natgillin/translations-raw huggingface dataset:
Polysorbate 80 Simeticone Sodium benzoate (E211) Sodium citrate dihydrate
polisorbat 80 simetikon natrijev benzoat (E211) natrijev citrat dihidrat citronska kislina monohidrat glicerol ksantanski gumi tekoča glukoza titanov dioksid (E171) umetna aroma češnje, ki vsebuje benzilalkohol in propilenglikol prečiščena voda
6.6 Special precautions for disposal
16 6. 6 Posebni varnostni ukrepi za odstranjevanje
Posaconazole SP 40 mg/ ml oral suspension posaconazole
Posaconazole SP 40 mg/ ml peroralna suspenzija posakonazol
Posaconazole SP can be used to treat the following types of fungal infections in adults:
Posaconazole SP lahko uporabljamo za zdravljenje naslednjih vrst glivičnih okužb pri odraslih:
BEFORE YOU TAKE POSACONAZOLE SP
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO POSACONAZOLE SP
Do not take Posaconazole SP
Ne jemljite zdravila Posaconazole SP
- If you are allergic (hypersensitive) to posaconazole or to any of the other ingredients of
- če ste alergični (preobčutljivi) na posakonazol ali katerokoli sestavino zdravila Posaconazole
Posaconazole SP.
SP.
these medicines, which can lead to very serious disturbances in heart rhythm: • terfenadine (used to treat allergies) • astemizole (used to treat allergies) • cisapride (used to treat stomach problems) • pimozide (used to treat symptoms of Tourette's disorder) • halofantrine (used to treat malaria) • quinidine (used to treat abnormal heart rhythms).
terfenadin (ki ga uporabljamo za zdravljenje alergij) astemizol (ki ga uporabljamo za zdravljenje alergij) cisaprid (ki ga uporabljamo za zdravljenje želodčnih težav) pimozid (ki ga uporabljamo za zdravljenje simptomov Tourettovega sindroma) halofantrin (ki ga uporabljamo za zdravljenje malarije) kinidin (ki ga uporabljamo za zdravljenje motenj srčnega ritma)
Please see the section “ Taking other medicines” for information on other medicines which may interact with Posaconazole SP.
Glejte poglavje “ Jemanje drugih zdravil ”, kjer so navedeni podatki o drugih zdravilih, ki imajo lahko medsebojno delovanje z zdravilom Posaconazole SP.
Take special care with Posaconazole SP Ask your doctor or pharmacist for advice before taking any medicine.
Bodite posebno pozorni pri jemanju zdravila Posaconazole SP Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
You may need special blood tests to be done while you
- če imate ali ste kdaj imeli jetrne težave - med jemanjem zdravila Posaconazole SP boste morda
are taking Posaconazole SP.
morali opraviti posebne krvne preiskave,
Posaconazole SP.
zdravila Posaconazole SP,
If you are already being treated with rifabutin, your blood counts and some possible side effects to rifabutin will need to be monitored. • Some medicines used to treat or prevent fits, such as phenytoin, carbamazepine, phenobarbital, primidone. • Efavirenz, which is used to treat HIV infection.
Če se že zdravite z rifabutinom, bo potrebno spremljanje vaše krvne slike in nekaterih mogočih neželenih učinkov rifabutina. • nekatera zdravila, ki jih uporabljamo za zdravljenje ali preprečevanje epileptičnih napadov, na primer fenitoin, karbamazepin, fenobarbital, primidon.
27 • Medicines used to decrease stomach acid such as cimetidine and ranitidine or omeprazole and similar medicines that are called proton pump inhibitors.
• zdravila, ki se uporabljajo za zmanjševanje količine želodčne kisline, kot so cimetidin in ranitidin ali omeprazol ter podobna zdravila, ki jih imenujemo zaviralci protonske črpalke.
Taking Posaconazole SP with food and drink Each dose of Posaconazole SP should be taken with food or a nutritional supplement if you are unable to tolerate food to enhance the oral absorption.
Jemanje zdravila Posaconazole SP skupaj s hrano in pijačo Vsak odmerek zdravila Posaconazole SP vzemite s hrano, če ne prenašate hrane pa s prehranskim dodatkom, da bi povečali peroralno absorpcijo zdravila.
