natgillin/translations-raw huggingface dataset:
Slide the syringe into the dose preparation guide until the needle goes through the centre ring of the grey stopper of the vial (see Diagram 3).
Z brizgo drsite po vodilu proti viali toliko časa, da z njo predrete osrednji kolobar sivega zamaška na viali (glejte shemo 3).
If the needle is correctly lined up, you should feel a slight resistance and then a “ pop” as the needle goes through the centre of the stopper.
Če držite iglo v pravilnem položaju, boste začutili rahel odpor in potem “ pok ”, ko bo igla predrla osrednji del zamaška.
Look for the needle tip inside the stopper window (see Diagram 4).
Skozi okence v zamašku preverite, če vidite konico igle (glejte shemo 4).
If the needle is not correctly lined up, you will feel constant resistance as it goes through the stopper and no “ pop”.
Če igla ne bo pravilno poravnana, boste pri prodiranju skozi zamašek ves čas čutili odpor in ne bo “ poka ”.
Do not insert the needle at an angle, this may cause the needle to bend and/ or prevent proper addition of the solvent into the vial (see Diagram 5).
Igle ne vstavljajte pod kotom, ker bi jo lahko tako ukrivili in/ ali s tem preprečili pravilno dovajanje vehikla v vialo (glejte shemo 5).
Diagram 3.
Shema 3
Diagram 4.
Shema 4
Diagram 5.
Shema 5
Diagram 6.
• Vstavite bat v brizgo. • Bat zavrtite v smeri urnega kazalca, dokler ne začutite rahlega odpora (glejte shemo 6).
 Push the plunger in VERY SLOWLY until all the solvent is in the vial.
• ZELO POČASI potiskajte bat v brizgo, dokler ne iztisnete ves vehikel v vialo.
This will help reduce foaming (lots of bubbles) (see Diagram 7).
Tako boste zmanjšali penjenje raztopine (nastajanje mehurčkov) (glejte shemo 7).
266 Diagram 7.
Shema 7
 Leave the syringe in place.
• Brizgo pustite v viali.
Gently move the dose preparation guide in circles a few times, to dissolve the powder (see Diagram 8).
Nekajkrat nežno krožno zavrtite podstavek z vialo, da se prašek raztopi (glejte shemo 8).
Some white foam may remain in the vial - this is normal.
V viali lahko ostane nekaj bele pene, kar je normalno.
Do NOT use Enbrel if all the powder in the vial is not dissolved within 10 minutes.
NE uporabljajte zdravila Enbrel, če se ves prašek ni raztopil v 10 minutah.
Start again with another dose tray.
V tem primeru si pripravite novo vialo.
Diagram 8.
Shema 8
 With the needle still in the vial, hold the dose preparation guide with the vial upside down at eye level.
• Ko je igla še vedno v viali, dvignite podstavek tako, da bo viala obrnjena na glavo, približno v višini oči.
Diagram 9.
Počasi potegnite bat nazaj, da izvlečete raztopino v brizgo (glejte shemo 9).
 With the needle still inserted in the vial, check the syringe for air bubbles.
Ko se nivo raztopine v viali zmanjša, boste morali iglo deloma izvleči, da bo konica igle ostala v tekočini.
Gently tap the syringe to make any bubbles rise to the top of the syringe, near the needle (see Diagram 10).
Za odraslega bolnika izvlecite celoten volumen raztopine, za otroka pa le toliko, kot je določil njegov zdravnik.
Slowly press the
253 Shema 9
267 plunger to push bubbles out of the syringe and into the vial.
• Ko je igla še v viali, preverite, ali so v brizgi zračni mehurčki.
When you do this, if you accidentally push liquid back into the vial, slowly pull the plunger to draw the liquid back into the syringe.
Če boste pri tem v vialo iztisnili tudi raztopino, morate bat ponovno počasi izvleči, da boste raztopino ponovno izvlekli v brizgo.
Diagram 10.
Shema 10
 Slide the syringe out of the dose preparation guide.
• Brizgo izvlecite iz vodila za pripravo odmerka.
Again, do not touch the needle or allow it to touch any surface (see Diagram 11).
Pri tem zopet pazite, da se igle ne boste dotaknili ali z njo kam zadeli (glejte shemo 11).
Diagram 11.
Shema 11
After you have completed these steps, a small amount of liquid may remain in the vial.
Tudi če ste postopek izvedli pravilno, lahko v viali ostane malo tekočine.
 The three recommended injection sites for Enbrel include:
• Za injiciranje zdravila Enbrel so priporočljiva tri injekcijska mesta:
(1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 12).
