natgillin/translations-raw huggingface dataset:
In case of overdose with ADROVANCE, milk or antacids should be given to bind alendronate.
Če bolnik vzame prekomeren odmerek zdravila ADROVANCE, naj pije mleko ali vzame antacid, ki vežeta alendronat.
In this study, mean 25-hydroxyvitamin D levels in patients with vitamin D insufficiency at baseline (25-hydroxyvitamin D, 22.5 to 37.5 nmol/l [9 to < 15 ng/ml]) increased from 30 nmol/l (12.1 ng/ml) to 40 nmol/l (15.9 ng/ml) at week 15 in the ADROVANCE (70 mg/2,800 IU) group (n=75) and decreased from 30 nmol/l (12.0 ng/ml) at baseline to 26 nmol/l (10.4 ng/ml) at week 15 in the alendronate-only group (n=70).
V tej študiji so se povprečne vrednosti 25-hidroksivitamina D pri bolnicah s pomanjkanjem vitamina D na začetku študije (25-hidroksivitamin D, 22,5 do 37,5 nmol/l [9 do <15 ng/ml]) v skupini, ki je prejemala zdravilo ADROVANCE (70 mg/2.800 i.e.) (n = 75), v 15. tednu zvišale s 30 nmol/l (12,1 ng/ml) na 40 nmol/l (15,9 ng/ml), v skupini, ki je prejemala le alendronat (n = 70) pa v 15. tednu znižale s 30 nmol/l (12,0 ng/ml) na 26 nmol/l (10,4 ng/ml).
The effect of the lower dose of ADROVANCE (alendronate 70 mg/vitamin D3 2,800 IU) on vitamin D status was demonstrated in a 15-week, multinational study that enrolled 682 osteoporotic postmenopausal women (serum 25-hydroxyvitamin D at baseline: mean, 56 nmol/l [22.3 ng/ml]; range, 22.5-225 nmol/l [9-90 ng/ml]).
Vpliv manjšega odmerka zdravila ADROVANCE (alendronat 70 mg/vitamin D3 2.800 i.e.) na status vitamina D so ugotavljali v 15-tedenski, mednarodni študiji, v katero je bilo vključenih 682 žensk s pomenopavzalno osteoporozo (serumski 25-hidroksivitamin D ob začetku študije: povprečna vrednost 56 nmol/l [22,3 ng/ml]; obseg vrednosti 22,5-225 nmol/l [9-90 ng/ml]).
Talk to your doctor or pharmacist before taking ADROVANCE if:
Pred začetkom jemanja zdravila ADROVANCE se posvetujte z zdravnikom ali farmacevtom:
It is likely that certain medicines or food additives may prevent the vitamin D in ADROVANCE from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol.
Določena zdravila ali dodatki hrani, vključno z umetnimi nadomestki maščob, mineralnimi olji, zdravili za hujšanje, orlistatom in zdravili za zniževanje holesterola, holestiraminom in holestipolom, lahko preprečijo absorpcijo vitamina D iz zdravila ADROVANCE v telo.
It is likely that food and beverages (including mineral water) will make ADROVANCE less effective if taken at the same time.
Zdravilo ADROVANCE skupaj s hrano in pijačo Hrana in pijače (vključno z mineralno vodo) lahko ob sočasnem zaužitju zmanjšajo učinek zdravila ADROVANCE.
The alendronate component in the ADROVANCE (70 mg/2,800 IU) combination tablet and the ADROVANCE (70 mg/5,600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Alendronat v kombinirani tableti ADROVANCE (70 mg/2.800 i.e.) in kombinirani tableti ADROVANCE (70 mg/5.600 i.e.) je bioekvivalenten alendronatu v 70 mg tableti.
EU/1/06/364/004 - 12 tablets
EU/1/06/364/008 - 12 tablet
The equivalence of intake of 5,600 IU of vitamin D3 weekly in ADROVANCE to daily dosing of vitamin D 800 IU has not been studied.
Ekvivalentnost vnosa 5.600 i.e. vitamina D3 tedensko z zdravilom ADROVANCE in 800 i.e. vitamina D pri dnevnemu odmerjanju ni bila preučevana.
In healthy adult subjects (males and females), following administration of ADROVANCE 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml.
