natgillin/translations-raw huggingface dataset:
The dosage should be adjusted on the basis of laboratory measurements of antithrombin activity.
Odmerek je treba prilagoditi na osnovi laboratorijskih meritev aktivnosti antitrombina.
Response to ATryn may vary in individual patients, achieving different levels of in vivo recovery and different half-lives.
Odziv na zdravilo ATryn se lahko pri posameznih bolnikih razlikuje, dosežene so razlicne ravni in vivo okrevanja in razlicne razpolovne dobe.
Frequent antithrombin activity assessments and dosing adjustments may be necessary when starting treatment and just after surgery.
Morda bodo potrebne pogoste ocene aktivnosti antitrombina in prilagajanje odmerka, ko zacenjate z zdravljenjem in takoj po operaciji.
After the start of the maintenance dose infusion, blood for AT activity levels should be drawn at 45 minutes after the start of the loading dose infusion.
Po zacetku infundiranja vzdrževalnega odmerka je treba odvzeti kri za preverjanje ravni aktivnosti antitrombina 45 minut po infundiranju zacetnega odmerka.
In case the AT activity level is between 80% and 120% (0.8 - 1.2 IU/ ml), no dose adjustment is needed.
Ce je raven aktivnosti antitrombina med 80% in 120% (0, 8 - 1, 2 i. e. / ml), ni potrebno prilagajanje odmerka.
In case the AT activity level is less than 80%, increase the maintenance infusion rate by 50%.
Ce je raven aktivnosti antitrombina manjša od 80%, povecajte hitrost vzdrževalnega infundiranja za 50%.
In case the AT activity level is greater than 120% decrease the infusion rate by 30%.
Ce je raven aktivnosti antitrombina vecja od 120%, zmanjšajte hitrost infundiranja za 30%.
Subsequently, antithrombin activity should be checked 1-2 times a day and dose adjustments made accordingly.
Aktivnost antitrombina morate nato preverjati 1- 2 krat dnevno in odmerek ustrezno prilagajati.
The antithrombin activity level should be maintained above 80% for the duration of the treatment, unless clinical particulars would indicate a different effective level.
Raven aktivnosti antitrombina morate v casu zdravljenja vzdrževati nad 80%, razen ce klinicni podatki ne narekujejo drugacne ucinkovite ravni.
In case the activity level is below 80% a 15 minutes bolus infusion of AT can be given to quickly restore the AT activity level.
V primeru, da je raven aktivnosti pod 80%, lahko opravite 15- minutno bolusno infundiranje antitrombina, da se raven aktivnosti antitrombina hitro povrne v prvotno stanje.
The dose can be calculated utilizing the post-surgical AT activity in the loading dose formula above.
Odmerek se da izracunati s pomocjo pooperacijske aktivnosti antitrombina v zgornji formuli za zacetni odmerek.
3 Method of administration:
3 Pediatricni bolniki
Hypersensitivity to any of the constituents.
Preobcutljivost za katerokoli pomožno snov.
Hypersensitivity to goat proteins or goat milk components.
Preobcutljivost za beljakovine kozjega mleka ali sestavine kozjega mleka.
As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Kot pri vsakem intravenskem beljakovinskem zdravilu so možne alergicne reakcije zaradi preobcutljivosti.
Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Bolnike je treba zaradi morebitnih simptomov med infundiranjem natancno nadzorovati in skrbno opazovati.
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Bolnike je treba pouciti o zgodnjih znakih preobcutljivostnih reakcij, vkljucno z izpušcaji, generalizirano utrikarijo, tišcanjem v prsih, sopihanjem, hipotenzijo in anafilaksijo.
If these symptoms occur after administration, they should contact their physician.
Ce se po uporabi zdravila pojavijo ti znaki, se morajo obrniti na zdravnika.
In case of shock, standard medical treatment should be administered.
Ce nastopi šok, je potrebna obicajna zdravniška oskrba.
Patients treated with ATryn should be monitored for possible clinical immunological reactions.
