natgillin/translations-raw huggingface dataset:
Preparation of a Refludan solution with a concentration of 2 mg/ ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ ml is needed: – Reconstitute two vials (each containing 50 mg of lepirudin) with 1 ml each using either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 2 mg/ ml is obtained by transfer of both solutions into one sterile, single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 50 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The infusion speed of the perfusor automate is to be set in a body weight-dependent fashion (see section 4.2). – The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
Priprava raztopine Refludana v koncentraciji 2 mg/ ml Za neprekinjeno intravensko infuzijo potrebujemo raztopino v koncentraciji 2 mg/ ml: – Uporabite dve viali s po 50 mg lepirudina; vsako od njih rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%). – Končno koncentracijo 2 mg/ mL dobimo s prenosom obeh raztopin v eno sterilno perfuzorsko brizgo za enkratno uporabo (s prostornino 50 ml) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/ mL (0, 9%) ali z raztopino 5% glukoze do skupnega volumna 50 ml. – Infuzijsko hitrost avtomatskega perfuzorja naravnamo v skladu s telesno maso bolnika (glejte poglavje 4. 2). – Brizgo perfuzorja je treba zamenjati najmanj vsakih 12 ur po nastavitvi infuzije.
EU/ 1/ 97/ 035/ 001 EU/ 1/ 97/ 035/ 002
EU/ 1/ 97/ 035/ 003 EU/ 1/ 97/ 035/ 004
REFLUDAN - 50 mg - Powder for solution for injection or infusion - 1 vial REFLUDAN - 50 mg - Powder for solution for injection or infusion - 10 vials
REFLUDAN - 50 mg - prašek za raztopino za injiciranje ali infundiranje – 1 viala REFLUDAN - 50 mg - prašek za raztopino za injiciranje ali infundiranje – 10 vial
CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Germany
CSL Behring GmbH Emil- von- Behring- Straße 76 35041 Marburg Nemčija
• CONDITIONS OR RESTRICTIONS WITH REGARD TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI IN OMEJITVE ZA VARNO IN UČINKOVITO UPORABO ZDRAVILA
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
23 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
OUTER CARTON:
ZUNANJA ZLOŽENKA:
20 mg x 1 VIAL
20 mg x 1 viala
Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution.
intravenska uporaba Eno vialo (20 mg lepirudina) rekonstituirajte z 0, 4 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%).
EXP {MM/ YYYY}
Uporabno do (MM/ LLLL)
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI
20 mg x 10 vials
20 mg x 10 vial
EXP {MM/ YYYY}
(MM/ LLLL)
VIAL LABEL:
NALEPKA NA VIALI:
Refludan 20 mg powder for solution for injection or infusion Lepirudin Intravenous use
Refludan 20 mg prašek za raztopino za injiciranje ali infundiranje lepirudin Intravenska uporaba
. Read the package leaflet before use
Pred uporabo preberite priloženo navodilo.
< EXP {MM/YYYY} >
(MM/ LLLL)
50 mg x 1 VIAL
50 mg x 1 viala
Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution.
Intravenska uporaba Eno vialo (50 mg lepirudina) rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%).
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI
50 mg x 10 vials
50 mg x 10 vial
Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution.
Eno vialo (50 mg lepirudina) rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%).
Justification for not including Braille accepted
PODATKI V V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
VIAL LABEL:
OZNAKA NA VIALI:
Refludan 50 mg powder for solution for injection or infusion Lepirudin Intravenous use.
Refludan, 50 mg prašek za raztopino za injiciranje ali infundiranje lepirudin Intravenska uporaba
Refludan 20 mg powder for solution for injection or infusion Lepirudin
Refludan 20 mg prašek za raztopino za injiciranje ali infundiranje Lepirudin
- If any of the side effects gets serious, or if you notice side effects not listed in this leaflet,
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
What Refludan is and what it is used for 2.
