natgillin/translations-raw huggingface dataset:
Medicines that belong to the group of anti-arrhythmics (e. g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e. g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e. g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), some antihistamines (e. g. terfenadine, astemizole, mizolastine), and other medicines (e. g. cisapride, intravenous vincamine, bepridil and diphemanil).
Ne jemljite zdravila [izmišljeno ime] sočasno z naslednjimi zdravili: zdravila, ki spadajo v skupino antiaritmikov (npr. kinidin, hidrokinidin, dizopiramid, amiodaron, sotalol, dofetilid, ibutilid), nevroleptiki (npr. fenotiazini, pimozid, sertindol, haloperidol, sultoprid), triciklični antidepresivi, nekatera protimikrobna zdravila (npr. sparfloksacin, intravenska oblika eritromicina, pentamidin, antimalariki, predvsem halofantrin), nekateri antihistaminiki (npr. terfenadin, astemizol, mizolastin) in druga zdravila (npr. cisaprid, intravenska oblika vinkamina, bepridil, difemanil).
- Any medicine containing magnesium or aluminium such as antacids for indigestion, or any
Zdravila, ki vsebujejo magnezij ali aluminij (npr. antacidi za zdravljenje prebavnih težav ali
medicine containing iron or zinc, medicine containing didanosine or medicine containing sucralfate to treat gastrointestinal disorders can reduce the action of [Invented name] tablets.
katerakoli zdravila, ki vsebujejo železo ali cink, didanozin, sukralfat za zdravljenje prebavnih motenj), lahko zmanjšajo delovanje tablet [izmišljeno ime].
- Taking oral medicinal charcoal at the same time as [Invented name] tablets reduces the action of
Ker sočasno peroralno jemanje aktivnega oglja in tablet [izmišljeno ime] zmanjšuje delovanje
Therefore it is recommended that these medicines are not used together.
zdravila [izmišljeno ime], sočasne uporabe ne priporočamo.
- If you are currently taking oral anti-coagulants (e. g. warfarin), it may be necessary for your
- Če jemljete peroralne antikoagulante (npr. varfarin), so potrebne laboratorijske kontrole
doctor to monitor your blood clotting times.
strjevanja krvi pri vašem zdravniku.
Pregnancy and breast-feeding Do not take [Invented name] if you are pregnant or breast-feeding.
Nosečnost in dojenje Če ste noseči ali dojite, ne jemljite zdravila [izmišljeno ime].
Important information about some of the ingredients of [Invented name] 400 mg film-coated tablets [Invented name] tablets contain lactose.
Pomembne informacije o nekaterih sestavinah zdravila [izmišljeno ime] 400 mg filmsko obložene tablete Tablete [izmišljeno ime] vsebujejo laktozo.
You should check with your doctor or pharmacist if you are not sure how to take [Invented name].
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
Unless otherwise indicated by your doctor the recommended durations of use of [Invented name] are: -
Če vam zdravnik ni predpisal drugače, je priporočeno trajanje zdravljenja z zdravilom [izmišljeno ime]:
Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis)
- nenadno poslabšanje kroničnega bronhitisa (akutna eksacerbacija kroničnega bronhitisa):
10 days - days
5 do 10 dni - -
Infection of the lungs acquired (pneumonia) outside the hospital, except severe cases
pljučnica (pnevmonija), pridobljena izven bolnišnice, razen hudih oblik: akutna okužba obnosnih votlin (akutni bakterijski sinusitis):
10
10 dni 7 dni
Acute infection of the sinuses (acute bacterial sinusitis)
- blage do zmerne okužbe ženskih notranjih spolovil (medenična vnetna bolezen) ter okužbe
7
jajcevodov in maternične sluznice:
14
14 dni
Before you take [Invented name]..., Take special care...).
Kaj morate vedeti, preden boste vzeli zdravilo [izmišljeno ime]..., Bodite posebno pozorni...).
If you take more [Invented name] 400 mg film-coated tablets than you should
Če ste vzeli večji odmerek zdravila [izmišljeno ime] 400 mg filmsko obložene tablete, kot bi smeli Če v enem dnevu pomotoma vzamete več kot eno tableto, takoj poiščite zdravniško pomoč.
