natgillin/translations-raw huggingface dataset:
Intanza is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications of the disease.
Zdravilo Intanza se uporablja za cepljenje odraslih proti gripi, zlasti tistih, pri katerih obstaja povečano tveganje za nastanek zapletov pri bolezni.
Intanza is given as one ‘ intradermal’ injection into the upper layer of the skin, using a special micro-injection system.
Zdravilo Intanza se daje kot intradermalna injekcija v zgornjo plast kožo ob uporabi posebnega mikroinjekcijskega sistema.
These virus strains need to be included in Intanza before the vaccine can be used.
Te seve virusov je treba vključiti v zdravilo Intanza, preden se cepivo uporabi.
Intanza currently contains fragments of the virus strains that were expected to cause flu in the 2006/ 2007 season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU).
Zdravilo Intanza trenutno vsebuje delce virusnih sevov, za katere se je glede na priporočila SZO za severno poloblo in priporočila Evropske unije (EU) predvidevalo, da bodo povzročali gripo v sezoni 2006/ 2007.
The virus strains in Intanza will need to be replaced again before the vaccine can be used in subsequent seasons.
Virusne seve v zdravilu Intanza bo treba ponovno zamenjati, preden bo cepivo mogoče uporabljati v naslednjih sezonah.
The effects of Intanza were first tested in experimental models before being studied in humans.
Učinki zdravila Intanza so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Four studies involving over 8,000 people were carried out to study the effectiveness of Intanza in protecting against flu.
Izvedene so bile štiri študije, v katere je bilo vključenih več kot 8 000 oseb, da bi raziskali učinkovitost zdravila Intanza pri zaščiti proti gripi.
In all of the studies, Intanza was compared with another flu vaccine given by injection into a muscle.
V vseh študijah so zdravilo Intanza primerjali z drugim cepivom proti gripi, ki je bilo injicirano v mišico.
In all studies, both Intanza and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
V vseh študijah so bile pri zdravilu Intanza in primerjalnem cepivu koncentracije protiteles ustrezne za zaščito proti vsem trem sevom gripe.
The most common side effects with Intanza (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), malaise (feeling unwell) and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching).
Najpogostejši neželeni učinki zdravila Intanza (opaženi pri več kot 1 bolniku izmed 10) so glavobol, mialgija (bolečine v mišicah), slabo počutje in lokalne reakcije na mestu cepljenja (pordelost, oteklost, otrdelost kože, bolečina in srbenje).
For the full list of all side effects reported with Intanza, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Intanza, glejte navodilo za uporabo.
Intanza should not be used in people who may be hypersensitive to the active substances, any of the other ingredients, egg, chicken protein, neomycin (an antibiotic), formaldehyde (a preservative) or octoxinol 9 (a detergent).
Zdravila Intanza ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilno učinkovino, katero koli drugo sestavino zdravila, jajca, kokošje beljakovine, neomicin (antibiotik), formaldehid (konzervans) ali oktoksinol 9 (detergent).
The Committee for Medicinal Products for Human Use (CHMP) decided that Intanza’ s benefits are greater than its risks for the prophylaxis of influenza in adults up to 59 years of age and in individuals 60 years of age and over, especially those who run an increased risk of associated complications.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Intanza pri zaščiti proti gripi pri odraslih, mlajših od 59 let, in posameznikih, starih 60 let ali več, zlasti tistih, pri katerih obstaja povečano tveganje za zaplete, povezane z gripo, večje od z njim povezanih tveganj.
The Committee recommended that Intanza be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Intanza odobri dovoljenje za promet.
Other information about Intanza:
Druge informacije o zdravilu Intanza:
The European Commission granted a marketing authorisation valid throughout the EU for Intanza to Sanofi Pasteur MSD SNC on 24 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Intanza, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pasteur MSD SNC dne 24. februarja 2009.
The full EPAR for Intanza can be found here.
Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo Intanza je na voljo tukaj.
INTANZA 9 microgram/ strain suspension for injection Influenza vaccine (split virion, inactivated)
Zdravilo INTANZA 9 mikrogramov/ sev suspenzija za injiciranje Cepivo proti gripi (razgrajen virion, inaktiviran)
The use of INTANZA should be based on official recommendations.
Uporaba zdravila INTANZA mora temeljiti na uradnih priporočilih.
4.3 Contraindications 2 Hypersensitivity to the active substances, to any of the excipients, to egg, chicken proteins, neomycin, formaldehyde and octoxinol 9.
Preobčutljivost na zdravilno učinkovino, na katero koli pomožno snov, na jajca, piščančje beljakovine, neomicin, formaldehid in oktoksinol 9.
