natgillin/translations-raw huggingface dataset:
Firazyr is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml. 
Zdravilo Firazyr je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski stekleni brizgi (3 ml).
In case of insufficient relief or recurrence of symptoms after self-treatment or administration by a caregiver, it is recommended that the patient or caregiver should seek medical advice. 
Če lajšanje simptomov po samoinjiciranju ali injiciranju, ki ga izvede negovalec ni zadostno ali se ti simptomi ponavljajo, se priporoča, da se bolnik ali negovalec obrneta na zdravnika.
- If you are not sure which dose to inject, ask your doctor, pharmacist or nurse. 
- Če niste prepričani, kateri odmerek je treba injicirati, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
In case of insufficient relief or recurrence of symptoms, a second injection of Firazyr can be administered after 6 hours. 
V primeru nezadostnega olajšanja ali ponovitve simptomov se lahko bolniku po 6 urah da druga injekcija zdravila Firazyr.
If you are breast-feeding you should not breast-feed for 12 hours after you have last received Firazyr. 
Če dojite, ne smete dojiti še 12 ur po zadnji uporabi zdravila Firazyr.
Accordingly, caution should be observed in the administration of icatibant to patients in the weeks following a stroke. 
Zato je pri dajanju ikatibanta bolnikom v tednih po možganski kapi potrebna previdnost.
Hepatic and Renal Impairment Limited data suggest that icatibant exposure is not influenced by hepatic or renal impairment. 
Jetrna in ledvična okvara Sicer pomanjkljivi podatki kažejo na to, da okvara jeter ali ledvic ne vpliva na izpostavljenost ikatibantu.
There are no observed differences in the exposure to icatibant between HAE patients with and without an attack. 
Pri bolnikih s HAE niso opazili razlik pri izpostavljenosti ikatibantu med bolnikih, ki so imeli napad in bolniki, ki napada niso imeli.
• Clean the work area (surface) to be used before beginning the process. 
1) Splošne informacije • Preden začnete postopek, očistite delovno površino.
Ischemic heart disease 
Ishemična bolezen srca
• Clean the injection site with a rubbing alcohol pad and allow it to dry. 
• Mesto injiciranja očistite s kosmom vate prepojenim z medicinskim alkoholom, potem pa počakajte, da se posuši.
Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received Firazyr. 
Nemudoma obvestite svojega zdravnika, če opazite, da so se simptomi napada po uporabi zdravila
Firazyr is injected with a short needle into the fatty tissue under the skin in the abdomen (tummy). 
Zdravilo Firazyr se injicira s kratko iglo v maščobno tkivo pod kožo v predelu trebuha.
Do not use this medicine after the expiry date stated on the label after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
For patients who have never received Firazyr previously, the first treatment should be given in a medical institution or under the guidance of a physician. 
Injiciranje, ki ga izvede negovalec/samoinjiciranje Pri bolnikih, ki še nikoli niso prejeli zdravila Firazyr, je treba prvo injiciranje opraviti v zdravstveni ustanovi ali pod zdravnikovim nadzorom.
The following step-by step instructions are intended for: - self-administration (adults) - administration by a caregiver or healthcare professional to adults, adolescents or children aged over 2 years (weighing at least 12 kg). 
Naslednja navodila za uporabo zdravila po korakih so namenjena: - samoinjiciranju (odrasli), - injiciranju pri odraslih, mladostnikih ali otrocih, starejših od 2 let (ki tehtajo najmanj
Adrenal gland hypertrophy was seen to reverse after cessation of icatibant treatment. 
Opazili so, da je hipertrofija nadledvične žleze po prenehanju zdravljenja z ikatibantom reverzibilna.
Almost all patients receiving Firazyr will experience a reaction at the site of the injection (such as skin irritation, swelling, pain, itchiness, redness of the skin and burning sensation). 
Skoraj vsi bolniki, ki prejemajo zdravilo Firazyr, občutijo reakcijo na mestu injiciranja (kot so draženje kože, otekanje, bolečina, srbenje, rdečina in pekoč občutek).
