natgillin/translations-raw huggingface dataset:
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, and magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and iron oxide yellow (E 172) all in the tablet coating.
Drugi sastojci su: mikrokristalična celuloza,umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat, sve u jezgri tablete; te hipromeloza, makrogol 400, titanijev dioksid (E171) i žuti željezov oksid (E172), sve u ovojnici tablete.
Hepatic impairment
Nepoznato hepatitis
EU/1/12/799/001 14 film-coated tablets EU/1/12/799/002 28 film-coated tablets EU/1/12/799/003 30 film-coated tablets EU/1/12/799/004 42 film-coated tablets EU/1/12/799/005 50 film-coated tablets EU/1/12/799/006 56 film-coated tablets EU/1/12/799/007 98 film-coated tablets EU/1/12/799/008 100 film-coated tablets EU/1/12/799/009 112 film-coated tablets
EU/1/12/799/001 14 filmom obloženih tableta EU/1/12/799/002 28 filmom obloženih tableta EU/1/12/799/003 30 filmom obloženih tableta EU/1/12/799/004 42 filmom obložene tablete EU/1/12/799/005 50 filmom obloženih tableta EU/1/12/799/006 56 filmom obloženih tableta EU/1/12/799/007 98 filmom obloženih tableta EU/1/12/799/008 100 filmom obloženih tableta EU/1/12/799/009 112 filmom obloženih tableta
Memantine Merz 10 mg tablets
Memantine Merz 10 mg tablete
20 mg tablets once a day
4. tjedan i nadalje tableta od 20 mg jednom dnevno
In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within
U ispitivanju u kojem je korišten oralno primijenjen 14C-memantin uklonjeno je prosječno 84% doze unutar 20 dana, a više od 99% izlučeno je putem bubrega.
EU/1/12/799/013 14 film-coated tablets EU/1/12/799/014 28 film-coated tablets EU/1/12/799/015 42 film-coated tablets EU/1/12/799/016 56 film-coated tablets EU/1/12/799/017 98 film-coated tablets EU/1/12/799/019 14 film-coated tablets EU/1/12/799/020 28 film-coated tablets EU/1/12/799/021 42 film-coated tablets EU/1/12/799/022 56 film-coated tablets EU/1/12/799/023 98 film-coated tablets
EU/1/12/799/013 14 filmom obloženih tableta EU/1/12/799/014 28 filmom obloženih tableta EU/1/12/799/015 42 filmom obložene tablete EU/1/12/799/016 56 filmom obloženih tableta EU/1/12/799/017 98 filmom obloženih tableta EU/1/12/799/019 14 filmom obloženih tableta EU/1/12/799/020 28 filmom obloženih tableta EU/1/12/799/021 42 filmom obložene tablete EU/1/12/799/022 56 filmom obloženih tableta EU/1/12/799/023 98 filmom obloženih tableta
Memantine Merz 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets Memantine hydrochloride
Memantine Merz 5 mg, 10 mg, 15 mg, 20 mg filmom obložene tablete memantinklorid
• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorder,
• glavobolja, pospanost, zatvor, povišene razine testova jetrene funkcije, omaglica, poremećaji ravnoteže, nedostatak zraka, povišeni krvni tlak i preosjetljivost na lijek
- if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Memantine Merz oral solution (listed in section 6).
- ako ste alergični (preosjetljivi) na memantinklorid ili neki drugi sastojak Memantine Merz oralne otopine (naveden u dijelu 6).
Memantine Merz 20 mg tablets
Memantine Merz 20 mg tablete
Τηλ.
Merzom.
Package leaflet: Information for the user Memantine Merz 5 mg/pump actuation, oral solution
Uputa o lijeku: Informacija za korisnika Memantine Merz 5 mg/potisak, oralna otopina memantinklorid
Colloidal anhydrous silica
- oralnih antikoagulansa
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (20x 42 TABLETS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKIH PAKIRANJA (20 x 42 TABLETE) ZAMOTANIH
Tablet cores for 5/10/15/20 mg film-coated tablets Microcrystalline cellulose Croscarmellose sodium
Jezgre tableta za 5 mg/10 mg/15 mg/20 mg filmom obložene tablete celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni magnezijev stearat
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician's interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study- activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
U 6. mjesecu ispitivanja pokazani su povoljni učinci liječenja memantinom u usporedbi s placebom (analiza opaženih slučajeva za promjene bazirane na dojmu kliničara nakon intervjua (CIBIC-plus; engl. the clinician´s interview based impression of change): p=0,025; kooperativno ispitivanje
OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE
DRUGO (A) POSEBNO (A) UPOZORENJE (A) (AKO JE POTREBNO) ROK VALJANOSTI
Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Svaka filmom obložena tableta sadrži 5 mg memantinklorida, što odgovara 4,15 mg memantina.