Bolnike, zdravljene z zdravilom ATryn, je treba nadzorovati za morebitne klinicne imunološke reakcije.
The experience from repeated treatment with ATryn is very limited.
Izkušnje z veckratnim zdravljenjem z zdravilom ATryn so zelo omejene.
Close surveillance with regard to immunological reactions is especially important in such situations.
Natancno spremljanje glede imunoloških reakcij je v takšnih situacijah še posebno pomembno.
Due to differences in pharmacokinetic characteristics of ATryn in pregnant versus non- pregnant patients, recommendations for dosing in pregnancy or in the peripartum period cannot be given.
Zaradi razlik v farmakokineticnih lastnostih zdravila ATryn pri nosecih in nenosecih bolnicah, ni mogoce podati priporocil za odmerjanje med nosecnostjo ali za obdobje pred in med porodom ter po porodu.
Clinical and biological surveillance when antithrombin is used together with heparin, low molecular weight heparin or other anticoagulants which potentiate the anticoagulant activity of antithrombin:
Potreben je klinicni in biološki nadzor, ko se antitrombin uporablja skupaj s heparinom, heparinom z nizko molekularno maso ali drugimi antikoagulanti, ki okrepijo antikoagulantno aktivnost antitrombina:
- In order to adjust dosage of the anticoagulant and to avoid excessive hypocoagulability,
- Da bi prilagodili odmerek antikoagulanta in se izognili prekomerni hipokoagula bilnosti, je treba
controls of the extent of anticoagulation (APTT, and where appropriate anti-Factor Xa activity) should be performed regularly, at close intervals and in particular in the first minutes/ hours following the start of antithr ombin use.
redno in dovolj pogosto, še posebej v prvih minutah / urah po zacetku uporabe antitrombina, preverjati stopnjo antikoagulacije (aktivirani parcialni tromboplastinski cas in kjer je primerno, aktivnost antifaktorja Xa).
- Measure antithrombin levels daily, in order to adjust the individual dose.
- Za prilagajanje posameznega odmerka opravljajte dnevne meritve ravni antitrombina.
The risk of
Upoštevati
diminution of antithrombin levels by prolonged treatment with a non-fractionated heparin should be taken into account.
je treba nevarnost zmanjšanja ravni antitrombina s podaljšanim zdravljenjem z nefrakcioniranim heparinom.
Antithrombin replacement during administration of anticoagulants that potentiate the anticoagulant activity of antithrombin (e. g., heparin, low molecular weight heparin), may increase the risk of bleeding.
Nadomešcanje antitrombina med uporabo antikoagulantov, ki okrepijo antikoagulantno aktivnost antitrombina (npr. heparin, heparin z nizko molekularno maso), lahko poveca nevarnost krvavitve.
Thus, concurrent administration of antithrombin with heparin, low molecular weight heparin, or other anticoagulants that potentiate the anticoagulant activity of antithrombin to a patient with increased risk of bleeding must be monitored clinically and biologically.
Zato je treba hkratno uporabo antitrombina s heparinom, heparinom z nizko molekularno maso ali drugimi antikoagulanti, ki okrepijo antikoagulantno aktivnost antitrombina, pri bolnikih s povecano nevarnostjo krvavenja nadzorovati klinicno in biološko.
4 No interaction studies have been performed.
Študij medsebojnega delovanja niso izvedli.
4.6 Pregnancy and lactation
4 4. 6 Nosecnost in dojenje
Limited clinical data are available on the use of ATryn in pregnant women.
Glede uporabe zdravila ATryn pri nosecnicah so na voljo le omejeni klinicni podatki.
Available data do not suggest harmful effects to the mother or infant.
Po podatkih, ki so na voljo, ne kaže, da bi škodoval materi ali dojencku.
However due to the difference in pharmacokinetic characteristics of ATryn in pregnant vs. non-pregnant patients no recommendation for dosing in pregnancy can be given at this time (see section 4.4).
Zaradi razlik v farmakokineticnih lastnostih zdravila ATryn pri nosecih in nenosecih bolnicah trenutno ni mogoce podati priporocila za odmerjanje med nosecnostjo (glejte poglavje 4. 4).
