natgillin/translations-raw huggingface dataset:
Store and transport frozen.
Zdravilo shranjujte in prevažajte zamrznjeno.
In animals, adverse effects of chlormethine on male fertility after systemic administration have been documented (see section 5.3).
Pri živalih so bili dokumentirani neželeni učinki klormetina na plodnost pri samcih po sistemski uporabi (glejte poglavje 5.3).
Ledaga 160 micrograms/g gel
Ledaga 160 mikrogramov/g gel
• Caregivers must wear disposable nitrile gloves when applying Ledaga to patients.
• Negovalci morajo pri nanašanju zdravila Ledaga bolnikom nositi nitrilne rokavice za enkratno uporabo.
Ledaga is an alcohol-based product and is flammable.
Zdravilo Ledaga je na alkoholni osnovi in je vnetljivo.
Propylene glycol and butylhydroxytoluene may also cause skin irritation.
Tudi propilenglikol in butilhidroksitoluen lahko povzročita draženje kože.
- Do not apply moisturisers or any other skin products (including medicines applied to the skin) for 2 hours before or 2 hours after the daily application of Ledaga.
- Blažil (vlažil) ali drugih izdelkov za lokalno uporabo (vključno z zdravili, ki se nanašajo na kožo) ne nanašajte na zdravljene dele kože 2 uri pred vsakodnevnem nanosu zdravila Ledaga ali 2 uri po njem.
Reductions in mean CAILS scores were observed as early as at 4 weeks, with further reductions observed with continuing therapy.
Že pri 4 tednih so opazili zmanjšanje povprečnih ocen po CAILS in nadaljnja zmanjšanja pri nadaljevanju zdravljenja.
Qualifying prior therapies included topical corticosteroids, phototherapy, topical bexarotene, and topical nitrogen mustard.
Primerna predhodna zdravljenja so vključevala lokalne kortikosteroide, fototerapijo, lokalni beksaroten in lokalni dušikov iperit.
How to use Ledaga
Kako uporabljati zdravilo Ledaga
Do not apply Ledaga more than once per day.
Če ste uporabili večji odmerek zdravila Ledaga, kot bi smeli Zdravila Ledaga ne nanesite več kot enkrat na dan.
Your doctor will determine how long you should use Ledaga for and when treatment may be stopped.
Če ste prenehali uporabljati zdravilo Ledaga Zdravnik bo odločil o tem, kako dolgo morate uporabljati zdravilo Ledaga in kdaj je treba z zdravljenjem prenehati.
- This medicine can cause skin reactions, such as inflammation of your skin (redness and swelling), itching, blisters, ulcers and skin infections (see section 4).
- Zdravilo lahko povzroči reakcije na koži, na primer vnetje kože (pordelost in oteklino), srbenje, mehurje, razjede in okužbe kože (glejte poglavje 4).
It is not known whether Ledaga passes into breast milk, and there may be a risk that the breast-feeding baby is exposed to Ledaga via contact with the mother's skin.
Ker ni znano, ali zdravilo Ledaga prehaja v materino mleko, in ker lahko obstaja tveganje za izpostavljenost dojenčka zdravilu Ledaga ob stiku z materino kožo, ni priporočljivo dojiti med jemanjem tega zdravila.
Ask your pharmacist how to throw away used nitrile gloves, the plastic bag and the medicine you no longer use.
O načinu odstranjevanja nitrilnih rokavic, plastične vrečke in zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
Ledaga is not recommended during pregnancy.
Uporaba zdravila Ledaga med nosečnostjo ni priporočljiva.
Patients should be assessed during treatment for skin reactions such as dermatitis (e.g., redness, swelling, inflammation), pruritus, blisters, ulceration, and skin infections.
Bolnike je treba med zdravljenjem pregledati glede reakcij na koži, kot so dermatitis (npr. pordelost, oteklina, vnetje), srbenje, mehurji, razjede in kožne okužbe.
Caregivers must wear nitrile gloves when handling Ledaga.
Negovalci morajo pri ravnanju z zdravilom Ledaga nositi nitrilne rokavice.
Chlormethine is a type of anti-cancer medicine called an ‘alkylating agent'.
