natgillin/translations-raw huggingface dataset:
Efient reduces the chances of you having a further heart attack or stroke or of dying from one of these atherothrombotic events.
Zdravilo Efient zmanjša možnost, da bi prišlo do naslednjega srčnega infarkta ali kapi ali da bi umrli zaradi enega izmed teh aterotrombotičnih dogodkov.
Your doctor will also give you acetylsalicylic acid (e. g. aspirin), another anti- platelet agent.
Vaš zdravnik vam bo predpisal tudi acetilsalicilno kislino (npr. aspirin), drugo zdravilo proti trombocitom.
BEFORE YOU TAKE EFIENT
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO EFIENT
Do not take Efient
Ne jemljite zdravila Efient
- If you are allergic (hypersensitive) to prasugrel or any of the other ingredients of Efient.
- Če ste alergični (preobčutljivi) na prasugrel ali katerokoli sestavino zdravila Efient.
An
Alergijsko
allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
reakcijo lahko prepoznate kot izpuščaj, srbenje, otečen obraz, otečene ustnice ali kratko sapo.
If this has happened to you, tell your doctor.
Če se vam to zgodi, povejte svojemu zdravniku.
- If you have a medical condition that is currently causing bleeding, such as bleeding from your
- Če imate zdravstveno stanje, ki trenutno povzroča krvavitev, kot je krvavitev iz želodca ali
stomach or intestines.
črevesja.
- If you have ever had a stroke or a transient ischaemic attack (TIA).
- Če ste kadarkoli imeli kap ali tranzitorno ishemično atako.
38 Take special care with Efient You should tell your doctor before taking Efient if any of the situations mentioned below apply to you:
38 Povejte svojemu zdravniku preden vzamete zdravilo Efient, če se katerokoli izmed spodnjih stanj nanaša na vas:
- If you have an increased risk of bleeding such as:
− Če imate povečano tveganje za krvavitev, kot je:
a recent serious injury recent surgery (including some dental procedures) recent or recurrent bleeding from the stomach or intestines (e. g. a stomach ulcer, colon polyps)
nedavna resna poškodba nedavni kirurški poseg (vključno z nekaterimi zobozdravstvenimi posegi) nedavna ali ponovna krvavitev iz želodca ali črevesja (npr. želodčni ulkus, polipi debelega črevesja)
body weight of less than 60 kg.
telesna masa nižja od 60 kg.
renal (kidney) disease or moderate liver problems taking certain types of medicines (see ‘ Taking other medicines’ below) planned surgery (including some dental procedures) in the next seven days.
ledvična bolezen ali zmerne težave z jetri jemanje nekaterih vrst zdravil (glejte ‘ Jemanje drugih zdravil ’ spodaj) načrtovan kirurški poseg (vključno z nekaterimi zobozdravstvenimi posegi) v naslednjih sedmih dneh.
Your doctor may wish you to stop taking Efient temporarily due to the increased risk of bleeding
Vaš zdravnik vam bo morda naročil, da začasno prenehate jemati zdravilo Efient, zaradi povečenega tveganja za krvavitev.
- If you are Asian- there is limited experience of Efient use in Asians
− Če ste azijske rase - izkušnje o uporabi zdravila Efient pri azijcih so omejene − Čeprav pri zdravilu Efient niso opazili nobenih primerov, se pri določenih drugih zdravilih proti trombocitom lahko pojavi zelo redko stanje, imenovano trombotična trombocitopenična purpura (TTP).
TTP is associated with fever, tiny round pin-point purplish-red bruises, small to medium-sized bruises, confusion, headaches and a decrease in the number of platelets.
TTP je povezana z vročino, drobnimi okroglimi pikčastimi škrlatno- rdečimi modricami, majhnimi do srednje- velikimi modricami, zmedenostjo, glavoboli in zmanjšanjem števila trombocitov.
If you notice tiny round pin-point purplish-red bruises, please contact your doctor immediately.
Če opazite drobne okrogle pikčaste škrlatno- rdeče modrice, se nemudoma obrnite na svojega zdravnika.
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, dietary supplements and herbal remedies.