21 If you take more than the prescribed one tablet a day, seek medical advice immediately and, if possible, take any remaining tablets, the packaging or this leaflet with you to show the doctor or pharmacist what you have taken.
Če ste pozabili vzeti zdravilo [izmišljeno ime] 400 mg filmsko obložene tablete
If you forget to take [Invented name] 400 mg film-coated tablets If you forget to take your tablet you should take it as soon as you remember on the same day.
22 Če ste pozabili vzeti tableto, jo morate vzeti isti dan takoj, ko se spomnite.
If you do not take your tablet on one day, take your normal dose (one tablet) on the next day.
Če ne vzamete tablete istega dne, vzemite običajni odmerek (eno tableto) naslednji dan.
London, 14 August 2008 EMEA/ CHMP/ 524135/ 2008
London, 14. avgust 2008 EMEA/ CHMP/ 524128/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 6( 12) ZA ZDRAVILO Actira in povezana imena
International non-proprietary name (INN): moxifloxacin
Mednarodno nelastniško ime (INN): moksifloksacin
This Referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of mild to moderate pelvic inflammatory disease (PID), i. e. infections of upper genital tract, including salpingitis and endometritis.
Napotitveni postopek se nanaša na zahtevo po arbitraži v zvezi s spremembo tipa II za novo indikacijo, ki bo vključevala zdravljenje blage do zmerne pelvične vnetne bolezni, tj. okužb zgornjega dela genitalnih organov, vključno s salpingitisom in endometritisom.
At the end of the mutual recognition procedure there was a discrepancy between different EU Member States regarding the wording of the indication that should adequately reflect the clinical data submitted by the company, and an official referral for arbitration according to Article 6(12) of Commission Regulation EC No 1084/ 2003, as amended, was notified by Belgium to the CHMP on 19 October 2007.
1084/ 2003, kakor je bila spremenjena.
The arbitration procedure was discussed by the CHMP at its plenary meeting in November 2007 and a Rapporteur (Dr Harald Enzmann) and Co-Rapporteur (Dr.
Harald Enzmann, za soporočevalca pa dr.
Pieter Neels) were appointed.
Pieter Neels.
Moxifloxacin should therefore be given in combination with another appropriate antibacterial agent (e. g. a cephalosporin) for the treatment of mild to moderate PID, unless moxifloxacin-resistant N. gonorrhoeae can be excluded.
Moksifloksacin je zaradi tega treba za zdravljenje blage do zmerne pelvične vnetne bolezni dajati v kombinaciji z drugim primernim protibakterijskim zdravilom (npr. cefalosporinom), razen če se lahko izključi prisotnost sevov N. gonorrhoeae, odpornih na moksifloksacin.
The Committee further considered that the benefit/ risk balance concerning the use of moxifloxacin up to 14 days in the PID indication remains positive, and that information and recommendations on the use of moxifloxacin, and the measures that should be taken before it is prescribed, are adequately addressed in the ‘ contraindications’ and ‘ special warnings and precautions for use’ sections of the EU SPC.
Odbor je tudi menil, da razmerje med koristmi in tveganji ob uporabi moksifloksacina do 14 dni pri pelvični vnetni bolezni ostaja pozitivno ter da so podatki in priporočila o uporabi moksifloksacina z ukrepi, ki jih je treba izvesti pred predpisovanjem tega zdravila, primerno obdelani v poglavjih Kontraindikacije ter Posebna opozorila in previdnostni ukrepi za uporabo v Povzetku glavnih značilnosti zdravila za EU.
In view of the data provided on efficacy and safety, the benefit/ risk of the proposed extended indication “ mild to moderate pelvic inflammatory disease” was therefore considered to be positive by the CHMP as the initially proposed wording was adequately revised to reflect the current knowledge.
CHMP je menil, da je razmerje med koristmi in tveganji za predlagano indikacijo „ blage do zmerne pelvične vnetne bolezni “ na podlagi priskrbljenih podatkov o učinkovitosti in varnosti pozitivno, saj je bilo prvotno predlagano besedilo primerno popravljeno, tako da odraža trenutno znanje.
