natgillin/translations-raw huggingface dataset:
This should be in line with the CHMP Guideline on Risk Management Systems for Medicinal Products for Human use and should be submitted within 30 days after the Commission Decision.
Ta predlog mora biti v skladu s Smernicami za sisteme upravljanja tveganja pri zdravilih za uporabo v humani medicini Odbora za zdravila za uporabo v humani medicini (CHMP) in mora biti predložen v 30 dneh po izdaji odločbe komisije.
Macugen 0.3 mg solution for injection pegaptanib sodium
Macugen 0, 3 mg raztopina za injiciranje natrijev pegaptanib
ST ATEMENT OF ACTIVE SUBSTANCE(S)
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide, hydrochloric acid, water for injections.
Natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev hidroksid, klorovodikova kislina, voda za injekcije.
Solution for injection, 90 µl.
Raztopina za injiciranje, 90 μl.
This pack contains one pre-filled syringe, a plunger stopper and a pre-attached plunger rod and is supplied without a needle.
Pakiranje ne vsebuje igle.
Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ Velika Britanija
18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
17 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Macugen 0.3mg injection pegaptanib
Macugen 0, 3 mg injekcija pegaptanib
Pouch containing pre-filled syringe, a plunger stopper and a pre-attached plunger rod
Vrečka, ki vsebuje napolnjeno injekcijsko brizgo z že vstavljenim potisnim batom in gumijastim tesnilom
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINSTRATION
IME ZDRAVILA
Macugen 0.3 mg solution for injection pegaptanib sodium Intravitreal use
Macugen 0, 3 mg raztopina za injiciranje natrijev pegaptanib
Macugen 0.3 mg solution for injection Pegaptanib sodium
Macugen 0, 3 mg raztopina za injiciranje natrijev pegaptanib
Read all of this leaflet carefully before your treatment with Macugen begins
Natančno preberite navodilo, preden se zdravljenje z zdravilom Macugen začne!
- -
- Navodilo shranite.
You may need to read it again If you have any further questions, please ask your doctor or pharmacist
- Če imate kakršnakoli vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
What Macugen is and what it is used for 2.
Kaj je zdravilo Macugen in za kaj ga uporabljamo 2.
Before Macugen is used 3.
Kaj morate vedeti, preden boste dobili zdravilo Macugen 3.
How the intravitreal injection of Macugen is administered 4.
Kako boste dobili injekcijo zdravila Macugen v steklovino 4.
How to store Macugen 6.
Možni neželeni učinki 5 Shranjevanje zdravila Macugen 6.
WHAT MACUGEN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO MACUGEN IN ZA KAJ GA UPORABLJAMO
Macugen is an ophthalmic product, which means it is for eye treatment only.
Macugen je oftalmično zdravilo, kar pomeni, da je namenjen le za zdravljenje oči.
It is a solution for injection contained within a glass pre-filled syringe.
Je raztopina za injiciranje v napolnjeni stekleni injekcijski brizgi.
Your doctor will administer the injection.
Injekcijo vam bo dal zdravnik.
Macugen is used for the treatment of the wet form of age-related macular degeneration (AMD).
Zdravilo Macugen uporabljamo za zdravljenje vlažne oblike starostne degeneracije makule (AMD – „ age- related macular degeneration “).
In the wet form of AMD, abnormal blood vessels grow under the retina and macula.
Pri vlažni obliki AMD se pod mrežnico in makulo vraščajo nenormalne žile.
Macugen is used for the treatment of all types of abnormal blood vessels growth in AMD patients.
Zdravilo Macugen uporabljamo za zdravljenje vseh vrst nenormalne rasti žil pri bolnikih z AMD.
Each pack of Macugen contains one pre-filled syringe, an elastomeric plunger stopper, and a pre- attached plunge-rod inside a sealed pouch.
Vsako pakiranje zdravila Macugen vsebuje eno napolnjeno injekcijsko brizgo v zaprti vrečki, z že vstavljenim potisnim batom in gumijastim tesnilom.
The pre-filled syringe will be used once and then thrown away.
