natgillin/translations-raw huggingface dataset:
Produtos Químicos e Farmacêuticos, Lda Av. José Malhoa, 16B - 2° 1070-159 Lisboa
Portugalska Organon Portuguesa Produtos Químicos e Farmacêuticos, Lda Av. José Malhoa, 16B - 2° 1070-159 Lisboa
A RMP proposal for Implanon NXT will be part of this variation.
Predlog načrta za obvladovanje tveganja za zdravilo Implanon NXT bo del te variacije;
The final results of the Mirena study were deemed to be of relevance and should contribute to the evaluation of the safety for Implanon.
Za končne rezultate študije o Mireni se domneva, da bodo relevantni in bi morali prispevati k ovrednotenju varnosti za zdravilo Implanon.
Implanon was approved in the EU during a MR procedure with the Netherlands (NL) as reference member state (RMS) and has been marketed since 1998 with the indication “contraception”.
Zdravilo Implanon je bilo odobreno v EU med postopkom za medsebojno priznavanje z Nizozemsko kot referenčno državo članico in se je tržil od leta 1998 z označbo „kontracepcija“.
• The MAH will submit a type II variation in 2009 to introduce the new Implanon (Implanon NXT).
• imetnik dovoljenja za promet z zdravilom bo predložil tip II variacije v letu 2009 za uvedbo novega zdravila Implanon (Implanon NXT).
Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona Spain
Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona Španija
The first European renewal of Implanon was successfully completed in 2003.
Prvič je bilo dovoljenje za promet z zdravilom v Evropi uspešno obnovljeno leta 2003.
Thus, many women actually experience a benefit with the bleeding pattern although the lack of predictability may remain a problem for some.
Tako ima mnogo žensk dejansko koristi pri ciklusu krvavenja, čeprav je nepredvidljivost krvavenja pri nekaterih še vedno problem.
The CHMP, having considered the data submitted in the application is of the opinion that further risk minimisation activities are necessary for the safe and effective use of the medicinal product.
CHMP ob upoštevanju predloženih podatkov v vlogi za obnovitev dovoljenja meni, da so nadaljnje dejavnosti za zmanjševanje tveganja nujne za varno in učinkovito uporabo zdravila.
The CHMP considers that bleeding pattern disturbance should not be considered as a serious health issue, as it disappears immediately upon discontinuation and is not associated with any known health risk to the woman.
CHMP meni, da motnje v ciklusu krvavenja ne smejo šteti za resen zdravstveni problem, saj ob prekinitvi takoj izgine in ni povezan z nobenim znanim tveganjem za zdravje žensk.
Of some relevance is the interim analysis data from the ongoing case-control study of the progestogen releasing contraceptive IUD (Mirena) (ICPE meeting report, 2008).
Nekoliko ustreznejša je vmesna analiza podatkov iz študije primerov in kontrol o kontracepciji IUD, ki sprošča progestogen (Mirena) (Poročilo o srečanju ICPE, 2008).
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Veljavni povzetek glavnih značilnost zdravila, označevanje in navodilo za uporabo so končne različice, pripravljene v postopku koordinacijske skupine.
It is crucial - and should be self evident - that anyone, who performs insertions/removals must be well trained and familiar with those procedures, as incorrect insertions will lead to removal problems.
Ključnega pomena je, kar bi moralo biti samo po sebi umevno, da mora biti oseba, ki implantant vstavlja/odstranjuje, primerno usposobljena in seznanjena s temi postopki, saj zaradi nepravilnega vstavljanja pri odstranitvi nastanejo težave.
Similarly, the removal of Implanon due to irregular bleeding should not be regarded as a serious consequence since the “surgical intervention” to remove Implanon must be considered minimal, requiring a 0,5-1cm superficial skin incision, after which the implant can be easily extracted.
Podobno odstranitev zdravila Implanon zaradi nerednega krvavenja ne sme predstavljati resnih posledic, saj mora „kirurški poseg“ za odstranitev zdravila Implanon šteti za minimalnega in zahtevati 0,5-1 cm površinskega reza v kožo, po katerem se implantant enostavno izvleče.
The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
CHMP je ocenil dokumentacijo in razpoložljive podatke, vključno s spornimi vprašanji nasprotujočih zadevnih držav članic.
- bleeding pattern disturbances should not be considered as a serious health issue,
- motnje v ciklusu krvavenja ne morejo predstavljati resnega zdravstvenega problema;
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, NAČIN UPORABE IN IMETNIKI DOVOLJENJ ZA PROMET V DRŽAVAH ČLANICAH
Furthermore, the reports on Implanon removals in breast cancer patients from the US AMP program are likely to yield valuable information from case series that are expected to be relatively complete.