Kaj je Refludan in za kaj ga uporabljamo 2.
Before you use Refludan 3.
Kaj morate vedeti, preden boste uporabili Refludan 3.
How to use Refludan 4.
Kako uporabljati zdravilo Refludan 4.
Possible side effects 5 How to store Refludan 6.
Možni neželeni učinki 5 Shranjevanje zdravila Refludan 6.
It may result in a too low number of blood platelets and/ or clots in your blood vessels (thrombosis).
Posledica je lahko premajhno število trombocitov in/ ali strdki v krvnih žilah (tromboza).
BEFORE YOU USE REFLUDAN
KAJ MORATE VEDETI, PREDEN BOSTE UPORBILI ZDRAVILO REFLUDAN
Do not use Refludan
Ne uporabljajte zdravila Refludan:
- if you are allergic (hypersensitive) to lepirudin, to hirudins or any of the other ingredients of
- če ste alergični na (preobčutljivi za) lepirudin, hirudine ali katerokoli sestavino zdravila Refludan
Take special care with Refludan If you have a bleeding tendency, your doctor will weigh the risk of Refludan administration against its benefit.
35 Bodite posebej pozorni pri uporabi zdravila Refludan Če ste nagnjeni h krvavitvam, bo vaš zdravnik pretehtal tveganje, povezano z uporabo Refludana, v primerjavi z njegovimi koristmi.
Thus, please tell your doctor if you have or have had: – Recent puncture of large vessels or organs – Anomaly of vessels or organs – Recent stroke, accident or surgery involving the brain – High blood pressure – Inflammation of the inner membrane of the heart – Advanced kidney disease – Advanced bleeding tendency
Prosimo, povejte svojemu zdravniku, če imate ali ste imeli kaj od spodaj naštetega: – pred kratkim punkcijo večjih žil ali organov – nepravilnosti ožilja ali organov – pred nedavnim kap, nesrečo ali operacijo možganov – visok krvni tlak – vnetje osrčnika (notranje srčeve ovojnice) – napredovalo bolezen ledvic – večjo nagnjenost h krvavitvam – pred kratkim večji operativni poseg – pred kratkim krvavitev (npr. v možganih, želodcu, črevesu, očeh, pljučih) – očitne znake krvavitve – pred kratkim aktivno želodčno razjedo – starost nad 65 let.
Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Prosimo, povejte svojemu zdravniku ali farmacevtu, če jemljete ali ste v zadnjem času jemali katerakoli druga zdravila, tudi takšna, ki niso na recept.
Very common (at least 1 in 10 people) – Bleeding
Zelo pogosti (pojavijo se pri najmanj 1 od 10 ljudi)
Reported bleeding events include: anaemia or drop in the haemoglobin value without obvious source of bleeding, bruising, bleeding from puncture sites, nose bleeding, blood in urine, gastrointestinal bleeding, vaginal bleeding, rectal bleeding, pulmonary haemorrhage, bleeding into chest space and around the heart following surgery, bleeding into the brain.
Krvavitve, o katerih poročajo, vključujejo: anemijo ali padec vrednosti hemoglobina brez očitnega izvora krvavitve, podplutbe, krvavitve iz punkcijskih mest, krvavitve iz nosu, kri v urinu, krvavitve iz
Severe bleeding and, in particular, intracranial bleeding may be fatal.
36 prebavil, vaginalne krvavitve, rektalne krvavitve, pljučno hemoragijo, krvavitev v prsno votlino in okolico srca po operaciji, možganske krvavitve.
In intensified post-marketing surveillance in HIT type II, fatal bleeding was reported in 1% and intracranial bleeding in 0.2% of patients.
V intenzivnem postmarketinškem spremljanju bolnikov s HIT tipa II so poročali o pojavu usodnih krvavitev pri 1% in o pojavu intrakranialnih krvavitev pri 0, 2% bolnikov.