(1) na sredini sprednjega dela stegna; (2) na trebuhu, razen na področju 5 cm okrog popka; in (3) na zunanjem delu nadlakti (glejte shemo 12).
Diagram 12.
254 Shema 12.
268  A different site should be used for each new injection.
• Za vsako naslednjo injekcijo morate uporabiti drugo mesto.
Avoid areas with scars or stretch marks.
Izogibajte se področij z brazgotinami ali strijami.
(It may be helpful to keep notes on the location of the previous injections.)  If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“ psoriasis skin lesions”).
(Pomagalo bo, če si boste beležili mesta predhodnih injekcij.) • Če imate vi ali otrok luskavico, se morate izogibati neposrednemu injiciranju v vsa privzdignjena, zadebeljena, rdeča ali luskava področja na koži ('psoriatične kožne spremembe').
 Wipe the site where Enbrel is to be injected with an alcohol swab, using a circular motion.
• Mesto, kjer nameravate vbrizgati zdravilo Enbrel, s krožnim gibom obrišite z alkoholnim zložencem.
DO NOT touch this area again before giving the injection.  When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
Nato se NE dotikajte več tega predela, dokler ne boste dali injekcije. • Ko se očiščeni predel kože posuši, ga z eno roko nežno stisnite in ga trdno primite.
With the other hand, hold the syringe like a pencil.  With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 13).
Z drugo roko kot svinčnik držite brizgo. • S hitro in kratko kretnjo potisnite iglo do konca v kožo pod kotom med 45 in 90 stopinj (glejte shemo 13).
Be careful not to push the needle into the skin too slowly, or with great force.
Pazite, da ne boste igle v kožo potisnili prepočasi ali z veliko silo.
Diagram 13
Shema 13
When the needle is completely inserted into the skin, release the skin that you are holding.
• Ko je igla v celoti v koži, spustite kožo, ki ste jo držali.
Diagram 14.
Nato potisnite bat tako, da boste počasi in enakomerno injicirali vso raztopino (glejte shemo 14).
 When the syringe is empty, remove the needle from the skin, being careful to keep it at the same angle it was when it was inserted.  Press a cotton ball over the injection site for 10 seconds.
• Ko je brizga prazna, izvlecite iglo iz kože pod istim kotom, kot ste jo zabodli vanjo. • Na mesto injiciranja za 10 sekund pritisnite tampon iz vate.
Do NOT rub the injection site.
Mesto injiciranja NE masirajte.
A bandage is optional.
Na mesto injiciranja lahko tudi nalepite obliž.
 The syringe and needle should NEVER be re-used.
• Brizge in igle ne smete NIKOLI ponovno uporabiti.
Never recap a needle.
Igle nikoli ponovno ne pokrivajte.
Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.
Uporabljene igle in brizge odstranjujte v skladu z navodili zdravnika, medicinske sestre ali farmacevta.
If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Enbrel.
Če imate kakršnakoli vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, ki dobro poznajo zdravilo Enbrel.
INFORMATION FOR THE USER
256 NAVODILO ZA UPORABO
Instructions for preparing and giving an injection of Enbrel (See overleaf).
Navodila za pripravo in dajanje injekcij zdravila Enbrel (glejte drugo stran navodila)
271  Polyarticular juvenile idiopathic arthritis (a type of juvenile arthritis that affects many joints) in patients from the age of 4 years who have had an inadequate response to (or are unable to take) methotrexate.
poliartikularnega juvenilnega idiopatskega artritisa (vrsta juvenilnega artritisa, ki prizadene številne sklepe) pri bolnikih od 4. leta starosti naprej, ki so se nezadostno odzvali na metotreksat (ali ga niso mogli jemati);
 Severe psoriasis in patients from the age of 8 years who have had an inadequate response to (or are unable to take), phototherapies and other systemic therapies.
hude psoriaze pri bolnikih od 8. leta starosti naprej, ki so se nezadostno odzvali na fototerapije ali druge sistemske terapije (ali jih niso prenašali).
Enbrel is not effective in the treatment of Wegener’ s granulomatosis, a rare inflammatory disease.
Zdravilo Enbrel ni učinkovito pri zdravljenju redke vnetne bolezni - Wegenerjeve granulomatoze.
If you or the child in your care have Wegener’ s granulomatosis talk to your doctor.
Če imate vi ali otrok za katerega skrbite Wegenerjevo granulomatozo, se posvetujte s svojim zdravnikom.