Pregnancy and breast-feeding Tell your doctor if you are or think you are pregnant before you start to take Posaconazole SP.
Nosečnost in dojenje Če ste noseči ali mislite, da ste noseči, morate to povedati svojemu zdravniku pred začetkom jemanja zdravila Posaconazole SP.
Driving and using machines There is no information on the effect of Posaconazole SP on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni podatkov o vplivu zdravila Posaconazole SP na sposobnost vožnje in upravljanja s stroji.
Important information about some of the ingredients of Posaconazole SP Posaconazole SP contains approximately 1.75 g of glucose per 5 ml of suspension.
Pomembne informacije o nekaterih sestavinah zdravila Posaconazole SP Posaconazole SP vsebuje približno 1, 75 g glukoze na 5 ml peroralne suspenzije.
HOW TO TAKE POSACONAZOLE SP
KAKO JEMATI ZDRAVILO POSACONAZOLE SP
If you forget to take Posaconazole SP If you have missed a dose, take it as soon as you remember and then carry on as before.
Če ste vzeti uporabiti zdravilo Posaconazole SP Če ste izpustili posamezen odmerek zdravila, ga zaužijte takoj, ko se spomnite, in potem nadaljujte z jemanjem zdravila kot prej.
HOW TO STORE POSACONAZOLE SP
SHRANJEVANJE ZDRAVILA POSACONAZOLE SP
- The active substance in Posaconazole SP oral suspension is posaconazole.
- Zdravilna učinkovina v zdravilu Posaconazole SP peroralna suspenzija je posakonazol.
Each millilitre of oral
En
suspension contains 40 milligrams of posaconazole.
mililiter peroralne suspenzije vsebuje 40 miligramov posakonazola.
30 What Posaconazole SP looks like and contents of the pack
Izgled zdravila Posaconazole SP in vsebina pakiranja
Posaconazole SP is a white, cherry flavoured, 105 ml oral suspension packaged in amber glass bottles.
31 Posaconazole SP je bela 105 ml peroralna suspenzija z okusom češnje, pakirana v stekleničke iz rjavega stekla.
Αγίου Δημητρίου 63 GR-174 55 Άλιμος Tηλ.: + 30-210 98 97 300
32 Ελλάδα Αγίου Δημητρίου 63 GR- 174 55 Άλιμος Tηλ.: + 30- 210 98 97 300
Italia Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano) Tel: + 39-02 2101 8.1
Italia Via Fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I- 20090 Segrate (Milano) Tel: + 39- 02 21018. 1
Pradaxa is a medicine containing the active substance dabigatran etexilate.
Pradaxa je zdravilo, ki vsebuje zdravilno učinkovino dabigatran eteksilat.
It is available as capsules (75 mg and 110 mg).
Na voljo je v obliki kapsul (75 mg in 110 mg).
Pradaxa is used to prevent the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee.
Zdravilo Pradaxa se uporablja za preprečevanje nastajanja krvnih strdkov v venah pri odraslih po operativni vstavitvi umetnega kolka ali kolena.
Treatment with Pradaxa should start with one 110 mg capsule taken one to four hours after the end of the operation.
Zdravljenje z zdravilom Pradaxa se mora pričeti z eno 110 mg kapsulo, ki jo bolnik vzame eno do štiri ure po koncu operacije.
Treatment then continues with two 110 mg capsules (220 mg) once a day for 28 to 35 days after hip replacement and for 10 days after knee replacement.
Zdravljenje se nato nadaljuje z dvema 110 mg kapsulama (220 mg) enkrat dnevno nadaljnjih 28 do 35 dni po vstavitvi umetnega kolka in 10 dni po vstavitvi umetnega kolena.
If treatment is not started on the day of the operation, it should start with two capsules once a day.
Če zdravljenja ne uvedemo na dan operacije, ga moramo začeti z dvema kapsulama enkrat dnevno.
A lower dose (150 mg once a day) is used in patients with mild or moderate kidney problems, in patients over 75 years of age, and in patients taking amiodarone (a medicine used to regulate the heart rhythm).