Severe bleeding may lead to decreased volume of circulating blood, low blood pressure, shock, and their clinical sequelae.
- alergijske kožne reakcije (vključno z izpuščajem), srbečica, navali vročine, zvišana telesna
Rare (less than 1 in 1,000 people affected) – Allergic skin reactions (including rash), itching, hot flushes, fever, chills.
- anafilaktične/ anafilaktoidne reakcije, vključno s koprivnico, težave z dihanjem (npr. spastični
36 – Anaphylactic/ oid reactions including urticaria, difficulty in breathing (e. g. consisting of spasms), cough, sharp sound when breathing, build-up of water in the body and in the inner wall of a vessel (including: face oedema, tongue oedema, throat oedema).
V hujših primerih lahko zaradi tega nastopi šok ali smrt.
In severe cases these may lead to shock and death. – Injection site reactions, including pain.
- reakcije na mestu injiciranja, vključno z bolečino.
Once reconstituted Refludan is to be used immediately.
Vso neuporabljeno raztopino je treba ustrezno zavreči.
What Refludan contains The active substance is lepirudin, a recombinant DNA product derived from yeast cells.
Kaj vsebuje zdravilo Refludan Zdravilna učinkovina je lepirudin, rekombinantni produkt DNA, pridobljen iz celic kvasovk.
What Refludan looks like and contents of the pack Refludan is a white powder for solution for injection or infusion supplied in a vial containing 20 mg lepirudin.
Izgled zdravila Refludan in vsebina pakiranja Refludan je bel prašek za raztopino za injiciranje ali infundiranje v viali, ki vsebuje 20 mg lepirudina.
Marketing Authorisation Holder Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom.
Imetnik dovoljenja za promet z zdravilom Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL 4 1NA, Združeno kraljestvo
Manufacturer CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Germany.
Izdelovalec CSL Behring GmbH, Emil- von- Behring- Straße 76, 35041 Marburg, Nemčija.
This leaflet was last approved on {date}
Navodilo je bilo odobreno {MM/ LL}
General recommendations – Reconstitution and further dilution must be carried out under sterile conditions. – For reconstitution water for injections or sodium chloride 9 mg/ ml (0.9%) solution are to be used. – For further dilution sodium chloride 9 mg/ ml (0.9%) or glucose 5% solutions are suitable. – For rapid, complete reconstitution, inject 0.4 ml of diluent into the vacuum vial and shake it gently.
Splošna priporočila – Rekonstituiranje in nadaljnje redčenje je treba izvajati v sterilnih pogojih. – Za rekonstitucijo se uporablja voda za injekcije ali raztopina natrijevega klorida 9 mg/ mL (0, 9%). – Za nadaljnje redčenje je primerna raztopina natrijevega klorida 9 mg/ mL (0, 9%) ali raztopina 5% glukoze. – Za hitro in popolno rekonstitucijo vbrizgajte 0, 4 mL vehikla v vakuumsko vialo in rahlo pretresite.
On reconstitution a clear, colourless solution is usually obtained within less than 3 minutes. – Do not use solutions which are cloudy or contain particles. – The reconstituted solution is to be used immediately. – The preparation should be warmed to room temperature before administration. – Any unused solution must be discarded appropriately. – For injection only polypropylene syringes may be used.
Ob rekonstituciji dobite prozorno, brezbarvno raztopino običajno v manj kot 3 minutah. – Ne uporabljajte raztopine, če je kalna ali če vsebuje delce. – Rekonstituirano raztopino je treba takoj uporabiti. – Pred uporabo je treba zdravilo ogreti do sobne temperature. – Vso neuporabljeno raztopino je treba ustrezno zavreči. – Za injiciranje se smejo uporabljati le polipropilenske brizge.
Preparation of a Refludan solution with a concentration of 5 mg/ ml For intravenous. bolus injection a solution with a concentration of 5 mg/ ml is needed: – Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 5 mg/ ml is obtained by transfer into a sterile, single-use syringe (of at least 5 ml capacity) and further dilution to a total volume of 4 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The final solution is to be administered in a body weight-dependent fashion.
