natgillin/translations-raw huggingface dataset:
Do not shake or drop the pre-filled pen. i dic
Napolnjenega injekcijskega peresnika ne stresajte; pazite, da ne pade.
One pre-filled pen of Trudexa One alcohol pad
en napolnjen injekcijski peresnik Trudexe en alkoholni zloženec
155 ed ris tho au 5.
t me pro POKROVČEK 2 (temnomoder)
Do not use the product if the date has passed the month and year shown.
Zdravila ne uporabljajte
Check the appearance of
Napolnjeni injekcijski peresnik držite tako, da bo sivi pokrovček (označen z '1') obrnjen navzgor.
ge the Trudexa solution through the windows on the sides of the pre-filled pen.
Skozi okenci ob strani napolnjenega peresnika preglejte raztopino Trudexa.
It must be clear and colourless.
Biti mora lje bistra in brezbarvna.
Do not use a pre-filled pen that is frozen or if it has been left in direct sunlight. lon
Ne uporabljajte napolnjenega injekcijskega peresnika, ki je zmrznjen ali je bil puščen izpostavljen neposredni sončni svetlobi. vo
lP
OKENCE do eā av
rod
BISTRA nim
uc
TEKOČINA V BRIZGI
Where should I give my injection? na
Kam naj si dam injekcijo? ilo
Choose a site on the top of your thigh or stomach (except the area around the navel). i dic Me
Izberite mesto na zgornjem delu stegna ali trebuha (ne v okolici popka). rav Zd
156 2.
156 2.
ed How do I give my injection?
Kako naj si dam injekcijo?
Do not touch the
S krožnim gibom obrišite kožo s priloženo alkoholno blazinico.
ris area again before injecting.
Tega predela se pred injiciranjem ne smete več dotakniti.
2.
pro 2.
With your other
Z eno roko primite napolnjeni injekcijski peresnik tako, da bo sivi pokrovček (1) obrnjen navzdol.
tho hand, pull the grey cap (1) straight off and discard cap.
Z drugo roko snemite sivi pokrovček (1) naravnost dol in ga zavrzite.
DO NOT RECAP as you may damage the
NE POKRIVAJTE S POKROVČKOM, ker lahko poškodujete iglo v notranjosti.
Pull the plum safety cap (labelled ‘2’) st raight off to expose the plum coloured activation button at the top.
Snemite temnomodri varnostni pokrovček (označen z '2') naravnost dol, da se bo pokazal temnomodri sprožilni gumb na vrhu.
Do not press the plum activation button until
Ne pritisnite temnomodrega sprožilnega gumba, dokler ni pravilno nameščen, ker
r properly positioned as this will result in discharge of medication.
nja boste sicer iztisnili zdravilo.
DO NOT RECAP as this
Peresnika NE POKRIVAJTE S POKROVČKOM, ker ga pri tem lahko sprožite.
ge could cause the unit to discharge.
lje Injiciranje
Giving the injection lon 1.
1.
2.
S prosto roko obzirno primite očiščeni predel kože in ga trdno držite (glejte spodaj). vo 2.
Place the white end of the pre-filled pen at a right angle (90 degrees) to the skin, so that you can see the window. no
Namestite beli konec napolnjenega injekcijskega peresnika pravokotno (90 stopinj) na kožo, tako da boste videli okence.
4.
Držite telo napolnjenega injekcijskega peresnika in peresnik rahlo pritisnite na mesto injiciranja do
to begin the injection (see below).
(držite ga na mestu, ne da bi ga premikali).
You will then hear a ‘click’ as the needle is released, and you uc
Ko se bo igla sprožila, boste zaslišali "klik", in ob njenem vbodu boste začutili droben bodljaj. eā
Do not remove the pre-filled pen while the injection is rod
Napolnjeni injekcijski peresnik še naprej pritiskajte in držite s stalnim pritiskom na mestu približno 10 sekund, da bo injiciranje popolno.
being given. lP i na dic Me
Napolnjenega injekcijskega peresnika med injiciranjem ne smete odstraniti. av nim ilo rav Zd
The injection is complete when the yellow indicator stops moving.
7.
157 7.
157 OKENCE
ed ris tho
t me pro
r
BELI
au
IGLE
ge gauze over the injection site for 10 seconds.
S kosmom vate ali koščkom gaze lahko 10 sekund pritiskate na mesto injiciranja.
