FrancophonIA/ELRC3.0 huggingface dataset:
English: You must not use TEPADINA during pregnancy.
Slovenian: Zdravila TEPADINA ne smete uporabljati med nosečnostjo.
English: Haematological diseases
Slovenian: Hematološke bolezni
English: TEPADINA is unstable in acid medium.
Slovenian: Zdravilo TEPADINA je nestabilno v kislem mediju.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: 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); neznani (ni mogoče oceniti iz razpoložljivih podatkov).
English: TEPADINA must be administered by a qualified healthcare professional as a 2-4 hours intravenous infusion via a central venous catheter.
Slovenian: Zdravilo TEPADINA mora aplicirati usposobljen zdravstveni delavec, in sicer kot intravensko infuzijo po centralnem venskem katetru, ki traja 2 do 4 ure.
English: From a microbiological point of view, the product should be used immediately after dilution.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po redčenju.
English: Studies in renally impaired patients have not been conducted.
Slovenian: Študije pri bolnikih z okvaro ledvic niso bile izvedene.
English: The administration of thiotepa has not been specifically investigated in elderly patients.
Slovenian: Uporaba tiotepe pri starejših bolnikih ni bila posebej raziskana.
English: In some cases, relapse rates of 35% and of 45% have been reported at 5 years and 6 years respectively.
Slovenian: V nekaterih primerih so za obdobji 5 in 6 let poročali o stopnjah ponovitve 35 oziroma 45 odstotkov.
English: Relapse: In all the reported conditioning regimens containing thiotepa, relapse rates at 12 to 57 months ranged from 33% to 57%.
Slovenian: Ponovitev bolezni: pri vseh režimih pripravljalnega zdravljenja s tiotepo, o katerih so poročali, so bile stopnje ponovitve v obdobju 12 do 57 mesecev med 33 in 57 %.
English: Disease Free Survival (DFS): With a follow-up of 36 to 57 months, DFS ranged from 46% to 70% in the reported studies.
Slovenian: Preživetje brez ponovitve bolezni : v obdobju 36 do 57 mesecev je bilo DFS med 46 in 70 % v študijah, o katerih so poročali.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Običajno se redčeno zdravilo ne hrani dlje kot v zgoraj navedenih pogojih, ko je zdravilo redčeno v nadzorovanih in validiranih aseptičnih pogojih.
English: In allogeneic HPCT, the conditioning treatment must be sufficiently immunosuppressive and myeloablative to overcome host rejection of the graft.
Slovenian: Pri alogenski PKMC mora biti pripravljalno zdravljenje zelo imunosupresivno in mieloablativno, da gostitelj ne zavrne presadka.
English: Precautions to be taken before handling or administering the medicinal product Topical reactions associated with accidental exposure to thiotepa may occur.
Slovenian: Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Lahko se pojavijo lokalne reakcije, povezane z nenamerno izpostavitvijo tiotepi.
English: As alkylating agent, thiotepa produces the most profound inhibition of tumour cell growth in vitro with the smallest increase in medicinal product concentration.
Slovenian: Tiotepa kot alkilirajoča učinkovina najbolj učinkovito zavira rast tumorskih celic in vitro z majhnim povečanjem koncentracije zdravila.
English: Side effects of TEPADINA may occur with certain frequencies, which are defined as follows:
Slovenian: Neželeni učinki zdravila TEPADINA se lahko pojavijo z določeno pogostnostjo, in sicer:
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): low values have been reported, confirming the safety of the conditioning treatments including thiotepa for allogeneic HPCT in adult patients with haematological diseases.
Slovenian: Z režimom povezana umrljivost in s presaditvijo povezana umrljivost: poročali so o nizkih vrednostih, kar potrjuje varnost pripravljalnih zdravljenj s tiotepo za alogensko PKMC pri odraslih bolnikih s hematološkimi boleznimi.
English: TEPADINA is administered by a qualified healthcare professional as an intravenous infusion (drip in a vein) after dilution of the individual vial.