Pack size of one pre-filled syringe with one needle or a multipack containing three pre-filled syringes with three needles. 
Posamično pakiranje z eno napolnjeno injekcijsko brizgo in eno iglo ali skupno pakiranje, ki vsebuje tri napolnjene injekcijske brizge in tri igle.
• Keeping the syringe in one hand, use your other hand to gently hold a fold of skin between your thumb and fingers at the previously disinfected injection site. 
• Brizgo držite v eni roki, z drugo pa kožno gubo na predhodno razkuženem mestu nežno primitemed palcem in preostalimi prsti.
Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). 
Vsaka napolnjena brizga vsebuje 30 miligramov ikatibanta (v obliki acetata).
All adverse reactions from post-marketing experience are italicised. 
Vsi neželeni učinki iz obdobja trženja zdravila so napisani v poševnem tisku.
Thirty-one patients received a single dose of icatibant and 1 patient (an adolescent) received icatibant for two HAE attacks (in total, two doses). 
Enaintrideset bolnikov je prejelo enkraten odmerek ikatibanta, 1 bolnik (mladostnik), pa je prejel ikatibant za dva napada HAE
At 1 and 2 hours post treatment, approximately 50% and 90% of patients experienced onset of symptom relief, respectively. 
Po 1 uri po odmerjanju zdravila se je izboljšanje simptomov pojavilo pri 50 %, po 2 urah pa pri 90 % bolnikov.
All patients received at least one dose of icatibant (0.4mg/kg body weight up to a maximum dose of 30 mg) and the majority of patients were followed up for a minimum of 6 months. 
Vsi bolniki so prejeli vsaj en odmerek ikatibanta (0,4mg/kg telesne mase do največjega odmerka 30 mg),
The solution should be clear and colourless and free from visible particles. 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Raztopina mora biti bistra in brezbarvna ter brez vidnih delcev.
3 ml of solution in a 3 ml pre-filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer). 
3 ml raztopine v 3 ml napolnjeni injekcijski brizgi (steklo tipa I) z batno zaporko (bromobutil,
Almost all subjects who were treated with subcutaneous icatibant in clinical trials developed reactions at the site of injection (characterised by skin irritation, swelling, pain, itchiness, erythema, burning sensation). 
Skoraj pri vseh bolnikih, ki so subkutano prejemali ikatibant v kliničnih preskušanjih, so se pojavile reakcije na mestu injiciranja (za katere so značilni draženje kože, otekanje, bolečina, srbenje, eritem, pekoč občutek).
If you are not sure which volume of solution to extract, ask your doctor, pharmacist or nurse 
Če niste prepričani, kakšno prostornino raztopine morate izvleči, vprašajte zdravnika, farmacevta ali medicinsko sestro.
Remove the seal from the needle cap (the needle should be still in the needle cap). 
• S pokrovčka za iglo odstranite tesnilo (pri tem mora igla ostati v pokrovčku).
Efficacy results for FAST-3 Efficacy Results: FAST-3; Controlled Phase -- ITT population 
(N = 56) Tabela 4: Rezultati študije FAST-3 za učinkovitost Rezultati za učinkovitost: FAST-3; nadzorovana faza - populacija, ki so jo nameravali zdraviti (ITT)
Solution for injection One pre-filled syringe One 25G needle 
Raztopina za injiciranje Ena napolnjena injekcijska brizga in ena igla 25 G.
The primary endpoint was time to onset of symptom relief assessed using a 3-item composite visual analog score (VAS-3) consisting of assessments of skin swelling, skin pain, and abdominal pain. 
Ocenili so ga s sestavljeno vizualno analogno lestvico s tremi postavkami (VAS-3), ki je vključevala oceno otekanja na koži, bolečine na koži in bolečine v trebuhu.
Your doctor will tell you when it is safe for you to go home. After discussion with your doctor or nurse and after training in subcutaneous (under the skin) injection technique, you may be able to inject yourself with Firazyr or your caregiver may inject Firazyr for you when you have an HAE attack. 
