natgillin/translations-raw huggingface dataset:
The active substance is recombinant interferon alfa-2b, 10 million IU in a single dose vial The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Kaj vsebuje zdravilo Viraferon - Zdravilna učinkovina je rekombinantni interferon alfa-2b, 10 milijonov i.e. v viali z enkratnim - Pomožne snovi so brezvodni natrijev hidrogenfosfat, natrijev dihidrogen fosfat monohidrat, natrijev edetat, natrijev klorid, m-krezol, polisorbat 80 in voda za injekcije.
EU/1/99/128/030 2 pens
EU/1/99/128/030 2 peresnika
Reconstituting Viraferon powder for injection
FARMACEVTSKA OBLIKA Raztopina za injiciranje.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Viraferon 5 million IU/0.5 ml solution for injection interferon alfa-2b
IME ZDRAVILA IN POT(I) UPORABE Viraferon 5 milijonov i.e./0,5 ml raztopina za injiciranje interferon alfa-2b s.c.
The active substance is recombinant interferon alfa-2b, 3 million IU in a single dose vial The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Kaj vsebuje zdravilo Viraferon - Zdravilna učinkovina je rekombinantni interferon alfa-2b, 3 milijoni i.e. v viali z enkratnim - Pomožne snovi so brezvodni natrijev hidrogenfosfat, natrijev dihidrogen fosfat monohidrat, natrijev edetat, natrijev klorid, m-krezol, polisorbat 80 in voda za injekcije.
MARKETING AUTHORISATION NUMBERS EU/1/99/128/006
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/128/006
Check with your doctor immediately if any of the following side effects occur:
Če se pojavi kateri od naslednjih neželenih učinkov, se nemudoma posvetujte s svojim zdravnikom:
Reconstitution of Viraferon, powder for solution for injection, for parenteral administration: Viraferon is supplied as a powder at strengths of 3 million IU/ml for single-dose use.
Rekonstitucija zdravila Viraferon, prašek za raztopino za injiciranje za parenteralno uporabo: Zdravilo Viraferon je na voljo v obliki praška z jakostjo 3 milijoni i.e./ml., za dajanje v enkratnem odmerku.
MARKETING AUTHORISATION NUMBERS EU/1/99/128/004
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/128/004
Viraferon, 10 million IU/ml powder and solvent for solution for injection Interferon alfa-2b
Viraferon 10 milijonov i.e./ml prašek in vehikel za raztopino za injiciranje interferon alfa-2b
EU/1/99/128/013 1 single dose vial
EU/1/99/128/013 1 viala z enkratnim odmerkom
NL-3542 DN Utrecht Tel: + 31-(0)800 778 78 78
Tel: + 31-(0)800 778 78 78
Discontinuation of Viraferon should be considered in patients who develop new or worsening ophthalmological disorders.
Pri bolnikih, pri katerih se pojavijo nove oftalmološke motnje ali se obstoječe poslabšajo, premislite o prekinitvi zdravljenja z zdravilom Viraferon.
PHARMACEUTICAL FORM AND CONTENTS 3 million IU/ml powder and solvent for solution for injection 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 6 vials of powder and 6 ampoules of solvent
3 milijoni i.e./ml prašek in vehikel za raztopino za injiciranje 1 viala s praškom, 1 ampula z vehiklom, 1 injekcijska brizga, 2 injekcijski igli in 1 čistilni tampon 6 vial s praškom in 6 ampul z vehiklom
EU/1/99/128/034 8 pens
EU/1/99/128/034 8 peresnikov
Cap
SERIJE
MARKETING AUTHORISATION NUMBERS EU/1/99/128/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/128/002
MARKETING AUTHORISATION NUMBER(S) EU/1/99/128/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/128/001
24 mg of powder (corresponding to 5 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) Pack sizes of 6
24 mg praška (kar ustreza 5 milijonom i.e.) v viali (iz stekla tipa I), z zamaškom (iz butilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) in 1 ml vode za injekcije v ampuli (iz stekla tipa I).
