natgillin/translations-raw huggingface dataset:
However the available evidence does not suggest it prevents the birth defects or malformations due to valproate exposure.
Vendar dostopni dokazi ne kažejo, da prepreči prirojene hibe ali malformacije zaradi izpostavljenosti valproatu.
Therefore, platelet count, fibrinogen plasma level, coagulation tests and coagulation factors should be investigated in neonates.
Zato je treba pri novorojenčkih kontrolirati število trombocitov, koncentracijo fibrinogena v plazmi, koagulacijske teste in koagulacijske faktorje.
Preferably <invented name> should be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation to avoid high peak plasma concentrations.
Zdravilo <Izmišljeno ime> naj bo po možnosti uporabljeno kot samostojno zdravljenje (monoterapija) in v najmanjšem učinkovitem odmerku, če je mogoče, v obliki s podaljšanim sproščanjem, da bi preprečili visoke vrhove koncentracije v plazmi.
If you are trying for a baby you should not use valproate.
Če poskušate zanositi, ne smete uporabljati valproata.
Female children, female adolescents, women of childbearing potential and pregnant women
Deklice, mladostnice, ženske v rodni dobi in nosečnice
- To institute specialized prenatal monitoring in order to detect the possible occurrence of neural tube defects or other malformations.
- Uvesti specializiran predporodni nadzor, da bi odkrili morebitne defekte nevralne cevi ali druge malformacije.
If you decide later you want to have a child you should not stop taking your medicine until you have discussed this with your doctor and agreed a plan for switching you onto another product if this is possible.
Če se pozneje odločite, da želite otroka, ne smete prenehati jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom in se z njim dogovorili za prehod na zdravljenje z drugim zdravilom, če je to mogoče.
Available data suggest that antiepileptic polytherapy including valproate is associated with a greater risk of congenital malformations than valproate monotherapy.
Dostopni podatki kažejo, da je antiepileptična politerapija, ki vključuje valproat, povezana z večjim tveganjem za prirojene malformacije kot monoterapija z valproatom.
Female children/Female adolescents/Women of childbearing potential/Pregnancy:
Deklice/mladostnice/ženske v rodni dobi/nosečnice:
• Do not take valproate if you are pregnant or if you are a women of childbearing potential and you are not using effective contraception.
• Ne jemljite valproata, če ste noseči ali če ste v rodni dobi in ne uporabljate učinkovite kontracepcije.
Your doctor may decide to change the dose of valproate or switch you to another medicine before you start trying for a baby.
Zdravnik vam bo morda spremenil odmerek valproata ali bo valproat nadomestil s kakšnim drugim zdravilom, še preden poskusite zanositi.
If this is the first time you have been prescribed valproate your doctor will have explained the risks to an unborn child if you become pregnant.
Če vam je zdravnik valproat predpisal prvič, vam bo pojasnil, kakšna so tveganja za nerojenega otroka v primeru, da zanosite.
[For all products referred to in Annex I]
[Za vsa zdravila, navedena v Prilogi I]
The most common types of malformations include neural tube defects, facial dysmorphism, cleft lip and palate, craniostenosis, cardiac, renal and urogenital defects, limb defects (including bilateral aplasia of the radius), and multiple anomalies involving various body systems.
Med najpogostejšimi malformacijami so defekti nevralne cevi, dismorfizmi obraza, heiloshiza in palatoshiza, kraniostenoza, srčne, ledvične in urogenitalne hibe, hibe udov (vključno z obojestransko aplazijo koželjnice) in multiple anomalije, ki zajamejo različne telesne sisteme.
The benefit and risk should be carefully reconsidered at regular treatment reviews, at puberty and urgently when a woman of childbearing potential treated with <invented name> plans a pregnancy or if she becomes pregnant.
Koristi in tveganja je treba skrbno znova oceniti v rednih presledkih med zdravljenjem, v puberteti ter nujno, če ženska v rodni dobi, ki jemlje zdravilo <Izmišljeno ime>, namerava zanositi ali zanosi.
Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development which can be seriously debilitating.
Otroci mater, ki jemljejo valproat, imajo resno tveganje za prirojene hibe in razvojne težave, zaradi katerih so lahko resno prizadeti.
Available data show that children exposed to valproate in utero are at increased risk of autistic spectrum disorder (approximately three-fold) and childhood autism (approximately five-fold) compared with the general study population.