Klormetin je vrsta zdravila za zdravljenje raka, ki se imenuje
Ledaga should be removed from the refrigerator just prior to application and returned to the refrigerator immediately after each use in its box inside the child-resistant, transparent, sealable, plastic bag.
Zdravilo Ledaga je treba vzeti iz hladilnika tik pred nanašanjem in ga spraviti nazaj v hladilnik v njegovi škatli v prozorni, za otroke varni plastični vrečki, ki jo je mogoče zapreti, takoj po vsaki uporabi.
Dosing could be suspended or continued at reduced frequency in the case of skin reactions.
Zdravljenje je bilo v primeru reakcij na koži dovoljeno začasno prekiniti ali nadaljevati z manjšo pogostnostjo.
Store and transport frozen (−15 °C to −25 °C).
Zdravilo shranjujte in prevažajte zamrznjeno (− 15 °C do − 25 °C).
SWAT Overall Response (CR+PR)
Celotni odziv po SWAT (PO + DO)
With clean hands, the tube should be placed back into the original box and the box should be placed in the supplied transparent, sealable, plastic bag for storage in the refrigerator.
Tubo je treba s čistimi rokami vstaviti nazaj v prvotno škatlo, škatlo pa v priloženo prozorno plastično vrečko, ki jo je mogoče zapreti, v kateri zdravilo hranite v hladilniku.
- Keep this leaflet.
S pokrovčkom prebodite tesnilo.
Skin ulceration and blistering, skin hyperpigmentation
Pogosti razjede in mehurji na koži, hiperpigmentacija kože
• Emollients (moisturisers) or other topical products may be applied to the treated areas 2 hours before or 2 hours after application of Ledaga.
• Blažila (vlažila) ali druge lokalne izdelke se sme na zdravljene dele kože nanesti 2 uri pred ali 2 uri po nanosu zdravila Ledaga.
In addition, butylhydroxytoluene has been reported to cause irritation to the eyes and mucous membranes.
Poročali so tudi, da butilhidroksitoluen povzroča draženje oči in sluznic.
- Keep away from children and contact with food by storing Ledaga in its box and inside the plastic bag.
- Zdravilo Ledaga hranite nedosegljivo otrokom in ločeno od živil, tako da shranjujete zdravilo Ledaga v njegovi škatli in v plastični vrečki.
CAILS Overall Response (CR+PR)
Celotni odziv po CAILS (PO + DO)
Patients who received Ledaga in Study 201 had no measurable concentrations of chlormethine in blood collected 1, 3 and 6 hours post-application on Day 1, and at the first month visit.
Bolniki, ki so prejemali zdravilo Ledaga v študiji 201, po 1, 3 in 6 urah po nanašanju 1. dne in ob obisku čez 1 mesec v odvzeti krvi niso imeli merljivih koncentracij klormetina.
Patients should apply Ledaga to affected areas of the skin.
Bolniki morajo zdravilo Ledaga nanesti le na prizadete površine kože.
A risk to newborns/infants cannot be excluded due to the potential for topical or systemic exposure of the breast-feeding child to chlormethine through contact with the mother's skin.
Zaradi možnosti lokalne ali sistemske izpostavljenosti dojenega otroka klormetinu ob stiku z materino kožo tveganja za novorojenčke in dojenčke ni mogoče izključiti.
Dermatitis, skin infections, pruritus
Zelo pogosti dermatitis, okužbe kože, srbenje
• A patient alert card, sized to be included in Ledaga outer packaging, together with the Patient Information Leaflet (PIL) is provided to all patients and caregivers who are expected to administer and use Ledaga.
• Vsi bolniki in negovalci, od katerih se pričakuje, da bodo dajali in uporabljali zdravilo Ledaga, prejmejo opozorilno izkaznico za bolnika v velikosti, ki jo je mogoče vstaviti v zunanjo ovojnino zdravila Ledaga skupaj z navodilom za uporabo.
What Ledaga looks like and contents of the pack
Izgled zdravila Ledaga in vsebina pakiranja
Management of overdose should consist of washing the exposed area with water.
Ravnanje v primeru prevelikega odmerjanja mora vključevati izpiranje izpostavljenega dela z vodo.
Treatment with Ledaga should be stopped for any grade of skin ulceration or blistering, or moderately severe or severe dermatitis (e.g., marked skin redness with oedema).
