natgillin/translations-raw huggingface dataset:
Instanyl 50 micrograms/dose nasal spray, solution EU/1/09/531/022-025 
Instanyl 50 mikrograma/doza sprej za nos, otopina EU/1/09/531/022-025
Name and address of the manufacturers responsible for batch release for single-dose nasal spray 
Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet za jednodozni sprej za nos
1 ml contains fentanyl citrate equivalent to 1,000 micrograms fentanyl. 
1 ml sadrži fentanilcitrat što odgovara 1000 mikrograma fentanila.
• For the single-dose nasal spray all unused devices or empty containers should be returned systematically according to the local regulation. 
• U slučaju jednodoznog spreja za nos svaki neiskorišteni uređaj ili prazne spremnike treba sistematično zbrinuti sukladno lokalnim propisima.
Also contains: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, water for injections 
POPIS POMOĆNIH TVARI Također sadrži: natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, vodu za injekcije.
NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms nasal spray, solution in single-dose container Instanyl 100 micrograms nasal spray, solution in single-dose container Instanyl 200 micrograms nasal spray, solution in single-dose container 
Instanyl 50 mikrograma sprej za nos, otopina u jednodoznom spremniku Instanyl 100 mikrograma sprej za nos, otopina u jednodoznom spremniku Instanyl 200 mikrograma sprej za nos, otopina u jednodoznom spremniku
- When closing the box, make sure that the side tabs locate back into the slots - Press down firmly until the side tabs click into position 
Pri zatvaranju kutije pazite da bočni jezičci uđu u utore
NAME OF THE MEDICINAL PRODUCT Instanyl 200 micrograms nasal spray, solution in single-dose container Fentanyl 
Instanyl 200 mikrograma sprej za nos, otopina u jednodoznom spremniku fentanil
Instanyl 50 micrograms/dose nasal spray, solution EU/1/09/531/001-003 
Instanyl 50 mikrograma/doza sprej za nos, otopina EU/1/09/531/001-003
Instanyl 200 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 200 micrograms fentanyl. 
Instanyl 200 mikrograma sprej za nos, otopina u jednodoznom spremniku Svaki jednodozni spremnik sadrži jednu dozu (100 mikrolitara) fentanilcitrata, što odgovara 200 mikrograma fentanila.
50 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 500 micrograms fentanyl. 
50 mikrograma/doza: 1 ml sadrži fentanilcitrat što odgovara 500 mikrograma fentanila.
Instanyl 50 micrograms/dose nasal spray, solution Instanyl 100 micrograms/dose nasal spray, solution Instanyl 200 micrograms/dose nasal spray, solution fentanyl 
Instanyl 50 mikrograma/doza sprej za nos, otopina Instanyl 100 mikrograma/doza sprej za nos, otopina Instanyl 200 mikrograma/doza sprej za nos, otopina fentanil
200 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 2,000 micrograms fentanyl. 
200 mikrograma/doza: 1 ml sadrži fentanilcitrat što odgovara 2000 mikrograma fentanila.
NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms nasal spray, solution in single-dose container Fentanyl 
Instanyl 50 mikrograma sprej za nos, otopina u jednodoznom spremniku fentanil
• For the multi-dose nasal spray and multi-dose nasal spray DoseGuard all unused devices or empty containers should be returned systematically according to the local regulation. 
• U slučaju višedoznog spreja za nos i višedoznog spreja za nos DoseGuard svaki neiskorišteni uređaj ili prazan spremnik treba sistematično zbrinuti sukladno lokalnim propisima.
1.8 ml containing 1.80 mg fentanyl ensuring the delivery of 10 doses of 100 micrograms 2.9 ml containing 2.90 mg fentanyl ensuring the delivery of 20 doses of 100 micrograms 5.0 ml containing 5.00 mg fentanyl ensuring the delivery of 40 doses of 100 micrograms 
1,8 ml sadrži 1,80 mg fentanila i osigurava unos 10 doza od 100 mikrograma 2,9 ml sadrži 2,90 mg fentanila i osigurava unos 20 doza od 100 mikrograma 5,0 ml sadrži 5,00 mg fentanila i osigurava unos 40 doza od 100 mikrograma
100 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 1,000 micrograms fentanyl. 
