natgillin/translations-raw huggingface dataset:
By using REGRANEX, it is more likely that your skin ulcers will heal quickly and completely.
Z uporabo zdravila REGRANEX povečamo verjetnost, da se bodo vaše kožne razjede hitro in popolnoma zacelile.
1 year.
1 leto
Novartis Pharmaceuticals Corporation (Novartis NPC)., 2010 Cessna Drive, Vacaville, CA 95688, USA.
ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca biološke zdravilne učinkovine Novartis Pharmaceuticals Corporation (Novartis NPC)., 2010 Cessna Drive, Vacaville, CA 95688, ZDA.
• If your ulcer is larger than 5 square centimetres (see diagram above)
• če je razjeda večja od 5 kvadratnih centimetrov (glejte zgornji diagram),
- The tip of the tube should not come into contact with the wound or any other surface.
- Vrh tube ne sme priti v stik z rano ali katerokoli drugo površino.
It contains a substance called becaplermin.
Vsebuje učinkovino, ki se imenuje bekaplermin.
• If your ulcer is infected
• če je razjeda okužena,
Do not use REGRANEX:
Ne uporabljajte zdravila REGRANEX:
Pharmacotherapeutic group: Preparation for treatment of wounds and ulcers, ATC code: D 03 AX06
Farmakoterapevtska skupina: Zdravila za oskrbo ran in razjed oznaka ATC: D03AX06
Stop using REGRANEX and tell your doctor straight away if you notice or suspect the following:
Prenehajte uporabljati zdravilo REGRANEX in se posvetujte z zdravnikom, če opazite ali sumite na:
- The use of a clean application aid is recommended and contact with other parts of the body should be avoided.
- Priporočamo uporabo čistega pripomočka za nanašanje gela in pri tem se morate izogibati stiku z drugimi deli telesa.
The dressing should be changed at least once a day to keep the wound moist.
Obkladke menjajte najmanj enkrat na dan, da bo razjeda ves čas vlažna.
• Are not more than 5 square centimetres (see diagram opposite) and have a good blood supply
• niso večje od 5 kvadratnih centimetrov (glejte diagram spodaj) in so zadostno prekrvavljene
REGRANEX should not be used in patients with ulcers that are not of primarily neuropathic origin, such as those due to arteriopathy or other factors.
Zdravila REGRANEX ne smete uporabljati pri bolnikih z ulkusi, ki niso primarno nevropatskega izvora, npr. pri ulkusih zaradi arteriopatije ali drugih dejavnikov.
Subjects recruited into these studies were diabetic adults aged 19 years or over who were suffering from at least one stage III or IV diabetic ulcer of at least 8 weeks duration.
Preiskovanci, ki so jih vključili v ta preskušanja, so bili odrasli bolniki s sladkorno boleznijo, stari 19 let ali več, ki so imeli vsaj po en diabetični ulkus stopnje III ali IV, ki je trajal najmanj 8 tednov.
Do not use this medicine if any of the above apply to you.
Zdravila Regranex ne smete uporabljati, če za vas velja karkoli od zgoraj navedenega.
• Do not apply a double amount to make up for a missed dose.
• Ne nanesite dvojne količine gela, da bi nadomestili izpuščeni odmerek.
Treatment with REGRANEX should be initiated and monitored by physicians (specialists or nonspecialists) who are experienced in the management of diabetic wounds.
Zdravljenje z zdravilom REGRANEX mora uvesti in spremljati zdravnik (specialist ali nespecialist), ki ima izkušnje z zdravljenjem diabetičnih kožnih ulkusov.
Becaplermin was not mutagenic in a battery of in vitro and in vivo tests.
Bekaplermin ni bil mutagen v seriji in vitro in in vivo testov.
• If you are allergic (hypersensitive) to becaplermin or to any of the other ingredients of
• če ste alergični (preobčutljivi) na bekaplermin ali katerokoli sestavino zdravila REGRANEX,
REGRANEX should not be used in ulcers of baseline surface area > 5 cm2, or for more than 20 weeks in any individual.
Zdravila REGRANEX ne smete uporabljati pri ulkusih z začetno površino > 5 cm2 ali dlje kot 20 tednov pri posameznem bolniku.