Tanko plast zdravila Ledaga je treba nanesti na prizadete dele kože enkrat na dan. Zdravljenje z zdravilom Ledaga je treba prekiniti v primeru kožnih razjed ali mehurjev katere koli stopnje ali v primeru zmerno hudega ali hudega dermatitisa (npr. izrazite pordelosti kože z edemom).
Contents of the pack and other information
Shranjevanje zdravila Ledaga Vsebina pakiranja in dodatne informacije
Ledaga is a cytotoxic medicinal product.
Zdravilo Ledaga je citotoksično zdravilo.
Do not use an opened or unopened tube of Ledaga after 60 days of storage in the refrigerator.
Po 60-dnevnem shranjevanju v hladilniku odprte ali neodprte tube zdravila Ledaga ne uporabljajte več.
The risk for inflammation of the skin is increased if you apply Ledaga to your face, genital area, anus or skin folds.
Nevarnost vnetja kože je povečana, če zdravilo Ledaga nanesete na obraz, predel spolovil, danko ali kožne pregibe.
No cases of overdose after cutaneous use of Ledaga were reported during the clinical development programme or post-marketing period.
V času izvajanja programa razvoja zdravila ali v obdobju trženja niso poročali o primerih prevelikega odmerjanja pri kožni uporabi zdravila Ledaga.
The efficacy and safety of Ledaga were assessed in a randomised, multicentre, observer-blinded, active-controlled, non-inferiority clinical trial (Study 201) of 260 adult patients with Stage IA (141), IB (115), and IIA (4) MF-type CTCL who had received at least one prior skin-directed therapy.
201) pri 260 odraslih bolnikih s CTLC vrste MF stopnje IA (141), IB (115) in IIA (4), ki so prejeli vsaj eno predhodno zdravljenje kože.
Clear, colourless gel.
gel Bister brezbarvni gel.
Exposure of mucous membranes such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, and these may be severe.
Izpostavljenost sluznic, na primer ustne ali nosne sluznice, zdravilu povzroči bolečino, pordelost in razjede, ki so lahko hude.
If there is accidental skin exposure to Ledaga, caregivers must immediately wash exposed areas thoroughly with soap and water for at least 15 minutes.
Če pride do nenamernega stika zdravila Ledaga s kožo, mora negovalec takoj izpirati izpostavljene dele z milom in vodo vsaj 15 minut.
What Ledaga is and what it is used for
Kaj je zdravilo Ledaga in za kaj ga uporabljamo
• irrigation should be performed immediately for at least 15 minutes with copious amounts of water (or sodium chloride 9 mg/ml (0.9%) solution for injection, or a balanced salt ophthalmic irrigating solution may be used if there is eye exposure), and
Bolnikom je za primer izpostavljenosti katere koli sluznice zdravilu treba svetovati naslednje: • izpostavljeni del je treba takoj vsaj 15 minut izpirati z veliko vode (v primeru izpostavljenosti očesa lahko uporabimo raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali uravnoteženo oftalmološko solno raztopino za izpiranje); in
There were no reports of systemic tumours after topical administration of chlormethine.
Po lokalni uporabi klormetina niso poročali o sistemskih tumorjih.
In a randomised-controlled trial (n=128 exposed to Ledaga for a median duration of 52 weeks), the most frequent adverse reactions to Ledaga were skin related: dermatitis (54.7%; e.g., skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20.3%), skin infections (11.7%), skin ulceration and blistering (6.3%), and skin hyperpigmentation (5.5%).
Ledaga je bila 52 tednov) so bili najpogostejši neželeni učinki, povezani s kožo: dermatitis (54,7 %; na primer draženje kože, eritem, izpuščaj, urtikarija, pekoč občutek na koži, bolečina kože), srbenje
Cytotoxic: Handle with caution Flammable: Avoid fire, flame, and smoking
Vnetljivo: Ne izpostavljajte ognju, plamenom in ne kadite.
- If Ledaga gets in your eyes, it can cause pain, burning, swelling, redness, sensitivity to light, and blurred vision.
- Če dobite zdravilo Ledaga v oči, lahko povzroči bolečino, opeklino, oteklino, pordelost, občutljivost na svetlobo in zamegljen vid. Lahko povzroči tudi slepoto in hudo trajno poškodbo oči.
