije promijenila boju, da nije zamućena te da nisu prisutne krupne čestice.
Pelgraz 6 mg solution for injection in pre-filled syringe Pelgraz 6 mg solution for injection in pre-filled injector 
Pelgraz 6 mg otopina za injekciju u napunjenoj štrcaljki Pelgraz 6 mg otopina za injekciju u napunjenom injektoru
Do not try to inject yourself unless you have received special training from your doctor or nurse. 
Ako niste prošli obuku od strane liječnika ili medicinske sestre, nemojte samostalno pokušavati injicirati lijek.
Pelgraz 6 mg solution for injection in pre-filled syringe Before use, Pelgraz solution should be inspected visually for particulate matter. 
Pelgraz 6 mg otopina za injekciju u napunjenoj štrcaljki Prije uporabe, potrebno je provjeriti sadrži li otopina Pelgraza vidljive čestice.
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections. 
- Pomoćne tvari su natrijev acetat, sorbitol (E420), polisorbat 20 i voda za injekcije (vidjeti dio 2).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (PRE-FILLED SYRINGE) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (NAPUNJENA ŠTRCALJKA)
Injecting Pelgraz yourself 
Samostalno davanje lijeka Pelgraz
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Pelgraz. 
Ako primjenjujete lijek Pelgraz, morate prekinuti s dojenjem, osim ako Vaš liječnik ne savjetuje drugačije.
In two randomised, double-blind, pivotal studies in patients with high-risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations). 
primjena pegfilgrastima, u pojedinačnoj dozi jednom po ciklusu, smanjila je trajanje neutropenije i učestalost pojave febrilne neutropenije slično kao dnevna primjena filgrastima (medijan od 11 dnevnih primjena).
How do I inject Pelgraz myself? 
Kako samostalno primijeniti injekciju lijeka Pelgraz?
Each pre-filled injector contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection. 
Jedan napunjeni injektor sadrži 6 mg pegfilgrastima u 0,6 ml (10 mg/ml) otopine za injekciju.
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%). 
Ukupna stopa febrilne neutropenije u bolesnika liječenih pegfilgrastimom iznosila je 9 %, a 18 % u bolesnika liječenih filgrastimom (razlika 9
Keep the pre-filled injector in the carton in order to protect from light. 
Napunjeni injektor čuvati u kutiji radi zaštite od svjetlosti.
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. 
AML-om liječenih kemoterapijom uspoređivan je pegfilgrastim (pojedinačna doza od 6 mg) s filgrastimom, primjenjivanima tijekom indukcijske kemoterapije.
Gastrointestin al disorders 
Tablični prikaz nuspojava
Keep the pre-filled injector in the outer carton in order to protect from light. 
Napunjeni injektor čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
Allow the pre -filled syringe to reach room temperature before injecting. 
Prije injiciranja pričekajte da napunjena štrcaljka dosegne sobnu temperaturu.
Each pre-filled syringe injector contains 0.6 mL of solution for injection. 
Jedan napunjeni injektor sadrži 0,6 ml otopine za injekciju.
Each pre-filled syringe contains 0.6 mL of solution for injection. 
Jedna napunjena štrcaljka sadrži 0,6 ml otopine za injekciju.
In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 mcg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults. 
U fazi II (n = 37) multicentričnog, randomiziranog, otvorenog ispitivanja pedijatrijskih bolesnika sa sarkomom koji su primali 100 μg/kg pegfilgrastima nakon 1. ciklusa kemoterapije vinkristinom, doksorubicinom i ciklofosfamidom (VAdriaC/IE) uočeno je dulje trajanje teške neutropenije
In a second study (n = 310), which used a weightadjusted dose (100 mcg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI -0.36, 0.30). 
stupnja u skupini liječenoj pegfilgrastimom iznosilo je 1,7 dana, u usporedbi s 1,8 dana u skupini liječenoj filgrastimom (razlika 0,03 dana, 95 % CI -0,36, 0,30).
Each pre-filled injector contains 6 mg of pegfilgrastim in 0.6 mL of solution. 
Jedan napunjeni injektor sadrži 6 mg pegfilgrastima u 0,6 ml otopine.
Pelgraz 6 mg solution for injection in pre-filled injector 
Pelgraz 6 mg otopina za injekciju u napunjenom injektoru
Adult Respiratory Distress 
Plućne nuspojave
Pelgraz 6 mg solution for injection in pre-filled syringe pegfilgrastim 
Pelgraz 6 mg otopina za injekciju u napunjenoj štrcaljki pegfilgrastim
Pelgraz 6 mg solution for injection in pre-filled injector pegfilgrastim 
Pelgraz 6 mg otopina za injekciju u napunjenom injektoru pegfilgrastim
Acute myeloid leukaemia (AML) 
Median Serum Pegfilgrastim Conc. (ng/ml)
Each pre-filled syringe contains 0.6 mL of solution. 
Jedna napunjena štrcaljka sadrži 0,6 ml otopine.