24 mg of powder (corresponding to 3 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml of water for injections in an ampoule (type I glass) Pack sizes of 6
24 mg praška (kar ustreza 3 milijonom i.e.) v viali (iz stekla tipa I), z zamaškom (iz butilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) in 1 ml vode za injekcije v ampuli (iz stekla tipa I).
Determine TSH levels if, during the course of Viraferon therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
Če se pri bolniku med zdravljenjem z zdravilom Viraferon pojavijo simptomi, ki kažejo na morebitne motnje delovanja žleze ščitnice, določite koncentracijo TSH.
§, hyperuricemia, increased appetite Hypertriglyceridemia
anoreksija hipertrigliceridemija§, hiperurikemija, povečan tek
24 mg of powder (corresponding to 5 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
24 mg praška (kar ustreza 5 milijonom i.e.) v viali (iz stekla tipa I), z zamaškom (iz butilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) in 1 ml vode za injekcije v ampuli (iz stekla tipa I), z 1 injekcijsko brizgo, 2 injekcijskima iglama in 1 čistilnim tamponom.
Within its shelf-life, for the purpose of transport, the solution can be kept at or below 25ºC for a period up to seven days before use.
V času roka uporabnosti pri prevozu lahko raztopino pred uporabo shranjujete pri temperaturi do vključno 25°C do 7 dni.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Viraferon 10 million IU/ml solution for injection interferon alfa-2b
IME ZDRAVILA IN POT(I) UPORABE Viraferon 10 milijonov i.e./ml raztopina za injiciranje interferon alfa-2b s.c.
24 mg of powder (corresponding to 3 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml of water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
24 mg praška (kar ustreza 3 milijonom i.e.) v viali (iz stekla tipa I), z zamaškom (iz butilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) in 1 ml vode za injekcije v ampuli (iz stekla tipa I), z 1 injekcijsko brizgo, 2 injekcijskima iglama in 1 čistilnim tamponom.
Caution must be exercised when administering Viraferon in combination with other potentially myelosuppressive agents.
Pri sočasni uporabi zdravila Viraferon in drugih potencialno mielosupresivnih snovi priporočamo previdnost.
24 mg of powder (corresponding to 10 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
24 mg praška (kar ustreza 10 milijonom i.e.) v viali (iz stekla tipa I), z zamaškom (iz butilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) in 1 ml vode za injekcije v ampuli (iz stekla tipa I), z 1 injekcijsko brizgo, 2 injekcijskima iglama in 1 čistilnim tamponom.
24 mg of powder (corresponding to 1 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
24 mg praška (kar ustreza 1 milijonu i.e.) v viali (iz stekla tipa I), z zamaškom (iz butilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) in 1 ml vode za injekcije v ampuli (iz stekla tipa I), z 1 injekcijsko brizgo, 2 injekcijskima iglama in 1 čistilnim tamponom.
Endocrine disorders Common:
Bolezni endokrinega sistema
Please discard these appropriately and safely.
Zavrzite jih v skladu z lokalnimi predpisi.
EU/1/99/128/037 8 pens
EU/1/99/128/037 8 peresnikov
Leukopaenia
Ščitnik
Do not touch the tip of the syringe.
Vzemite brizgo iz ovojnine, pri tem pa se ne smete dotakniti vrha brizge.
Interferon alfa-2b (6 MIU/m
Vrednost p a interferon alfa-2b (100 ali 150c µg/
1 ml of solution (corresponding to 10 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flipoff seal (aluminium) with a bonnet (polypropylene)
1 ml raztopine (kar ustreza 10 milijonom i.e.) v viali (iz stekla tipa I), z zamaškom (iz halobutilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) Velikost pakiranja: 1 komplet ali
Important advice for women
Pomembni nasveti za ženske
Key messages:
Ključna sporočila:
Your doctor will advise you further.
Dodatno vam bo svetoval zdravnik.
It may harm them, even if their symptoms seem the same as yours.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Pristojni organi držav članic lahko v nadaljevanju posodobijo informacije o zdravilu v povezavi z referenčno državo članico, kot je ustrezno, v skladu s postopki iz poglavja 4 naslova III Direktive 2001/83/ES.
Your doctor will discuss this with you but you must also follow the advice in section 2 of this leaflet.