Pri bolnikih z lažjimi ali zmernimi težavami z ledvicami, bolnikih, starih več kot 75 let, ter bolnikih, ki prejemajo amiodaron (zdravilo, ki se uporablja za uravnavanje srčnega ritma), se uporablja manjši odmerek (150 mg enkrat dnevno).
Pradaxa should not be used in patients who have severe problems with their kidneys and it is not recommended for use in patients with signs of existing liver problems.
Uporaba zdravila Pradaxa pri bolnikih s hudo okvaro ledvic ni dovoljena, pri bolnikih, ki imajo znake obstoječih težav z jetri, pa ni priporočljiva.
Pradaxa should be used with caution in patients at risk of bleeding or who could have high blood levels of the medicine, such as those who have moderate problems with their kidneys.
Prav tako ga je treba uporabljati previdno pri bolnikih, pri katerih obstaja tveganje za krvavitve, ali pri bolnikih, pri katerih bi se utegnila pojaviti povečana koncentracija zdravila v krvi, npr. pri bolnikih z zmernimi težavami z ledvicami.
Patients weighing less than 50 kg or more than 110 kg should be closely monitored for signs of bleeding or anaemia (low red blood cell counts).
Bolnike, ki tehtajo manj kot 50 kg ali več kot 110 kg, je treba skrbno spremljati glede znakov krvavitve ali anemije (nizke koncentracije rdečih krvničk).
Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in the veins.
Pri bolnikih, pri katerih se izvede operativna vstavitev umetnega kolka ali kolena, obstaja veliko tveganje za nastanek krvnih strdkov.
These clots, which include deep vein thrombosis (DVT), can be dangerous if they move to another part of the body such as the lungs or the brain.
Ti strdki, ki vključujejo tudi globoko vensko trombozo (DVT), so lahko nevarni, če se premaknejo v drugi del telesa, npr. v pljuča ali možgane.
The active substance in Pradaxa, dabigatran etexilate, is a ‘ prodrug ’ of dabigatran.
Zdravilna učinkovina zdravila Pradaxa, dabigatran eteksilat, je „ predzdravilo “ dabigatrana.
This means that it is converted into dabigatran in the body.
To pomeni, da se v telesu pretvori v dabigatran.
Dabigatran is an anticoagulant, meaning that it prevents the blood from coagulating (clotting).
Blokira
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. snov, imenovano trombin, ki je ključna za proces strjevanja krvi, ter tako zmanjšuje tveganje za nastanek krvnih strdkov v venah.
The effects of Pradaxa were first tested in experimental models before being studied in humans.
Učinki zdravila Pradaxa so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The effectiveness of Pradaxa was studied in two main studies, both of which compared Pradaxa (either 220 or 150 mg a day) with enoxaparin (another anticoagulant).
Učinkovitost zdravila Pradaxa je bila raziskana v dveh glavnih študijah, v katerih so zdravilo Pradaxa (220 ali 150 mg dnevno) primerjali z enoksaparinom (drugim antikoagulantom).
The first study involved a total of 2,101 patients who had had a knee replacement operation, and the second involved a total of 3,494 patients who had had a hip replacement.
V prvo študijo je bilo vključenih 2 101 bolnikov, ki so jim operativno vstavili umetno koleno, v drugo pa 3 494 bolnikov, ki so jim operativno vstavili umetni kolk.
In both studies, the main measure of effectiveness was the number of patients who formed blood clots in the veins or who died of any cause during the treatment period.
V obeh študijah je bilo glavno merilo učinkovitosti število bolnikov, pri katerih so nastali krvni strdki v venah ali ki so med zdravljenjem umrli zaradi katerega koli razloga.
In most cases, blood clot formation was detected using scans of the veins or by looking for signs of blood clots in the lungs.
V večini primerov so nastanek krvnih strdkov ugotavljali s pomočjo slikanja ven ali s preverjanjem znakov krvnih strdkov v pljučih.
In both studies, Pradaxa was as effective as enoxaparin in preventing the formation of blood clots or death.