INTANZA does not contain more than 0.05 microgram ovalbumin per dose.
Zdravilo INTANZA ne vsebuje več kot 0, 05 mikrograma ovalbumina na odmerek.
INTANZA should under no circumstances be administered intravascularly.
Zdravilo INTANZA se pod nobenim pogojem ne sme dajati intravaskularno.
For INTANZA no clinical data on exposed pregnancies are available.
Za zdravilo INTANZA ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
One animal study with INTANZA did not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/ fetal development, parturition or postnatal development.
Ena študija na živalih z zdravilom INTANZA ni kazala neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj embria/ fetusa, kotitev ali razvoj po skotitvi.
The use of INTANZA may be considered from the second trimester of pregnancy.
Zdravilo INTANZA se lahko uporablja od drugega trimesečja nosečnosti dalje.
The vaccine INTANZA may be used during breast-feeding.
Cepivo INTANZA se lahko uporablja med dojenjem.
The safety of INTANZA has been assessed in 2 open-label randomised clinical trials in which 2,384 vaccinees received an injection of INTANZA.
Varnost zdravila INTANZA je bila ocenjena v 2 odprtih, randomiziranih kliničnih preskušanjih, v katerih je bilo 2384 oseb cepljenih z zdravilom INTANZA.
Systemic safety profile of INTANZA is similar to the comparator vaccine administered intramuscularly.
Sistemski profil varnosti zdravila INTANZA je podoben primerjanemu cepivu, ki se daje intramuskularno.
After repetitive yearly injections the safety profile of INTANZA is similar to the previous injections.
Po ponovnem vsakoletnem cepljenju je bil profil varnosti zdravila INTANZA podoben prejšnjim injekcijam.
There is no safety data from post-marketing experience with INTANZA.
Podatkov o varnosti iz izkušenj po začetku trženja z zdravilom INTANZA ni.
Immune system disorders Allergic reactions, in rare cases leading to shock, angioedema 4 Nervous system disorders Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Bolezni imunskega sistema 4 alergijske reakcije, ki so v redkih primerih povzročile šok, angioedem
Vascular disorders Vasculitis associated in very rare cases with transient renal involvement
Bolezni živčevja nevralgija, febrilne konvulzije, nevrološke motnje kot je encefalomielitis, nevritis in Guillain- Barréjev sindrom
In a randomised comparative phase III trial, 1,796 subjects from 18 to 59 years of age received 0.1 ml of INTANZA by intradermal route and 453 subjects from 18 to 59 years of age received 0.5 ml of trivalent inactivated influenza vaccine administered by intramuscular route.
V randomiziranih primerjalnih preskušanjih faze III je 1796 oseb, starih od 18 do 59 let, prejelo 0, 1 ml zdravila INTANZA intradermalno, 453 oseb, starih od 18 do 59 let, pa je prejelo 0, 5 ml trivalentno inaktiviranega cepiva gripe po intramuskularni poti.
INTANZA is as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 18 to 59 years of age.
Zdravilo INTANZA je enako imunogeno kot primerjano trivalentno inaktivirano cepivo gripe, ki se daje intramuskularno, za vse 3 seve gripe pri osebah, starih od 18 do 59 let.
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk, F- 69007 Lyon, Francija.
INTANZA 15 microgram/ strain suspension for injection Influenza vaccine (split virion, inactivated)
Zdravilo INTANZA 15 mikrogramov/ sev, suspenzija za injiciranje Cepivo proti gripi (razgrajen virion, inaktiviran)
The safety of INTANZA has been assessed in 2 open-label randomised clinical trials, 2,974 vaccinees received an injection of INTANZA.
Varnost zdravila INTANZA je bila ocenjena v 2 odprtih, randomiziranih kliničnih preskušanjih, v katerih je bilo 2974 oseb cepljenih z zdravilom INTANZA.
11 Most reactions resolved spontaneously within 1 to 3 days after onset.
Večina reakcij je spontano izzvenela v 1 do 3 dneh po nastanku.
After repetitive yearly injections the safety profile of INTANZA is similar to the previous injections.
11 Po ponovnem vsakoletnem cepljenju je bil profil varnosti zdravila INTANZA podoben prejšnjim injekcijam.
In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of INTANZA by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
V randomiziranih primerjalnih preskušanjih faze III je 2606 oseb, starih nad 60 let, prejelo 0, 1 ml zdravila INTANZA intradermalno, 1089 oseb, starih nad 60 let, pa je prejelo 0, 5 ml trivalentno inaktiviranega cepiva gripe po intramuskularni poti.
INTANZA is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of age and over.
