FrancophonIA/ELRC3.0 huggingface dataset:
English: This will help protect the cattle against BVD infections.
Slovenian: To bo pripomoglo k zaščiti goveda pred okužbami z govejo virusno diarejo.
English: In the laboratory studies Bovela prevented PI in 100% of calves while the animals that received no vaccination gave birth to 100% PI calves.
Slovenian: V laboratorijskih študijah je zdravilo Bovela preprečilo trajno okužbo pri 100 % telet, medtem ko so krave, ki niso prejele cepiva, skotile 100 % telet s trajno okužbo.
English: How has Bovela been studied?
Slovenian: Kako je bilo zdravilo Bovela raziskano?
English: They may progress to have mucosal disease which is another form of BVD disease with ulcers and blisters on the snout and inside of the mouth.
Slovenian: Njihova bolezen lahko napreduje v mukozno bolezen, ki je ena od oblik goveje virusne diareje, zaznamujejo pa jo razjede in mehurji na gobcu in v ustih.
English: In non-pregnant animals the infection is generally mild, with signs affecting the airways such as cough, and reduced milk yield.
Slovenian: Pri živalih, ki niso breje, je okužba na splošno blaga ter prizadene dihalne poti (kašelj) in zmanjšuje mlečnost.
English: However a severe form of BVD can occur, when cattle have a high temperature and bloody diarrhoea.
Slovenian: Pojavi se lahko tudi hujša oblika goveje virusne diareje, zaradi katere ima govedo povišano telesno temperaturo in krvavo drisko.
English: PI animals are a constant source of BVD virus, infecting other cattle in the herd.
Slovenian: Živali s trajno okužbo so nenehen vir virusa goveje virusne diareje in tako okužbo prenašajo na drugo govedo v čredi.
English: Bovela is used to protect cattle against BVD viral infection.
Slovenian: Zdravilo Bovela se uporablja za zaščito goveda pred okužbo z govejo virusno diarejo.
English: How does Bovela work?
Slovenian: Kako zdravilo Bovela deluje?
English: In pregnant cows, BVD infection can cause abortions or result in the birth of calves that are persistently infected (PI).
Slovenian: Pri brejih kravah lahko okužba z govejo virusno diarejo povzroči splav ali kotitev telet s trajno okužbo.
English: The withdrawal period for Bovela for cattle is zero days.
Slovenian: Karenca za zdravilo Bovela za govedo je nič dni.
English: What is Bovela?
Slovenian: Kaj je zdravilo Bovela?
English: • If you are under 18 years of age.
Slovenian: • če ste mlajši od 18 let.
English: Safety and effectiveness in children and adolescents below the age of 18 years have not been established.
Slovenian: Varnosti in učinkovitosti pri otrocih, mlajših od 18 let, še niso ugotovili.
English: • Apply the next dose as soon as possible.
Slovenian: • Nanesite naslednji odmerek takoj, ko je mogoče.
English: There are no known incompatibilities.
Slovenian: Ni znanih inkompatibilnosti.
English: • Are due to complications of diabetes.
Slovenian: • so posledica zapletov sladkorne bolezni.
English: • You have any severe or persistently worsening types of cancer
Slovenian: • imate hudo ali stalno napredujočo vrsto raka,
English: Use within 6 weeks after first opening.
Slovenian: Porabite v 6 tednih po prvem odpiranju.
English: • You have diseases of the arteries.
Slovenian: • imate bolezen, ki prizadane arterije.
English: Date opened:
Slovenian: Datum odpiranja:
English: If it is almost time for the next application, forget about the missed dose and continue as normal
Slovenian: Če je že skoraj čas za naslednji nanos, preskočite pozabljeni odmerek in nadaljujte kot normalno.
English: Date of latest renewal: 19 March 2009
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 19. marec 2009
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
English: Further information
Slovenian: Dodatni podatki
English: Refers to erythema at the application site.
Slovenian: Nanaša se na eritem na mestu aplikacije.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 March 1999
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 29. marec 1999
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernico CHMP o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
English: Always try to follow the instructions for use exactly.
Slovenian: Kljub temu pa skušajte vedno natančno upoštevati navodila za uporabo.
English: These 1883 patients had at least one topical administration of REGRANEX and provided safety data.
Slovenian: Pri teh 1.883 bolnikih so najmanj enkrat topikalno nanesli zdravilo REGRANEX in posredovali podatke o varnosti.
English: There are no adequate data from the use of becaplermin in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi bekaplermina pri nosečnicah.
