natgillin/translations-raw huggingface dataset:
• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses 
• spolni odnosi samo z moškim partnerjem, ki je imel vazektomijo; vazektomijo je treba potrditi z dvema negativnima analizama sperme
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so dolčene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
• Worsening of Parkinson's disease symptoms (such as tremor, depression or confusion). 
• poslabšanje simptomov Parkinsonove bolezni (kot so tremor, depresija ali zmedenost),
Other side effects include: 
Drugi neželeni učinki vključujejo:
• Take the capsules as a single dose before going to bed. 
• Kapsule vzemite kot enkraten odmerek pred spanjem.
This includes medicines obtained without a prescription, including herbal medicines. 
To vključuje tudi zdravila, ki ste jih dobili brez recepta, vključno z zdravili rastlinskega izvora.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data). 
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
If you experience such symptoms, speak to your doctor straight away, who may reduce the dose or discontinue the treatment. 
Če izkusite take simptome, takoj povejte zdravniku, ki bo lahko zmanjšal odmerek ali prekinil zdravljenje.
Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow. 
Vaš zdravnik lahko preveri, ali imate številne tumorje po vsem telesu, vključno v kostnem mozgu.
The conditions of the Pregnancy Prevention Programme must be fulfilled for all male and female patients. 
Pogoji programa za preprečevanje nosečnosti morajo biti izpolnjeni pri vseh bolnikih in bolnicah.
In a phase 3 study, the median time to first neuropathy event was 42.3 weeks. 
V 3. stopnji študije je bil mediani čas do prvega dogodka nevropatije 42,3 tedne.
• Periodic Safety Update Reports (PSUR) 
• Redno posodobljena poročila o varnosti zdravila (PSUR)
In addition, the addition of interruption or discontinuation recommendations regarding the risk of severe skin reactions in general, in line with the one already approved for the structural analogues lenalidomide and pomalidomide, is supported. 
Poleg tega podpira vključitev priporočil za prekinitev ali ukinitev v zvezi s tveganjem za hude reakcije na koži na splošno, v skladu z že odobrenim priporočilom za strukturna analoga lenalidomid in pomalidomid.
Total systemic exposure (AUC) is proportional to dose at single-dose conditions. 
Skupna sistemska izpostavljenost (AUC) je sorazmerna z odmerkom pri pogojih enega odmerka.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
The median dose of thalidomide was 217 mg and > 40 % of patients received 9 cycles. 
Mediana odmerka talidomida je znašala 217 mg in > 40 % bolnikov je prejelo 9 ciklov.
No time dependency of the pharmacokinetics has been observed. 
Časovne odvisnosti farmakokinetike niso opazili.
This will make you less likely to feel sleepy at other times. 
Zaradi tega bo verjetnost, da se boste ob drugih trenutkih počutili zaspane, manjša.
It may not go away, or may go away slowly. 
Lahko se zgodi, da sploh ne izgine ali izgine počasi.
Follow-up and end of treatment 
Nadaljevanje in konec zdravljenja
• Premature ovarian failure confirmed by a specialist gynaecologist. 
• Prezgodnja odpoved jajčnikov, ki jo potrdi specialist ginekolog.
• if you are allergic to thalidomide or any of the other ingredients of this medicine listed in section 6 “Contents of the pack and other information”. 
• če ste alergični na talidomid ali katero koli drugo sestavino tega zdravila, navedeno v poglavju 6 „Vsebina pakiranja in dodatne informacije“.
Eighteen cases of overdose have been reported in the literature concerning doses up to 14.4 grams. 
V literaturi so poročali o osemnajstih primerih prevelikega odmerjanja za odmerke do 14,4 grama.
• Educational brochures for patients: o The educational brochures for patients should be of 3 types: 
• Izobraževalne brošure za bolnike: o Izobraževalne brošure za bolnike morajo biti treh vrst:
Other less frequent abnormalities have also been described. 
Poročali so tudi o drugih manj pogostih okvarah.
Thalidomide has a chiral centre and is used clinically as a racemate of (+)-(R)- and (-)-(S)-thalidomide. 
Talidomid ima kiralni center in se uporablja klinično kot racemat (+)-(R)- in (-)-(S)-talidomida.
Do not take thalidomide if you are pregnant or could become pregnant. 
Ne jemljite talidomida, če ste noseči ali bi lahko zanosili.
In one 2-year-old child who took 700 mg, there was an abnormal plantar response in addition to drowsiness and irritability. 