Slovenian: Zdravilo TEPADINA vam bo dal usposobljen zdravstveni delavec, in sicer v obliki intravenske infuzije (kapalne infuzije v veno) po razredčenju posamezne viale.
English: Therefore, a clinical monitoring should be exercised during the concomitant use of thiotepa and these medicinal products.
Slovenian: Zato je treba bolnike pozorno klinično spremljati med sočasno uporabo tiotepe in teh zdravil.
English: Other medicines and TEPADINA
Slovenian: Druga zdravila in zdravilo TEPADINA
English: Considering that all patients were treated for high risk solid tumours, DFS results confirm that conditioning treatments containing thiotepa following autologous HPCT are effective therapeutic strategies for treating paediatric patients with solid tumours.
Slovenian: Ker so bili vsi bolniki zdravljeni zaradi čvrstih tumorjev z visokim tveganjem, rezultati potrjujejo, da so pripravljalna zdravljenja s tiotepo po avtologni PKMC učinkovite terapevtske strategije za zdravljenje pediatričnih bolnikov s čvrstimi tumorji.
English: TEPADINA must be delivered after the completion of any cyclophosphamide infusion (see section 4.5).
Slovenian: Zdravilo TEPADINA je treba odmeriti po zaključku infundiranja ciklofosfamida (glejte poglavje 4.5).
English: Respiratory arrest
Slovenian: - zastoj dihanja
English: Tabulated list of adverse reactions
Slovenian: Tabelarični zapis neželenih učinkov
English: Co-administration with inhibitors of CYP2B6 (for example clopidogrel and ticlopidine) or CYP3A4 (for example azole antifungals, macrolides like erythromycin, clarithromycin, telithromycin, and protease inhibitors) may increase the plasma concentrations of thiotepa and potentially decrease the concentrations of the active metabolite TEPA.
Slovenian: Sočasna uporaba z zaviralci CYP2B6 (na primer klopidogrelom in tiklopidinom) ali CYP3A4 (na primer azolni antimikotiki, makrolidi, kot so eritromicin, klaritromicin, telitromicin, ter zaviralci proteaz) lahko zviša koncentracijo tiotepe v plazmi in potencialno zniža koncentracije aktivnega presnovka tetraetilenpentamina (TEPA).
English: TEPADINA administration must be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Slovenian: Uporabo zdravila TEPADINA mora nadzorovati zdravnik z izkušnjami na področju pripravljalnega zdravljenja pred presaditvijo krvotvornih matičnih celic.
English: TEPADINA is administered at different doses, in combination with other chemotherapeutic medicinal products, in patients with haematological diseases or solid tumours prior to HPCT.
Slovenian: Zdravilo TEPADINA se uporablja v različnih odmerkih, v kombinaciji z drugimi kemoterapevtiki, pri bolnikih z hematološkimi boleznimi ali čvrstimi tumorji pred PKMC.
English: The concomitant use of thiotepa and other myelosuppressive or myelotoxic agents (i.e. cyclophosphamide, melphalan, busulfan, fludarabine, treosulfan) may potentiate the risk of haematologic adverse reactions due to overlapping toxicity profiles of these medicinal products.
Slovenian: Sočasna uporaba tiotepe in drugih mielosupresivnih ali mielotoksičnih učinkovin (tj. ciklofosfamid, melfalan, busulfan, fludarabin, treosulfan) lahko poveča tveganje neželenih hematoloških učinkov zaradi prekrivajočih se profilov toksičnosti teh zdravil.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila TEPADINA Vsebina pakiranja in dodatne informacije
English: DFS results confirm that conditioning treatment containing thiotepa following allogeneic HPCT are effective therapeutic strategies for treating paediatric patients with haematological diseases.
Slovenian: Rezultati DFS potrjujejo, da so pripravljalna zdravljenja s tiotepo po alogenski PKMC učinkovite terapevtske strategije za zdravljenje pediatričnih bolnikov s hematološkimi boleznimi.
English: After reconstitution and dilution
Slovenian: Po rekonstituciji in redčenju
English: Co-administration of inducers of cytochrome P450 (such as rifampicin, carbamazepine, phenobarbital) may increase the metabolism of thiotepa leading to increased plasma concentrations of the active metabolite.