Zdravilo INTANZA je enako imunogeno kot primerjano trivalentno inaktivirano cepivo gripe, ki se daje intramuskularno, za vse 3 seve gripe pri osebah, starih nad 60 let.
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France.
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk, F- 69007 Lyon, Francija.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kakor je opisano v verziji 1. 0 in navedeno v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet, vzpostavljen in deluje pred in po začetku trženja zdravila.
Strains 2006/ 2007
Zdravilo INTANZA 9 mikrogramov/ sev suspenzija za injiciranje Cepivo proti gripi (razgrajen virion, inaktiviran) Sevi 2006/ 2007
INTANZA does not contain more than 0.05 microgram ovalbumin per dose.
Zdravilo INTANZA ne vsebuje več kot 0, 05 mikrogramov ovalbumina na odmerek.
Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon France
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk F- 69007 Lyon Francija
Strains 2006/ 2007
Zdravilo INTANZA 15 mikrogramov/ sev suspenzija za injiciranje Cepivo proti gripi (razgrajen virion, inaktiviran) Sevi 2006/ 2007
INTANZA 9 µg/ strain suspension for injection Influenza vaccine Strains 2006/ 2007 Intradermal use
Zdravilo INTANZA 9 µg/ sev suspenzija za injiciranje Cepivo proti gripi Sevi 2006/ 2007 Intradermalna uporaba
Strains 2006/ 2007 Intradermal use
Zdravilo INTANZA 15 µg/ sev suspenzija za injiciranje Cepivo proti gripi Sevi 2006/ 2007 Intradermalna uporaba
What INTANZA is and what it is used for 2.
Kaj je zdravilo INTANZA in za kaj ga uporabljamo 2.
Before you use INTANZA 3.
Kaj morate vedeti, preden boste vzeli zdravilo INTANZA 3.
How to use INTANZA 4.
Kako uporabljati zdravilo INTANZA 4.
How to store INTANZA 6.
Shranjevanje zdravila INTANZA 6.
WHAT INTANZA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO INTANZA IN ZA KAJ GA UPORABLJAMO
INTANZA is a vaccine.
Zdravilo INTANZA je cepivo.
When an injection of INTANZA is given, the immune system (body's natural defences) will develop protection against flu infection.
Po injiciranju zdravila INTANZA razvije imunski sistem (naravna obramba telesa) zaščito proti okužbi z gripo.
INTANZA will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them.
Zdravilo INTANZA pomaga pri zaščiti pred tremi sevi virusov, ki so zajeti v cepivu, in drugimi sevi, ki so tesno povezani z njimi.
BEFORE YOU USE INTANZA
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO INTANZA
Do not use INTANZA
Ne uporabljajte zdravila INTANZA
The active substances, or any of the other ingredients of INTANZA listed in section 6 of this leaflet in the section "FURTHER INFORMATION",
zdravilno učinkovino ali katerokoli sestavino zdravila INTANZA, navedeno v poglavju 6 tega navodila pod poglavjem ''DODATNE INFORMACIJE'',
Take special care with INTANZA
Bodite posebno pozorni pri jemanju zdravila INTANZA
- You should tell your doctor before vaccination if you have a poor immune response
- Obvestite zdravnika pred cepljenjem, če imate oslabljen imunski sistem (imunosupresija) zaradi
- INTANZA should under no circumstances be administered into a vein (intravascularly).
- Cepiva INTANZA se pod nobenim pogojem ne sme dajati v žilo (intravaskularno).
INTANZA is not recommended for use in children and adolescents below 18 years.
Uporaba zdravil INTANZA ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
INTANZA can be given at the same time as other vaccines by using separate
- Druga cepiva: zdravilo INTANZA se lahko daje sočasno z drugimi cepivi, vendar v ločene
limbs.
okončine.
Your doctor or pharmacist will be able to decide if you should receive INTANZA.
Zdravnik ali farmacevt se bo odločil, ali boste prejeli cepivo INTANZA.
HOW TO USE INTANZA
KAKO UPORABLJATI ZDRAVILO INTANZA
INTANZA is administered to you by your doctor or nurse.
Z zdravilom INTANZA vas cepi zdravnik ali medicinska sestra.
INTANZA is given as an injection into the upper layer of the skin (preferably the muscle of the upper arm).
Zdravilo INTANZA se daje v obliki injekcije v zgornjo plast kože (po možnosti v mišico nadlakti).
Like all medicines, INTANZA can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo INTANZA neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
During clinical trials, the following side effects were reported with the use of INTANZA.
V kliničnih preskušanjih so pri uporabi zdravila INTANZA opazili naslednje neželene učinke.