Jemanje drugih zdravil Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, prehranska dopolnila ali zeliščna sredstva.
It is particularly important to tell your doctor if you are being treated with clopidogrel (an anti-platelet agent), warfarin (an anti-coagulant), or “ non steroidal anti inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib).
Še posebej je pomembno, da poveste svojemu zdravniku, če se zdravite s klopidogrelom (zdravilom proti trombocitom), varfarinom (antikoagulantom) ali “ nesteroidnimi protivnetnimi zdravili ” za bolečino in vročino (kot je ibuprofen, naproksen, etorikoksib).
Taking Efient with food and drink Efient may be taken with or without food.
Jemanje zdravila Efient skupaj s hrano in pijačo Zdravilo Efient lahko jemljete z ali brez hrane.
Pregnancy and breast-feeding Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Efient.
Nosečnost in dojenje Povejte svojemu zdravniku, če zanosite ali poskušate zanositi, medtem ko jemljete zdravilo Efient.
Driving and using machines No studies on the effects of Efient on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev Študij o vplivu zdravila Efient na sposobnost upravljanja vozil in strojev niso opravili.
Important information about some of the ingredients of Efient Efient contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila Efient Zdravilo Efient vsebuje laktozo.
If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
HOW TO TAKE EFIENT
39 Pri jemanju zdravila Efient natančno upoštevajte zdravnikova navodila.
Your doctor will tell you how many Efient tablets to take.
Vaš zdravnik vam bo povedal koliko tablet zdravila Efient morate vzeti.
If you take more Efient than you should Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding.
Če ste vzeli večji odmerek zdravila Efient, kot bi smeli Nemudoma se obrnite na svojega zdravnika ali bolnišnico, saj imate morda tveganje za prekomerno krvavitev.
If you forget to take Efient If you miss your scheduled daily dose, take Efient when you remember.
Če ste pozabili vzeti zdravilo Efient Če ste pozabili vzeti predvideni dnevni odmerek, vzemite zdravilo Efient, ko se spomnite.
For the 14, 28, 56 84 and 98 tablet pack sizes, you can check the day on which you last took a tablet of Efient by referring to the calendar printed on the blister.
Za velikosti pakiranja tablet po 14, 28, 56, 84 in 98, lahko preverite tudi dan, ko ste zadnjič vzeli tableto zdravila Efient, glede na koledar, ki je natisnjen na pretisnem omotu.
If you stop taking Efient Do not stop taking Efient without consulting your doctor.
Če ste prenehali jemati zdravilo Efient Ne prenehajte jemati zdravilo Efient, ne da bi se prej posvetovali s svojim zdravnikom.
It is especially important to discuss with your doctor before stopping Efient because both the risks and the benefits are based on regular use.
Še posebej je pomembno, da se pogovorite s svojim zdravnikom, preden prenehate jemati zdravilo Efient, zaradi tveganj in koristi, ki so posledica redne uporabe zdravila.
• Frequencies of the observed side effects are defined as: • very common: affects more than 1 user in 10 • common: affects 1 to 10 users in 100 • uncommon: affects 1 to 10 users in 1,000 • rare: affects 1 to 10 users in 10,000 • very rare: affects less than 1 user in 10,000 • not known: frequency cannot be estimated from the available data
• Pogostnosti opazovanih neželenih učinkov so določene kot: • zelo pogosti: prizadanejo več kot 1 uporabnika na 10 • pogosti: prizadanejo 1 do 10 uporabnikov na 100 • občasni: prizadanejo 1 do 10 uporabnikov na 1. 000 • redki: prizadanejo 1 do 10 uporabnikov na 10. 000 • zelo redki: prizadanejo manj kot 1 uporabnika na 10. 000 • ni znano: ocena pogostnosti iz danih podatkov ni možna
•
• telesa,
Sudden numbness or weakness of the arm, leg or face, especially if only on one side of
Nenadna odrevenelost ali šibkost rok, nog ali obraza, zlasti če je to samo na eni strani
sudden confusion, difficulty speaking or understanding others sudden difficulty in walking or loss of balance or co-ordination sudden dizziness or sudden severe headache with no known cause
nenadna zmedenost, težave z govorom ali razumevanjem drugih, nenadne težave pri hoji ali izguba ravnotežja ali koordinacije, nenadna omotica ali nenaden hud glavobol brez znanega vzroka.
