FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms of pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing; - sudden coughing which may be associated with haemoptysis; - sharp chest pain; - severe light headedness or dizziness; - rapid or irregular heartbeat.
Slovenian: Simptomi pljučne embolije (PE) lahko vključujejo: - nenadni pojav nepojasnjene kratke sape ali hitrega dihanja; - nenadno kašljanje, ki je lahko povezano s hemoptizo; - ostro bolečino v prsnem košu; - hudo vrtoglavico ali omotičnost; - hiter ali nereden srčni utrip.
English: • If you have an inflammation in the veins under the skin (superficial thrombophlebitis).
Slovenian: • če imate vnetje podkožnih žil (povrhnji tromboflebitis).
English: • change in colour of the skin on the leg e.g. turning pale, red or blue
Slovenian: • spremenjena barva kože na nogi, npr. bledica, rdečina ali modrikavost kože globoka venska tromboza
English: If any of the above conditions change while you are using [invented name], for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
Slovenian: Če se med uporabo zdravila [izmišljeno ime] katero od zgoraj navedenih stanj spremeni, na primer pri bližnjem sorodniku nastane krvni strdek zaradi neznanega vzroka, ali če se močno zredite, obvestite zdravnika.
English: Positive family history (arterial thromboembolism ever in a sibling or parent especially at relatively early age e.g. below 50).
Slovenian: Pozitivna družinska anamneza (arterijska trombembolija kadar koli pri sorojencu ali staršu, predvsem v sorazmerno zgodnji starosti, npr. pred 50 letom starosti).
English: It is not yet known how the risk of VTE with CHCs that contain [progestogen] in combination with estradiol compares with the risk with low dose levonorgestrel-containing CHCs.
Slovenian: Ni znano kakšno je tveganje za VTE pri kombiniranih hormonskih kontraceptivih, ki vsebujejo [progestogen] v kombinaciji z estradiolom v primerjavi s tveganjem pri kombiniranih hormonskih kontraceptivih, ki vsebujejo nizke odmerke levonorgestrela.
English: [The following graph should be inserted here]
Slovenian: [Tukaj je treba vstaviti naslednji graf]
English: If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors - in this case her total risk should be considered.
Slovenian: Če ima ženska več kot en dejavnik tveganja, se lahko tveganje poveča za več kot je seštevek posameznih dejavnikov - v tem primeru je treba upoštevati skupno tveganje.
English: Heart attack
Slovenian: možganska kap
English: Desogestrel-containing CHC (9-12 events)
Slovenian: CHC, ki vsebujejo dezogestrel (9-12 dogodkov)
English: If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors - in this case her total risk of VTE should be considered.
Slovenian: Če ima ženska več kot en dejavnik tveganja, se lahko tveganje poveča za več kot je seštevek posameznih dejavnikov - v tem primeru je treba upoštevati skupno tveganje za VTE.
English: • harmful blood clots in a vein or artery for example: o in a leg or foot (i.e. DVT) o in a lung (i.e. PE) o heart attack o stroke o mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA) o blood clots in the liver, stomach/intestine, kidneys or eye.
Slovenian: • škodljivi krvni strdki v venah ali arterijah, na primer: o v nogi ali stopalu (npr. globoka venska tromboza) o v pljučih (npr. pljučna embolija) o srčni infarkt o možganska kap o manjša kap ali začasni, kapi podobni simptomi, znani kot tranzitorna ishemična ataka (TIA) o krvni strdki v jetrih, želodcu/črevesju, ledvicah ali očesu.
English: [Invented name] is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis (see section 4.3).
Slovenian: Uporaba zdravila [izmišljeno ime] je kontraindicirana pri ženskah z več dejavniki tveganja, ker pri njih obstaja veliko tveganje za vensko trombozo (glejte poglavje 4.3).
English: [The wording below should be inserted in this section] In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year.
Slovenian: [Spodnje besedilo je treba vstaviti v to poglavje] - Pri približno 2 od 10.000 žensk, ki ne uporabljajo kombiniranih hormonskih kontraceptivov in niso noseče, se bo v enem letu pojavila VTE.
English: The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with [invented name], how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.
Slovenian: Odločitev za uporabo katerega koli zdravila razen tistega z najmanjšim tveganjem za VTE, je treba sprejeti po pogovoru z žensko, ko le-ta zagotovo razume tveganje za VTE, povezano z zdravilom [izmišljeno ime], kako na to tveganje vplivajo prisotni dejavniki tveganja in da je tveganje za VTE največje v prvem letu uporabe.
