natgillin/translations-raw huggingface dataset:
A female patient or a female partner of a male patient is considered of non-childbearing potential if she meets at least one of the following criteria:
Za bolnico ali partnerico moškega bolnika velja, da ne more zanositi, če izpolnjuje vsaj eno od naslednjih meril:
• Description of the PPP
• opis PPN,
Pomalidomide also inhibits angiogenesis by blocking the migration and adhesion of endothelial cells.
Pomalidomid zavira tudi angiogenezo, tako da blokira migracijo in adhezijo endotelijskih celic.
• you have or have had neuropathy (nerve damage causing tingling or pain in your hands or feet).
• imate ali ste imeli nevropatijo (okvaro živcev, ki povzroča ščemenje ali bolečine v rokah ali nogah);
If affected, patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with pomalidomide.
Prizadete bolnike je treba poučiti, naj ne vozijo avtomobila, upravljajo strojev ali opravljajo nevarnih del, medtem ko se zdravijo s pomalidomidom.
Neutropenia*
Nevtropenija*
Your doctor will advise you of how and when to take Imnovid if you have kidney problems and are receiving dialysis treatment.
Zdravnik vam bo svetoval, kako in kdaj jemljite zdravilo Imnovid, če imate težave z ledvicami in vas zdravijo z dializo.
The p-value is based on a stratified log-rank test with the same stratification factors as the above Cox model.
Vrednost p temelji na stratificiranem testu log-rank z enakimi stratifikacijskimi faktorji kot zgornji Coxov model.
Your doctor may recommend you take additional treatments (e.g. warfarin) or lower the dose of Imnovid to reduce the chance that you get blood clots.
Vaš zdravnik vam lahko priporoča dodatno zdravljenje (npr. varfarin) ali nižje odmerke zdravila Imnovid, da zmanjša možnost nastanka krvnih strdkov;
• Need for effective contraception and definition of effective contraception
• potrebo po zanesljivi kontracepciji in opredelitev zanesljive kontracepcije,
• certain antidepressants such as fluvoxamine.
• nekatere antidepresive, na primer fluvoksamin.
Median OS time from Kaplan-Meier estimates has not been reached for the Pom + LD-Dex, but would be expected to be at least 48 weeks, which is the lower boundary of the 95% CI.
Mediana časa celokupnega preživetja po oceni Kaplan-Meier ni bila dosežena za POM + NO-deks, vendar bi po pričakovanjih trajala vsaj 48 tednov, kar je spodnja meja 95 % IZ.
This can result in kidney problems.
To lahko povzroči težave z ledvicami.
• She understands the expected teratogenic risk to the unborn child
• razume pričakovano tveganje za teratogene učinke pri nerojenem otroku,
• Male patients unable to follow or comply with the required contraceptive measures (see section 4.4).
• moški bolniki, ki niso sposobni slediti zahtevanim kontracepcijskim ukrepom ali ravnati v skladu z njimi (glejte poglavje 4.4),
No metabolites were present at >10% relative to parent or total radioactivity in plasma.
Presnovki niso bili prisotni z > 10 % glede na izhodno ali skupno radioaktivnost v plazmi.
• Loss of consciousness, fainting.
• izguba zavesti, omedlevica,
• The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding
• bolnica upošteva vse pogoje programa za preprečevanje nosečnosti, vključno s potrditvijo, da jih ustrezno razume,
Died n (%)
Umrli n (%)
A dose modification may be required (see section 4.2).
Odmerek bo morda treba prilagoditi (glejte poglavje 4.2).
• Previous bilateral salpingo-oophorectomy, or hysterectomy
• predhodna bilateralna salpingo-ooforektomija ali histerektomija,
The predominant metabolic pathways of excreted radioactivity are hydroxylation with subsequent glucuronidation, or hydrolysis.
Prevladujoča presnovna pot izločene radioaktivnosti je hidroksilacija s sledečo glukuronidacijo ali hidroliza.
