natgillin/translations-raw huggingface dataset:
The implant may be removed by a simple surgical procedure if needed. 
Implantat se lahko po potrebi odstrani s preprostim kirurškim posegom.
Pharmacokinetic data for afamelanotide or any of its metabolites are very limited. 
Farmakokinetični podatki o afamelanotidu ali njegovih presnovkih so zelo omejeni.
The MAH shall also agree the details of the controlled access programme to ensure distribution of SCENESSE only to centres where the physicians received the educational materials and have been trained. 
Imetnik dovoljenja za promet z zdravilom se bo prav tako dogovoril glede programa z nadzorovanim dostopom, ki bo zagotavljal distribucijo zdravila Scenesse samo centrom, v katerih so zdravniki prejeli izobraževalno gradivo in opravili usposabljanje.
- Select a 14 gauge (1.6 mm inner diameter) catheter with needle. 
- Izberite kateter velikosti 14 G (z notranjim premerom 1,6 mm) z iglo.
It presumably undergoes hydrolysis within a short time; its metabolites' pharmacokinetics and pharmacodynamics are not understood yet. 
Predvidevajo, da je hitro izpostavljen hidrolizi; farmakokinetika in farmakodinamika njegovih presnovkov pa še ni znana.
Afamelanotide is a melanocortin receptor agonist and binds predominantly to the melanocortin-1 receptor (MC1R). 
Afamelanotid je agonist receptorjev melanokortina in se večinoma veže na receptor melanokortina-1 (MC1R).
Administration of afamelanotide may, therefore, result in increased production of eumelanin in the skin of the EPP patient independently of exposure to sunlight or artificial UV light. 
Farmakodinamični učinki Uporaba afamelanotida lahko posledično poveča tvorbo evmelanina v koži bolnika z EPP, ne glede na izpostavljenost sončni svetlobi ali umetni UV-svetlobi.
SCENESSE is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). 
Zdravilo Scenesse je indicirano za preprečevanje fototoksičnosti pri odraslih bolnikih z eritropoetsko protoporfirijo (EPP).
- Apply a small pressure dressing to the injection site. 
- Na mesto injiciranja namestite majhno kompresijsko obvezo.
The implant will be inserted by a doctor who has been trained in the administration procedure. 
Implantat bo vstavil zdravnik, ki se je usposobil za postopek vsaditve.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 implant 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 implantat
Afamelanotide is used to increase the tolerance to sunlight in adults with a confirmed diagnosis of erythropoietic protoporphyria (EPP). 
Afamelanotid se uporablja za povečanje odpornosti (tolerance) proti sončni svetlobi pri odraslih s potrjeno diagnozo eritropoetske protoporfirije (EPP).
It is unknown whether afamelanotide or any of its metabolites are excreted in breast milk. 
Ni znano, ali se afamelanotid ali njegovi presnovki izločajo v materino mleko.
A regular full body skin examination (every 6 months) is recommended to monitor all pigmentary lesions and other skin abnormalities. 
Priporočljivo je redno pregledovanje kože po celem telesu (vsakih 6 mesecev) zaradi spremljanja pigmentnih lezij in drugih kožnih sprememb.
There are no clinical data on the effects of afamelanotide on fertility. 
Kliničnih podatkov o učinkih afamelanotida na plodnost ni.
SPECIFIC OBLIGATIONS TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
System Organ Class Very common Common 
Organski sistem Zelo pogosti
Clinically significant disorders of the gastrointestinal, cardiovascular, respiratory, endocrine (including diabetes, Cushing's disease, Addison's disease, Peutz-Jeghers syndrome), neurological (including seizures) and haematological (especially anaemia) systems have not been evaluated. 
Klinično pomembne gastrointestinalne, kardiovaskularne, respiratorne, endokrine (vključno s sladkorno boleznijo, Cushingovo boleznijo, Addisonovo boleznijo, Peutz-Jeghersovim sindromom), nevrološke (vključno z epileptičnimi napadi) in hematološke motnje (predvsem anemije) niso bile ocenjene.
• Face to face training material, 
• gradivo za neposredno usposabljanje,
- Swollen eye lids, red eyes, dry eye, difficulty focusing on close objects, ringing in ears 
− otekle očesne veke, rdeče oči, suho oko, težave pri osredotočanju na predmete v bližini,
SCENESSE should only be prescribed by specialist physicians in recognised porphyria centres and administration should be performed by a physician trained and accredited by the marketing authorisation holder to administer the implant. 
Zdravilo Scenesse smejo predpisati samo specialisti v priznanih centrih za porfirijo, uporabljajo pa ga lahko samo zdravniki, ki jih je imetnik dovoljenja za promet z zdravilom usposobil in pooblastil za uporabo implantata.