English: Women who are not using a combined hormonal pill/patch/ring and are not pregnant
Slovenian: Ženske, ki ne uporabljajo kombiniranih hormonskih tablet/obliža/obročka in niso noseče približno 2 od 10.000 žensk
English: When you should not use [Invented name]
Slovenian: Kdaj zdravila [izmišljeno ime] ne smete uporabljati
English: - The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot” below).
Slovenian: - Tveganje za nastanek krvnega strdka se razlikuje glede na vašo osebno anamnezo (glejte »Dejavniki, ki povečujejo vaše tveganje za nastanek krvnega strdka« spodaj).
English: The decision to use [invented name] should be taken after a discussion with the woman to ensure she understands the risk of VTE with [invented name], how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.
Slovenian: Odločitev za uporabo katerega koli zdravila je treba sprejeti po pogovoru z žensko, ko le-ta zagotovo razume tveganje za VTE, povezano z zdravilom [izmišljeno ime], kako na to tveganje vplivajo prisotni dejavniki tveganja in da je tveganje za VTE največje v prvem letu uporabe.
English: Epidemiological studies in women who use low dose combined oral contraceptives (<50 μg ethinylestradiol) have found that out of 10,000 women between about 6 to 12 will develop a VTE in one year.
Slovenian: V epidemioloških študijah pri ženskah, ki uporabljajo nizkoodmerne kombinirane peroralne kontraceptive (< 50 mikrogramov etinilestradiola), je bilo ugotovljeno, da se bo v enem letu VTE pojavila pri približno 6 do 12 od 10.000 žensk.
English: In both cases, the number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.
Slovenian: V obeh primerih je število VTE na leto manjše kot pričakovano število VTE pri ženskah med nosečnostjo ali v obdobju po porodu.
English: [The following text should be inserted in this section]
Slovenian: [Naslednje besedilo je treba vstaviti v to poglavje]
English: Symptoms of deep vein thrombosis (DVT) can include: - unilateral swelling of the leg and/or foot or along a vein in the leg; - pain or tenderness in the leg which may be felt only when standing or walking, - increased warmth in the affected leg; red or discoloured skin on the leg.
Slovenian: Simptomi globoke venske tromboze (DVT) lahko vključujejo: - oteklost ene noge in/ali stopala ali vzdolž vene v nogi; - bolečino ali občutljivost noge, ki se lahko občuti le med stanjem ali hojo;, - večji občutek toplote v prizadeti nogi; rdeča ali spremenjena barva kože noge.
English: • diabetes mellitus with vascular symptoms
Slovenian: • sladkorna bolezen z zapleti na ožilju
English: • painless blurring of vision which can progress to loss of vision
Slovenian: • zameglitev vida brez bolečine, ki lahko napreduje v izgubo vida tromboza mrežnične vene (krvni strdek v očesu)
English: - Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
Slovenian: - Pri približno 2 od 10.000 žensk, ki ne uporabljajo kombiniranih hormonskih kontraceptivov in niso noseče, se bo v enem letu pojavila VTE.
English: Epidemiological studies in women who use low dose (<50 μg ethinylestradiol) combined hormonal contraceptives have found that out of 10,000 women between about 6 and 12 will develop a VTE in one year
Slovenian: V epidemioloških študijah pri ženskah, ki uporabljajo nizkoodmerne kombinirane hormonske kontraceptive (< 50 mikrogramov etinilestradiola), je bilo ugotovljeno, da se bo v enem letu VTE pojavila pri približno 6 do 12 od 10.000 žensk.
English: An increased risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in section 4.4.
Slovenian: Pri ženskah, ki uporabljajo kombinirane hormonske kontraceptive, so opazili povečano tveganje za arterijske in venske trombotične in trombembolične dogodke, tudi miokardni infarkt, možgansko kap, tranzitorno ishemično atako, vensko trombozo in pljučno embolijo, ki so bolj podrobno opisani v poglavju 4.4.
English: • severe dyslipoproteinaemia
Slovenian: • huda dislipoproteinemija
English: It is not yet known how the risk with chlormadinone-containing CHCs compares with the risk with levonorgestrel-containing CHCs.
