natgillin/translations-raw huggingface dataset:
Becaplermin acts like the natural growth factor, it stimulates cell growth and helps the growth of normal tissue for healing.
Bekaplermin deluje kot naravni rastni faktor in pospešuje rast celic ter pripomore pri rasti normalnega tkiva za celjenje.
Regranex has been studied in 4 clinical trials, lasting 20 weeks, in diabetic adults who had been suffering from at least one diabetic ulcer for at least 8 weeks (total number of ulcers:
Opravljena so bila pri odraslih bolnikih s sladkorno boleznijo, ki so imeli najmanj eno diabetično razjedo najmanj 8 tednov (skupno število razjed:
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V raziskavi so primerjali zdravilo Regranex s placebom (navideznim 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 14 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Regranex shown during the studies?
Glavno merilo učinkovitosti je bilo popolna zacelitev razjed.
When the results of all four studies were analysed together, Regranex was showed to heal about 10% more ulcers after 20 weeks than a placebo gel.
Skupna analiza rezultatov vseh štirih raziskav je pokazala, da se z zdravilom Regranex po 20 tednih zaceli približno 10% več razjed kot z uporabo placebo gela.
Regranex healed 47% of the ulcers that were less than 5 cm2, when the percentage healed using either a placebo gel, or no treatment, were 35 and 30%, respectively.
Z uporabo zdravila Regranex se je zacelilo 47% razjed, ki so bili manjše od 5 cm2, v primerjavi s 35% zaceljenih razjed, ki so bile zdravljene le s placebo gelom in 30% zaceljenih razjed, ki niso bile zdravljene.
The following side effects have been reported in clinical trials: infection, skin ulceration, erythema (redness of the skin) and pain.
V kliničnih preizkušanjih so zabeležili naslednje neželene učinke: okužba, kožne razjede, eritem (pordelost) in bolečine.
These are not clearly related to treatment with Regranex.
Navedeni učinki niso jasno povezani z zdravljenjem z zdravilom Regranex.
Rarely, treatment with Regranex has been associated with bullous eruption (blisters), oedema (swelling) and hypertrophic granulation (excessive production of tissue during healing).
V redkih primerih je bilo zdravljenje z zdravilom Regranex povezano z žulji, edemom (oteklino) in hipertrofično granulacijo (čezmerno nastajanje tkiva med celjenjem).
Regranex should not be used in people who may be hypersensitive (allergic) to becaplermin or to any of the other ingredients, and it should not be applied on or near skin cancers.
Zdravila Regranex se ne sme nanašati na ali v bližino kožnega raka.
The Committee for Medicinal Products for Human Use (CHMP) decided that Regranex’ s benefits are greater than its risks to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers ≤ 5 cm2.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so za spodbujanje nastajanja granulacijskega tkiva in s tem celjenje globokih, nevropatskih, kroničnih, diabetičnih razjed ≤ 5 cm2 koristi zdravila Regranex večje od z njim povezanih tveganj.
They recommended that Regranex be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Regranex.
The European Commission granted a marketing authorisation valid throughout the European Union, for Regranex to Janssen-Cilag International N. V on 29 March 1999.
Evropska Komisija je dovoljenje za promet z zdravilom Regranex, veljavno po vsej Evropski uniji, odobrila družbi Janssen- Cilag International N. V dne 29. marca 1999.
The marketing authorisation was renewed on 29 March 2004.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 29. marca 2004.
The full EPAR for Regranex is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Regranex je na voljo tukaj.
EU Number
< vsebina
Invented name
>
Route of Administration
velikost pakiranja
Cutaneous use
za dermalno
15 g
tuba za večkratno 15 g
1
1 tuba
REGRANEX contains100 µg of becaplermin per gram of gel.
Zdravilo REGRANEX vsebuje 100 μg bekaplermina na gram gela.
Becaplermin is a recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB).
Bekaplermin je rekombinantni humani rastni faktor iz trombocitov- BB (rhPDGF- BB).
It is produced by insertion of the gene for the B chain of human platelet derived growth factor into the yeast, Saccharomyces cerevisiae. rhPDGF-BB is a dimeric protein with a molecular weight of approximately 24,500 daltons.