Pri zdravih odraslih preiskovancih (moških in ženskah) je po zaužitju ADROVANCE 70 mg/5.600 i.e. tablet zjutraj na tešče in dve uri pred obrokom povprečna površina pod krivuljo serumska koncentracija-čas (AUC0-80 ur) za vitamin D3 (neprilagojen endogenim vrednostim vitamina D3) znašala 490,2 ngh/ml.
There have been side effects (for example blurred vision, dizziness and severe bone, muscle or joint pain) reported with ADROVANCE that may affect your ability to drive or operate machinery (see section 4).
Vpliv na sposobnost upravljanja vozil in strojev Pri uporabi zdravila ADROVANCE so poročali o neželenih učinkih (na primer zamegljenem vidu, omotici in hudih bolečinah v kosteh, mišicah ali sklepih), ki lahko vplivajo na vašo sposobnost vožnje ali upravljanja strojev (glejte poglavje 4).
The equivalence of intake of 2,800 IU of vitamin D3 weekly in ADROVANCE to daily dosing of vitamin D 400 IU has not been studied.
Ekvivalentnost vnosa 2.800 i.e. vitamina D3 tedensko z zdravilom ADROVANCE in 400 i.e. vitamina D pri dnevnemu odmerjanju ni bila preučevana.
In healthy adult subjects (males and females), following administration of ADROVANCE 70 mg/2,800 IU tablets after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng•hr/ml.
Pri zdravih odraslih preiskovancih (moških in ženskah) je po zaužitju ADROVANCE 70 mg/2.800 i.e. tablet zjutraj na tešče in dve uri pred obrokom povprečna površina pod krivuljo serumska koncentracija-čas (AUC0-120 ur) za vitamin D3 (neprilagojen endogenim vrednostim vitamina D3) znašala 296,4 ngh/ml.
After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26 %) in the ADROVANCE (70 mg/2,800 IU) group (56 nmol/l [23 ng/ml]) than in the alendronate-only group (46 nmol/l [18.2 ng/ml]).
Po 15 tednih zdravljenja so bile povprečne vrednosti 25-hidroksivitamina D v serumu v skupini, ki je dobivala zdravilo ADROVANCE (70 mg/2.800 i.e.), pomembno višje (26 %) (56 nmol/l [23 ng/ml]) kot v skupini, ki je jemala samo alendronat (46 nmol/l [18,2 ng/ml]).
ADROVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Zdravilo ADROVANCE je indicirano za zdravljenje pomenopavzalne osteoporoze pri ženskah s tveganjem za pomanjkanje vitamina D. Zdravilo zmanjša tveganje za vertebralne zlome in za zlome kolka.
Merck Sharp & Dohme BV Tel: +31 (0)800 99 99 000 (+31 (0)23 5153153) medicalinfo.nl@merck.com
Merck Sharp & Dohme BV Tel: +31 (0)800 99 99 000 (+31 (0)23
EU/1/06/364/001 (2 tablets) EU/1/06/364/002 (4 tablets) EU/1/06/364/003 (6 tablets) EU/1/06/364/004 (12 tablets)
EU/1/06/364/001 (2 tableti) EU/1/06/364/002 (4 tablete) EU/1/06/364/003 (6 tablet) EU/1/06/364/004 (12 tablet)
It is important that you take ADROVANCE for as long as your doctor prescribes the medicine.
Če ste prenehali jemati zdravilo ADROVANCE Pomembno je, da zdravilo ADROVANCE jemljete tako dolgo, kot vam je predpisal zdravnik.
Your doctor has prescribed ADROVANCE to treat your osteoporosis and because you are at risk of vitamin D insufficiency.
Zdravnik vam je predpisal zdravilo ADROVANCE za zdravljenje osteoporoze in zato, ker pri vas obstaja tveganje za pomanjkanje vitamina D. Zdravilo zmanjša tveganje za zlome hrbtenice in za zlome kolka pri ženskah po menopavzi.
ADROVANCE 70 mg/2,800 IU tablets
ADROVANCE 70 mg/2.800 i.e. tablete
ADROVANCE 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
ADROVANCE 70 mg/2.800 i.e tablete so na voljo v pakiranjih, ki vsebujejo 2, 4, 6 ali 12 tablet.