- The other ingredient is poly (D,L-lactide-co-glycolide). 
- Druga sestavina zdravila je poli (D,L-laktid-ko-glikolid).
Afamelanotide is thought to mimic the endogenous compound's pharmacological activity by activating the synthesis of eumelanin mediated by the MC1R receptor. 
Domneva se, da afamelanotid posnema farmakološko delovanje endogene sestavine, tako da aktivira sintezo evmelanina, v katero je vključen receptor MC1R.
Prior to launch in Member States, the MAH shall establish a disease registry to gather long term safety data and outcome endpoints in patients with EPP. 
Pred dajanjem zdravila v promet v državah članicah bo imetnik dovoljenja za promet vzpostavil register bolezni, s katerim bo zbiral dolgoročne varnostne podatke in opazovane dogodke pri bolnikih z
What SCENESSE looks like and contents of the pack 
Izgled zdravila Scenesse in vsebina pakiranja
Patients taking substances which reduce coagulation, such as vitamin K antagonists (e.g. warfarin), acetylsalicylic acid and non-steroidal anti-inflammatory drug (NSAIDs) may experience increased bruising or bleeding at the site of implantation. 
Pri bolnikih, ki jemljejo učinkovine za zmanjševanje koagulacije, kot so denimo antagonisti vitamina K (npr. varfarin), acetilsalicilna kislina in nesteroidna protivnetna zdravila (NSAID), se lahko pojavi povečanje podplutb ali krvavitev na mestu vsaditve.
Animal studies are insufficient with respect to developmental toxicity (see section 5.3). 
Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmoževanja (glejte poglavje 5.3).
Blood urine present Biopsy skin 
prisotnost krvi v urinu, biopsija kože
Afamelanotide is a synthetic tridecapeptide and a structural analogue of α-melanocyte stimulating hormone (α-MSH). 
Afamelanotid je sintetični tridekapeptid in strukturni analog α-melanocit stimulirajočega hormona (α-MSH).
The implant can be surgically removed if needed. 
Po potrebi se lahko implantat kirurško odstrani.
- Wound complication, open wound 
− zapleti na rani, odprta rana.
A study in Sprague-Dawley rats showed no adverse effects on embryo-fetal development at exposures approximately 135-fold the human exposure (based on Cmax). 
Sprague-Dawley ni pokazala nobenih neželenih učinkov na razvoj zarodka in ploda pri izpostavljenosti, približno 135-krat večji kot pri človeku (na podlagi Cmax).
If such patients are treated they must be monitored after administration of every implant, including vital signs, routine haematology and biochemistry. 
Če se zdravilo uporablja pri takih bolnikih, jih je treba spremljati po vsaki vsaditvi implantata, vključno z vitalnimi znaki in rednimi hematološkimi ter biokemijskimi preiskavami.
The implant is a solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter in an amber glass vial sealed with a PTFE coated rubber stopper. 
Implantat je bela do umazano bela paličica z dolžino približno 1,7 cm in premerom 1,5 mm v rumenorjavi stekleni viali, zatesnjeni z gumijastim zamaškom, obloženim s PTFE.
Afamelanotide is a synthetic form of a body hormone called alpha-melanocyte stimulating hormone (α-MSH). 
Afamelanotid je sintetična oblika telesnega hormona, imenovanega alfa-melanocit stimulirajoči hormon (α-MSH).
Always verify the presence of the implant, if in doubt of its presence, check whether the implant has remained in the catheter. 
Če niste prepričani glede njegove prisotnosti, preverite, ali je implantat ostal v katetru.
- Transfer the implant to the outlet of the catheter. 
- Implantat prenesite na izhodno odprtino katetra.
Education and training programme for physicians 
• Dodatni ukrepi za zmanjševanje tveganj Program izobraževanja in usposabljanja za zdravnike
- The active substance is afamelanotide. 
- Učinkovina je afamelanotid.
Haematoma Diastolic hypertension Hypertension 
diastolična hipertenzija,
SCENESSE should not be used during breastfeeding. 
Uporabi zdravila Scenesse med dojenjem se je treba izogibati.
Solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter. 
Bela do umazano bela paličica z dolžino približno 1,7 cm in premerom 1,5 mm.
The following side effects are considered to be: 
Ti neželeni učinki so lahko:
If such patients are treated they must be monitored after each implant administration, including vital signs, routine haematology, and biochemistry. 
Če se zdravilo uporablja za take bolnike, jih je treba spremljati po vsaki vsaditvi implantata, vključno z vitalnimi znaki in rednimi hematološkimi ter biokemijskimi preiskavami.