Po pogovoru z zdravnikom ali medicinsko sestro in po usposabljanju o tehniki subkutanega (podkožnega) injiciranja si boste ob napadu hereditarnega angioedema zdravilo Firazyr injicirali sami ali vam ga bo injiciral vaš negovalec.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTI-PACK (INCLUDING BLUE BOX) 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z »BLUE BOX« PODATKI)
- If your symptoms are not resolved following one self- or caregiver administered injection of Firazyr, you should seek medical advice regarding additional injections of Firazyr. 
- Če simptomi po enem samoinjiciranju zdravila Firazyr ne izginejo, se obrnite na zdravnika, ki vam bo svetoval glede nadaljnjega injiciranja zdravila Firazyr.
Refer to table 1 for dosage information. 
Informacije o odmerjanju so v preglednici 1.
2) Screw the connector onto the pre-filled syringe. 
2) Privijte vmesnik na napolnjeno injekcijsko brizgo.
Acetic acid, glacial (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections 
natrijev hidroksid (za uravnavanje pH)
No dose adjustment is required in patients with hepatic impairment. 
Pri bolnikih z okvaro jeter prilagoditev odmerka ni potrebna.
Population pharmacokinetic modelling using both adult and paediatric data showed that clearance of icatibant is related to body weight with lower clearance values noted for lower body weights in the paediatric HAE population. 
Populacijsko farmakokinetično modeliranje, pri katerem so uporabili podatke, zbrane pri odraslih in pediatričnih bolnikih, je pokazalo, da je očistek ikatibanta povezan s telesno maso.
1) To start transfer of icatibant solution, push the pre-filled syringe plunger (on far left of below image). 
1) Prenos raztopine ikatibanta sprožite tako, da potisnete bat napolnjene injekcijske brizge (čisto levo na spodnji sliki).
Median time to regression of symptoms, by patient (hours) 
Mediana časa do zmanjšanja simptomov, po oceni bolnika (v urah)
- This medicine has been prescribed for you only. 
- Zdravilo je predpisano vam osebno in ga ne smete dajati drugim.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA POSAMIČNO PAKIRANJE
Contains: acetic acid glacial, sodium hydroxide, sodium chloride, water for injections. 
SEZNAM POMOŽNIH SNOVI Pomožne snovi: koncentrirana ocetna kislina, natrijev hidroksid, natrijev klorid, voda za injekcije.
There is limited experience with treatment of more than one HAE attack with Firazyr in the paediatric population. 
Pri pediatrični populaciji je malo izkušenj z zdravljenjem več kot enega napada HAE z zdravilom
Firazyr may be self-administered or administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional. 
Zdravilo Firazyr lahko bolnik sam ali njegov negovalec uporabi, šele ko ga je zdravstveni delavec poučil o tehniki subkutanega injiciranja.
In addition: - You or your caregiver must be trained on subcutaneous (under the skin) injection technique before you self-inject or your caregiver injects you with Firazyr. 
Poleg tega: - Preden si sami injicirate zdravilo Firazyr ali vam ga injicira negovalec, se morate vi ali vaš negovalec poučiti o tehniki subkutanega (podkožnega) injiciranja.
5) Discard the pre-filled syringe and connector into the sharps container. 
5) Zavrzite napolnjeno injekcijsko brizgo in vmesnik v posodo za ostre predmete.
An open label, non-randomised single-arm study (HGT-FIR-086) was performed with a total of 32 patients. 
Pediatrična populacija Pri skupno 32 bolnikih so izvedli odprto, nerandomizirano študijo z eno skupino (HGT-FIR-086).
- Immediately after you self-inject Firazyr or your caregiver injects you with Firazyr while you are experiencing a laryngeal attack (obstruction of the upper airway), you must seek medical care in a medical institution. 
- Če si zdravilo Firazyr injicirate med laringealnim napadom (neprehodnost zgornjih dihal) ali vam ga injicira negovalec, se morate takoj po tem obrniti na zdravniško pomoč v zdravstveni ustanovi.