All of the above may be signs of a stroke.
40 Vse zgoraj našteto so lahko znaki kapi.
Stroke is an uncommon side effect of Efient in patients who have never had a stroke or transient ischaemic attack (TIA).
Kap je občasen neželen učinek zdravila Efient pri bolnikih, ki niso nikoli imeli kapi ali tranzitorne ishemične atake (TIA).
40 Tell your doctor promptly if you notice any of the following:
Svojega zdravnika takoj obvestite, če opazite karkoli od naslednjega:
Blood in your urine Bleeding from your rectum, blood in your stools or black stools Uncontrollable bleeding, for example from a cut
Kri v vašem urinu Krvavitev iz vaše danke, kri v vašem blatu ali črno blato Nenadzorovana krvavitev, na primer od ureza
Side effects seen in clinical trials with Efient include:
Neželeni učinki, ki so jih opazili v kliničnih preskušanjih z zdravilom Efient, vključujejo:
Common side effects Bleeding in the stomach or bowels Bleeding from a needle puncture site Nose bleeds Skin rash Small red bruises on the skin (ecchymoses) Blood in urine Haematoma (bleeding under the skin at the site of an injection, or into a muscle, causing swelling) Low haemoglobin or red blood cell count (anaemia) Bruising
Pogosti neželeni učinki Krvavitev v želodec ali črevesje Krvavitev iz mesta vboda igle Krvavitev iz nosu Kožni izpuščaj Majhne rdeče modrice na koži (ekhimoza) Kri v urinu Hematom (podkožna krvavitev na mestu injiciranja ali v mišico, ki povzroča oteklino) Nizek hemoglobin ali nizko število rdečih krvnih celic (anemija) Modrice
Uncommon side effects Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs Bleeding after surgery Coughing up blood Blood in stools
Občasni neželeni učinki Spontana krvavitev iz očesa, danke, dlesni ali v trebuh okrog notranjih organov Krvavitev po operaciji Izkašljevanje krvi Kri v blatu
Rare side effects Subcutaneous haematoma (bleeding under the skin causing a swelling)
Redki neželeni učinki Podkožni hematom (podkožna krvavitev, ki povzroča oteklino)
HOW TO STORE EFIENT
SHRANJEVANJE ZDRAVILA EFIENT
What Efient contains
Kaj vsebuje zdravilo Efient
- The active substance is prasugrel.
- Zdravilna učinkovina je prasugrel.
Each tablet contains 10 mg of prasugrel (as hydrochloride).
Ena tableta vsebuje 10 mg prasugrela (v obliki klorida).
Each tablet contains 5 mg of prasugrel (as hydrochloride).
Ena tableta vsebuje 5 mg prasugrela (v obliki klorida).
- The other ingredients are microcrystalline cellulose, mannitol (E421), croscarmellose sodium,
- Pomožne snovi so mikrokristalna celuloza, manitol (E421), natrijev karmelozat, premreženi,
hypromellose (E464) magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron oxide red (10 mg tablets only) (E172), iron oxide yellow (E172) and talc.
hipromeloza (E464), magnezijev stearat, laktoza monohidrat, titanov dioksid (E171), triacetin (E1518), rdeči železov oksid (samo 10 mg tablete) (E172), rumeni železov oksid (E172) in smukec.
What Efient looks like and contents of the pack Efient 10 mg :The tablets are beige and double-arrow shaped, with ”10 mg” debossed on one side and “4759” on the other.
Tablete so bež barve, v obliki dvojne puščice, z vtisnjenim “ 10 mg ” na eni strani in “ 4759 ” na drugi strani.
The tablets are yellow and double-arrow-shaped, with “5 mg” debossed on one side and “4760” on the other.
Tablete so rumene barve, v obliki dvojne puščice, z vtisnjenim “ 5 mg ” na eni strani in “ 4760 ” na drugi strani.