The recommended maintenance dose is 20 mg (2 ml solution, equivalent to four pump actuations) per day.
Bolesnik treba uzimati 2 ml otopine (20 mg) što odgovara četiri potiska pumpice dnevno.
Pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.
Blijedožuta do žuta filmom obložena tableta ovalnog oblika, s razdjelnom crtom i utisnutim oznakama “1-0” na jednoj strani i “M M” na drugoj strani.
Merz Pharma GmbH + Co. KGaA Eckenheimer Landstr.
Merz Pharma GmbH + Co.
Memantine Merz 5mg Memantine Merz 10 mg Memantine Merz 15 mg Memantine Merz 20 mg film-coated tablets
Memantine Merz 5 mg Memantine Merz 10 mg Memantine Merz 15 mg Memantine Merz 20 mg filmom obložene tablete
Do not use Memantine Merz after the expiry date which is stated on the carton and the blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskoj kutiji i blisteru nakon “Rok valjanosti”.
Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske Agencije za lijekove (EMA) http://www.ema.europa.eu.
Maintenance dose The recommended maintenance dose is 20 mg per day.
Preporučena doza održavanja je 20 mg na dan.
Memantine Merz 5 mg/pump actuation, oral solution memantine hydrochloride
Memantine Merz 5 mg/potisak, oralna otopina memantinklorid
Each pump actuation delivers 0.5 ml solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.
Svaki potisak pumpice oslobađa 0,5 ml otopine koja sadrži 5 mg memantinklorida, što odgovara 4,16 mg memantina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (20 x 42 TABLETS, 20 x 50 TABLETS AND 10 x 98 TABLETS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKIH PAKIRANJA (20 x 42 TABLETA, 20 x 50 TABLETA
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Svaka filmom obložena tableta sadrži 15 mg memantinklorida, što odgovara 12,46 mg memantina.
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
2. tjedan (8. - 14. dan): Bolesnik treba uzimati jednu filmom obloženu tabletu od 10 mg (10 mg) dnevno tijekom 7 dana.
1 g of solution contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
1 g otopine sadrži 10 mg memantinklorida, što odgovara 8,31 mg memantina.
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Svaka filmom obložena tableta sadrži 20 mg memantinklorida što odgovara 16,62 mg memantina.
- if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Memantine Merz tablets (listed in section 6).
- ako ste alergični (preosjetljivi) na memantinklorid ili neki drugi sastojak Memantine Merz filmom obloženih tableta (naveden u dijelu 6.).
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
3. tjedan (15. - 21. dan): Bolesnik treba uzimati jednu i pol filmom obloženu tabletu od 10 mg (15 mg) dnevno tijekom 7 dana.
Very rare
Često konstipacija
Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
1. tjedan (1. - 7. dan): Bolesnik treba uzimati polovicu filmom obložene tablete od 10 mg (5 mg) dnevno tijekom 7 dana.
Pack sizes of 14, 28, 42, 56, 98 or multipacks containing 840 (20 x 42) film-coated tablets are presented.
Filmom obložene tablete se nalaze u pakiranjima od 14, 28, 42, 56, 98 ili višestruko pakiranje 840 (20 x 42) tableta.
The 5 mg film-coated tablets are white to off-white, oval-oblong film-coated tablets with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Filmom obložene tablete od 5 mg su bijele do gotovo bijele, ovalno duguljaste filmom obložene tablete s utisnutom oznakom ‘5' na jednoj strani i ‘MEM' na drugoj strani.
The 15 mg film-coated tablets are orange to grey-orange, oval-oblong film-coated tablets with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Filmom obložene tablete od 15 mg su narančaste do sivo-narančaste, ovalno duguljaste filmom obložene tablete s utisnutom oznakom ‘15' na jednoj strani i ‘MEM' na drugoj strani.
• Seizures
• napadaji
The maximum daily dose is 20 mg per day.
Titriranje doze Maksimalna dnevna doza je 20 mg na dan.
Lot {number} See embossed stamp.
Broj serije {broj} Vidjeti reljefni otisak.
Memantine Merz 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Memantine Merz 20 mg filmom obložene tablete su blijedocrvene do sivo-crvene, ovalno duguljaste s utisnutom oznakom ‘20' na jednoj strani i ‘MEM' na drugoj strani.