The needle safety guard will cover the needle when releasing the plunger. 
Kada otpustite klip, sigurnosni štitnik za iglu će prekriti iglu.
Each pre-filled injector contains 0.6 mL of solution. 
Jedan napunjeni injektor sadrži 0,6 ml otopine.
Keep the pre-filled syringe in the carton in order to protect from light. 
Napunjenu štrcaljku čuvati u kutiji radi zaštite od svjetlosti.
Package leaflet: Information for the user Pelgraz 6 mg solution for injection in pre-filled syringe pegfilgrastim This medicine is subject to additional monitoring. 
Uputa o lijeku: Informacije za bolesnika Pelgraz 6 mg otopina za injekciju u napunjenoj štrcaljki pegfilgrastim
Uncommonly, cases have resulted in respiratory failure or ARDS, which may be fatal (see section 4.4). 
koji mogu imati smrtni ishod (vidjeti dio 4.4).
Package leaflet: Information for the user Pelgraz 6 mg solution for injection in pre-filled injector pegfilgrastim This medicine is subject to additional monitoring. 
Uputa o lijeku: Informacije za bolesnika Pelgraz 6 mg otopina za injekciju u napunjenom injektoru pegfilgrastim
4 cycles). 
oticanje lica).
Not better? 
Nije bolje?
Check for a response, to see if the person is conscious. 
Provjerite reakciju da vidite je li osoba pri svijesti.
• Difficulty in sleeping. 
• probleme sa spavanjem.
This leaflet was last revised in. 
Ova uputa zadnji put je revidirana u.
Can you feel breath on the cheek? 
Osjećate li dah na obrazu?
Be aware - even if they wake up, they may become unconscious again, and stop breathing. 
Pazite - čak i ako se probudi, ponovno se može onesvijestiti i prestati disati.
Always tell your friends and family that you carry Nyxoid with you. 
Uvijek recite prijateljima i obitelji da sa sobom nosite Nyxoid.
Lay the patient on their back. 
Polegnite bolesnika na leđa.
Can you hear breathing sounds? 
Čujete li zvuk disanja?
Emergency services may administer further doses according to local guidelines. 
Hitne službe mogu dati dodatne doze u skladu s lokalnim smjernicama.
In some cases, further doses may be necessary. 
U nekim slučajevima mogu biti potrebne dodatne doze.
3832 RC Leusden Netherlands 
3832 RC Leusden Nizozemska
This can be done while the patient is in the recovery position. 
To se može obaviti dok je bolesnik u bočnom položaju.
Tell your doctor if you experience any of these symptoms. 
Obavijestite liječnika ako dobijete bilo koji od ovih simptoma.
• A list of the educational material included in the training program 
• Popis edukacijskog materijala uključenog u program za obuku
This should be performed in accordance with the educational guidance for Nyxoid. 
To je potrebno provesti u skladu s edukacijskom smjernicom za Nyxoid.
• If you take opioids to control pain. 
• ako uzimate opioide za kontrolu boli.
After 2-3 mins, use 2nd spray. 
Nakon 2-3 minute, upotrijebiti 2. sprej.
• Increased skin sensitivity 
• povećanu osjetljivost kože
What Nyxoid is and what it is used for 
Što je Nyxoid i za što se koristi
Like all medicines, this medicine can cause side effects although not everyone gets them. 
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
Nyxoid is intended for use by appropriately trained individuals. 
Nyxoid je predviđen za upotrebu od strane odgovarajuće obučenih osoba.
• not responding to a loud noise or touch. 
• nereagiranje na glasan zvuk ili dodir.
Check airways and breathing. 
Provjerite dišne puteve i disanje.
Medis Hungary Kft 
Magyarország Medis Hungary Kft
Nyxoid should be administered as soon as possible to avoid damage to the central nervous system or death. 
Nyxoid treba dati što je brže moguće kako bi se izbjeglo oštećenje središnjeg živčanog sustava ili smrt.
• Information about Nyxoid and the fact that it cannot replace provision of basic life support 
• Informaciju o Nyxoidu i činjenicu da on ne može zamijeniti pružanje osnovnih mjera održavanja života
Check with your doctor, pharmacist or nurse if you are not sure. 
Provjerite s liječnikom,ljekarnikom ili medicinskom sestrom ako niste sigurni.
If you are at risk of an opioid overdose you should always carry your Nyxoid with you. 
Ako kod Vas postoji rizik od predoziranja opioidima, trebate uvijek nositi Nyxoid sa sobom.
Call an ambulance 
Pozovite hitnu pomoć
Call for an ambulance. 
Zovite hitnu pomoć.
Other medicines and Nyxoid 
Drugi lijekovi i Nyxoid
Lay in recovery position. 
Poleći u bočni položaj.
• Sweating 
• Znojenje
If the patient does not respond to two doses, further doses may be given (if available). 
Ako bolesnik ne reagira na dvije doze, mogu se dati dodatne doze (ako su raspoložive).
For 10 seconds check for breathing - is the chest moving? 