Marketing Authorisation Holder Eli Lilly Nederland BV Grootslag 1 – 5 NL-3991 RA, Houten The Netherlands.
Eli Lilly Nederland BV Grootslag 1 – 5 NL- 3991 RA, Houten Nizozemska
Avda. de la Industria 30 28108 Alcobendas Madrid Spain.
Avda. de la Industria 30 28108 Alcobendas Madrid Španija
Tel: +34 (0) 91 539 99 11
Tel: +34 (0) 91 539 99 11
42 France Daiichi Sankyo France SAS Tél: +33 (0) 1 55 62 14 60 Ireland Daiichi Sankyo UK Ltd Tel: +44 (0) 1753 893 600 Ísland Icepharma hf.
42 France Daiichi Sankyo France SAS Tél: +33 (0) 1 55 62 14 60 Ireland Daiichi Sankyo UK Ltd Tel: +44 (0) 1753 893 600 Ísland Icepharma hf.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http//www.emea.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu
Elaprase is a concentrate for solution for infusion that contains the active substance idursulfase.
Zdravilo Elaprase je koncentrat za raztopino za infundiranje, ki vsebuje zdravilno učinkovino idursulfazo.
Elaprase is used to treat patients with Hunter syndrome.
Zdravilo Elaprase se uporablja za zdravljenje bolnikov s Hunterjevim sindromom.
It is designed for long-term use.
Namenjeno je dolgoročni uporabi.
Patients with Hunter syndrome do not produce an enzyme called iduronate-2-sulfatase.
Hunterjev sindrom, poznan tudi kot mukopolisaharidoza II, je redka dedna bolezen, ki prizadene predvsem moške.
This enzyme is needed to break down substances in the body called glycosaminoglycans (GAGs).
Bolniki s Hunterjevim sindromom ne proizvajajo encima, imenovanega iduronat- 2 - sulfataze.
Since patients with Hunter syndrome cannot break these substances down, the GAGs gradually build up in most of the organs in the body and damage them.
Ta encim je potreben, da v telesu razgradi snovi, imenovane glikozaminoglikani (GAGi) Ker bolnik s Hunterjevim sindromom ne more razgraditi teh snovi, se GAGi sčasoma nakopičijo v organih v telesu in jih poškodujejo.
This causes a wide range of symptoms, particularly difficulty breathing and difficulty walking.
Tako nastane širok spekter simptomov, zlasti težave z dihanjem in težave pri hoji.
Without treatment, these symptoms become more severe over time.
Če niso zdravljeni, se ti simptomi s časom poslabšujejo.
Because the number of patients with Hunter syndrome is low, the disease is rare, and Elaprase was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 11 December 2001.
Bolnikov s Hunterjevim simptomom je malo, bolezen je redka, zato je bilo zdravilo Elaprase dne 11. decembra 2001 določeno kot ‘ zdravilo sirota ’ (zdravilo za redke bolezni).
Elaprase is given every week, as an infusion (drip into a vein).
Zdravilo Elaprase se daje enkrat tedensko v obliki infuzije (kapalna infuzija v veno).
The dose in adults, children and adolescents is 0.5 mg/ kg body weight.
Odmerek pri odraslih, otrocih in mladostnikih je 0, 5 mg/ kg telesne teže.
The appropriate dose of Elaprase must be diluted in saline before it is infused.
Ustrezen odmerek zdravila Elaprase je treba pred infundiranjem raztopiti v fiziološki raztopini.
The infusion should last 3 hours.
Infundiranje traja 3 ure.
However, as long as the patient does not develop an infusion reaction (rash, itching, fever, headache, high blood pressure or flushing), the medicine can be infused more rapidly, by gradually reducing the duration of infusion to 1 hour.
Če pri bolniku ni opaziti reakcij, povezanih z infundiranjem (izpuščaji, srbenje, povišana telesna temperatura, glavobol, visok krvni tlak ali zardevanje), se zdravilo lahko infundira hitreje, in sicer se trajanje infundiranja lahko postopno skrajša na eno uro.