Memantine Merz 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Memantine Merz 5 mg filmom obložene tablete su bijele do gotovo bijele, ovalno duguljaste s utisnutom oznakom ‘5' na jednoj strani i ‘MEM' na drugoj strani.
Memantine Merz 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Memantine Merz 15 mg filmom obložene tablete su narančaste do sivo-narančaste, ovalno duguljaste s utisnutom oznakom ‘15' na jednoj strani i ‘MEM' na drugoj strani.
The 20 mg film-coated tablets are pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Filmom obložene tablete od 20 mg su blijedocrvene do sivo-crvene, ovalno duguljaste filmom obložene tablete s utisnutom oznakom ‘20' na jednoj strani i ‘MEM' na drugoj strani.
Memantine Merz 5 mg/pump actuation, oral solution
Memantine Merz 5 mg/potisak, oralna otopina
Memantine Merz 15 mg 7 film-coated tablets.
Memantine Merz 15 mg 7 filmom obloženih tableta.
One pump actuation delivers 0.5 ml solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.
Svaki potisak oslobađa 0,5 ml otopine koja sadrži 5 mg memantinklorida što odgovara 4,16 mg memantina.
two pump actuations.
2. tjedan dva potiska pumpice
Name and address of the manufacturer(s) responsible for batch release
Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet Merz Pharma GmbH & Co.
In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
30-49 ml/min), dnevna doza bi trebala biti 10 mg (1 ml otopine, što odgovara dva potiska pumpice).
one pump actuation.
1. tjedan jedan potisak pumpice
Do not use Memantine Merz after the expiry date which is stated on the carton and the bottle label after the EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskoj kutiji i naljepnici boce nakon “Rok valjanosti”.
100 D-60318 Frankfurt/Main Germany
Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100 D-60318 Frankfurt/Main Njemačka
half a 10 mg tablet week 2
3. tjedan jedna i pol tableta od 10 mg
Memantine Merz 5 mg 7 film-coated tablets.
Memantine Merz 5 mg 7 filmom obloženih tableta.
Titanium dioxide (E 171) Iron oxide yellow and red (E 172)
Ovojnica tablete hipromeloza makrogol 400 titanijev dioksid (E 171) željezov oksid, žuti i crveni (E 172)
5 mg tablet week 2
1. tjedan tableta od 5 mg
Week 3 (day 15-21): The patient should take one 15 mg film-coated tablet per day for 7 days.
3. tjedan (15. - 21. dan): Bolesnik treba uzimati jednu filmom obloženu tabletu od 15 mg dnevno, tijekom 7 dana.
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day as described above.
Temeljem kliničkih ispitivanja, preporučena doza za bolesnike starije od 65 godina iznosi 20 mg na dan
Pale red to grey-red, oval-oblong film-coated tablets with imprint “20” on one side and imprint “MEM” on the other side.
Blijedocrvene do sivo-crvene duguljaste ovalne filmom obložene tablete s utisnutim oznakama “20” na jednoj strani i “MEM” na drugoj strani.
Memantine Merz 20 mg film-coated tablets
Memantine Merz 20 mg filmom obložene tablete
Memantine Merz 10 mg 7 film-coated tablets.
Memantine Merz 10 mg 7 filmom obloženih tableta.
Administration
SUSTAVA
Memantine Merz 5 mg film-coated tablets Memantine Merz 10 mg film-coated tablets Memantine Merz 15 mg film-coated tablets Memantine Merz 20 mg film-coated tablets Memantine hydrochloride
Memantine Merz 5 mg filmom obložene tablete Memantine Merz 10 mg filmom obložene tablete Memantine Merz 15 mg filmom obložene tablete Memantine Merz 20 mg filmom obložene tablete memantinklorid
Memantine Merz film-coated tablets are presented as pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Memantine Merz filmom obložene tablete su blijedocrvene do sivo-crvene, ovalno duguljaste filmom obložene tablete s utisnutom oznakom ‘20' na jednoj strani i ‘MEM' na drugoj strani.
Memantine Merz film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.
Memantine Merz filmom obložene tablete su blijedožute do žute boje, filmom obložene tablete ovalnog oblika s razdjelom crtom i utisnutim oznakama “1-0” na jednoj strani te “M M” na drugoj strani.
Lundbeck Slovensko s.r.o.
Lundbeck Italia S.p.A.
Titanium dioxide (E 171) Iron oxide yellow (E 172)
Ovojnica tablete hipromeloza makrogol 400 titanijev dioksid (E 171) željezov oksid, žuti (E 172)
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet per day for 7 days.
2. tjedan (8. - 14. dan): Bolesnik treba uzimati jednu filmom obloženu tabletu od 10 mg dnevno, tijekom 7 dana.