The list of product names concerned is given in Annex I.
Seznam zadevnih imen zdravil je naveden v Dodatku I.
The scientific conclusions are provided in Annex II, together with the amended product information in Annex III.
Znanstveni zaključki so na voljo v Dodatku II, dopolnjeni povzetek glavnih značilnosti zdravila pa v Dodatku III.
∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 19 March 2008.
Informacije, podane v tem dokumentu in njegovih dodatkih, odražajo le mnenje CHMP z dne 19. marca 2008.
The Member States’ competent authorities will continue to keep the product under regular review.
Pristojne oblasti držav članic bodo zdravilo še naprej redno nadzorovale.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV / IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
1 Member State
1 Država članica
Marketing Authorisation Holder
Imetnik dovoljenja za Predlagatelj promet z zdravilom
Novo Nordisk Pharma GmbH Opernring 3-5 A-1010 Vienna Austria
Novo Nordisk Pharma GmbH Opernring 3- 5 A- 1010 Vienna Avstrija
Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
0, 5 mg estradiola (v Filmsko obložene obliki hemihidrata) + tablete 0, 1 mg noretisteronacetata
Novo Nordisk Pharma
Za peroralno uporabo.
Activelle minor
Belgija
N. V Boulevard International 55/ 6, B-1070 Brussel Belgium
Novo Nordisk Pharma N. V Boulevard International 55/ 6, B- 1070 Brussel Belgija
+ Norethisterone acetate 0.1 mg
0, 5 mg estradiola (v Filmsko obložene obliki hemihidrata) + tablete 0, 1 mg noretisteronacetata
Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
0, 5 mg estradiola (v obliki hemihidrata) + 0, 1 mg noretisteronacetata
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Allé DK- 2880 Bagsværd Danska
Activelle low filmovertrukne tabletter
filmovertrukne obliki hemihidrata) + tabletter 0, 1 mg noretisteronacetata
Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
Activelle 0, 5 mg estradiola (v obliki hemihidrata) + 0, 1 mg noretisteronacetata
Estonia
Filmsko obložene tablete
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Za peroralno uporabo.
Activelle
Finska
Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
Activelle 0, 5 0, 5 mg estradiola (v mg/ 0, 1 mg tabl. obliki hemihidrata) + 0, 1 mg noretisteronacetata
Finland
Filmsko obložene tablete
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd
Za peroralno uporabo.
Activelle 0,5 mg/ 0,1 mg tabl.
Novo Nordisk Pharmaceutique S. A.
Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
Activelle 0, 5 0, 5 mg estradiola (v mg/ 0, 1 mg obliki hemihidrata) +
Marketing Authorisation Holder
0, 1 mg noretisteronacetata
Applicant
Nemčija
(Invented) Name
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd Danska
Strength
Noviana
Pharmaceutical Form
Filmsko obložene tablete
Route of administration
Za peroralno uporabo.
Denmark France
Madžarska
Novo Nordisk Pharmaceutique S. A.
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd Danska
30 Rue De Valmy FR-92936 Paris La Defence Cedex France
Noviana filmtabletta
Activelle 0,5 mg/ 0,1 Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use mg comprimé pelliculé + Norethisterone acetate 0.1 mg
0, 5 mg estradiola (v obliki hemihidrata) + 0, 1 mg noretisteronacetata
Germany
Islandija
Noviana Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
0, 5 mg estradiola (v obliki hemihidrata) + 0, 1 mg noretisteronacetata
Noviana filmtabletta Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
0, 5 mg estradiola (v obliki hemihidrata) + 0, 1 mg noretisteronacetata
Activelle low 0.5 Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use mg/ 0.1 mg tablets + Norethisterone acetate 0.1 mg filmuhúðaðar töflur
0, 5 mg estradiola (v obliki hemihidrata) + 0, 1 mg noretisteronacetata
Activelle Tablets Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
0, 5 mg estradiola (v obliki hemihidrata) + 0, 1 mg noretisteronacetata
Activelle 0,5 mg/ 0,1 Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use mg compresse film- + Norethisterone acetate 0.1 mg rivestite
0, 5 mg estradiola (v obliki hemihidrata) + 0, 1 mg noretisteronacetata
Latvia
Filmsko obložene tablete
Noviana 0,5 mg/ 0,1 Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use mg apvalkotā s tabletes + Norethisterone acetate 0.1 mg
0, 5 mg estradiola (v obliki hemihidrata) +
Marketing Authorisation Holder
Riverside Business Park Boulevard International BE- 1070 Brussels Belgija
Applicant
pelliculés
(Invented) Name
0, 1 mg noretisteronacetata
Strength
Nizozemska
Pharmaceutical Form
Novo Nordisk Farma B. V.