If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.  Serious blood infection:
Nemudoma se posvetujte s svojim zdravnikom. • Resna okužba krvi:
If you or the child have, or are at risk of developing a serious blood infection called sepsis.
Če imate vi ali otrok resno okužbo krvi (sepso), ali če pri vas ali otroku obstaja tveganje za njen pojav.
If you are not sure, please contact your doctor.  Infections:
Če ste v dvomih, se posvetujte s svojim zdravnikom. • Okužbe:
If you or the child develop a new infection, or are about to have any major surgery,, your doctor may wish to monitor the treatment with Enbrel.  Infections/ diabetes:
Če se pri vas ali otroku pojavi nova okužba, ali če je pri vas ali otroku predvidena kakršnakoli večja operacija, bo zdravnik morda želel zdravljenje z zdravilom Enbrel nadzirati. • Okužbe/ sladkorna bolezen:
272  Nervous system and eye disorders:
Ti simptomi namreč lahko kažejo na pojav smrtno nevarne bolezni krvi, pri kateri bo zdravljenje z zdravilom Enbrel morda treba prekiniti. • Bolezni živčevja in očesne bolezni:
Tell your doctor if you or the child have a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.  Vaccinations:
V tem primeru je potrebna previdnost pri uporabi zdravila Enbrel. • Cepljenja:
Some vaccines, such as oral polio vaccine, should not be given while using Enbrel.
Med zdravljenjem z zdravilom Enbrel se nekaterih cepiv, npr. peroralnega
Your doctor will determine if preventive treatment for chickenpox is appropriate.
Zdravnik bo presodil, če je potrebno preventivno zdravljenje proti noricam.
Dosing for adult patients (aged 18 years or over)
Odmerjanje pri odraslih (starih 18 let in starejših)
The usual dose is25 mg twice a week or 50 mg once a week.
Običajni odmerek je 25 mg dvakrat na teden ali 50 mg enkrat na teden.
273 Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Druga možnost je, da vam predpišejo 50 mg dvakrat na teden za največ 12 tednov, čemur sledi odmerek 25 mg dvakrat na teden ali 50 mg enkrat na teden.
Dosing for children and adolescents
259 Odmerjanje pri otrocih in mladostnikih
For psoriasis in patients from the age of 8 years, the dose recommended is 0.8 mg of Enbrel per kg bodyweight (up to a maximum of 50mg), and should be given once weekly.
Za psoriazo pri bolnikih od 8. leta starosti naprej je priporočeni odmerek 0, 8 mg zdravila Enbrel na kg telesne mase (do največ 50 mg), dajati pa ga je treba enkrat na teden.
Detailed instructions on how to prepare and inject Enbrel are provided in section 7, “ INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL”.
Podrobna navodila o pripravi in injiciranju zdravila Enbrel so v poglavju 7, “ NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJ ENBREL ”.
If you forget to inject Enbrel
Če ste pozabili uporabiti zdravilo Enbrel
274 Other side effects that are not listed in this leaflet may occur.
Pojavijo se lahko tudi neželeni učinki, ki niso navedeni v tem navodilu.
 Trouble swallowing or breathing.  Swelling of the face, throat, hands, or feet.  Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/ or a warm feeling.  Severe rash, itching, or hives (elevated patches of red or pale skin that often itch).
260 • Težave pri požiranju ali dihanju. • Otekanje obraza, žrela, rok ali nog. • Občutek živčnosti ali tesnobe, utripajoč občutek, nenadna pordelost kože in/ ali občutek toplote. • Hud izpuščaj, srbenje ali koprivnica (rdeče ali blede kožne spremembe nad ravnjo kože, ki pogosto srbijo).
 Uncommon (may occur in less than 1 in 100, but more than 1 in 1,000 patients): serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at
• Občasni (pojavijo se lahko pri manj kot 1 od 100, vendar več kot 1 od 1. 000 bolnikov): resne okužbe (vključno s pljučnico, globokimi okužbami kože, okužbami sklepov, okužbo krvi in okužbami na različnih mestih), lokalizirano otekanje kože (angioedem), nizko število trombocitov, koprivnica (rdeče ali blede kožne spremembe nad ravnjo kože, ki pogosto srbijo); luskavica; izpuščaj; vnetje ali brazgotinjenje pljuč.
275 various sites); localized swelling of the skin (angioedema); low blood platelet count; hives (elevated patches of red or pale skin that often itch); psoriasis; rash; inflammation or scarring of the lungs.