Dostopni podatki kažejo, da imajo otroci, in utero izpostavljeni valproatu, večje tveganje za spekter avtističnih motenj (približno trikratno) in otroški avtizem (približno petkratno) v primerjavi s splošno proučevano populacijo.
Valproate administration may also impair fertility in men (see section 4.8).
Uporaba valproata lahko poslabša tudi plodnost moških (glejte poglavje 4.8).
The prescriber must ensure that the patient is provided with comprehensive information on the risks alongside relevant materials, such as a patient information booklet, to support her understanding of the risks.
Zdravnik, ki predpiše zdravilo, mora poskrbeti, da bolnica poleg ustreznih gradiv (na primer informativne knjižice za bolnice) dobi izčrpne informacije o tveganjih, da bo lahko razumela tveganja.
The use of a prolonged release formulation may be preferable to other treatment formulations in order to avoid high peak plasma concentrations.
Oblika zdravila s podaljšanim sproščanjem ima prednost pred drugimi oblikami, saj prepreči visoke vrhove koncentracije v plazmi.
The risk is dose dependent but a threshold dose below which no risk exists cannot be established.
Tveganje je odvisno od odmerka, toda praga odmerka, pod katerim tveganja ni, ni mogoče ugotoviti.
• It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development.
• Ocenjujejo, da ima v zgodnjem otroštvu težave z razvojem od 30 do 40 % tistih predšolskih otrok, katerih matere so med nosečnostjo jemale valproat.
However, it it unlikely that it will reduce the risk of birth defects associated with valproate use.
Ni pa verjetno, da bi zmanjšala tveganje za prirojene hibe, povezane z uporabo valproata.
[The text below should be inserted in all indications].
[Spodnje besedilo je treba vstaviti za vse indikacije.]
<Invented name> should not be used in female children, in female adolescents, in women of childbearing potential and in pregnant women unless other treatments are ineffective or not tolerated.
Zdravila <Izmišljeno ime> se ne sme uporabljati pri deklicah, mladostnicah, ženskah v rodni dobi in nosečnicah, razen če so druga zdravila neučinkovita ali jih bolnica ne prenese.
Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies.
Folna kislina lahko pri vseh nosečnicah zmanjša splošno tveganje za pojav spine bifide in zgodnji spontani splav.
[This section should be amended to include the following wording]
[To poglavje je treba dopolniti, tako da vključuje naslednje besedilo]
• If you are a woman capable of becoming pregnant your doctor should only prescribe valproate for you if nothing else works for you.
• Če ste ženska v rodni dobi, vam sme zdravnik predpisati valproat le, če vam ne pomaga nobeno drugo zdravilo.
- Folate supplementation before the pregnancy may decrease the risk of neural tube defects common to all pregnancies.
- Dodajanje folata pred nosečnostjo; to lahko zmanjša tveganje za defekte nevralne cevi, kot velja za vse nosečnosti.
Treatment should only be initiated if other treatments are ineffective or not tolerated (see section 4.3, 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews.
To zdravilo se sme uvesti le, če druga zdravila niso učinkovita ali jih bolnica ne prenese (glejte poglavja 4.3, 4.4 in 4.6), koristi in tveganja pa je treba skrbno ocenjevati v rednih presledkih.
Birth defects which have been reported include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects.
Med opisanimi prirojenimi hibami so spina bifida (pri kateri se kosti v hrbtenici ne razvijejo pravilno), malformacije obraza in lobanje, malformacije srca, ledvic, sečil in spolnih organov ter okvare udov.
Hematological disorders have been shown in breastfed newborns/infants of treated women (see section 4.8).
Pri dojenih novorojenčkih/dojenčkih zdravljenih žensk so ugotovili hematološke motnje (glejte poglavje 4.8).
Treatment should only be initiated if other treatments are ineffective or not tolerated (see section 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews.
To zdravilo se sme uvesti le, če druga zdravila niso učinkovita ali jih bolnica ne prenese (glejte poglavji 4.4 in 4.6), koristi in tveganja pa je treba skrbno ocenjevati v rednih presledkih.
• If a woman plans a pregnancy or becomes pregnant, valproate therapy should be stopped.
