natgillin/translations-raw huggingface dataset:
The applicant did not convincingly show that the sensitivity analyses performed were able to mitigate the risk of systematic biases in the evaluation of PFS and were adequate to provide sufficient reassurance that bevacizumab produces a PFS increase of clinically important magnitude.
Predlagatelj ni prepričljivo pokazal, da so izvedene občutljivostne analize zmanjšale tveganje za sistematična odstopanja pri oceni preživetja brez napredovanja bolezni in da so zadostno dokazale, da bevacizumab povzroča klinično pomembno podaljšanje preživetja brez napredovanja bolezni.
Therefore, the CHMP has recommended the refusal of the variation of the marketing authorisation for Avastin in the treatment of adult patients with newly diagnosed glioblastoma in combination with radiotherapy and temozolomide.
Zato je odbor CHMP priporočil zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Avastin za zdravljenje odraslih bolnikov z novopostavljeno diagnozo glioblastoma v kombinaciji z radioterapijo in temozolomidom.
Overall, the toxicity of bevacizumab in this regimen and combination did not, in itself, raise major concerns.
Na splošno toksičnost bevacizumaba pri tem režimu in kombinaciji sama po sebi ni povzročila večjih zadržkov, vendar zaradi odsotnosti dokazane učinkovitosti toksičnosti pri tem režimu ni mogoče šteti za sprejemljivo.
The results of the post hoc analysis according to the RANO criteria were not considered sufficiently robust to resolve the uncertainties around the PFS results.
Rezultati naknadne analize po merilu RANO niso bili zadostno robustni, da bi odpravili negotovosti glede rezultatov preživetja brez napredovanja bolezni.
The MAH for Avastin applied for an extension of indication to include Avastin in combination with radiotherapy and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma.
Imetnik dovoljenja za promet z zdravilom Avastin je vložil vlogo za razširitev indikacije, tako da bi se zdravilo Avastin uporabljalo v kombinaciji z radioterapijo in temozolomidom za zdravljenje odraslih bolnikov z novopostavljeno diagnozo glioblastoma.
The main efficacy issue was about the clinical relevance of the radiological endpoint PFS in the absence of a clinically relevant effect on OS. Antiangiogenic agents, especially those targeting vascular endothelial growth factor (VEGF), such as bevacizumab, can produce marked decrease in contrast enhancement and commonly result in high radiologic response rates.
Antiangiogena zdravila, zlasti tista, ki delujejo na žilni endotelijski rastni faktor (VEGF), kot je bevacizumab, lahko povzročijo izrazito zmanjšanje krepitve kontrasta in običajno povzročijo visoke stopnje odziva na obsevanje.
The analysis OS showed no statistically significant difference in survival time between the bevacizumab arm and the placebo arm. Arguably, one-way cross-over after progression may hamper the detection of a difference in OS.
Analiza celokupnega preživetja ni pokazala nobene statistično pomembne razlike v času preživetja med skupino, ki je prejemala bevacizumab, in skupino, ki je prejemala placebo.
Overall survival (OS) and progression-free survival (PFS) as assessed by the investigator were co-primary endpoints of the trial.
Dve primarni končni točki preskušanja, ki jih je ocenil raziskovalec, sta bili celokupno preživetje (OS) in preživetje brez napredovanja bolezni (PFS).
Date of first authorisation: 15 June 2011 Date of latest renewal: 26 May 2016
Datum prve odobritve: 15. junij 2011 Datum zadnjega podaljšanja: 26 maj 2016
n= number of subjects evaluated.
n= število ocenjenih preiskovancev.
()) every 3 or 4 days for 12 weeks.
) vsake 3 ali 4 dni v trajanju 12 tednov.
This can include allergic-type reactions.
To lahko vključuje tudi alergijske reakcije.
No special investigations have been performed.
Posebne raziskave niso bile opravljene.
Although they are rare, the symptoms can be severe.
