FrancophonIA/ELRC3.0 huggingface dataset:
English: Olazax 20 mg tablets
Slovenian: Olazax 20 mg tablete olanzapin
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Slovenian: Občasni neželeni učinki (lahko prizadenejo do 1 od 100 bolnikov) vključujejo preobčutljivost (npr. otekanje v ustih in grlu, srbenje, izpuščaj), sladkorno bolezen ali poslabšanje sladkorne bolezni, občasno povezano s ketoacidozo (ketoni v krvi in urinu) ali komo, krče, običajno povezane s krči (epileptičnimi napadi) v preteklosti, mišično okorelost ali krče (vključno z obračanjem zrkel), sindrom nemirnih nog, težave pri govoru, jecljanje, upočasnjen srčni utrip, občutljivost za sončno svetlobo,
English: Caution should be exercised and follow-up organized in patients with elevated ALT and/or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
Slovenian: Pri bolnikih s zvišano ALT in/ali AST, bolnikih z znaki in simptomi okvarjenega delovanja jeter, bolnikih s prej obstoječimi stanji, povezanimi z omejeno jetrno funkcionalno rezervo,
English: (≥ 5.17- < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Slovenian: (≥ 6,2 mmol/l).
English: 13Following short term treatment (median duration 22 days), weight gain ≥ 7% of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Slovenian: 13 S kratkotrajnim zdravljenjem (srednje trajanje 22 dni) povezano povečanje telesne mase za ≥ 7 % od osnovne telesne mase (kg) je bilo zelo pogosto (40,6 %), ≥ 15 % pogosto (7,1 %) in za ≥ 25 %
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: DODATEK II A. IZDELOVALCI ZDRAVILA, ODGOVORNI ZA
English: Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term exposure
Slovenian: Zvečanje osnovne telesne mase za ≥ 7 %, ≥ 15 % in
English: Excipient with known effect: Each tablet contains 0.69 mg aspartame For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,69 mg aspartama.
English: Excipient with known effect: Each tablet contains 0.46 mg aspartame For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,46 mg aspartama.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Olazax Vsebina pakiranja in dodatne
English: Following short term treatment (median duration 47 days), weight gain ≥ 7 % of baseline body weight was very common (22.2%), ≥ 15% was common (4.2%) and ≥25% was uncommon
Slovenian: S kratkoročnim zdravljenjem (srednje trajanje 47 dni) povezano zvečanje telesne mase za ≥ 7 % od osnovne telesne mase je bilo zelo pogosto (22,2 %), ≥ 15 %
English: NAME OF THE MEDICINAL PRODUCT Olazax 20 mg tablets
Slovenian: IME ZDRAVILA Olazax 20 mg tablete
English: Olazax 5 mg tablets
Slovenian: Olazax 5 mg tablete olanzapin
English: What Olazax contains - The active substance is olanzapine - Each tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine - The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
Slovenian: Pomožne snovi so manitol (E 421), mikrokristalna celuloza, aspartam (E 951), krospovidon, magnezijev stearat.
English: NAME OF THE MEDICINAL PRODUCT Olazax 10 mg tablets
Slovenian: IME ZDRAVILA Olazax 10 mg tablete
English: Olazax 15 mg tablets
Slovenian: Olazax 15 mg tablete olanzapin
English: Olazax 10 mg tablets
Slovenian: Olazax 10 mg tablete olanzapin
English: Excipient with known effect: Each tablet contains 0.23 mg aspartame For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,23 mg aspartama.
English: Yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Slovenian: rumena, okrogla, ploščata tableta z zaobljenim robom in oznako 'C' na eni strani.
English: NAME OF THE MEDICINAL PRODUCT Olazax 5 mg tablets
Slovenian: IME ZDRAVILA Olazax 5 mg tablete
English: Very common symptoms in overdose (> 10 % incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Slovenian: vznemirjenost/nasilnost, dizartrijo, različne ekstrapiramidne simptome in motnje zavesti v razponu od sedacije do kome.