Slovenian: Sočasna uporaba induktorjev citokroma P450 (kot so rifampicin, karbamazepin, fenobarbital) lahko zveča presnovo tiotepe, kar privede do zvišane koncentracije aktivnega presnovka v plazmi.
English: The adverse reactions considered at least possibly related to conditioning treatment including thiotepa, reported in adult patients as more than an isolated case, are listed below by system organ class and by frequency.
Slovenian: Neželeni učinki, ki so vsaj potencialno povezani s pripravljalnim zdravljenjem, ki vključuje tiotepo, in o katerih so poročali pri odraslih bolnikih o več kot le o posameznem primeru, so navedeni spodaj glede na organski sistem in pogostnost.
English: Thiotepa undergoes oxidative desulphuration via the cytochrome P450 CYP2B and CYP3A isoenzyme families to the major and active metabolite TEPA (triethylenephosphoramide).
Slovenian: Tiotepa se oksidativno desulfurira prek izoencimov CYP3A4 in CYP3A citokroma P450 v poglavitni in aktivni metabolit TEPA (trietilenfosforamid).
English: Therefore, the use of gloves is recommended in preparing the solution for infusion.
Slovenian: Zato je pri pripravi raztopine za infundiranje priporočljiva uporaba rokavic.
English: Disease Free Survival (DFS): Percentages of 40% - 75% with follow-up of more than 1 year have been reported.
Slovenian: Preživetje brez ponovitve bolezni : poročali so o odstotkih med 40 in 75 % za obdobje več kot enega leta.
English: Cardiovascular insufficiency Cardiac failure
Slovenian: Srčne bolezni zastoj srca kardiovaskularna insuficienca odpoved srca
English: Since thiotepa is mainly metabolized through the liver, caution needs to be exercised when thiotepa is used in patients with preexisting impairment of liver function, especially in those with severe hepatic impairment.
Slovenian: Ker se tiotepa presnavlja predvsem v jetrih, je potrebna previdnost, ko se tiotepa uporablja pri bolnikih s predhodno obstoječo okvaro jetrne funkcije, zlasti pri bolnikih s hudo okvaro jeter.
English: Contraindications of concomitant use Yellow fever vaccine: risk of fatal generalized vaccine-induced disease.
Slovenian: Kontraindicirana sočasna uporaba Cepivo proti rumeni mrzlici: tveganje generalizirane, s cepivom sprožene bolezni s smrtnim izidom.
English: Overall Survival (OS): OS ranged from 50% to 100% with a follow-up ranging from 9.4 up to 121 months.
Slovenian: Celokupno preživetje: celokupno preživetje je bilo med 50 % in 100 % v obdobju med 9,4 in 121 meseci.
English: Thiotepa is unreliably absorbed from the gastrointestinal tract: acid instability prevents thiotepa from being administered orally.
Slovenian: Tiotepa se iz prebavil slabo absorbira: zaradi nestabilnosti v kislem mediju se tiotepe ne uporablja peroralno.
English: TEPADINA contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents.
Slovenian: Zdravilo TEPADINA vsebuje učinkovino tiotepa, ki spada v skupino zdravil, imenovanih alkilirajoče učinkovine.
English: The adverse reactions considered at least possibly related to conditioning treatment including thiotepa, reported in paediatric patients as more than an isolated case, are listed below by system organ class and by frequency.
Slovenian: Neželeni učinki, ki so vsaj potencialno povezani s pripravljalnim zdravljenjem, ki vključuje tiotepo, in o katerih so poročali pri pediatričnih bolnikih o več kot le o posameznem primeru, so navedeni spodaj glede na organski sistem in pogostnost.
English: TEPADINA is administered at different doses in combination with other chemotherapeutic medicinal products in patients prior to conventional haematopoietic progenitor cell transplantation (HPCT) for haematological diseases or solid tumours.