EU/1/06/364/006 (2 tablets) EU/1/06/364/007 (4 tablets) EU/1/06/364/008 (12 tablets)
EU/1/06/364/006 (2 tableti) EU/1/06/364/007 (4 tablete) EU/1/06/364/008 (12 tablet)
ADROVANCE 70 mg/5,600 IU tablets
ADROVANCE 70 mg/5.600 i.e. tablete
The percentage of patients with vitamin D deficiency (serum 25-hydroxyvitamin D  22.5 nmol/l [ 9 ng/ml]) was significantly reduced by 92 % with ADROVANCE (70 mg/2,800 IU) vs. alendronate-only (1 % vs 13 %, respectively).
Delež bolnic s pomanjkanjem vitamina D (serumski 25-hidroksivitamin D < 22,5 nmol/l [<9 ng/ml]) je bil v skupini, ki je prejemala zdravilo ADROVANCE (70 mg/2.800 i.e.), pomembno nižji (za 92 %) kot v skupini, ki je prejemala le alendronat (1 % oz. 13 %).
ADROVANCE 70 mg/2,800 IU tablets ADROVANCE 70 mg/5,600 IU tablets
ADROVANCE 70 mg/2.800 i.e. tablete ADROVANCE 70 mg/5.600 i.e. tablete
ADROVANCE 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets.
ADROVANCE 70 mg/5.600 i.e tablete so na voljo v pakiranjih, ki vsebujejo 2, 4 ali 12 tablet.
• ADROVANCE should not be taken at bedtime or before arising for the day.
• Bolnik zdravila ADROVANCE ne sme vzeti pred spanjem ali preden zjutraj vstane.
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Olestra, mineralna olja, orlistat in izmenjevalci žolčnih kislin (npr. holestiramin, holestipol) lahko motijo absorpcijo vitamina D. Antikonvulzivi, cimetidin in tiazidi lahko povečajo razgradnjo vitamina D. Pri posameznih bolnikih lahko pride v poštev še dodatno jemanje vitamina D.
How to take ADROVANCE
Kako jemati zdravilo ADROVANCE
The percentage of patients with vitamin D insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with ADROVANCE (70 mg/2,800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15.
Delež bolnic s pomanjkanjem vitamina D (serumski 25-hidroksivitamin D < 37,5 nmol/l [< 15 ng/ml]) je bil v skupini, ki je prejemala zdravilo ADROVANCE (70 mg/2.800 i.e.), v 15. tednu pomembno nižji (za 62,5 %) kot v skupini, ki je prejemala le alendronat (12 % oz. 32 %).
ADROVANCE 70 mg/2,800 IU tablets are available as modified capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710' on the other.
ADROVANCE 70 mg/2.800 i.e. tablete imajo obliko modificirane kapsule, so bele do skoraj bele barve, na eni strani imajo vtisnjen obris kosti, na drugi pa oznako ‘710'.
ADROVANCE 70 mg/5,600 IU tablets EU/1/06/364/006 - 2 tablets EU/1/06/364/007 - 4 tablets EU/1/06/364/008 - 12 tablets
ADROVANCE 70 mg/5.600 i.e. tablete EU/1/06/364/006 - 2 tableti EU/1/06/364/007 - 4 tablete
Patients in the Vitamin D3 2,800 group received ADROVANCE (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received ADROVANCE (70 mg/2,800 IU) plus an additional 2,800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
Bolnice v skupini "Vitamin D3 2.800" so prejemale zdravilo ADROVANCE (70 mg/2.800 i.e.) (n = 299), bolnice v skupini "Vitamin D3 5.600" pa so prejemale zdravilo ADROVANCE (70 mg/2.800 i.e.) in dodatnih 2.800 i.e. vitamina D3 (n = 309) enkrat tedensko; dovoljeni so bili tudi drugi dodatki vitamina D. Po 24 tednih zdravljenja so bile povprečne vrednosti 25-hidroksivitamina D v serumu v skupini "Vitamin D3 5.600" pomembno višje (69 nmol/l [27,6 ng/ml]) kot v skupini "Vitamin D3 2.800" (64 nmol/l [25,5 ng/ml]).
ADROVANCE 70 mg/5,600 IU tablets are available as modified rectangle-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘270' on the other.