Lithuania
Norveška
Activelle
Noviana 0, 5 mg/ 0, 1 mg tablett filmdrasjert
Novo Nordisk Pharma N. V Riverside Business Park Boulevard International BE-1070 Brussels Belgium
Novo Nordisk, A/ S DNK Novo Allé, DK- 2880 Bagsvaerd Danska
Activelle comprimés pelliculés
Activelle
Netherlands
Filmsko obložene tablete
Novo Nordisk Farma B. V.
Za peroralno uporabo.
Flemingweg 18 NL-2408 AV Alphen a/ d Rijn Netherlands
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd Danska
Activelle filmomhulde tabletten
Noviana comprimate filmate
Norway
Slovaška
Novo Nordisk A/ S
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd Danska
Noviana 0,5 mg/ 0,1
Noviana
Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use
0, 5 mg estradiola (v obliki hemihidrata) + 0, 1 mg noretisteronacetata
Novo Allé DK-2880 Bagsværd Denmark
Filmsko obložene tablete
mg tablett filmdrasjert + Norethisterone acetate 0.1 mg
Za peroralno uporabo.
Novo Nordisk, A/ S DNK Novo Allé, DK-2880 Bagsvaerd Denmark
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd Danska
Activelle Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
Noviana filmsko 0, 5 mg estradiola (v obložene tablete obliki hemihidrata) + 0, 1 mg noretisteronacetata
Noviana comprimate Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use filmate + Norethisterone acetate 0.1 mg
Activelle 0, 5 0, 5 mg estradiola (v mg / 0, 1 mg obliki hemihidrata) + comprimidos 0, 1 mg recubiertos de noretisteronacetata película
Slovak Republic
Filmsko obložene tablete
Applicant
Švedska
(Invented) Name
Novo Nordisk A/ S
Strength
Activelle 0, 5
Pharmaceutical Form
mg estradiola (v
Route of administration
Filmsko obložene Za peroralno
Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
obliki hemihidrata) + 0, 1 mg noretisteronacetata
Spain
tablete
Novo Nordisk A/ S Novo Allé
uporabo.
Activelle 0,5 mg/ 0,1 mg comprimidos
Velika Britanija
Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
Novo Nordisk Pharma Ltd Broadfield Park Brighton Road UK - RH11 9RT Crawley West Sussex Velika Britanija
DK-2880 Bagsværd Denmark
Noviana film - coated tablets
Activelle Estradiol (as hemihydrate) 0.5 mg Film-coated tablets Oral use + Norethisterone acetate 0.1 mg
0, 5 mg estradiola (v obliki hemihidrata) + 0, 1 mg noretisteronacetata
United Kingdom
Filmsko obložene tablete
Novo Nordisk Pharma Ltd Broadfield Park Brighton Road UK- RH11 9RT Crawley West Sussex United Kingdom
Za peroralno uporabo.
5 ANNEX II
5 DODATEK II
SCIENTIFIC CONCLUSIONS AND GROUNDS PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
6 SCIENTIFIC CONCLUSIONS
6 ZNANSTVENI ZAKLJUČKI
Activelle 0.5 mg/ 0.1 mg is a continuous combined hormone replacement therapy (HRT) product containing 0.5 mg estradiol (E2) and 0.1 mg norethisterone acetate (NETA).
Activelle 0, 5 mg/ 0, 1 mg je zdravilo, ki se uporablja za kontinuirano kombinirano hormonsko nadomestno zdravljenje (HNZ) in vsebuje 0, 5 mg estradiola (E2) ter 0, 1 mg noretisteron acetata (NETA).