Čeprav so simptomi redki, so lahko zelo hudi.
Adults and adolescents (12 years and above)
Odrasli in mladostniki (stari 12 let in več)
Your doctor will discuss with you the risks and benefits of taking this medicine.
Zdravnik se bo pogovoril z vami o tveganju in koristih uporabe tega zdravila.
Make sure all the powder is completely dissolved.
Prepričajte se, da je ves prašek popolnoma raztopljen.
If you are injecting Cinryze yourself, always use it exactly as your doctor has instructed you.
Če si zdravilo Cinryze injicirate sami, ga vedno uporabljajte natančno tako, kot vam je naročil zdravnik.
It is important to tell your doctor if you think you have ever had an allergic reaction to any of the ingredients in Cinryze.
Pomembno je, da poveste zdravniku, če mislite, da ste kdaj imeli alergijsko reakcijo na katerokoli sestavino zdravila Cinryze.
Low serum C4 levels often correlate with HAE attacks.
Nizke serumske ravni C4 so pogosto v korelaciji z napadi HAE.
None of these adverse reactions were severe, and none led to discontinuation of medicinal product.
Nobeden od teh neželenih učinkov ni bil hud in nobeden ni povzročil ukinitve zdravila.
* Historically assigned potency values are expressed in in-house Units (U).
* Zgodovinsko pripisane vrednosti aktivnosti so izražene v internih enotah (e.).
If there is no vacuum in the vial, do not use the product.
Če v viali ni vakuuma, ne uporabite zdravila.
Data supporting dosing recommendations in children less than 6 years old are very limited.
Podatkov, ki podpirajo priporočila za odmerjanje pri otrocih, mlajših od 6 let, je zelo malo.
Data collected in this registry should be reported to the CHMP at the time of PSUR submissions.
O podatkih, zbranih v tem registru, je treba poročati CHMP sočasno s predložitvami PSUR.
Patients with known risk factors for thrombotic events (including indwelling catheters) should be monitored closely.
Bolnike z znanimi dejavniki tveganja za trombotične dogodke (vključno s stalnimi katetri) moramo skrbno spremljati.
• Before you start treatment with Cinryze, it is important that you tell your doctor if you have, or have had, problems with your blood clotting (thrombotic events).
• Preden se začnete zdraviti z zdravilom Cinryze, je pomembno, da poveste zdravniku, če imate ali ste kdaj imeli težave s strjevanjem krvi (trombotični dogodki).
The main function of serpins is to regulate the activity of serine proteases.
Glavna funkcija serpinov je uravnavanje aktivnosti serinskih proteaz.
However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature (15C - 25C).
Vendar pa so kemijsko in fizikalno stabilnost med uporabo dokazali za 3 ure pri sobni temperaturi (15 C - 25 C).
• voice-box (larynx), which may make breathing difficult
• grla (larinksa), ki lahko oteži dihanje,
Hypersensitivity reactions may have symptoms similar to angioedema attacks.
Simptomi preobčutljivostnih reakcij so lahko podobni simptomom napadov angioedema.
Prevention:
Preprečevanje:
In case of anaphylactic reactions or shock, emergency medical treatment should be administered.
V primeru anafilaktične reakcije ali šoka je potrebno nujno medicinsko zdravljenje.
The Marketing Authorisation Holder (MAH) should ensure that all healthcare professionals who are expected to prescribe Cinryze are provided with an Educational pack.
Imetnik dovoljenja za promet z zdravilom (MAH) mora zagotoviti, da bodo vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali zdravilo Cinryze, prejeli izobraževalni paket.
Among reports of venous thrombosis, the most common underlying risk factor was presence of an indwelling catheter.
Med poročili o venski trombozi je bil najpogostejši osnovni dejavnik tveganja prisotnost stalnega katetra.
Therefore, Cinryze should be given to pregnant women only if clearly indicated.