Vsako napolnjeno injekcijsko brizgo uporabijo le enkrat in jo potem zavržejo.
BEFORE MACUGEN IS USED
KAJ MORATE VEDETI, PREDEN BOSTE DOBILI ZDRAVILO MACUGEN
Macugen must not be used:
Zdravila Macugen ne smete dobiti:
If you are hypersensitive (allergic) to pegaptanib sodium or any of the other ingredients.
Če ste preobčutljivi za (alergični na) natrijev pegaptanib ali katerokoli sestavino zdravila Macugen.
If you have an infection in or around the eye.
Če imate kakšno okužbo v očesu ali njegovi okolici.
Take special care with Macugen:
Pri zdravljenju z zdravilom Macugen bodite posebno pozorni:
Please contact your doctor if you are allergic to any substance.
Če ste alergični na katerokoli snov, se posvetujte s svojim zdravnikom.
Macugen is given as an injection into the eye.
Zdravilo Macugen boste dobili kot injekcijo v oko.
Occasionally, an infection in the internal portion of the eye can occur after Macugen treatment (in the next two weeks).
Občasno se lahko po zdravljenju z zdravilom Macugen (v naslednjih dveh tednih) pojavi okužba notranjega dela očesa.
It is important to identify and treat this type of infection as soon as possible.
Zelo pomembno je, da takšno okužbo čim prej prepoznamo in zdravimo.
If your doctor cannot be reached for any reason, an alternate should be contacted immediately.
Če zaradi kakršnegakoli razloga ne morete priti do svojega zdravnika, se morate nemudoma obrniti na kakšnega drugega.
In some patients the pressure inside the treated eye may increase for a short period directly after the injection.
21 Nekaterim bolnikom se lahko za krajši čas neposredno po injiciranju zviša tlak v zdravljenem očesu.
Your doctor may monitor this after each injection.
Zdravnik bo to predvidoma nadziral po vsakem injiciranju.
22 Taking other medicines:
Jemanje drugih zdravil:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
There is no experience of using Macugen in pregnant women; therefore the potential risks are unknown.
Z uporabo zdravila Macugen pri nosečnicah ni izkušenj, zato morebitna tveganja niso znana.
If you are pregnant or planning to become pregnant, please discuss this with your doctor before Macugen treatment.
Če ste noseči ali nameravate zanositi, morate to zdravniku povedati pred zdravljenjem z zdravilom Macugen.
Ask your doctor or pharmacist for advice before Macugen treatment.
Pred zdravljenjem z zdravilom Macugen se posvetujte z zdravnikom ali s farmacevtom.
If you are affected you should not drive or use machines until this resolves.
Če se to zgodi, ne smete upravljati vozil in strojev, dokler ne mine.
HOW THE INTRAVITREAL INJECTION OF MACUGEN IS ADMINISTERED
KAKO BOSTE DOBILI INJEKCIJO ZDRAVILA MACUGEN V STEKLOVINO
All injections of Macugen will be admin istered by your doctor.
Vse injekcije zdravila Macugen vam bo dal zdravnik.
Macugen is administered as a single injection into your eye at intervals of 6 weeks (i.e.
Zdravilo Macugen boste dobili v oko z enkratnim injiciranjem vsakih 6 tednov (tj.
9 times per year).
9- krat na leto).
Your doctor will monitor your condition and recommend how long you should be treated with Macugen.
Zdravnik bo spremljal vaše stanje in vam bo svetoval, kako dolgo naj traja zdravljenje z zdravilom Macugen.
Before the treatment is given your doctor may ask you to use antibiotic eye drops, or to wash your eyes carefully.
Preden boste dobili zdravilo, vam bo zdravnik morda naročil, da uporabite antibiotične kapljice za oko ali da si oči dobro umijete.
Please tell your doctor if you are known to be allergic to any substance.
Obvestite svojega zdravnika, če veste, da ste alergični na katerokoli snov.
Please follow these instructions carefully.
Natančno upoštevajte ta navodila.
Before the injection, your doctor will give you some local anaesthetic (numbing medication).