Animal studies performed in rats did not indicate harmful effects on parturition, embryonal/ foetal and post-natal development.
Študije na podganah niso pokazale škodljivih vplivov na porod, razvoj zarodka/ ploda in otroka po porodu.
4.8 Undesirable effects
4. 8 Neželeni ucinki
In clinical trials involving congenital antithrombin deficient patients (n=35) one mild undesirable effect of “ Application site pruritis” was reported as related to treatment with ATryn.
Pri klinicnih preskušanjih na bolnikih s prirojenim pomanjkanjem antitrombina (n =35) se je ob zdravljenju z zdravilom ATryn pojavil blag neželen ucinek “ pruritus na mestu aplikacije ”.
In other clinical trials with acquired antithrombin deficient cardiac surgery patients (n=118) and healthy volunteers (n=102), undesirable effects reported to be related to treatment with ATryn that were observed more than once are listed by System Organ Class in the table below.
Pri drugih klinicnih preskušanjih na bolnikih po operaciji srca in pomanjkanjem antitrombina (n =118) in zdravih prostovoljcih (n =102) so neželeni ucinki, povezani z zdravljenjem z zdravilom ATryn, ki so jih opazili vec kot enkrat, navedeni po razvrstitvi telesnega sistema organov v spodnji preglednici.
Common (1-10% of subje cts) Nervous system disorders dizziness headache Vascular disorders haemorrhage Gastrointestinal disorders nausea General disorders and administration site conditions venipuncture site haemorrhage Injury and poisoning post procedural haemorrhage wound secretion
Pogosti (1- 10% oseb) Bolezni živcevja omotica glavobol Žilne bole zni krvavitev Bolezni prebavil slabost Splošne težave in spremembe na mestu aplikacije krvavitev na mestu vboda v veno Poškodbe in zastrupitve krvavitev po opravljenem postopku izlocanje iz rane
Uncommon (0.1-1% of subjects) General disorders and administration site conditions Feeling hot Infusion site erythema Infusion site pain Infusion site rash Venipuncture site bruise
Obcasni (0, 1- 1% oseb) Splošne težave in spre membe na mestu aplikacije obcutek vrocice eritem na mestu infundiranja bolecina na mestu infundiranja izpušcaj na mestu infundiranja modrica na mestu vboda v veno
No case of overdose has been reported.
Ni porocil o primerih prevelikega odmerjanja.
5.1 Pharmacodynamic properties
5. 1 Farmakodinamicne lastnosti
Pharmacotherapeutic Group:
Farmakoterapevtska skupina:
Antithrombotic agents: heparin group.
Antitrombotiki: heparinska skupina heparinov.
The factors most strongly inhibited are thrombin and Factor Xa, but also factors of contact activation, intrinsic system and the Factor VIIa/ tissue factor complex.
Faktorja, ki sta najmocneje inhibirana, sta trombin in faktor Xa, a tudi faktorji kontaktne aktivacije, intrinzicnega sistema in faktor VIIa/ kompleks tkivnega faktorja.
Antithrombin activity is greatly enhanced by heparin and the anticoagulant effects of heparin depend on the presence of antithrombin.
Heparin mocno poveca aktivnost antitrombina, antikoagulantni ucinki heparina pa so odvisni od prisotnosti antitrombina.
The first contains the reactive centre and provides a cleavage site for proteinases such as thrombin, a prerequisite for forming a stable proteinase-inhibitor complex.
Prva vsebuje aktivno mesto, ki predstavlja cepitveno mesto za proteaze, kot je trombin, ki je najpomembnejši za nastajanje stabilnega kompleksa zaviralca proteaze.
Normal antithrombin activity in adults is 80 - 120% (0.8-1.2 IU/ ml) and levels in neonates are about 40 - 60% (0.4-0.6 IU/ ml).