Poleg tega bodo poročila o odstranitvi zdravila Implanon pri bolnicah z rakom na dojkah iz programa aktivnega spremljanja v ZDA najverjetneje prinesla pomembne informacije iz serije primerov, za katere se pričakuje, da bodo relativno zaključeni.
The study includes correction for the age of the study population, enabling comparisons to the Implanon user population and therefore, the final results of this study will be of relevance also for Implanon.
Študija vključuje popravek za starost raziskovane populacije, kar omogoča primerjavo s populacijo uporabnic zdravila Implanon, zaradi česar bodo končni rezultati študije ustrezni tudi za zdravilo Implanon.
Implanon 68 mg implant 68mg Implant
Implanon 68 mg implant 68 mg implantat
The CHMP agreed on the following proposal for conditions of the renewal of the Marketing Authorisation previously presented by the RMS:
CHMP se je strinjal o naslednjem predlogu za pogoje obnovitve dovoljenja za promet z zdravilom, ki jih je prej predstavila referenčna država članica:
• With the 6 monthly IRRE report, the MAH will submit the latest results of the ongoing active monitoring program (AMP) in the USA.
• s šestmesečnim poročilom IRRE bo imetnik dovoljenja za promet z zdravilom predložil najnovejše rezultate potekajočega programa dejavnega spremljanja (AMP) v ZDA;
- no signals of an increased risk of breast cancer have been identified,
- znaki za povečanje tveganja za raka na dojkah niso bili prepoznani;
It is acknowledged that the available studies have limitations, e.g. the lack of data on the associations with POPs, limited power to examine risk relationships in subgroups, and further no meaningful data to examine the effects of implants.
Priznava se, da so razpoložljive študije omejene, npr. pomanjkanje podatkov v povezavi s POP, omejena zmožnost proučevanja razmerij tveganja v podskupinah, poleg tega pa ne vsebujejo podatkov za proučevanje učinkov implantantov.
The CHMP is of the opinion that a new epidemiological study of breast cancer in Implanon users is not justified at the present time.
CHMP meni, da nova epidemiološka študija o raku na dojkah pri uporabnicah zdravila Implanon trenutno ni upravičena.
The CHMP considered that bleeding irregularities are expected with all progestogen-only methods, in particular those that inhibit ovulation.
CHMP je menil, da se nepravilnosti pri krvavenju pričakujejo pri vseh metodah, ki vsebujejo le progestogen, in zlasti tistih, ki zavirajo ovulacijo.
• The MAH will continue with the 6-monthly reports of all unintended pregnancy and insertion/removal related problems (IRRE) during the next 5 year renewal period.
• imetnik dovoljenja za promet z zdravilom bo v naslednjih petih letih obnovitve nadaljeval s šestmesečnimi poročili o vseh neželenih nosečnostih in problemih, povezanih z vstavljanjem/odstranitvijo (IRRE);
The proposal by the MAH to further update bleeding data information in section 4.8 with new US data and to improve the information material on bleeding pattern was endorsed.
Odobren je bil predlog imetnika dovoljenja za promet z zdravilom za nadaljnje posodabljanje informacij o krvavenju v poglavju 4.8 z novimi podatki iz ZDA in za izboljšanje informacij o ciklusih krvavenja.
• The MAH will develop further information and counselling materials for the Health Care Professionals and the women about the bleeding patterns that may be experienced during use of Implanon, which can be presented to the woman when she is considering use of Implanon for contraception.
• imetnik dovoljenja za promet z zdravilom bo pripravil nadaljnje informacije in gradivo za svetovanje zdravstvenemu osebju in ženskam o ciklusih krvavenja, ki lahko nastopijo med uporabo zdravila Implanon, pripravljeno gradivo pa bo na voljo ženskam, ki se odločajo o uporabi zdravila Implanon za kontracepcijo.
The CHMP acknowledged the issue of underreporting but did not consider that any signals indicating an increased risk of breast cancer have been identified.
CHMP je priznal problem pomanjkanja poročil, vendar ni menil, da so bili ugotovljeni kakršni koli znaki, ki kažejo na povečano tveganje za raka na dojkah.
In summary, the CHMP agreed that there is at this time no firm evidence of an association between Implanon exposure and an increased risk of breast cancer in young women.
Če povzamemo, CHMP se strinja, da trenutno ni trdnih dokazov za obstoj povezave med izpostavljenostjo zdravilu Implanon in povečanju tveganja za raka na dojkah pri mladih ženskah.