- Anaesthetise the insertion area if deemed necessary and in consultation with the patient. 
- Anestezirajte mesto vboda, če menite, da je to potrebno, oziroma če to želi bolnik.
- Decrease white blood cells, abnormal liver function tests, decreased iron binding, increased cholesterol, increased sugar level, decreased blood iron level, increased blood pressure, blood in urine 
− zmanjšano število rdečih krvničk, nenormalne preiskave delovanja jeter, zmanjšana vezava železa, povišana raven holesterola, povišana raven sladkorja, znižana raven železa v krvi, povišan krvni tlak, kri v urinu;
In a fertility study no effects on the reproductive function of male or female Sprague-Dawley rats were observed after subcutaneous application of afamelanotide. 
V študiji plodnosti po subkutani uporabi afamelanotida niso opazili nobenih učinkov na razmnoževalno funkcijo samcev in samic podgan vrste Sprague-Dawley.
• Registry information sheet. 
• list z registracijskimi podatki.
Skin exfoliation Skin hypopigmentation Hair colour changes Hyperhidrosis 
hipopigmentacija kože, sprememba barve las, hiperhidroza
There is a risk of feeling drowsy and tired when using this medicine, especially within 72 hours of administration. 
Vpliv na sposobnost upravljanja vozil in strojev Pri uporabi tega zdravila ste lahko izpostavljeni tveganju za dremavost in utrujenost, predvsem v 72 urah po vsaditvi.
Pharmacotherapeutic group: Emollients and protectives, protectives against UV-radiation for systemic use, ATC code: D02BB02 
UV-sevanjem za sistemsko uporabo, oznaka ATC: D02BB02 Mehanizem delovanja
SCENESSE contains the active substance afamelanotide. 
Zdravilo Scenesse vsebuje učinkovino afamelanotid.
If you experience discomfort and are concerned, speak to your doctor. 
Če občutite neugodje ali ste zaskrbljeni, se posvetujte z zdravnikom.
Keep in mind that increased exposure to UV light will contribute to skin cancer development. 
UV-svetlobi prispevala k razvoju kožnega raka.
Afamelanotide may induce darkening of pre-existing pigmentary lesions due to its pharmacological effect. 
Afamelanotid lahko zaradi svojega farmakološkega učinka spodbudi potemnitev obstoječih pigmentnih lezij.
The adverse reactions reported during clinical trials conducted with afamelanotide are listed in the table below by MedDRA system organ class and frequency convention. 
Preglednica z neželenimi učinki Neželeni učinki, o katerih so poročali v kliničnih preskušanjih z afamelanotidom, so navedeni v spodnji preglednici glede na organske sisteme po MedDRA in naslednjo pogostnost.
Contents of the pack and other information 
Shranjevanje zdravila Scenesse Vsebina pakiranja in dodatne informacije
This finding is not considered relevant to human safety since the Harderian gland is not present in man. 
Ta ugotovitev ni pomembna za varnost pri človeku,
It is recommended that sun protection measures routinely adopted by each patient to manage their photosensitivity related to EPP and in accordance with their skin type (Fitzpatrick scale) are maintained during treatment with this medicinal product. 
Priporočljivo je, da vsak bolnik med zdravljenjem s tem zdravilom vzdržuje izvajanje običajnih rednih ukrepov za zaščito pred soncem, s katerimi obvladuje občutljivost za svetlobo, povezano z EPP, glede na svoj kožni tip (po Fitzpatrickovi lestvici).
Instruction for use 
Navodila za uporabo
- Palpitations, fast heart rate, bruising, high blood pressure, difficulty to make some sounds 
− palpitacije (občutek hitrega ali močnega utripanja srca), hiter srčni utrip, podplutbe, visok krvni tlak, težave pri proizvajanju nekaterih zvokov;
What you need to know before you receive SCENESSE 3. 
Kaj morate vedeti, preden boste prejeli zdravilo Scenesse Ne uporabljajte zdravila Scenesse:
These may include warfarin, acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever or to prevent blood clotting) and a group of medicines called non-steroidal antiinflammatory drug (NSAIDs), used to treat common ailments, such as arthritis, headaches, mild fever, rheumatism and sore throats. 
Ti lahko vključujejo varfarin, acetilsalicilno kislino (učinkovino v mnogih zdravilih, ki se uporabljajo za lajšanje bolečine, zniževanje zvišane telesne temperature ali preprečevanje strjevanja krvi) in skupino zdravil, imenovanih nesteroidna protivnetna zdravila, ki se uporabljajo za zdravljenje pogostih stanj,
This is recommended to be performed every 6 months. 
To je priporočljivo izvajati vsakih
There are no data available on symptoms or treatment of overdose with afamelanotide. 