Obicajna aktivnost antitrombina pri odraslih je 80 – 120% (0, 8- 1, 2 i. e. / ml), raven aktivnosti pri novorojenckih pa je med 40 – 60% (0, 4- 0, 6 i. e. / ml).
In a formal clinical trial employing serial Duplex ultrasound examinations, antithrombin alfa was shown to be effective in the prevention of thromboembolic events in fourteen congenital antithrombin deficient patients in clinical high risk situations.
V uradnih klinicnih preskušanjih, kjer so izvedli vrsto dvojnih ultrazvocnih pregledov, je antitrombin alfa uspešno prepreceval tromboembolicne dogodke pri štirinajstih bolnikih s prirojenim pomanjkanjem antitrombina v klinicno zelo nevarnih razmerah.
Some additional data have been obtained from a number of patients in a compassionate use programme.
Do dodatnih rezultatov so prišli pri številnih bolnikih, vkljucenih v program socutne uporabe.
This medicinal product has been authorized under “ Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v “ izjemnih okolišcinah ”.
This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
To pomeni, da zaradi redkosti bolezni ni b mogoce pridobiti vseh podatkov o zdravilu.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo ilo vsako leto pregledala vse nove podatke, ki bodo na voljo, in posodobila povzetek glavnih znacilnosti zdravila, ce bo potrebno.
5.2 Pharmacokinetic properties
5. 2 Farmakokineticne lastnosti
After intravenous administration of ATryn (IV bolus dose of 50 IU/ kg or 100 IU/ kg body weight) to congenital antithrombin deficient patients without clinical symptoms of thrombosis, and not using heparin, the incremental recovery was 2.07 ± 1.54 %/ IU/ kg body weight (mean ± SD).
Po intravenski uporabi zdravila ATryn (i. v. bolusni odmerek 50 i. e. / kg ali 100 i. e. / kg telesne mase) pri bolnikih s prirojenim pomanjkanjem antitrombina brez klinicnih simptomov tromboze, ki ne uporabljajo heparina, je bilo postopno okrevanje pri 2, 07 ± 1, 54% / i. e. / kg telesne mase (povprecje ± SD).
Population pharmacokinetic parameters for ATryn derived from the same study revealed (mean ± SD): • Area under the curve:
Populacijski farmakokineticni parametri za ATryn, pridobljeni iz iste študije, so pokazali (povprecje ± SD): • Površina pod krivuljo:
587.88 ± 1.63 (% x h) • Distribution half-life:
587, 88 ± 1, 63 (% x h) • Porazdelitvena razpolovna doba:
1.74 ± 1.28 h, elimination half-life:
1, 74 ± 1, 28 h, razpolovna doba izlocanja:
10.16 ± 1.28 h. • Mean residence time (MRT):
10, 16 ± 1, 28 h. • Povprecen cas zadrževanja (MRT):
8.57 ± 1.24 h • Clearance:
8, 57 ± 1, 24 h. • Ocistek:
0.665 ± 0.0493 l/ h (Mean ± SE)
0, 665 ± 0, 0493 l/ h (povprecje ± SE)
6 5.3 Preclinical safety data
5. 3 Predklinicni podatki o varnosti
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Neklinicni podatki na osnovi obicajnih študij farmakološke varnosti, toksicnosti pri ponavljajocih se odmerkih, genotoksicnosti in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za cloveka.
Glycine Sodium citrate Sodium chloride
Glicin Natrijev citrat 6 Natrijev klorid
It is recommended to reconstitute the product immediately prior to use.
Zdravilo je priporocljivo rekonstituirati tik pred uporabo.
Reconstituted product should be used immediately after preparation.
Rekonstituirano zdravilo porabite takoj po pripravi.
Powder containing 1750 IU antithrombin alfa in a clear vial (type I glass) with a stopper (siliconised bromobutyl rubber) and capped with a band (aluminium) and flip-off cap (plastic).
Prašek s 1750 i. e. antitrombina alfa v stekleni viali (steklo tipa I) z zamaškom (silikoniziran bromobutil), prekriti s trakom (aluminij) in snemljivim pokrovckom (plastika).