Details of the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
O podrobnostih PPN se je treba dogovoriti s pristojnimi nacionalnimi organi v vsaki državi članici in program uvesti pred prihodom zdravila na trg.
Also some other medicines can affect the way Imnovid works.
Tudi nekatera druga zdravila lahko vplivajo na način delovanja zdravila Imnovid.
Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Bolnikom je treba naročiti, da poiščejo zdravniško pomoč, če se razvijejo simptomi, kot so zasoplost, bolečine v prsnem košu, oteklost rok ali nog.
For male patients taking pomalidomide, pharmacokinetic data has demonstrated that pomalidomide is present in human semen during treatment.
Za moške bolnike, ki jemljejo pomalidomid, so farmakokinetični podatki pokazali, da je pomalidomid med zdravljenjem prisoten v človeški spermi.
Use diuretics as needed and decrease dose by one dose level.
Uporabite diuretike, kot je potrebno, in odmerek zmanjšajte za eno raven.
Anticoagulation therapy (unless contraindicated) is recommended (see section 4.4).
Priporočljivo je antikoagulacijsko zdravljenje (razen če je kontraindicirano) (glejte poglavje 4.4).
It is also a substrate for P-glycoprotein.
Je tudi substrat za P-glikoprotein.
In monkeys, pomalidomide was evaluated in repeat-dose studies of up to 9 months in duration.
Pri opicah so pomalidomid ocenjevali v do 9 mesecev trajajočih študijah s ponavljajočim odmerkom.
In vitro binding of pomalidomide enantiomers to proteins in human plasma ranges from 12% to 44% and is not concentration dependent.
Razpon vezave enantiomerov pomalidomida in vitro na beljakovine v plazmi pri človeku je med 12 % do 44 % in ni odvisen od koncentracije.
Patients with serum total bilirubin > 1.5 x ULN (upper limit of normal range) were excluded from clinical studies.
Bolniki s skupnim bilirubinom v serumu > 1.5 x zgornja meja normalnega območja (ULN - upper limit of normal range) so bili izključeni iz kliničnih študij.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
95% CI about the median.
95 % IZ okrog mediane.
Following multiple doses, pomalidomide has an accumulation ratio of 27 to 31% on AUC.
Po večkratnem odmerjanju je razmerje kopičenja pomalidomida 27 do 31 % na AUC.
The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and /or dispensing controls, and the collection of detailed data relating to the indication in order to monitor the off-label use within the national territory.
Nadzorovani sistem razdeljevanja vključuje uporabo kartice za bolnika in/ali enakovredno orodje za nadzor predpisovanja in izdajanja in zbiranje podrobnih podatkov v zvezi z indikacijo zaradi natančnega nadzora nenamenske uporabe znotraj nacionalnega območja.
Educational materials, prescribing and dispensing restrictions
Izobraževalna gradiva, omejitve glede predpisovanja in izdajanja
When treated males on this study were mated with untreated females, all uterine parameters were comparable to the controls.
Pri parjenju zdravljenih samcev v tej študiji z nezdravljenimi samicami so bili vsi parametri v maternici primerljivi s kontrolami.
You must follow the Imnovid Pregnancy Prevention Programme.
Upoštevati morate program za preprečevanje nosečnosti za zdravilo Imnovid.
Effect of other medicinal products on pomalidomide
Učinek drugih zdravil na pomalidomid
The capsules should be swallowed whole, preferably with water, with or without food.
Kapsule je treba zaužiti cele, najbolje z vodo, s hrano ali brez nje.
Btz = bortezomib; CI = Confidence interval; CR = Complete response; DoR = Duration of response; HR = Hazard Ratio; LD-Dex = low-dose dexamethasone; OR = Odds ratio; ORR = Overall response rate; PFS = Progression free survival; POM = pomalidomide; PR = Partial Response; sCR = Stringent complete response VGPR = Very good partial response.
