FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration should be performed by a physician trained and accredited by the marketing authorisation holder to administer the implant.
Slovenian: Postopek mora opraviti zdravnik, ki ga je imetnik dovoljenja za promet z zdravilom usposobil in pooblastil za uporabo implantata.
English: - Irregularity of skin, rash with small blisters, itch, rash, red rash, red swelling on skin, rash with small bumps, itchy rash, skin irritation, lighter skin patches, acne, eczema, secretions on skin, skin peeling, skin with loss of colour, hair colour changes, excessive sweating
Slovenian: − kožne nepravilnosti, izpuščaj z mehurčki, srbenje, izpuščaj, rdeč izpuščaj, rdeče otekanje kože, izpuščaj z bunkicami, srbeč izpuščaj, draženje kože, svetlejše kožne lise, akne, ekcem, izločki na koži, luščenje kože, koža z izgubo barve, spremembe barve las, čezmerno potenje;
English: This is because patients taking such medicines may experience increased bruising or bleeding at the site of the implant.
Slovenian: Če bolnik jemlje taka zdravila, se lahko na mestu vsaditve pojavi povečanje podplutb in krvavitev.
English: If you suffer from continued drowsiness, then you should speak to your doctor.
Slovenian: Če je dremavost stalna, se morate posvetovati z zdravnikom.
English: Haemangioma
Slovenian: hemangiom
English: Inflammation was observed in the Harderian gland in the rat.
Slovenian: Harderjevi žlezi pri podganah so opazili vnetje.
English: - Depression, inability to sleep, poor quality sleep, fainting, fainting sensation, fall, hangover, weakness, inability to get legs comfortable, increased sensitivity to touch, headache following injury, burning sensation, abnormal taste sensation
Slovenian: − depresija, nespečnost, poslabšana kakovost spanja, omedlevica, občutek omedlevice, padec, maček, šibkost, nezmožnost sprostitve nog, povečana občutljivost na dotik, glavobol po poškodbi, pekoč občutek, nenormalen okus;
English: No clinical data are available on the use of afamelanotide in breastfeeding women.
Slovenian: Klinični podatki o uporabi afamelanotida pri doječih materah niso na voljo.
English: One implant contains 16 mg of afamelanotide.
Slovenian: En implantat vsebuje 16 mg afamelanotida.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Subcutaneous use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: - Remove the needle from within the catheter using a sterile technique.
Slovenian: - S sterilno tehniko odstranite iglo iz notranjosti katetra.
English: Women who could become pregnant should use adequate contraception such as oral contraceptives, diaphragm plus spermicide, intrauterine device (also known as a coil) during treatment and for three months after the last SCENESSE implantation.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom Scenesse in tri mesece po njegovi zadnji vsaditvi uporabljati ustrezno kontracepcijo, kot so peroralna kontracepcija, diafragma v kombinaciji s spermicidom ali maternični vložek.
English: - Hold the catheter at its base using a sterile technique, pinch and hold the skinfold cranial to, or overlying the patient's supra-iliac crest with two fingers.
Slovenian: - S sterilno tehniko primite kateter na njegovem korenu in s prstoma stisnite ter primite kožno gubo na mestu, ki je nad ali prekriva bolnikovo suprailiakalno kristo.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Type I amber glass vial sealed with a PTFE coated rubber stopper.
Slovenian: Viala iz svetlorjavega stekla tipa I, zatesnjena z gumijastim zamaškom, obloženem s PTFE.
English: - Confirm insertion of the implant by palpating the skin with subcutis cranial to/overlying the suprailiac crest until the implant is located.
Slovenian: - Vsaditev implantata potrdite s palpacijo kože, ki je nad/prekriva suprailiakalno kristo, dokler ne ugotovite mesta implantata.
English: Very common (may affect more than 1 in 10 people): - Nausea (feeling sick), - headache; - reactions at the implant site including pain, redness, itching, bruising and changes to colour of overlying skin.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): − splošne kožne spremembe, vključno s pegami in potemnitvijo kože;
English: - Heavy and prolonged period, abnormal period, breast tenderness, irregular periods, discharge from vagina, decreased sex drive
Slovenian: − močna in podaljšana menstruacija, nenormalna menstruacija, občutljive dojke, neredna menstruacija, izcedek iz nožnice, zmanjšana spolna sla;
English: There are no or limited amounts of data from the use of afamelanotide in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi afamelanotida pri nosečnicah ni oziroma so omejeni.
English: LIST OF EXCIPIENTS Poly (DL-lactide-co-glycolide).