Slovenian: Zdravilo TEPADINA se uporablja v različnih odmerkih, v kombinaciji z drugimi kemoterapevtiki, pri bolnikih pred konvencionalno presaditvijo krvotvornih matičnih celic (PKMC) za hematološke bolezni ali čvrste tumorje.
English: Caution must be used in patients with history of cardiac diseases, and cardiac function must be monitored regularly in patients receiving thiotepa.
Slovenian: Previdnost je potrebna pri bolnikih z anamnezo srčnih bolezni, pri bolnikih, ki prejemajo tiotepo, pa je treba redno spremljati delovanje srca.
English: Leukoencephalopathy
Slovenian: Levkoencefalopatija
English: Engraftment: It has been achieved with all reported conditioning regimens including thiotepa.
Slovenian: Sprejem presadka: dosežen je bil pri vseh režimih pripravljalnega zdravljenja s tiotepo, o katerih so poročali.
English: - The active substance is thiotepa.
Slovenian: - Učinkovina je tiotepa.
English: Thiotepa was shown to impair fertility and interfere with spermatogenesis in male mice, and to impair ovarian function in female mice.
Slovenian: Tiotepa vpliva na plodnost in sicer pri mišjih samcih na spermatogenezo ter pri mišjih samicah na funkcije jajčnikov.
English: Calculation of dose of TEPADINA
Slovenian: Izračun odmerka zdravila TEPADINA
English: The most serious side effects of TEPADINA therapy or the transplant procedure may include - decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion) - infection - liver disorders including blocking of a liver vein - the graft attacks your body (graft versus host disease) - respiratory complications
Slovenian: Najbolj resni neželeni učinki zdravljenja z zdravilom TEPADINA ali postopka presaditve lahko vključujejo: - zmanjšanje števila krvnih celic v obtoku (pričakovan učinek zdravila, ki vas pripravi na transplantacijsko infuzijo) - okužbo
English: The increased risk of a secondary malignancy with thiotepa, a known carcinogen in humans, must be explained to the patient.
Slovenian: Bolnika je treba obvestiti, da s tiotepo, znano karcinogeno snovjo pri ljudeh, obstaja povečano tveganje sekundarnega malignega obolenja.
English: TEPADINA must be delivered after the completion of any cyclophosphamide infusion.
Slovenian: Zdravilo TEPADINA je treba odmeriti po zaključku infundiranja ciklofosfamida.
English: MULTIPLE MYELOMA
Slovenian: MULTIPLI MIELOM
English: If thiotepa solution accidentally contacts the skin, the skin must be immediately and thoroughly washed with soap and water.
Slovenian: Če raztopina tiotepe nenamerno pride v stik s kožo, kožo nemudoma in temeljito umijte z milom in vodo.
English: LEUKAEMIA
Slovenian: LEVKEMIJA
English: The consequence of treatment with thiotepa at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Slovenian: Posledica zdravljenja s tiotepo s priporočenim odmerkom in režimom odmerjanja je močna mielosupresija pri vseh bolnikih.
English: OVARIAN CANCER
Slovenian: RAK JAJČNIKOV
English: Store and transport refrigerated (2°C-8°C).
Slovenian: Zdravilo shranjujte in prevažajte v hladilniku (2 °C-8 °C).
English: Thiotepa is a polyfunctional cytotoxic agent related chemically and pharmacologically to the nitrogen mustard.
Slovenian: Mehanizem delovanja Tiotepa je večfunkcijska citotoksična snov, kemijsko in farmakološko sorodna dušikovemu iperitu.
English: Type I clear glass vial with a rubber stopper (bromobutyl or chlorobutyl), containing 15 mg thiotepa.
Slovenian: Viala iz prozornega stekla tipa I z gumijastim zamaškom (bromobutil ali klorobutil), ki vsebuje 15 mg tiotepe.
English: As most alkylating agents, thiotepa might impair male and female fertility.
Slovenian: Kot večina alkilirajočih učinkovin lahko tiotepa zmanjša plodnost pri moških in ženskah.
English: Overall Survival (OS): OS ranged from 17% to 84% with a follow-up ranging from 12.3 up to 99.6 months.