Priprava raztopine Refludana v koncentraciji 5 mg/ ml Za intravensko bolusno injekcijo potrebujemo raztopino v koncentraciji 5 mg/ ml: – Eno vialo (20 mg lepirudina) rekonstituirajte z 0, 4 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%). – Končno koncentracijo 5 mg/ mL dobimo s prenosom v sterilno brizgo za enkratno uporabo (s prostornino najmanj 5 ml) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/ mL (0, 9%) ali z raztopino 5% glukoze do skupnega volumna 4 ml. – Končno raztopino moramo aplicirati v skladu s telesno maso bolnika.
Preparation of a Refludan solution with a concentration of 2 mg/ ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ ml is needed: – Reconstitute two vials (each containing 20 mg of lepirudin) with 0.4 ml each using either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 2 mg/ ml is obtained by transfer of both solutions into one sterile, single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 20 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The infusion speed of the perfusor automate is to be set in a body weight-dependent fashion. – The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
Priprava raztopine Refludana v koncentraciji 2 mg/ ml Za neprekinjeno intravensko infuzijo potrebujemo raztopino v koncentraciji 2 mg/ ml: – Uporabite dve viali s po 20 mg lepirudina; vsako od njih rekonstituirajte z 0, 4 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%). – Končno koncentracijo 2 mg/ mL dobimo s prenosom obeh raztopin v eno sterilno perfuzijsko brizgo za enkratno uporabo (s prostornino 50 ml) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/ mL (0, 9%) ali z raztopino 5% glukoze do skupnega volumna 20 ml. – Infuzijsko hitrost avtomatskega perfuzorja naravnamo v skladu s telesno maso bolnika. – Brizgo perfuzorja je treba zamenjati najmanj vsakih 12 ur po nastavitvi infuzije.
38 PACKAGE LEAFLET:
38 NAVODILO ZA UPORABO:
Refludan 50 mg powder for solution for injection or infusion Lepirudin
Refludan 50 mg prašek za raztopino za injiciranje ali infundiranje Lepirudin Pred uporabo natančno preberite navodilo.
What Refludan is and what it is used for 2.
Kaj je zdravilo Refludan in za kaj ga uporabljamo 2.
Before you use Refludan 3.
Kaj morate vedeti, preden boste uporabili zdravilo Refludan 3.
- if you are allergic (hypersensitive) to lepirudin, to hirudins or any of the other ingredients of
- če ste alergični na (preobčutljivi za) na lepirudin, hirudine ali katerokoli sestavino zdravila
Refludan.
Refludan
Thus, please tell your doctor if you have or have had: – Recent puncture of large vessels or organs – Anomaly of vessels or organs – Recent stroke, accident or surgery involving the brain – High blood pressure – Inflammation of the inner membrane of the heart – Advanced kidney disease – Advanced bleeding tendency
Prosimo, povejte svojemu zdravniku, če imate ali ste imeli kaj od spodaj naštetega: – pred kratkim punkcijo večjih žil ali organov – nepravilnosti ožilja ali organov – pred nedavnim kap, nesrečo ali operacijo možganov – visok krvni tlak – vnetje osrčnika (notranje srčeve ovojnice) – napredovalo bolezen ledvic – večjo nagnjenost h krvavitvam – pred kratkim večji operativni poseg – pred kratkim krvavitev (npr. v možganih, želodcu, črevesu, očeh, pljučih)
39 – Recent major surgery – Recent bleeding (e. g. in brain, stomach/ intestine, eye, lung) – Obvious signs of bleeding – Recent active peptic ulcer – Age > 65 years
39 – očitne znake krvavitve – pred kratkim aktivno želodčno razjedo – starost nad 65 let.