Each gram of gel contains chlormethine hydrochloride equivalent to 160 micrograms of chlormethine.
En gram gela vsebuje klormetinijev klorid v količini, ki ustreza 160 mikrogramom klormetina.
Caregivers who accidentally come into contact with Ledaga must wash the affected area right away for at least 15 minutes.
Negovalci, ki nenamerno pridejo v stik z zdravilom Ledaga, naj si izpostavljene dele takoj izpirajo z milom in vodo vsaj 15 minut.
The dose is the same for elderly patients (aged 65 years and older) as for younger adult patients (aged 18 years and older).
Priporočeni odmerek je nanos tanke plasti na prizadete dele kože enkrat na dan. Odmerek je pri starostnikih (starih 65 let in starejših) enak kot pri mlajših odraslih bolnikih (starih vsaj 18 let).
The European Medicines Agency has waived the obligation to submit the results of studies with Ledaga in all subsets of the paediatric population in cutaneous T-cell lymphoma (see section 4.2 for information on paediatric use).
Ledaga za vse podskupine pediatrične populacije s kožnim T-celičnim limfomom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
- Allow the area to dry for 5 to 10 minutes after applying your medicine and before covering with clothing.
- Predel kože naj se po nanosu suši od 5 do 10 minut, preden ga pokrijete z obleko.
Each gram of gel contains 160 micrograms of chlormethine.
En gram gela vsebuje 160 mikrogramov klormetina.
Diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol, lactic acid, hydroxypropylcellulose, sodium chloride, menthol racemic, disodium edetate, butylhydroxytoluene.
Dietilenglikolmonoetileter, propilenglikol, izopropilni alkohol, glicerol, mlečna kislina, hidroksipropilceluloza, natrijev klorid, racemni mentol, dinatrijev edetat, butilhidroksitoluen.
Ledaga 160 micrograms/g gel chlormethine
Ledaga 160 mikrogramov/g gel klormetin
In order to minimise and prevent the Important Identified Risk of “Toxicity to mucous membranes / eye” and the Important Potential Risk of “Secondary exposure to someone other than the patient”, the MAH shall ensure that, the following additional risk minimisation measures are fulfilled in each Member State (MS) where Ledaga is marketed:
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje dodatne ukrepe za zmanjševanje tveganj v vseh državah članicah, kjer je v prometu zdravilo Ledaga, za zmanjšanje pomembnega ugotovljenega tveganja »toksičnost za sluznice/oči« in pomembnega potencialnega tveganja »sekundarne izpostavljenosti drugih oseb, razen bolnika«:
Ledaga is provided in a white aluminium tube with an inner lacquer and an aluminium seal and a white polypropylene screw cap. Each tube contains 60 g of gel.
Zdravilo Ledaga prejmete v beli aluminijasti tubi z notranjim lakom in aluminijastim tesnilom ter belim polipropilenskim navojnim pokrovčkom.
• Patients must wash hands thoroughly with soap and water immediately after handling or applying Ledaga.
• Bolniki si morajo takoj po nanašanju zdravila Ledaga dobro umiti roke z milom in vodo.
- For patients applying the gel, wash your hands with soap and water immediately after applying.
- Za bolnike, ki sami nanašajo gel: po nanosu si roke takoj umijte z milom in vodo.
- Apply Ledaga to affected areas of the skin.
- Zdravilo Ledaga nanesite na prizadete površine kože.
- Ledaga is supplied within a child-resistant transparent, sealable, plastic bag.
- Zdravilo Ledaga je dobavljeno v prozorni plastični vrečki, ki jo je mogoče zapreti in je varna za otroke.
- Until Ledaga has dried on the skin, avoid contact with an open flame or a lit cigarette.
- Izogibajte se stiku z odprtim plamenom ali prižgano cigareto, dokler se zdravilo Ledaga na koži ne posuši.
- Use Ledaga exactly as your doctor or pharmacist tells you.
- Pri uporabi zdravila Ledaga natančno upoštevajte navodila zdravnika ali farmacevta.
Contact your doctor or seek immediate medical attention if you experience allergic reactions to Ledaga (see section
Če opazite alergijske reakcije na zdravilo Ledaga, se posvetujte z zdravnikom ali poiščite takojšnjo medicinsko oskrbo (glejte poglavje 4).