1, 10 or 25 vials.
1, 10 ali 25 vial.
6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje
Each vial of ATryn contains a lyophilised powder of 1750 IU antithrombin alfa and is intended for single use only.
Vsaka viala zdravila ATryn vsebuje 1. 750 i. e. liofiliziranega praška antitrombina alfa in je namenjena le enkratni uporabi.
Vials should be brought to room temperature prior to reconstitution and kept no longer than 3 hours.
Viale morajo pred rekonstituiranjem doseci sobno temperaturo, pri kateri se lahko hranijo najvec 3 ure.
The powder should be reconstituted with 10 ml of Sterile Water for Injection (WFI) injected along the side wall of the vial and g swirled (not shaken) to prevent foaming.
Prašek je treba rekonstituirati z 10 ml sterilne vode za injekcije, ki jo vbrizgamo vzdolž stene viale in rahlo zavrtimo (ne stresamo), da preprecimo penjenje.
The reconstituted product should be inspected
Raztopina mora biti prozorna ali rahlo opalescentna.
The solution should be clear or slightly opalescent.
Rekonstituirano zdravilo je treba pred uporabo preveriti na prisotnost delcev in razbarvanje.
The reconstituted product should be administered by intravenous infusion using a sterile disposable syringe or an infusion bag wit h a 0.22 micron pore size in-line filter.
Rekonstituirano zdravilo se daje z intravensko infuzijo s sterilno injekcijsko brizgo za enkratno uporabo ali z infuzijsko vrecko s filtrom z velikostjo por 0, 22 mikrona.
Normal sodium chloride solution 9 mg/ ml (0.9%) may be added to dilute to a concentration convenient for administration.
Da bo raztopina primerna za uporabo, jo lahko razredcite z raztopino natrijevega klorida 9 mg/ ml (0, 9%) za injiciranje.
The contents of infusion syringes or diluted solution prepared in infusion bags should be administered within 8 hours of preparation.
Vsebino v brizgah ali razredceno raztopino, pripravljeno v infuzijskih vreckah, je treba uporabiti v 8- ih urah po pripravi.
Compatibility with PVC infusion lines with in-line filters has been established.
Dokazana je bila kompatibilnost s PVC infuzijskimi kanali s filtri.
LEO Pharma A/ S Industriparken 55 DK-2750 Ballerup Denmark
LEO Pharma A/ S Industriparken 55 DK- 2750 Ballerup Danska
8 ANNEX II
8 DODATEK II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UCINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠCANJE SERIJE
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca biološke zdravilne ucinkovine
97 South Street Hopkinton, MA 01748-2204 USA
97 South Street Hopkinton, MA 01748- 2204 ZDA
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca, odgovornega za sprošcanje serije
Summary of Product Characteristics, section 4.2).
Povzetek glavnih znacilnosti zdravila, poglavje 4. 2).
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UCINKOVITO UPORABO ZDRAVILA
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Imetnik dovoljenja za promet z zdravilom mora pred lansiranjem zdravila na trg zagotoviti vzpostavitev in delovanje sistema farmakovigilance.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne dejavnosti farmakovigilance, podrobno navedene v Nacrtu farmakovigilance.
An updated risk management plan should be provided as per the CHMP guideline on risk management systems for medicinal products for human use.
V skladu s smernico Odbora za zdravila za uporabo v humani medicini, o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini, je treba zagotoviti posodobljeni nacrt o obvladovanju tveganja.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Imetnik dovoljenja za promet z zdravilom mora v dolocenem casovnem obdobju izvesti naslednji program študij, katerih rezultati služijo kot osnova za vsakoletno ponovno oceno razmerja koristi/ tveganj.
10 Clinical aspects
10 Klinicni vidiki
1. Protocol GTC AT HD 012-04:
GTC AT HD 012- 04:
A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin alfa in Hereditary Antithrombin (AT) Deficient Patients in High- Risk Situations for Thrombosis.