Slovenian: Celokupno preživetje: celokupno preživetje je bilo med 17 % in 84 % v obdobju med 12,3 in 99,6 meseci.
English: Uncommon Not known
Slovenian: Neznana pogostnost
English: Relapse: In all the reported conditioning regimens containing thiotepa, the relapse rate was in the range of 15% - 44%.
Slovenian: Ponovitev bolezni: pri vseh režimih pripravljalnega zdravljenja s tiotepo, o katerih so poročali, je bila stopnja ponovitve med 15 in 44 odstotki.
English: Thiotepa must not be concurrently administered with cyclophosphamide when both medicinal products are present in the same conditioning treatment.
Slovenian: Tiotepe se ne sme uporabljati hkrati s ciklofosfamidom, če sta obe zdravili prisotni v istem pripravljalnem zdravljenju.
English: TEPADINA infusion solution should be inspected visually for particulate matter prior to administration.
Slovenian: Raztopino za infundiranje zdravila TEPADINA je treba pred uporabo vizualno pregledati glede delcev.
English: How to use TEPADINA
Slovenian: Kako uporabljati zdravilo TEPADINA
English: Interaction common to all cytotoxics
Slovenian: Interakcije, skupne vsem citotoksičnim učinkovinam
English: Platelet and red blood cell support, as well as the use of growth factors such as Granulocytecolony stimulating factor (G-CSF), should be employed as medically indicated.
Slovenian: Kadar so prisotne zdravstvene indikacije, je treba nuditi trombocitno in eritrocitno podporo ter uporabiti rastne faktorje, kot je granulocitne kolonije stimulirajoči faktor (G-CSF: Granulocyte-colony stimulating factor).
English: CSF and plasma concentrations of TEPA, the first reported active metabolite of thiotepa, exceed the concentrations of the parent compound.
Slovenian: Koncentracije TEPA, prvega aktivnega metabolita tiotepe, o katerem so poročali, v CSF in plazmi , so večje od koncentracij matične spojine.
English: Frequent complete blood counts, including differential white blood cell counts, and platelet counts need to be performed during the treatment and until recovery is achieved.
Slovenian: Med zdravljenjem in do okrevanja je treba izvajati pogoste preglede celotne krvne slike, vključno z diferencialno sliko belih krvnih celic in številom trombocitov.
English: There is no experience with overdoses of thiotepa.
Slovenian: Izkušenj s prevelikim odmerjanjem tiotepe ni.
English: Type I clear glass vial with a rubber stopper (bromobutyl or buthyl), containing 100 mg thiotepa.
Slovenian: Viala iz prozornega stekla tipa I z gumijastim zamaškom (bromobutil ali butil), ki vsebuje 100 mg tiotepe.
English: Therefore, during the concomitant use of thiotepa and these medicinal products, patients should be carefully monitored clinically.
Slovenian: Zato je treba bolnike med sočasno uporabo tiotepe in teh zdravil klinično nadzorovati.
English: Caution must be used in patients with history of renal diseases and periodic monitoring of renal function should be considered during therapy with thiotepa.
Slovenian: Previdnost je potrebna pri bolnikih z anamnezo ledvičnih bolezni, med zdravljenjem s tiotepo pa je treba redno spremljati delovanje ledvic.
English: Concomitant use to take into consideration Ciclosporine, tacrolimus: excessive immunosuppression with risk of lymphoproliferation.
Slovenian: Ciklosporin, takrolimus: čezmerna imunosupresija s tveganjem limfoproliferacije.
English: Treatment related second malignancy
Slovenian: z zdravljenjem povezana sekundarna malignost
English: Topical reactions associated with accidental exposure to thiotepa may occur.
Slovenian: Lahko se pojavijo lokalne reakcije, povezane z nenamerno izpostavitvijo tiotepi.