The active ingredient in Elaprase, idursulfase, is a copy of the human enzyme iduronate-2-sulfatase.
Zdravilna učinkovina v zdravilu Elaprase je idursulfaza, ki je kopija humanega encima iduronat- 2 - sulfataze.
It is produced by a method known as ‘ recombinant DNA technology’.
Proizvaja se po metodi, imenovani “ rekombinantna DNA tehnologija ”.
This means that the enzyme is made by a human cell that has received a gene (DNA), which makes it able to produce the enzyme.
To pomeni, da encim izdela človeška celica, ki je prejela gen (DNA), s pomočjo katerega postane sposobna tvoriti encim.
Idursulfase replaces the enzyme that is missing or defective in patients with Hunter syndrome.
Idursulfataza nadomesti encim, ki ga delno ali v celoti primanjkuje bolnikom s Hunterjevim sindromom.
By supplying the enzyme, the symptoms of the disease are improved or controlled.
Z nadomeščanjem encima se simptomi bolezni izboljšajo ali nadzorujejo.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Elaprase been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Elaprase raziskano?
The effects of Elaprase were first tested in experimental models before being studied in humans.
Učinki zdravila Elaprase so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
The main study of Elaprase involved 96 male patients aged between 5 and 31 years, and compared its effectiveness with that of a placebo (dummy treatment).
V glavni raziskavi zdravila Elaprase je sodelovalo 96 bolnikov moškega spola, starih od 5 do 31 let, v njej pa so primerjali njegovo učinkovitost z učinkovitostjo placeba (zdravila brez zdravilne učinkovine).
The main measures of effectiveness were lung function (‘ forced vital capacity’, the maximum amount of air the patient could exhale), and the distance the patients could walk in 6 minutes, which measures the combined effects of the illness on the heart, lungs, joints and other organs.
Glavno merilo učinkovitosti je bilo delovanje pljuč (‘ forsirana vitalna kapaciteta ’, največja količina zraka, ki jo bolnik lahko izdihne) ter razdalja, ki jo je bolnik lahko prehodil v 6 minutah, s čimer se merijo kombinirani vplivi bolezni na srce, pljuča, sklepe in druge organe.
These measurements were taken before treatment and again after 52 weeks of treatment.
Meritve so opravili pred začetkom zdravljenja in po 52 tednih zdravljenja.
What benefit has Elaprase shown during the studies?
Kakšne koristi je zdravilo Elaprase izkazalo med raziskavami?
The study showed that Elaprase improved both lung function and the walking ability of the patients.
Raziskava je pokazala, da se je z zdravilom Elaprase pri bolnikih izboljšalo tako delovanje pljuč kot zmožnost hoje.
After 52 weeks, the patients receiving Elaprase could walk 43.3 m in 6 minutes, whereas patients receiving placebo could walk 8.2 m.
Po 52 tednih so bolniki, ki so prejemali zdravilo Elaprse lahko v 6 minutah prehodili 43, 3 m, medtem ko so bolniki, ki so prejemali placebo lahko prehodili 8, 2 m.
The medicine also produced an improvement in lung function, while the patients on placebo showed a slight worsening.
Zdravilo je izkazalo tudi izboljšanje delovanja pljuč, medtem ko je bilo pri uporabi placeba opaziti rahlo poslabšanje.
The most common side effects with Elaprase (seen in more than 1 in 10 patients) were related to the infusion, including skin reactions (rash or itching), pyrexia (fever), headache, hypertension (high blood pressure) and swelling at the site of the infusion.
Najpogostejši neželeni učinki zdravila Elaprase (opaženi pri več kot 1 bolniku od 10) so bili povezani z infundiranjem, med drugim kožne reakcije (izpuščaj ali srbenje), pireksija (povišana telesna temperatura), glavobol, hipertenzija (visok krvni tlak) ter otekanje na mestu infundiranja.
Other very common side effects were dyspepsia (heartburn) and chest pain.
Drugi zelo pogosti neželeni učinki so bili dispepsija (zgaga) in bolečine v prsih.