V obeh študijah se je zdravilo Pradaxa izkazalo za enako učinkovito kot enoksaparin pri preprečevanju nastanka krvnih strdkov ali smrti.
In the study of patients undergoing knee replacement, blood clots were detected in 182 (36%) of the 503 patients taking the 220-mg dose of Pradaxa, compared with 192 (38%) of the 512 receiving enoxaparin.
V študiji z bolniki, ki so jim operativno vstavili umetno koleno, so krvne strdke odkrili pri 182 (36%) od 503 bolnikov, ki so prejemali 220 mg odmerek zdravila Pradaxa, v primerjavi s 192 (38%) od 512 bolnikov, ki so prejemali enoksaparin.
There was only one death in each group (less than 1%).
V vsaki od obeh skupin je prišlo le do ene smrti (manj kot 1%).
After hip replacement, blood clots were detected in 50 (6%) of the 880 patients taking 220 mg Pradaxa, compared with 60 (7%) of the 897 receiving enoxaparin.
Po operaciji vstavitve umetnega kolka so krvne strdke odkrili pri 50 (6%) od 880 bolnikov, ki so prejemali 220 mg odmerek zdravila Pradaxa, v primerjavi s 60 (7%) od 897 bolnikov, ki so prejemali enoksaparin.
Three patients in the Pradaxa group died (less than 1%), but two of these deaths were unrelated to blood clots.
Umrli so trije bolniki (manj kot 1%), ki so prejemali zdravilo Pradaxa, vendar dve od teh smrti nista bili povezani s strjevanjem krvi.
In both studies, the 220-mg dose showed a trend towards being more effective than the 150-mg dose.
V obeh študijah se je 220 mg odmerek izkazal za bolj učinkovitega od 150 mg.
The most common side effect with Pradaxa (seen in more than 1 patient in 10) is bleeding.
Najpogostejši neželeni učinek pri jemanju zdravila Pradaxa (opažen pri več kot 1 bolniku izmed 10) je krvavenje.
For the full list of all side effects reported with Pradaxa, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pradaxa, glejte navodilo za uporabo.
Pradaxa should not be used in people who may be hypersensitive (allergic) to dabigatran etexilate or any of the other ingredients.
Zdravila Pradaxa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) dabigatran eteksilat ali katerokoli drugo sestavino zdravila.
It should not be used in patients who have severe problems with their kidneys, active significant bleeding, tissue damage that could lead to bleeding, problems with the blood clotting process (this may be inborn, of unknown cause or due to other medicines), or liver problems that could be life-threatening.
Zdravila Pradaxa se ne sme uporabljati pri ljudeh, ki imajo hudo okvaro ledvic, aktivne klinično pomembne krvavitve, poškodbe tkiv, pri katerih bi lahko prišlo do krvavenja, težave s strjevanjem krvi (ne glede na to, ali je ta motnja prirojena, neznanega izvora ali pa posledica drugih zdravil) ali težave z jetri, ki bi lahko bile usodne.
Pradaxa should also not be used in patients taking quinidine (another medicine used to regulate the heart rhythm).
Zdravila Pradaxa se prav tako ne sme uporabljati pri bolnikih, ki jemljejo kinidin (drugo zdravilo za zdravljenje motenj srčnega ritma).
The Committee for Medicinal Products for Human Use (CHMP) decided that Pradaxa’ s benefits are greater than its risks for primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Pradaxa pri primarnem preprečevanju venskih trombemboličnih dogodkov pri odraslih bolnikih po operativni vstavitvi umetnega kolka ali kolena večje od z njim povezanih tveganj.
The Committee recommended that Pradaxa be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Pradaxa odobri dovoljenje za promet.
Other information about Pradaxa:
Druge informacije o zdravilu Pradaxa:
The European Commission granted a marketing authorisation valid throughout the European Union for Pradaxa to Boehringer Ingelheim International GmbH on 18 March 2008.
Evropska komisija je dovoljenje za promet z zdravilom Pradaxa, veljavno po vsej Evropski uniji, odobrila družbi Boehringer Ingelheim International GmbH dne 18. marca 2008.