Use a plaster if you want to. lon Throwing away supplies
Če želite, lahko uporabite
• Do not put either of the caps back on the pre-filled pen. • Put used pre-filled pen immediately into the special container as instructed by your doctor, nurse or pharmacist. no
Kako zavreči ostanke lje • Ne enega ne drugega pokrovčka ne natikajte nazaj na napolnjeni injekcijski peresnik. • Odrabljeni napolnjeni injekcijski peresnik takoj zavrzite v poseben vsebnik, kot vam je naročil vo zdravnik, medicinska sestra ali farmacevt. • Ta vsebnik shranjujte nedosegljivo otrokom. • Odrabljenih napolnjenih injekcijskih peresnikov nikdar ne zavrzite med običajne gospodinjske do
• Keep this container out of the reach and sight of children. • Never put the pre-filled pens that you have used into your normal household rubbish bin. • Only use each pre-filled pen for one injection. t uc
odpadke. • Vsak napolnjeni injekcijski peresnik uporabite le za eno injiciranje. eā
If you accidentally inject Trudexa more frequently than told to by your doctor, you should call your rod
Če pomotoma injicirate Trudexo pogosteje, kot vam je naročil zdravnik, se morate posvetovati z njim av
doctor and tell him/her that you have taken more.
in mu povedati, da ste uporabili večji odmerek.
If you forget to take Trudexa: lP
Če ste pozabili vzeti Trudexo nim
Then take your next dose as you would have on your originally scheduled day, had you na
Nato upo - rabite naslednji odmerek, kot bi ga uporabili po prvotnem urniku injciranja, če ne bi pozabili odmerka.
If you have any further questions on the use of this product, ask your doctor or pharmacist. i dic
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom. ilo
Most side Me
Kot vsa zdravila ima lahko tudi Trudexa neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Side effects may occur at least up to 5 months after the last treatment.
Zd
Tell your doctor immediately if you notice any of the following: • Severe rash, hives or other signs of allergic reaction; • Swollen face, hands, feet; • Trouble breathing, swallowing; 158 • Shortness of breath with exertion or upon lying down or swelling of the feet; • Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.
158 • znaki in simptomi, ki nakazujejo bolezni krvi, npr. trdovratna zvišana telesna temperatura, modrice, krvavitve, bledica.
Tell your doctor as soon as possible if you notice any of the following: • Signs of infection such as fever, malaise, wounds, dental problems, burning on urination;
Zdravniku čim prej povejte, če opazite kaj od naslednjega: • znake okužbe, npr. zvišano telesno temperaturo, splošno slabo počutje, rane, težave z zobmi, pekoč občutek med uriniranjem;
ed • Feeling weak or tired; • Coughing; • Tingling;
t me • občutek šibkosti ali utrujenosti; • kašelj; • mravljinčenje; • omrtvelost;
ris • Numbness; • Double vision;
pro • dvojni vid; • šibkost rok ali nog.
tho • A rm or leg weakness.
Opisani simptomi so lahko znaki naslednjih neželenih učinkov, ugotovljenih med uporabo Trudexe:
The symptoms described above can be signs of the below listed side effects, which have been observed with Trudexa:
za Zelo pogosto (≥1/ 10 bolnikov): • reakcije na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo in srbenjem).
au Very common (≥ 1/10 patients): • injection site reactions (including pain, swelling, redness or itching).