Btz = bortezomib; IZ = interval zaupanja; CR = popolni odziv (complete response); DoR = trajanje odziva (duration of response); HR = razmerje tveganja (hazard ratio); NO-deks = nizkoodmerni deksametazon; OR = razmerje verjetnosti (odds ratio); ORR = celotna odzivnost (overall response rate); PFS = preživetje brez napredovanja (progression free survival); POM = pomalidomid; PR = delen odziv (partial response); sCR = prepričljiv popoln odziv (stringent complete response); VGPR = zelo dober delen odziv (very good partial response).
• She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
• mora biti obveščena ter razumeti možne posledice nosečnosti in potrebo po takojšnjem posvetu, če obstaja tveganje za zanositev,
Cycle 1-8
Cikel 1-8
Patients at greatest risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Bolniki z največjim tveganjem za sindrom tumorske lize so tisti, ki so imeli pred zdravljenjem največje tumorsko breme.
Treat with insulin or oral hypoglycaemic agents as needed.
Zdravite z insulinom ali peroralnimi hipoglikemičnimi zdravili po potrebi.
Pomalidomide (4 mg) Bortezomib (1.3 mg/m2) Dexamethasone (20 mg) * • •
pomalidomid (4 mg) bortezomib (1,3 mg/m2) deksametazon (20 mg) * • •
How much Imnovid to take with other medicines
Koliko zdravila Imnovid vzeti z drugimi zdravili
• Feeling confused.
• občutek zmedenosti,
This is because Imnovid can affect the way some other medicines work.
Zdravilo Imnovid lahko vpliva na način delovanja nekaterih drugih zdravil.
• Inability to pass urine.
• nezmožnost odvajanja urina,
Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups.
Na podlagi modela sorazmernih ogroženosti po Coxu s primerjavo funkcij tveganja, povezanih z zdravljenimi skupinami.
Pomalidomide binds directly to the protein cereblon (CRBN), which is part of an E3 ligase complex that includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4 (CUL4), and regulator of cullins-1 (Roc1), and can inhibit the auto-ubiquitination of CRBN within the complex.
Pomalidomid se veže neposredno na beljakovino cereblon (CRBN), ki je del kompleksa ligaze E3, ki vključuje beljakovino, ki se veže na poškodbe deoksiribonukleinske kisline (DDB1 - DNA damagebinding protein 1-), kulin 4 (CUL4) in kulinski regulator 1 (Roc1- regulator of cullins-1), in lahko inhibira avto-ubikvitinacijo CRBN v kompleksu.
Pomalidomide is partly metabolised by CYP1A2 and CYP3A4/5.
Pomalidomid delno presnavljata encima CYP1A2 in CYP3A4/5.
In clinical studies, patients received prophylactic acetylsalicylic acid or alternative antithrombotic therapy.
V kliničnih študijah so bolniki profilaktično prejemali acetilsalicilno kislino ali alternativno antitrombotično zdravljenje.
• Swelling of face, lips, tongue and throat, which may cause difficulty breathing (due to a serious type of allergic reaction called angioedema).
• otekanje obraza, ustnic, jezika in žrela, ki lahko povzroči težave z dihanjem (zaradi hude vrste alergijske reakcije, imenovane angioedem);
Confusion or mood alteration ≥ Grade 2
Zmedenost ali spremenjeno razpoloženje ≥ 2. stopnje
A teratogenic effect of pomalidomide in humans is expected.
Pričakuje se teratogeni učinek pomalidomida pri ljudeh.
If you forget to take Imnovid
Če ste pozabili vzeti zdravilo Imnovid
The effect of dexamethasone on warfarin is unknown.
Učinek deksametazona na varfarin ni znan.
Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Bolnikom in zdravnikom je treba svetovati, da opazujejo pojav znakov in simptomov trombembolije.
Your doctor will advise if you should stop or continue breast-feeding.
Vaš zdravnik vam bo svetoval, ali naj z dojenjem prenehate ali nadaljujete.
VTE was reported as serious in 1.7-4.3% of patients, no fatal reactions were reported, and VTE was associated with pomalidomide discontinuation in up to 1.8% of patients.