Dose (Injection Volume) 
Odmerek (prostornina injiciranega zdravila)
- The recommended dose of Firazyr is one injection of 1 ml up to a maximum of 3 ml based on body weight injected subcutaneously (under the skin) as soon as you develop symptoms of an angioedema attack (for example increased skin swelling, particularly affecting the face and neck, increasing tummy pain). 
Otroci in mladostniki, stari od 2 do 17 let - Priporočeni odmerek zdravila Firazyr je ena injekcija z odmerkom od 1 ml do največ 3 ml glede na telesno maso, injicirana subkutano (pod kožo) takoj, ko se pojavijo simptomi napada angioedema (npr. povečano otekanje kože, ki delno zajame obraz in vrat, okrepljene bolečine v trebuhu).
Patients experiencing a laryngeal attack should always seek medical advice and be observed in a medical institution also after having taken the injection at home. 
Podatkov o dajanju nadaljnjih odmerkov pri istem napadu pri mladostnikih ali otrocih ni. Bolnik z laringealnim napadom se mora vedno obrniti na zdravnika in ga je treba opazovati v zdravstveni ustanovi, tudi če si je zdravilo injiciral že doma.
Firazyr is not recommended for use in children under 2 years of age or weighing less than 12 kg because it has not been studied in these patients. 
manjšo od 12 kg, ker pri teh bolnikih študije niso bile izvedene.
Each ml of the solution contains 10 mg of icatibant. 
En mililiter raztopine vsebuje 10 mg ikatibanta.
Median time to almost complete symptom relief (hours) 
Čas do skoraj popolnega lajšanja simptomov (ure)
Firazyr is intended for subcutaneous administration preferably in the abdominal area. 
Zdravilo Firazyr je namenjeno subkutani uporabi, najbolje v predelu trebuha.
Special populations 
populaciji
If you get any side effects talk to your doctor. 
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
Refer to the patient information leaflet for instructions for use. 
Glejte navodilo za uporabo glede navodil za uporabo zdravila.
- See section on instructions for use for the dose to inject. 
- Za odmerek, ki ga je treba injicirati, glejte navodilo za uporabo zdravila.
12.0 All episodes (N = 56) 
12,0 Vse epizode
1) Remove the caps on each end of the connector. 
1) Odstranite pokrovčka z obeh strani vmesnika.
4) Remove the pre-filled syringe and connector from the graduated syringe. 
4) Odstranite napolnjeno injekcijsko brizgo in vmesnik z brizge z oznakami za prostornino.
A total of 66 patients with attacks of HAE affecting the larynx were treated in these controlled Phase III clinical trials. 
V teh nadzorovanih kliničnih preskušanjih 3. faze je bilo zdravljenih skupno 66 bolnikov s HAE, ki so prizadeli grlo.
• Open the tray by peeling back the seal. 
• Odprite podstavek, tako da tesnilo povlečete nazaj.
3) Preparing the injection site 
Priprava mesta injiciranja
51 kg to 65 kg 
Od 51 kg do 65 kg
Firazyr 30 mg solution for injection in pre-filled syringe Icatibant 
Firazyr 30 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ikatibant
No dose adjustment is required in patients with renal impairment. 
Pri bolnikih z okvaro ledvic prilagoditev odmerka ni potrebna.
If you are taking a medicine known as an Angiotensin Converting Enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) which is used to lower your blood pressure or for any other reason, you should inform your doctor before receiving Firazyr. 
Če jemljete zdravilo, znano kot zaviralec angiotenzin konvertaze (zaviralec ACE) (na primer: kaptopril, enalapril, ramipril,
Firazyr 30 mg solution for injection in pre-filled syringe 
Firazyr 30 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Rash Erythema Pruritus 
izpuščaj eritem pruritus urtikarija
Remove the needle cap from the blister. 
• Iz pretisnega omota odstranite pokrovček za iglo.
The active substance is icatibant. 
Zdravila učinkovina je ikatibant.
• Remove the pre-filled syringe from the tray. 
• Napolnjeno injekcijsko brizgo odstranite iz podstavka.
• 3 ml (recommended) graduated syringe 
• brizga z oznakami prostornine velikosti 3 ml (priporočena).