ADROVANCE 70 mg/5.600 i.e. tablete imajo obliko modificiranega pravokotnika, so bele do skoraj bele barve, na eni strani imajo vtisnjen obris kosti, na drugi pa oznako ‘270'.
Always take ADROVANCE exactly as your doctor or pharmacist has told you.
Pri jemanju zdravila ADROVANCE natančno upoštevajte navodila zdravnika ali farmacevta.
These side effects may worsen if patients continue to take ADROVANCE after developing these symptoms.
Če potem, ko so se že pojavili neželeni učinki, bolnik nadaljuje z jemanjem zdravila ADROVANCE, se lahko neželeni učinki še poslabšajo.
There is important additional information about how to take ADROVANCE in the package leaflet.
V priloženem navodilu za uporabo so pomembne dodatne informacije o jemanju zdravila ADROVANCE.
1) Choose the day of the week that best fits your schedule.
1) Izberite dan v tednu, ki vam najbolj ustreza, nato pa vsak teden na izbrani dan vzemite eno tableto ADROVANCE.
ADROVANCE 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
ADROVANCE 70 mg/2.800 i.e. tablete Pretisni omoti (aluminij/aluminij) v škatlah, ki vsebujejo 2, 4, 6 ali 12 tablet.
ADROVANCE 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
ADROVANCE 70 mg/5.600 i.e. tablete Pretisni omoti (aluminij/aluminij) v škatlah, ki vsebujejo 2, 4 ali 12 tablet.
Each ADROVANCE 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3).
Ena ADROVANCE 70 mg/2.800 i.e. tableta vsebuje 70 mg alendronske kisline (v obliki natrijevega trihidrata) in 70 mikrogramov (2.800 i.e.) holekalciferola (vitamina D3).
Each ADROVANCE 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Ena ADROVANCE 70 mg/5.600 i.e. tableta vsebuje 70 mg alendronske kisline (v obliki natrijevega trihidrata) in 140 mikrogramov (5.600 i.e.) holekalciferola (vitamina D3).
BLISTER FOR ADROVANCE 70 mg/2,800 IU
ŠKATLA ZA ZDRAVILO ADROVANCE 70 mg/2.800 i.e.
ADROVANCE 70 mg/5,600 IU tablets alendronic acid /colecalciferol
ADROVANCE 70 mg/5.600 i.e. tablete alendronska kislina/holekalciferol
ADROVANCE 70 mg/2,800 IU tablets alendronic acid/colecalciferol
ADROVANCE 70 mg/2.800 i.e. tablete alendronska kislina/holekalciferol
What ADROVANCE contains
Kaj vsebuje zdravilo ADROVANCE
In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with ADROVANCE.
Količina vitamina D v zdravilu ADROVANCE ne zadošča za odpravo pomanjkanja vitamina D. Pri bolnikih s temi boleznimi je treba med zdravljenjem z zdravilom ADROVANCE spremljati vrednost kalcija v serumu in simptome hipokalciemije.
BLISTER FOR ADROVANCE 70 mg/5,600 IU
ŠKATLA ZA ZDRAVILO ADROVANCE 70 mg/5.600 i.e.
How to store ADROVANCE
Shranjevanje zdravila ADROVANCE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR ADROVANCE 70 mg/2,800 IU
PRETISNI OMOT ZA ZDRAVILO ADROVANCE 70 mg/2.800 i.e.
• Use of antibiotics
• uporabo antibiotikov
The educational material contains the following:
Izobraževalno gradivo vsebuje:
The physician information should contain the following key elements:
Informacije za zdravnika morajo vsebovati naslednje ključne elemente:
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented.
Države članice morajo zagotoviti, da so izpolnjeni vsi pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, opisani v nadaljevanju.
• When to seek urgent attention from their health care provider
• v katerih primerih je treba poiskati nujno zdravstveno pomoč
• Aseptic techniques to minimise the risk of infection
• aseptične tehnike za zmanjševanje tveganja okužbe
The Member States shall ensure that the provision of educational material implemented for the authorised indication of treatment of adult patients with macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO), is extended to the potential prescribers concerned by the new indication: treatment of adult patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis.
