natgillin/translations-raw huggingface dataset:
- Apply some pressure to the insertion area with your finger while removing the stylet and the catheter. 
- Prstom pritisnite područje umetanja prilikom uklanjanja stileta i katetera.
- Palpitations, fast heart rate, bruising, high blood pressure, difficulty to make some sounds 
- Osjećaj lupanja srca, ubrzani puls, modrice, visoki krvni tlak, poteškoće pri stvaranju određenih zvukova
Sensation of heaviness 
osjećaj težine,
The adverse reactions reported during clinical trials conducted with afamelanotide are listed in the table below by MedDRA system organ class and frequency convention. 
Nuspojave prijavljene tijekom kliničkih ispitivanja provedenih s afamelanotidom navedene su u tablici niže u tekstu prema MedDRA klasifikaciji organskih sustava i učestalosti.
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. 
Klinički značajni poremećaji gastrointestinalnog, kardiovaskularnog, respiratornog, endokrinog sustava (uključujući dijabetes, Cushingovu bolest, Addisonovu bolest, Peutz-Jeghersov sindrom), neurološki (uključujući napadaje) i hematološki poremećaji (posebice anemija) nisu ocijenjeni.
• Risk management plan (RMP) The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP. 
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
Afamelanotide is a synthetic form of a body hormone called alpha-melanocyte stimulating hormone (α-MSH). 
Afamelanotid je sintetski oblik tjelesnog hormona naziva alfa-melanocit stimulirajući hormon (α-MSH).
Inflammation was observed in the Harderian gland in the rat. 
U štakora je zabilježena upala u Harderovoj žlijezdi.
Afamelanotide is thought to mimic the endogenous compound's pharmacological activity by activating the synthesis of eumelanin mediated by the MC1R receptor. 
Smatra se da afamelanotid oponaša farmakološko djelovanje endogenog spoja aktivirajući sintezu eumelanina putem receptora MC1R.
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. 
To mogu biti varfarin, acetilsalicilatna kiselina (tvar prisutna u mnogim lijekovima koji se koriste za ublažavanje boli i snižavanje vrućice ili za sprječavanje zgrušavanja krvi) i skupina lijekova zvanih nesteroidni protuupalni lijekovi (NSAIL), koji se koriste za liječenje uobičajenih tegoba, poput artritisa, glavobolje, blaže vrućice, reumatizma i grlobolje.
Implant. 
OBLIK Implantat.
Prior to launch of SCENESSE in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational package, including communication media, distribution modalities, and any other aspects, with the National Competent Authority. 
Program edukacije i obuke za liječnike Prije stavljanja lijeka SCENESSE u promet u svakoj pojedinoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora usuglasiti s nadležnim nacionalnim tijelom sadržaj i oblik edukacijskog paketa, uključujući medij komunikacije, način distribucije i sve druge aspekte.
Store in a refrigerator (2˚C - 8˚C) 
6.4 Posebne mjere pri čuvanju lijeka Čuvati u hladnjaku (2˚C - 8˚C)
If such patients are treated they must be monitored after administration of every implant, including vital signs, routine haematology and biochemistry. 
Ako se ovi bolesnici liječe, mora ih se pratiti nakon primjene svakog implantata, uključujući vitalne znakove, rutinske hematološke i biokemijske parametre.
SPECIFIC OBLIGATIONS TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
Pack of one vial containing one implant. 
Pakiranje od jedne bočice koja sadrži jedan implantat.
The implant is given as injection under your skin using a catheter tube and needle (subcutaneous use). 
Implantat se umeće injekcijom pod kožu pomoću kateterske cjevi i igle (supkutana primjena).
Depression Depressed mood Insomnia 
Psihijatrijski poremećaji depresija, depresivno raspoloženje, nesanica,
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. 
Bolesnici koji uzimaju tvari koje smanjuju koagulaciju, poput antagonista vitamina K (primjerice varfarin), acetilsalicilatne kiseline i nesteroidnih protuupalnih lijekova (NSAIL) mogu iskusiti pojačano stvaranje modrica ili krvarenje na mjestu implantacije.
Solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter. 
