natgillin/translations-raw huggingface dataset:
91 1.
47 1.
Temodal 2.5 mg/ml powder for solution for infusion
Temodal 2, 5 mg/ ml prašek za raztopino za infundiranje
After reconstitution, 1 ml solution for infusion contains 2.5 mg temozolomide.
Ena viala vsebuje 100 mg temozolomida Po rekonstituciji 1 ml raztopine za infundiranje vsebuje 2, 5 mg temozolomida.
Each vial contains 2.4 mmol sodium.
Ena viala vsebuje 2, 4 mmol natrija.
Temodal 2.5 mg/ ml is indicated for the treatment of:
Zdravilo Temodal 2, 5 mg/ ml je indicirano za zdravljenje:
- children from the age of three years, adolescents and adult patients with malignant glioma, such
- otrok, starih 3 leta in več, mladostnikov in odraslih bolnikov z malignimi gliomi, npr.
as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
multiformnimi glioblastomi ali anaplastičnimi astrocitomi, ki se po standardnem zdravljenju ponovijo ali napredujejo.
Temodal 2.5 mg/ml should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Zdravilo Temodal 2, 5 mg/ ml smejo predpisati le zdravniki, ki imajo izkušnje z zdravljenjem možganskih tumorjev.
Temodal 2.5 mg/ml is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Zdravilo Temodal 2, 5 mg/ ml se uporablja v kombinaciji z žariščno radioterapijo (faza sočasne terapije), temu pa sledi do 6 ciklov monoterapije (monoterapijska faza) z temozolomidom (TMZ).
TMZ is administered at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
Faza sočasne terapije TMZ naj bolnik jemlje v odmerku 75 mg/ m2 na dan 42 dni, sočasno z žariščno radioterapijo (60 Gy, danih v 30 delnih odmerkih).
No dose reductions are recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non- haematological toxicity criteria.
Zmanjševanje odmerka ni priporočeno, vendar se boste vsak teden odločili o morebitni odložitvi jemanja TMZ ali njegovi ukinitvi na podlagi kriterijev hematološke in nehematološke toksičnosti.
TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
TMZ lahko bolnik jemlje ves čas 42- dnevnega obdobja sočasne terapije (do 49 dni), če so izpolnjeni vsi od naslednjih pogojev: • absolutno število nevtrofilcev (ANC – Absolute Neutrophil Count) ≥ 1, 5 x 109/ l; • število trombocitov ≥ 100 x 109/ l;
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia,
48 • skupna merila toksičnosti (SMT) za nehematološko toksičnost ≤ 1. stopnje (z izjemo alopecije, navzee in bruhanja).
TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Prekinitev ali ukinitev jemanja TMZ med sočasno radioterapijo in zdravljenjem s TMZ Prekiniteva TMZ
TMZ discontinuation
Absolutno število nevtrofilcev
Absolute neutrophil count
≥ 0, 5 in < 1, 5 x 109/ l
≥ 0.5 and < 1.5 x 10 /l
< 0, 5
< 0.5 x 109/l
x 109/ l
Thrombocyte count CTC non-h aematological toxicity
Število trombocitov SMT za nehematološko toksičnost (z izjemo alopecije, navzeje in
Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Sočasno zdravljenje s TMZ lahko nadaljujete, če so izpolnjeni vsi od naslednjih pogojev: absolutno število nevtrofilcev ≥ 1, 5 x 109/ l; število trombocitov ≥ 100 x 109/ l; SMT za nehematološko toksičnost ≤ 1. stopnje (z izjemo alopecije, navzeje in bruhanja).
Four weeks after completing the TMZ + RT concomitant phase, TMZ is administered for up to 6 cycles of monotherapy treatment.
Faza monoterapije Štiri tedne po zaključku faze sočasnega zdravljenja s TMZ in RT naj bolnik jemlje TMZ do 6 ciklov monoterapije.
Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
V 1. ciklu (monoterapije) je odmerek zdravila 150 mg/ m2 enkrat na dan 5 dni, temu pa naj sledi 23 dni brez terapije.