The recommended dose of Firazyr based on body weight in children and adolescents (aged 2 to 17 years) is provided in table 1 below. 
Priporočeni odmerek zdravila Firazyr na podlagi telesne mase pri otrocih in mladostnikih (starih od 2
Other Endpoints Time to Onset of Primary Symptom Relief (hrs) 
Čas do pojava lajšanja primarnega simptoma (ure)
FAST-3 was a randomized, placebo-controlled, parallel-group study of 98 adult patients with a median age of 36 years. 
98 odraslih bolnikih z mediano starostjo 36 let.
Change in Composite Investigator-Assessed Symptom Score at 2 hours 
Sprememba sestavljenega rezultata simptomov, ki jih je ocenjeval raziskovalec, po
Number of subjects in ITT Population 36 
Število oseb v populaciji, ki so jih nameravali zdraviti
Hypodermic needle is included in the pack. 
Igla za subkutano aplikacijo je priložena pakiranju.
2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less 2b) Preparing the syringe and needle for injection (all patients) 3) Preparing the injection site 
2b) Priprava brizge in igle za injiciranje (za vse bolnike) 3) Priprava mesta injiciranja 4) Injiciranje raztopine
26 kg to 40 kg 
Od 26 kg do 40 kg
12 kg to 25 kg 
Od 12 kg do 25 kg
One pre-filled syringe and one 25G needle. 
Ena igla 25G
All episodes (N = 56) 
(N = 56)
Firazyr is available as a single pack containing one pre-filled syringe with one needle or as a multipack containing three pre-filled syringes with three needles. 
Firazyr je na voljo v posamičnem pakiranju, ki vsebuje eno napolnjeno injekcijsko brizgo in eno iglo,
Children and adolescents aged 2-17 years 
2a) Priprava brizge za otroke in mladostnike (stare 2-17 let)
Median time to onset of symptom relief (hours) 
Mediana časa do nastopa olajšanja simptomov (v urah)
Additional injection site reactions (pressure sensation, bruising, reduced sensation and/or numbness, raised itchy skin rash and warmth). 
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): dodatne reakcije na mestu injiciranja (občutek pritiska, podplutbe, zmanjšan čut in/ali otopelost, izbočen srbeč kožni izpuščaj ter občutek toplote)
Step-by-Step Instructions for Injection 1) General Information 
Navodila za injiciranje po korakih
Baseline VAS(mm) 
koprivnica (urtikarija)
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
51.0 All episodes (N = 56) 
51,0 Vse epizode
• Screw the syringe on the needle still fixed in the needle cap. 
• Napolnjeno injekcijsko brizgo privijte na iglo, ki je še vedno zaščitena s pokrovčkom.
Other medicines and Firazyr 
3 injekcije zdravila Firazyr.
41 kg to 50 kg 
Od 41 kg do 50 kg
Each 3 ml pre-filled syringe contains icatibant acetate equivalent to 30 mg icatibant. 
Ena 3 ml napolnjena injekcijska brizga vsebuje 30 mg ikatibanta v obliki ikatibant acetata.
Subcutaneous use Read the package leaflet before use For single use only 
Pred uporabo preberite priloženo navodilo.
Transferring the icatibant solution to the graduated syringe: 
Prenos raztopine ikatibanta v brizgo z oznakami prostornine:
Fatigue, lethargy, tiredness, somnolence, and dizziness have been reported following the use of Firazyr. 
Firazyr so poročali o primerih utrujenosti, letargije, somnolence in omotice.
Solution for injection. 
Raztopina za injiciranje
• Turn the connected syringes so that the pre-filled syringe is on top (see below image). 
• Obrnite priključeni brizgi tako, da je napolnjena injekcijska brizga zgoraj.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {BLISTER TRAY LID} 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Tranexamic acid 
Injiciranje raztopine
Always use this medicine exactly as your doctor has told you. 
Kako uporabljati zdravilo Firazyr Pri uporabi tega zdravila natančno upoštevajte navodila svojega zdravnika.