100 mikrograma/doza: 1 ml sadrži fentanilcitrat što odgovara 1000 mikrograma fentanila.
200 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 200 micrograms fentanyl. 
200 mikrograma: 1 doza (100 mikrolitara) sadrži fentanilcitrat što odgovara 200 mikrograma fentanila.
Instanyl 50 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 50 micrograms fentanyl. 
Instanyl 50 mikrograma sprej za nos, otopina u jednodoznom spremniku Svaki jednodozni spremnik sadrži jednu dozu (100 mikrolitara) fentanilcitrata, što odgovara 50 mikrograma fentanila.
If the product has not been used for a period of more than 7 days, the nasal spray must be primed again by actuating once before the next dose is taken. 
Ako se proizvod ne koristi tijekom razdoblja duljeg od 7 dana, prije uzimanja sljedeće doze sprej za nos je potrebno ponovno pripremiti ispuštanjem jedne doze u zrak.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/531/001 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/531/001
What Instanyl looks like and contents of the pack Instanyl DoseGuard is a nasal spray, solution. 
Instanyl DoseGuard je sprej za nos, otopina.
Particular caution should be exercised when titrating Instanyl in elderly patients. 
Kod starijih bolesnika dozu treba titrirati s posebnim oprezom.
Instanyl 100 micrograms/dose nasal spray, solution EU/1/09/531/026-029 
Instanyl 100 mikrograma/doza sprej za nos, otopina EU/1/09/531/026-029
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CHILD-RESISTANT OUTER BOX (Multi dose) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA SIGURNA ZA DJECU (Višedozni)
For nasal use 
Za nos
You should not drive or use machinery whilst being treated with Instanyl. 
Za vrijeme liječenja Instanylom ne upravljajte vozilima i strojevima.
1 dose of 100 microlitres equals 200 micrograms fentanyl. 
1 doza od 100 mikrolitara odgovara 200 mikrograma fentanila.
Instanyl 100 micrograms/dose nasal spray, solution. 
Instanyl 100 mikrograma/doza sprej za nos, otopina.
1.8 ml containing 0.90 mg fentanyl ensuring the delivery of 10 doses of 50 micrograms 2.9 ml containing 1.45 mg fentanyl ensuring the delivery of 20 doses of 50 micrograms 5.0 ml containing 2.50 mg fentanyl ensuring the delivery of 40 doses of 50 micrograms 
1,8 ml sadrži 0,90 mg fentanila i osigurava unos 10 doza od 50 mikrograma 2,9 ml sadrži 1,45 mg fentanila i osigurava unos 20 doza od 50 mikrograma 5,0 ml sadrži 2,50 mg fentanila i osigurava unos 40 doza od 50 mikrograma
The concomitant use of other central nervous system depressants, (including opioids, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquillisers, sedating antihistamines and alcohol) and skeletal muscle relaxants, may produce additive depressant effects: 
Istovremena primjena drugih depresora središnjeg živčanog sustava (uključujući opioide, sedative, hipnotike, opće anestetike, fenotiazine, trankvilizatore, sedirajuće antihistaminike i alkohol) i relaksansa skeletnih mišića, mogu izazvati jače depresivne učinke: hipoventilaciju, hipotenziju, duboku sedaciju, komu ili smrt.
100 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 100 micrograms fentanyl. 
100 mikrograma: 1 doza (100 mikrolitara) sadrži fentanilcitrat što odgovara 100 mikrograma fentanila.
NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms nasal spray, solution in single-dose container Fentanyl 
Instanyl 100 mikrograma sprej za nos, otopina u jednodoznom spremniku fentanil
Instanyl 100 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 100 micrograms fentanyl. 
Instanyl 100 mikrograma sprej za nos, otopina u jednodoznom spremniku Svaki jednodozni spremnik sadrži jednu dozu (100 mikrolitara) fentanilcitrata, što odgovara 100 mikrograma fentanila.
50 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 50 micrograms fentanyl. 
50 mikrograma: 1 doza (100 mikrolitara) sadrži fentanilcitrat što odgovara 50 mikrograma fentanila.