Krut bijeli do gotovo bijeli štapić dužine otprilike 1,7 cm i promjera 1,5 mm.
- 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. 
- S ukošenim vrhom igle okrenutim prema gore, uvedite kateter lateralno 1,5 do 2 cm u supkutani sloj pod kutom od 30 do 45 stupnjeva u odnosu na površinu kože jednim kontinuiranim fluidnim pokretom.
- With the catheter in place, aseptically remove the implant from the vial. 
Nakon što je kateter postavljen, aseptički izvadite implantat iz bočice.
Poly (DL-lactide-co-glycolide) 
poli (DL-laktid-ko-glikolid).
There are no data available on symptoms or treatment of overdose with afamelanotide. 
Nema dostupnih podataka o simptomima ili liječenju predoziranja afamelanotidom.
If such patients are treated they must be monitored after each implant administration, including vital signs, routine haematology, and biochemistry. 
Ako se ovakvi bolesnici liječe, mora ih se pratiti nakon svake primjene implantata, uključujući vitalne znakove, rutinske hematološke i biokemijske parametre.
• Methods to prevent or minimise application errors and application site reactions Registry information sheet shall contain the following key messages: 
• metode sprječavanja ili minimiziranja pogrešaka prilikom primjene i reakcija na mjestu primjene
Following administration of this medicinal product, somnolence, fatigue, dizziness, and nausea have been reported. 
Nakon primjene ovog lijeka, prijavljeni su slučajevi somnolencije, umora, omaglice i mučnine.
There are no clinical data on the effects of afamelanotide on fertility. 
Ne postoje klinički podaci o utjecaju afamelanotida na plodnost.
• Registry information sheet. 
• obrazac s informacijama o registru.
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 kruti bijeli do gotovo bijeli štapić dužine otprilike 1,7 cm i promjera 1,5 mm u smeđoj staklenoj bočici zatvorenoj gumenim čepom obloženim PTFE-om.
The implant is inserted directly under the skin folds on your waist or abdomen in an area known as the supra-iliac crest. 
Implantat se umeće izravno ispod kožnog nabora na struku ili trbuhu u iznad područja koje se zove ilijačni greben.
• Face to face training material, 
• materijal za individualnu obuku,
Pack size of one vial containing one implant. 
Veličina pakiranja od jedne bočice koja sadrži jedan implantat.
- Transfer the implant to the outlet of the catheter. 
- Prenesite implantat do otvora katetera.
SCENESSE contains the active substance afamelanotide. 
SCENESSE sadrži djelatnu tvar afamelanotid.
The face to face training material, including the educational video, shall contain the following key messages: 
Obrazac s informacijama o registru mora sadržavati sljedeće ključne poruke:
Decreased appetite Hypercholesterolaemia Increased appetite 
Smanjeni apetit hiperkolesterolemija,
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. 
Tijekom liječenja ovim lijekom preporučuje se održavanje mjera zaštite od sunca koje je rutinski usvojio svaki bolesnik za zbrinjavanje svoje fotoosjetljivosti povezane s EPP-om u skladu sa svojim tipom kože (Fitzpatrickova ljestvica).
QUALITATIVE AND QUANTITATIVE COMPOSITION The implant contains 16 mg of afamelanotide. 
KVALITATIVNI I KVANTITATIVNI SASTAV Implantat sadrži 16 mg afamelanotida.
Administration should be performed by a physician trained and accredited by the marketing authorisation holder to administer the implant. 
Primjenu treba provesti liječnik koji je obučen i ovlašten od strane nositelja odobrenja za primjenu implantata.
How to use SCENESSE 
Kako čuvati SCENESSE
In a fertility study no effects on the reproductive function of male or female Sprague-Dawley rats were observed after subcutaneous application of afamelanotide. 
U ispitivanju plodnosti nisu uočeni učinci na reproduktivnu funkciju mužjaka ni ženki Sprague
One implant contains 16 mg of afamelanotide. 
Jedan implantat sadrži 16 mg afamelanotida.