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).
For cutaneous use only.
Le za dermalno uporabo.
Like all medicines, REGRANEX can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo REGRANEX neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In animal wound models, the predominant effect of becaplermin is to enhance the formation of granulation tissue.
V živalskih modelih ran je prevladujoč učinek bekaplermina spodbujanje tvorbe granulacijskega tkiva.
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.
The name of your medicine is REGRANEX.
Vaše zdravilo je REGRANEX.
Based on pooled safety data from these clinical trials, the most commonly reported (≥5% incidence) adverse drug reactions (ADRs) were (with % incidence) infected skin ulcer (12.3), cellulitis (10.3), and osteomyelitis (7.2).
Na osnovi združenih podatkov o varnosti iz teh kliničnih preskušanj, so najpogosteje (pojavnost ≥ 5%) poročali o naslednjih neželenih učinkih (pojavnost v %): okužba kožnega ulkusa (12,3), celulitis (10,3) in osteomielitis (7,2).
Systemic absorption of a single dose and multiple applications for 5 consecutive days of becaplermin to those wounds was insignificant.
Sistemska absorpcija, pri enkratnem odmerjanju in pri večkratnem odmerjanju bekaplermina na te rane v času 5 zaporednih dni, je bila neznatna.
In view of these data and since becaplermin is a growth factor, Regranex treatment is contraindicated in patients with any known malignancies.
Zaradi tega in ker je bekaplermin rastni faktor, je zdravilo REGRANEX kontraindicirano pri bolnikih z znano maligno boleznijo.
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.
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, dokler se okužba ne pozdravi.
WHAT REGRANEX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO REGRANEX IN ZA KAJ GA UPORABLJAMO
NAME OF THE MEDICINAL PRODUCT REGRANEX 0.01% gel
IME ZDRAVILA REGRANEX 0,01 % gel
The safety of REGRANEX Gel was evaluated in 1883 adult patients who participated in 17 clinical trials of REGRANEX and placebo and/or standard therapy (saline dressing).
Varnost zdravila REGRANEX gel so ocenili pri 1.883 odraslih bolnikih, ki so sodelovali v 17 kliničnih preskušanjih zdravila REGRANEX v primerjavi s placebom in/ali klasičnim zdravljenjem (gaza s fiziološko raztopino).
If during treatment with REGRANEX no meaningful healing progress is evident after the first ten weeks of continuous therapy, treatment should be re-evaluated, and factors known to compromise healing (such as osteomyelitis, ischaemia, infection) should be re-assessed.
Če med zdravljenjem z zdravilom REGRANEX po prvih 10 tednih neprekinjenega zdravljenja ne opazite bistvenega napredka pri celjenju ulkusa, ponovno ovrednotite zdravljenje in dejavnike, za katere je znano, da slabo vplivajo na celjenje ran (npr. osteomielitis, ishemija, okužbe).
• Redness and pain of skin
• rdeča in boleča koža.
If your ulcer heals and then returns, do not use REGRANEX again without first checking with your doctor.
Če se razjeda pozdravi in nato ponovno pojavi, zdravila REGRANEX ne smete začeti uporabljati, ne da bi se pred tem posvetovali z zdravnikom.
You can obtain wooden spatulas from your pharmacist
Lesene lopatke lahko dobite v lekarni.
The soft tissue adjacent to the injection site had fibroplasia with accompanying mononuclear cell infiltration reflective of the ability of PDGF to stimulate connective tissue growth.
V mehkih tkivih ob mestu injiciranja so opazili fibroplazijo s spremljajočo infiltracijo mononuklearnih celic, kar kaže na zmožnost PDGF, da spodbudi rast vezivnega tkiva.
After treatment is completed, any unused gel should be discarded in accordance with local requirements.
Po zaključenem zdravljenju, neuporabljen gel zavrzite v skladu z lokalnimi predpisi.
Insert diagram of size (circle measuring 2.524 cm in diameter)
Dodati diagram (krog premera 2,524 cm).
- A tube of REGRANEX should be used on a single patient only.
- Posamezno tubo zdravila REGRANEX uporabljajte le za zdravljenje enega bolnika.
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.
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.