Time to InvestigatorAssessed Initial Visual Symptom Improvement (hrs) 
Čas do prvotnega vidnega izboljšanja simptomov, kot ga je ocenil raziskovalec (ure)
What you need to know before you use Firazyr 3. 
Kaj je zdravilo Firazyr in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Firazyr Kako uporabljati zdravilo Firazyr
Where the dose is less than 30 mg (3 ml), the following equipment is required to extract the appropriate dose (see below): a) Firazyr pre-filled syringe (containing icatibant solution) b) Connector (adapter) c) 3 ml graduated syringe 
a) napolnjena injekcijska brizga z zdravilom Firazyr (ki vsebuje raztopino ikatibanta) b) vmesnik (adapter) c) brizga z oznakami prostornine, velikosti 3 ml
Time to Subject-Assessed Initial Symptom Improvement (hrs) 
Čas do prvotnega izboljšanja simptomov, kot so ga ocenili preskušanci (ure)
Biotransformation 
Telesna masa
Immunogenicity 
Imunogenost:
• Withdraw the required volume of icatibant solution. 
• Izvlecite raztopino ikatibanta, ki ustreza potrebni prostornini za injiciranje.
Primary Endpoint Time to Onset of Symptom Relief-- Composite VAS (hrs) 
Čas do pojava lajšanja simptomov - sestavljena lestvica VAS (ure)
Package Leaflet: Information for the user Firazyr 30 mg solution for injection pre-filled syringe 
NAVODILO ZA UPORABO Firazyr 30 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid ocetna kislina, koncentrirana (za uravnavanje pH)
Firazyr is intended for use under the guidance of a healthcare professional. 
Zdravstveni delavec mora bolniku ali njegovemu negovalcu dati navodila za uporabo zdravila Firazyr.
--1 Attenuated infectious bursal disease virus, strain 1052, live, 101.48 to 102.63 PU* per dose * PU: Potency Units 
--1 Oslabljeni virus infekcijske bolezni burze, sev 1052, živi, od 101.48 do 102.63 PU* na odmerek * PU: Potency Units - enote za izražanje jakosti
Immediate packaging 
Pakiranje za takojšnjo uporabo
Content 
Karenca
MA (EU) number (Invented) name Strength Pharmaceutical Form 
Številka (EU) DzP (Izmišljeno) ime
250 µg Solution for injection 
250 µg raztopina za injiciranje intravenska uporaba viala (steklena)
Content (concentration) 
Način uporabe Stična ovojnina Vsebina (koncentracija)
• A copy of the SPC 
• Izvod SPC-ja
• Emphasis that: o Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including fatal events) or those weighing < 60 kg o Treatment with prasugrel is generally not recommended for patients of ≥ 75 years of age. 
• S poudarkom na: o Hude krvavitve so pogostejše pri bolnikih starih ≥ 75 let (vključno s smrtnimi primeri) ali s telesno maso < 60 kg. o Zdravljenje s prasugrelom na splošno ni priporočeno za bolnike stare ≥ 75 let.
The MAH provides educational material to all physicians who may be involved in treating patients with prasugrel. 
Imetnik dovoljenja za promet z zdravilom posreduje gradivo za izobraževanje vsem zdravnikom, ki bi lahko bili vključeni v zdravljenje bolnikov s prasugrelom.
o Patients weighing < 60 kg should have a reduced maintenance dose of 5mg o The evidence for a 5mg dose is based only on PK/PD analyses and no clinical data currently exist on the safety of this dose in the at risk sub groups. 
o Če je po skrbni oceni lečečega zdravnika glede posameznikove koristi/tveganja zdravljenje v starostni skupini ≥ 75 let potrebno, mora biti po enkratnemu 60 mg polnilnemu odmerku predpisan nižji vzdrževalni odmerek 5 mg. o Bolniki s telesno maso < 60 kg morajo jemati nižji vzdrževalni odmerek 5 mg. o Podatki za 5 mg odmerek so osnovani samo na farmakodinamičnih/farmakokinetičnih analizah, saj trenutno ni na voljo kliničnih podatkov glede varnosti tega odmerka pri tveganih podskupinah bolnikov.