Slovenian: Ni znano kolikšno je tveganje pri kombiniranih hormonskih kontraceptivih, ki vsebujejo klormadinon v primerjavi s tveganjem pri kombiniranih hormonskih kontraceptivih, ki vsebujejo levonorgestrel.
English: You should ask your doctor how soon after delivery you can start taking [invented name];
Slovenian: Posvetujte se z zdravnikom, kdaj po porodu lahko začnete jemati zdravilo [izmišljeno ime];
English: This number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.
Slovenian: To število VTE na leto je manjše, kot pričakovano število VTE pri ženskah med nosečnostjo ali v obdobju po porodu.
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year.
Slovenian: - Pri 10.000 ženskah, ki uporabljajo kombinirane hormonske kontraceptive, ki vsebujejo levonorgestrel, noretisteron ali norgestimat, bo krvni strdek nastal pri približno 5-7 ženskah na leto.
English: • fullness, indigestion or choking feeling;
Slovenian: • občutek polnosti, prebavne motnje ali občutek dušenja;
English: • Presence or risk of venous thromboembolism (VTE) o Venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]) o Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency o Major surgery with prolonged immobilisation (see section 4.4) o A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4)
Slovenian: • Prisotnost ali tveganje za vensko trombembolijo (VTE) o venska trombembolija - obstoječa VTE (zdravljenje z antikoagulanti) ali v anamnezi (npr. globoka venska tromboza [DVT - deep venous thrombosis] ali pljučna embolija [PE- pulmonary embolism]) o znana dedna ali pridobljena nagnjenost za vensko trombembolijo, kot je odpornost za aktivirani protein C (vključno s faktorjem V Leiden), pomanjkanje antitrombina-III, pomanjkanje proteina C, pomanjkanje proteina S o velik kirurški poseg s podaljšano imobilizacijo (glejte poglavje 4.4) o veliko tveganje za vensko trombembolijo zaradi prisotnosti več dejavnikov tveganja (glejte poglavje 4.4)
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Slovenian: Dopolnitev ustreznih poglavij v povzetkih glavnih značilnosti zdravil in navodilih za uporabo Opomba:
English: Symptoms of myocardial infarction (MI) can include: - pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; - discomfort radiating to the back, jaw, throat, arm, stomach; - feeling of being full, having indigestion or choking; - sweating, nausea, vomiting or dizziness; - extreme weakness, anxiety, or shortness of breath; - rapid or irregular heartbeats.
Slovenian: rokah ali pod prsnico; - nelagodje, ki se širi v hrbet, čeljust, žrelo, roko, želodec; - občutek polnosti, prebavne motnje ali dušenja; - znojenje, navzeo, bruhanje ali omotico; - izjemno šibkost, tesnobo ali kratko sapo; - hiter ali nereden srčni utrip.
English: [This section should be amended to include the below wording]
Slovenian: [To poglavje je treba spremeniti tako, da se dodajo naslednje kontraindikacije]
English: Stroke
Slovenian: Starost
English: ANNEX III.A - chlormadinone containing combined hormonal contraceptives
Slovenian: Priloga III.A - kombinirani hormonski kontraceptivi, ki vsebujejo klormadinon
English: vision
Slovenian: V
English: - rapid or irregular heartbeat.
Slovenian: • hiter ali nereden srčni utrip;
English: [The below wording should be inserted in this section]
Slovenian: [Spodnje besedilo je treba vstaviti v to poglavje]
English: ANNEX III.D - drospirenone containing combined hormonal contraceptives
Slovenian: Priloga III.D - kombinirani hormonski kontraceptivi, ki vsebujejo drospirenon
English: Package Leaflet
Slovenian: Splošna opozorila
English: [For dienogest containing products in combination with estradiol valerate]
Slovenian: [Za zdravila, ki vsebujejo dienogest, navedena v prilogi I]
English: Section 4.6 - Fertility, pregnancy and lactation Pregnancy [The following wording should be added to this section] The increased risk of VTE during the postpartum period should be considered when re-starting [invented name] (see section 4.2 and 4.4).
Slovenian: Pri ponovni uvedbi zdravila [izmišljeno ime] je treba upoštevati , da je tveganje za VTE v poporodnem obdobju povečano (glejte poglavje 4.2 in 4.4).
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains etonogestrel or norelgestromin such as [invented name] between about 6 and 12 women will develop a blood clot in a year.