The full EPAR for Pradaxa can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pradaxa je na voljo tukaj.
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Kapsula, trda Kapsula, trda Kapsula, trda Kapsula, trda Kapsula, trda Kapsula, trda Kapsula, trda Kapsula, trda
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
blister (Alu/ alu) blister (Alu/ alu) blister (Alu/ alu) bottle (PP) blister (Alu/ alu) blister (Alu/ alu) blister (Alu/ alu) bottle (PP)
Pretisni omot (Alu/ alu) Pretisni omot (Alu/ alu) pretisni omot (Alu/ alu) Steklenička (PP) Pretisni omot (Alu/ alu) Pretisni omot (Alu/ alu) Pretisni omot (Alu/ alu) steklenička (PP)
10 x 1 capsules 30 x 1 capsules 60 x 1 capsules 60 capsules 10 x 1 capsules 30 x 1 capsules 60 x 1 capsules 60 capsules
10 x 1 kapsula 30 x 1 kapsula 60 x 1 kapsula 60 kapsul 10 x 1 kapsula 30 x 1 kapsula 60 x 1 kapsula 60 kapsul
Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate) Excipients:
Ena trda kapsula vsebuje 75 mg dabigatran eteksilata (v obliki mesilata).
Each hard capsule contains 2 micrograms sunset yellow (E110)
Pomožne snovi: ena trda kapsula vsebuje 2 mikrograma barvila oranžno FCF (E110)
Imprinted capsules with light blue, opaque cap and cream-coloured, opaque body of size 2 filled with yellowish pellets.
Potiskane kapsule s svetlo modrim, neprozornim pokrovčkom in telesom kremne barve, velikosti 2, napolnjene z rumenkastimi peletami.
The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “ R75”.
Na pokrovčku kapsule je vtisnjen znak podjetja Boehringer Ingelheim, na njenem telesu pa oznaka » R75 «.
Prevention of Venous Thromboembolism (VTE) in patients following elective knee replacement surgery:
Preprečevanje venske trombembolije (VTE) po vstavitvi umetnega kolena:
The recommended dose of Pradaxa is 220 mg once daily taken as 2 capsules of 110 mg.
Priporočeni odmerek zdravila Pradaxa je 220 mg 1- krat na dan, kar bolnik vzame v 2 kapsulah po 110 mg.
Treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.
Zdravljenje z zdravilom Pradaxa moramo začeti peroralno, 1 do 4 ure po končani operaciji, z eno kapsulo in ga nadaljevati z 2 kapsulama, 1- krat na dan, skupno 10 dni.
Prevention of Venous Thromboembolism (VTE) in patients following elective hip replacement surgery:
Preprečevanje venske trombembolije (VTE) po vstavitvi umetnega kolka:
Treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 28-35 days.
Zdravljenje z zdravilom Pradaxa moramo začeti peroralno, 1 do 4 ure po končani operaciji, z eno kapsulo in ga nadaljevati z 2 kapsulama, 1- krat na dan, skupno 28 do 35 dni.
If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Če zdravljenja ne uvedemo na dan operacije, ga moramo začeti z 2 kapsulama 1- krat na dan.
Special patient populations:
Posebne skupine bolnikov
Treatment with Pradaxa in patients with severe renal impairment (creatinine clearance < 30 ml/ min) is contraindicated (see section 4.3).
Zdravljenje bolnikov s hudo ledvično okvaro (kreatininski očistek < 30 ml/ min) je kontraindicirano (glejte poglavje 4. 3).
2 In patients with moderate renal impairment (creatinine clearance 30-50 ml/ min), there is limited clinical experience.
Z uporabo pri bolnikih z zmerno ledvično okvaro (kreatininski očistek 30- 50 ml/ min) je malo kliničnih izkušenj.
The recommended dose is 150 mg taken once daily as 2 capsules of 75 mg (see section 4.4 and 5.1).
Priporočeno odmerjanje je 150 mg, enkrat na dan v 2 kapsulah po 75 mg (glejte poglavji 4. 4 in 5. 1).
After knee replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.