Preden boste dobili injekcijo, vam bo zdravnik dal lokalni anestetik (sredstvo za omrtvičenje).
This will reduce or prevent any pain you might have with the injection, which is a simple and rapid procedure.
To bo zmanjšalo ali preprečilo vse bolečine, ki bi se lahko pojavile med injiciranjem, ki je preprost in hiter poseg.
After each injection you might be asked to use antibiotic eye drops (or another type of antibiotic treatment) to guard against eye infection.
Po vsakem injiciranju vam bo zdravnik morda naročil, da za zaščito pred okužbo uporabite kapljice za oko (ali kakšno drugo vrsto antibiotičnega zdravila).
If you forget to attend an appointment:
Če pozabite priti k zdravniku, ko ste naročeni:
Contact the hospital or clinic as soon as possible to re-schedule your appointment.
Čim prej se obrnite na bolnišnico ali ambulanto, da boste dobili drug datum.
Like all medicines, Macugen can have side effects although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Macugen neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most commonly reported side effects (occurring in more than one of 10 patients in clinical trials) are most probably caused by the injection procedure rather than the drug, and include: eye inflammation eye pain, increased pressure inside the eye, small marks on the eye surface (punctate keratitis), small particles or spots in your vision (vitreous floaters or opacities).
Med njimi so: vnetje očesa, bolečine v očesu, zvišan tlak v očesu, drobne poškodbe na površini očesa (točkasti keratitis), drobni delci ali pike v vidnem polju (mušice ali motnjave v steklovini).
Occasionally, an infection in the internal portion of the eye can occur after Macugen treatment in the next two weeks.
Občasno se lahko v dveh tednih po zdravljenju z zdravilom Macugen razvije okužba notranjega dela očesa.
The symptoms you might experience are described in Section 2 of this leaflet ("Take special care with Macugen").
Simptomi, ki se vam lahko pojavijo, so opisani v 2. poglavju tega navodila (“ Pri zdravljenju z zdravilom Macugen bodite posebno pozorni ”).
Please read Section 2.
Preberite 2. poglavje.
It tells you what to do if you have any of these symptoms.
V njem boste našli napotke za ravnanje v primeru, da se pojavi kateri od simptomov.
23 Other common eye side effects reported to be possibly caused by the drug or by the injection procedure include (occurring in more than one in 100 patients in clinical trials): blurred vision, visual disturbance, eye discomfort, decreased vision, increased sensitivity to light, appearance of flashing lights, bleeding that occurs around the eye (periorbital bleeding), bloodshot eye (conjunctival haemorrhage), disorder of the jelly portion inside the eye (vitreous disorder), such as displacement or tear (vitreous detachment), clouding of the lens (cataract), disorder of the surface of the eye (cornea),, swelling or inflammation of the eyelid, swelling of the area on the inside of the eyelid or the outer surface of the eye (conjunctiva), eye inflammation, tears, inflammation of the conjunctiva (conjunctivitis), dryness, eye discharge, eye irritation, itching of the eye, eye redness or enlargement of the pupil,
22 Med drugimi pogostimi očesnimi neželenimi učinki, za katere je opisano, da so morda posledica zdravila ali postopka injiciranja (in so se v kliničnih preskušanjih pojavili pri več kot 1 od 100 bolnikov), so: zamegljen vid, motnje vida, nelagodje v očesu, poslabšanje vida, večja občutljivost za svetlobo, bliskanje pred očmi, krvavitev v okolici očesa (periorbitalna krvavitev), krvavo oko (krvavitev v veznico), spremembe zdrizastega dela v očesni notranjosti (motnje steklovine), kot npr. odstop ali pretrganje (odstop steklovine), zamotnitev leče (katarakta), spremembe na površini očesa (roženici), oteklost ali vnetje veke, oteklost tkiva na notranji površini veke ali zunanji površini očesa (veznice), vnetje očesa, solzenje, vnetje veznice (konjunktivitis), suhost, izcedek iz očesa, draženje očesa, srbenje očesa, pordelost očesa ali razširjenost zenice.