• Če ženska načrtuje nosečnost ali zanosi, je treba zdravljenje z valproatom končati.
[The following text should be inserted in all products referred to in Annex I]
[Naslednje besedilo je treba vstaviti pri vseh zdravilih, navedenih v Prilogi I]
• Autistic spectrum disorders are more often diagnosed in children exposed to valproate and there is some evidence children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
• Pri otrocih, izpostavljenih valproatu, so pogostejše motnje iz spektra avtizma; nekaj je tudi dokazov, da so pri teh otrocih verjetnejši simptomi motnje pomanjkanja pozornosti shiperaktivnostjo (ADHD - attention deficit/hyperactivity disorder).
If you are continuing treatment with valproate and you are now thinking of trying for a baby you must not stop taking either your valproate or your contraceptive medicine until you have discussed this with your prescriber.
Če nadaljujete zdravljenje z valproatom in zdaj želite zanositi, ne smete prenehati uporabljati valproata in tudi ne kontracepcije, dokler se ne posvetujete z zdravnikom, ki vam je predpisal valproat.
In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible (see section 4.6).
Pri ženskah, ki nameravajo zanositi, si je treba prizadevati, da bi prešle na drugo ustrezno zdravilo, preden zanosijo, če je to mogoče (glejte poglavje 4.6).
<Invented name> should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated because of its high teratogenic potential and risk of developmental disorders in infants exposed in utero to valproate.
Zdravila <Izmišljeno ime> se ne sme uporabljati pri deklicah, mladostnicah, ženskah v rodni dobi in nosečnicah, razen če so druga zdravila neučinkovita ali jih bolnica ne prenese; valproat spremljata velika možnost teratogenosti in tveganje za razvojne motnje pri otrocih, ki so mu izpostavljeni in utero.
Amenorrhoea, polycystic ovaries and increased testosterone levels have been reported in women using valproate (see section 4.8).
Pri ženskah, ki so jemale valproat, so bili opisani amenoreja, policistični jajčniki in zvišana koncentracija testosterona (glejte poglavje 4.8).
If you are a female of childbearing age you should use an effective method of contraception throughout your treatment.
Če ste ženska v rodni dobi, morate ves čas zdravljenja uporabljati učinkovito kontracepcijo.
• Prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate (see sections 4.4 and 4.6).
• Za profilakso migrenskih napadov pri nosečnicah in ženskah v rodni dobi, ki med zdravljenjem z valproatom ne uporabljajo učinkovite kontracepcije (glejte poglavji 4.4 in 4.6).
[This statement below should be inserted at the top of the package leaflet for all products referred to in Annex I] ▼This medicine is subject to additional monitoring.
[Spodnjo navedbo je treba vstaviti na vrh navodila za uporabo za vsa zdravila, navedena v Prilogi I] ▼Za to zdravilo se izvaja dodatno spremljanje varnosti.
If you are taking valproate and you think you are pregnant or might be pregnant contact your doctor at once.
Če jemljete valproat in mislite, da ste noseči, ali da bi lahko bili noseči, se takoj posvetujte z zdravnikom.
<Invented name> is contraindicated as migraine prophylaxis in pregnant women and in women of childbearing potential, who do not use effective methods of contraception, as sufficient therapeutic alternatives are present (see section 4.3).
Zdravilo <Izmišljeno ime> je kontraindicirano za profilakso migrene pri nosečnicah in ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, ker je na voljo dovolj terapevtskih alternativ (glejte poglavje 4.3).
- Cases of hemorrhagic syndrome have been reported very rarely in neonates whose mothers have taken valproate during pregnancy.
Tveganje pri novorojenčkih - Zelo redko so pri novorojenčkih mater, ki so med nosečnostjo jemale valproat, zabeležili hemoragični sindrom.
The risk seems to be dose-dependent but a threshold dose below which no risk exists, cannot be established based on available data.
Po vsem sodeč je tveganje odvisno od odmerka, toda na podlagi dostopnih podatkov ni mogoče ugotoviti praga odmerka, pod katerim tveganja ni.
• Pregnancy must be excluded before start of treatment with valproate.
• Pred začetkom zdravljenja z valproatom je treba izključiti nosečnost.
If a Woman wants to plan a Pregnancy [The sentence below should be inserted only where the marketing authorisation currently includes the epilepsy indication]
Če želi ženska načrtovati nosečnost [Spodnji stavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo epilepsija.]