Pri dvoletnem otroku, ki je vzel odmerek 700 mg, je poleg zaspanosti in razdražljivosti prišlo tudi do nenormalnega plantarnega odziva.
Pregnancy testing 
Test nosečnosti
In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure and respiratory status. 
V primeru prevelikega odmerka je treba nadzirati življenjske znake bolnika in nuditi ustrezno podporno zdravljenje za vzdrževanje krvnega tlaka in stanje dihanja.
The use of thalidomide could be associated with menstrual disorders including amenorrhea. 
Uporaba talidomida je lahko povezana z menstrualnimi motnjami, vključno z amenorejo.
A diagnosis of PRES/RPLS requires confirmation by brain imaging. 
Za diagnozo PRES/ RPLS je potrebna potrditev s slikanjem možganov.
• Previous bilateral salpingo-oophorectomy, or hysterectomy. 
• Predhodna bilateralna salpingo-ooforektomija ali histerektomija.
However, combined hormonal contraceptives are not recommended due to the increased risk of venous thromboembolic disease. 
Vendar pa kombinirani hormonski kontraceptivi niso priporočljivi zaradi povečanega tveganja za vensko trombembolično bolezen.
• you have had a heart attack, have ever had a blood clot in the past, or if you smoke, have high blood pressure or high cholesterol levels. 
• ste imeli srčni infarkt, ste kdaj v preteklosti imeli krvni strdek, če kadite, imate visok krvni tlak ali visoke vrednosti holesterola.
Reduce dose or interrupt treatment and continue to monitor the patient with clinical and neurological examination. 
Zmanjšajte odmerek ali prekinite zdravljenje in nadaljujte z nadzorovanjem bolnika s kliničnimi in nevrološkimi pregledi.
Co-administration of food delayed absorption but did not alter the overall extent of absorption. 
Sočasno zaužitje hrane je absorpcijo upočasnilo, a ni vplivalo na njen skupni obseg.
Therefore, do not have unprotected intercourse, even if you had a vasectomy. 
Zaradi tega ne imejte nezaščitenih spolnih odnosov, tudi če ste prestali vazektomijo.
If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day. 
Če je od izpuščenega odmerka ob običajnem času preteklo več kot 12 ur, bolnik odmerka ne sme vzeti, pač pa naj vzame naslednji odmerek ob običajnem času naslednji dan.
Teratogenic effects 
Teratogeni učinki
• cause sleepiness as thalidomide may increase their effects. 
• povzročajo zaspanost, saj lahko talidomid poveča njihov učinek.
Continue to monitor the patient with clinical examination. 
Nadaljujte z nadzorovanjem bolnika s kliničnimi pregledi.
Prior to starting treatment 
Pred začetkom zdravljenja
It is recommended to press only on one end of the capsule to remove it from the blister, thereby reducing the risk of capsule deformation or breakage. 
Priporočljivo je pritisniti samo na en konec kapsule, da jo odstranite iz pretisnega omota, s čimer boste zmanjšali nevarnost, da bi se kapsula deformirala ali prelomila.
Do not apply pressure on the centre of the capsule as this can cause it to break. 
Ne pritiskajte na osrednji del kapsule, ker bi jo s tem lahko prelomili.
The in vivo relevance of these findings is unknown. 
Pomembnost teh izsledkov in vivo ni znana.
You must stop treatment and inform your doctor straight away if: 
Takoj morate zdravljenje ustaviti in obvestiti zdravnika, če:
PVC/PCTFE/aluminium blister containing 14 capsules. 
Pretisni omot iz PVC/PCTFE/aluminija, ki vsebuje 14 kapsul.
• Sleepiness, feeling tired. 
• zaspanost, utrujenost,
Children and adolescents Thalidomide Celgene is not recommended for use in children and young people under 18 years. 
Uporaba zdravila Thalidomide Celgene ni priporočljiva pri otrocih in mladostnikih, starih manj kot 18 let.
The spectrum of activity of thalidomide is not fully characterised. 
Spekter aktivnosti talidomida ni v celoti podrobno opisan.
All 4 cases involved other possible contributing factors preventing the establishment of a definite direct causal relationship between thalidomide and DRESS, but a link with thalidomide could also not be excluded. 
Pri vseh 4 primerih so bili prisotni tudi drugi možni prispevajoči dejavniki, zaradi česar ni bilo mogoče dokazati dokončne neposredne vzročne zveze med talidomidom in DRESS, vendar pa povezave s talidomidom ni bilo mogoče izključiti.
• Brochure for male patients 
• brošure za moške bolnike
Results of the user testing will have to be provided to the national competent authority and final materials validated at a national level. 