English: NAME OF THE MEDICINAL PRODUCT Olazax 15 mg tablets
Slovenian: IME ZDRAVILA Olazax 15 mg tablete
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg olanzapine Excipient with known effect: Each tablet contains 0.92 mg aspartame For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,92 mg aspartama.
English: Drug withdraw al syndrome neonatal
Slovenian: Odtegnitveni sindrom pri novorojenčku
English: High Uric Acid 10
Slovenian: Visoka raven sečne kisline10
English: Gynaecomastia/breas t enlargement in males
Slovenian: Ginekomastija/po večanje dojk pri moških
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg olanzapine.
Slovenian: Ena tableta vsebuje 10 mg olanzapina.
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly.
Slovenian: Prekinitev zdravljenja Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
English: < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Slovenian: (≥ 2,26 mmol/l).
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ( ≥0.01% and < 0.1%) when olanzapine is stopped abruptly.
Slovenian: Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
English: Excipient with known effect: Each tablet contains 0.35 mg aspartame For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim delovanjem: Ena tableta vsebuje 0,35 mg aspartama.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg olanzapine.
Slovenian: Ena tableta vsebuje 5 mg olanzapina.
English: Crospovidone Magnesium stearate
Slovenian: Prehodna asimptomatska zvišanja jetrnih aminotransferaz
English: Photosensitivit y reaction Alopecia
Slovenian: Splošne težave in spremembe na mestu aplikacije Astenija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/002
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/597/002
English: Olazax with alcohol
Slovenian: Zdravilo Olazax vsebuje laktozo
English: Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Slovenian: rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'E' na drugi strani.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine
Slovenian: Ena tableta vsebuje 20 mg olanzapina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/597/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/005
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/597/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/004
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/597/004
English: Yellow coloured circular flat bevelled edge with ‘OL' debossed on one side and ‘F' debossed on other side.
Slovenian: rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'F' na drugi strani.
English: • Weight gain has been seen in patients taking Olazax.
Slovenian: • Pri bolnikih, ki so jemali zdravilo OLANZAPINE , so opazili porast telesne mase.
English: Dose escalation, when indicated, should be conservative in such patients (See sections 4.5 and 5.2.
Slovenian: Višanje odmerka, kadar je to indicirano, naj bo pri takih bolnikih previdno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/003
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/597/003
English: Tardive
Slovenian: Občasni
English: Bradycardia
Slovenian: Amenoreja
English: Your doctor will urgently review your treatment.
Slovenian: Vaš zdravnik bo nujno proučil vaše zdravljenje.
English: • For migraine prevention (in countries where this use is authorised)
Slovenian: • Za preprečevanje migrene (v državah, kjer je odobrena uporaba za ta namen)
English: In some EU Member States they are also authorised to prevent migraine headaches.
Slovenian: V nekaterih državah članicah EU so odobrena tudi za preprečevanje migrenskih glavobolov.
English: Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Slovenian: Zdravila, ki vsebujejo valproat, so bila z nacionalnimi postopki odobrena v vseh državah članicah EU ter na Norveškem in v Islandiji.
English: Healthcare professionals in the EU will be sent a dear healthcare professional letter plus additional educational material concerning these recommendations.
Slovenian: Zdravstveni delavci v EU bodo prejeli pismo za zdravstvene delavce in dodatno izobraževalno gradivo v zvezi s temi priporočili.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards across the EU for medicines authorised via national procedures.
Slovenian: Skupina CMDh, organ, ki predstavlja vse države članice EU, je odgovorna za zagotavljanje usklajenih varnostnih standardov po vsej EU za zdravila, odobrena z nacionalnimi postopki.