• In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible.
• Pri ženskah, ki nameravajo zanositi, si je treba prizadevati, da bi prešle na ustrezno drugo zdravilo, preden zanosijo, če je to mogoče.
<Invented name> treatment must be started and supervised by a doctor specialised in the treatment of migraine.
Zdravljenje z zdravilom <Izmišljeno ime> mora začeti in nadzorovati zdravnik specialist za zdravljenje migrene.
• The need to rapidly consult her physician if she is thinking of becoming pregnant or there is a possibility of pregnancy.
• Potrebo po tem, da se mora takoj posvetovati z zdravnikom, če razmišlja, da bi zanosila,
• Tell your doctor at once if you know you are pregnant or think you might be pregnant.
• Zdravnika morate takoj obvestiti, če veste, da ste noseči, ali mislite, da bi lahko bili noseči.
Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD).
Maloštevilni podatki kažejo, da imajo lahko otroci, in utero izpostavljeni valproatu, večjo verjetnost za simptome motnje pomanjkanja pozornosti s hiperaktivnostjo (ADHD - attention deficit/hyperactivity disorder).
In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible.
Pri ženskah, ki nameravajo zanositi, si je treba prizadevati, da bi prešle na drugo ustrezno zdravilo, preden zanosijo, če je to mogoče.
This compares to 2-3 babies in ever 100 born to women who don't have epilepsy.
Med otroki žensk brez epilepsije je ta delež 2 do 3 na 100 otrok.
Women of childbearing potential must use effective contraception during treatment and be informed of the risks associated with the use of <invented name> during pregnancy (see section 4.6).
Seznaniti jih je treba s tveganji uporabe zdravila <Izmišljeno ime> med nosečnostjo (glejte poglavje 4.6).
[This section should be amended to include the following box]
[To poglavje je treba dopolniti, tako da vključuje naslednji okvir]
<Invented name> is contraindicated for prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate (see sections 4.4 and 4.6 above).
Zdravilo <Izmišljeno ime> je kontraindicirano za profilakso migrenskih napadov pri nosečnicah in ženskah v rodni dobi, ki med zdravljenjem z valproatom ne uporabljajo učinkovite kontracepcije (glejte poglavji 4.4 in 4.6, zgoraj).
- Withdrawal syndrome (such as, in particular, agitation, irritability, hyper-excitability, jitteriness, hyperkinesia, tonicity disorders, tremor, convulsions and feeding disorders) may occur in neonates whose mothers have taken valproate during the last trimester of their pregnancy.
- Novorojenčkom mater, ki so v zadnjem trimesečju nosečnosti jemale valproat, se lahko pojavi odtegnitveni sindrom (npr. zlasti agitiranost, razdražljivost, hiperekscitabilnost, trzavica, hiperkinezija, motnje toničnosti, tremor, konvulzije in motnje hranjenja).
• During pregnancy, maternal tonic clonic seizures and status epilepticus with hypoxia may carry a particular risk of death for mother and the unborn child. [The sentence below should be inserted only where the marketing authorisation currently includes the epilepsy and/or bipolar indications]
• Med nosečnostjo lahko tonično-klonični napadi ali status epilepticus s hipoksijo pri materi še posebej ogrozijo življenje matere in nerojenega otroka.
• Make sure you are using an effective method of contraception.
• Poskrbite za učinkovito kontracepcijsko zaščito.
Section 4.3 Contraindications [The text below is only to be implemented where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Poglavje 4.3 Kontraindikacije [Spodnje besedilo je treba uporabiti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo za profilakso migrenskih napadov]
<Invented name> treatment must be started and supervised by a doctor specialised in the treatment of <epilepsy> <or> <bipolar disorders>.
Zdravljenje z zdravilom <Izmišljeno ime> mora začeti in nadzorovati zdravnik specialist za zdravljenje <epilepsije> <ali> <bipolarne motnje>.
<Invented name> should be initiated and supervised by a specialist experienced in the management of <epilepsy> <or> <bipolar disorder>.
Zdravljenje z zdravilom <Izmišljeno ime> mora uvesti in nadzorovati specialist, ki ima izkušnje z vodenjem <epilepsije> <ali> <bipolarne motnje>.