Zato smemo dati zdravilo Cinryze nosečnicam samo ob nedvomni indikaciji.
The safety and efficacy of Cinryze in children less than 2 years old has not been established.
Varnost in učinkovitost zdravila Cinryze pri otrocih, mlajših od 2 let, še nista bili dokazani.
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Njihova pogostnost je določena kot: 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), in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Both doses resulted in similar reduction of attack-frequency and showed clinical benefit regarding severity, duration, and requirement for acute treatment of attacks.
Oba odmerka sta povzročila podobno zmanjšanje pogostosti napadov in izkazala klinično korist glede na resnost, trajanje in potrebo po akutnem zdravljenju napadov.
A post-marketing registry should be set-up with the objective to gain additional information on the safety and the use of Cinryze in the EU.
Treba je vzpostaviti register po prihodu zdravila na trg, katerega cilj bo pridobivanje dodatnih informacij o varnosti in uporabi zdravila Cinryze v EU.
No specific studies on fertility, early embryonic and postnatal development, or carcinogenicity studies were conducted (see section 5.3).
Posebne študije glede plodnosti, zgodnjega embrionalnega in postnatalnega razvoja ali študije kancerogenosti niso bile izvedene (glejte poglavje 5.3).
Remove protective covering from the top of the transfer device package.
Odstranite zaščitno pokrivalo z vrha pakiranja priprave za prenos.
For 95% of attacks, clinical relief was observed and/or subjects were discharged to home within 4 hours.
Pri 95 % napadov je bilo ugotovljeno klinično olajšanje in/ali so bili preiskovanci odpuščeni iz bolnišnice v 4 urah.
• face, eyelids, lips or tongue
• obraza, očesnih vek, ustnic ali jezika,
Two additional studies evaluated plasma levels in children (6-11 years).
V dveh dodatnih študijah so ocenili plazemske koncentracije pri otrocih (6-11 let).
• If you are allergic to C1 inhibitor or any of the other ingredients of Cinryze (listed in section 6).
• če ste alergični na zaviralec C1 ali katero koli sestavino zdravila Cinryze (navedeno v poglavju 6).
This leaflet was last revised in
Navodilo je bilo nazadnje revidirano.
The maximum serum concentration (Cmax) and area under the serum concentration-time curve (AUC) appeared to increase from the single to double dose, although the increase was not dose-proportional.
Zdelo se je, da sta se najvišja serumska koncentracija (Cmaks) in površina pod krivuljo serumska koncentracija-čas (AUC) od enojnega do dvojnega odmerka zvišali, čeprav zvišanje ni bilo sorazmerno odmerku.
Local reactions at the injection site were uncommon.
Lokalne reakcije na mestu injiciranja so bile občasne.
What Cinryze is and what it is used for
Kaj je zdravilo Cinryze in za kaj ga uporabljamo
• hands and feet
• dlani in stopal,
If your doctor decides that you may be suitable for such home-treatment, he/she will give you detailed instructions.
Če se vaš zdravnik odloči, da bi utegnili biti primerni za tako zdravljenje na domu, vam bo dal natančna navodila.
Further information to be collected includes data on drug exposure, adverse drug reactions, frequency of attacks, long-term safety data, use in pregnant patients with outcome of pregnancies, as well as use in the paediatric population.
Nadaljnje informacije, ki jih bo treba zbirati, bodo obsegale podatke o izpostavljenosti zdravilu, neželenih učinkih zdravila, pogostnosti napadov, dolgoročnih podatkih o varnosti, uporabi pri nosečnicah z izidom nosečnosti, pa tudi o uporabi v pediatrični populaciji.
You will be carefully monitored if this is the case.
V tem primeru vas bodo med zdravljenjem skrbno spremljali.
Symptoms may include stomach pains and swelling of the:
Med simptomi so lahko bolečine v trebuhu in otekanje:
Side effects in children and adolescents are expected to be similar to those in adults.