Provjerite disanje tijekom 10 sekundi - pomiču li se prsa?
The Video should include: 
Video treba sadržavati:
If this happens, a second dose can be given immediately. 
Ako dođe do toga, druga doza može se dati odmah.
For overdose of opioids (such as heroin) 
Za predoziranje opioidima (kao što je heroin)
Tell your doctor if you have damage to the inside of your nose as this could affect how Nyxoid works. 
Recite liječniku ako imate oštećenje unutarnjeg dijela nosa jer bi to moglo utjecati na djelovanje
In view of the indication and the broad therapeutic margin, overdose is not to be expected. 
U svjetlu indikacija i široke terapijske granice, ne očekuje se predoziranje.
The secondary packaging (actuator) is comprised of polypropylene and stainless steel. 
Sekundarni spremnik (aktivator) sastoji se od polipropilena i nehrđajućeg čelika.
• High blood pressure, low blood pressure 
• Visoki krvni tlak, niski krvni tlak
• If you use buprenorphine. 
• ako primjenjujete buprenorfin.
Contents of the pack and other information What Nyxoid contains 
Sadržaj pakiranja i druge informacije Što Nyxoid sadrži
• Emergency services should be called if an opioid overdose is suspected. 
• Hitna medicinska služba treba se pozvati ako se sumnja na predoziranje opioidima.
Each spray contains only one dose. 
Svaki sprej sadrži samo jednu dozu.
Support the back of the neck and allow the head to tilt back. 
Napravite potporu stražnjem dijelu vrata i omogućite da se glava zabaci unatrag.
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 
Kategorije učestalosti dodijeljene su onim nuspojavama za koje se smatra da su bile barem moguće uzročno povezane s naloksonom i definirane su kao vrlo često: (≥ 1/10); često: (≥ 1/100, < 1/10); manje često: (≥ 1/1000, < 1/100); rijetko: (≥ 1/10 000, < 1/1000) vrlo rijetko: (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
Nyxoid should not be used during pregnancy unless the clinical condition of the woman requires treatment with naloxone. 
Nyxoid se ne smije koristiti tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje naloksonom.
• Information on how to manage and monitor the patient until the emergency medical assistance arrives 
• Informaciju o tome kako postupati i nadzirati bolesnika dok ne dođe služba hitne medicinske pomoći
• Emphasis on the need to make an immediate emergency call for an ambulance 
• Naglasak na potrebu žurnog poziva službi za hitnu medicinsku pomoć
In patients who are unconscious and not breathing normally additional life-saving support should be given if possible. 
Bolesnicima koji su u nesvijesti i koji ne dišu normalno, potrebno je pružiti dodatne mjere spašavanja i održavanja života ako je moguće.
Genotoxicity and carcinogenicity 
Genotoksičnost i kancerogenost
In addition, training is provided via a video and a Patient Information Card. 
Osim toga, omogućena je obuka putem video prikaza i kartice s informacijama za bolesnika.
If an incomplete response occurs, respiration should be mechanically assisted. 
Ako je odgovor nepotpun, potrebno je primijeniti mehanički potpomognuto disanje.
Watch for an improvement in the patient's breathing level, alertness and response to noise and touch. 
Pazite na poboljšanje bolesnikove razine disanja, budnosti i odgovora na zvuk i dodir.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving a supply of this medicine. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego Vam propišu i izdaju ovaj lijek.
Naloxone is therefore not teratogenic in rats or rabbits. 
Nalokson stoga nije teratogen za štakore ili zečeve.
Monitoring of the patient for a response 
Nadzor bolesnika u vezi odgovora na lijek
Press firmly on the plunger until it clicks to give the dose. 
Čvrsto pritisnite klip dok se ne čuje klik kako bi dali dozu.
Nyxoid will be supplied to you only after you or your carer have been taught how to use it. 
Nyxoid će Vam biti propisan i izdan tek nakon što ste Vi ili Vaš njegovatelj upućeni kako da ga koristite.
Frequency, type and severity of adverse reactions in adolescents are expected to be the same as in adults. 
Očekuje se da će učestalost, vrsta i težina nuspojava u adolescenata biti jednaka kao i u odraslih.
The Patient Information Card should include: 
Kartica s informacijama za bolesnika treba sadržavati:
What Nyxoid looks like and contents of the pack 
Kako Nyxoid izgleda i sadržaj pakiranja
You may get strong withdrawal symptoms with this medicine (see later in section 4 of this leaflet under ‘Conditions to look out for') 
Mogu Vam se pojaviti snažni simptomi ustezanja uz ovaj lijek (vidjeti dalje u dijelu 4 ove upute pod „Stanja na koja treba obratiti pozornost”)
There are no adequate data from the use of naloxone in pregnant women. 
Nema odgovarajućih podataka o upotrebi naloksona kod trudnih žena.
Pharmacotherapeutic group: Antidotes, ATC code: V03AB15 
Farmakoterapijska skupina: Antidoti, ATK oznaka: V03AB15