English: These recommendations follow a review of recent studies showing developmental problems in up to 30 to 40% of pre-school children exposed to valproate in the womb, including delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability.1,2,3,4,5
Slovenian: Ta priporočila so bila oblikovana po pregledu nedavnih študij, ki so pokazale težave v razvoju pri do 30 do 40 % predšolskih otrok, izpostavljenih valproatu v maternici, vključno s tem, da ti otroci kasneje shodijo in spregovorijo ter imajo težave s spominom, govorom in jezikom in manjše intelektualne sposobnosti.1,2,3,4,5
English: • If you can become pregnant, you should use an effective method of contraception.
Slovenian: • Če lahko zanosite, morate uporabljati učinkovito kontracepcijsko metodo.
English: • If you have any questions about your treatment or contraception, speak to your doctor or pharmacist.
Slovenian: • V kolikor imate kakršnokoli vprašanje o svojem zdravljenju ali kontracepciji, se posvetujte z zdravnikom ali farmacevtom.
English: • Tell your doctor at once if you become pregnant, think you might be pregnant or are planning to become pregnant.
Slovenian: • Nemudoma obvestite svojega zdravnika, če ste zanosili, če mislite, da bi lahko bili noseči, ali če nameravate zanositi.
English: As valproate medicines in the EU are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) for a position.
Slovenian: Ker so vsa zdravila, ki vsebujejo valproat, v EU odobrena na nacionalni ravni, so bila priporočila posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) za stališče.
English: They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel.
Slovenian: Tržijo se pod različnimi tržnimi imeni, vključno z naslednjimi: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil in Valhel.
English: The review of valproate medicines started in October 2013 at the request of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Article 31 of Directive 2001/83/EC, following the publication of new data on the risks of malformations and developmental problems in babies exposed to valproate in the womb.
Slovenian: Pregled zdravil, ki vsebujejo valproat, se je začel oktobra 2013 na zahtevo regulatorne agencije Združenega kraljestva za zdravila in zdravstvene pripomočke (Medicines and Healthcare Products Regulatory Agency, MHRA) v skladu s členom 31 Direktive 2001/83/ES, in sicer po objavi novih podatkov o tveganju malformacij in težav v razvoju pri otrocih, ki so bili izpostavljeni valproatu v maternici.
English: There are also limited data suggesting that children exposed to valproate in the womb may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).6,7,8
Slovenian: Obstajajo tudi omejeni podatki, ki kažejo, da bi lahko obstajala večja verjetnost, da se bodo pri otrocih, izpostavljenih valproatu v maternici, razvili simptomi motnje pomanjkanja pozornosti s hiperaktivnostjo (ADHD).6,7,8
English: * The Coordination Group for Mutual Recognition and Decentralised Procedures - Human
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini
English: The recommendations on the use of valproate in women and girls will be implemented by EU Member States according to an agreed timetable.
Slovenian: Priporočila o uporabi valproata pri ženskah in dekletih bodo države članice EU uveljavile v skladu s sprejetim časovnim razporedom.
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA's Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Slovenian: Pregled je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), odbor Evropske agencije za zdravila, zadolžen za ocenjevanje vprašanj v zvezi z varnostjo zdravil za uporabo v humani medicini, ki je pripravil sklop priporočil.
English: Previous data have shown that children exposed to valproate in the womb are also at increased risk of autistic spectrum disorder (around 3 times higher than in the general population) and childhood autism (5 times higher than in the general population).
Slovenian: Predhodni podatki so pokazali, da je pri otrocih, ki so bili izpostavljeni valproatu v maternici, prav tako večje tveganje za motnjo avtističnega spektra (približno trikrat večje kot pri splošni populaciji) in otroški avtizem (približno petkrat večje kot pri splošni populaciji).
English: • Valproate medicines can cause malformations and problems with early development of children if they are exposed to these medicines in the womb.
Slovenian: • Zdravila, ki vsebujejo valproat, lahko povzročijo malformacije in težave v zgodnjem razvoju otrok, v kolikor so tem zdravilom izpostavljeni v maternici.
English: In countries where valproate medicines are also authorised for the prevention of migraine, valproate must not be used for this purpose in pregnant women, and doctors should exclude pregnancy before starting preventive treatment for migraine.