Pričakujemo, da bodo neželeni učinki pri otrocih in mladostnikih podobni kot pri odraslih.
Particular attention should be given to the monitoring of cases of severe and laryngeal attacks as well as cases where treatment started later than 4 hours after onset of attack; details about the administered dose, timing of dosing, safety and efficacy outcome should be reported.
Posebno pozornost bo treba posvetiti spremljanju primerov hudih in laringealnih napadov, pa tudi primerov, pri katerih se zdravljenje začne več kot 4 ure po začetku napada; poročati je treba o podrobnostih glede uporabljenega odmerka, časovni razporeditvi odmerjanja, varnosti in izidu učinkovitosti.
Work on the mat provided and wash your hands before performing the following procedures.
Delo opravite na priloženi zaščitni podlogi, pred opravljanjem naslednjih postopkov si umijte roke.
No genotoxicity studies were performed as the active substance is unlikely to interact directly with DNA or other chromosomal material.
Študije genotoksičnosti niso bile opravljene, ker ni verjetno, da bi zdravilna učinkovina vzajemno delovala neposredno z DNK ali drugim kromosomskim materialom.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Cinryze.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
• When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
• Kadar so zdravila izdelana iz humane krvi ali plazme, se uporabljajo nekateri ukrepi, ki preprečujejo, da bi se okužbe prenašale na bolnike.
The continued need for regular prophylaxis with Cinryze should be reviewed on a regular basis.
Stalno potrebo po redni profilaksi z zdravilom Cinryze morate redno preverjati.
If you have a low amount of C1 inhibitor in your blood or your C1 inhibitor is not working properly, this can lead to swelling attacks (called angioedema).
Če imate nizko koncentracijo zaviralca C1 v krvi ali če zaviralec C1 pri vas ne deluje pravilno, se lahko pojavljajo napadi otekanja (ki se imenujejo angioedem).
Overall, the safety and tolerability of Cinryze are similar in children, adolescents and adults.
V celoti gledano sta varnost in prenašanje zdravila Cinryze pri otrocih, mladostnikih in odraslih podobna.
Functional C1 inhibitor activity was measured in children in the two open label studies (see section 5.1).
Aktivnost funkcionalnega zaviralca C1 so merili pri otrocih v dveh odprtih študijah (glejte poglavje 5.1).
6 to 11 years:
Od 6 do 11 let:
PSUR Cycle
Cikel PSUR
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Cinryze therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Cinryze, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
No case of overdose has been reported.
Poročali niso o nobenem primeru prevelikega odmerjanja.
C1 inhibitor is a naturally occurring protein that is normally present in the blood.
Zaviralec C1 je naravna beljakovina, ki je normalno prisotna v krvi.
For 98% of procedures, no HAE attacks were reported within the 72 hours after the Cinryze dose.
Pri 98 % posegov niso poročali o nobenem napadu HAE znotraj 72 ur po odmerku zdravila Cinryze.
Age-Group 6-11 years:
Starostna skupina 6-11 let:
The total protein content of the reconstituted solution is 15 ± 5 mg/ml.
Celotna vsebnost beljakovin rekonstituirane raztopine je 15 ± 5 mg/ml.
Pharmacotherapeutic group: Drugs used in hereditary angioedema, C1 inhibitor, plasma derived, ATC code: B06AC01.
Farmakoterapevtska skupina: zdravila, ki se uporabljajo za dedni angioedem, zaviralci C1, izpeljani iz plazme, oznaka ATC: B06AC01.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Izdelovalci teh izdelkov pri predelavi krvi in plazme uporabljajo tudi ukrepe, ki lahko inaktivirajo ali odstranijo viruse.
2 to 11 years, >25 kg:
Od 2 do 11 let, > 25 kg:
This also applies to any unknown or emerging viruses or other types of infections.