4.9 Preveliko odmerjanje Podatki o simptomih ali zdravljenju prevelikega odmerjanja afamelanotida niso na voljo.
Administration should be performed by a physician trained and accredited by the marketing authorisation holder to administer the implant. 
Postopek mora opraviti zdravnik, ki ga je imetnik dovoljenja za promet z zdravilom usposobil in pooblastil za uporabo implantata.
- 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 
− 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;
This is because patients taking such medicines may experience increased bruising or bleeding at the site of the implant. 
Če bolnik jemlje taka zdravila, se lahko na mestu vsaditve pojavi povečanje podplutb in krvavitev.
If you suffer from continued drowsiness, then you should speak to your doctor. 
Če je dremavost stalna, se morate posvetovati z zdravnikom.
Inflammation was observed in the Harderian gland in the rat. 
Harderjevi žlezi pri podganah so opazili vnetje.
- 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 
− 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;
No clinical data are available on the use of afamelanotide in breastfeeding women. 
Klinični podatki o uporabi afamelanotida pri doječih materah niso na voljo.
One implant contains 16 mg of afamelanotide. 
En implantat vsebuje 16 mg afamelanotida.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Subcutaneous use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
- Remove the needle from within the catheter using a sterile technique. 
- S sterilno tehniko odstranite iglo iz notranjosti katetra.
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. 
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.
- 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. 
- 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.
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. 
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.
Type I amber glass vial sealed with a PTFE coated rubber stopper. 
Viala iz svetlorjavega stekla tipa I, zatesnjena z gumijastim zamaškom, obloženem s PTFE.
- Confirm insertion of the implant by palpating the skin with subcutis cranial to/overlying the suprailiac crest until the implant is located. 
- Vsaditev implantata potrdite s palpacijo kože, ki je nad/prekriva suprailiakalno kristo, dokler ne ugotovite mesta implantata.
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. 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): − splošne kožne spremembe, vključno s pegami in potemnitvijo kože;
- Heavy and prolonged period, abnormal period, breast tenderness, irregular periods, discharge from vagina, decreased sex drive 
− močna in podaljšana menstruacija, nenormalna menstruacija, občutljive dojke, neredna menstruacija, izcedek iz nožnice, zmanjšana spolna sla;
There are no or limited amounts of data from the use of afamelanotide in pregnant women. 
Nosečnost Podatkov o uporabi afamelanotida pri nosečnicah ni oziroma so omejeni.
LIST OF EXCIPIENTS Poly (DL-lactide-co-glycolide). 
SEZNAM POMOŽNIH SNOVI poli (DL-laktid-ko-glikolid)
EXP 
EPP.
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). 
preizkušancev, ki so prejeli zdravljenje s tem zdravilom, glavobol (20 %) in reakcije na mestu vsaditve
How to use SCENESSE 
Kako se daje zdravilo Scenesse
- 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 
− 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;
What SCENESSE contains 
Kaj vsebuje navodilo
- 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 
− 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;
What you need to know before you receive SCENESSE 
Kaj je zdravilo Scenesse in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Scenesse Kako se daje zdravilo Scenesse
Sensation of heaviness 
pekoč občutek,
- Chills, fever, flu, flu-like illness, blocked nose, blocked sinuses, inflamed nose and throat, nose inflammation 
− mrzlica, zvišana telesna temperatura, gripa, gripi podobna bolezen, zamašen nos, zamašeni sinusi, vnetje nosu in grla, vnetje nosu;
Lip swelling 
OVOJNINAH VIALA
- 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. 
- 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.
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. 
Namen dveh pregledov kože po celotnem telesu na leto je: - zgodnje odkrivanje kožnega raka in njegovih predznakov, ki jih povzroča izpostavljenost
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. 
- 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)
Palpitations Tachycardia 
Srčne bolezni palpitacije, tahikardija
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. 
- odkrivanje in spremljanje sprememb pigmentnih lezij, kar omogoča zgodnje odkrivanje melanoma.
Upper respiratory tract infection 
− okužbe zgornjih dihal (prehladi).
NAME OF THE MEDICINAL PRODUCT SCENESSE 16 mg implant 
IME ZDRAVILA Scenesse 16 mg implantat
If you get any side effects, talk to your doctor. 
Če opazite katerega koli neželenih učinkov, se posvetujte z zdravnikom.
Name and address of the manufacturer(s) responsible for batch release 
A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij
- Keep this leaflet. 
mehurčkasti izpuščaj,
Uncommon unspecified (incl cysts and polyps) Blood and lymphatic system disorders 
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
SCENESSE 16 mg implant afamelanotide 
Navodilo za uporabo Scenesse 16 mg implantat afamelanotid