English: • Excessive growth of new tissue at the wound (rare)
Slovenian: • prekomerno rast novega tkiva v razjedi (redko),
English: Pregnancy and breast-feeding • Do not use this medicine if you are pregnant, think you might be pregnant or planning to
Slovenian: Nosečnost in dojenje • Zdravila REGRANEX ne smete uporabljati če ste noseči, mislite, da ste noseči ali nameravate
English: • If you have or have had cancer
Slovenian: • če imate ali ste imeli rakavo obolenje,
English: There are insufficient data to support safe use of the product for more than 20 weeks (see 5.1 Pharmacodynamic properties).
Slovenian: Podatki, ki bi potrjevali varno uporabo zdravila dlje kot 20 tednov, so nezadostni (glejte poglavje 5.1 Farmakodinamične lastnosti).
English: REGRANEX 0.01% gel becaplermin
Slovenian: REGRANEX 0,01 % gel bekaplermin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/101/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/101/001
English: Please record the date of opening on the tube label.
Slovenian: Datum odpiranja vpišite na nalepko na tubi.
English: REGRANEX is used for skin ulcers that:
Slovenian: Zdravilo REGRANEX se uporablja pri kožnih razjedah, ki:
English: • Keeping weight off your feet, perhaps by wearing special orthopaedic shoes or by other methods
Slovenian: • ukrepe za razbremenitev nog, morda uporabo posebnih ortopedskih čevljev ali druge ukrepe,
English: Gel in a multidose tube (15 gram).
Slovenian: Gel v tubi za večkratno odmerjanje (15 gramov).
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 1.0 načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: By using REGRANEX, it is more likely that your skin ulcers will heal quickly and completely.
Slovenian: Z uporabo zdravila REGRANEX povečamo verjetnost, da se bodo vaše kožne razjede hitro in popolnoma zacelile.
English: 1 year.
Slovenian: 1 leto
English: Novartis Pharmaceuticals Corporation (Novartis NPC)., 2010 Cessna Drive, Vacaville, CA 95688, USA.
Slovenian: ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca biološke zdravilne učinkovine Novartis Pharmaceuticals Corporation (Novartis NPC)., 2010 Cessna Drive, Vacaville, CA 95688, ZDA.
English: • If your ulcer is larger than 5 square centimetres (see diagram above)
Slovenian: • če je razjeda večja od 5 kvadratnih centimetrov (glejte zgornji diagram),
English: - The tip of the tube should not come into contact with the wound or any other surface.
Slovenian: - Vrh tube ne sme priti v stik z rano ali katerokoli drugo površino.
English: It contains a substance called becaplermin.
Slovenian: Vsebuje učinkovino, ki se imenuje bekaplermin.
English: • If your ulcer is infected
Slovenian: • če je razjeda okužena,
English: Do not use REGRANEX:
Slovenian: Ne uporabljajte zdravila REGRANEX:
English: Pharmacotherapeutic group: Preparation for treatment of wounds and ulcers, ATC code: D 03 AX06
Slovenian: Farmakoterapevtska skupina: Zdravila za oskrbo ran in razjed oznaka ATC: D03AX06
English: Stop using REGRANEX and tell your doctor straight away if you notice or suspect the following:
Slovenian: Prenehajte uporabljati zdravilo REGRANEX in se posvetujte z zdravnikom, če opazite ali sumite na:
English: - The use of a clean application aid is recommended and contact with other parts of the body should be avoided.
Slovenian: - Priporočamo uporabo čistega pripomočka za nanašanje gela in pri tem se morate izogibati stiku z drugimi deli telesa.
English: The dressing should be changed at least once a day to keep the wound moist.
Slovenian: Obkladke menjajte najmanj enkrat na dan, da bo razjeda ves čas vlažna.
English: • Are not more than 5 square centimetres (see diagram opposite) and have a good blood supply
Slovenian: • niso večje od 5 kvadratnih centimetrov (glejte diagram spodaj) in so zadostno prekrvavljene
English: 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.
Slovenian: Zdravila REGRANEX ne smete uporabljati pri bolnikih z ulkusi, ki niso primarno nevropatskega izvora, npr. pri ulkusih zaradi arteriopatije ali drugih dejavnikov.
English: 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.
Slovenian: 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.
English: Do not use this medicine if any of the above apply to you.
Slovenian: Zdravila Regranex ne smete uporabljati, če za vas velja karkoli od zgoraj navedenega.
English: • Do not apply a double amount to make up for a missed dose.
Slovenian: • Ne nanesite dvojne količine gela, da bi nadomestili izpuščeni odmerek.