nja Pogosto (≥1/ 100 in < 1/ 10 bolnikov): • okužbe spodnjih dihal (npr. bronhitis, pljučnica); • okužbe zgornjih dihal (vključno s prehladom, izcedkom iz nosu, okužbo obnosnih votlin); •
r Common (≥ 1/100 and < 1/10 patients):
okužbe sečil, ocvirki, pasovec;
ge • lower respiratory tract infections (such as bronchitis, pneumonia); • upper respiratory tract infections (including cold, runny nose, sinus infection); • urinary tract infection, cold blisters, shingles; lon • dizziness, including vertigo, headache; • eye inflammation; • cough, sore throat; • nausea, diarrhoea, abdominal pain, mouth ulcers; no
• omotica, vključno z vrtoglavico, glavobol; • vnetje očesa; vo • kašelj, vnetje žrela; • slabost v želodcu, driska, bolečine v trebuhu, razjede v ustih; • zvišanje jetrnih encimov; do
• elevated liver enzymes; • rash, itching, hair loss; • fatigue; • fever. t uc
• izpuščaj, srbenje, izpadanje las in dlak; • utrujenost; • povišana telesna temperatura. eā
Uncommon (≥ 1/1000 and < 1/100 patients): • serious infections (such as sepsis [blood poisoning]), joint infection, fungal infections; rod
Občasno (≥1/ 1000 in < 1/ 100 bolnikov): • resne okužbe (npr. sepsa [zastrupitev krvi]), okužba sklepa, glivične okužbe; • bradavica na koži; av
• skin wart; • anaemia, low white blood cell counts; • allergic reactions; • increased lipid values, appetite disorders; lP
• anemija, zmanjšanje števila belih krvnih celic; • alergijske reakcije; • zvišani lipidi, motnje apetita; nim
• anxiety, depression, feeling sleepy and difficulty sleeping; • nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances; • vision disturbances; • ear discomfort; na
• tesnobnost, depresija, zaspanost in težave s spanjem; • bolezni živčevja (npr. multipla skleroza in vnetje očesnega živca), motnje okusa; • motnje vida; • neprijeten občutek v ušesu; • občutek hitrega bitja srca, visok krvni pritisk; ilo
• sensation of heart beating rapidly, high blood pressure; • asthma, shortness of breath; • abdominal symptoms (such as vomiting, indigestion, constipation), rectal bleeding; i dic
• astma, hitra zadihanost; • trebušni simptomi (npr. bruhanje, prebavne težave, zaprtje), krvavitve v danko; • bolezni kože (npr. luskavica, ekcem ali okužbe), srbeč izpuščaj, počasno celjenje ran; rav
• skin disorders (such as psoriasis, eczema or infections)itchy rash, slow wound healing; • muscle weakness; • urinary disturbances (such as blood in urine, increas ed urinary frequency); • increased menstrual bleeding; Me
Zd
• flu like symptoms, chest pain, swelling of the feet.
Redko (≥1/ 10. 000 do < 1/ 1. 000) • glavkom; • kožni rak; • bolezni ščitnice; • beljakovine v urinu.
159 Rare (< 1/1000) • glaucoma; • skin cancer; • thyroid disorders; • protein in urine.
159 Drugi neželeni učinki, zabeleženi pri bolnikih, ki so jemali Trudexo: • tuberkuloza in druge oportunistične okužbe (okužbe, ki se pojavijo, kadar se zmanjša odpornost proti boleznim); • pljučna bolezen.
ed • Other side effects that have been observed in patients taking Trudexa: • tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered);
t me Če katerikoli neželen učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
ris • lung disease.
pro 5.
r Do not use the Trudexa pre-filled pen after the expiry date stated on the label/blister/carton after EXP:.
Zdravila Trudexa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na
ge The expiry date refers to the last day of that month.
za nalepki/ pretisnem omotu/ škatlici za “ Uporabno do: ”.
Keep the pre-filled pen in the outer carton.
Ne
Do not freeze. lon 6.
lje 6.
Trudexa 40 mg solution for injection in pre-filled pen is supplied as a sterile solution of 40 mg no
Trudexa 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku je na voljo kot sterilna vo raztopina 40 mg adalimumaba, raztopljenega v 0, 8 ml raztopine.
What Trudexa contains t uc
Kaj vsebuje zdravilo Trudexa do
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium rod
Pomožne snovi so manitol, citronska kislina monohidrat, natrijev citrat, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, polisorbat 80, natrijev hidroksid in voda za eā
hydroxide and water for injections.
injekcije.
What the Trudexa pre-filled pen looks like and contents of the pack lP
Izgled zdravila Trudexa in vsebina pakiranja av
There are two caps – one is grey and labelled ‘1’ and the other is plum and labelled ‘2’.
Nameščena ima dva pokrovčka – eden je siv in označen nim
syringe.
Na obeh straneh peresnika je okence; skozi okenci lahko vidite raztopino Trudexa v notranjosti brizge.
Each pre- i
Napolnjeni injekcijski peresnik Trudexa je na voljo v pakiranjih, ki vsebujejo 1, 2, 4 ali 6 napolnjenih injekcijskih peresnikov.
filled pen comes with 1 alcohol pad.