Slovenian: V državah, kjer so zdravila, ki vsebujejo valproat, odobrena tudi za preprečevanje migrene, se valproat v ta namen ne sme uporabljati pri nosečnicah, zdravnik pa mora pred začetkom preventivnega zdravljenja migrene izključiti nosečnost.
English: Arch Dis Child 2011 July;96(7):643-7.
Slovenian: Arch Dis Child 2011 julij;96(7):643-7. 5.
English: The CMDh,* a regulatory body representing EU Member States, has agreed to strengthen warnings on the use of valproate medicines in women and girls due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb.
Slovenian: Skupina CMDh*, regulativni organ, ki predstavlja države članice EU, se je strinjala z okrepitvijo opozoril o uporabi zdravil, ki vsebujejo valproat, pri ženskah in dekletih zaradi tveganja pojava malformacij in težav v razvoju pri otrocih, ki so bili izpostavljeni valproatu v maternici.
English: Information to healthcare professionals Following an evaluation of the data on the risks of valproate use during pregnancy, the recommendations for the use of valproate in women and girls have been updated:
Slovenian: Informacije za zdravstvene delavce Po oceni podatkov o tveganjih uporabe valproata med nosečnostjo so bila priporočila o uporabi valproata pri ženskah in dekletih posodobljena:
English: − Do not prescribe valproate for female patients who can have children if they are not using effective methods of contraception or if they are already pregnant - such use is now contraindicated.
Slovenian: − Ne predpisujte valproata bolnicam, ki lahko zanosijo, če ne uporabljajo učinkovite kontracepcijske metode, ali nosečnicam - tovrstna uporaba je zdaj kontraindicirana.
English: In addition, children exposed to valproate in the womb are at an approximately 11% risk of malformations at birth (such as neural tube defects and cleft palate)9 compared with a 2 to 3% risk for children in the general population.
Slovenian: Poleg tega je tveganje za prirojene malformacije (kot so npr. okvare nevralne cevi in palatoshiza)9 pri otrocih, izpostavljenih valproatu v maternici, približno 11─odstotno, pri otrocih v splošni populaciji pa od 2─ do 3─odstotno.
English: The warnings aim to ensure that patients are aware of the risks and that they take valproate only when clearly necessary.
Slovenian: Namen opozoril je zagotoviti, da se bolnice zavedajo tveganj in valproat jemljejo le v nujnih primerih.
English: Doctors must not prescribe valproate for migraine prevention for women who are not on effective contraception.
Slovenian: Zdravniki valproata ne smejo predpisovati za preprečevanje migren pri ženskah, ki ne uporabljajo učinkovite kontracepcije.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 November 2014 EMA/709243/2014
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Doctors should ensure that their patients are adequately informed of the risks of taking valproate during pregnancy, and should regularly review the need for treatment in female patients who can have children.
Slovenian: Zdravniki bi morali zagotoviti, da so njihove bolnice ustrezno obveščene o tveganjih, povezanih z jemanjem valproata med nosečnostjo, in redno ocenjevati potrebo po zdravljenju pri bolnicah, ki lahko zanosijo.
English: The CMDh position was agreed by consensus, and the recommendations on the use of valproate in women and girls will be implemented by EU Member States according to an agreed timetable.
Slovenian: Stališče skupine CMDh je bilo sprejeto soglasno, priporočila o uporabi valproata pri ženskah in dekletih pa bodo države članice EU uveljavile v skladu s sprejetim časovnim razporedom.
English: − Ensure that the treatment of epilepsy or bipolar disorder is supervised by a doctor experienced in treating these conditions.
Slovenian: − Zagotovite, da zdravljenje epilepsije ali bipolarne motnje nadzoruje zdravnik z izkušnjami z zdravljenjem teh bolezni.