Valproate can cause birth defects and problems with early development of the child if it is taken during pregnancy.
Med nosečnostjo uporabljani valproat lahko povzroči prirojene hibe in težave v zgodnjem otrokovem razvoju.
[This sentence below should be adapted to National requirements] Make sure you read the patient booklet and sign the Acknowledgement of Risk form which should be given to you and discussed with you by your doctor or pharmacist.
Prebrati morate knjižico za bolnice in podpisati Obrazec o seznanitvi s tveganji; to dvoje vam mora izročiti zdravnik ali farmacevt, ki se mora o tem z vami tudi pogovoriti.
If you are continuing treatment with valproate but you don't plan to have a baby make sure you are using an effective method of contraception.
NADALJEVANJE ZDRAVLJENJA, ČE NE NAMERAVATE ZANOSITI Če nadaljujete zdravljenje z valproatom in ne načrtujete nosečnosti, poskrbite za učinkovito kontracepcijsko zaščito.
Once you are of childbearing age, you will need to make sure you use an effective method of contraception throughout your treatment.
V rodni dobi boste morali ves čas zdravljenja uporabljati učinkovito kontracepcijo.
UNPLANNED PREGNANCY WHILST CONTINUING TREATMENT [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
NENAČRTOVANA NOSEČNOST MED NADALJEVANJEM ZDRAVLJENJA [Spodnji odstavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo "profilaksa migrenskih napadov".]
• Valproate can be harmful to unborn children when taken by a woman during pregnancy.
• Če ženska jemlje valproat med nosečnostjo, lahko valproat škoduje nerojenemu otroku.
Possible side effects [This section should be amended to include the below wording in all indications]
[To poglavje je treba dopolniti, tako da vključuje spodnje besedilo za vse indikacije]
CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
NADALJEVANJE ZDRAVLJENJA, ČE NAMERAVATE ZANOSITI [Spodnji odstavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo "profilaksa migrenskih napadov".]
Valproate therapy should only be continued after a reassessment of the benefits and risks of the treatment with valproate for the patient by a physician experienced in the management of
Zdravljenje z valproatom se sme nadaljevati le, ko zdravnik, ki ima izkušnje z vodenjem <epilepsije> <ali> <bipolarne motnje>, ponovni oceni koristi in tveganja takšnega zdravljenja za bolnico.
Both valproate monotherapy and valproate polytherapy are associated with abnormal pregnancy outcomes.
Tveganje, povezano z izpostavljenostjo valproatu med nosečnostjo Nenormalni izidi nosečnosti spremljajo tako monoterapijo kot politerapijo z valproatom.
[All text below should be inserted only where the marketing authorisation currently includes the indications for epilepsy and/or bipolar disorder].
[Vse spodnje besedilo je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo epilepsija in/ali bipolarna motnja.]
[The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
[Spodnji odstavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo "profilaksa migrenskih napadov".]
- Cases of hypothyroidism have been reported in neonates whose mothers have taken valproate during pregnancy.
- Pri novorojenčkih mater, ki so med nosečnostjo jemale valproat, so bili opisani primeri hipotiroidizma.
[The following sentence should be inserted only where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
[Naslednji stavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo za profilakso migrenskih napadov]
[All text below should be inserted only where the marketing authorisation currently includes the indications epilepsy and/or bipolar disorders] Valproate therapy should not be discontinued without a reassessment of the benefits and risks of the treatment with valproate for the patient by a physician experienced in the management of <epilepsy> <or> <bipolar disorder>.
Zdravljenja z valproatom se ne sme prekiniti, dokler zdravnik, ki ima izkušnje z vodenjem <epilepsije> <ali> <bipolarne motnje>, ponovno ne oceni koristi in tveganja takšnega zdravljenja za bolnico.
[The text below should be inserted only where the marketing authorisation currently includes indications for the epilepsy and/or bipolar disorder].
[Spodnje besedilo je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo epilepsija in/ali bipolarna motnja.]
- Cases of hypoglycaemia have been reported in neonates whose mothers have taken valproate during the third trimester of their pregnancy.
- Pri novorojenčkih mater, ki so v prvem trimesečju nosečnosti jemale valproat, so bile opisane hipoglikemije.
[The following paragraph should be inserted only where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
[Naslednji odstavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo za profilakso migrenskih napadov]