To velja tudi za morebitne neznane oziroma nove viruse ali druge vrste okužb.
Use either the filter transfer device provided with Cinryze or a commercially available double-ended needle.
Uporabite bodisi pripravo za prenos s filtrom, ki je priložena zdravilu Cinryze, bodisi iglo z dvema koncema, ki je komercialno na voljo.
Cinryze is not for use in children below 6 years of age for routine prevention of angioedema attacks.
Zdravilo Cinryze ni namenjeno uporabi pri otrocih, mlajših od 6 let, za rutinsko preprečevanje napadov angioedema.
No studies on fertility, early embryonic and post-natal development, or carcinogenicity studies were conducted because chronic dosing in animals would be expected to be associated with development of neutralising antibodies to the human protein.
Študije plodnosti, zgodnjega razvoja zarodka in ploda ter študije kancerogenosti niso bile opravljene, ker je pričakovati, da bo kronično odmerjanje živalim povezano z razvojem nevtralizirajočih protiteles proti humani beljakovini.
Educational materials for non-healthcare professionals
Izobraževalna gradiva za osebe, ki niso zdravstveni delavci.
Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE).
Zdravljenje in predoperativno preprečevanje napadov angioedema pri odraslih, mladostnikih in otrocih (starih 2 leti in več) z dednim angioedemom (HAE-hereditary angioedema).
In clinical studies local reactions (described as pain, bruising, or rash at the injection/catheter site, venous burning or phlebitis) occurred in association with approximately 0.2% of infusions.
V kliničnih študijah so se lokalne reakcije (opisane kot bolečina, modrica ali izpuščaj na mestu injiciranja/katetra, občutek pečenja v veni ali flebitis) pojavile v povezavi s približno 0,2 % infuzij.
Adverse reactions reported in clinical studies and in postmarketing reports
Neželeni učinki, o katerih so poročali v kliničnih študijah in v poročilih v obdobju trženja Organski sistem
What you need to know before you take Cinryze
Kaj morate vedeti, preden boste vzeli zdravilo Cinryze
There is limited information on the safety of Cinryze use during pregnancy and breast-feeding.
Podatkov o varnosti uporabe zdravila Cinryze med nosečnostjo in dojenjem je malo.
The recommended dose of Cinryze for adults, adolescents, children, the elderly, or patients suffering from kidney or liver problems is as follows:
Priporočeni odmerek zdravila Cinryze za odrasle, mladostnike, otroke, starejše bolnike in bolnike, ki imajo težave z ledvicami ali jetri, je:
After it has been dissolved in the water for injections the solution is clear and colourless to slightly blue.
Potem ko se prašek raztopi v vodi za injekcije, je raztopina bistra in brezbarvna do rahlo modra.
It is unknown whether C1 inhibitor is excreted in human milk.
Ni znano, ali se zaviralec C1 izloča v materino mleko.
The dosing interval and dose may need to be adjusted according to individual response.
Presledek med odmerki in odmerek po potrebi prilagodite odzivu posameznika.
Gently swirl the powder vial until all powder is dissolved.
Nežno sukajte vialo s praškom, dokler se ne raztopi ves prašek.
Tell your doctor immediately if you experience any of the following symptoms after taking this medicine.
Nemudoma povejte zdravniku, če po uporabi tega zdravila opazite enega ali več od naslednjih simptomov.
2 to 11 years, 10-25 kg:
Od 2 do 11 let, 10-25 kg:
Potential risks associated with home-treatment are related to the administration itself as well as the handling of adverse reactions, particularly hypersensitivity.
Možne nevarnosti, povezane z zdravljenjem na domu, so povezane s samo uporabo zdravila, pa tudi z ukrepanjem pri neželenih učinkih, posebno pri preobčutljivosti.
For subjects with >1 attack, the proportion of attacks responding within 4 hours after Cinryze dosing and the time to response was comparable regardless of the number of attacks treated.