English: Women to be better informed of risks of valproate use in pregnancy and need for contraception
Slovenian: Boljše obveščanje žensk o tveganjih zdravljenja z valproatom v nosečnosti in o potrebi po uporabi kontracepcije
English: Women and girls who have been prescribed valproate should not stop taking their medicines without consulting their doctor as doing so could result in harm to themselves or to an unborn child.
Slovenian: Ženske in dekleta, ki jim je bil predpisan valproat, ne smejo prenehati z jemanjem zdravil, ne da bi se pred tem posvetovale s svojim zdravnikom, saj lahko tako škodijo sebi ali nerojenemu otroku.
English: • For treatment of epilepsy and bipolar disorder in female patients who can have children
Slovenian: • Za zdravljenje epilepsije in bipolarne motnje pri bolnicah, ki lahko zanosijo
English: Those for whom valproate is the only option for epilepsy or bipolar disorder should be advised on the use of effective contraception and treatment should be started and supervised by a doctor experienced in treating these conditions.
Slovenian: Bolnicam, pri katerih je valproat edina možnost za zdravljenje epilepsije ali bipolarne motnje, bi morali svetovati uporabo učinkovitih kontracepcijskih sredstev, zdravljenje pa bi moral uvesti in nadzorovati zdravnik z izkušnjami z zdravljenjem teh bolezni.
English: JAMA 2013 Apr 24;309(16):1696-1703.
Slovenian: JAMA 2013 april 24;309(16):1696-1703. 7.
English: − Ensure that female patients who can become pregnant are aware that they must keep to their contraception throughout treatment.
Slovenian: − Zagotovite, da se bolnice, ki lahko zanosijo, zavedajo, da morajo ves čas zdravljenja uporabljati kontracepcijo.
English: • Do not stop taking your valproate medicine without consulting your doctor as doing so could cause harm to you or an unborn child.
Slovenian: • Ne prenehajte z jemanjem zdravila, ki vsebuje valproat, ne da bi se posvetovali s svojim zdravnikom, saj lahko tako škodujete sebi ali nerojenemu otroku.
English: The review of valproate was conducted by the EMA's Pharmacovigilance and Risks Assessment Committee (PRAC), following which the CMDh endorsed the PRAC's recommendations.
Slovenian: Pregled valproata je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila, na podlagi pregleda pa je skupina CMDh podprla priporočila odbora PRAC.
English: Doctors in the EU are now advised not to prescribe valproate for epilepsy or bipolar disorder in pregnant women, in women who can become pregnant or in girls unless other treatments are ineffective or not tolerated.
Slovenian: Zdravnikom v EU se zdaj svetuje, naj za zdravljenje epilepsije ali bipolarne motnje ne predpisujejo valproata nosečnicam, ženskam, ki lahko zanosijo, in dekletom, razen v kolikor so druge oblike zdravljenja neučinkovite ali jih bolnice ne prenašajo.
English: − Inform patients of the risks of taking valproate during pregnancy.
Slovenian: − Seznanite bolnice s tveganji jemanja valproata med nosečnostjo.
English: Regularly review the need for treatment and re-assess the balance of the benefits and risks for female patients taking valproate and for girls reaching puberty.
Slovenian: Redno ocenjujte potrebo po zdravljenju ter razmerje med koristmi in tveganji pri bolnicah, ki jemljejo valproat, in dekletih, ki so dosegla puberteto.
English: − Advise patients taking valproate medicines about effective contraception during their treatment.
Slovenian: − Bolnicam, ki jemljejo zdravila, ki vsebujejo valproat, svetujte, naj med zdravljenjem uporabljajo učinkovito kontracepcijsko metodo.
English: Doctors should also re-assess the balance of the benefits and risks of valproate medicines for any female patient who becomes or plans to become pregnant and for girls reaching puberty.
Slovenian: Zdravniki bi prav tako morali ponovno oceniti razmerje med koristmi in tveganji uporabe zdravil, ki vsebujejo valproat, pri bolnicah, ki zanosijo ali nameravajo zanositi, ter dekletih, ki so dosegle puberteto.