natgillin/translations-raw huggingface dataset:
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) 
Pogostnost neželenih učinkov je opredeljena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali in kažejo negativno reakcijo/-e tekom enega zdravljenja) - pogosti (pojavijo se pri 1 od 10 živali od 100 živali)
INDICATION(S) For treatment of clinical signs, including oedema and effusion, related to congestive heart failure. 
Za zdravljenje kliničnih znakov, vključno z edemom in izlivom, povezanim s kongestivnim srčnim popuščanjem.
MARKETING AUTHORISATION NUMBER(S) 
ŠTEVILKA DOVOLJENJA/ŠTEVILKE DOVOLJENJ ZA PROMET
Co-administration of loop diuretics and non-steroidal anti-inflammatory drugs can result in a decreased natriuretic response. 
Sočasna uporaba diuretikov Henleyjeve zanke in nesteroidnih protivnetnih zdravil lahko povzroči zmanjšan natriuretični odgovor.
INDICATION(S) 
INDIKACIJA/-E
Cardboard box 
PODATKI NA ZUNANJI OVOJNINI Kartonasta škatla
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use. 
NAČIN IN POT/-I UPORABE ZDRAVILA Peroralna uporaba.
Erythema of the inner pinnae may be observed. 
Opazimo lahko eritem notranjega dela uhlja.
Sodium laurilsulfate Crospovidone Microcrystalline cellulose Sodium stearyl fumarate Bacon flavour 
6.1 Seznam pomožnih snovi laktoza monohidrat povidon natrijev lavrilsulfat krospovidon mikrokristalna celuloza natrijev stearilfumarat okus klobase
CONTRAINDICATIONS 
KONTRAINDIKACIJE:
Care should be exercised when administering torasemide with other highly plasma protein bound drugs. 
Pri dajanju torasemida z drugimi zdravili, ki se vežejo na plazemske proteine, je potrebna previdnost.
0.75 mg torasemide 3 mg torasemide 7.5 mg torasemide 18 mg torasemide 
0,75 mg toresamida 3 mg toresamida 7,5 mg toresamida 18 mg toresamida
Keep tablets in the blister packs until required, and keep the blisters in the outer carton. 
Ko tablet ne potrebujete, jih hranite v pretisnih omotih, te pa hranite v zunanji ovojnini.
UpCard 7.5 mg tablets for dogs 
UpCard 7,5 mg tablete za pse
UpCard 3 mg tablets for dogs 
UpCard 3 mg tablete za pse
UpCard 18 mg tablets for dogs 
UpCard 18 mg tablete za pse
SPECIAL WARNING(S) 
POSEBNO OPOZORILO/POSEBNA OPOZORILA
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
UpCard 3 mg, 7.5 mg and 18 mg tablets: oblong white to off-white tablets with 3 break-lines on each side. 
UpCard 3 mg, 7,5 mg in 18 mg tablete: podolgovate bele do sivo-bele tablete s 3 zarezami za lomljenje na obeh straneh.
UpCard 3 mg, 7.5 mg and 18 mg tablets are oblong white to off-white tablets with 3 break-lines on each side. 
UpCard 3 mg, 7,5 mg in 18 mg tablete so podolgovate bele do sivo-bele tablete s 3 zarezami za lomljenje na obeh straneh.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC ZDRAVILNE UČINKOVINE, ODGOVOREN ZA SPROSTITEV SERIJE
UpCard 0.75 mg tablets: oblong white to off-white tablets with 1 break-line on each side. 
UpCard 0,75 mg tablete: podolgovate bele do sivo-bele tablete z 1 zarezo za lomljenje na obeh straneh.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
PODATKI, KI MORAJO BITI OBVEZNO NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
B. PACKAGE LEAFLET 
B. NAVODILA ZA UPORABO
PACKAGE LEAFLET FOR: UpCard 0.75 mg tablets for dogs UpCard 3 mg tablets for dogs UpCard 7.5 mg tablets for dogs UpCard 18 mg tablets for dogs 
NAVODILA ZA UPORABO ZA: 0,75 mg tablete za pse UpCard 3 mg tablete za pse UpCard 7,5 mg tablete za pse UpCard 18 mg tablete za pse UpCard
UpCard 0.75 mg tablets for dogs 
Vsaka tableta vsebuje: UpCard 0,75 mg tablete za pse
UpCard 0.75 mg tablets are oblong white to off-white tablets with 1 break-line on each side. 
UpCard 0,75 mg tablete so podolgovate bele do sivo-bele tablete z 1 zarezo za lomljenje na obeh straneh, ki jih lahko razpolovimo na enaki polovici.
The indicated period of use is 3 years. 
Predvideno obdobje uporabe je tri leta.
In total, about 5 million Implanon implants have been sold worldwide up to July 2008. 
Skupaj je bilo do julija 2008 po celem svetu prodanih približno 5 milijonov implantantov zdravila Implanon.
This is well known and sometimes a reason for method discontinuation. 
To je dobro znano in včasih razlog za prekinitev metode.
The renewal will be granted for 5 years with the following conditions: 
Obnovitev se odobri za pet let pod naslednjimi pogoji:
81737 Munich Germany 
81737 Munich Nemčija
Because no agreement was reached at Day 60, the procedure was referred to the CHMP. 