The CHMP was of the view that written informed consent in the EU is associated with products where there are established serious risks and that the introduction of a request for informed consent for Implanon, one of several widely used methods of contraception, is unjustified and would strongly signal a risk that is certainly not present.
CHMP je menil, da je pisno soglasje v EU povezano z zdravili, pri katerih je ugotovljeno resno tveganje, in da je uvedba zahteve za soglasje za zdravilo Implanon, ki je ena izmed široko uporabljenih metod kontracepcije, neupravičena in bi trdno kazala na tveganje, ki zagotovo ne obstaja.
The RMP will be submitted to the RMS within 3 months and will include the activities mentioned in the conditions of the renewal of the Marketing Authorisation.
Načrt za obvladovanje tveganja bo predložen referenčni državi članici v treh mesecih, pri tem pa bodo vključene dejavnosti, omenjene v pogojih za obnovitev dovoljenja za promet z zdravilom.
The contraceptive action of Implanon is primarily achieved by inhibition of ovulation.
Kontracepcijski učinek zdravila Implanon je primarno dosežen z zaviranjem ovulacije.
Furthermore, the degree of underreporting is assumed to be lower for Implanon compared to spontaneous ADR reporting in general, therefore the CHMP does not consider that spontaneous reports on breast cancer in users of Implanon give rise to a new signal of an adverse effect.
Poleg tega se za stopnjo pomanjkanja poročanja predvideva, da je nižja za zdravilo Implanon v primerjavi s poročanjem o neželenih učinkih zdravila (ADR) na splošno, zato CHMP ne meni, da spontana poročila o raku na dojkah pri uporabnicah zdravila Implanon pomenijo nov pojav neželenega učinka.
The MAH was requested to report the results from the active monitoring program for IRREs in the USA.
Imetnik dovoljenja za promet z zdravilom je bil naprošen, da poroča o rezultatih dejavnega spremljanja programa IRRE v ZDA.
• The marketing authorisation holder (MAH) will continue with the 12 monthly Periodic Safety Update Reports (PSURs).
• imetnik dovoljenja za promet z zdravilom bo nadaljeval z 12-mesečnimi periodičnimi poročili o varnosti zdravila (PSUR);
Because the US AMP does not include the new inserter (Implanon NXT), the MAH is also requested to closely monitor the introduction and performance of the new inserter as a part of the RMP.
Ker program dejavnega spremljanja (AMP) v ZDA ne vključuje novega vstavka (Implanon NXT), je bil imetnik dovoljenja za promet z zdravilom naprošen tudi, da skrbno spremlja uvedbo in učinkovitost novega vstavka kot del načrta za obvladovanje tveganja.
- correct insertion is a simple procedure and IRRE problems can be prevented or reduced by compliance with updated instructions and training materials,
- pravilno vstavljanje je enostaven postopek in težave z IRRE se lahko preprečijo ali zmanjšajo z upoštevanjem posodobljenih navodil in gradiv za usposabljanje;
The CHMP concluded that the contraceptive efficacy of Implanon is superior to that of other hormonal contraceptives and that the Pearl Indices obtained for Implanon are significantly lower than those obtained with other systemic hormonal contraceptives, and certainly lower than those obtained with combined oral contraceptives, especially as these are prone to non-compliance, and gastrointestinal disturbances.
CHMP je ugotovil, da učinkovitost kontracepcije zdravila Implanon prekaša učinkovitost ostalih hormonskih kontracepcij ter da so Pearlovi indeksi za zdravilo Implanon znatno nižji kot pri drugih sistematičnih hormonskih vrstah kontracepcije ter vsekakor nižji od tistih pri kombiniranih oralnih kontracepcijah, zlasti zato ker se pri teh pojavljata nesprejemanje in gastrointestinalne motnje.
Relevant parts of the above mentioned activities should be included in a Risk Management Plan (RMP) proposal presented by the MAH within three months.
Ustrezne dele zgoraj omenjenih dejavnosti je treba vključiti v predlog načrta za obvladovanje tveganja, ki ga imetnik dovoljenja za promet z zdravilom predstavi v treh mesecih.
In addition, the following issues should be included in the RMP proposal:
Poleg tega je treba v predlog načrta za obvladovanje tveganja vključiti tudi naslednje zadeve:
- the obvious benefits are the long duration of use and the lack of compliance problems
- očitne koristi so dolgotrajna uporaba in odsotnost težav s sprejemanjem;
The CHMP considers that correct insertion is a simple procedure and that the IRRE problems can be prevented or reduced by compliance with updated instructions and training materials.
CHMP meni, da je pravilno vstavljanje enostaven postopek in da se težave z IRRE lahko preprečijo ali zmanjšajo z upoštevanjem posodobljenih navodil in gradiv za usposabljanje.