Izsledke testiranja uporabnikov se predloži pristojnim nacionalnim organom, končno dokumentacijo pa se ovrednoti na nacionalni ravni.
• The collection of detailed data to understand demographics of target population, indication and number of women of child bearing potential in order to monitor closely the off-label use within national territory. 
• zbiranju podrobnih podatkov, da bi razumeli demografijo ciljne populacije, indikacijo in število žensk v rodni dobi, z namenom natančnega spremljanja neodobrene uporabe znotraj nacionalnega območja.
No specific dose adjustments are recommended for the elderly ≤ 75 years of age. 
Ni priporočil o posebnem prilagajanju odmerkov za starejše bolnike, stare ≤ 75 let.
Grade 2 (interfering with function but not with activities of daily living) 
2. stopnja (ovira funkcije, vendar ne dnevnih aktivnosti)
The adverse reaction of the skin may appear as rashes with or without blisters. 
Neželena reakcija na koži se lahko pokaže kot izpuščaji z mehurji ali brez njih.
In plasma, unchanged thalidomide represents 80 % of the circulatory components. 
V plazmi nespremenjeni talidomid predstavlja 80 % sestavin v krvnem obtoku.
• The patient has acknowledged the aforementioned conditions. 
• Bolnik/bolnica sprejema zgoraj navedene pogoje.
This requirement includes women of childbearing potential who practice absolute and continuous abstinence. 
Ta zahteva vključuje ženske v rodni dobi, ki se zavežejo k popolni in neprekinjeni spolni vzdržnosti.
• are used for heart problems and complications (such as digoxin), or for thinning the blood (such as warfarin). 
• se uporabljajo za zdravljenje težav in zapletov s srcem (kot je digoksin) ali za redčenje krvi (kot je varfarin);
• The most appropriate strategies to monitor the off-label use within national territories 
• najustreznejših strategijah za nadzor neodobrene uporabe zdravila znotraj nacionalnega območja,
• Tumour Lysis Syndrome - metabolic complications that can occur during the treatment of cancer and sometimes even without treatment. 
• sindrom tumorske lize - presnovni zapleti, ki se lahko pojavijo med zdravljenjem raka, včasih tudi brez zdravljenja.
A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria: 
Predpostavlja se, da bolnica ali partnerica moškega bolnika lahko zanosi, razen če izpolnjuje vsaj eno od naslednjih meril:
The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception. 
Tveganje za vensko trombembolijo se nadaljuje še 4-6 tednov po ukinitvi jemanja kombinirane peroralne kontracepcije.
• She is informed and understands the potential consequences of pregnancy and the need to rapidly consult her doctor if there is a risk of pregnancy 
• Bolnica je obveščena in razume možne posledice nosečnosti in potrebo po takojšnjem posvetovanju z zdravnikom, če obstaja tveganje za zanositev.
• if you are able to become pregnant, unless you are able to follow or comply with the required contraceptive measures to prevent you from becoming pregnant (see section 2 “Warnings and precautions” and “Pregnancy and breast-feeding”). 
• če lahko zanosite, razen če lahko sledite potrebnim kontracepcijskim ukrepom za preprečevanje nosečnosti oziroma ravnate v skladu z njimi (glejte poglavje 2 „Opozorila in previdnostni ukrepi“ in „Nosečnost in dojenje“).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
• Sudden pain in your chest or difficulty in breathing. 
• Nenadna bolečina v prsih ali težko dihanje.
Hepatitis B virus status should be established before initiating treatment with thalidomide. 
Status virusa hepatitisa B je treba ugotoviti pred začetkom zdravljenja s talidomidom.
• if you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation. 
• če lahko zanosite, bo zdravnik z vsakim receptom zabeležil, da so bili izvedeni potrebni ukrepi, in vam izročil to potrdilo.
• Pregnancy and any exposure during pregnancy must be avoided. 
• Preprečite nosečnost in vsakršno izpostavitev med nosečnostjo.
The MAH should agree on the implementation of the patient card system in each Member State. 
Imetnik dovoljenja za promet z zdravilom se mora dogovoriti o izvajanju sistema kartic za bolnike v vsaki državi članici.
Platelet counts should be monitored on an ongoing basis, in accordance with oncology guidelines. 
Redno je treba kontrolirati število trombocitov v skladu z onkološkimi smernicami.
Pharmacotherapeutic group: immunosuppressants, other immunosuppressants, ATC code: L04AX02. 
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, drugi imunosupresivi, oznaka ATC: L04AX02.