Other common non-visual side effects reported to be possibly caused by the drug or by the injection procedure includes (occurring in more than one in 100 patients in clinical trials): headache or nasal discharge.
Druga pogosta neočesna neželena učinka, za katera je opisano, da sta morda posledica zdravila ali postopka injiciranja (in sta se v kliničnih preskušanjih pojavila pri več kot 1 od 100 bolnikov), sta glavobol ali izcedek iz nosu.
Uncommon eye side effects reported to be possibly caused by the drug or by the injection procedure include (occurring in less than one in 100 but more than one in 1000 patients in clinical trials): inflammation of your eye or of the outer surface of the eye, bleeding in the eye or the internal portion of the eye (vitreous), eye strain, inflammation of the central part of the surface of the eye (keratitis), small deposits on the eye or on the surface of the eye (cornea), deposits in the back of the eye, itching of the eyelids, disturbance in your eye’s reaction to the light (pupillary reflex impaired), small erosion on the central part of the surface of the eye (cornea), drooping eyelid, scar inside the eye (retinal scar), small lump on your eyelid due to inflammation (chalazion), decreased pressure inside the eye, injection site reaction, injection site vesicles, displacement or tear of a layer in the back of the eye (retina), disorder of the pupil, of the coloured part of the eye (iris), retinal artery occlusion, eversion of the eyelid, eye movement disorder, eyelid irritation, blood in your eye, discoloured eye, deposit eye, inflammation of the eye (iritis), optic nerve cupping, deformation of the pupil, occlusion of the vein at the back of the eye, discharge of inner jelly of the eye.
Med občasnimi očesnimi neželenimi učinki, za katere je opisano, da so morda posledica zdravila ali postopka injiciranja (in so se v kliničnih preskušanjih pojavili pri manj kot 1 od 100, a pri več kot 1 od 1. 000 bolnikov), so: vnetje očesa ali zunanje površine očesa, krvavitev v notranjosti očesa (steklovina), naprezanje očesa, vnetje osrednjega dela površine očesa (keratitis), majhni odložki na očesu ali površini očesa (roženici), odložki na zadnjem delu očesa, srbenje vek, moteno odzivanje očesa na svetlobo (okvara zeničnega refleksa), drobna razjeda na osrednjem delu površine očesa (roženice), povešenost veke, brazgotina v očesu (mrežnična brazgotina), zaradi vnetja nastala majhna zadebelina na veki (halazij), znižan tlak v očesu, reakcija na mestu injiciranja, mehurčki na mestu injiciranja, odstop ali pretrganje plasti na zadnji strani očesa (mrežnice), motnje zenice, obarvanega dela očesa (šarenice), zapora mrežnične arterije, izvihanje veke, moteno gibanje zrkla, draženje vek, kri v očesu, obarvanje očesa, odložki v očesu, vnetje šarenice (iritis), uvlek vidnega živca, deformiranost zenice, zapora vene v zadnjem delu očesa, zdrs očesne steklovine.
(occurring in less than one in 100 but more than one in 1000 patients in clinical trials): nightmare, depression, deafness, vertigo, palpitations, high blood pressure, dilatation of the aorta (the main blood vessel), inflammation of the higher respiratory tract, vomiting, indigestion, irritation and inflammation of the skin, hair colour changes, rash, itching night sweats, back pain, fatigue, shivering, tenderness, chest pain, sudden fever, generalised aches and pains, elevation of the liver enzymes, abrasion.
Med občasnimi neočesnimi neželenimi učinki, za katere je opisano, da so morda posledica zdravila ali postopka injiciranja (in so se v kliničnih preskušanjih pojavili pri manj kot 1 od 100, a pri več kot 1 od 1. 000 bolnikov), so: nočne more, depresija, naglušnost, vrtoglavica, razbijanje srca, visok krvni tlak, razširitev aorte (glavne telesne odvodnice), vnetje zgornjega dela dihal, bruhanje, prebavne težave, draženje in vnetje kože, spremembe barve las, izpuščaj, srbenje, nočno znojenje, bolečine v hrbtu, utrujenost, drgetanje, občutljivost, bolečine v prsih, nenadno zvišanje telesne temperature, generalizirane bolj ali manj izrazite bolečine, zvišanje jetrnih encimov, abrazija.