Slovenian: - Pri 10.000 ženskah, ki uporabljajo kombinirane hormonske kontraceptive, ki vsebujejo etonogestrel ali norelgestromin kot je zdravilo [izmišljeno ime], bo krvni strdek nastal pri približno 6-12 ženskah na leto.
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel or norethisterone, or norgestimate such as [Invented name], about 5-7 will develop a blood clot in a year.
Slovenian: - Pri 10.000 ženskah, ki uporabljajo kombinirane hormonske kontraceptive, ki vsebujejo levonorgestrel ali noretisteron ali norgestimat kot je zdravilo [izmišljeno ime], bo krvni strdek nastal pri približno 5-7 ženskah na leto.
English: ANNEX III.E - etonogestrel containing combined hormonal contraceptives
Slovenian: Priloga III.E - kombinirani hormonski kontraceptivi, ki vsebujejo etonogestrel
English: • Presence or risk of arterial thromboembolism (ATE) o Arterial thromboembolism - current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris) o Cerebrovascular disease - current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA) o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
Slovenian: • Prisotnost ali tveganje za arterijsko trombembolijo (ATE - arterial thromboembolism) o arterijska trombembolija - obstoječa arterijska trombembolija, arterijska trombembolija v anamnezi (npr. miokardni infarkt) ali prodrom (npr. angina pektoris) o cerebrovaskularna bolezen - obstoječa možganska kap, možganska kap v anamnezi ali prodrom (npr. tranzitorna ishemična ataka [TIA - transient ischaemic attack])
English: Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate
Slovenian: Ženske, ki uporabljajo tableto kombiniranega hormonskega kontraceptiva, ki vsebuje levonorgestrel, noretisteron ali norgestimat približno 5-7 od 10.000 žensk
English: You should ask your doctor how soon after delivery you can start taking [invented name].
Slovenian: Posvetujte se z zdravnikom, kdaj po porodu lahko začnete jemati zdravilo [izmišljeno ime].
English: ANNEX III.G - norgestimate containing combined hormonal contraceptives
Slovenian: Priloga III.G - kombinirani hormonski kontraceptivi, ki vsebujejo norgestimat
English: If the condition develops, or gets worse while you are using [invented name], you should also tell your doctor.
Slovenian: Obvestite svojega zdravnika, če se katero od spodaj naštetih stanj nanaša na vas Če se razvije katero od stanj ali se med uporabo zdravila [izmišljeno ime] poslabša, morate o tem obvestiti zdravnika.
English: [The wording below should be inserted at the top of the package leaflet]
Slovenian: [Spodnje besedilo je treba vključiti na začetku navodila]
English: [This section should be amended to include the following contraindications] Combined hormonal contraceptives (CHCs) should not be used in the following conditions.
Slovenian: [To poglavje je treba spremeniti tako, da se doda naslednje besedilo] Zdravila [izmišljeno ime] ne smete uporabljati, če imate katerega od spodaj opisanih stanj.
English: ANNEX III.B - desogestrel containing combined hormonal contraceptives
Slovenian: Priloga III.B - kombinirani hormonski kontraceptivi, ki vsebujejo dezogestrel
English: It is estimated1 that out of 10,000 women who use a CHC containing drospirenone, between 9 and 12 women will develop a VTE in one year; this compares with about 62 in women who use a levonorgestrel-containing CHC.
Slovenian: Ocenjuje1 se, da se bo v enem letu pojavila VTE pri 9 do 12 od 10.000 žensk, ki uporabljajo kombinirane hormonske kontraceptive ki vsebujejo dezogestrel; v primerjavi s 62 ženskami, ki uporabljajo kombinirane hormonske kontraceptive, ki vsebujejo levonorgestrel.
English: 2 Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
Slovenian: 2 Srednja vrednost območja od 5-7 na 10.000 žensk-let; temelji na relativnem tveganju za kombinirane hormonske kontraceptive, ki vsebujejo levonorgestrel v primerjavi z neuporabo, ki je približno 2,3 do 3,6.
English: ANNEX III.F - gestodene containing combined hormonal contraceptives
Slovenian: Priloga III.F - kombinirani hormonski kontraceptivi, ki vsebujejo gestoden
English: The number of VTEs per year with low dose CHCs is fewer than the number expected in women during pregnancy or in the postpartum period.
Slovenian: To število VTE na leto pri uporabi nizkoodmernih kombiniranih hormonskih kontraceptivov je manjše kot pričakovano število VTE pri ženskah med nosečnostjo ali v obdobju po porodu.