31 Common
31 Pogosti
HOW TO STORE INTANZA
SHRANJEVANJE ZDRAVILA INTANZA
Do not use INTANZA after the expiry date which is stated on the carton after EXP.
Zdravila INTANZA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP.
What INTANZA looks like and contents of the pack
Izgled zdravila INTANZA in vsebina pakiranja
INTANZA is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection System in packs of 1, 10 or 20.
Zdravilo INTANZA je suspenzija za injiciranje v napolnjenih injekcijskih brizgah z 0, 1 ml s sistemom za mikro- injiciranje, pakirana po 1, 10 ali 20 enot.
Manufacturer: sanofi pasteur - Parc Industriel d’Incarville - 27100 Val-de-Reuil - France sanofi pasteur, Campus Mérieux – 1541, avenue Marcel Mérieux – 69280 Marcy l’Etoile - France
Sanofi Pasteur - Parc Industriel d’ Incarville - 27100 Val- de- Reuil - Francija Sanofi Pasteur, Campus Mérieux – 1541, avenue Marcel Mérieux – 69280 Marcy l’ Etoile - Francija
Nedele shield
Zaščita za iglo
INTANZA 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
Zdravilo INTANZA 15 mikrogramov/ sev suspenzija za injiciranje Cepivo proti gripi (razgrajen virion, inaktiviran)
The active substances or any of the other ingredients of INTANZA listed in section 6 of this leaflet in the section "FURTHER INFORMATION",
zdravilno učinkovino ali katerokoli sestavino zdravila INTANZA, navedeno v poglavju 6 tega navodila pod poglavjem ''DODATNE INFORMACIJE'',
- Feeling generally unwell, fever (38.0°C or higher) and shivering.
- Splošno počutje nelagodja, povišana telesna temperatura (38, 0°C ali več) in tresenje.
38 Uncommon
38 Občasni
- Tiredness, joint pain and increased sweating.
- utrujenost, bolečine v sklepih in povečano znojenje.
39 B/ Malaysia/2506/2004 like strain (B/Malaysia/2506/2004) 15 micrograms HA **
B / Malaysia/ 2506/ 2004, podoben sevu (B/ Malaysia/ 2506/ 2004) 15 mikrogramov HA **
Per 0.1 ml dose
39 na 0, 1 ml odmerka
The needle shielding system is designed to cover the micro-needle after use.
• Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju • Pred uporabo počakajte, da doseže cepivo sobno temperaturo. • Če so v suspenziji prisotni tujki, cepiva ne smete uporabiti. • Cepiva pred uporabo ni potrebno pretresati. • Sistem za mikro- injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro- iglo (1, 5 mm) in s sistemom za zaščito igle.
41 Micro-Injection System
41 Sistem za zaščito igle je zasnovan tako, da po uporabi mikro- iglo pokrije.
Micro-needle
Sistem za mikroinjiciranje
Finger pads
Mikroigla
INTEGRILIN
INTEGRILIN Povzetek EPAR za javnost
What is INTEGRILIN?
Kaj je zdravilo INTEGRILIN?
INTEGRILIN exists as a solution for infusion and a solution for injection.
INTEGRILIN je na voljo v obliki raztopine za infundiranje in v obliki raztopine za injiciranje.
INTEGRILIN contains the active substance eptifibatide.
INTEGRILIN vsebuje zdravilno učinkovino eptifibatid.
What is INTEGRILIN used for?
Za kaj se zdravilo INTEGRILIN uporablja?
INTEGRILIN is used to prevent a myocardial infarction (heart attack) in adult patients who have unstable angina (chest pains due to narrowed arteries to heart) or already have had a non-Q-wave myocardial infarction (a type of heart attack), when the symptoms have been seen in the last 24 hours and they have abnormalities on their ECG or biological changes detected in the blood.
INTEGRILIN se uporablja za preprečevanje miokardnega infarkta (srčnega napada) pri odraslih bolnikih z nestabilno angino pektoris (bolečinami v prsnem košu zaradi zoženih arterij, ki vodijo do srca) ali z miokardnim infarktom brez zobca Q (vrsta srčnega napada), kadar so se simptomi pojavili v zadnjih 24 urah in so pri bolnikih ugotovili odstopanja od normalnega EKG ali pa biološke spremembe v njihovi krvi.
It is given with aspirin and unfractionated heparin (other medicines that prevent blood clots).
Zdravilo se daje skupaj z aspirinom in nefrakcioniranim heparinom (drugi dve zdravili, ki preprečujeta krvne strdke).