In some rare cases, serious allergic reaction has been reported soon after the injection.
V nekaj redkih primerih so poročali o hudih alergijskih reakcijah kmalu po injiciranju.
Please seek immediate medical help if you experience any of the following soon after the injection: sudden onset of breathing difficulty or wheezing, swollen mouth, face, hands or feet, itching skin, fainting, rapid pulse, stomach cramps, nausea, vomiting or diarrhoea.
Prosimo, nemudoma poiščite zdravniško pomoč, če boste kmalu po injiciranju doživeli: nenaden pojav težav z dihanjem ali sopenje, otekla usta, obraz, roke ali noge, srbenje, omedlevico, pospešen srčni utrip, trebušne krče, siljenje na bruhanje, bruhanje ali drisko.
If you notice other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Če opazite katerikoli neželen učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE MACUGEN
SHRANJEVANJE ZDRAVILA MACUGEN
Store in a refrigerator (2oC -8oC).
Shranjujte v hladilniku (2 °C in 8 °C).
Do not use after the expiry date stated which is on the label and carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
Medicines should not be disposed of via wastewater or household waste.
23 Zdravil ne smete zavreči v odpadne vode ali med gospodinjske odpadke.
What MACUGEN contains
Kaj vsebuje zdravilo MACUGEN
- The active substance is pegaptanib sodium.
- Zdravilna učinkovina je natrijev pegaptanib.
Each single dose pre-filled syringe delivers a dose of
Ena enoodmerna napolnjena injekcijska brizga
0.3 mg pegaptanib sodium.
vsebuje 0, 3 mg natrijevega pegaptaniba.
- The other ingredients are sodium chloride, monobasic sodium phosphate monohydrate, dibasic
- Pomožne snovi so natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat
sodium phosphate heptahydrate, sodium hydroxide, hydrochloric acid and water for injections.
heptahidrat, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
What MACUGEN looks like and contents of the pack
Izgled zdravila MACUGEN in vsebina pakiranja
Each pack contains a pouch in a carton, containing a 1 ml pre-filled syringe, Type I glass, sealed with an elastomeric plunger stopper and a pre-attached plunger rod, held by a plastic clip.
Potisni bat drži na mestu plastični zatič.
The syringe has a pre-attached polycarbonate plastic .luer lock adaptor and the tip is sealed with an elastomeric tip cap.
Injekcijska brizga ima že nameščen zaskočni nastavek „ luer lock “ iz polikarbonatne plastike, na vrhu pa je zaprta z gumijasto zaporko.
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich CT13 9NJ United Kingdom
Imetnik dovoljenja za promet z zdravilom Pfizer Limited Ramsgate Road Sandwich CT13 9NJ Velika Britanija
Manufacturer Pfizer Ireland Pharmaceuticals Pottery Road Dun Laoghaire Co Dublin Ireland
Izdelovalec Pfizer Ireland Pharmaceuticals Pottery Road Dun Laoghaire Co Dublin Irska
25 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Česká republika Pfizer s.r.o.
Malta Česká republika V. J.
Tel: + 356 21 22 01 74
Tel: + 356 21 22 01 74 Tel: +420 283 004 111
Deutschland Pfizer Pharma GmbH Tel: +49 (0) 30 550055 51000
24 Norge Deutschland Pfizer AS Pfizer Pharma GmbH Tlf: +47 67 52 61 00 Tel: +49 (0) 30 550055 51000
România Pfizer Romania S.R.L.
România France Pfizer Romania S. R. L.
Slovenija Pfizer Luxembourg SARL, Pfizer podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Slovenija Ireland Pfizer Luxembourg SARL, Pfizer, podružnica za Pfizer Healthcare Ireland svetovanje s področja farmacevtske dejavnosti, Tel:
Tel: + 386 (0)1 52 11 400
1800 633 363 (toll free) Ljubljana Tel: + 386 (0) 1 52 11 400 +44 (0) 1304 616161
Ísland Vistor hf Sími: +354 535 7000
Slovenská republika Ísland Pfizer Luxembourg SARL, organizačná zložka Vistor hf.
Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: +421-2-3355 5500
Tel: +421- 2- 3355 5500 Sími: +354 535 7000
26 Latvija Pfizer Luxembourg SARL, filiāle Latvijā Tel: +371 670 35 775
Latvija Pfizer Luxembourg SARL, Filiāle Latvijā Tel: +371 670 35 775
Lietuva Pfizer Luxembourg SARL, filialas Lietuvoje Tel. +3705 2514000
Lietuva Pfizer Luxembourg SARL, Filialas Lietuvoje Tel. +3705 2514000
This leaflet was last approved in Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /
Metalyse is a vial containing a white powder and a prefilled syringe containing a solvent, to make up a solution for injection.
Zdravilo Metalyse se dobi v obliki viale, ki vsebuje bel prašek, in napolnjene brizge, ki vsebuje vehikel za pripravo raztopine za injiciranje.
Metalyse contains the active substance tenecteplase.
Metalyse vsebuje zdravilno učinkovino tenekteplazo.
Metalyse is used in patients to dissolve the blood clots that have formed in the vessels of the heart in patients who are suspected of having had an acute myocardial infarction (heart attack).
Metalyse se uporablja za raztapljanje krvnih strdkov, ki so nastali v srčnih žilah pri bolnikih, za katere se sumi, da so imeli akutni miokardni infarkt (srčni napad).
Metalyse is used within 6 hours of the first symptoms of the heart attack.
Metalyse se daje v 6 urah po pojavu prvih simptomov srčnega napada.
Metalyse should be prescribed by doctors who have experience in the use of thrombolytic treatment.
Metalyse mora predpisati zdravnik, ki ima izkušnje s trombolitičnim zdravljenjem.
Treatment with Metalyse should be started as soon as possible after the start of heart attack symptoms.
Zdravljenje z zdravilom Metalyse moramo začeti čimprej po pojavu simptomov srčnega napada.
Metalyse is given as a single intravenous (into a vein) injection over about 10 seconds.
Metalyse vnesemo z eno intravensko injekcijo (v veno) v približno 10 sekundah.
The doses are adjusted according to the patient’ s weight (see the Package Leaflet).
Odmerek je treba prilagoditi glede na bolnikovo telesno maso (glejte Navodila za uporabo).
It is given with other medicines (aspirin, heparin) that prevent blood clots.
Daje se hkrati z drugimi zdravili (aspirin, heparin) za preprečevanje krvnih strdkov.
Metalyse is a thrombolytic (also known as a fibrinolytic, as it dissolves blood clots, which are made out of a substance called fibrin).
Metalyse je trombolitik (znan tudi kot fibrinolitik, saj raztaplja krvne strdke, zgrajene iz snovi, imenovane fibrin).
The active substance in Metalyse, tenecteplase, is a modified form of the natural enzyme, human plasminogen activator.
Zdravilna učinkovina v zdravilu Metalyse, tenekteplaza, je modificirana oblika naravnega encima, in sicer človeškega aktivatorja plazminogena.
It is made by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce it.
Proizvaja se po metodi, imenovani » tehnologija rekombinantne DNA «: encim proizvede celica, ki je prejela gen (DNA), s pomočjo katerega postane sposobna tvoriti encim.
Tenecteplase is a plasminogen activator, this means that it triggers the transformation of a substance (plasminogen) into plasmin.
Tenekteplaza je aktivator plazminogena, kar pomeni, da spodbuja pretvorbo plazminogena v plazmin.
Plasmin breaks up clots.
Plazmin je snov, ki razkraja strdke.
In myocardial infarction, clots have formed in the arteries to the heart.
Do miokardnega infarkta pride zaradi strdkov, nastalih v arterijah, ki vodijo do srca.
Metalyse dissolves the blood clots and helps restore the normal blood flow to the heart.
Zdravilo Metalyse raztaplja krvne strdke in pomaga pri vzpostavljanju normalnega pretoka krvi do srca.