Izdelujejo ga z vstavljanjem gena za verigo B humanega rastnega faktorja iz trombocitov v kvasovko Saccharomyces cerevisiae. rhPDGF- BB je dimerni protein z molekulsko maso približno 24. 500 daltonov.
For excipients, see 6.1.
Za pomožne snovi glejte poglavje 6. 1.
REGRANEX is a clear colourless to straw-coloured preserved gel.
Zdravilo REGRANEX je bister in brezbarven do rumenkast gel s konzervansom.
REGRANEX should always be used in conjunction with good wound care consisting of initial debridement (to remove all the necrotic and/ or infected tissue), additional debridement as necessary and a non-weight-bearing regimen to alleviate pressure on the ulcer.
Zdravilo REGRANEX vedno uporabljajte skupaj z ukrepi pravilne nege ran, ki sestojijo iz začetnega čiščenja rane (za odstranjevanje vsega nekrotičnega in/ ali okuženega tkiva), dodatnega čiščenja rane po potrebi ter neobremenjevanja uda za zmanjšanje pritiska na ulkus.
Wound-related infection should be identified and treated with appropriate antimicrobial therapy prior to the use of REGRANEX.
Okužbe ran morate ugotoviti in zdraviti z ustrezno antimikrobno terapijo še pred uporabo zdravila REGRANEX.
REGRANEX should be applied as a continuous thin layer to the entire ulcerated area(s) once daily using a clean application aid.
Zdravilo REGRANEX nanesite v neprekinjeni tanki plasti na celotno področje ulkusa( ov) enkrat na dan, z uporabo čistega pripomočka za nanašanje.
The site(s) of application should then be covered by a moist saline gauze dressing that maintains a moist wound-healing environment.
Mesto( a) nanosa gela potem prekrijte z mokrim obkladkom iz gaze, namočene v fiziološko raztopino, ki bo ohranjal vlažno okolje za boljše celjenje rane.
REGRANEX should not be used for more than 20 weeks in any individual patient.
Pri posameznem bolniku zdravila REGRANEX ne smete uporabljati dlje kot 20 tednov.
2 REGRANEX is not intended for repeated use.
2 Zdravilo REGRANEX ni namenjeno večkratni uporabi.
REGRANEX has not been studied in children.
Uporabe zdravila REGRANEX niso raziskovali pri otrocih.
- Known hypersensitivity to the active substance or to any of the excipients of this product.
- Znana preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov zdravila,
- Known neoplasm(s) at or near the site(s) of application.
- znane neoplazme na ali v bližini mesta nanosa gela,
(See section 4.4).
- pri bolnikih s klinično okuženimi ulkusi (glejte poglavje 4. 4).
Safety and effectiveness in children and adolescents below the age of 18 years have not been established.
Varnosti in učinkovitosti zdravila pri otrocih in mladostnikih, mlajših od 18 let, še niso ugotovili.
In view of the lack of data, REGRANEX should be used with caution in patients with known malignancies.
Zaradi pomanjkanja podatkov morate zdravilo REGRANEX uporabljati previdno pri bolnikih z znano maligno boleznijo.
Infection should be treated prior to the use of REGRANEX.
Pred uporabo zdravila REGRANEX je treba okužbo ulkusa pozdraviti.
If a wound becomes infected during REGRANEX therapy, the product should be discontinued until the infection has cleared.
Če se rana okuži med zdravljenjem z zdravilom REGRANEX, je treba zdravljenje prekiniti, pozdraviti okužbo ter šele nato ponovno uvesti zdravilo REGRANEX.
There are insufficient data to support safe use of the product for more than 20 weeks (see 5.1 Pharmacodynamic properties).
Podatki, ki bi potrjevali varno uporabo zdravila dlje kot 20 tednov, so nezadostni (glejte poglavje 5. 1 Farmakodinamične lastnosti).
Consequently, it is recommended that REGRANEX should not be applied to the ulcer site in conjunction with other topical medications.