O resnih VTE so poročali pri 1,7-4,3 % bolnikov, o smrtnih primerih niso poročali, VTE pa so bili povezani z ukinitvijo pomalidomida pri do 1,8 % bolnikov.
The doctor may also change the dose or stop the medicine because of your general health.
Odmerek lahko zdravnik spremeni ali prekine uporabo zdravila tudi zaradi vašega splošnega stanja.
Other medicines and Imnovid
Druga zdravila in zdravilo Imnovid
Women of childbearing potential should use effective method of contraception.
Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijsko metodo.
• Do not take this medicine if you are pregnant or could become pregnant.
Ne jemljite tega zdravila, če ste noseči ali lahko zanosite.
Evaluation of recovery animals indicated that all treatment-related findings were reversible after 8 weeks of dosing cessation, except for proliferation of intrahepatic bile ducts observed in 1 animal in the 1 mg/kg/day group.
Ocenitev živali, ki so okrevale, je pokazala, da so bili vsi izsledki, povezani z zdravljenjem, reverzibilni v 8 tednih od prenehanja odmerjanja, razen proliferacije intrahepatičnga žolčevoda, kar so opazili pri 1 živali v skupini z odmerkom 1 mg/kg/dan.
The Direct Healthcare Professional Communication shall consist of two parts:
Neposredno obvestilo za zdravstvene delavce naj sestoji iz dveh delov:
Censored n (%)
Cenzurirano n (%)
Such patients may be at higher risk of hypersensitivity reactions and should not receive pomalidomide.
Pri takih bolnikih je morda tveganje za preobčutljivostne reakcije večje in ne smejo dobivati pomalidomida.
The primary toxicities observed in monkeys were associated with the haematopoietic/lymphoreticular systems.
Primarne toksičnosti, ki so jih opazili pri opicah, so bile povezane s hematopoetskim/limforetikularnim sistemom.
• National or other applicable specific arrangements for a prescription for pomalidomide to be dispensed
• nacionalne in druge ustrezne dogovore glede predpisovanja in izdajanja pomalidomida;
Decrease dose by one dose level.
Odmerek zmanjšajte za eno raven.
The majority of patients were male (59%) and white (79%); the median age for the overall population was 64 years (min, max: 35, 87 years).
Večina bolnikov je bila moških (59 %) in belcev (79 %); mediana starost celotne populacije je bila 64 let (min, maks: 35, 87 let).
Based on the results of both PFS and OS endpoints, the Data Monitoring Committee established for this study recommended that the study be completed and patients in the HD-Dex arm be crossed over to the Pom + LD-Dex arm.
Na podlagi rezultatov obeh končnih ciljev PFS in celokupnega preživetja je Odbor za spremljanje podatkov (Data Monitoring Committee) za to študijo priporočil, da se zaključi, bolnike iz skupine VOdeks pa se priključi skupini POM + NO-deks.
Significant cardiac dysfunction
Pomembna motnja v delovanju srca
Date of first authorisation: 05 August 2013 Date of latest renewal: 11 July 2018
Datum zadnjega podaljšanja: 11. julij 2018
Patients with significant cardiac dysfunction (congestive heart failure [NY Heart Association Class III or IV]; myocardial infarction within 12 months of starting study; unstable or poorly controlled angina pectoris) were excluded from clinical studies with pomalidomide.
Bolniki s pomembno motnjo v delovanju srca (kongestivno srčno popuščanje [razred III ali IV po razvrstitvi NYHA]; miokardni infarkt v 12 mesecih od začetka študije; nestabilna ali slabo nadzirana angina pektoris) so bili iz kliničnih študij s pomalidomidom izključeni.
• Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential)
• starost ≥ 50 let in naravna amenoreja ≥ 1 leto (amenoreja po zdravljenju raka ali med dojenjem ne izključuje zmožnosti zanositve),
Coadministration with a high-fat and high-calorie meal slows the rate of absorption, decreasing mean plasma Cmax by approximately 27%, but has minimal effect on the overall extent of absorption with an 8% decrease in mean AUC.
Sočasno dajanje z obrokom z visoko vsebnostjo maščob ali z visokokaloričnim obrokom upočasni hitrost absorpcije, zniža srednjo Cmax v plazmi za približno 27 %, vendar ima minimalni učinek na splošni obseg absorpcije z 8 % znižanjem srednje AUC.
Anticoagulation therapy (unless contraindicated) is recommended, (such as acetylsalicylic acid, warfarin, heparin or clopidogrel), especially in patients with additional thrombotic risk factors.
Priporoča se antikoagulacijsko zdravljenje (razen kjer je kontraindicirano) (kot so acetilsalicilna kislina, varfarin, heparin ali klopidogrel), zlasti pri bolnikih z dodatnimi dejavniki tveganja za trombozo.
If you notice any changes to your skin whilst taking Imnovid, tell your doctor as soon as possible.
Če opazite kakršne koli spremembe na koži, medtem ko jemljete zdravilo Imnovid, to čimprej povejte zdravniku;
The test should ensure the patient is not pregnant when she starts treatment with pomalidomide.
Test mora zagotavljati, da bolnica ob začetku zdravljenja s pomalidomidom ni noseča.
Strong CYP1A2 inhibitors
Močni zaviralci CYP1A2
Interrupt pomalidomide treatment for remainder of cycle.
Prekinite zdravljenje s pomalidomidom za preostali del cikla.
• National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o To ensure that all appropriate measures have been performed prior to pomalidomide being dispensed
• za državo značilnih zahtev, po dogovoru s pristojnim nacionalnim organom, glede: o distribucije zdravila, o zagotovitve izvajanja vseh ustreznih ukrepov pred izdajanjem pomalidomida.
Progression free survival (PFS), N Censored, n (%)
Preživetje brez napredovanja (PFS), N Cenzurirano, n (%)
In the presence of pomalidomide in vitro, substrate proteins Aiolos and Ikaros are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects.
V prisotnosti pomalidomida in vitro sta substratni beljakovini Aiolos in Ikaros tarči ubikvitinacije in poznejše degradacije, kar vodi v neposredne citotoksične in imunomodulatorne učinke.
It is important to note that patients with multiple myeloma treated with pomalidomide may develop additional types of cancer, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed this medicine.
Pomembno je opomniti, da se lahko pri bolnikih z diseminiranim plazmocitomom, ki so zdravljeni s pomalidomidom, razvijejo dodatne vrste raka, zato mora zdravnik, ki zdravilo predpiše, skrbno oceniti koristi in tveganja.
There have also been cases of hepatitis that resulted in discontinuation of pomalidomide.
Prišlo je tudi do primerov hepatitisa, ki so privedli do ukinitve zdravljenja s pomalidomidom.
• Description of the patient card and its necessity
• opis kartice za bolnika in razlago, zakaj je potrebna;
Pomalidomide is present in human semen.
Pomalidomid je prisoten v spermi.
Pomalidomide must be discontinued for exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected, and should not be resumed following discontinuation for these reactions.
Pomalidomid je treba ukiniti pri eksfoliativnem ali buloznem izpuščaju ali če posumimo na SJS, TEN ali DRESS in ga po ukinitvi zaradi teh reakcij ne smemo spet začeti dajati.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake "EXP".
• If your partner is pregnant or able to become pregnant, you must use condoms for the whole time you are taking treatment and for 7 days after the end of treatment.
• Če je vaša partnerica noseča ali lahko zanosi, morate uporabljati kondome ves čas jemanja zdravila in še 7 dni po koncu zdravljenja.
In vitro, CYP1A2 and CYP3A4 were identified as the primary enzymes involved in the CYP-mediated hydroxylation of pomalidomide, with additional minor contributions from CYP2C19 and CYP2D6.
In vitro sta bila encima CYP1A2 in CYP3A4 opredeljena kot primarna encima, ki sodelujeta v hidroksilaciji pomalidomida, ki jo posreduje encim CYP, z dodatnimi manjšimi prispevki encimov CYP2C19 in CYP2D6.