Instanyl 100 micrograms/dose nasal spray, solution EU/1/09/531/004-006 
Instanyl 100 mikrograma/doza sprej za nos, otopina EU/1/09/531/004-006
Following long-term treatment, fentanyl may cause withdrawal in the new-born infant. 
Dugotrajno liječenje za vrijeme trudnoće može izazvati simptome ustezanja kod novorođenčeta.
3.2 ml containing 6.40 mg fentanyl ensuring the delivery of 20 doses of 200 micrograms 4.3 ml containing 8.60 mg fentanyl ensuring the delivery of 30 doses of 200 micrograms 5.3 ml containing 10.60 mg fentanyl ensuring the delivery of 40 doses of 200 micrograms 
2,0 ml sadrži 4,00 mg fentanila i osigurava unos 10 doza od 200 mikrograma 3,2 ml sadrži 6,40 mg fentanila i osigurava unos 20 doza od 200 mikrograma 4,3 ml sadrži 8,60 mg fentanila i osigurava unos 30 doza od 200 mikrograma 5,3 ml sadrži 10,60 mg fentanila i osigurava unos 40 doza od 200 mikrograma
2.0 ml containing 1.00 mg fentanyl ensuring the delivery of 10 doses of 50 micrograms 3.2 ml containing 1.60 mg fentanyl ensuring the delivery of 20 doses of 50 micrograms 4.3 ml containing 2.15 mg fentanyl ensuring the delivery of 30 doses of 50 micrograms 5.3 ml containing 2.65 mg fentanyl ensuring the delivery of 40 doses of 50 micrograms 
DoseGuard 2,0 ml sadrži 1,00 mg fentanila i osigurava unos 10 doza od 50 mikrograma3,2 ml sadrži 1,60 mg fentanila i osigurava unos 20 doza od 50 mikrograma 4,3 ml sadrži 2,15 mg fentanila i osigurava unos 30 doza od 50 mikrograma 5,3 ml sadrži 2,65 mg fentanila i osigurava unos 40 doza od 50 mikrograma
Instanyl 50 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 500 micrograms fentanyl. 
Instanyl 50 mikrograma/doza sprej za nos, otopina Jedan ml otopine sadrži fentanilcitrat što odgovara 500 mikrograma fentanila.
1 dose (100 microlitres) contains 200 micrograms fentanyl. 
1 doza (100 mikrolitara) sadrži 200 mikrograma fentanila.
o That for the multi-dose nasal spray and multi-dose nasal spray DoseGuard all unused devices or empty containers should be returned systematically according to the local regulation. 
• Uputama da u slučaju višedoznog spreja za nos i višedoznog spreja za nos DoseGuard svaki neiskorišteni uređaj ili prazan spremnik treba sistematično zbrinuti sukladno lokalnim propisima.
To re-attach, place the child-resistant cap on the nasal spray and turn the cap clockwise. 
Za vraćanje zatvarača na mjesto, postavite zatvarač siguran za djecu na sprej za nos i okrenite zatvarač u smjeru kretanja kazaljke na satu.
1 dose of 100 microlitres equals 50 micrograms fentanyl. 
1 doza od 100 mikrolitara odgovara 50 mikrograma fentanila.
Instanyl is for nasal use. 
Instanyl je sprej za nos, otopina.
1 dose of 100 microlitres equals 100 micrograms fentanyl. 
1 doza od 100 mikrolitara odgovara 100 mikrograma fentanila.
NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms nasal spray Fentanyl 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Instanyl 50 mikrograma sprej za nos fentanil
1 dose (100 microlitres) contains 100 micrograms fentanyl. 
1 doza (100 mikrolitara) sadrži 100 mikrograma fentanila.
How to use Instanyl nasal spray 
Kako koristiti sprej za nos Instanyl
MARKETING AUTHORISATION NUMBER(S) EU/1/09/531/007 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/531/007
Instanyl 200 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 2,000 micrograms fentanyl. 
Instanyl 200 mikrograma/doza sprej za nos, otopina Jedan ml otopine sadrži fentanilcitrat što odgovara 2000 mikrograma fentanila.
