natgillin/translations-raw huggingface dataset:
Tablet cores for 10/20 mg film-coated tablets: Cellulose, microcrystalline Croscarmellose sodium Magnesium stearate
Jedro tablete za 10/20 mg filmsko obložene tablete: celuloza, mikrokristalna natrijev karmelozat, premreženi magnezijev stearat smukec silicijev dioksid, koloidni, brezvodni
Memantine Mylan film-coated tablets are available in blister packs of 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 or 112 film-coated tablets.
Memantin Mylan filmsko obložene tablete so na voljo v pretisnih omotih v naslednjih velikostih pakiranj: 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 ali 112 filmsko obloženih tablet.
A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Temeljna študija memantina v monoterapiji pri zdravljenju bolnikov z blago do zmerno Alzheimerjevo boleznijo (skupna ocena pri KPSS ob vključitvi 10 do 22 točk) je zajela 403 bolnike.
These factors include drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers.
Mednje spadajo izrazite spremembe v prehranjevanju, kot npr. prehod z običajne na vegetarijansko prehrano ali zaužitje večjih količin alkalno delujočih antacidov.
98 x 1 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets 112 film-coated tablets
98 x 1 filmsko obložena tableta 100 filmsko obloženih tablet 100 x 1 filmsko obložena tableta 112 filmsko obloženih tablet
• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
• glavobol, zaspanost, zaprtje, zvišane vrednosti testov jetrne funkcije, omotica, motnje ravnotežja, zasoplost, visok krvni tlak in preobčutljivost na zdravilo
EU/1/13/827/001 EU/1/13/827/002 EU/1/13/827/003 EU/1/13/827/004 EU/1/13/827/005 EU/1/13/827/006 EU/1/13/827/007
EU/1/13/827/001 EU/1/13/827/002 EU/1/13/827/003 EU/1/13/827/004 EU/1/13/827/005
• The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
• Na podlagi mehanizma delovanja se pričakuje, da se ob sočasnem zdravljenju z antagonisti NMDA kot je memantin, učinki L-dope, dopaminergičnih agonistov in antiholinergikov, lahko okrepijo.
Breast-feeding Women taking Memantine Mylan should not breast-feed.
Dojenje Ženske, ki jemljejo zdravilo Memantin Mylan, ne smejo dojiti.
OTHER Mon → Tue → Wed → Thu → Fri → Sat → Sun
DRUGI PODATKI Pon → Tor → Sre → Čet → Pet → Sob → Ned
Other medicines and Memantine Mylan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
INFORMATION IN BRAILLE Memantine Mylan 10 mg
PODATKI V BRAILLOVI PISAVI Memantin Mylan 10 mg
Standard clinical procedures to remove active substance material, e.g. gastric lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate.
Pri odstranjevanju učinkovine uporabljamo ustrezne standardne klinične postopke, kot so izpiranje želodca, medicinsko oglje (preprečevanje možne enterohepatične recirkulacije), nakisanje urina, prisilna diureza.
Clear PVC-PVdC film with push through aluminium foil lidding blisters in pack sizes of 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 or 112 film-coated tablets.
Memantin Mylan filmsko obložene tablete so na voljo v prozornih PVC-PVdC/Alu pretisnih omotih v naslednjih velikostih pakiranj: 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 ali 112 filmsko obloženih tablet.
In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) daily dose should be 10 mg per day.
Pri bolnikih z zmerno okvaro delovanja ledvic (očistek kreatinina 3049 ml/min) naj bo dnevni odmerek 10 mg.
INFORMATION IN BRAILLE Memantine Mylan 20 mg
PODATKI V BRAILLOVI PISAVI Memantin Mylan 20 mg
How to take Memantine Mylan
Kako jemati zdravilo Memantin Mylan
There are no or limited amount of data from the use of memantine in pregnant women.
Podatkov o uporabi memantina pri nosečnicah ni, oziroma so omejeni.
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine Mylan reassessed by your doctor on a regular basis.
Vaš zdravnik naj redno ocenjuje klinično korist zdravila Memantin Mylan.
Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers.
Alkalizacija urina lahko nastopi po izraziti spremembi v prehrani, npr. po prehodu z običajne na vegetarijansko, ali pri čezmernem zaužitju alkalnih učinkovin za uravnavanje želodčne kisline.
Also, Memantine Mylan may change your reactivity, making driving or operating machinery inappropriate.
Tudi zdravilo Memantin Mylan lahko vpliva na vašo sposobnost odzivanja, zato vožnja in upravljanje strojev nista priporočljiva.