For the full list of all side effects reported with Elaprase, see the Package Leaflet.
Celovit seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Elaprase, najdete v Navodilih za uporabo.
Elaprase should not be used in people who may be allergic (hypersensitive) to idursulfase or any of the other ingredients.
Zdravila Elaprase ne smejo uporabljati osebe, ki utegnejo biti alergične (preobčutljive) na idursulfazo ali katero koli drugo sestavino.
The Committee for Medicinal products for Human Use (CHMP) concluded that the improvements shown in the study, even if limited, represent a clinical benefit in the treatment of Hunter syndrome.
Odbor za zdravila za uporabo v humani medicini (CHMP) je prišel do zaključka, da v raziskavi izkazana izboljšanja, četudi omejena, pomenijo klinično korist pri zdravljenju Hunterjevega sindroma.
They decided that the benefits of Elaprase are greater than its risks in the long-term treatment of patients with Hunter syndrome and recommended that Elaprase be given marketing authorisation.
Odbor je odločil, da so koristi zdravila Elaprase večje od z njim povezanih tveganj pri dolgotrajnem zdravljenju bolnikov s Hunterjevim sindromom in je priporočil odobritev dovoljenja za promet z zdravilom Elaprase.
Elaprase has been authorised under ‘ exceptional circumstances’.
Zdravilo Elaprase je bilo odobreno “ v izjemnih okoliščinah ”.
This means that because Hunter syndrome is rare, it had not been possible to obtain complete information about Elaprase.
To pomeni, da zaradi redkosti Hunterjevega sindroma ni bilo mogoče pridobiti vseh informacij o zdravilu Elaprase.
The company that makes Elaprase will investigate the long-term effects of the medicine, and whether it stimulates the body to produce special proteins called antibodies against the medicine.
Podjetje, ki izdeluje zdravilo Elaprase, bo preučilo dolgotrajne učinke zdravila, in raziskalo, ali zdravilo spodbuja telo k proizvajanju posebnih proteinov, ki se imenujejo protitelesa proti zdravilu.
The company will also study the medicine ’ s effectiveness in patients below 5 years of age, and investigate whether it has any effects on the lungs, the heart or the blood vessels.
Podjetje bo učinkovitost zdravila preučilo tudi na bolnikih, mlajših od 5 let, in raziskalo, ali ima kakršen koli učinek na pljuča, srce ali krvne žile.
Which measures are being taken to ensure the safe use of Elaprase?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Elaprase?
The company that makes Elaprase will monitor the safety of the medicine in a long-term survey of patients with Hunter syndrome.
Podjetje, ki izdeluje zdravilo Elaprase, bo varnost zdravila spremljalo v dolgoročni raziskavi na bolnikih s Hunterjevim sindromom.
This will include analysis of the medicine ’ s effects in female patients and whether it can be used safely in the patient ’ s home.
V tej raziskavi bodo analizirali tudi učinke zdravila na bolnikih ženskega spola in preučili, ali ga lahko bolnik varno uporablja doma.
Other information about Elaprase:
Druge informacije o zdravilu Elaprase:
The European Commission granted a marketing authorisation valid throughout the European Union for Elaprase to Shire Human Genetic Therapies AB on 8 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Elaprase, veljavno po vsej Evropski uniji, odobrila družbi Shire Human Genetic Therapies AB dne 8. januarja 2007.
The record of Elaprase’ s designation as an orphan medicine is available here.
Zapis o določitvi zdravila Elaprase kot zdravila sirote najdete tukaj.
The full EPAR for Elaprase can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Elaprase je na voljo tukaj.
EU/ 1/ 06/ 365/ 001
Številka EU EU/ 1/ 06/ 365/ 001
Elaprase
Izmišljeno ime Elaprase
2 mg/ ml
Jakost 2 mg/ ml
Concentrate for solution for infusion
Farmacevtska oblika Koncentrat za pripravo raztopine za infundiranje
Intravenous use
Pot uporabe Intravenska uporaba
Vial (glass)
Ovojnina Viala (steklena)
3 ml
Vsebina 3 ml
1 vial
Velikost pakiranja 1 viala