Memantine Merz 5 mg film-coated tablets Memantine Merz 10 mg film-coated tablets Memantine Merz 15 mg film-coated tablets Memantine Merz 20 mg film-coated tablets
Memantine Merz 5 mg filmom obložene tablete Memantine Merz 10 mg filmom obložene tablete Memantine Merz 15 mg filmom obložene tablete Memantine Merz 20 mg filmom obložene tablete
Memantine Merz 10 mg film-coated tablets
Memantine Merz 10 mg filmom obložene tablete
Memantine Merz 10 mg film-coated tablets Memantine hydrochloride
Memantine Merz 10 mg filmom obložene tablete memantinklorid
See package leaflet for further information.
Za dodatne informacije vidjetu Uputu o lijeku.
The 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side The tablet can be divided into equal halves.
Filmom obložene tablete od 10 mg su blijedožute do žute, filmom obložene tablete ovalnog oblika, s razdjelnom crtom i utisnutom oznakom “1-0” na jednoj strani i “M M” na drugoj strani.
Memantine Merz 20 mg film-coated tablets Memantine hydrochloride
Memantine Merz 20 mg filmom obložene tablete memantinklorid
The dosing pump head has two positions and is easy to turn: anticlockwise to unlock and clockwise to lock.
Kako radi pumpica za doziranje: Vrh pumpice za doziranje ima dva položaja i može se lako okrenuti:
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Svaka filmom obložena tableta sadrži 10 mg memantinklorida što odgovara 8,31 mg memantina.
Drug hypersensitivity
Često preosjetljivost na lijek
Lundbeck Pharma d.o.o.
Lundbeck B.V.
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
(konfuziju, omamljenost, somnolenciju, vrtoglavicu, agitaciju, agresiju, halucinacije i poremećaj hoda) i/ili gastrointestinalne simptome (povraćanje i proljev).
Renal impairment
UČESTALOST NUSPOJAVA
Lundbeck Hungaria Kft. Tel: +36 1 4369980
Lundbeck Croatia d.o.o. Tel.: + 385 1 3649 210
Memantine Merz 10 mg film-coated tablets are presented as pale yellow to yellow, oval shaped filmcoated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side The tablet can be divided into equal halves.
Memantine Merz 10 mg filmom obložene tablete su blijedožute do žute, filmom obložene tablete ovalnog oblika, s razdjelnom crtom i utisnutom oznakom “1 0” na jednoj strani i “M M” na drugoj strani.
Week 1 (day 1-7): The patient should take one 5 mg film-coated tablet per day for 7 days.
1. tjedan (1. - 7. dan): Bolesnik treba uzimati jednu filmom obloženu tabletu od 5 mg dnevno, tijekom 7 dana.
Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) -and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Alzheimer´s disease assessment scale) (p=0,003) i CIBIC-plus (p=0,004) u 24. tjednu liječenja (zadnje opažanje preneseno dalje (LOCF; engl. last observation carried forward)).
Week 3 (day 15-21): The patient should take 1.5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days.
Bolesnik treba uzimati 1,5 ml otopine (15 mg) što odgovara tri potiska pumpice dnevno, tijekom 7 dana.
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism) Very rare (may affect up to 1 in 10,000 users):
Manje često (mogu se javiti u do 1 na 100 osoba): • umor, gljivične infekcije, smetenost, halucinacije, povraćanje, poremećaj hoda, zatajenje srca i zgrušavanje venske krvi (tromboza/tromboembolija)
Somnolence
Dojenje
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
TVARI Svaka filmom obložena tableta sadrži 10 mg memantinklorida što odgovara 8,31 mg memantina.
MARKETING AUTHORISATION NUMBER(S) 13.
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
one 10 mg tablet week 3
2. tjedan jedna tableta od 10 mg
Week 1 (day 1-7): The patient should take 0.5 ml solution (5 mg) equivalent to one pump actuation per day for 7 days.
Bolesnik treba uzimati 0,5 ml otopine (5 mg) što odgovara jednom potisku pumpice dnevno, tijekom 7 dana.
10 mg tablet week 3
2. tjedan tableta od 10 mg
Week 1 (day 1-7): Take one 5 mg tablet once a day (white to off-white, oval-oblong) for 7 days.
Uzimajte jednu tabletu od 5 mg jednom dnevno (bijelu do gotovo bijelu, duguljasto ovalnu) tijekom 7 dana.
- If you get side effects, talk to your doctor or pharmacist.
Ako pumpica ne radi ispravno, obratite se svom liječniku ili ljekarniku.