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Zdravilo Memantin Mylan skupaj s hrano in pijačo Obvestite zdravnika, če ste pred kratkim spremenili ali če nameravate bistveno spremeniti prehrano (npr. če preidete iz običajne hrane na strogo vegetarijansko prehrano), ali če imate ledvično tubularno acidozo (preveliko količino kislih spojin v krvi zaradi renalne disfunkcije (slabega delovanja ledvic)) ali če ste zboleli zaradi hudega vnetja sečil (strukture po kateri se prenaša seč).
• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity Uncommon (may affect up to 1 in 100 people):
• glavobol, zaspanost, zaprtje, zvišane vrednosti testov jetrne funkcije, omotica, motnje ravnotežja, zasoplost, visok krvni tlak in preobčutljivost na zdravilo Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
From Week 4 on: The patient should take two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet per day.
Bolnik mora jemati dve 10-miligramski filmsko obloženi tableti (20 mg) ali eno 20-miligramsko filmsko obloženo tableto na dan.
56 x 1 film-coated tablets 60 film-coated tablets
56 x 1 filmsko obložena tableta 60 filmsko obloženih tablet
The pack sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blisters.
Velikosti pakiranj s po 28 x 1, 56 x 1, 98 x 1 in 100 x 1 filmsko obloženo tableto so na voljo v enoodmernih pretisnih omotih.
28 x 1 film-coated tablets 30 film-coated tablets
28 x 1 filmsko obložena tableta 30 filmsko obloženih tablet
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Ena filmsko obložena tableta vsebuje 10 mg memantinijevega klorida, kar ustreza 8,31 mg memantina.
The recommended dose of Memantine Mylan for adults and older people is 20 mg once a day.
Za odrasle in starejše bolnike je priporočeni odmerek zdravila Memantin Mylan 20 mg enkrat na dan.
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc and colloidal anyhdrous silica, all in the tablet core; polydextrose (E1200), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide red (E172), macrogol 400 (E1521), macrogol 8000, all in the tablet coating.
- Pomožne snovi so: mikrokristalna celuloza, premrežen natrijev karmelozat, magnezijev stearat, smukec in brezvodni koloidni silicijev dioksid, vse v jedru tablete; polidekstroza (E1200), hipermeloza 3cP (E464), hipermeloza 6cP (E464), hipromeloza 50cP (E464), rdeči železov oksid (E172), makrogol 400 (E1521), makrogol 8000, vse v oblogi tablete.
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc and colloidal anyhdrous silica, all in the tablet core; polydextrose (E1200), titanium dioxide (E171), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide yellow (E172), macrogol 400 (E1521), macrogol 8000, indigo carmine aluminium lake (E132) and iron oxide red (E172), all in the tablet coating.
- Pomožne snovi so: mikrokristalna celuloza, premrežen natrijev karmelozat, magnezijev stearat, smukec in brezvodni koloidni silicijev dioksid, vse v jedru tablete; polidekstroza (E1200), titanov dioksid (E171), hipromeloza 3cP (E464), hipromeloza 6cP (E464), hipromeloza 50cP (E464), rumeni železov oksid (E172), makrogol 400 (E1521), makrogol 8000, indigotin (E132) in rdeči železov oksid (E172), vse v oblogi tablete.
To benefit from your medicine you should take it regularly every day at the same time of the day.
Zdravilo Memantin Mylan jemljite peroralno enkrat na dan. Da bi vam zdravilo koristilo, ga morate jemati redno, vsak dan ob istem času.
What Memantine Mylan contains - The active substance is memantine.
Kaj vsebuje zdravilo Memantin Mylan - Učinkovina je memantin.
In man, about 80% of the circulating memantine-related material is present as the parent compound.
Pri človeku je okoli 80 % memantina v obtoku v izvorni (nespremenjeni) obliki.
The pack sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in clear PVC-PVdC film with push through aluminium foil lidding perforated unit dose blisters.
Velikosti pakiranj s po 28 x 1, 56 x 1, 98 x 1 in 100 x 1 filmsko obloženo tableto so na voljo v prozornih PVC-PVdC/Alu perforiranih enoodmernih pretisnih omotih.
Fungal infections
Žilne bolezni
Memantine Mylan contains the active substance memantine.
Zdravilo Memantin Mylan vsebuje učinkovino memantin.
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablets (15 mg) per day for 7 days.
3. teden (15.-21. dan): Bolnik mora sedem dni jemati eno in pol 10-miligramsko filmsko obloženo tableto (15 mg) na dan.
Administration of Memantine Mylan is not recommended in patients with severe hepatic impairment.
Dajanje zdravila Memantin Mylan bolnikom s hudo jetrno okvaro ni priporočljivo.