It is a lower strength with a lower oestrogen/ progestogen ratio than the currently approved Activelle, which contains 1 mg E2 and 0.5 mg NETA.
Zdravilo ima manjšo jakost in manjše razmerje estrogena/ progestogena kot trenutno odobrena oblika zdravila Activelle, ki vsebuje 1 mg E2 in 0, 5 mg NETA.
The referral under article 29(4) of directive 2001/ 83/ EC was notified to the CHMP on March 3rd, 2008 as Germany and France did not consider the application acceptable.
Napotitveni postopek v skladu s členom 29( 4) Direktive 2001/ 83/ ES so pri CHMP prijavili dne 3. marca 2008, ker Nemčija in Francija vloge nista imeli za sprejemljivo.
Both considered the endometrial safety of Activelle 0.5 mg/ 0.1 mg to be insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/ CHMP/ 021/ 97 rev 1).
Obe državi sta menili, da endometrijska varnost zdravila Activelle 0, 5 mg/ 0, 1 mg glede na smernice CHMP za hormonska nadomestna zdravila (EMEA/ CHMP/ 021/ 97 rev 1) ni bila zadostno dokazana.
Endometrial Safety The applicant/ MAH was asked to demonstrate the endometrial safety of Activelle 0.5mg/ 0.1mg for the following reasons:
Endometrijska varnost Predlagatelja/ imetnika dovoljenja za promet z zdravilom so pozvali, naj dokaže endometrijsko varnost zdravila Activelle 0, 5 mg/ 0, 1 mg zaradi naslednjih razlogov:
- The endometrial safety data is not in accordance with the European guideline on clinical
- Podatki o endometrijski varnosti niso skladni z evropskimi smernicami o kliničnem preskušanju
investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in post menopausal women (EMEA/ CHMP/ 021/ 97 rev1).
zdravil za hormonsko nadomestno zdravljenje simptomov pomanjkanja estrogena pri ženskah v postmenopavzalnem obdobju (EMEA/ CHMP/ 021/ 97 rev 1).
- The endometrial safety data was extrapolated from another combination containing 1.0 mg estradiol
- Podatki o endometrijski varnosti so bili ekstrapolirani iz druge terapevtske kombinacije, ki je
and 0.1mg norethisterone acetate (NETA).
vsebovala 1, 0 mg estradiola in 0, 1 mg noretisteron acetata (NETA).
In this study, the upper limit of the two-sided 95% CI of the incidence of endometrial hyperplasia was higher than the upper limit of 2%, and is therefore not considered acceptable. -The endometrial safety of the combination of oestrogen and progestogen for the new ratio of 0.5mg/ 0.1mg cannot be extrapolated from the already licensed dose of Activelle, which contains 1mg estradiol and 0.5mg NETA.
V tej študiji je bila zgornja omejitev dvostranskega 95% intervala zaupanja za pojavnost endometrijske hiperplazije višja kot zgornja meja 2%, zaradi česar ni sprejemljiva.
In the already licensed dose of Activelle, the ratio between NETA and E2 is 1:2, while this ratio is 1:5 in the new strength of Activelle.
V že odobrenem odmerku zdravila Activelle je razmerje med NETA in E2 enako 1: 2, medtem ko je to razmerje v zdravilu Activelle z novo jakostjo spremenjeno v 1: 5.
Activelle 0.5 mg/ 0.1 mg is a continuous combined HRT that contains the half dose of estradiol (E2) and the fifth of the dose of norethisterone acetate (NETA) that in the known fixed combination Activelle (E2 1 mg/ NETA 0.5 mg).
Zdravilo Activelle 0, 5 mg/ 0, 1 mg se uporablja za kontinuirano kombinirano HNZ, vsebuje pa polovico odmerka estradiola (E2) in petino odmerka noretisteron acetata (NETA) iz stare fiksne kombinacije zdravila Activelle (E2 1 mg/ NETA 0, 5 mg).
This means that the doses of E2 and NETA are decreased by 50% and 80%, respectively.