If you forget to use REGRANEX
Če ste pozabili uporabiti zdravilo Regranex
• Continuing to visit your doctor or healthcare professional and following your treatment plan
• redne obiske pri zdravniku in upoštevanje načrta zdravljenja.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C-8 °C).
REGRANEX should not be used for more than 20 weeks.
Zdravila REGRANEX ne smete uporabljati dlje kot 20 tednov.
If there is no sign of healing after the first ten weeks of treatment, contact your doctor.
Če po prvih desetih tednih zdravljenja ni nikakršnih znakov celjenja, se posvetujte s svojim zdravnikom, ki bo določil, ali naj nadaljujete z zdravljenjem.
Janssen-Pharmaceutica N.V., Turnhoutseweg 30, B-2340 Beerse, Belgium.
Ime in naslov izdelovalca, odgovornega za sproščanje serije Janssen-Pharmaceutica N.V., Turnhoutseweg 30, B-2340 Beerse, Belgija.
15 g of gel in a multidose tube (laminated polyethylene-lined).
15 g gela v tubi za večkratno odmerjanje (laminirana, obložena s polietilenom).
Consequently, it is recommended that REGRANEX should not be applied to the ulcer site in conjunction with other topical medications.
Zato priporočamo, da zdravila REGRANEX ne nanašate na ulkus skupaj z drugimi zdravili za lokalno uporabo.
Use within 6 weeks after opening the seal of the tube.
Zdravilo uporabite v 6 tednih po odpiranju zaporne folije na tubi.
This is important to ensure the ulcer heals as quickly and completely as possible, and to remove any REGRANEX gel from the
To je pomembno, saj tako zagotovite hitro in čimbolj popolno celjenje razjede ter hkrati z nje odstranite ostanke REGRANEX gela od
Dermatitis bullous, Excessive granulation tissue
Bolezni kože in podkožja bulozni dermatitis prekomerno granulacijsko tkivo
Regranex is presented as a gel and is filled in multi-dose tubes containing 15 grams.
Zdravilo Regranex je gel in je na voljo v tubi za večkratno odmerjanje, ki vsebuje 15 gramov gela.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Pogostnost pojava neželenih učinkov je določena z naslednjim dogovorom: zelo pogosti (pojavijo se pri več kot 1 na 10 bolnikov), pogosti (pojavijo se pri 1 do 10 na 100 bolnikov), občasni (pojavijo se pri 1 do 10 na 1.000 bolnikov), redki (pojavijo se pri 1 do 10 na 10.000 bolnikov), zelo redki (pojavijo se pri manj kot 1 na 10.000 bolnikov), neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Ulcers with a suspicious appearance should be biopsied to exclude malignancy.
Pri ulkusih sumljivega videza opravite biopsijo, da izključite maligni proces.
Rare (≥1/10,000 to <1/1,000)
Občasni (≥ 1/1.000 do <1/
Avoid contact with any other area of the body
Stiku zdravila s katerimkoli drugim delom telesa se morate izogibati.
Close the tube tightly after each use.
Po vsaki uporabi tubo tesno zaprite.
Consequently, REGRANEX should not be used during pregnancy.
Zdravila REGRANEX ne smete uporabljati med nosečnostjo.
In the process of healing the wound, becaplermin induces cell proliferation.
V procesu celjenja rane bekaplermin inducira celično proliferacijo.
* Recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB) produced in Saccharomyces cerevisiae by recombinant DNA technology.
* Rekombinantni humani rastni faktor iz trombocitov-BB (rhPDGF-BB), izdelan v kvasovki Saccharomyces cerevisiae z rekombinantno DNA tehnologijo.
If you apply too much REGRANEX, it is unlikely to do you any harm.
Če ste uporabili večji odmerek zdravila REGRANEX, kot bi smeli Če ste nanesli preveč zdravila REGRANEX, je malo verjetno, da bi vam to škodovalo.
What REGRANEX looks like and contents of the pack
Izgled zdravila REGRANEX in vsebina pakiranja
Follow your doctor's advice to relieve pressure from your ulcer.
Upoštevajte zdravnikova navodila o tem kako zmanjšati pritisk na razjedo.
Each gram of Regranex contains 100 micrograms of becaplermin.