• There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is coadministered with HCT or any combination with HCT.
• Ob sočasni uporabi memantina in hidroklorotiazida (HCT) oziroma zdravil, ki vsebujejo HCT, lahko pride do zmanjšanja serumske koncentracije HCT.
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
2. teden (8.-14. dan): Bolnik mora sedem dni jemati eno 10-miligramsko filmsko obloženo tableto (10 mg) na dan.
These events have been reported in patients treated with memantine hydrochloride.
Pri bolnikih, zdravljenih z memantinom, so poročali o teh dogodkih.
Titanium dioxide (E171)
Dodatno za 10 mg filmsko obložene tablete: titanov dioksid (E171) rumeni železov oksid (E 172) indigotin (E132)
• Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
• Zaradi možnosti pojava farmakotoksične psihoze, se je sočasni uporabi memantina in amantadina potrebno izogniti.
Dose titration
PRETISNI OMOT
Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
1. teden (1.-7. dan): Bolnik mora sedem dni jemati polovico 10-miligramske filmsko obložene tablete (5 mg) na dan.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI TRAKU
What Memantine Mylan looks like and contents of the pack A red film-coated, oval, biconvex, beveled edge tablet marked with “ME” on one side of the tablet and “20” on the other side.
Izgled zdravila Memantin Mylan in vsebina pakiranja Rdeče, ovalne, bikonveksne filmsko obložene tablete s prirezanim robom in označene z "ME" na eni strani tablete in "20" na drugi strani.
A red film-coated, oval, biconvex, bevelled edge tablet debossed with “ME” on one side of the tablet and “20” on the other side.
Rdeče, ovalne, bikonveksne filmsko obložene tablete s prirezanim robom in z vtisnjeno oznako "ME" na eni strani tablete in "20" na drugi strani.
A dark yellow film-coated, tapered oblong shaped, biconvex tablet debossed with “ME” on the left of the score and “10” on the right of the score on one side of the tablet and a score on the other side.
Temno rumene, stožčaste, podolgovate, bikonveksne filmsko obložene tablete, z vtisnjeno oznako "ME" levo in "10" desno od razdelilne zareze na eni strani tablete ter razdelilno zarezo na drugi strani.
The following adverse reactions listed in the Table below have been accumulated in clinical studies with memantine and since its introduction in the market.
V spodnji preglednici so navedeni podatki o neželenih učinkih memantina, zbrani v kliničnih študijah in v obdobju trženja zdravila.
How to store Memantine Mylan
Shranjevanje zdravila Memantin Mylan
In post-marketing experience these reactions have been reported in patients treated with memantine.
Pri bolnikih, zdravljenih z memantinom, so o teh učinkih poročali v okviru izkušenj v obdobju trženja zdravila.
Hepatic impairment
Neznana hepatitis
What Memantine Mylan looks like and contents of the pack A dark yellow film-coated, tapered oblong shaped, biconvex tablet marked with “ME” on the left of the score and “10” on the right of the score on one side of the tablet and a score on the other side.
Izgled zdravila Memantin Mylan in vsebina pakiranja Temno rumene, stožčaste, podolgovate, bikonveksne filmsko obložene tablete, označene z "ME" levo in "10" desno od razdelilne zareze na eni strani tablete ter razdelilno zarezo na drugi strani.
In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Pojavili so se učinki na centralni živčni sistem (desetdnevna koma, kasneje diplopija in vznemirjenost).
one and a half 10 mg tablets week 4 and beyond two 10 mg tablets once a day
4. teden in naprej dve 10-miligramski tableti enkrat na dan
In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
V drugi študiji zdravljenja z monoterapijo pri blagi do zmerni Alzheimerjevi bolezni (skupna ocena KPSS ob vključitvi 11 do 23 točk), je bilo zajetih in naključno razdeljenih 470 bolnikov.
This is increased to one 10 mg tablet once a day (10 mg) in the second week and to 1 and a half 10 mg tablets once a day in the third week.
V drugem tednu odmerek povišamo na eno 10-miligramsko tableto enkrat na dan (10 mg) in v tretjem tednu na eno 10-miligramsko tableto in pol enkrat na dan. Od četrtega tedna naprej sta običajni odmerek dve 10-miligramski tableti enkrat na dan (20 mg).
Memantine Mylan 20 mg film-coated tablets
Memantin Mylan 20 mg filmsko obložene tablete
Memantine Mylan 10 mg film-coated tablets
Memantin Mylan 10 mg filmsko obložene tablete
Gait abnormal
Občasni nenormalna hoja
If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, farmacevtom ali z medicinsko sestro.