Lot {number}
Broj serije {broj}
Week 1 (day 1-7): The patient should take one 5 mg film-coated tablet per day (white to off-white, oval-oblong) for 7 days.
Bolesnik treba uzimati jednu filmom obloženu tabletu od 5 mg (bijelu do prljavo bijelu, duguljasto ovalnu) dnevno tijekom 7 dana.
Lundbeck Hellas A.E Τηλ.
Lundbeck Hungaria Kft.
Confusion
Primjena
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
I SAŽETAK OPISA SVOJSTAVA LIJEKA
Fungal infections
Manje često gljivične infekcije
98 film-coated tablets
I 10 x 98 TABLETA)
week 1
1. tjedan (1. - 7. dan):
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (20 mg once a day) as described above.
Temeljem kliničkih ispitivanja preporučena doza za bolesnike starije od 65 godina iznosi 20 mg na dan,
The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine
- barbiturata (lijekovi koji se uglavnom koriste za uspavljivanje) - dopaminergičkih agonista (lijekovi kao što su L-dopa, bromokriptin)
If the pump does not function properly, consult your doctor or a pharmacist.Lock the dosing pump after using Memantine Merz.
Zaključajte pumpicu za doziranje nakon primjene Memantine Merza.
EU-Number
Broj (EU) odobrenja
Package size
Sastav Veličina pakovanja
Pharmaceutical Form Route of Administration Packaging
Put primjene Pakovanje
Strength Pharmaceutical Form Route of Administration
Broj (EU) odobrenja Zaštićeno ime Doza Farmaceutski oblik
1 vial + 1 vial
Put primjene Unutarnje pakovanje Sastav (koncentracija)
This should be done right after step J.
To treba učiniti odmah nakon koraka J.
You will also need:
Trebat ćete i:
b Calculation based on 67 profiles.
b Izračun na temelju 67 profila.
The package contains:
Pakiranje sadrži:
Always wash your hands and ensure that the area around you is clean.
Uvijek operite ruke i pobrinite se da područje oko Vas bude čisto.
You can do this by holding them in your hands until they feel as warm as your hands, see figure A.
To se može postići tako da ih držite u rukama sve dok ne osjetite da su tople kao i Vaše ruke, pogledajte sliku A.
• Inject slowly over approximately 2 minutes.
• Injicirajte polako tijekom otprilike 2 minute.
Use a new package instead.
Umjesto toga upotrijebite novo pakiranje.
Repeat after 24 hours if necessary
Po potrebi ponoviti nakon 24 sata
The equipment is for single use only.
Pribor je namijenjen samo za jednokratnu uporabu.
• You will be monitored carefully for development of these inhibitors
• Bit ćete detaljno praćeni na razvoj takvih inhibitora
Always use an aseptic technique.
Uvijek treba primjenjivati aseptičku tehniku.
Within one hour before surgery
Unutar jednog sata prije kirurškog zahvata
Osmolality: 590 mOsmol/kg.
Osmolalnost: 590 mOsmol/kg.
Your doctor will calculate your dose for you.
Liječnik će izračunati dozu lijeka za Vas.
• Take out the number of Esperoct packages you need.
• Uzmite onoliki broj Esperoct pakiranja koliko trebate.
After reconstitution
Nakon rekonstitucije
• These inhibitors, especially at high levels, stop the treatment working properly
• Ti inhibitori, posebice pri visokim razinama, zaustavljaju pravilno liječenje
Do not use the powder if the colour has changed.
Nemojte upotrijebiti prašak ako mu se boja promijenila.
No correlation with adverse events could be established.
Nije ustanovljena korelacija sa štetnim događajima.
Talk to your doctor or pharmacist if you have heart disease or you are at risk of heart disease.
Razgovarajte sa svojim liječnikom ili ljekarnikom ako imate bolest srca ili imate rizik za razvoj bolesti srca.
Proceed with the next injection as scheduled and continue as advised by your doctor.
Nastavite s idućom injekcijom prema rasporedu i nastavite kako Vam je savjetovao Vaš liječnik.
In case of shock, standard medical treatment for shock should be implemented.
U slučaju šoka, treba primijeniti standardno liječenje šoka.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10.
DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
Protective paper
Zaštitni papir
If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Ako se pojave takvi inhibitori, stanje će se manifestirati kao nedovoljan klinički odgovor.
Prophylaxis in adults/adolescents
Profilaksa u odraslih/adolescenata
• Wash your hands and dry them properly using a clean towel or let them air dry.
• Operite ruke i dobro ih osušite čistim ručnikom ili pustite da se osuše na zraku.