The big advantage of implants is the absence of problems with compliance or gastro-intestinal disturbances that negatively affect contraceptive efficacy versus the disadvantages of irregular bleeding being there with all continuous progestogen-only methods that inhibit ovulation.
Velika prednost implantantov je odsotnost problemov sprejemanja ali gastrointestinalnih motenj, ki negativno vplivajo na učinkovitost kontracepcije, slabost pa neredno krvavenje, ki je prisotno pri vseh neprekinjenih metodah, ki vsebujejo le progestogen in zavirajo ovulacijo.
The main benefit of any contraceptive method is efficacy and the CHMP considered that Implanon shows excellent efficacy with no evidence of decline neither during the 3rd year of use nor in heavy women and that the current text in the SPC regarding efficacy and weight is appropriate.
Glavna prednost katere koli metode kontracepcije je njena učinkovitost in CHMP je menil, da je zdravilo Implanon izjemno učinkovito brez dokazov o zmanjšanju učinkovitosti med tretjim letom uporabe ali pri ženskah s prekomerno težo ter da je trenutno besedilo v Povzetku glavnih značilnosti zdravila glede učinkovitosti in telesne mase primerno.
Thus, most data pertain to injectable POC, little data exist for other POCs, no data are available for Implanon.
Zato se večina podatkov nanaša na injicirani POC, malo podatkov je na voljo o ostalih vrstah uporabe POC, ni pa podatkov za zdravilo Implanon.
Strength Pharmaceutical Form Route of administration
Jakost Farmacevtska oblika
• The body weight at the time of removal will be asked for in case of early removal (including pregnancy) in the AMP.
• v primeru zgodnje odstranitve (vključno z nosečnostjo) v programu dejavnega spremljanja se ob odstranitvi ugotovi telesna masa;
the CHMP has recommended the renewal of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Implanon.
CHMP je priporočil obnovitev dovoljenj za promet z zdravilom Implanon, z njim povezani povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so navedeni v Dodatku III.
Applicant (Invented) Name
(Lastniško) ime
• An update on bleeding in section 4.8 in the SPC and leaflet as proposed in the draft MAH labelling.
• posodobitev podatkov o krvavenju v poglavju 4.8 Povzetka glavnih značilnosti zdravila in navodilu za uporabo, kot je predlagano v osnutku označevanja imetnika dovoljenja za promet z zdravilom.
The MAH has compiled data of available relevant studies and overall, the epidemiological data on the association between progestogen-only contraception (POC) and breast cancer risk are sparse and reflect mostly the use of injectable DMPA.
Imetnik dovoljenja za promet z zdravilom je zbral podatke o razpoložljivih zadevnih študijah in na splošno, epidemiološki podatki o povezavi med kontracepcijo, ki vsebuje le progestogen (POC), in tveganjem raka na dojkah pa so redki in kažejo večinoma na uporabo injiciranega DMPA.
Implanon is a non-biodegradable, long-acting, progestagen-only contraceptive implant inserted subdermally.
Zdravilo Implanon je biološko nerazgradljiv kontracepcijski implantant z dolgotrajnim delovanjem, ki vsebuje samo progestagen in se vsadi pod kožo.
The Mirena study and reports from the US AMP should be included in the updated RMP.
Študija o Mireni in poročila iz programa dejavnega spremljanja v ZDA morajo biti vključeni v posodobljenem načrtu za obvladovanje tveganja.
In conclusion, the CHMP considers Implanon to be an effective method of contraception with no apparent safety concerns and that the benefit-risk balance of Implanon is positive.
Končno CHMP meni, da je zdravilo Implanon učinkovita metoda kontracepcije brez očitnih zadržkov glede varnosti ter da je razmerje med koristmi in tveganji pozitivno.
- Implanon has clearly proven to be an effective method of contraception - including in obese womendespite a low dose,
- zdravilo Implanon se je kljub majhnim odmerkom jasno dokazalo kot učinkovita metoda kontracepcije, tudi pri ženskah s prekomerno telesno maso.
In conclusion, the CHMP considers Implanon to be an effective method of contraception with no apparent safety concerns and is therefore of the opinion that the benefit-risk profile of Implanon is positive.
Nazadnje CHMP meni, da je zdravilo Implanon učinkovita metoda kontracepcije, nima očitnih zadržkov glede varnosti in meni, da je razmerje med koristmi in tveganji pozitivno.
From the interim analysis, the study hypothesis of an adverse effect on breast cancer risk has no support.
Hipoteza študije o neželenem učinku za raka na dojkah tudi ni podprta v vmesni analizi.