Ni znano, ali zdravilo REGRANEX medsebojno deluje z drugimi lokalnimi zdravili, nanesenimi na mesto ulkusa, zato priporočamo, da zdravila REGRANEX ne nanašate na ulkus skupaj z drugimi zdravili za lokalno uporabo.
Therefore, REGRANEX should not be used in pregnant women.
Študije pri nosečih ženskah niso bile opravljene, zato zdravila REGRANEX ne smete uporabljati pri nosečih ženskah.
Nursing mothers
Doječe matere
Therefore, REGRANEX should not be used in nursing mothers.
Ni znano, ali se bekaplermin izloča v materino mleko pri človeku, zato zdravila REGRANEX ne smete uporabljati pri doječih materah.
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience.
Naslednji seznam neželenih reakcij temelji na podatkih iz kliničnih preskušanj in postmarketinških izkušnjah.
3 Adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100); rare (> 1/10,000, < 1/ 1000); very rare (< 1/10 ,000).
Pogostnost neželenih učinkov je opredeljena, kot sledi: zelo pogosti (> 1/ 10); pogosti (> 1/ 100, < 1/ 10); občasni (> 1/ 1. 000, < 1/ 100); redki (> 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000).
Serious adverse reactions reported in clinical trials.
Resne neželene reakcije o katerih so poročali v kliničnih preskušanjih.
The following adverse reactions were reported in the randomised clinical trials of REGRANEX therapy:
V randomiziranih kliničnih preskušanjih z zdravilom REGRANEX so poročali o naslednjih neželenih reakcijah:
Infection (very common), osteomyelitis (common), cellulitis (very common), skin ulceration (very common), skin disorder (including erythema) (common), and pain (common).
Okužbe (zelo pogosto), osteomielitis (pogosto), celulit (zelo pogosto), kožni ulkus (zelo pogosto), kožne bolezni (vključno z eritemom) (pogosto), in bolečina (pogosto).
Bullous eruption and oedema were reported rarely.
Redko so poročali o buloznem izpuščaju in edemu.
Serious adverse reactions based on postmarketing experience.
Resne neželene reakcije o katerih so poročali v postmarketinškem obdobju.
Rare cases of hypertrophic granulation have been reported.
Poročali so o redkih primerih hipertrofičnih granulacij.
Since absorption is insignificant from the site of topical application, no untoward systemic events are expected.
Ker je absorpcija zdravila z mesta lokalnega nanosa neznatna, ni pričakovati nikakršnih neželenih sistemskih dogodkov.
Preparation for treatment of wounds and ulcers, ATC code:
Zdravila za oskrbo ran in ulkusov, oznaka ATC:
REGRANEX contains becaplermin, a recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB).
Zdravilo REGRANEX vsebuje bekaplermin, rekombinantni humani rastni faktor iz trombocitov- BB (rhPDGF- BB).
From data combined from 4 clinical trials conducted over a 20 week treatment phase for ulcers of baseline surface area less than or equal to 5 cm2, 47% of ulcers treated with becaplermin 100 µg/ g gel completely healed, compared to 35% which were treated with placebo gel alone.
Na podlagi zbranih podatkov iz 4 kliničnih preskušanj, ki so bila opravljena v 20- tedenski fazi zdravljenja ulkusov z začetno površino manj kot ali enako 5 cm2, se je popolnoma zacelilo 47% ulkusov, zdravljenih z bekaplerminom v odmerku 100 μg/ g gela, v primerjavi s 35% ulkusov, ki so bili zdravljeni le s placebo gelom.
Since becaplermin is a growth factor, which stimulates the proliferation of cells, it must be cautiously used in patients with malignancies.
Ker je bekaplermin rastni faktor, ki spodbuja proliferacijo celic, ga morate previdno uporabljati pri bolnikih z malignimi boleznimi.
Clinical absorption studies were conducted in patients with a mean diabetic ulcer area of 10.5 cm² (range 2.3 - 43.5 cm²).
Klinične študije absorpcije so bile opravljene pri bolnikih s srednjo vrednostjo površine diabetičnega ulkusa 10, 5 cm² (razpon od 2, 3 do 43, 5 cm²).