• Redki (pojavijo se lahko pri manj kot 1 od 1. 000 bolnikov): resne alergijske reakcije (vključno s hudim lokaliziranim otekanjem kože in piskajočim dihanjem), kombinacija znižanja števila trombocitov in rdečih ter belih krvnih celic, motnje živčevja (z znaki in simptomi, podobnimi multipli sklerozi ali vnetje očesnih živcev ali hrbtenjače), tuberkuloza, poslabšanje kongestivnega srčnega popuščanja, epileptični napadi, lupus ali lupusu podoben sindrom (med simptomi so lahko trdovraten izpuščaj, zvišana telesna temperatura, bolečine v sklepih in utrujenost), vnetje krvnih žil, nizko število rdečih krvnih celic, nizko število belih krvnih celic,
 Rare (may occur in less than 1 in 1,000 patients): serious allergic reactions (including severe localized swelling of the skin and wheezing); combined low platelet, red, and white blood cell count; nervous system disorders (with signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; worsening congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); inflammation of the blood vessels; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; elevated liver blood tests; skin rash which may lead to severe blistering and peeling of the skin..
261 nizko število nevtrofilcev (vrste belih krvnih celic), povišane vrednosti jetrnih encimov pri krvnih preiskavah; kožni izpuščaj, ki lahko povzroči močno mehurjenje in luščenje kože.
Enbrel 25 mg is supplied as a white powder for solution for injection.
Izgled zdravila Enbrel in vsebina pakiranja Zdravilo Enbrel 25 mg je na voljo v obliki belega praška za raztopino za injiciranje.
Each pack contains 4 single dose vials and 8 alcohol swabs.
Vsako pakiranje vsebuje 4 enoodmerne viale in 8 alkoholnih tamponov.
Wyeth Pharmaceuticals New Lane Havant Hampshire, PO9 2NG United Kingdom
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262 Polska Ireland België/ Belgique/ Belgien / Wyeth Sp. z o. o Wyeth Pharmaceuticals Luxembourg/ Luxemburg Tel: +48 22 457 1000 Tel: +353 1 449 3500 Wyeth Pharmaceuticals Fax: +48 22 457 1001 Fax: +353 1 449 3522 S. A. / N. V.
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You will be instructed by your doctor or his/ her assistant on the techniques of self-injection or on giving an injection to a child.
Zdravnik ali medicinska sestra vas bosta natančno poučila o pravilni tehniki samoinjiciranja ali dajanja injekcij otroku.
A sterile syringe and needle(s) of 25 gauge x 16 mm or similar A vial or ampoule of water for injections 2 alcohol swabs  Inspect the expiry dates on both the Enbrel vial label and the water for injections.
• Temeljito si umijte roke. • Izberite čisto, dobro osvetljeno ravno delovno površino. • Vzemite vialo zdravila ENBREL iz hladilnika in jo postavite na ravno površino. • Potrebujete še naslednje: sterilno injekcijsko brizgo in iglo( e) 25 x 16 mm ali podobno, vialo ali ampulo vode za injekcije 2 alkoholna tampona • Preverite rok uporabnosti viale zdravila Enbrel in na vode za injekcije.
 Remove the plastic cap from the Enbrel vial.
• Z viale zdravila Enbrel odstranite plastičen pokrovček.
After cleaning, do not touch the stopper with your hands.  Check that a needle is on your syringe; if you are not sure how to attach a needle ask your doctor or nurse.  Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 1).
Če niste prepričani, kako natakniti iglo, vprašajte svojega zdravnika ali medicinsko sestro. • Z ravnim potegom odstranite pokrovček igle z injekcijske brizge in pri tem pazite, da se s prsti ne dotaknete igle in da se z iglo ne dotaknete ničesar (glejte shemo 1).
Diagram 1.
264 Shema 1
 Check your syringe contains 1 ml of water for injections.  If you are not sure how to fill your syringe ask your doctor or nurse.  Make sure your syringe does not contain any air bubbles.  With the Enbrel vial upright on a flat surface, such as a table, insert the syringe needle straight down through the centre ring of the grey stopper of the vial (see Diagram 2).
• Preverite, če brizga vsebuje 1 ml vode za injekcije. • Če niste prepričani, kako napolniti injekcijsko brizgo, vprašajte svojega zdravnika ali medicinsko sestro. • Prepričajte se, da v brizgi ni zračnih mehurčkov. • Ko je viala z zdravilom Enbrel postavljena pokončno na ravni površini, na primer mizi, vstavite iglo brizge naravnost navzdol skozi osrednji obroč sivega zamaška viale (glejte shemo 2).
Look for the needle tip inside the stopper window (see Diagram 3).