STATEMENT OF ACTIVE SUBSTANCE(S)
Popolni odziv (PO) Delni odziv (DO)
These reactions may include some or all of the following symptoms: - Swelling of the lips, face, throat or tongue
Reakcije lahko vključujejo naslednje simptome (nekatere od njih ali vse):
See end of section 2 for further information on propylene glycol and butylhydroxytoluene.
Za nadaljnje informacije o propilenglikolu in butilhidroksitoluenu glejte na koncu poglavja 2.
Ledaga is for topical application to the skin.
Zdravilo Ledaga je za lokalno nanašanje na kožo.
Ledaga contains propylene glycol and butylhydroxytoluene
Zdravilo Ledaga vsebuje propilenglikol in butilhidroksitoluen.
Occlusive (air- or water-tight) dressings should not be used on areas of the skin where Ledaga was applied.
Na delih kože, na katere je bilo naneseno zdravilo Ledaga, se ne sme uporabljati okluzivnih (za zrako ali vodo neprepustnih) povojev ali oblek.
In case of Ledaga exposure to non-affected areas of the skin, patients should wash the exposed area with soap and water.
Če so zdravilu Ledaga izpostavljeni neprizadeti deli kože, jih mora bolnik umiti z milom in vodo.
Talk to your doctor or pharmacist before using Ledaga.
Pred začetkom uporabe zdravila Ledaga se posvetujte z zdravnikom ali farmacevtom.
- With clean hands, place Ledaga back in the box it came in and the box in the plastic bag.
- Zdravilo Ledaga s čistimi rokami vstavite nazaj v škatlo, iz katere ste ga vzeli, in v prozorno plastično vrečko, ki jo je mogoče zapreti.
The tube should not be used and the pharmacist should be contacted if the seal is missing, punctured, or lifted.
Če tesnilo manjka, je predrto ali odprto, se tube ne sme uporabiti in posvetovati se je treba s farmacevtom.
The MAH must agree about the content and format of the text prior to the launch of Ledaga in each MS with the National Competent Authority (NCA).
Pred začetkom sprostitve zdravila Ledaga v promet v vsaki od držav članic se mora imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim nacionalnim organom o vsebini in obliki tega besedila.
In case of Ledaga exposure to non-affected areas of the skin, wash the exposed area with soap and water.
Če so zdravilu Ledaga izpostavljeni neprizadeti deli kože, jih umijte z milom in vodo.
Therefore, it is not recommended to breast-feed while taking this medicine.You should talk to your doctor before breast-feeding to determine whether or not it is best to breast-feed or to use Ledaga.
Pred dojenjem se posvetujte z zdravnikom, da ugotovite, ali je bolje, da dojite ali da uporabljate zdravilo Ledaga.
• The other ingredients are: diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol, lactic acid, hydroxypropylcellulose, sodium chloride, menthol racemic, disodium edetate, and butylhydroxytoluene.
• Druge pomožne snovi so: dietilenglikolmonoetileter, propilenglikol, izopropilni alkohol, glicerol,
What you need to know before you use Ledaga Do not use Ledaga
Kaj morate vedeti, preden boste uporabili zdravilo Ledaga Ne uporabljajte zdravila Ledaga
Very common side effects on the treatment area (may affect more than 1 in 10 people): - Skin inflammation - Infections of the skin - Itching (pruritus)
Zelo pogosti neželeni učinki na zdravljenem delu (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Panel 3
Preglednica 1.
STOP taking Ledaga and tell your doctor immediately if you experience allergic reactions (hypersensitivity).
Če opazite alergijske reakcije (preobčutljivost), takoj PRENEHAJTE uporabljati zdravilo Ledaga in o tem obvestite zdravnika.
How to store Ledaga
Shranjevanje zdravila Ledaga
Studies in animals have shown reproductive toxicity after systemic administration (see section 5.3).
Študije na živalih so pokazale toksičen vpliv na sposobnost razmnoževanja po sistemski uporabi
Your doctor will check your skin for skin cancers during and after your treatment with Ledaga.
Zdravnik bo med zdravljenjem z zdravilom Ledaga in po njem pregledal, ali se je na koži pojavil kožni rak.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 60 g TUBE
OVOJNINAH 60 g TUBA
- Do not cover the treated area with air- or water-tight bandages after you have applied this medicine.