Following 14 consecutive daily topical applications of REGRANEX, only insignificant systemic absorption of becaplermin occurred.
Po 14 zaporednih vsakodnevnih nanašanjih gela REGRANEX na ulkuse je prišlo le do neznatne sistemske absorpcije bekaplermina.
4 5.3 Preclinical safety data
4 5. 3 Predklinični podatki o varnosti
Since absorption is insignificant from the site of topical application in man, carcinogenesis and reproductive toxicity studies have not been conducted with REGRANEX.
Ker je absorpcija zdravila REGRANEX z mesta nanosa pri človeku neznatna, študije kancerogenosti in vpliva na sposobnost razmnoževanja niso bile opravljene.
However, skin tumours have not been reported in the clinical trials at the site of application or in close proximity.
V procesu celjenja rane bekaplermin inducira celično proliferacijo, vendar v kliničnih preskušanjih niso poročali o kožnih tumorjih na mestu nanašanja zdravila ali v njegovi bližini.
In a preclinical study designed to determine the effects of PDGF on exposed bone, rats injected at the metatarsals with 3 or 10 µg/ site (concentration of 30 or 100 µg/ ml/ site) of becaplermin every other day for 13 days displayed histological changes indicative of accelerated bone remodelling consisting of periosteal hyperplasia and subperiosteal bone resorption and exostosis.
Pri podganah so potem opazili histološke spremembe, ki kažejo na pospešeno pregradnjo kosti, s hiperplazijo periosta, resorpcijo kosti pod periostom in eksostozami.
Preclinical absorption studies through full-thickness wounds were conducted in rats with a wound area of 1.4 - 1.6 cm².
Predklinična preskušanja absorpcije zdravila skozi rane, ki segajo skozi vso debelino kože, so bila opravljena pri podganah s površino rane od 1, 4 do 1, 6 cm².
carmellose sodium (E466) sodium chloride sodium acetate glacial acetic acid (E260) methyl parahydroxybenzoate (methylparaben) (E218) propyl parahydroxybenzoate (propylparaben) (E216) m-cresol lysine hydrochloride water for injections
natrijev karmelozat (E466) natrijev klorid natrijev acetat koncentrirana ocetna kislina (ledocet) (E260) metilparahidroksibenzoat (metilparaben) (E218) propilparahidroksibenzoat (propilparaben) (E216) m- krezol lizinijev klorid voda za injekcije
REGRANEX is supplied in 15 g laminated polyethylene-lined multidose tubes.
Zdravilo REGRANEX je na voljo v 15 g laminiranih, s polietilenom obloženih tubah za večkratno odmerjanje.
5
5 6. 6 Navodila za pripravo in ravnanje z zdravilom in odlaganje
- A tube of REGRANEX should be used on a single patient only.
- Posamezno tubo zdravila REGRANEX smete uporabiti le za zdravljenje enega bolnika.
- The use of a clean application aid is recommended and contact with other parts of the body should
- Priporočamo uporabo čistega pripomočka za nanašanje gela in pri tem se morate izogibati stiku z
be avoided.
drugimi deli telesa.
- Before each application, the ulcer should be gently rinsed with saline or water to remove residual
- Pred vsakim nanosom gela ulkus previdno sperite s fiziološko raztopino ali vodo, da z njega
gel.
odstranite preostali gel.
- After treatment is completed, any unused gel should be discarded.
- Po zaključku zdravljenja neporabljen gel zavrzite.
JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg, 30 B-2340 Beerse Belgium
JANSSEN- CILAG INTERNATIONAL NV Turnhoutseweg, 30 B- 2340 Beerse Belgija
NUMBER IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
ŠTEVILKA DOVOLJENJA ZA PROMET
March 29, 1999/ March 31, 2004
29. marec 1999 / 31. marec 2004
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Imetnik tega dovoljenja za promet z zdravilom mora obvestiti evropsko komisijo o marketinškem načrtu za zadevno zdravilo.