To pomeni, da sta odmerka E2 in NETA manjša za 50% in 80%.
Therefore, this new product contains a known progestogen at a lower dose than the known marketed dose, and a new ratio oestrogen/ progestogen (1:5 instead of 1:2).
Zaradi tega vsebuje to novo zdravilo znani progestogen v odmerku, ki je nižji od odmerka, ki je že na trgu, in novo razmerje med estrogenom ter progestogenom (1: 5 namesto 1: 2).
According to the guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women (EMEA/ CHMP/ 021/ 97 Rev.
Skladno s smernicami za klinično preskušanje zdravil za hormonsko nadomestno zdravljenje simptomov pomanjkanja estrogena pri ženskah v obdobju postmenopavze (EMEA/ CHMP/ 021/ 97 Rev.
1) endometrial safety has to be demonstrated unequivocally before approval.
1) je treba pred odobritvijo nedvoumno dokazati endometrijsko varnost.
It states that “ for a new combination of oestrogen/ progestogen (e. g. new administration scheme or new strength) or a new progestogen in a fixed combination, endometrial data are required, except for a known progestogen, with the same administration route and the same progestogen dose as in known fixed combination with oestrogen, where data on endometrial safety can be extrapolated from the fixed combination if exposure to the oestrogen is similar or lower”.
Smernice navajajo, da so „ za novo kombinacijo estrogena/ progestogena (npr. nova shema dajanja zdravila ali nova jakost) ali novo količino progestogena v fiksni kombinaciji potrebni podatki o endometriju, z izjemo za znane količine progestogena ob isti poti uporabe in istemu odmerku progestogena kot pri znani fiksni kombinaciji z estrogenom, kjer je podatke o endometrijski varnosti mogoče ekstrapolirati iz fiksne kombinacije, če je izpostavljenost estrogenu podobna ali nižja “.
According to this recommendation, the applicant provided data from a trial (KLIM/ PD/ 7/ USA) which studied endometrial safety of the combination of E2 1 mg and NETA 0.1 mg.
Skladno s tem priporočilom je predlagatelj priskrbel podatke iz preskušanja (KLIM/ PD/ 7/ USA), v katerem so raziskovali endometrijsko varnost kombinacije E2 1 mg in NETA 0, 1 mg.
However, the some members of the CHMP noted that this trial failed to demonstrate the endometrial safety of the combination of E2 1 mg and NETA 0.1 mg, as the upper limit of the two-sided 95% confidence
Vendar pa so nekateri člani CHMP opazili, da s tem preskušanjem niso uspeli dokazati endometrijske varnosti kombinacije 1 mg E2 in 0, 1 mg NETA, ker je bila zgornja meja dvostranskega 95% intervala
7 interval of the observed frequency of endometrial hyperplasia was 2.90% and then exceeded the acceptable limit of 2%.
7 zaupanja ugotovljene pogostosti hiperplazije endometrija enaka 2, 90% in je tako presegala sprejemljivo mejo 2%.
- Pooled data from several recently authorized sequential and continuous oestrogen/ progestin HRT
Podatki, zbrani iz več v Evropi nedavno odobrenih kombinacij estrogena/ progestina za
combinations in Europe show that the incidence of hyperplasia or more serious adverse endometrial outcomes was approximately 0.26% during the first year of treatment, that is well under the observed hyperplasia incidence of 0.8% in the KLIM/ PD/ 7/ USA trial.
sekvenčno ali kontinuirano HNZ kažejo, da je pojavnost hiperplazije ali resnejših neželenih endometrijskih rezultatov znašala približno 0, 26% v prvem letu zdravljenja, kar je precej nižje od pojavnosti hiperplazije v preskušanju KLIM/ PD/ 7/ USA, kjer je ta znašala 0, 8%.
- The proportion of proliferative endometrium (71%) was higher, on the contrary the proportion of
Delež proliferacijskega endometrija (71%) je bil večji, v nasprotju s tem pa je bil delež
atrophic endometrium was lower (19%) than expected for a continuous combination.
atropičnega endometrija nižji (19%) od vrednosti, pričakovane za kombinacijo za kontinuirano uporabo.