Special caution is warranted in patients with an - individual or family history of melanoma (inclusive of in-situ melanoma, e.g. lentigo maligna) 
Poseban oprez je potreban u bolesnika s - osobnom ili obiteljskom anamnezom melanoma (uključujući melanom in situ, primjerice lentigo maligna) ili sa suspektnom ili potvrđenom sklonosti kožnom melanomu (CMM1,
Afamelanotide is a synthetic tridecapeptide and a structural analogue of α-melanocyte stimulating hormone (α-MSH). 
Afamelanotid je sintetski tridekapeptid i strukturalni analog α-melanocit stimulirajućeg hormona
Instruction for use 
15. UPUTE ZA UPORABU
Type I amber glass vial sealed with a PTFE coated rubber stopper. 
I zatvorena gumenim čepom obloženim PTFE-om.
- 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. 
- Sterilnom tehnikom primite kateter u bazi katetera, te s dva prsta uštipnite i držite nabor kože na mjestu koje je iznad ili prekriva bolesnikov ilijačni greben.
Afamelanotide may induce darkening of pre-existing pigmentary lesions due to its pharmacological effect. 
Uslijed farmakološkog djelovanja, afamelanotid može uzrokovati tamnjenje prethodno postojećih pigmentacijskih lezija.
Haematoma Diastolic hypertension Hypertension 
dijastolička hipertenzija,
- Wound complication, open wound 
krv u urinu - Komplikacije rana, otvorena rana
• Demonstration of the correct application technique, highlighting the measures needed to ensure the implant is not damaged during use. 
Materijal za individualnu obuku, uključujući edukacijski video, obuhvaća sljedeće ključne poruke: • demonstraciju ispravne tehnike primjene, naglašavajući mjere potrebne kako bi se osiguralo da se implantat ne ošteti tijekom uporabe.
Disease registry 
Registar bolesti
Women of childbearing potential have to use effective contraception during treatment with SCENESSE and for a period of three months thereafter. 
Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom
Pre- and post-natal development of Sprague-Dawley rats was not affected at exposures of about 135-times the human exposure (based on Cmax). 
Sprague-Dawley štakora pri otprilike 135 puta većoj izloženosti od izloženosti u ljudi (na temelju
- 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. 
- anemiju (nizak broj crvenih krvnih stanica u krvi). - melanom (agresivan tip raka kože), uključujući melanom in situ, primjerice lentigo maligna; ili ako imate određena nasljednja stanja koja povećavaju rizik od razvoja melanoma. - rak kože sljedećih tipova: karcinom bazalnih stanica ili karcinom pločastih stanica (uključujući karcinom in situ, primjerice Bowenovu bolest), karcinom Merkelovih stanica ili drugi maligni ili predmaligni problemi kože.
- Apply a small pressure dressing to the injection site. 
- Na ubodno mjesto primijenite mali kompresivni zavoj.
- Remove the needle from within the catheter using a sterile technique. 
- Primjenom sterilne tehnike izvadite iglu iz unutrašnjosti katetera.
- 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 
- Bol u zglobovima, mišićna bol, bol u rukama i nogama, iznenadne mišićne kontrakcije, bol u mišićima i kostima, ukočenost mišića i kosti, ukočenost zglobova, bol u preponama, osjećaj težine, oticanje donjih udova
Over time the implant will be absorbed by the body, this will happen within 50 to 60 days after implantation. 
To će se dogoditi 50 do 60 dana nakon ugradnje.
- 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 
- Bol, oticanje oko mjesta ugradnje implantata, modrice na mjestu injekcije, nadraženost na mjestu injekcije, povećanje na mjestu implantata, svrbež na mjestu implantata, ispadanje implantata, promjena boje kože na mjestu implantata
Eumelanin contributes to photoprotection through different mechanisms including: - strong broadband absorption of UV and visible light, where eumelanin acts as a filter - antioxidant activity through scavenging of free radicals; and - inactivation of the superoxide anion and increased availability of superoxide dismutase to reduce oxidative stress. 
Eumelanin doprinosi fotozaštiti putem različitih mehanizama uključujući: - snažnu širokopojasnu apsorpciju UV i vidljivog svjetla, pri čemu eumelanin djeluje kao filtar
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. 