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
REGRANEX 0.01% gel becaplermin
REGRANEX 0, 01% gel bekaplermin
100 microgram / g gel becaplermin
100 mikrogramov bekaplermina na gram gela
Contains carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), m-cresol, lysine hydrochloride and water for injections.
Vsebuje natrijev karmelozat (E466), natrijev klorid, natrijev acetat, koncentrirano ocetno kislino (ledocet) (E260), metilparahidroksibenzoat (metilparaben) (E218), propil parahidroksibenzoat (propilparaben) (E216), m- krezol, lizinijev klorid in vodo za injekcije.
Multidose tube containing 15 gram of gel
Tuba za večkratno odmerjanje s 15 grami gela
For cutaneous use only
Le za dermalno uporabo
Batch No.
Serija:
Read the package leaflet before use Use within 6 weeks after first opening
Zdravilo porabite v 6 tednih po prvem odpiranju.
Contains carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), m-cresol, lysine hydrochloride and water for injections.
Vsebuje natrijev karmelozat (E466), natrijev klorid, natrijev acetat, koncentrirano ocetno kislino (ledocet) (E260), metilparahidroksibenzoat (metilparaben) (E218), propilparahidroksibenzoat (propilparaben) (E216), m- krezol, lizinijev klorid in vodo za injekcije.
For cutaneous use only
Le za kutano uporabo
Date
Uporabno do:
Store in a refrigerator (2°C - 8°C) Do not freeze Close tightly after each use
Po vsaki uporabi tubo tesno zaprite.
Please read this leaflet carefully because it contains important information about your medicine.
Morda ga boste želeli ponovno prebrati.
If there is anything that you do not understand or if you need further information or advice, you should ask your doctor or your pharmacist who will have more details.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
What REGRANEX is and what it is used for 2.
Kaj je zdravilo REGRANEX in za kaj ga uporabljamo 2.
Before you use REGRANEX 3.
Kaj morate vedeti, preden boste uporabili zdravilo REGRANEX 3.
How to use REGRANEX 4.
Kako uporabljati zdravilo REGRANEX 4.
Storing REGRANEX 6.
Shranjevanje zdravila REGRANEX 6.
REGRANEX 0.01% Gel Becaplermin
REGRANEX 0, 01% gel bekaplermin
The active substance in REGRANEX is becaplermin.
Zdravilna učinkovina v zdravilu REGRANEX je bekaplermin.
Each gram of REGRANEX contains 100 micrograms of becaplermin.
Vsak gram zdravila REGRANEX vsebuje 100 mikrogramov bekaplermina.
The other ingredients are: carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), m-cresol, lysine hydrochloride and water for injections.
Pomožne snovi so: natrijev karmelozat (E466), natrijev klorid, natrijev acetat, koncentrirana ocetna kislina (ledocet) (E260), metilparahidroksibenzoat (metilparaben) (E218), propilparahidroksibenzoat (propilparaben) (E216), m- krezol, lizinijev klorid in voda za injekcije.
JANSSEN PHARMACEUTICA NV Turnhoutseweg, 30 B-2340 Beerse Belgium
JANSSEN PHARMACEUTICA NV Turnhoutseweg, 30 B- 2340 Beerse Belgija
Becaplermin is a human recombinant Platelet Derived Growth Factor (rhPDGF), which helps the growth of normal tissue in order to heal ulcers.
Bekaplermin je humani rekombinantni rastni faktor iz trombocitov (rhPDGF), ki pomaga pri rasti normalnih tkiv za boljše celjenje razjed.
REGRANEX is a clear colourless to straw-coloured non-sterile preserved gel and is filled in multidose tubes containing 15 grams.
Zdravilo REGRANEX je bister in brezbarven do rumenkast nesterilen gel s konzervansom, ki je napolnjen v tube za večkratno odmerjanje, po 15 gramov gela na tubo.
REGRANEX is used in association with other good wound care measures to promote the healing of skin ulcers that measure less than or equal to 5 square centimetres which are due to complications of diabetes and have adequate blood supply.
Zdravilo REGRANEX se uporablja skupaj z drugimi ukrepi pravilne oskrbe ran za spodbujanje celjenja kožnih razjed s površino, manjšo ali enako 5 kvadratnim centimetrom, ki nastanejo kot posledica zapletov sladkorne bolezni in so zadostno prekrvljene.