Ker po 60 dneh dogovor ni bil dosežen, je bil postopek posredovan CHMP.
GROUNDS FOR OPINION 
RAZLOGI ZA MNENJE
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF IMPLANON 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA IMPLANON
Co. Dublin Ireland 
Co. Dublin Irska
ANNEX IV CONDITIONS FOR THE RENEWAL OF THE MARKETING AUTHORISATION 
DODATEK IV POGOJI ZA OBNOVITEV DOVOLJENJA ZA PROMET
This is because Mirena represents a continuous and long-term systemic progestogen exposure in young women. 
To pa zato, ker Mirena predstavlja nenehno in dolgotrajno sistematično izpostavljenost progestogenu pri mladih ženskah.
The ENG dose released by Implanon is equivalent to 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the 3rd year. 
Odmerek ENG, ki ga sprosti zdravilo Implanon, je enak 6070 μg/dan kmalu po vstavku in se zmanjša na približno 40 μg/dan na začetku drugega leta ter na približno 25-30 μg/dan na koncu tretjega leta.
The issue was referred to the CMD (h) and an assessment was carried out by the RMS. 
Zadeva je bila posredovana skupini CMD(h), referenčna država članica pa je izvedla oceno.
Almost all women experience a decrease in the total amount of blood loss, even those with an increase in the number of bleeding days. 
Skoraj vse ženske izkusijo zmanjšanje skupne količine izgube krvi, tudi tiste, pri katerih se število dni krvavenja poveča.
Thus, the possibility of an excess risk is not supported by these post-marketing data. 
Zato možnost pretiranega tveganja ni utemeljena s temi podatki po trženju zdravila.
The CHMP considered that insertion, migration and removal related events (collectively known as IRREs) occur at a low and decreasing frequency. 
CHMP je menil, da se dogodki, povezani z vstavkom, migracijo in odstranitvijo (skupno znani kot IRRE), zgodijo z nizko ali upadajočo frekvenco.
Immeuble Optima 10, rue Godefroy 92821 Puteaux Cedex, France 
Immeuble Optima 10, rue Godefroy 92821 Puteaux Cedex, Francija
All experience shows that careful information and counselling before method start as well as support counselling and bleeding diary during use are important for long-term acceptability and compliance. 
Vse izkušnje kažejo, da so skrbne informacije in svetovanje pred uvedbo metode kot tudi podporno svetovanje in dnevnik krvavenja med uporabo koristni za dolgotrajno sprejemljivost in skladnost.
A second European renewal was initiated in September 2007, in which a majority of EU member states agreed that the benefit/risk profile continues to be positive and supported the recommendation of the RMS to grant another 5-year renewal. 
Druga obnovitev se je v Evropi začela septembra 2005, pri tem pa je večina držav članic EU potrdila, da je razmerje koristi/tveganja še vedno pozitivno, ter podprla predlog referenčne države članice za odobritev 5-letne obnovitve.
5340 BH, Oss The Netherlands 
5340 BH, Oss Nizozemska
The information already included in section 4.4 of the SPC is considered sufficient. 
Informacije, ki so že vključene v poglavju 4.4 Povzetka glavnih značilnostih zdravila, štejejo za zadostne.
The difference between the observed and the expected numbers of cases is substantial and is unlikely to be explained by underreporting alone. 
Razlika med opaženim in pričakovanim številom primerov je izjemna in ni verjetno, da bi bila posledica zgolj pomanjkljivega poročanja.
One contraceptive method will not fulfil all requirements at all times and, therefore, a wide choice of methods appears to be necessary in order for each individual woman to find a method that suits the current needs. 
Ena metoda kontracepcije pa ne izpolne vedno vseh zahtev, zato se zdi, da je široka izbira metod nujna za vsako žensko, da poišče kontracepcijo, ki ustreza njenim trenutnim potrebam.
The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders: 
Nacionalni pristojni organi, katerih delo usklajuje referenčna država članica, zagotovijo, da imetniki dovoljenja za promet z zdravilom izpolnjujejo naslednje pogoje:
The implant is a single rod of 4 cm length and 2 mm in diameter and contains 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) co-polymer. 
Implantant je paličica, dolga štiri cm, s premerom dva mm, z 68 mg etonogestrela (ENG), ki je razpršen v matrici kopolimera etilen-vinil acetata (EVA).
However, although the bleeding pattern often is unpredictable, many women report reduction in episode frequency and total number of bleeding days compared to their normal menstrual pattern. 
Čeprav je ciklus krvavenja pogosto nepredvidljiv, pa mnogo žensk poroča o zmanjšanju pogostosti epizod in skupnega števila dni krvavenja v primerjavi z njihovim običajnim menstrualnim ciklusom.
Although Mirena releases levonorgestrel in a very low dose, the data would seem to be relevant also for implants. 
Čeprav Mirena sprošča levonorgestrel v zelo majhnih odmerkih, se za podatke zdi, da so ustrezni tudi za implantante.
The additional data on this issue that will come from the active monitoring programme in the USA is welcome, in particular the data on efficacy in obese women. 
Dodatni podatki o tem vprašanju iz programa dejavnega spremljanja v ZDA bodo dobrodošli, zlasti podatki o učinkovitosti pri ženskah s prekomerno telesno maso.
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;