In intensified post-marketing surveillance in HIT type II, fatal bleeding was reported in 1% and intracranial bleeding in 0.2% of patients.
V intenzivne, postmarketinškem spremljanju bolnikov s HIT tipa II so poročali o pojavu usodnih krvavitev pri 1% in o pojavu intrakranialnih krvavitev pri 0, 2% bolnikov.
40 – Anaphylactic/ oid reactions including urticaria, difficulty in breathing (e. g. consisting of spasms), cough, sharp sound when breathing, build-up of water in the body and in the inner wall of a vessel (including: face oedema, tongue oedema, throat oedema).
V hujših primerih lahko zaradi tega nastopi šok ali smrt.
Do not use Refludan if the reconstituted solution is cloudy or contains particles.
Zdravila ne uporabljajte po datumu izteka roka uporabnosti, ki je označen na škatli in na viali.
Once reconstituted Refludan is to be used immediately.
Če je rekonstituirana raztopina Refludana motna ali če vsebuje delce, je ne uporabite.
What Refludan contains The active substance is lepirudin, a recombinant DNA product derived from yeast cells.
Kaj vsebuje zdravilo Refludan Aktivna učinkovina je lepirudin, rekombinantni produkt DNA, pridobljen iz celic kvasovk.
What Refludan looks like and contents of the pack Refludan is a white powder for solution for injection or infusion supplied in a vial containing 50 mg lepirudin.
Izgled zdravila Refludan in vsebina pakiranja Refludan je bel prašek za raztopino za injiciranje ali infundiranje v viali, ki vsebuje 50 mg lepirudina.
Marketing Authorisation Holder Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL 4 1NA, Združeno kraljestvo
General recommendations – Reconstitution and further dilution must be carried out under sterile conditions. – For reconstitution water for injections or sodium chloride 9 mg/ ml (0.9%) solution are to be used. – For further dilution sodium chloride 9 mg/ ml (0.9%) or glucose 5% solutions are suitable. – For rapid, complete reconstitution, inject 1 ml of diluent into the vacuum vial and shake it gently.
Splošna priporočila – Rekonstituiranje in nadaljnje redčenje je treba izvajati v sterilnih pogojih. – Za rekonstitucijo se uporablja voda za injekcije ali raztopina natrijevega klorida 9 mg/ mL (0, 9%). – Za nadaljnje redčenje je primerna raztopina natrijevega klorida 9 mg/ mL (0, 9%) ali raztopina 5% glukoze. – Za hitro in popolno rekonstitucijo vbrizgajte 1 mL vehikla v vakuumsko vialo in rahlo pretresite.
Preparation of a Refludan solution with a concentration of 5 mg/ ml For intravenous. bolus injection a solution with a concentration of 5 mg/ ml is needed: – Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 5 mg/ ml is obtained by transfer into a sterile, single-use syringe (of at least 10 ml capacity) and further dilution to a total volume of 10 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The final solution is to be administered in a body weight-dependent fashion.
Priprava raztopine Refludana v koncentraciji 5 mg/ mL Za intravensko bolusno injekcijo potrebujemo raztopino v koncentraciji 5 mg/ mL: – Eno vialo (50 mg lepirudina) rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%). – Končno koncentracijo 5 mg/ mL dobimo s prenosom v sterilno brizgo za enkratno uporabo (s prostornino najmanj 10 mL) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/ mL (0, 9%) ali z raztopino 5% glukoze do skupnega volumna 10 mL. – Končno raztopino moramo aplicirati v skladu s telesno maso bolnika.