Dva pregleda kože cijeloga tijela godišnje namijenjena su: - ranom otkrivanju svih vrsta raka kože i njegovih prekursora uzrokovanih izlaganjem UV
Haemangioma 
hemangiom
There are no or limited amounts of data from the use of afamelanotide in pregnant women. 
Nema podataka ili su podaci o primjeni afamelanotida u trudnica ograničeni.
- Confirm insertion of the implant by palpating the skin with subcutis cranial to/overlying the suprailiac crest until the implant is located. 
- Palpacijom kože potvrdite umetanje implantata u potkožno tkivo na mjestu koje je iznad ili prekriva ilijačni greben sve dok ne locirate implantat.
Back pain 
- bol u leđima
Abdominal pain Abdominal pain upper Diarrhoea 
Mučnina bol u abdomenu bol u gornjem dijelu abdomena Proljev
- 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 
- Povećana glad, mučnina nakon umetanja implantata, probavne tegobe, infekcija u želucu i crijevima, upaljen želudac i crijeva, žgaravica, upaljen želudac, neredovito pražnjenje crijeva, vjetrovi, napuhnut trbuh, bol u trbuhu
Due to limited data in treatment of elderly patients, the use of afamelanotide is not recommended (see section 4.4). 
Zbog ograničenih podataka o liječenju starijih bolesnika, primjena afamelanotida se ne preporučuje
Liver function test abnormal Transaminases increased Transferrin saturation decreased 
poremećene vrijednosti testa jetrene funkcije, povišene transaminaze,
Blood cholesterol increased Blood glucose increased Blood iron decreased Blood pressure diastolic increased 
povišen kolesterol, povišene razine šećera, smanjene razine željeza u krvi, povišen krvni tlak,
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Presence of severe hepatic disease - Hepatic impairment (see section 5.2) - Renal impairment (see section 5.2) 
- Oštećenje funkcije jetre (vidjeti dio 5.2) - Oštećenje funkcije bubrega (vidjeti dio 5.2)
Upper respiratory tract infection 
- infekcije gornjih dišnih putova (prehlade).
- 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, nesanica, slaba kvaliteta sna, nesvjestica, osjećaj nesvjestice, padanje, mamurnost, slabost, nekontrolirani poriv za pokretanje nogu zbog neugodnog osjećaja u nogama, povećana osjetljivost na dodir, glavobolja nakon ozljede, osjećaj žarenja, nenormalan osjet okusa - Nateknuti očni kapci, crvene oči, suho oko, poteškoće s fokusiranjem na predmete koji su blizu,
AUTHORISATION 
Efelidi
- Heavy and prolonged period, abnormal period, breast tenderness, irregular periods, discharge from vagina, decreased sex drive 
- Obilna i produljena mjesečnica, nenormalna mjesečnica, osjetljivost dojki, neredovite mjesečnice, iscjedak iz rodnice, smanjeni seksualni nagon
How SCENESSE is stored 
Kako se primjenjuje SCENESSE
Melanocytic naevus Pigmentation disorder Skin discolouration Skin hyperpigmentation Ephelides 
Poremećaj pigmentacije Promjena boje kože Hiperpigmentacija kože
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Subcutaneous use 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
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. 
MIM #155600, sinonimi: obiteljski sindrom atipičnog madeža-malignog melanoma, FAMMM; sindrom displastičnih nevusa, DNS; sindrom B-K madeža; CMM2 MIM #155601)
- Chills, fever, flu, flu-like illness, blocked nose, blocked sinuses, inflamed nose and throat, nose inflammation 
- Inficirani folikuli kose, gljivična infekcija, infekcija mokraćnog sustava - Zimice, vrućica, gripa, bolest nalik gripi, začepljen nos, začepljeni sinusi, upaljen nos i grlo,
Procedural nausea 
mučnina tijekom postupka,
• Summary of product characteristics, 
• sažetak opisa svojstava lijeka,
NAME OF THE MEDICINAL PRODUCT SCENESSE 16 mg implant 
NAZIV LIJEKA SCENESSE 16 mg implantat
No clinical data are available on the use of afamelanotide in breastfeeding women. 
Nema dostupnih kliničkih podataka o primjeni afamelanotida u dojilja.