Države članice morajo zagotoviti, da bodo izobraževalno gradivo, uporabljeno za odobrene indikacije zdravljenja pri odraslih bolnikih z makularnim edemom po okluziji veje retinalne vene (BRVOBranch Retinal Vein Occlusion) ali okluziji centralne retinalne vene (CRVO-Central Retinal Vein Occlusion), dobili vsi zdravniki, ki nameravajo predpisovati zdravilo z navedeno novo indikacijo: zdravljenje odraslih bolnikov z vnetjem posteriornega dela očesa, ki se kaže kot nenalezljivi uveitis.
• Key signs and symptoms of serious adverse events including increased intraocular pressure and ocular hypertension
• ključne znake in simptome resnih neželenih dogodkov, vključno s povišanim očesnim tlakom in očesno hipertenzijo
• How to prepare for Ozurdex treatment
• kako se pripraviti na zdravljenje z zdravilom Ozurdex
• Key signs and symptoms of IVT injection related adverse events including increased intraocular pressure, glaucoma, ocular hypertension, cataract, traumatic cataract related to injection technique, vitreous detachment, vitreous haemorrhage, endophthalmitis,
• ključne znake in simptome neželenih dogodkov, povezanih z intravitrealnim injiciranjem, vključno s povišanim očesnim tlakom, glavkomom, očesno hipertenzijo, katarakto, poškodbeno katarakto v povezavi s tehniko injiciranja, odstopom steklovine, vitrealno krvavitvijo, endoftalmitisom, odstopom mrežnice, raztrganino mrežnice, mehansko okvaro pripomočka in vstavitvijo vsadka v nepravilen položaj
• What are the steps following treatment with Ozurdex
• kaj sledi zdravljenju z zdravilom Ozurdex
The Member States shall agree the final educational material with the Marketing Authorisation Holder (MAH) prior to launch of the new indication in their territory.
Države članice se morajo pred začetkom dajanja zdravila z novo indikacijo v promet na njihovem ozemlju dogovoriti z imetnikom dovoljenja za promet z zdravilom o vsebini končnega izobraževalnega gradiva.
• Management of IVT injection related adverse events The patient information pack should be provided in both the form of patient information booklet and an audio-CD that contain following key elements:
Komplet informacij za bolnika je treba zagotoviti v obliki brošure in kot zvočno zgoščenko, ki vsebujeta naslednje ključne elemente:
• Patient information leaflet
• komplet informacij za bolnika
• Patient monitoring after IVT injection
• spremljanje bolnika po intravitrealnem injiciranju
• Techniques for the intravitreal injection
• tehnike intravitrealnega injiciranja
The red area will fade over the next few days to a week.
Rdečina bo izginila v naslednjih nekaj dneh ali tednu.
This may affect serum concentrations.
To lahko vpliva na serumske koncentracije.
The Healthcare provider educational Programme shall contain the following key messages:
Izobraževalni program za zdravstvene delavce mora vsebovati ta ključna sporočila:
The maximum treatment duration is 72 hours, although the majority of patients should only need one system.
Najdaljše trajanje zdravljenja je 72 ur, čeprav bo večina bolnikov verjetno potrebovala samo en sistem.
Probable cause
Verjetni vzrok
EXP Use immediately after opening.
EXP Uporabite takoj po odprtju.
Currently available data are described in section 4.8, but no recommendation on posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavju 4.8, vendar priporočil o odmerjanju ni mogoče dati.
This is common, and nothing to worry about.
To je pogost pojav in naj vas ne skrbi.
Do not let these touch your mouth or eyes.
Ne pustite, da se gela dotakneta ust ali oči.
The table below represents the different error messages that may occur, together with the probable cause and the action to be taken.
V spodnji preglednici so različna sporočila o napakah, ki se lahko pojavijo, skupaj z verjetnim vzrokom in potrebnim ukrepom.
The next dose cannot be initiated until the previous 10-minute delivery period is complete.
Dovajanje naslednjega odmerka se ne more začeti, dokler prejšnje 10-minutno obdobje odmerjanja ni končano.
These were mostly of mild to moderate severity.
Večinoma so blagi do zmerni.
• Each dose will last for 10 minutes.
• Vsako odmerjanje traja 10 minut.
• abnormal dreams or hallucinations (seeing or hearing things that are not there)
• nenormalne sanje ali halucinacije (videnje ali slišanje stvari, ki jih ni)
The mean systemic bioavailability is 87%.
Povprečna sistemska biološka uporabnost je 87 %.