Preparation of a Refludan solution with a concentration of 2 mg/ ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ ml is needed: – Reconstitute two vials (each containing 50 mg of lepirudin) with 1 ml each using either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 2 mg/ ml is obtained by transfer of both solutions into one sterile, single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 50 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The infusion speed of the perfusor automate is to be set in a body weight-dependent fashion. – The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
Priprava raztopine Refludana v koncentraciji 2 mg/ mL Za neprekinjeno intravensko infuzijo potrebujemo raztopino v koncentraciji 2 mg/ mL: – Uporabite dve viali s po 50 mg lepirudina; vsako od njih rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/ mL (0, 9%). – Končno koncentracijo 2 mg/ mL dobimo s prenosom obeh raztopin v eno sterilno perfuzijsko brizgo za enkratno uporabo (s prostornino 50 mL) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/ mL (0, 9%) ali z raztopino 5% glukoze do skupnega volumna 50 mL. – Infuzijsko hitrost avtomatskega perfuzorja naravnamo v skladu s telesno maso bolnika. – Brizgo perfuzorja je treba zamenjati vsaj vsakih 12 ur po začetku infuzije.
Regranex is a clear colourless to straw-coloured gel, which contains 0.01% of the active substance becaplermin.
Zdravilo Regranex je bister in brezbarven do rumenkast gel, ki vsebuje 0, 01% zdravilne učinkovine bekaplermin.
Regranex is used together with other wound care measures to help granulation (healing of skin tissue) of long term, diabetic ulcers less than or equal to 5 cm2 (people with diabetes have a higher risk of developing skin ulcers).
Zdravilo Regranex se uporablja skupaj z drugimi ukrepi za nego ran za spodbujanje nastajanja granulacijskega tkiva (celjenja tkiva kože) kroničnih diabetičnih razjed, ki imajo površino manjšo ali enako 5 cm2.
Regranex is used in neuropathic ulcers: these are ulcers due to a nerve problem, and not to a problem with the blood supply to the area affected.
Zdravilo Regranex se uporablja za nevropatske razjede (to so razjede zaradi težav z živci in ne zaradi oteženega dotoka krvi v prizadeto področje).
Regranex should be applied as a layer to the entire ulcer(s) once daily using a clean application aid, such as a cotton swab.
Zdravilo Regranex nanesemo v plasti na celotno področje razjed( e) enkrat dnevno s čistim pripomočkom za nanašanje, npr. vatirano palčko.
The site(s) should then be covered by a moist saline gauze dressing (not an occlusive dressing).
Mesto( a) nanosa gela potem prekrijemo z mokrim obkladkom iz gaze, namočene v fiziološko raztopino (ne smemo uporabljati okluzivnega povoja).
Regranex should not be used for more than 20 weeks, and should always be used alongside other measures that promote the healing of ulcers, such as keeping the ulcer clean and not applying any pressure onto it while it is healing.
Zdravila REGRANEX ne smemo uporabljati dlje kot 20 tednov in vedno skupaj z drugimi ukrepi za pospeševanje celjenja razjed, kot so redno čiščenje razjede in neobremenjevanje področja med zdravljenjem.
Regranex contains becaplermin, a recombinant human Platelet Derived Growth Factor-BB (rhPDGF- BB).
Zdravilo Regranex vsebuje bekaplermin, rekombinantni človeški rastni faktor iz trombocitov- BB (rhPDGF- BB).
Growth Factors are proteins that can stimulate cells to make them multiply.
Rastni faktorji so beljakovine, ki spodbujajo razmnoževanje celic.
Platelet-Derived Growth Factors act on cells that are involved in wound repair.
Rastni faktorji iz trombocitov delujejo na celice, ki sodelujejo pri celjenju ran.
The active ingredient of Regranex, becaplermin, is produced by a method known as ‘ recombinant DNA technology’.
Zdravilna učinkovina zdravila Regranex je bekaplermin, ki je izdelan z metodo, imenovano „ tehnologija rekombinantne DNA “.
The becaplermin is made by a yeast that has received a gene (DNA), which makes it able to produce human Platelet Derived Growth Factor-BB.
Bekaplermin izdela kvasovka, ki je prejela gen (DNA), s katerim lahko tvori človeški rastni faktor iz trombocitov - BB.