Any used or unused nasal spray should be returned systematically and suitably in the child-resistant outer box and discarded according to local requirements or returned to the pharmacy. 
Svaki korišteni ili nekorišteni sprej za nos treba sistematično zbrinuti u skladu s lokalnim propisima ili vratiti u ljekarnu u kutiji sigurnoj za djecu.
Fentanyl should therefore be used with caution in patients with previous or pre-existing bradyarrhythmias. 
U bolesnika s prijašnjim ili postojećim bradiaritmijama treba ga stoga koristiti s oprezom.
Instanyl 50 micrograms/dose nasal spray, solution 
Instanyl 50 mikrograma/doza sprej za nos, otopina
MARKETING AUTHORISATION NUMBER(S) EU/1/09/531/004 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/531/004
NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms nasal spray Fentanyl 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Instanyl 100 mikrograma sprej za nos fentanil
1 dose (100 microlitres) contains 50 micrograms fentanyl. 
1 doza (100 mikrolitara) sadrži 50 mikrograma fentanila.
Instanyl 100 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 1,000 micrograms fentanyl. 
Instanyl 100 mikrograma/doza sprej za nos, otopina Jedan ml otopine sadrži fentanilcitrat što odgovara 1000 mikrograma fentanila.
1 puff (100 microlitres) contains 200 micrograms fentanyl. 
1 potisak (100 mikrolitara) sadrži 200 mikrograma fentanila.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 50 micrograms/dose nasal spray 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Instanyl 50 mikrograma/doza sprej za nos fentanil
NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms/dose nasal spray, solution Fentanyl 
Instanyl 50 mikrograma/doza sprej za nos, otopina fentanil
Before using the nasal spray for the first time: 
Priprema Instanyl spreja za nos za primjenu: - Prije prve primjene spreja za nos:
1 puff (100 microlitres) contains 50 micrograms fentanyl. 
1 potisak (100 mikrolitara) sadrži 50 mikrograma fentanila.
Dose adjustment of the background opioid therapy following pain reassessment should be considered if the patient frequently presents with breakthrough pain episodes that are less than 4 hours apart or with more than four breakthrough pain episodes per 24 hours. 
Ukoliko se epizode probojne boli često javljaju u razmacima kraćim od 4 sata, ili u više od četiri epizode probojne boli unutar 24 sata potrebno je razmotriti prilagodbu doze osnovne opioidne terapije nakon ponovne procjene boli.
- If you get any side effects, talk to your doctor, nurse or pharmacist. 
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
NAME OF THE MEDICINAL PRODUCT Instanyl 200 micrograms nasal spray Fentanyl 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Instanyl 200 mikrograma sprej za nos fentanil
Tel.: + 420 234 722 722 
Takeda Pharmaceuticals Czech Republic s.r.o. Tel.: + 420 234 722 722
If you have not used Instanyl for more than 7 days the pump must be primed again by spraying once before the next dose is taken. 
- Ako niste Instanyl koristili dulje od 7 dana, nužno je prije uzimanja sljedeće doze ponovno pripremiti sprej ispuštanjem jedne doze u zrak.
Instanyl 100 micrograms/dose nasal spray, solution 
Instanyl 100 mikrograma/doza sprej za nos, otopina
1 puff (100 microlitres) contains 100 micrograms fentanyl. 
1 potisak (100 mikrolitara) sadrži 100 mikrograma fentanila.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 200 micrograms/dose nasal spray 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Instanyl 200 mikrograma/doza sprej za nos fentanil
Hold the nasal spray upright. 
4. držite sprej za nos uspravno;
TAKEDA ΕΛΛΑΣ Α.Ε. 
Takeda Italia S.p.A.
• Always to put the multi-dose nasal spray back in the child-resistant box after use. 
• Da nakon svake primjene uvijek vrate višedozni sprej za nos u kutiju sigurnu za djecu.
NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms/dose nasal spray, solution Instanyl 100 micrograms/dose nasal spray, solution Instanyl 200 micrograms/dose nasal spray, solution 
Instanyla razlikuje se po boji: 50 mikrograma/doza, označeno je narančasto 100 mikrograma/doza, označeno je ljubičasto 200 mikrograma/doza, označeno je zelenkastoplavo
During the priming process product will be expelled. 