Slovenian: SEZNAM POMOŽNIH SNOVI poli (DL-laktid-ko-glikolid)
English: EXP
Slovenian: EPP.
English: The most commonly reported adverse reactions are nausea, experienced by approximately 19% of subjects who received treatment with this medicinal product, headache (20%), and implant site reactions (21%; mainly discolouration, pain, haematoma, erythema).
Slovenian: preizkušancev, ki so prejeli zdravljenje s tem zdravilom, glavobol (20 %) in reakcije na mestu vsaditve
English: How to use SCENESSE
Slovenian: Kako se daje zdravilo Scenesse
English: - Joint pain, muscle pain, pain in arms and legs, sudden muscle contraction, pain in muscles and bones, stiffness of muscles and bones, joint stiffness, groin pain, feeling of heaviness, swelling in lower limbs
Slovenian: − bolečine v sklepih, bolečina v mišicah, bolečine v rokah in nogah, nenadno krčenje mišic, bolečine v mišicah in kosteh, togost mišic in kosti, togost sklepov, bolečine v dimljah, občutek težkosti, otekanje v spodnjih okončinah;
English: What SCENESSE contains
Slovenian: Kaj vsebuje navodilo
English: - Increased hunger, nausea following implant insertion, indigestion, infection in stomach and intestines, inflamed stomach and intestines, heartburn, inflamed stomach, irregular bowel movements, wind, bloated tummy, tummy pain
Slovenian: − povečana lakota, slabost po vstavljanju implantata, slaba prebava, okužba želodca in črevesa, vnetje želodca in črevesa, zgaga, vnetje želodca, neredno izločanje blata, vetrovi, napihnjen trebuh, bolečine v trebuhu;
English: What you need to know before you receive SCENESSE
Slovenian: Kaj je zdravilo Scenesse in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Scenesse Kako se daje zdravilo Scenesse
English: Sensation of heaviness
Slovenian: pekoč občutek,
English: - Chills, fever, flu, flu-like illness, blocked nose, blocked sinuses, inflamed nose and throat, nose inflammation
Slovenian: − mrzlica, zvišana telesna temperatura, gripa, gripi podobna bolezen, zamašen nos, zamašeni sinusi, vnetje nosu in grla, vnetje nosu;
English: Lip swelling
Slovenian: OVOJNINAH VIALA
English: - Cushing's disease (a hormone disorder where the body produces too much of the hormone cortisol); - Addison's disease (a disorder of the adrenal glands causing a lack of some hormones); - Peutz-Jeghers syndrome (a disorder that causes blockage of the bowel and where your hands, soles of your feet and surface of your lips may have brown freckles); - epilepsy (or have been told that you are at risk of having fits); - anaemia (low counts of red blood cells in your blood); - melanoma (an aggressive type of skin cancer), including in-situ melanoma, e.g. lentigo maligna; or if you have certain inherited conditions that increase the risk of developing a melanoma; - skin cancer of the types, basal cell carcinoma or squamous cell carcinoma (inclusive of carcinoma in situ, e.g. Bowen's disease), Merkel cell carcinoma or other malignant or premalignant skin problems.
Slovenian: - melanom (agresivno vrsto kožnega raka), vključno z melanomom in situ, npr. malignim lentigom, ali nekatera dedna stanja, ki povečajo tveganje za razvoj melanoma; - kožnega raka vrste bazalnocelični karcinom ali skvamozni karcinom (vključno s karcinomom in situ, npr. Bowenovo boleznijo), karcinom Merklovih celic ali druge maligne ali predmaligne kožne težave.
English: The two total full body skin examinations per year are intended to: - detect early any skin cancers and their precursors induced by UV-exposure, as EPP patients can be expected to significantly increase their exposure to sunlight and UV light while on treatment with afamelanotide.
Slovenian: Namen dveh pregledov kože po celotnem telesu na leto je: - zgodnje odkrivanje kožnega raka in njegovih predznakov, ki jih povzroča izpostavljenost
English: synonyms: familial atypical mole-malignant melanoma syndrome, FAMMM; dysplastic naevus syndrome, DNS; B-K mole syndrome; CMM2 MIM #155601) and/or an - individual history of basal cell carcinoma, squamous cell carcinoma (inclusive of carcinoma in situ, e.g. Bowen's disease), Merkel cell carcinoma, or other malignant or premalignant skin lesions.