Allergic reactions and severe skin reactions 
Alergijske reakcije in hude reakcije na koži
If a patient is currently using combined oral contraception, she should switch to one of the effective methods listed above. 
Če bolnica trenutno uporablja kombinirano peroralno kontracepcijo, mora preiti na eno od zgoraj naštetih zanesljivih metod.
The risk of intra-uterine death or severe birth defects, primarily phocomelia, is extremely high. 
Tveganje intrauterine smrti ali resnih prirojenih okvar, zlasti fokomelije, je izjemno veliko.
The plasma protein binding of the (+)-(R) and (-)-(S) enantiomers was found to be 55 % and 65 % respectively. 
Vezava na plazemske proteine (+)-(R) enantiomerov je znašala 55 % in (-)-(S) enantiomerov 65 %.
If less than 12 hours has elapsed since missing a dose, the patient can take the dose. 
Če je od izpuščenega odmerka preteklo manj kot 12 ur, bolnik odmerek lahko vzame.
Do not use this medicine after the expiry date which is stated on the wallet card and the blister after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake ''EXP''.
You will have been given specific instructions by your doctor, particularly on the effects of thalidomide on unborn babies (outlined in the Thalidomide Celgene Pregnancy Prevention Programme). 
Zdravnik vam bo dal posebna navodila, zlasti o učinkih talidomida na nerojene otroke (ti so navedeni v Programu Thalidomide Celgene za preprečevanje nosečnosti).
For women taking Thalidomide Celgene Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely. 
Za ženske, ki jemljejo zdravilo Thalidomide Celgene Pred začetkom zdravljenja morate vprašati zdravnika, ali lahko zanosite, tudi če mislite, da to ni verjetno.
No effects were observed in dogs; however in rats, there was an apparent dose-dependent decrease in total and free T4 that was more consistent in the female. 
Učinkov pri psih niso opazili, pri podganah pa je bilo očitno od odmerka odvisno zmanjšanje pri skupnem in prostem T4, ki je bilo bolj enakomerno pri samicah.
The latter appears to be related to thalidomide and occurred at exposures greater than 2.4-fold the human exposure. 
Kaže, da je slednje povezano s talidomidom in se pojavi pri izpostavljenostih, ki so 2,4-krat višje od izpostavljenosti pri ljudeh.
Survival time median ± se (month) 
Čas preživetja mediana ± sn (mesec)
• National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o Procedures to ensure that all appropriate measures have been performed prior to thalidomide being dispensed 
• posebnih zahtev posameznih držav po dogovoru s pristojnim nacionalnim organom glede: o distribucije zdravila, o postopkov za zagotovitev izvedbe vseh ustreznih ukrepov pred začetkom izdajanja talidomida.
Tell your doctor straight away if you notice any of the following serious side effects: 
Takoj obvestite zdravnika, če opazite katerega od naslednjih resnih neželenih učinkov:
Prescribing and dispensing restrictions 
Omejitve v zvezi s predpisovanjem in izdajanjem
White blood cell count and differential should be monitored on an ongoing basis, in accordance with oncology guidelines, especially in patients who may be more prone to neutropenia. 
Redno je treba kontrolirati število belih krvničk in diferencialno krvno sliko v skladu z onkološkimi smernicami, zlasti pri bolnikih, ki so nagnjeni k nevtropeniji.
Patients should be advised as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks (see section 4.7). 
Bolnikom je treba svetovati glede možnega poslabšanja mentalnih in/ali fizičnih sposobnosti, potrebnih za izvajanje nevarnih nalog (glejte poglavje 4.7).
> 75 < 1,500 but 
> 75 < 1.500, vendar
Treatment with Thalidomide Celgene may cause a virus to become active again in patients who carry it, resulting in a recurrence of the infection. 
Zdravljenje z zdravilom Thalidomide Celgene lahko povzroči, da postane virus pri bolnikih, ki ga prenašajo, spet aktiven, zato se okužba ponovi.
Careful monitoring of patients for symptoms of neuropathy is recommended. 
Priporoča se skrbno spremljanje bolnikov v zvezi s simptomi nevropatije.
Infections Patients should be monitored for severe infections including sepsis and septic shock. 
Okužbe Bolnike je treba spremljati glede pojava hudih okužb, vključno s sepso in septičnim šokom.
In thirteen of these cases, patients took thalidomide alone; amounts ranged from 350 mg to 4000 mg. 
Pri trinajstih od teh primerov so bolniki jemali samo talidomid v odmerkih med 350 mg in 4000 mg.