- Zdravljenega predela kože ne ovijte s povojem, ki je neprepusten za zrak ali vodo.
Package leaflet: Information for the patient Ledaga 160 micrograms/g gel chlormethine
Navodilo za uporabo Ledaga 160 mikrogramov/g gel klormetin
Sodium chloride Menthol racemic Disodium edetate Butylhydroxytoluene
hidroksipropilceluloza, natrijev klorid, racemni mentol, dinatrijev edetat, butilhidroksitoluen.
Topical use.
Način uporabe
Common side effects on the treatment area (may affect up to 1 in 10 people): - Skin ulcers - Blisters - Darkening of the skin
Pogosti neželeni učinki na zdravljenem delu (pojavijo se lahko pri največ 1 od 10 bolnikov):
The face, genitalia, anus, and intertriginous skin are at increased risk of skin reactions to topical chlormethine.
Tveganje za reakcije na koži zaradi lokalnega klormetina je povečano pri uporabi na obrazu, spolovilih, danki in intertriginozni koži.
Ratio 95% CI
Razmerje odstotni IZ
Your doctor may stop your treatment if you develop severe inflammation of the skin (i.e., redness and swelling), blisters and ulcers.
Zdravnik bo morda prekinil vaše zdravljenje, če dobite hudo vnetje kože (t.j.
Tell your doctor or pharmacist as soon as possible if you notice any of the following side effects listed below.
Drugi neželeni učinki lahko vključujejo: Obvestite zdravnika ali farmacevta, če opazite katerega od neželenih učinkov,
- Direct skin contact with Ledaga should be avoided in individuals other than the patient, such as caregivers.
- Posamezniki, ki niso bolniki, na primer negovalci, naj se izogibajo neposrednemu stiku zdravila
Each carton contains 1 bottle.
Vsaka škatla vsebuje 1 plastenko.
• Sudden difficulty in walking or loss of balance or co-ordination
• nenadne težave pri hoji ali izguba ravnotežja ali koordinacije,
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Table 3: Patients with outcome events in TRITON primary analysis
Preglednica 3: Bolniki z izidi v primarni analizi TRITON
It may be administered with or without food.
Lahko se daje s hrano ali brez hrane.
The results of the discussion, and where appropriate the material, should be agreed with the national competent authority and be available prior to launch in each member state.
Rezultati dogovora ter gradivo (kjer je ustrezno) morajo biti dogovorjeni s pristojnim nacionalnim organom in morajo biti na voljo v vsaki državi članici pred prihodom zdravila na trg.
• Sudden confusion, difficulty speaking or understanding others
• nenadna zmedenost, težave z govorom ali razumevanjem drugih,
• ≥75 years of age (see below).
• ≥ 75 let starosti (glejte spodaj).
Use of any thienopyridine within 5 days before enrolment was an exclusion criterion.
Uporaba katerega koli tienopiridina v 5 dneh pred vključitvijo je bila izključitveni kriterij.
No significant difference was seen in the STEMI population.
V populacijah STEMI niso opazili značilne razlike.
TRITON was a 13,608 patient, multicentre international, randomised, double blind, parallel group study.
TRITON s 13.608 bolniki je bila multicentrična, mednarodna, randomizirana, dvojno slepa študija s paralelno skupino.
The patient population was 92% Caucasian, 26% female, and 39% ≥65 years of age.
Populacija bolnikov je bila 92 % belcev, 26 % žensk in 39 % ≥ 65 let starosti.
Primary Individual Outcome Events
Primarni posamezni izidi
• Sudden dizziness or sudden severe headache with no known cause
• nenadna omotica ali nenaden hud glavobol brez znanega vzroka.
The active metabolite has an elimination half-life of about 7.4 hours (range 2 to 15 hours).
Aktivni presnovek ima razpolovni čas izločanja približno 7,4 ure (razpon 2-15 ur).
These may be signs of a severe allergic reaction (see section 2 ‘What you need to know before you take Prasugrel Mylan')
To so lahko znaki hude alergijske reakcije (glejte poglavje 2 »Kaj morate vedeti, preden boste vzeli zdravilo Prasugrel Mylan«)