Slovenian: - z melanomom v osebni ali družinski anamnezi (vključno z melanomom in situ, npr. maligni lentigo) ali domnevno ali potrjeno občutljivostjo za kožni melanom (CMM1, MIM #155600, sinonimi: družinski sindrom atipičnega kožnega znamenja/malignega melanoma, FAMMM; sindrom displastičnega nevusa, DNS; sindrom kožnega znamenja B-K; CMM2 MIM #155601)
English: Palpitations Tachycardia
Slovenian: Srčne bolezni palpitacije, tahikardija
English: EPP patients with fair skin may be more likely to request treatment and are more prone to developing UV light-associated skin changes, including cancer; - detect and monitor changes in pigmentary lesions, thus allowing early detection of melanoma.
Slovenian: - odkrivanje in spremljanje sprememb pigmentnih lezij, kar omogoča zgodnje odkrivanje melanoma.
English: Upper respiratory tract infection
Slovenian: − okužbe zgornjih dihal (prehladi).
English: NAME OF THE MEDICINAL PRODUCT SCENESSE 16 mg implant
Slovenian: IME ZDRAVILA Scenesse 16 mg implantat
English: If you get any side effects, talk to your doctor.
Slovenian: Če opazite katerega koli neželenih učinkov, se posvetujte z zdravnikom.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij
English: - Keep this leaflet.
Slovenian: mehurčkasti izpuščaj,
English: Uncommon unspecified (incl cysts and polyps) Blood and lymphatic system disorders
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
English: SCENESSE 16 mg implant afamelanotide
Slovenian: Navodilo za uporabo Scenesse 16 mg implantat afamelanotid
English: In most cases these adverse reactions are reported to be mild in severity.
Slovenian: Poročali so, da je bila resnost večine teh neželenih učinkov blaga.
English: Reproductive system and breast disorders
Slovenian: Bolezni krvi in limfatičnega sistema levkopenija
English: - With the bevel of the needle facing upwards, insert the catheter laterally 1.5 to 2 cm into the subcutaneous layer at a 30 to 45 degree angle to the skin surface in one continuous flowing movement.
Slovenian: - Kateter z enim neprekinjenim gibom lateralno vstavite 1,5 do 2 cm v subkutano plast pod kotom
English: NAME OF THE MEDICINAL PRODUCT SCENESSE 16 mg implant afamelanotide
Slovenian: IME ZDRAVILA Scenesse 16 mg implantat afamelanotid
English: Pain in extremity Muscle spasm Musculoskeletal pain Musculoskeletal stiffness Joint stiffness Groin pain
Slovenian: mišični spazem, mišično-skeletna bolečina,
English: - Inflamed lips, lip swelling, colouration on lip, gum pain, toothache, discoloured gums, reduced sense of touch in mouth, lip discolouration, tongue discolouration
Slovenian: − vnetje ustnic, otekanje ustnic, obarvanje ustnic, bolečina v dlesni, zobobol, sprememba barve dlesni, zmanjšan občutek dotika v ustih, sprememba barve ustnic, sprememba barve jezika;
English: Pre- and post-natal development of Sprague-Dawley rats was not affected at exposures of about 135-times the human exposure (based on Cmax).
Slovenian: Pri izpostavljenosti, približno 135 krat večji kot pri človeku (na podlagi Cmax), ni bilo nobenih učinkov na razvoj podgan vrste Sprague-Dawley pred skotitvijo in po njej.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SCENESSE 16 mg implant afamelanotide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Scenesse 16 mg implantat afamelanotid subkutana uporaba
English: Decreased appetite Hypercholesterolaemia Increased appetite
Slovenian: Presnovne in prehranske motnje zmanjšan tek hiperholesterolemija,
English: - Pain, swelling around site of implantation, bruising at injection site, irritation at injection site, enlargement at implant site, itching at implant site, implant falling out, change in colour of skin at implant site
Slovenian: − bolečina, otekanje na mestu vsaditve, podplutbe na mestu injiciranja, draženje na mestu injiciranja, povečanje na mestu vsaditve, srbenje na mestu vsaditve, izpad implantata,
English: Gastrointestinal infection Gastroenteritis Folliculitis
Slovenian: Infekcijske in parazitske bolezni okužba zgornjih dihal gripa, okužba prebavil, gastroenteritis,
English: Pregnancy and breastfeeding
Slovenian: − driska in bruhanje;
English: The implant is inserted directly under the skin folds on your waist or abdomen in an area known as the supra-iliac crest.
Slovenian: Implantat se vstavi neposredno pod kožno gubo na pasu ali trebuhu, tj.