Multicentricna, multinacionalna študija za ocenitev varnosti in ucinkovitosti antitrombina alfa pri bolnikih z dednim pomanjkanjem antitrombina (AT) v razmerah z zelo visokim tveganjem za nastanek tromboze.
The results of ongoing study GTC AT HD 012-04 and in particular the results of investigations in pregnant women treated during the peri-partum period will be submitted when enrollment is completed (total of 17 patients, a mix of surgical and pregnant women).
Rezultati traja joce študije GTC AT HD 012- 04 in še posebno rezultati raziskav pri nosecnicah, zdravljenih v obdobju pred in med porodom ter po porodu, bodo predloženi, ko bo zakljucen postopek vkljucevanja bolnikov v študijo (skupaj 17 bolnikov, mešanica kirurško zdravljenih bolnikov in nosecnic).
Assuming positive results of the trial, a marketing authorization variation will be submitted to expand the indication and dosing of pregnant women.
Ce bodo rezultati preskušanja pozitivni, bo dan predolog za spremembo dovoljenja za promet z zdravilom, da se bosta razširila podrocje uporabe in nacin odmerjanja pri nosecnicah.
An update on the status of the trial will be submitted on an annual basis until such time as the study is completed.
Dopolnitve statusa preskušanja bodo predložene vsako leto, dokler študija ne bo koncana.
2. Post-marketing surveillance a) Prior to launch in any EU Member State, the MAH will set up a post-marketing surveillance programme to collect the following information about congenital AT deficient patients treated with ATryn
Spremljanje po zacetku trženja
• • • • • • • •
a)
Demographics Indication Posology Length of treatment Prior treatment with ATryn Use of anti-coagulants Adverse drug reactions including lack of efficacy Development of antibodies
Pred zacetkom trženja v katerikoli državi clanici EU bo imetnik dovoljenja za promet z zdravilom vzpostavil program za spremljanje zdravila po dajanju na trg z namenom zbiranja sledecih informacij o bolnikih s prirojenem pomanjkanjem antitrombina, zdravljenih z zdravilom ATryn: • demografski podatki • indikacije • odmerjanje • trajanje zdravljenja • predhodno zdravljenje z zdravilom ATryn • uporaba antikoagulantov • neželeni ucinki, vkljucno z neucinkovitostjo • razvoj protiteles.
Physicians should be encouraged to enrol patients in the surveillance programme and results of the surveillance should be provided in the update to the EU-RMP or at the time of the annual reassessment, whichever comes first.
Zdravnike je treba spodbujati k vkljucevanju bolnikov v program spremljanja, rezultate spremljanja pa je treba vkljuciti v dopolnitve Nacrta EU za upravljenje s tveganji ali predložiti ob vsakoletni ponovni oceni, kar nastopi prej.
b) Prior to launch in any EU Member State, the MAH will set up an immunosurveillance programme and provide antibody testing for anti-ATryn antibodies to physicians.
b) Pred zacetkom trženja v katerikoli državi clanici EU bo imetnik dovoljenja za promet z zdravilom vzpostavil program nadziranja delovanja imunskega statusa in zdravnikom omogocil testiranje na protitelesa proti zdravilu ATryn.
This antibody testing should be provided upon request of a physi cian and when the MAH receives a report suggestive of a possible immune reaction or lack of efficacy.
To testiranje na protitelesa je treba omogociti na zahtevo zdravnika in kadar imetnik dovoljenja za promet z zdravilom dobi porocilo, znacilno za morebitne imunske reakcije ali neucinkovitost zdravila.
c) The MAH will ensure that material provided to physicians provides information on the post-marketing surveillance programme and the immunosurveillance programme.
c) Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bo material, ki ga bodo prejeli zdravniki, vseboval informacije o programu spremljanja zdravila po dajanju na trg in o programu imunskega nadzora.
This post-marketing surveillance will run up until such time as 40 patients are enrolled.
Pomarketinško spremljanje bo trajalo dokler ne bo vkljucenih 40 bolnikov.
LABELLING AND PACKAGE LEAFLET
OZNACEVANJE IN NAVODILO ZA UPORABO