English: Treatment with REGRANEX should be initiated and monitored by physicians (specialists or nonspecialists) who are experienced in the management of diabetic wounds.
Slovenian: Zdravljenje z zdravilom REGRANEX mora uvesti in spremljati zdravnik (specialist ali nespecialist), ki ima izkušnje z zdravljenjem diabetičnih kožnih ulkusov.
English: Becaplermin was not mutagenic in a battery of in vitro and in vivo tests.
Slovenian: Bekaplermin ni bil mutagen v seriji in vitro in in vivo testov.
English: • If you are allergic (hypersensitive) to becaplermin or to any of the other ingredients of
Slovenian: • če ste alergični (preobčutljivi) na bekaplermin ali katerokoli sestavino zdravila REGRANEX,
English: REGRANEX should not be used in ulcers of baseline surface area > 5 cm2, or for more than 20 weeks in any individual.
Slovenian: Zdravila REGRANEX ne smete uporabljati pri ulkusih z začetno površino > 5 cm2 ali dlje kot 20 tednov pri posameznem bolniku.
English: Clinical absorption studies were conducted in patients with a mean diabetic ulcer area of 10.5 cm² (range 2.3 - 43.5 cm²).
Slovenian: 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).
English: For cutaneous use only.
Slovenian: Le za dermalno uporabo.
English: Like all medicines, REGRANEX can have side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo REGRANEX neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: In animal wound models, the predominant effect of becaplermin is to enhance the formation of granulation tissue.
Slovenian: V živalskih modelih ran je prevladujoč učinek bekaplermina spodbujanje tvorbe granulacijskega tkiva.
English: 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.
Slovenian: 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.
English: The name of your medicine is REGRANEX.
Slovenian: Vaše zdravilo je REGRANEX.
English: 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).
Slovenian: 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).
English: Systemic absorption of a single dose and multiple applications for 5 consecutive days of becaplermin to those wounds was insignificant.
Slovenian: Sistemska absorpcija, pri enkratnem odmerjanju in pri večkratnem odmerjanju bekaplermina na te rane v času 5 zaporednih dni, je bila neznatna.
English: In view of these data and since becaplermin is a growth factor, Regranex treatment is contraindicated in patients with any known malignancies.
Slovenian: Zaradi tega in ker je bekaplermin rastni faktor, je zdravilo REGRANEX kontraindicirano pri bolnikih z znano maligno boleznijo.
English: Preclinical absorption studies through full-thickness wounds were conducted in rats with a wound area of 1.4 - 1.6 cm².
Slovenian: 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.
English: If a wound becomes infected during REGRANEX therapy, the product should be discontinued until the infection has cleared.
Slovenian: Če se rana okuži med zdravljenjem z zdravilom REGRANEX, je treba zdravljenje prekiniti, dokler se okužba ne pozdravi.
English: WHAT REGRANEX IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO REGRANEX IN ZA KAJ GA UPORABLJAMO
English: NAME OF THE MEDICINAL PRODUCT REGRANEX 0.01% gel
Slovenian: IME ZDRAVILA REGRANEX 0,01 % gel
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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).
English: • Redness and pain of skin
Slovenian: • rdeča in boleča koža.
English: If your ulcer heals and then returns, do not use REGRANEX again without first checking with your doctor.
Slovenian: Če se razjeda pozdravi in nato ponovno pojavi, zdravila REGRANEX ne smete začeti uporabljati, ne da bi se pred tem posvetovali z zdravnikom.
English: You can obtain wooden spatulas from your pharmacist
Slovenian: Lesene lopatke lahko dobite v lekarni.
English: 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.
Slovenian: V mehkih tkivih ob mestu injiciranja so opazili fibroplazijo s spremljajočo infiltracijo mononuklearnih celic, kar kaže na zmožnost PDGF, da spodbudi rast vezivnega tkiva.
English: After treatment is completed, any unused gel should be discarded in accordance with local requirements.
Slovenian: Po zaključenem zdravljenju, neuporabljen gel zavrzite v skladu z lokalnimi predpisi.
English: Insert diagram of size (circle measuring 2.524 cm in diameter)
Slovenian: Dodati diagram (krog premera 2,524 cm).
English: - A tube of REGRANEX should be used on a single patient only.
Slovenian: - Posamezno tubo zdravila REGRANEX uporabljajte le za zdravljenje enega bolnika.
English: REGRANEX should be applied as a continuous thin layer to the entire ulcerated area(s) once daily using a clean application aid.