Tijekom postupka pripreme spreja istiskuje se lijek.
Patients should wait 4 hours before treating another breakthrough pain episode with Instanyl during both titration and maintenance therapy. 
I u fazi titracije i u terapiji održavanja bolesnici trebaju pričekati 4 sata prije liječenja sljedeće epizode probojne boli Instanylom.
NAME OF THE MEDICINAL PRODUCT Instanyl 200 micrograms/dose nasal spray, solution Fentanyl 
Instanyl 200 mikrograma/doza sprej za nos, otopina fentanil
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 100 micrograms/dose nasal spray 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Instanyl 100 mikrograma/doza sprej za nos fentanil
Do not open the blister before you are ready to use the spray. 
Blister otvorite neposredno prije primjene spreja.
Talk to your doctor before using Instanyl, especially: - if you suffer from a long-term obstructive lung disease, your breathing may be impaired by 
Razgovarajte s liječnikom prije primjene Instanyla, naročito: - ako patite od kronične opstruktivne bolesti pluća, Instanyl može otežati vaše disanje; - ako imate problema sa srcem, a naročito usporen srčani ritam, niski krvni tlak ili niski volumen krvi; - ako imate teškoća sa jetrom ili bubrezima; - ako imate teškoća s moždanom funkcijom, na primjer zbog tumora na mozgu, ozljede glave ili povišenog intrakranijalnog tlaka;
The labelling of the three Instanyl strengths is differentiated by colour: 50 micrograms labelling is orange. 
Instanyla razlikuje se po boji: 50 mikrograma označeno je narančasto 100 mikrograma označeno je ljubičasto 200 mikrograma označeno je zelenkastoplavo
NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms/dose nasal spray, solution Fentanyl 
Instanyl 100 mikrograma/doza sprej za nos, otopina fentanil
• Instructions for use of the nasal spray device. 
• Upute o upotrebi spreja za nos
If you have not been using these medicines you must not use Instanyl, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop. 
Ako niste uzimali ove lijekove ne smijete uzeti Instanyl jer može povećati rizik od opasnog usporavanja disanja i/ili plitkog disanja ili čak potpunog prestanka disanja; - ako uzimate lijek koji sadrži natrijev oksibat; - ako patite od kratkotrajnih bolova koji nisu probojna bol; - ako imate ozbiljnih teškoća s disanjem ili patite od ozbiljne opstruktivne bolesti pluća; - ako ste liječeni zračenjem u području lica; - ako imate ponavljajuće epizode krvarenja iz nosa.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 100 mcg nasal spray 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Instanyl 100 μg sprej za nos fentanil
Always place Instanyl in the child-resistant box after use. 
Nakon primjene Instanyl uvijek vratite u kutiju sigurnu za djecu.
What Instanyl looks like and contents of the pack Instanyl is a nasal spray, solution. 
Kako Instanyl izgleda i sadržaj pakiraja
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 50 mcg nasal spray 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Instanyl 50 μg sprej za nos fentanil
Clean the nasal spray tip after use with a clean tissue, and then throw away the tissue afterwards. 
Istisnutu dozu možda nećete osjetiti u nosu, ali primili ste je kad ste pritisnuli pumpicu; 8. nakon uporabe čistom maramicom očistite vrh spreja za nos, a potom bacite maramicu.
Always place the nasal spray in the child-resistant box after use. 
Nakon primjene sprej za nos uvijek vratite u kutiju sigurnu za djecu.
Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10 
Nositelj odobrenja za stavljanje u promet lijeka Takeda Pharma A/S
- other medicines taken via the nose, especially oxymetazoline, xylometazoline and similar medicines, which are used for relief of nose congestions. 
Možete dobiti simptome sindroma ustezanja (mučninu, povraćanje, proljev, tjeskobu, zimice, nevoljno drhtanje i znojenje); - druge lijekove koji se primjenjuju u nos, naročito oksimetazolin, ksilometazolin i slične lijekove za ublažavanje začepljenosti nosa.