• Medroxyprogesterone acetate depot 
• depo medroksiprogesteronacetat
For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. 
Pri bolnikih s pozitivnim testom na okužbo s HBV se priporoča posvet z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B.
The mean elimination half-life of thalidomide in plasma following single oral doses between 50 mg and 400 mg was 5.5 to 7.3 hours. 
Srednja razpolovna doba izločanja talidomida v plazmi po enkratnih peroralnih odmerkih med 50 mg in 400 mg je znašala 5,5 do 7,3 ure.
If the neuropathy resolves to Grade 1 or better, the treatment may be restarted, if the benefit/risk is favourable. 
Če se nevropatija izboljša do 1. stopnje ali še bolj, se lahko ponovno prične z zdravljenjem, če je razmerje med koristjo in tveganjem ugodno.
Patients should be instructed to avoid situations where somnolence may be a problem and to seek medical advice before taking other medicinal products known to cause somnolence. 
Bolnike je treba poučiti, da naj se izognejo situacijam, kjer somnolenca lahko povzroča težave, in se posvetujejo z zdravnikom, preden vzamejo druga zdravila, za katera je znano, da povzročajo somnolenco.
Patients should be monitored and dose delay, reduction or discontinuation may be required (see section 4.2). 
Bolnike je treba spremljati in odmerek odložiti, zmanjšati ali ukiniti (glejte poglavje 4.2).
Do not take Thalidomide Celgene if any of the above applies to you. 
Ne jemljite zdravila Thalidomide Celgene, če kar koli od navedenega velja za vas.
• Shaking (tremor). 
• tresavica (tremor),
If no improvement or continued worsening of the neuropathy, discontinue treatment. 
Če ni izboljšanja ali se nevropatija nenehno slabša, ukinite zdravljenje.
• Having difficulty in seeing or speaking, which is temporary. 
• Kratkotrajne težave pri gledanju ali govorjenju.
The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and/or dispensing controls, and the collecting of detailed data relating to the indication in order to monitor closely the off-label use within the national territory. 
Nadzorovani sistem distribucije vključuje uporabo kartice za bolnika in/ali drugega orodja za nadzor predpisovanja in/ali izdajanja zdravila ter zbiranje podrobnih podatkov v zvezi z indikacijo, da bi skrbno nadzorovali neodobreno uporabo znotraj nacionalnega območja.
If you do not fully understand these instructions, please ask your doctor to explain them again before you take thalidomide. 
Če teh navodil niste v celoti razumeli, prosite zdravnika, da vam jih ponovno razloži, preden vzamete talidomid.
Even if you do not have a menstrual bleeding following cancer therapy, you may become pregnant. 
Tudi če zaradi zdravljenja raka ali dojenja nimate menstrualne krvavitve, lahko zanosite.
The capsules are supplied in a wallet card containing 28 capsules (2 blisters of 14 capsules each). 
Kapsule se nahajajo v škatlah, ki vsebujejo 28 kapsul (2 pretisna omota s po 14 kapsulami).
≤ 75 < 1,500 but 
≤ 75 < 1.500, vendar
• Core text as agreed by the CHMP 
• osrednjega besedila, kot ga je odobril Odbor za zdravila za uporabo v humani medicini (CHMP),
• Pregnancy prevention requirement, definition and need for adequate contraceptive methods 
• opredelitev zahteve preprečevanja nosečnosti in potrebe po ustreznih kontracepcijskih metodah
Bradycardic effect 
Učinek bradikardije
This 18 month difference was statistically significant with a hazard ratio of reduction of risk of death in the MPT arm of 0.59, 97.5 % confidence interval of 0.42-0.84 and p-value of < 0.001 (see Figure 1). 
Ta 18-mesečna razlika je bila statistično pomembna z znižanjem razmerja nevarnosti tveganja za smrti v skupini MPT z 0,59; 97,5 %, interval zaupanja 0,42-0,84 in vrednostjo p < 0,001 (glejte sliko 1).
ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S) 
PRILOGA IV ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Symptoms may occur some time after thalidomide treatment has been stopped and may resolve slowly or not at all. 
Simptomi se lahko pojavijo nekaj časa po prenehanju zdravljenja s talidomidom in lahko izginejo počasi ali pa sploh ne izginejo.
The MAH shall implement a Pregnancy Prevention Programme (PPP) in each Member State. 
Imetnik dovoljenja za promet z zdravilom mora izvajati program za preprečevanje nosečnosti (PPN) v vsaki državi članici.
Educational materials 
Izobraževalna gradiva