Slovenian: Zdravilo REGRANEX nanesite v neprekinjeni tanki plasti na celotno področje ulkusa(ov) enkrat na dan, z uporabo čistega pripomočka za nanašanje.
English: 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.
Slovenian: 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.
English: If you forget to use REGRANEX
Slovenian: Če ste pozabili uporabiti zdravilo Regranex
English: • Continuing to visit your doctor or healthcare professional and following your treatment plan
Slovenian: • redne obiske pri zdravniku in upoštevanje načrta zdravljenja.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C-8 °C).
English: REGRANEX should not be used for more than 20 weeks.
Slovenian: Zdravila REGRANEX ne smete uporabljati dlje kot 20 tednov.
English: If there is no sign of healing after the first ten weeks of treatment, contact your doctor.
Slovenian: Če po prvih desetih tednih zdravljenja ni nikakršnih znakov celjenja, se posvetujte s svojim zdravnikom, ki bo določil, ali naj nadaljujete z zdravljenjem.
English: Janssen-Pharmaceutica N.V., Turnhoutseweg 30, B-2340 Beerse, Belgium.
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije Janssen-Pharmaceutica N.V., Turnhoutseweg 30, B-2340 Beerse, Belgija.
English: 15 g of gel in a multidose tube (laminated polyethylene-lined).
Slovenian: 15 g gela v tubi za večkratno odmerjanje (laminirana, obložena s polietilenom).
English: Consequently, it is recommended that REGRANEX should not be applied to the ulcer site in conjunction with other topical medications.
Slovenian: Zato priporočamo, da zdravila REGRANEX ne nanašate na ulkus skupaj z drugimi zdravili za lokalno uporabo.
English: Use within 6 weeks after opening the seal of the tube.
Slovenian: Zdravilo uporabite v 6 tednih po odpiranju zaporne folije na tubi.
English: This is important to ensure the ulcer heals as quickly and completely as possible, and to remove any REGRANEX gel from the
Slovenian: To je pomembno, saj tako zagotovite hitro in čimbolj popolno celjenje razjede ter hkrati z nje odstranite ostanke REGRANEX gela od
English: Dermatitis bullous, Excessive granulation tissue
Slovenian: Bolezni kože in podkožja bulozni dermatitis prekomerno granulacijsko tkivo
English: Regranex is presented as a gel and is filled in multi-dose tubes containing 15 grams.
Slovenian: Zdravilo Regranex je gel in je na voljo v tubi za večkratno odmerjanje, ki vsebuje 15 gramov gela.
English: 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).
Slovenian: 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).
English: Ulcers with a suspicious appearance should be biopsied to exclude malignancy.
Slovenian: Pri ulkusih sumljivega videza opravite biopsijo, da izključite maligni proces.
English: Rare (≥1/10,000 to <1/1,000)
Slovenian: Občasni (≥ 1/1.000 do <1/
English: Avoid contact with any other area of the body
Slovenian: Stiku zdravila s katerimkoli drugim delom telesa se morate izogibati.
English: Close the tube tightly after each use.
Slovenian: Po vsaki uporabi tubo tesno zaprite.
English: Consequently, REGRANEX should not be used during pregnancy.
Slovenian: Zdravila REGRANEX ne smete uporabljati med nosečnostjo.
English: In the process of healing the wound, becaplermin induces cell proliferation.
Slovenian: V procesu celjenja rane bekaplermin inducira celično proliferacijo.
English: * Recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB) produced in Saccharomyces cerevisiae by recombinant DNA technology.
Slovenian: * Rekombinantni humani rastni faktor iz trombocitov-BB (rhPDGF-BB), izdelan v kvasovki Saccharomyces cerevisiae z rekombinantno DNA tehnologijo.
English: If you apply too much REGRANEX, it is unlikely to do you any harm.
Slovenian: Če ste uporabili večji odmerek zdravila REGRANEX, kot bi smeli Če ste nanesli preveč zdravila REGRANEX, je malo verjetno, da bi vam to škodovalo.
English: What REGRANEX looks like and contents of the pack
Slovenian: Izgled zdravila REGRANEX in vsebina pakiranja
English: Follow your doctor's advice to relieve pressure from your ulcer.
Slovenian: Upoštevajte zdravnikova navodila o tem kako zmanjšati pritisk na razjedo.
English: Each gram of Regranex contains 100 micrograms of becaplermin.
Slovenian: Vsak gram zdravila Regranex vsebuje 100 mikrogramov
English: Please tell your doctor or pharmacist if you are using or have recently used any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: 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.
Slovenian: 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.
English: • 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).
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE