33 • -- da lahko zdravilo Volibris povzroči resne okvare ploda, če ženska zanosi pred, med ali v enem mesecu po prekinitvi zdravljenja. • - da se zdravljenje z zdravilom Volibris ne sme uvesti, če je bolnica noseča. • - da morajo ženske v rodni dobi neposredno pred začetkom zdravljenja z zdravilom Volibris opraviti test za ugotavljanje nosečnosti in ga nato med zdravljenjem opravljati v mesečnih intervalih. • - da morajo ženske v rodni dobi uporabljati zanesljivo metodo kontracepcije in da morajo bolnice pred izdajo novega recepta svojega zdravnika obvestiti o vsaki možnosti zanositve. • -- da mora ženska v rodni dobi, ki mora spremeniti ali prenehati uporabljati dosedanjo metodo kontracepcije zdravnika, ki ji je predpisal kontracepcijo obvestiti, da jemlje zdravilo Volibris. • --- da mora ženska v rodni dobi, ki mora spremeniti ali prenehati uporabljati dosedanjo metodo kontracepcije, o tem obvestiti zdravnika, ki ji je predpisal zdravilo Volibris. • - da mora bolnica o vsaki možnosti zanositve nemudoma obvestiti svojega lečečega zdravnika. • - da se mora bolnica posvetovati s svojim zdravnikom, če namerava zanositi. • - da lahko zdravilo Volibris povzroči okvaro jeter. • - da je zaradi možne okvare jeter in anemije treba redno izvajati krvne preiskave in da mora bolnik obvestiti svojega zdravnika, če se pojavi kakršenkoli simptom okvare jeter. • - da bolnik zdravila Volibris ne sme dajati drugi osebi. • -- da mora bolnik svojega zdravnika obvestiti o vsakem neželenem učinku.
• That Volibris may cause serious birth defects in unborn babies conceived before, during, or within a month after stopping treatment. • That Volibris cannot be initiated if patient is pregnant. • Women with child-bearing potential must have a pregnancy test immediately prior to the first prescription and at monthly intervals whilst taking Volibris. • The need to ensure that women of child-bearing potential are using reliable contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued. • That if a women of child-bearing potential needs to change or stop her method of contraception she should inform the physician prescribing her contraception that she is taking Volibris. • That if a women of child-bearing potential needs to change or stop her method of contraception she should inform the physician prescribing Volibris. • The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant. • The need for the patient to discuss with her doctor if she is planning to become pregnant. • That Volibris may cause liver injury. • That because of the potential for liver injury and anaemia, patients should have regular blood tests and also tell their doctor if experiencing any symptoms of liver injury. • That the patient should not give Volibris to any other person. • That the patient should tell their doctor about any adverse event.