However, a number of concerns were raised by the objecting CMS which did not consider the second renewal acceptable.
Vendar pa so nasprotujoče zadevne države članice, ki druge obnovitve dovoljenja za promet z zdravilom niso ocenile kot primerno, izrazile številne dvome.
Austria
Avstria
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
PRILOGA I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Roche Farmacêutica Química, Lda
Portugalska Roche Farmacêutica Química, Lda
Roche Hungary Ltd Edison ut 1
Madžarska Roche Hungary Ltd Edison ut 1
Protection lasts for one year.
Zaščita traja eno leto.
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to stimulate a better response.
Cepivo vsebuje tudi „adjuvansa“ (aluminijev hidroksid in saponin) za spodbujanje boljšega odziva.
The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease.
Cepivo se uporablja za preprečevanje viremije (prisotnosti virusa v krvi) in zmanjševanje kliničnih znakov bolezni.
Vaccination may be followed by a small local swelling at the injection site (up to 24 cm2) for a short period (up to two weeks).
Po cepljenju se lahko na mestu injiciranja za kratek čas (največ dva tedna) pojavi manjša lokalizirana oteklina (največ 24 cm2).
Animals may show a slight rise in body temperature, normally no more than 1.1°C on average, in the 24 hours following vaccination.
Pri živalih so v prvih 24 urah po cepljenju opazili rahlo povečanje telesne temperature, ki pa navadno ne preseže 1,1 °C.
The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the quality, safety and efficacy of the vaccine.
Evropska agencija za zdravila (EMA) je pregledala vse nove podatke o kakovosti, varnosti in učinkovitosti cepiva, ki so bili predloženi po dogovorjenem časovnem razporedu.
The safety and effectiveness studies showed that the vaccine is safe for sheep and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 2 and 4.
Študije varnosti in učinkovitosti so pokazale, da je cepivo varno za uporabo pri ovcah ter da zmanjša klinične znake bolezni in preprečuje viremijo pri živalih od enega meseca starosti dalje, ki so okužene z virusom modrega jezika, serotipa 2 in 4.
The vaccine is given to young animals as an injection under the skin.
Cepivo se injicira mladim živalim v podkožje.
In the future, if the animals are exposed to bluetongue virus, the immune system will be able to produce antibodies more quickly.
Ob ponovni izpostavitvi virusu bolezni modrega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
The European Commission granted a marketing authorisation valid throughout the EU for BTVPUR AlSap 2-4 on 5 November 2010.
Evropska komisija je dovoljenje za promet z zdravilom BTVPUR AlSap 2-4, veljavno po vsej Evropski uniji, odobrila 5. novembra 2010.
The injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal is likely to have inherited antibodies against the virus from a mother that is already immune to the disease.
Živalim, ki še nikoli niso bile izpostavljene bolezni, se prva injekcija vbrizga po dopolnjenem enem mesecu starosti, živalim, ki so protitelesa proti virusu verjetno prejele od matere, ki je že imuna na to bolezen, pa po dopolnjenih dveh mesecih in pol starosti.
In 2014 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR Alsap 2-4 to convert to a normal status.
Leta 2014 je CVMP menil, da predloženi podatki zadostujejo, da se dovoljenje za promet s cepivom BTVPUR AlSap 2-4 spremeni v običajno dovoljenje.
When it is given to sheep, the animals' immune systems recognise the viruses as ‘foreign' and make antibodies against them.
Ko ovco cepimo, imunski sistem viruse prepozna kot „tujek“ in proti njim razvije protitelesa.
The studies also showed that the vaccine can be used in pregnant and lactating sheep.
Pokazale so tudi, da se cepivo lahko uporabi pri brejih ovcah in ovcah v laktaciji.
It is available as a suspension for injection that contains inactivated (killed) bluetongue serotype 2 and 4 viruses.
Na voljo je v obliki suspenzije za injiciranje, ki vsebuje inaktivirane (uničene) viruse modrega jezika, serotipa 2 in 4.
BTVPUR AlSap 2-4 was initially authorised under ‘exceptional circumstances'.
Cepivo BTVPUR AlSap 2-4 je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
The effectiveness of the vaccine in sheep was studied in a pivotal laboratory trial using the vaccine in sheep from a young age.
Učinkovitost cepiva pri ovcah so raziskovali v ključnem laboratorijskem preskušanju, v katerem so ovce cepili že od zgodnje starosti dalje.
The withdrawal period for BTVPUR Alsap 2-4 for meat and milk for sheep is zero days.
Obdobje karence za cepivo BTVPUR AlSap 2-4 za meso in mleko pri ovcah je nič dni.