Somnolence, dizziness, headache 
Poremećaji živčanog sustava Somnolencija, omaglica, glavobolja
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 200 mcg nasal spray 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Instanyl 200 μg sprej za nos fentanil
1 dose (100 microlitres) contains fentanyl citrate equivalent to 200 micrograms (mcg) fentanyl 
NAVOĐENJE DJELATNE(IH) TVARI 1 doza (100 mikrolitara) sadrži fentanilcitrat što odgovara 200 mikrograma (μg) fentanila.
Instanyl is intended for nasal use only. 
Instanyl se primjenjuje isključivo nazalno.
1 dose (100 microlitres) contains fentanyl citrate equivalent to 100 micrograms (mcg) fentanyl 
NAVOĐENJE DJELATNE(IH) TVARI 1 doza (100 mikrolitara) sadrži fentanilcitrat što odgovara 100 mikrograma (μg) fentanila.
Ziagen abacavir 
Ziagen abakavir
The full EPAR for Ziagen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR za lijek Ziagen nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This can be taken either as a single daily dose or divided into 300 mg twice a day. 
Ta se doza može uzimati kao jedna dnevna doza ili podijeljena u 300 mg dvaput na dan.
In addition, studies were carried out to examine once daily versus twice daily dosing in children. 
Nadalje, ispitivanja su provedena kako bi se ispitalo doziranje jednom dnevno u odnosu na doziranje dvaput dnevno u djece.
It does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and avoid the development of infections and diseases associated with AIDS. 
Ne liječi zaraze HIV-om niti AIDS, no može odgoditi oštećenje imunosnog sustava te spriječiti razvijanje infekcija i bolesti povezanih s AIDS-om.
It is available as tablets (300 mg) and as an oral solution (20 mg/ml). 
Dostupan je u obliku tableta (300 mg) te kao oralna otopina (20 mg/ml).
In children weighing less than 25 kg the recommended dose depends on body weight. 
U djece s tjelesnom masom manjom od 25 kg preporučena doza ovisi o njihovoj masi.
The European Commission granted a marketing authorisation valid throughout the European Union for Ziagen on 8 July 1999. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Ziagen na snazi u Europskoj uniji od 8. srpnja 1999.
Other information about Ziagen: 
Ostale informacije o lijeku Ziagen:
The recommended dose of Ziagen for adults and children weighing at least 25 kg is 600 mg daily. 
Preporučena doza lijeka Ziagen za odrasle i djecu tjelesne mase od najmanje 25 kg iznosi 600 mg dnevno.
In one of the studies in adults, 77% of the patients taking Ziagen with lamivudine and zidovudine had viral loads below 400 copies/ml after 16 weeks (67 out of 87), compared with 38% of the adults taking lamivudine and zidovudine without Ziagen (33 out of 86). 
U jednom od ispitivanja na odraslim osobama, 77 % bolesnika koji su uzimali Ziagen s lamivudinom i zidovudinom imalo je virusno opterećenje niže od 400 kopija/ml nakon 16 tjedana (67 od 87), u usporedbi s 38 % odraslih osoba koje su uzimale lamivudin i zidovudin bez Ziagena (33 od 86).
Hypersensitivity reactions (allergic reactions) occur in patients taking Ziagen, usually within the first six weeks of treatment, and can be life-threatening. 
Reakcije preosjetljivosti (alergijske reakcije) nastupaju u bolesnika koji uzimaju lijek Ziagen obično unutar prvih šest tjedana terapije i mogu biti opasne po život.
Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain (stomach ache), dyspnoea (difficulty breathing), cough, fever, lethargy, malaise (feeling unwell), headache, signs of liver damage in the blood and myalgia (muscle pain). 
Simptomi gotovo uvijek uključuju groznicu ili osip, no također vrlo često obuhvaćaju mučninu, povraćanje, proljev, abdominalnu bol (bol u trbuhu), dispneju (otežano disanje), kašalj, vrućicu, letargiju, malaksalost (osjećaj zamaranja), glavobolju, znakove oštećenja jetre u krvi i mijalgiju (bol u mišićima).