Zdravnik se bo z vami pogovoril o tem, a upoštevati morate tudi nasvete v 2. poglavju tega navodila.
Annex III Amendments to relevant sections of the Product Information
Priloga III Spremembe ustreznih poglavij informacij o zdravilu
Teratogenicity and Developmental Effects
Teratogenost in učinki na razvoj
If a woman plans a pregnancy
Če ženska načrtuje nosečnost
The higher the dose, the higher the risks but all doses carry a risk.
Tveganje je toliko večje, kolikor večji je odmerek, vendar pa tveganje spremlja vse odmerke.
You and your partner could receive counselling and support regarding the valproate exposed pregnancy.
Vi in vaš partner sta lahko deležna svetovanja in podpore v zvezi z nosečnostjo, izpostavljeno valproatu.
Children affected can be slow to walk and talk , intellectually less able than other children, and have difficulty with language and memory.
Prizadeti otroci pozneje shodijo in začnejo pozneje govoriti, so intelektualno manj sposobni od drugih otrok ter imajo težave z jezikom in spominom.
These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Te spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so izid napotitvenega postopka.
This compares to 2 to 3 babies in every 100 born to women who don't have epilepsy.
Za primerjavo: takšne napake se pojavijo pri 2 do 3 od 100 otrok žensk, ki nimajo epilepsije.
The daily dose should be divided into at least two single doses (see section 4.6).
Dnevni odmerek je treba razdeliti na vsaj dva enkratna odmerka (glejte poglavje 4.6).
• Use the lowest effective dose and divide the daily dose of valproate into several small doses to be taken throughout the day.
• uporabljati najmanjši učinkoviti odmerek in razdeliti dnevni odmerek valproata na več majhnih odmerkov, ki jih ženska jemlje v teku dneva.
<Invented name> is contraindicated in the following situations:
Zdravilo <Izmišljeno ime> je kontraindicirano v naslednjih primerih:
The risks of valproate when taken during pregnancy (irrespective of the disease for which valproate is used)
Tveganja uporabe valproata med nosečnostjo (ne glede na bolezen, za katero se uporablja valproat)
If valproate is the only suitable treatment, the need for using effective contraception and all other conditions of pregnancy prevention programme should be discussed.
Če je valproat edino primerno zdravilo, se je treba pogovoriti o potrebi po uporabi učinkovite kontracepcije in o vseh drugih pogojih programa za preprečevanje nosečnosti.
[*For the printed material, please refer to the guidance of the annotated QRD template.]
[*Za tiskano gradivo glejte smernice označene predloge QRD.]
These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
Ti pogoji veljajo tudi za ženske, ki trenutno niso spolno aktivne, razen če predpisujoči zdravnik na podlagi prepričljivih razlogov oceni, da tveganja za nosečnost pri bolnici ni.
<Invented name> is contraindicated in the following situations: Treatment of epilepsy
Zdravilo <Izmišljeno ime> je kontraindicirano v naslednjih primerih: Zdravljenje epilepsije
If switching is not possible, the woman should receive further counselling regarding the valproate risks for the unborn child to support her informed decision making regarding family planning.
Če zamenjava ni mogoča, mora biti ženska deležna dodatnega svetovanja o tveganjih valproata za nerojenega otroka kot pomoč pri njeni obveščeni odločitvi glede načrtovanja družine.
MAHs of all valproate and related substances containing products authorised in the EU should amend the product information (insertion, replacement or deletion of the text, as appropriate) to reflect the wording as provided below, and in conjunction to the Scientific conclusions:
Imetniki dovoljenj za promet z vsemi zdravili, ki vsebujejo valproat ali sorodne snovi in so odobrena v EU, morajo informacije o zdravilu (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) spremeniti tako, da bodo ustrezale spodaj navedenemu besedilu, in v skladu z znanstvenimi zaključki:
Every effort should be made by the specialist to switch the female children to alternative treatment before they reach adulthood.
Specialist si mora po najboljših močeh prizadevati, da bi deklice prešle na drugo zdravilo, preden dosežejo odraslo dobo.
Valproate should preferably be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation.