Skozi okence v zamašku preverite, če vidite konico igle (glejte shemo 3).
Do not insert the needle at an angle, this may cause the needle to bend and/ or prevent proper addition of the solvent into the vial (see Diagram 4).
Igle ne vstavljajte pod kotom, ker bi jo lahko tako ukrivili in/ ali s tem preprečili pravilno dovajanje vehikla v vialo (glejte shemo 4).
CORRECT
.
INCORRECT
NEPRAVILNO PRAVILNO
 Push the plunger in VERY SLOWLY until all the water for injections is in the vial.
• ZELO POČASI potiskajte bat v injekcijsko brizgo, dokler ne iztisnete vso vodo za injekcije v vialo.
This will help reduce foaming (lots of bubbles) (see Diagram 5).
Tako boste zmanjšali penjenje raztopine (nastajanje mehurčkov) (glejte shemo 5).
Gently move the vial in circles a few times, to dissolve the powder (see Diagram 6).
Nekajkrat nežno krožno zavrtite vialo, da se prašek raztopi (glejte shemo 6).
Start again with a new Enbrel vial, water for injections, syringe, needle and swabs.
V tem primeru si pripravite novo vialo.
Diagram 6.
265 Shema 6
 With the needle still in the vial, hold the vial upside down at eye level.
• Ko je igla še vedno v viali, dvignite vialo tako, da bo obrnjena na glavo, približno v višini oči.
Slowly pull the plunger back to draw the liquid into the syringe (see Diagram 7).
Počasi potegnite bat nazaj, da izvlečete raztopino v brizgo (glejte shemo 7).
As the liquid level drops in the vial, you may need to withdraw the needle partially to keep the tip of the needle in the liquid.
Ko raven raztopine v viali pade, boste morali iglo deloma izvleči, da bo konica igle ostala v tekočini.
For children, remove only the portion of liquid as directed by your child’ s doctor.
Za odraslega bolnika izvlecite celoten volumen raztopine, za otroka pa le toliko, kot je določil njegov zdravnik.
280 Diagram 7.
Shema 7
 With the needle still inserted in the vial, check the syringe for air bubbles.
• Ko je igla še v viali, preverite, ali so v brizgi zračni mehurčki.
Gently tap the syringe to make any bubbles rise to the top of the syringe, near the needle (see Diagram 8).
Rahlo udarite po brizgi, da se bodo mehurčki dvignili na vrh brizge, v bližino igle (glejte shemo 8).
Slowly press the plunger to push bubbles out of the syringe and into the vial.
Počasi pritisnite na bat, da boste mehurčke iztisnili iz brizge v vialo.
 Pull the needle completely out of the vial.
• Iglo povsem izvlecite iz viale.
Again, do not touch the needle or allow it to touch any surface.
Pri tem zopet pazite, da se igle ne boste dotaknili ali z njo kam zadeli.
f.
266 f.
(1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 9).
(1) na sredini sprednjega dela stegna; (2) na trebuhu, razen na področju 5 cm okrog popka; in (3) na zunanjem delu nadlakti (glejte shemo 9).
281 Diagram 9.
Shema 9.
 A different site should be used for each new injection.
• Za vsako naslednjo injekcijo morate uporabiti drugo mesto.
(It may be helpful to keep notes on the location of the previous injections.)  If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“ psoriasis skin lesions”).
(Pomagalo bo, če si boste beležili mesta predhodnih injekcij.) • Če imate vi ali otrok luskavico, se morate izogibati neposrednemu injiciranju v vsa privzdignjena, zadebeljena, rdeča ali luskava področja na koži (‘ psoriatične kožne spremembe ’).
With the other hand, hold the syringe like a pencil.  With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 10).
Z drugo roko kot svinčnik držite brizgo. • S hitro in kratko kretnjo potisnite iglo do konca v kožo pod kotom 45 do 90 stopinj (glejte shemo 10).
 When the needle is completely inserted into the skin, release the skin that you are holding.
• Ko je igla v celoti v koži, spustite kožo, ki ste jo držali.
Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 11).
Nato potisnite bat tako, da boste počasi in enakomerno injicirali vso raztopino (glejte shemo 11).
282 Diagram 11
267 Shema 11
 Press a cotton ball over the injection site for 10 seconds.
• Ko je brizga prazna, izvlecite iglo iz kože pod istim kotom, kot ste jo zabodli vanjo. • Na mesto injiciranja za 10 sekund pritisnite tampon iz vate.
INFORMATION FOR THE USER
268 NAVODILO ZA UPORABO