- Inflamed lips, lip swelling, colouration on lip, gum pain, toothache, discoloured gums, reduced sense of touch in mouth, lip discolouration, tongue discolouration 
- Upaljene usnice, oticanje usnica, obojanost usnice, bol u zubnom mesu, zubobolja, promjena boje zubnog mesa, smanjeni osjet dodira u ustima, promjena boje usnice, promjena boje jezika
- The active substance is afamelanotide. 
Što SCENESSE sadrži - Djelatna tvar je afamelanotid.
Aspartate aminotransferase increased 
Povišena razina kreatin fosfokinaze u krvi povišena alaninaminotransferaza, povišena aspartataminotransferaza,
Flushing Hot flush 
- navale vrućine
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SCENESSE 16 mg implant afamelanotide 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA SCENESSE 16 mg implantat afamelanotid
SCENESSE 16 mg implant afamelanotide 
NAZIV LIJEKA SCENESSE 16 mg implantat afamelanotid
Gingival discolouration 
Tablični prikaz nuspojava
Blood urine present Biopsy skin 
povišen dijastolički krvni tlak, prisutnost krvi u urinu, biopsija kože,
- Mark 1.5 to 2 cm on the catheter shaft using surgical ink. 
- Na trupu katetera označite kirurškom tintom 1,5 do 2 cm.
If you suffer from continued drowsiness, then you should speak to your doctor. 
Ako omamljenost ne prestaje, obratite se svom liječniku.
Eye disorders 
zujanje u ušima
Injury, poisoning and procedural complications 
Ozljede, trovanja i proceduralne komplikacije komplikacija rane, otvorena rana, pad,
Gastroesophageal reflux disease 
Retrospektivno ispitivanje s pregledom kartona bolesnika
Lip oedema 
RMP-a.
Myalgia 
mijalgija,
Palpitations Tachycardia 
Srčani poremećaji palpitacije, tahikardija,
- 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 
akne, ekcemi, sekrecije na koži, guljenje kože, koža s gubitkom boje, promjene u boji kose, prekomjerno znojenje
Uncommon unspecified (incl cysts and polyps) Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava leukopenija
Menorrhagia Dysmenorrhoea Breast tenderness Menstruation irregular Vaginal discharge Libido decreased 
Poremećaji reproduktivnog sustava i dojki menoragija, dismenoreja, osjetljivost dojki, neredovite menstruacije, vaginalni iscjedak, smanjeni libido,
STATEMENT OF ACTIVE SUBSTANCE(S) Each implant contains 16 mg afamelanotide. 
Svaki implantat sadrži 16 mg afamelanotida.
Eyelid oedema Ocular hyperaemia Dry eye 
okularna hiperemija, suho oko, prezbiopija,
- decreased appetite; - fatigue (tiredness), - dizziness, drowsiness and weakness; - hot flushes; - upper respiratory tract infections (colds). 
- iscrpljenost (umor) - omaglica, omamljenost i slabost
Lip swelling 
(α-MSH).
Pain in extremity Muscle spasm Musculoskeletal pain Musculoskeletal stiffness Joint stiffness Groin pain 
mišićno-koštana ukočenost, ukočenost zglobova,
- 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 
- Smanjenje broja bijelih krvnih stanica, abnormalan test funkcije jetre, smanjeno vezanje željeza,
Neoplasms benign, malignant and 
san slabe kvalitete, disgeuzija,
Cardiac disorders 
Krvožilni poremećaji
Nausea 
- mučnina
Injection site haematoma Injection site irritation 
Hematom na mjestu implantata
NAME OF THE MEDICINAL PRODUCT SCENESSE 16 mg implant afamelanotide 
Uputa o lijeku: Informacije za bolesnika SCENESSE 16 mg implantat afamelanotid
Infections and infestations 
- proljev i povraćanje
- Infected hair follicle, fungal infection, urinary tract infection 
Infekcije i infestacije infekcija gornjih dišnih putova influenca, gastrointestinalna infekcija, gastroenteritis, folikulitis, kandidijaza, nazofaringitis,
The recommended dose is one tablet a day. 
Preporučena je doza jedna tableta na dan.
Further information on Biktarvy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Više informacija o lijeku Biktarvy možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.