Vsakemu napolnjenemu injekcijskemu peresniku je priložena 1 alkoholna ilo
Trudexa is also available as dic
Trudexa je na voljo tudi v vialah in napolnjenih injekcijskih brizgah. rav
a vial or pre-filled syringe.
Imetnik dovoljenja za promet
Marketing Authorisation Holder Me
Abbott Laboratories Ltd Queenborough Zd
Abbott Laboratories Ltd Queenborough Kent ME11 5EL Unit ed Kingdom
Kent ME11 5EL Velika Britanija
160 Manufacturer
Izdelovalec
Abbott Biotechnology Deutschland GmbH Max-Planck-Ring 2 D – 65205 Wiesbaden Germany
Abbott Biotechnology Deutschland GmBH
België/Belgique/Belgien
160 Max- Planck- Ring 2 D- 65205 Wiesbaden Nemčija
Luxembourg/Luxemburg
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
tho Abbott SA Parc Scientifique Rue du Bosquet, 2 B-1348 Ottignies/Louvain-la-Neuve
t me België/ Belgique/ Belgien Abbott SA Parc Scientifique
au Tél/Tel: + 32 10 475311
pro Rue du Bosquet, 2 B- 1348 Ottignies/ Louvain- la- Neuve Tél/ Tel: + 32 10 475311
r България
za България Т. П.
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Teл.: + 359 2 846 8429
nja Teл.: + 359 2 846 8429
Tel.: + 36 1 465 2100
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Česká republika Abbott Laboratories s. r. o.
Česká republika
Mal ta V.J.Salomone Pharma Limited 79, Simpson Street,
V. J. Salomone Pharma Limited 79, Simpson Street, Marsa HMR 14,
Evropská 2590/33d CZ-160 00 Praha 6 Tel: + 420 267 292 111
vo CZ- 160 00 Praha 6 Tel: + 420 267 292 111
uc
do
Danmark Abbott Laboratories A/S Smakkedalen 6
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KG Max-Planck-Ring 2 na
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Eesti Österreich dic
Eesti Österreich Abbott Laboratories Baltics ilo
Abbott Laboratories Baltics Vienibas 87h LV-1004 Riia Me
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ul.
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ris Abbott France 10, rue d’Arcueil BP 90233
t Abbott France
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au I reland Abbott Laboratories, Ireland, Ltd 4051 Kingswood Drive
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rod
Aprilia eā
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162 This leaflet was last approved in {MM/YYYY}
Vienibas 87h LV- 1004 Rīga Latvia Tel: + 371 7605580
ed ris tho aur ge lon
Navodilo je bilo odobreno {MM/ LLLL}
dic
162 Zd rav ilo nim av eā
163
163 do vo lje nja za pro me t
Truvada is a medicine containing two active substances emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Truvada je zdravilo, ki vsebuje dve zdravilni učinkovini, emtricitabin (200 mg) in tenofovir dizoproksil (245 mg).
It is available as blue capsule-shaped tablets.
Zdravilo je na voljo v obliki modrih tablet, ki so podobne kapsulam.
Truvada is an antiviral medicine.
Zdravilo Truvada je protivirusno zdravilo.
It is used in combination with at least one other antiviral medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo se uporablja v kombinaciji z vsaj enim drugim protivirusnim zdravilom za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti 1 (HIV- 1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
Treatment with Truvada should be initiated by a doctor who has experience in the management of HIV infection.
Zdravljenje z zdravilom Truvada lahko uvede le zdravnik, ki ima izkušnje z vodenjem okužbe s HIV.
The recommended dose of Truvada is one tablet once a day, taken with food.
Priporočen odmerek zdravila Truvada je ena tableta enkrat na dan, ki se jo vzame s hrano ali brez.
The tablets may need to be taken less frequently in patients with kidney disease.
Bolniki z boleznimi ledvic bodo morda morali zdravilo jemati manj pogosto.
Truvada is not recommended for patients who have severe problems with their kidneys or who require haemodialysis (a blood clearance technique).
Zdravilo Truvada ni priporočeno za bolnike, ki imajo hude težave z jetri ali potrebujejo dializo (umetno čiščenje krvi).
In exceptional cases, patients who have difficulty swallowing can crush the tablet and mix it in about 100 ml of water, orange juice or grape juice before taking it immediately.
V izjemnih primerih lahko bolniki s težavami pri požiranju tableto tik pred zaužitjem zdrobijo in jo zmešajo s približno 100 ml vode, pomarančnega ali grozdnega soka.