NAME OF THE MEDICINAL PRODUCT Memantine Mylan 10 mg film-coated tablets Memantine Mylan 20 mg film-coated tablets
Memantin Mylan 10 mg filmsko obložene tablete Memantin Mylan 20 mg filmsko obložene tablete
EU/1/13/827/033 98 x 1 film-coated tablets EU/1/13/827/034 100 film-coated tablets EU/1/13/827/035 100 x 1 film-coated tablets EU/1/13/827/036 112 film-coated tablets
EU/1/13/827/033 98 x 1 filmsko obložena tableta EU/1/13/827/034 100 filmsko obloženih tablet EU/1/13/827/035 100 x 1 filmsko obložena tableta EU/1/13/827/036 112 filmsko obloženih tablet
EU/1/13/827/015 98 x 1 film-coated tablets EU/1/13/827/016 100 film-coated tablets EU/1/13/827/017 100 x 1 film-coated tablets EU/1/13/827/018 112 film-coated tablets
EU/1/13/827/015 98 x 1 filmsko obložena tableta EU/1/13/827/016 100 filmsko obloženih tablet EU/1/13/827/017 100 x 1 filmsko obložena tableta EU/1/13/827/018 112 filmsko obloženih tablet
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
V temeljno klinično študijo je bilo vključenih 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo, ki so ob vključitvi pri kratkem preizkusu spoznavnih sposobnosti (MMSE - mini-mental state examination) dosegli 3-14 točk.
There was no evidence of any carcinogenicity in life long studies in mice and rats.
V šudijah na miših in podganah, ki so potekale celo življenjsko dobo, niso opazili karcinogenosti.
one and a half 10 mg tablets week 4 and beyond one 20 mg tablet once a day
4. teden in naprej ena 20-miligramska tableta enkrat na dan
EU/1/13/827/007 42 film-coated tablets
EU/1/13/827/007 42 filmsko obloženih tablet
EU/1/13/827/025 42 film-coated tablets
EU/1/13/827/025 42 filmsko obloženih tablet
Memantine Mylan 10 mg film-coated tablets memantine hydrochloride
Memantin Mylan 10 mg filmsko obložene tablete memantinijev klorid
Memantine Mylan 20 mg film-coated tablets memantine hydrochloride
Memantin Mylan 20 mg filmsko obložene tablete memantinijev klorid
EU/1/13/827/005 28 x 1 film-coated tablets EU/1/13/827/006 30 film-coated tablets
EU/1/13/827/005 28 x 1 filmsko obložena tableta EU/1/13/827/006 30 filmsko obloženih tablet
EU/1/13/827/022 28 film-coated tablets
EU/1/13/827/022 28 filmsko obloženih tablet
EU/1/13/827/019 7 film-coated tablets
EU/1/13/827/019 7 filmsko obloženih tablet
EU/1/13/827/030 70 film-coated tablets
EU/1/13/827/030 70 filmsko obloženih tablet
EU/1/13/827/023 28 x 1 film-coated tablets EU/1/13/827/024 30 film-coated tablets
EU/1/13/827/023 28 x 1 filmsko obložena tableta EU/1/13/827/024 30 filmsko obloženih tablet
EU/1/13/827/032 98 film-coated tablets
EU/1/13/827/032 98 filmsko obloženih tablet
EU/1/13/827/020 10 film-coated tablets
EU/1/13/827/020 10 filmsko obloženih tablet
EU/1/13/827/010 56 x 1 film-coated tablets EU/1/13/827/011 60 film-coated tablets
EU/1/13/827/010 56 x 1 filmsko obložena tableta EU/1/13/827/011 60 filmsko obloženih tablet
Silica, colloidal anhydrous
Bolezni jeter, žolčnika in žolčevodov
EU/1/13/827/009 56 film-coated tablets
EU/1/13/827/009 56 filmsko obloženih tablet
Continue to take Memantine Mylan as long as it is of benefit to you.
Zdravilo Memantin Mylan jemljite tako dolgo, kot vam pomaga in se ne pojavijo neželeni učinki, ki jih ne prenašate.