Valproat naj bi po možnosti predpisovali kot monoterapijo in v najmanjšem učinkovitem odmerku ter po možnosti v obliki s podaljšanim sproščanjem.
Your specialist can put several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible.
Specialist lahko uporabi več ukrepov, da bo nosečnost potekala čim bolj nemoteno in da bodo tveganja za nerojenega otroka čim manjša.
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 napakami 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.
Conditions of Pregnancy Prevention Programme: The prescriber must ensure that
Pogoji programa za preprečevanje nosečnosti: Zdravnik, ki predpiše zdravilo, mora poskrbeti:
Because valproate has been used for many years we know that in women who take valproate around 10 babies in every 100 will have birth defects.
Ker je valproat v uporabi že dolga leta, vemo, da bo imelo prirojene napake 10 od 100 otrok žensk, ki jemljejo valproat.
Your doctor will advise you further (see below under “Pregnancy, breast-feeding and fertility - Important advice for women”).
Dodatno vam bo svetoval zdravnik (prosimo glejte spodaj “Nosečnost, dojenje in plodnost - Pomembni nasveti za ženske”).
In the exceptional circumstances when <Invented name> is the only available treatment option during pregnancy, you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.
V izrednih okoliščinah, ko je zdravilo <Izmišljeno ime> edina dostopna možnost zdravljenja med nosečnostjo, vas bodo zelo natančno nadzorovali, tako zaradi vodenja osnovne bolezni kot zaradi preverjanja razvoja še nerojenega otroka.
• If you take valproate during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment.
• Če med nosečnostjo jemljete valproat, imate v primerjavi z drugimi ženskami večje tveganje, da bo imel vaš otrok prirojene napake, ki bodo zahtevale zdravljenje.
At least one effective method of contraception (preferably a user independent form such as an intra-uterine device or implant) or two complementary forms of contraception including a barrier method should be used.
Uporabljati morajo vsaj en učinkovit način kontracepcije (po možnosti način, ki ni odvisen od uporabnice, na primer maternični vložek ali vsadek), ali dva komplementarna načina kontracepcije, vključno s pregradnim načinom.
However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Ni pa verjetno, da bi zmanjšala tveganje za prirojene napake, povezane z uporabo valproata.
During this visit your doctor will make sure you are well aware and have understood all the risks and advices related to the use of valproate during pregnancy.
Na tem obisku se bo zdravnik prepričal, ali se dobro zavedate in razumete tveganja in nasvete, povezane z uporabo valproata med nosečnostjo.
What you need to know before you take <invented name>
Kaj morate vedeti, preden boste vzeli zdravilo <izmišljeno ime>
In case of pregnancy
V primeru nosečnosti
If you decide later you want to have a baby you must not stop taking your medicine or your method of contraception until you have discussed this with your doctor.
Če se pozneje odločite, da želite otroka, ne smete prenehati jemati tega zdravila ali uporabljati kontracepcije, dokler se ne posvetujete z zdravnikom.
[Quick Response (QR) code: A QR code should be included in the packaging material and/or the package leaflet, and its location should take into account the overall readability.]
[Koda QR: Na ovojnini in/ali v navodilu za uporabo mora biti vključena koda QR; njen položaj je treba izbrati upoštevaje splošno berljivost.]
• 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 težave z razvojem v zgodnjem otroštvu od 30 do 40 % tistih predšolskih otrok, katerih matere so med nosečnostjo jemale valproat.
Specialized prenatal monitoring should take place to detect the possible occurrence of neural tube defects or other malformations.
Potrebno je specializirano predporodno spremljanje, da bi odkrili možne defekte nevralne cevi ali druge malformacije.
However the available evidence does not suggest it prevents the birth defects or malformations due to valproate exposure.
Vendar izsledki, ki so na voljo, ne kažejo, da bi preprečil prirojene napake ali malformacije zaradi izpostavljenosti valproatu.
• Make sure you are referred to a specialist for prenatal monitoring in order to detect possible occurrences of malformations.
• Poskrbite, da vas bo zdravnik napotil k specialistu za predporodno spremljanje, da bi tako odkrili pojav morebitnih malformacij.