Vsak gram zdravila Regranex vsebuje 100 mikrogramov
Please tell your doctor or pharmacist if you are using or have recently used any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
REGRANEX is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.
Zdravilo REGRANEX je indicirano, skupaj z drugimi ukrepi pravilne nege ran, za spodbujanje nastajanja granulacijskega tkiva in celjenje nevropatskih, kroničnih diabetičnih ulkusov, ki segajo skozi vso debelino kože in imajo površino manjšo ali enako 5 cm2.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Peripheral arteriopathy should be excluded by assessment of the pedal pulses or other techniques.
Osteomielitis ugotavljajte z rentgenskim pregledom, periferno arteriopatijo pa izključite z oceno stopalnih pulzov ali z drugimi tehnikami.
Becaplermin is produced by insertion of the gene for the B chain of human platelet derived growth factor into the yeast, Saccharomyces cerevisiae.
Bekaplermin izdelujejo z vstavljanjem gena za verigo B humanega rastnega faktorja iz trombocitov v kvasovko Saccharomyces cerevisiae.
• Do not apply pressure or walk on the ulcer during treatment.
• Med zdravljenjem na razjedo ne smete pritiskati ali hoditi po njej.
The displayed frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available clinical trial data).
pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
REGRANEX is used to help the growth of normal tissue in order to heal skin ulcers.
Zdravilo REGRANEX se uporablja za pomoč pri rasti normalnih tkiv za boljše celjenje razjed.
• Infected skin ulcer (very common)
• okužbo razjede (zelo pogosto).
The biological activity of becaplermin includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair.
Med biološke učinke bekaplermina sodi tudi spodbujanje kemotaktičnega privabljanja in proliferacije celic, ki sodelujejo pri celjenju ran.
INFORMATION IN BRAILLE (CARTON ONLY) REGRANEX
PODATKI V BRAILLOVI PISAVI regranex
It is used with other good wound care measures to help with the healing of the ulcers.
Uporablja se skupaj z drugimi ukrepi pravilne oskrbe ran za pomoč pri celjenju razjed.
OUTER BOX/TUBE
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ZUNANJA ŠKATLA/TUBA
• Your ulcer should be cleaned with salt solution or water.
• Razjedo morate očistiti s fiziološko raztopino ali z vodo.
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.
V predklinični študiji, katere namen je bil ugotoviti učinke PDGF na izpostavljeno kost, so podganam injicirali bekaplermin v metatarzalne kosti v odmerku 3 ali 10 μg na posamezno mesto injiciranja (koncentracija 30 ali 100 μg/ml na mesto injiciranja), in sicer vsak drugi dan,13 dni.
Burning sensation1
Bolezni živčevja pekoč občutek1
• Do not touch the wound with the tip of the tube
• Z vrhom tube se ne smete dotakniti rane.
- The tube should be closed tightly after each use.
- Po vsaki uporabi tubo tesno zaprite.
If you are unsure, talk to your doctor or pharmacist before using REGRANEX.
Če ste negotovi, se pred uporabo zdravila REGRANEX posvetujte s svojim zdravnikom ali s farmacevtom.
Becaplermin is a human recombinant Platelet Derived Growth Factor (rhPDGF).
Bekaplermin je humani rekombinantni rastni faktor iz trombocitov (rhPDGF).
• Infections of the bone which may be seen as fever, severe pain, swelling and redness around the bone that is affected
• okužbe kosti, ki se kažejo s povišano telesno temperaturo, hudo bolečino, oteklino in rdečino ob prizadeti kosti.
• Only apply REGRANEX to the wound area.
• Zdravilo REGRANEX nanesite samo na razjedo.
The usual dose is one application once a day for a maximum of 20 weeks.
Običajni odmerek je en nanos gela na dan, največ 20 dni.
The bundled term burning sensation consists of the preferred terms burning sensation, skin burning sensation, and application site irritation, all of which referred specifically to burning at
Izraz pekoč občutek združuje izraze pekoč občutek, pekoč občutek na koži in draženje mesta aplikacije (ki se nanaša na pekoč občutek na mestu aplikacije).
Each gram contains E218 (methyl parahydroxybenzoate) 1.56 mg and E216 (propyl parahydroxybenzoate) 0.17 mg, see section 4.4.