A total of 455 patients were enrolled in the study: 302 in the Pom+LD-Dex arm and 153 in the HD-Dex arm.
V študijo je bilo vključenih skupaj 455 bolnikov: 302 v skupino POM + NO-deks in 153 v skupino VO-deks.
Patients should be monitored for haematological adverse reactions, especially neutropenia.
Bolnike je treba spremljati za hematološke neželene učinke, zlasti nevtropenijo.
Discontinue dexamethasone from treatment regimen.
Izpustite deksametazon iz režima zdravljenja.
Close monitoring of warfarin concentration is advised during treatment.
Zato je med zdravljenjem priporočeno pozorno spremljati koncentracijo varfarina.
Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called the ‘plasma cell').
Diseminirani plazmocitom je vrsta raka, ki prizadene določeno vrsto belih krvnih celic (imenovanih "plazmatke").
Physicians should observe patients for signs of bleeding including epistaxes, especially with use of concomitant medicinal products known to increase the risk of bleeding (see section 4.8).
Zdravniki morajo bolnike nadzirati glede znakov krvavitve, vključno z epistaksami, zlasti ob sočasni uporabi zdravil, za katera je znano, da povečujejo tveganje za krvavitve (glejte poglavje 4.8).
Pomalidomide was found to impact negatively on fertility and be teratogenic in animals.
Ugotovili so, da pomalidomid negativno vpliva na plodnost in je pri živalih teratogen.
Follow CBC*** weekly.
Tedensko spremljajte CKS***.
Day IMN BOR DEX
Dan IMN BOR deks
• Infections of the lungs (pneumonia and bronchitis).
• okužbe pljuč (pljučnica in bronhitis),
However, if you are over 75, the recommended starting dose is 10 mg per day.
Če ste starejši od 75 let, pa je priporočeni začetni odmerek 10 mg na dan.
Pomalidomide has a mean apparent volume of distribution (Vd/F) between 62 and 138 L at steady state.
Pomalidomid ima srednji navidezni volumen porazdelitve (Vd/F) med 62 in 138 l v stanju dinamičnega ravnovesja.
ANC** < 0.5 x 109/l or febrile neutropenia (fever ≥38.5°C and ANC <1 x 109/l)
• ANC** < 0,5 x 109/l ali febrilna nevtropenija (zvišana telesna temperatura ≥ 38,5 °C in ANC < 1 x 109/l)
• you have ever had an allergic reaction such as rash, itching, swelling, feeling dizzy or trouble breathing while taking related medicines called ‘thalidomide' or ‘lenalidomide'.
• ste kadar koli imeli alergijsko reakcijo, na primer izpuščaj, srbenje, oteklino, občutek vrtoglavice ali oteženo dihanje, medtem ko ste jemali sorodni zdravili, ki se imenujeta 'talidomid' ali 'lenalidomid';
Pack size of 14 or 21 capsules.
Velikost pakiranja je 14 ali 21 kapsul.
Refer also to the bortezomib SmPC.
Glejte tudi SmPC za bortezomib.
• Abnormal liver test.
• nenormalni rezultati jetrnih testov,
• Maximum duration of prescription o 4 weeks for women with childbearing potential o 12 weeks for men and women without childbearing potential
• najdaljši obdobje predpisanega zdravljenja: o 4 tedne za ženske v rodni dobi, o 12 tednov za moške in ženske, ki niso v rodni dobi,
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, objavljenem na evropskem spletnem portalu o zdravilih.
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
Imetnik dovoljenja za promet z zdravilom se mora o podrobnostih sistema nadzorovane distribucije dogovoriti s pristojnimi nacionalnimi organi in izvajati ta program na nacionalni ravni, da tako zagotovi naslednje:
Fatal infections (Grade 5) occurred in 2.7-4.0% of patients.
Smrtne okužbe (5. stopnja) so se pojavile pri 2,7-4,0 % bolnikov.
It is not known if Imnovid passes into human breast milk.
Ni znano, ali zdravilo Imnovid prehaja v materino mleko.