By using REGRANEX, it is more likely that your ulcers will heal completely and that the time needed for your ulcers to heal will be reduced.
Z uporabo zdravila REGRANEX povečamo verjetnost, da se bodo vaše kožne razjede popolnoma zacelile in skrajšamo čas, ki je potreben za zacelitev razjed.
BEFORE YOU USE REGRANEX
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO REGRANEX
Do not to use REGRANEX:
Ne uporabljajte zdravila REGRANEX:
- If you are allergic to the active substance or to the other ingredients of REGRANEX.
- če ste preobčutljivi za (alergični na) učinkovino ali katerokoli drugo sestavino zdravila
- If you have a skin tumour at or near the site of application of REGRANEX.
REGRANEX,
- If your ulcer is infected.
- če imate kožni tumor na mestu nanašanja zdravila REGRANEX ali blizu njega,
Should your wound become infected during the use of REGRANEX,
- če je razjeda okužena – če se razjeda okuži med uporabo zdravila REGRANEX, ga prenehajte
the product should be discontinued until the infection has cleared.
uporabljati, dokler ne bo okužba ozdravljena,
- If your ulcer is larger than 5 square centimetres
- če je razjeda večja od 5 kvadratnih centimetrov.
- Special warning
- Posebno opozorilo
You should inform your doctor if you have any malignant condition(s).
Obvestite svojega zdravnika, če imate katero od rakavih bolezni.
- Pregnancy and breast-feeding
- Nosečnost in dojenje
REGRANEX should not be used by pregnant women or by nursing mothers.
Zdravila REGRANEX ne smejo uporabljati noseče ženske ali doječe matere.
- Children and the elderly
- Otroci in starostniki
REGRANEX has not been tested in children under the age of 18.
Zdravilo REGRANEX ni bilo preizkušeno pri otrocih, mlajših od 18 let.
There are no special instructions necessary for the elderly.
Posebna navodila za starostnike niso potrebna.
- Other medicines
- Uporaba drugih zdravil
You should not apply other topical medicines on your ulcer while using REGRANEX.
Med uporabo zdravila REGRANEX na razjedo ne smete nanašati drugih zdravil za lokalno uporabo.
Only saline sodium chloride solution or water should be used to clean the ulcer.
Za čiščenje razjede smete uporabljati le fiziološko raztopino natrijevega klorida ali vodo.
- Driving and operating machinery
- Vpliv na sposobnost upravljanja vozil in strojev
Please observe these instructions for use, in order to fully benefit from REGRANEX
Natančno upoštevajte zdravnikova navodila, da boste imeli kar največje koristi od zdravljenja z zdravilom REGRANEX.
Before treatment with REGRANEX, your ulcer should be cleaned.
Pred zdravljenjem z zdravilom REGRANEX mora biti razjeda očiščena.
It is very important to make sure that you also take very good care of your ulcers while using REGRANEX to help them heal quickly and as fully as possible.
Zelo je pomembno, da zagotovite tudi pravilno nego razjed med uporabo zdravila REGRANEX, da bi pomagali k njihovemu hitremu in čimbolj popolnemu celjenju.
If you experience signs of infection of the ulcer (e. g. redness, swelling, fever, pain, odour), you should consult your doctor immediately for specific treatment.
Če opazite znake okužbe razjede (npr. pordelost, otekanje, zvišano telesno temperaturo, bolečino ali vonj), se nemudoma posvetujte s svojim zdravnikom, da vam predpiše ustrezno zdravljenje.
You should not apply pressure or walk on the ulcer during treatment and should closely follow your doctor’ s advice on proper care of the ulcer together with other measures that may be needed to relieve pressure from your ulcer.
Med zdravljenjem na razjedo ne smete pritiskati ali hoditi po njej in morate natančno upoštevati zdravnikova navodila glede pravilne nege razjed, skupaj z drugimi ukrepi, ki bodo morda potrebni za zmanjšanje pritiska na razjedo.