• Before prescribing this medicine to you, your doctor will have explained what might happen to your baby if you become pregnant whilst taking valproate.
• Preden vam bo zdravnik predpisal to zdravilo, vam bo pojasnil, kaj se lahko zgodi vašemu otroku, če med jemanjem valproata zanosite.
These patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception.
Tem bolnicam je treba zagotoviti izčrpne informacije o preprečevanju nosečnosti; če ne uporabljajo učinkovite kontracepcije, jih je treba napotiti na svetovanje o kontracepciji.
During pregnancy, maternal tonic clonic seizures and status epilepticus with hypoxia may carry a particular risk of death for mother and the unborn child.
Tonično-klonični napadi ali status epilepticus s hipoksijo pri materi lahko med nosečnostjo še posebej ogrozijo življenje matere in nerojenega otroka.
The use of a prolonged release formulation may be preferable to other treatment formulations in order to avoid high peak plasma concentrations (see section
Uporaba oblike s podaljšanim sproščanjem ima lahko prednost pred drugimi oblikami zdravila, da bi se tako izognili visokim vrhovom koncentracije v plazmi (glejte poglavje 4.2).
Folate supplementation before the pregnancy may decrease the risk of neural tube defects which may occur in all pregnancies.
Dodajanje folata pred nosečnostjo lahko zmanjša tveganje za defekte nevralne cevi, ki se lahko pojavijo pri vseh nosečnostih.
If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z <zdravnikom> <ali><,> <farmacevtom> <ali medicinsko sestro>.
Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies.
Folna kislina lahko zmanjša splošno tveganje za spino bifido in zgodnji spontani splav, ki obstaja pri vseh nosečnostih.
• the patient has acknowledged that she has understood the hazards and necessary precautions associated with valproate use (Annual Risk Acknowledgement Form).
• da bolnica potrdi, da razume nevarnosti in potrebne previdnostne ukrepe v zvezi z uporabo valproata (letni obrazec o seznanitvi s tveganji).
In order to assist healthcare professionals and patients in avoiding exposure to valproate during pregnancy, the Marketing Authorisation Holder has provided educational materials to reinforce the warnings and provide guidance regarding use of valproate in women of childbearing potential and the details of the pregnancy prevention programmeme.
Da bi zdravstvenim delavcem in bolnicam pomagal pri izogibanju izpostavljenosti valproatu med nosečnostjo, je imetnik dovoljenja za promet z zdravilom pripravil izobraževalna gradiva, ki poudarjajo opozorila, dajejo smernice za uporabo valproata pri ženskah v rodni dobi in navajajo podrobnosti o programu preprečevanja nosečnosti.
• 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 aktivnosti in pozornosti (ADHD).
• the potential for pregnancy is assessed for all female patients.
• da pri vseh bolnicah oceni možnost nosečnosti.
How to take <invented name>
Kako jemati zdravilo <izmišljeno ime>
• First schedule an appointment with your doctor.
• Najprej se dogovorite za pregled pri zdravniku.
Bipolar disorder <and> <migraine>
Bipolarna motnja <in> <migrena>
• the patient understands the need to undergo pregnancy testing prior to initiation of treatment and during treatment, as needed.
• da bolnica razume potrebo po izvajanju testa nosečnosti pred uvedbo zdravljenja in med zdravljenjem, kot je potrebno.
Pregnancy test
Test nosečnosti
• Pregnancy must be excluded before start of treatment with <Invented name> with the result of a pregnancy test, confirmed by your doctor.
• Nosečnost je treba pred začetkom zdravljenja z zdravilom <Izmišljeno ime> izključiti z izvidom testa nosečnosti, ki ga potrdi zdravnik.
Pregnancy must be excluded before start of treatment with valproate.
Pred začetkom zdravljenja z valproatom je treba izključiti nosečnost.
• Do not stop using your methods of birth control (contraception) before you have talked to your doctor and worked together on a plan to ensure your condition is controlled and the risks to your baby are reduced.
• Ne nehajte uporabljati kontracepcije, dokler se ne posvetujete z zdravnikom in skupaj z njim oblikujete načrt, po katerem bo vaša bolezen obvladana, tveganja za otroka pa bodo majhna.