English: Gingival discolouration
Slovenian: zmanjšan libido
English: Gastroesophageal reflux disease
Slovenian: Žilne bolezni zardevanje,
English: Alanine aminotransferase increased
Slovenian: povečan tek
English: Arrange for an early appointment with your porphyria specialist if pigmented lesions like moles grow or if other growing, non-healing, weeping, plaque-like, wart-like, or ulcerated lesions appear.
Slovenian: Če se pigmentne lezije, kot so kožna znamenja, večajo ali če se pojavijo druge večajoče se ploščam podobne, bradavicam podobne ali ulcerozne kožne spremembe z izcedkom, ki se ne celijo, se naročite na zgodnji obisk pri specialistu za porfirijo.
English: Musculoskeletal and connective tissue disorders
Slovenian: mišično-skeletna togost, togost sklepa,
English: • Methods to prevent or minimise application errors and application site reactions Registry information sheet shall contain the following key messages:
Slovenian: • pomembnost ohranjevanja aseptičnih pogojev; • metode za preprečevanje ali zmanjševanje napak pri vsaditvi in reakcij na mestu vsaditve.
English: Abdominal discomfort Toothache
Slovenian: Bolezni sečil cistitis
English: Oedema peripheral Oedema mucosal Pain
Slovenian: Občasni folikulitis, kandidoza, nazofaringitis
English: Presbyopia
Slovenian: hipertenzija
English: Blood cholesterol increased Blood glucose increased Blood iron decreased Blood pressure diastolic increased
Slovenian: zvišan diastolični krvni tlak,
English: Melanocytic naevus Pigmentation disorder Skin discolouration Skin hyperpigmentation Ephelides
Slovenian: Bolezni kože in podkožja eritem, melanocitni nevus, motnja pigmentacije, sprememba barve kože, hiperpigmentacija kože, efelide, pruritus lichen planus,
English: Menorrhagia Dysmenorrhoea Breast tenderness Menstruation irregular Vaginal discharge Libido decreased
Slovenian: Motnje reprodukcije in dojk menoragija, dismenoreja,
English: Eyelid oedema Ocular hyperaemia Dry eye
Slovenian: Očesne bolezni edem očesne veke, očesna hiperemija,
English: Migraine Dizziness Lethargy Somnolence
Slovenian: slaba kakovost spanja, disgevzija
English: Lichen planus Rash vesicular Pruritus generalised Rash
Slovenian: generalizirani pruritus,
English: Abdominal pain Abdominal pain upper Diarrhoea
Slovenian: Občasni zobobol, abdominalni simptom,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION The implant contains 16 mg of afamelanotide.
Slovenian: Implantat vsebuje 16 mg afamelanotida.
English: - Mark 1.5 to 2 cm on the catheter shaft using surgical ink.
Slovenian: - S kirurškim črnilom označite kanal katetra med 1,5 in 2 cm.
English: Eye disorders
Slovenian: − vročinski oblivi;
English: Flushing Hot flush
Slovenian: vročinski oblivi hematom,
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih zapleti na rani, odprta rana, padec, navzea med postopkom
English: The European Commission granted a marketing authorisation valid throughout the European Union for BindRen on 21 January 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom BindRen, veljavno po vsej Evropski uniji, odobrila dne 21. januarja 2013.
English: BindRen colestilan
Slovenian: BindRen kolestilan
English: This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart and bone disease.
Slovenian: To vodi do hiperfosfatemije, ki lahko dolgoročno povzroči zaplete, na primer bolezni srca in kosti.
English: The full EPAR for BindRen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo BindRen je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets (1 g) and as granules (sachets containing 2 or 3 g).
Slovenian: Na voljo je v obliki tablet (1 g) in zrnc (vrečke vsebujejo 2 ali 3 g).
English: All patients were on dialysis and received BindRen for three months.
Slovenian: Vsi bolniki so bili na dializi in prejemali zdravilo BindRen tri mesece.
English: This is a summary of the European public assessment report (EPAR) for BindRen.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo BindRen.
English: Other information about BindRen
Slovenian: Druge informacije o zdravilu BindRen
English: The effects of BindRen were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila BindRen so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: For more information about treatment with BindRen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom BindRen preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The dose of BindRen should be adjusted every two to three weeks to a maximum of 15 g per day to reach an acceptable level of phosphate in the blood, which should then be monitored regularly.
Slovenian: Odmerek zdravila BindRen je treba prilagoditi vsaka dva do tri tedne do največ 15 g na dan, da se doseže sprejemljiva raven fosfatov v krvi, ki jo je nato treba redno spremljati.