EU/1/13/827/027 56 film-coated tablets
EU/1/13/827/027 56 filmsko obloženih tablet
EU/1/13/827/008 50 film-coated tablets
EU/1/13/827/008 50 filmsko obloženih tablet
EU/1/13/827/026 50 film-coated tablets
EU/1/13/827/026 50 filmsko obloženih tablet
EU/1/13/827/004 28 film-coated tablets
EU/1/13/827/004 28 filmsko obloženih tablet
EU/1/13/827/002 10 film-coated tablets
EU/1/13/827/002 10 filmsko obloženih tablet
one 10 mg tablet week 3
2. teden ena 10-miligramska tableta
EU/1/13/827/028 56 x 1 film-coated tablets EU/1/13/827/029 60 film-coated tablets
EU/1/13/827/028 56 x 1 filmsko obložena tableta EU/1/13/827/029 60 filmsko obloženih tablet
EU/1/13/827/021 14 film-coated tablets
EU/1/13/827/021 14 filmsko obloženih tablet
EU/1/13/827/014 98 film-coated tablets
EU/1/13/827/014 98 filmsko obloženih tablet
EU/1/13/827/031 84 film-coated tablets
EU/1/13/827/031 84 filmsko obloženih tablet
Drug hypersensitivity
Pogosti hipertenzija
EU/1/13/827/012 70 film-coated tablets
EU/1/13/827/012 70 filmsko obloženih tablet
EU/1/13/827/001 7 film-coated tablets
EU/1/13/827/001 7 filmsko obloženih tablet
Very rare
Pogosti dispneja
EU/1/13/827/013 84 film-coated tablets
EU/1/13/827/013 84 filmsko obloženih tablet
EU/1/13/827/003 14 film-coated tablets
EU/1/13/827/003 14 filmsko obloženih tablet
No cytochrome P 450 catalysed metabolism has been detected in vitro.
Noben od teh presnovkov nima antagonističnega učinka na NMDA. In vitro niso zaznali presnove preko citokroma P 450.
Balance disorders
Pogosti motnje ravnotežja
half a 10 mg tablet week 2
3. teden ena in pol 10-miligramska tableta
Hypertension
Linearnost
• Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Obstaja povezava med Alzheimerjevo boleznijo in depresijo, samomorilnimi mislimi in samomorom.
It is a well-known substance, which has been used to control pain for many years.
To je dobro znana snov, ki se že več let uporablja za obvladovanje bolečin.
Further information on PecFent can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Nadaljnje informacije za zdravilo PecFent so na voljo na spletni strani agencije: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
This means that it is similar to ‘reference medicines' containing the same active substance, but given in a different way.
To pomeni, da je podobno „referenčnima zdraviloma“, ki vsebujeta enako učinkovino, vendar se dajeta na drugačen način.
What measures are being taken to ensure the safe and effective use of PecFent?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila PecFent?
PecFent received a marketing authorisation valid throughout the EU on 31 August 2010.
Za zdravilo PecFent je bilo 31. avgusta 2010 izdano dovoljenje za promet, veljavno po vsej EU.
The first trial dose should always be 100 micrograms (one spray into one nostril).
Prvi poskusni odmerek mora biti vedno 100 mikrogramov (en vpih pršila v eno nosnico).
Based on available data, the Agency concluded that PecFent's benefits are greater than its risks and it can be authorised for use in the EU.
Na podlagi razpoložljivih podatkov je agencija zaključila, da so koristi zdravila PecFent večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The average reduction in pain during the first 30 minutes after use was 6.6 points in patients receiving PecFent compared with 4.5 in those receiving placebo.
V prvih 30 minutah po uporabi se je bolečina pri bolnikih, ki so prejemali zdravilo PecFent, povprečno zmanjšala za 6,6 točke, pri bolnikih, ki so prejemali placebo, pa za 4,5 točke.
Other information about PecFent:
Druge informacije o zdravilu PecFent:
The main measure of effectiveness was the change in the severity of pain measured by the patients ranking their pain on a scale from 0 to 10.
Glavno merilo učinkovitosti je bila sprememba jakosti bolečine, ki so jo bolniki ocenili na lestvici od 0 do 10.
Because PecFent is a hybrid medicine, the applicant presented data on the reference medicines in addition to results from its own studies.
Ker je zdravilo PecFent hibridno zdravilo, je predlagatelj poleg rezultatov svojih študij predložil tudi podatke o referenčnih zdravilih.
Patients should not take more than four doses a day and should leave a gap of at least four hours between treating each episode of pain.
Bolniki ne smejo prejeti več kot štiri odmerke dnevno, poleg tega mora biti med zdravljenjem posamičnih epizod bolečine najmanj štiriurni premor.
An overview of PecFent and why it is authorised in the EU
Pregled zdravila PecFent in zakaj je odobreno v EU
The most serious of these side effects are respiratory depression (inhibition of breathing), circulatory depression (slow heartbeat), hypotension (low blood pressure) and shock (a steep fall in blood pressure).
Najresnejši od teh neželenih učinkov so depresija dihanja (oteženo dihanje), depresija krvnega obtoka (počasen srčni utrip), hipotenzija (nizek krvni tlak) in šok (močan padec krvnega tlaka).