2 Po operativni vstavitvi umetnega kolena je treba zdravljenje začeti peroralno z eno kapsulo 1 do 4 ure po koncu operacije in ga nadaljevati z 2 kapsulama, 1- krat na dan, skupno 10 dni.
After hip replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 28-35 days.
Po operativni vstavitvi umetnega kolka je treba zdravljenje začeti peroralno z eno kapsulo 1 do 4 ure po koncu operacije in ga nadaljevati z 2 kapsulama, 1- krat na dan, skupno 28 do 35 dni.
The recommended dose is 150 mg taken once daily as 2 capsules of 75 mg (see section 4.4 and 5.1).
Priporočeno odmerjanje je 150 mg 1- krat na dan v 2 kapsulah po 75 mg (glejte poglavji 4. 4 in 5. 1).
After knee replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.
Po operativni vstavitvi umetnega kolena je treba zdravljenje začeti peroralno z eno kapsulo 1 do 4 ure po koncu operacije in ga nadaljevati z 2 kapsulama, 1- krat na dan, skupno 10 dni.
After hip replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 28-35 days.
Po operativni vstavitvi umetnega kolka je treba zravljenje začeti peroralno z eno kapsulo 1 do 4 ure po koncu operacije in ga nadaljevati z 2 kapsulama, 1- krat na dan, skupno 28 do 35 dni.
Patients with elevated liver enzymes > 2 upper limit of normal (ULN) were excluded in clinical trials.
Bolnike s povečanimi jetrnimi encimi na več kot 2- kratno zgornjo mejo normalnih vrednosti (ULN) so iz kliničnih preskušanj izključili.
Therefore the use of Pradaxa is not recommended in this population (see sections 4.4 and 5.2).
Zato uporabe zdravila Pradaxa za to skupino bolnikov ne priporočamo (glejte poglavji 4. 4 in 5. 2).
ALT should be measured as part of the standard pre-operative evaluation (see section 4.4).
ALT je treba meriti v sklopu standardne predoperacijske obravnave (glejte poglavje 4. 4).
Weight:
Telesna masa
Given the available clinical and kinetic data no adjustment is necessary (see section 5.2) but close clinical surveillance is recommended (see section 4.4).
Glede na dosegljive klinične in kinetične podatke odmerka ni treba prilagajati (glejte poglavje 5. 2), toda priporočamo natančno klinično spremljanje (glejte poglavje 4. 4).
Post-surgical patients with an increased risk for bleeding:
Bolniki s povečanim tveganjem krvavitve po operaciji:
Patients at risk for bleeding or patients at risk of overexposure, notably patients with moderate renal impairment (creatinine clearance 30 – 50 ml/ min), should be treated with caution (see sections 4.4 and 5.1).
Bolnike, pri katerih je povečana nevarnost krvavitve ali prevelike izpostavljenosti zdravilu, posebno bolnike z zmerno ledvično okvaro (kreatininski očistek 30 do 50 ml/ min) je treba previdno zdraviti (glejte poglavji 4. 4 in 5. 1).
Pradaxa is not recommended for use in patients below 18 years due to lack of data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravilaPradaxa pri bolnikih pod 18 let ni priporočljiva.
Concomitant use of Pradaxa with Amiodarone:
Sočasna uporaba zdravila Pradaxa in amiodarona:
Dosing should be reduced to 150 mg Pradaxa daily in patients who received concomitantly dabigatran etexilate and amiodarone (see section 4.5).
Bolnikom, ki hkrati prejemajo dabigatran eteksilat in amiodaron, moramo odmerek zdravila Pradaxa zmanjšati na 150 mg na dan (glejte poglavje 4. 5).
Switching from Pradaxa treatment to parenteral anticoagulant:
Zamenjava zdravila Pradaxa s parenteralnim antikoagulantom
It is recommended to wait 24 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant (see section 4.5).
Priporočljivo je počakati 24 ur po zadnjem odmerku, preden boste zamenjali zdravilo Pradaxa s parenteralnim antikoagulantom (glejte poglavje 4. 5).
3 Switching from parenteral anticoagulants treatment to Pradaxa:
Zamenjava parenteralnega antikoagulanta z zdravilom Pradaxa