If patients need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.
Če bi morali bolniki prekiniti jemanje bodisi emtricitabina ali tenofovirja oziroma bi bilo treba odmerke teh spremeniti, bodo dobivali zdravila, ki vsebujejo le emtricitabin ali tenofovir dizoproksil.
Truvada contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘ prodrug ’ of tenofovir.
Zdravilo Truvada vsebuje dve zdravilni učinkovini: emtricitabin, ki je zaviralec nukleotidne reverzne transkriptaze; in tenofovir dizoproksil, ki je neaktivirana oblika zdravila tenofovirja (prozdravilo).
Both groups of medicines are known as NRTIs.
Obe skupini zdravil sta znani kot NRTI- ji.
Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Tako emtricitabin in tenofovir na podoben način zavirata aktivnost reverzne transkriptaze, t. j. encima, ki ga tvori HIV, da bi lahko okužil celice ter tvoril še večje število virusov.
Truvada, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo v kombinaciji z vsaj enim protivirusnim zdravilom zniža količino HIV v krvi in jo zadržuje na nizki ravni.
Truvada does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Truvada ne ozdravi okužbe s HIV ali AIDS- a, lahko pa podaljša čas do nastopa poškodb imunskega sistema in razvoja okužb ter bolezni, ki so povezane z AIDS- om.
Both active substances have been available in the European Union (EU) since the early 2000s: emtricitabine was granted marketing approval as Emtriva in 2003, and tenofovir disoproxil was granted marketing approval as Viread in 2002.
Obe zdravilni učinkovini sta v Evropski uniji (EU) na voljo že od zgodnjih 2000- ih: emtricitabin je dobil dovoljenje za promet pod tržnim imenom Emtriva leta 2003, tenofovir dizoproksil pa pod tržnim imenom Viread leta 2002.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Truvada been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Truvada raziskano?
The main studies examined the effects of Truvada’ s active substances, emtricitabine and tenofovir disoproxil, in 683 treatment-naïve patients infected with HIV-1 (who had not taken treatment for HIV infection before).
Glavne študije so preučevale učinke zdravilnih učinkovin zdravila Truvada, t. j. emtricitabina in tenofovir dizoproksila, pri 683 bolnikih, ki pred tem niso bili deležni zdravljenja okužbe s HIV.
The first study compared the combination of emtricitabine and tenofovir disoproxil to the combination of lamivudine and zidovudine (other antiviral medicines), both taken in combination with efavirenz (another antiviral medicine) in 487 patients.
V prvi študiji so primerjali kombinacijo emtricitabina in tenofovir dizoproksila s kombinacijo lamivudina in zidovudina (druga vrsta protivirusnih zdravil), obe kombinaciji pa so prejemali še v kombinaciji z efavirenzom (še ena vrsta protivirusnih zdravil) pri 487 bolnikih.
The second study examined the effects of emtricitabine and tenofovir disoproxil, taken with lopinavir and ritonavir (other antiviral medicines) in 196 patients.
V drugi študiji so preučevali učinke jemanja emtricitabina in tenofovir dizoproksila skupaj z lopinavirjem in ritonavirjem (druga vrsta zdravil proti virusom) pri 196 bolnikih.
The main measure of effectiveness was the proportion of patients whose HIV levels in the blood (viral loads) had fallen to below 400 or 50 copies/ ml and were maintained below these levels until the 48th week of treatment.
Glavno merilo učinkovitosti je bilo sodelovanje bolnikov, katerih ravni HIV v krvi (virusno breme) so se zmanjšale pod 400 ali 50 kopij/ ml, kjer so se zadržale do 48. tedna zdravljenja.
The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate medicines.
Podjetje je raziskalo tudi način, na katerega se kombinirane tablete absorbirajo v telesu v primerjavi z ločenima zdraviloma.
What benefit has Truvada shown during the studies?
Kakšne koristi je zdravilo Truvada izkazalo med raziskavami?
Truvada’ s active substances, taken in combination with other antiviral medicines, reduced viral loads in the majority of patients and were more effective than the comparator medicines.
Zdravilni učinkovini zdravila Truvada v kombinaciji z drugimi protivirusnimi zdravili znižata virusno breme pri večini bolnikov in sta bolj učinkoviti kot primerjalna zdravila.