English: ANNEX III.C - dienogest containing combined hormonal contraceptives
Slovenian: Priloga III.C - kombinirani hormonski kontraceptivi, ki vsebujejo dienogest
English: 1 Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
Slovenian: 1 Srednja vrednost območja od 5-7 na 10.000 žensk-let; temelji na relativnem tveganju za kombinirane hormonske kontraceptive, ki vsebujejo levonorgestrel v primerjavi z neuporabo, ki je približno 2,3 do 3,6.
English: Table: Risk factors for VTE
Slovenian: Preglednica: Dejavniki tveganja za VTE Dejavnik tveganja
English: Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
Slovenian: 5 Srednja vrednost območja od 5-7 na 10.000 žensk-let; temelji na relativnem tveganju za kombinirane hormonske kontraceptive, ki vsebujejo levonorgestrel v primerjavi z neuporabo, ki je približno 2,3 do 3,6.
English: It is estimated2 that out of 10,000 women who use a CHC containing desogestrel between 9 and 12 women will develop a VTE in one year; this compares with about 63 in women who use a levonorgestrel-containing CHC.
Slovenian: Ocenjuje4 se, da se bo v enem letu pojavila VTE pri 9 do 12 od 10.000 žensk, ki uporabljajo kombinirane hormonske kontraceptive, ki vsebujejo drospirenon; v primerjavi s 65 ženskami, ki uporabljajo kombinirane hormonske kontraceptive ki vsebujejo levonorgestrel.
English: [The following wording to be kept/added, as appropriate] Extremely rarely, thrombosis has been reported to occur in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries.
Slovenian: Izredno redko so pri ženskah, ki so uporabljale kombinirane hormonske kontraceptive, poročali o trombozi v drugih žilah, npr. jetrnih, mezenteričnih, ledvičnih ali mrežničnih venah in arterijah.
English: o A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as:
Slovenian: o znana dedna ali pridobljena nagnjenost za arterijsko trombembolijo, kot sta hiperhomocisteinemija in antifosfolipidna protitelesa (antikardiolipinska protitelesa, lupusni antikoagulant) o napadi migrene z žariščnimi nevrološkimi simptomi v anamnezi o veliko tveganje za arterijsko trombembolijo zaradi več dejavnikov tveganja (glejte poglavje 4.4) ali prisotnost katerega od resnih dejavnikov tveganja, kot so:
English: • if you need an operation or if you are off your feet for a long time (see section ‘Blood clots');
Slovenian: • če je pri vas potreben kirurški poseg ali če ste dalj časa nepokretni (glejte poglavje "Krvni strdki");
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains desogestrel, such as [invented name], between about 9 and 12 women will develop a blood clot in a year.
Slovenian: - Pri 10.000 ženskah, ki uporabljajo kombinirane hormonske kontraceptive, ki vsebujejo dezogestrel kot je zdravilo [izmišljeno ime], bo krvni strdek nastal pri približno 9-12 ženskah na leto.
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains drospirenone, such as [invented name], between about 9 and 12 women will develop a blood clot in a year.
Slovenian: - Pri 10.000 ženskah, ki uporabljajo kombinirane hormonske kontraceptive, ki vsebujejo drospirenon kot je zdravilo [izmišljeno ime], bo krvni strdek nastal pri približno 9-12 ženskah na leto.
English: In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year.
Slovenian: Pri približno 2 od 10.000 žensk, ki ne uporabljajo kombiniranih hormonskih kontraceptivov in niso noseče, se bo v enem letu pojavila VTE.
English: • if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots ');
Slovenian: • če potrebujete kirurški poseg ali če ste dalj časa nepokretni (glejte poglavje 2 "Krvni strdki");
English: • if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots');
Slovenian: • če potrebujete kirurški poseg ali če ste dalj časa nepokretni (glejte poglavje 2 "Krvni strdki ");
English: • if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots').
Slovenian: • če potrebujete kirurški poseg ali če ste dalj časa nepokretni (glejte poglavje 2 "Krvni strdki").
English: [For all norgestimate containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Slovenian: [Za vsa zdravila, ki vsebujejo norgestimat, navedena v Prilogi I, se obstoječe informacije o zdravilu spremenijo (vstaviti, nadomestiti ali izbrisati besedila, kot je ustrezno) tako, da vsebujejo dogovorjeno besedilo, kot je navedeno spodaj]