English: Patients with severe kidney disease cannot eliminate phosphate from their bodies.
Slovenian: Bolniki z resnim obolenjem ledvic iz telesa ne morejo izločati fosfatov.
English: There were no major safety concerns and the overall safety profile was similar to that of other phosphate binders, as the side effects affected mainly the gut and resolved by themselves.
Slovenian: Opazil ni nobenih večjih varnostnih zadržkov, splošni varnostni profil pa je podoben drugim vezalcem fosfatov, saj so neželeni učinki večinoma povezani z črevesjem in samodejno izzvenijo.
English: The recommended starting dose of BindRen is 6 to 9 g per day, taken in three equally divided doses together with or immediately after meals.
Slovenian: Priporočeni začetni odmerek zdravila BindRen je 6 do 9 g na dan, ki se razdeli v tri enake odmerke in se jemlje hkrati z obrokom ali takoj po njem.
English: When taken with meals, colestilan attaches to phosphate from food within the gut, preventing it from being absorbed into the body.
Slovenian: Če se jemlje hkrati z obrokom, se v črevesju veže na fosfate iz hrane, s čimer preprečuje njihovo absorpcijo v telo.
English: In clinical trials, around 3 in 10 patients experienced at least one side effect.
Slovenian: V kliničnih preskušanjih so se pri vsaj enem bolniku od treh pojavili neželeni učinki.
English: All studies looked at the change in the average amount of phosphate in the blood after three months.
Slovenian: V vseh študijah so opazovali spremembo povprečnih ravni fosfatov v krvi po treh mesecih.
English: BindRen must not be used in people who are hypersensitive (allergic) to colestilan or any of the other ingredients.
Slovenian: Zdravila BindRen ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) kolestilan ali katero koli drugo sestavino zdravila.
English: What benefit has BindRen shown during the studies?
Slovenian: Kakšne koristi je zdravilo BindRen izkazalo med študijami?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for BindRen.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo BindRen, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The third study also showed that BindRen was more effective than placebo when used at doses of 6, 9, 12 and 15 g/day: compared with placebo, the reduction in blood phosphate levels seen with BindRen was 0.16, 0.21, 0.19 and 0.37 mmol/l respectively.
Slovenian: Tretja študija je prav tako pokazala, da je zdravilo BindRen učinkovitejše od placeba, kadar se uporablja v odmerkih 6, 9, 12 ali 15 g na dan: in sicer je bilo v primerjavi s placebom znižanje ravni fosfatov v krvi po uporabi zdravila BindRen glede na gornje odmerke 0,16 mmol/l, 0,21 mmol/l, 0,19 mmol/l in 0,37 mmol/l.
English: BindRen was investigated in two main studies involving 273 adults with long-term kidney disease and hyperphosphataemia.
Slovenian: Zdravilo BindRen so raziskali v dveh glavnih študijah, v katerih je sodelovalo 273 odraslih z dolgotrajnim obolenjem ledvic in hiperfosfatemijo.
English: What is the risk associated with BindRen?
Slovenian: Kakšna tveganja so povezana z zdravilom BindRen?
English: The CHMP noted that treatment with BindRen has a beneficial effect in lowering phosphate levels.
Slovenian: CHMP je ugotovil, da zdravilo BindRen pozitivno vpliva na zniževanje ravni fosfatov.
English: It is used in patients on haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Slovenian: Uporablja se pri bolnikih, ki prejemajo hemodializo (z uporabo naprave za filtriranje krvi) ali peritonealno dializo (pri čemer se tekočina črpa v trebuh, notranja telesna membrana pa filtrira kri).
English: BindRen is a medicine that contains the active substance colestilan.
Slovenian: BindRen je zdravilo, ki vsebuje zdravilno učinkovino kolestilan.
English: A third main study involving 642 patients compared the effects of giving BindRen at various doses with placebo (a dummy treatment) for three months.
Slovenian: V tretji glavni študiji so tri mesece pri 642 bolnikih primerjali učinke dajanja zdravila BindRen v različnih odmerkih z učinki placeba (zdravila brez zdravilne učinkovine).
English: The first two studies showed that BindRen was effective at controlling blood phosphate levels in patients with long-term kidney disease who were on dialysis.
Slovenian: Prvi dve študiji sta pokazali, da je zdravilo BindRen učinkovito pri nadzoru ravni fosfatov v krvi pri bolnikih z dolgotrajnim obolenjem ledvic, ki so na dializi.
English: The CHMP decided that BindRen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila BindRen večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.