English: Prior to and following each infusion, the indwelling catheter line should be flushed with approximately 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Pred in po vsakem infudiranju je treba stalni kateter izprati s približno 5 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Severe toxic skin reactions including cases of StevensJohnson syndrome and toxic epidermal necrolysis
Slovenian: Hude toksične reakcije kože, vključno s primeri Stevens
English: Engraftment: Conditioning treatments including thiotepa have proved to be myeloablative.
Slovenian: Sprejem presadka: pripravljalna zdravljenja s tiotepo so se izkazala za mieloablativna.
English: Male patients should seek for sperm preservation before therapy is started and should not father a child while treated and during the year after cessation of treatment.
Slovenian: Moški bolniki naj poskrbijo za shranjevanje sperme pred začetkom terapije, med zdravljenjem in leto dni po prenehanju zdravljenja pa naj ne spočnejo otroka.
English: After reconstitution the product is stable for 8 hours when stored at 2°C -8°C.
Slovenian: Po rekonstituciji je zdravilo stabilno 8 ur, če je shranjeno pri temperaturi 2 °C-8 °C.
English: Cardiomyopathy Myocarditis
Slovenian: - vnetje srčnega mišičnega tkiva (miokarditis)
English: Because TEPADINA destroys bone marrow cells responsible for producing blood cells, regular blood tests will be taken during treatment to check your blood cell counts.
Slovenian: Ker zdravilo TEPADINA uničuje celice kostnega mozga, ki so odgovorne za proizvodnjo krvnih celic,
English: What TEPADINA looks like and contents of the pack
Slovenian: Izgled zdravila TEPADINA in vsebina pakiranja
English: Thiotepa has marrow ablation as its dose-limiting toxicity, allowing significant dose escalation with the infusion of autologous HPCT.
Slovenian: Toksični učinek tiotepe, odvisen od odmerka, je ablacija mozga, kar omogoča precejšnje stopnjevanje odmerka z infundiranjem avtologne PKMC.
English: It was teratogenic in mice and in rats, and foeto-lethal in rabbits.
Slovenian: Je teratogena pri miših in podganah.
English: In children, if the dose is lower than 250 mg, an appropriate volume of sodium chloride 9 mg/ml (0.9%) solution for injection may be used in order to obtain a final TEPADINA concentration between 0.5 and 1 mg/ml.
Slovenian: Pri otrocih, pri katerih je odmerek manjši od 250 mg, pripravite ustrezno količino raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, s katero zagotovite končno koncentracijo zdravila TEPADINA med 0,5 in 1 mg/ml.
English: Nervous system disorders
Slovenian: TUMOR OSREDNJEGA ŽIVČNEGA SISTEMA
English: Male patients should seek for sperm cryopreservation before therapy is started and should not father a child while treated and during the year after cessation of treatment (see section 5.3).
Slovenian: Moški bolniki naj poskrbijo za shranjevanje sperme z zamrznitvijo pred začetkom zdravljenja, med zdravljenjem in leto dni po prenehanju zdravljenja pa naj ne spočnejo otroka (glejte poglavje 5.3).
English: You should tell your doctor if you have: - liver or kidney problems, - heart or lung problems, - seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin).
Slovenian: Obvestite svojega zdravnika, če imate: - jetrne ali ledvične težave; - težave s srcem ali pljuči;
English: It works by destroying bone marrow cells.
Slovenian: Zdravilo uniči celice kostnega mozga.
English: As with other cytotoxic compounds, caution need to be exercised in handling and preparation of TEPADINA solutions to avoid accidental contact with skin or mucous membranes.
Slovenian: Kot pri drugih citotoksičnih spojinah morate biti pri ravnanju z zdravilom TEPADINA in pripravi raztopin zdravila TEPADINA previdni, da se izognete nenamernim stikom s kožo ali sluznico.
English: Male patients should seek for sperm cryopreservation before therapy is started and should not father a child while treated and during the year after cessation of treatment (see section 4.6).
Slovenian: Moški bolniki naj poskrbijo za shranjevanje sperme z zamrznitvijo pred začetkom zdravljenja, med zdravljenjem in leto dni po prenehanju zdravljenja pa naj ne spočnejo otroka (glejte poglavje 4.6).