En gram gela vsebuje 1,56 mg E218 (metilparahidroksibenzoat) in 0,17 mg E216 (propilparahidroksibenzoat), glejte poglavje 4.4.
REGRANEX should not be used continuously for more than 20 weeks.
Kdaj je treba prenehati z uporabo zdravila REGRANEX Zdravila REGRANEX ne smete neprekinjeno uporabljati dlje kot 20 tednov.
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.
If you are unsure, check with your doctor or pharmacist
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
- Hands should be washed thoroughly before applying REGRANEX.
- Pred nanašanjem zdravila REGRANEX si temeljito umijte roke.
REGRANEX should not be used in conjunction with occlusive dressings.
Zdravila REGRANEX ne smete uporabljati skupaj z okluzivnim povojem.
- Before each application, the ulcer should be gently rinsed with saline or water to remove residual gel.
- Pred vsakim nanosom gela ulkus previdno sperite s fiziološko raztopino ali vodo, da z njega odstranite preostali gel.
There are limited data on the effects of becaplermin overdose.
Podatkov o prekomernem odmerjanju bekaplermina je malo.
REGRANEX is a clear colourless to straw-coloured gel.
Zdravilo Regranex je prozoren, brezbarven do rumenkast gel.
Following 14 consecutive daily topical applications of REGRANEX, there was no consistent increase in plasma platelet-derived growth factor-BB concentrations above pre-treatment concentrations.
Po 14 dnevnem zaporednem nanašanju gela REGRANEX na razjede ni bilo enotnih podatkov o povečanju plazemskih koncentracij rastnega dejavnika iz trombocitov-BB v primerjavi s koncentracijami pred zdravljenjem.
Do not use REGRANEX after the expiry date, which is stated on the tube and the outer carton after EXP.
Zdravila REGRANEX ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na tubi in na škatli za oznako Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
• You have infections of the bone which may be seen as fever, severe pain around the bone that is affected, swelling and redness of the joints
• imate okužbo kosti, ki se lahko kaže s povišano telesno temperaturo, hudo bolečino ob prizadeti kosti, oteklimi ali rdečimi sklepi,
Including the above-mentioned ADRs, the following table displays ADRs that have been reported with the use of REGRANEX from either clinical trial or postmarketing experiences.
V spodnji preglednici so, vključno z zgoraj omenjenimi, navedeni neželeni učinki, o katerih so poročali v kliničnih preskušanjih ali v redni klinični praksi.
Thus it helps the growth of normal tissue for healing.
Tako bekaplermin pomaga pri rasti normalnega tkiva, ki je potrebna za celjenje.
Marketing authorisation holder: JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg, 30
Imetnik dovoljenja za promet z zdravilom: JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg, 30
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).
Efficacy has not been demonstrated for ulcers of baseline surface area > 5 cm2.
Pri ulkusih z začetno površino > 5 cm2 niso dokazali učinkovitosti zdravila.
• If you have any further questions, ask your doctor or your pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
It is not known whether becaplermin is excreted in human milk.
Ni znano, ali se bekaplermin izloča v materino mleko pri človeku, zato zdravila REGRANEX pri dojenju ne smete uporabljati.
Good wound care measures include: • Your doctor or healthcare professional removing dead skin/debris from the wound whenever
• po potrebi zdravnik ali drug zdravstveni delavec odstrani mrtvo kožo/ostanke rane,
Prior to the use of REGRANEX, related underlying conditions such as osteomyelitis and peripheral arteriopathy should be excluded or treated if present.
Pred uporabo zdravila REGRANEX morate tudi bodisi izključiti ali pozdraviti morebitne druge sorodne osnovne bolezni, ki jih ima bolnik, kot na primer osteomielitis in periferno arteriopatijo.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE AUTHORISATION HOLDER (S) RESPONSIBLE FOR
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE
Therapy should be continued to the maximum of 20 weeks as long as healing progress is seen on periodic evaluations.
Če ob rednih kontrolnih pregledih opažate napredek pri celjenju ulkusa, lahko s terapijo nadaljujete do največ 20 tednov.
What REGRANEX contains
Kaj vsebuje zdravilo REGRANEX