Adequate body temperature and fluid intake should also be maintained.
Poleg tega je treba ohranjati ustrezno telesno temperaturo in vnos tekočin.
Tel: +44 (0)800 587 4149 or +44 (0)203 684 6344 Email: medical.information@themedco.com
Tel.: +44 (0)800 587 4149 ali +44 (0)203 684 6344 E-pošta: medical.information@themedco.com
• If you do accidentally touch the gels on the underside of the system:
• Če se pomotoma dotaknete gelov na spodnji strani sistema:
p-value C-2001-011 27 % (64/235) 57 % (116/204) <0.0001
vrednost p C-2001-011 27 % (64/235) 57 % (116/204) 0,0001
Information for the Healthcare Professional: Instructions for use and disposal
Informacije za zdravstveno osebje: Navodila za uporabo in odstranjevanje
The used system should be handled carefully by the sides and top.
Uporabljen sistem je treba previdno prijeti ob straneh in zgoraj.
Take care not to touch the hydrogels.
Pazite, da se ne dotaknete hidrogelov.
Patients should not wear more than one system at a time.
Bolniki ne smejo nositi več kot enega sistema naenkrat.
Efficacy results at the end of 24 hours, are presented in Table 2 below for the evaluable patient population.
Rezultati učinkovitosti na koncu 24 ur so predstavljeni v preglednici 2 spodaj za ocenljivo populacijo bolnikov.
Do not use the system.
Sistema ne uporabljajte.
This tray contains: 1 Drug Unit, 1 Controller.
Podstavek vsebuje: 1 zdravilno enoto, 1 upravljalnik.
Patients were instructed to use the system for pain relief.
Bolnike so poučili o uporabi sistema za lajšanje bolečin.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1050/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1050/001
• blue skin colour (lips and finger tips)
• modra obarvanost kože (ustnice in konice prstov)
• Educational material (including prescriber checklist) for the healthcare professionals
• izobraževalno gradivo (vključno s kontrolnim seznamom za predpisovalce) za zdravstvene delavce.
After this point 727 patients remained in the studies using only the IONSYS or control system, and were evaluated for efficacy.
Potem je 727 bolnikov ostalo v študijah, kjer so uporabljali samo sistem IONSYS ali kontrolni sistem in bili ocenjeni glede na učinkovitost.
Its primary therapeutic actions are analgesia and sedation.
Primarna terapevtska učinka sta analgezija in sedacija.
Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
Opioidni analgetiki poslabšajo psihično in/ali telesno sposobnost, potrebno za opravljanje potencialno nevarnih nalog (npr. vožnje avtomobila ali upravljanja strojev).
Action required
Potrebni ukrep
After 24 hours or 80 doses, a new system should be applied if necessary.
Po 24 urah ali 80 odmerkih se po potrebi uporabi nov sistem.
A mutagenic risk for the use of therapeutic doses seems unlikely since effects appeared only at high concentrations.
Tveganje mutagenih učinkov se zdi pri uporabi terapevtskih odmerkov malo verjetno, saj so se učinki pojavili samo pri visokih koncentracijah.
Special precautions for disposal should be followed (see section 6.6).
Upoštevati je treba posebne previdnostne ukrepe za odstranjevanje (glejte poglavje 6.6).
Head injuries and increased intracranial pressure
Poškodbe glave in zvišan intrakranialni tlak
Each patient and investigator was asked to rate the patient's method of pain control as either poor, fair, good, or excellent.
Vsak bolnik in raziskovalec je ocenil bolnikovo metodo obvladovanja bolečine kot slabo, zadostno, dobro ali odlično.
Oxygen should be administered and respiration assisted or controlled, as appropriate.
Treba je dajati kisik in podpirati ali nadzorovati dihanje, kakor je primerno.
Remove system from patient.
Odstranite sistem z bolnika.
Prolonged contact with water could affect system performance and cause the system to fall off.
Daljši stik z vodo bi lahko vplival na delovanje sistema in povzročil, da bi se sistem odlepil s kože.
Swallowing or touching these gels may cause life-threatening breathing difficulties or death, even after you have stopped using the system and it has been removed.
Zaužitje ali dotik teh gelov lahko povzroči smrtno nevarne težave z dihanjem ali smrt, tudi potem ko sistem prenehate uporabljati in je že odstranjen.