The patients more likely to benefit from a treatment with INTEGRILIN are those who have had acute angina and may have a special type of surgery to clear up the arteries to the heart (percutaneous transluminal coronary angiography, or PTCA).
Bolniki, pri katerih obstaja večja verjetnost, da bi jim zdravljenje z zdravilom INTEGRILIN koristilo, so bolniki, ki so imeli akutno angino in pri katerih bi lahko bil opravljen poseben kirurški poseg za očiščenje srčnih arterij (perkutana transluminalna koronarna angiografija oziroma PTCA).
How is INTEGRILIN used?
Kako se zdravilo INTEGRILIN uporablja?
INTEGRILIN should be given intravenously (into a vein) by a doctor who has experience in the management of heart conditions.
Zdravnik specialist za srčna obolenja mora INTEGRILIN dati intravensko (v veno).
The recommended dose is a single injection into a vein (180 microgram/ kg body weight) given as soon as possible after diagnosis.
Priporočeni odmerek je ena injekcija v veno (180 mikrogramov/ kg telesne mase), ki jo je treba dati čim prej po postavitvi diagnoze.
This is followed by a continuous infusion (drip into a vein) of 2.0 microgram/ kg/ min for up to 72 hours, until the start of surgery, or until discharge from the hospital (whichever occurs first).
Temu sledi kontinuirana infuzija (kapalna infuzija v veno) 2, 0 mikrogramov/ kg/ min v trajanju do 72 ur bodisi do začetka kirurškega posega ali do odpusta iz bolnišnice (karkoli nastopi prej).
Patients who have moderate problems with their kidneys should receive a dose of 1.0 microgram/ kg/ min during the continuous infusion.
Bolniki z zmernimi težavami z ledvicami morajo s kontinuirano infuzijo prejeti odmerek v višini 1, 0 mikrograma/ kg/ min.
The medicine should not be used in patients with severe kidney problems.
Pri bolnikih s hudimi težavami z ledvicami se tega zdravila ne sme uporabljati.
When the patient undergoes a percutaneous coronary intervention, then the treatment can be continued for up to 20-24 hours after surgery, to a maximum of 96 hours.
Kadar se pri bolniku opravi perkutani koronarni poseg, se lahko zdravljenje nadaljuje še 20– 24 ur po kirurškem posegu, najdaljše skupno trajanje zdravljenja pa je 96 ur.
How does INTEGRILIN work?
Kako zdravilo INTEGRILIN deluje?
INTEGRILIN is an inhibitor of platelet aggregation.
INTEGRILIN je zaviralec združevanja (agregacije) krvnih ploščic (trombocitov).
When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Kri se strjuje zaradi posebnih celic v krvi, krvnih ploščic, ki se združujejo (agregacija).
Eptifibatide, the active substance in INTEGRILIN, stops the platelets aggregating by blocking the special protein on their surface that contributes to making them sticky (glycoprotein IIb/ III).
Eptifibatid, zdravilna učinkovina v zdravilu INTEGRILIN, zaustavi združevanje krvnih ploščic tako, da blokira posebno beljakovino na njihovi površini, zaradi
(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 INTEGRILIN 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 katere so ploščice lepljive (glikoprotein IIb/ III).
The effectiveness of INTEGRILIN was studied in a large clinical trial, PURSUIT (11,000 patients), where INTEGRILIN was compared with placebo (dummy treatment) in hospital patients who had signs that they may soon develop a heart attack, or who already had a small heart attack.
Učinkovitost zdravila INTEGRILIN so preučevali v obsežni klinični raziskavi PURSUIT (11. 000 bolnikov), v kateri so INTEGRILIN primerjali s placebom (zdravilom brez zdravilne učinkovine) pri hospitaliziranih bolnikih, ki so kazali znake, da bi pri njih lahko kmalu prišlo do srčnega napada, ali pri bolnikih, ki so že imeli manjši srčni napad.
Another study, ESPRIT, compared INTEGRILIN with a placebo in 2,000 patients who were having PTCA to remove a blood clot from the coronary arteries and insert a stent (a short tube that remains in the artery to stop it closing).
V drugi raziskavi, ESPRIT, so INTEGRILIN primerjali s placebom pri 2. 000 bolnikih, pri katerih je bila opravljena perkutana transluminalna koronarna angiografija (PTCA) za odstranitev krvnega strdka iz koronarnih arterij in vstavljena žilna opornica (stent) – kratka cevka, ki ostaja v arteriji in tako preprečuje njeno zaprtje.
In both studies, patients also received other medicines to prevent blood clotting.
V obeh raziskavah so bolniki prejemali tudi druga zdravila za preprečevanje strjevanja krvi.