Pri preiskovancih z več kot enim napadom sta bila delež napadov, ki so se odzvali v štirih urah po odmerku zdravila Cinryze, in čas do odziva primerljiva ne glede na število zdravljenih napadov.
The very common adverse reactions observed following Cinryze infusion in clinical studies were headache and nausea.
Zelo pogosta neželena učinka, ki so ju opazili po infuziji zdravila Cinryze v kliničnih študijah, sta bila glavobol in navzea.
The decision on the use of home- treatment for an individual patient should be made by the treating physician, who should ensure that appropriate training is provided and the use reviewed at intervals.
Odločitev o uporabi zdravljenja posameznega bolnika na domu mora sprejeti lečeči zdravnik, ki mora zagotoviti, da je na voljo ustrezno izobraževanje in da se uporaba ocenjuje v rednih presledkih.
Do not use Cinryze after the expiry date which is stated on the carton or vials after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali vialah poleg oznake “EXP”.
You will be required to keep a diary in order to document each treatment received at home and to bring it to each of your visits to the doctor.
Voditi boste morali dnevnik, da boste dokumentirali vsak doma prejeti odmerek zdravila, in ga pri vsakem obisku prinesti zdravniku.
Study LEVP 2006-1: Twenty-two paediatric subjects were treated for 121 acute HAE attacks.
Študija LEVP 2006-1: Dvaindvajset pediatričnih preiskovancev se je zdravilo zaradi 121 akutnih napadov HAE.
Regular review of the administration by the patient/carer needs to be performed to ensure maintenance of optimal practice.
Treba je redno ocenjevati bolnikovo/negovalčevo uporabo zdravila, da se zagotovi vzdrževanje najboljše prakse.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Standardni ukrepi za preprečevanje infekcij, ki nastanejo zaradi uporabe zdravil, pripravljenih iz humane krvi ali plazme, vključujejo izbiro dajalcev, presejalno testiranje krvi posameznih dajalcev in zalog plazme na specifične označevalce okužb in vključitev učinkovitih izdelavnih standardov za inaktivacijo/odstranitev virusov.
Across clinical studies, there were 61 unique paediatric subjects enrolled and exposed to over 2,500 infusions of Cinryze (2-5 years, n=3; 6-11 years, n=32; 12-17 years, n=26).
V klinične študije je bilo vključenih 61 različnih pediatričnih bolnikov, ki so bili izpostavljeni več kot 2500 infuzijam zdravila Cinryze (2-5 let, n=3; 6-11 let, n=32; 12-17 let, n=26).
For safety with respect to transmissible agents, see section 4.4.
Za varnost v zvezi s prenosljivimi povzročitelji bolezni glejte poglavje 4.4.
Data from two randomised, double-blind, placebo-controlled studies (LEVP 2005-1/A and LEVP 2005-1/B), data from two open-label studies (LEVP 2006-1 and LEVP 2006-4) and 2 paediatric clinical studies (0624-203 and 0624-301) demonstrated the efficacy of Cinryze for the treatment and prevention of angioedema attacks in subjects with HAE.
Podatki iz dveh randomiziranih, dvojno slepih, s placebom kontroliranih študij (LEVP 2005-1/A in LEVP 2005-1/B), podatki iz dveh odprtih študij (LEVP 2006-1 in LEVP 2006-4) in 2 pediatričnih kliničnih študij (0624-203 in 0624-301) so pokazali učinkovitost zdravila Cinryze za zdravljenje in preprečevanje napadov angioedema pri osebah s HAE.
Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
Nenadna zasoplost, oteženo dihanje, otekanje vek, obraza ali ustnic, izpuščaj ali srbenje (posebno po vsem telesu).
Only frequencies based on reporting rates from clinical trials are used to assign frequency category.
Za dodelitev v kategorijo pogostnosti so uporabili le pogostnosti na podlagi stopenj poročanja iz kliničnih preskušanj.