Dose level
Raven odmerka – 1
TMZ dose (mg/m2/day)
Odmerek TMZ (mg/ m2/ dan) 100
Remarks
Opombe Zmanjšanje zaradi predhodne toksičnosti Odmerek med 1. ciklom
Reduction for prior toxicity Dose during Cycle 1 Dose during Cycles 2-6 in absence of toxicity
Odmerek med cikli od 2 do 6 brez toksičnosti
93 Table 3.
49 Preglednica 3.
< 1.0 x 109/l < 50 x 109/l
< 1, 0 x 109/ l < 50 x 109/ l
See footnote b See footnote b
Glejte opombo b Glejte opombo b SMT 4.. stopnjeb
(except for alopecia, nausea, vomiting) a:
izjemo alopecije, navzeje in bruhanja) a:
TMZ dose levels are listed in Table 2. b:
Ravni odmerkov TMZ so v preglednici 2 b:
TMZ is to be discontinued if:
TMZ morate ukiniti, če
CTC Grade 4b
SMT 3. stopnje
dose level -1 (100 mg/m2) still results in unacceptable toxicity the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
raven odmerka – 1 (100 mg/ m2) še vedno povzroči nesprejemljivo toksičnost • • po zmanjšanju odmerka ponovno nastopi ista nehematološka toksičnost 3. stopnje (z izjemo alopecije, slabosti in bruhanja).
In patients previously untreated with chemotherapy, TMZ is administered at a dose of 200 mg/m2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Bolniki, ki še niso bili zdravljeni s kemoterapijo, naj jemljejo TMZ v odmerku 200 mg/ m2 enkrat na dan prvih 5 dni, temu pa naj sledi 23- dnevni premor (skupaj 28 dni).
Temodal 2.5 mg/ ml powder for solution for infusion must be administered only by intravenous infusion.
Zdravilo Temodal 2, 5 mg/ ml prašek za raztopino za injiciranje se sme dejati samo z intravenskim infundiranjem.
94 As with other similar chemotherapeutic agents, caution is recommended to avoid extravasation.
50 Kot pri drugih podobnih kemoterapevtikih, je priporočena previdnost, da se izognete ekstravazaciji.
Local injection site adverse reactions, which were mostly mild and short-lived were reported in patients receiving Temodal 2.5 mg/ml powder for solution for infusion.
Pri bolnikih, ki so prejemali zdravilo Temodal 2, 5 mg/ ml prašek za raztopino za infundiranje, so poročali o lokalnih neželenih reakcijah na mestu injiciranja.
Preclinical studies did not show permanent tissue damage (see sections 4.8 and 5.3).
Predklinične študije niso pokazale trajne poškodbe tkiva (glejte poglavji 4. 8 in 5. 3).
Temodal 2.5 mg/ml powder for solution for infusion, given as an intravenous infusion over 90 minutes, is bioequivalent to the hard capsule formulation (see section 5.2).
Zdravilo Temodal 2, 5 mg/ ml prašek za raztopino za infundiranje, ki se intravensko infundira 90 min, je biološko ekvivalentno formulaciji v trdih kapsulah (glejte poglavje 5. 2).
If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle, the next cycle should be
Če med katerimkoli ciklom ANC pade na
95 reduced one dose level (see section 4.2).
51 < 1, 0 x 109/ l ali število trombocitov na < 50 x 109/ l, morate odmerek zdravila v naslednjem ciklu zmanjšati za eno stopnjo (glejte poglavje 4. 2).
This medicinal product contains 2.4 mmol sodium per vial.
To zdravilo vsebuje 2, 4 mmol natrija na vialo.
In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
V ločeni študiji 1. faze, sočasna uporaba TMZ in ranitidina ni povzročila spremembe obsega absorpcije temozolomida ali izpostavljenosti njegovem aktivnem presnovku monometiltriazenoimidazol karboksamidu (MTIK).
Temodal 2.5 mg/ml should not be administered to pregnant women.
Zdravilo Temodal 2, 5 mg/ ml se ne sme dajati nosečnicam.
96 It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
52 Ni znano, ali se TMZ izloča v materino mleko, zato je treba med zdravljenjem s TMZ dojenje prekiniti.
Therefore, men being treated with it should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment, because of the possibility of irreversible infertility due to therapy with TMZ.
Moškim, ki se zdravijo s TMZ je treba svetovati, naj ne zaplodijo otroka še šest mesecev po zadnjem prejetem odmerku in naj se zaradi možnosti ireverzibilne neplodnosti zaradi zdravljenja s TMZ pred zdravljenjem posvetujejo o možnostih za shranitev zmrznjene sperme.
The ability to drive and use machines may be impaired in patients treated with TMZ due to fatigue and somnolence.
Pri bolnikih, ki se zdravijo s TMZ, je lahko sposobnost vožnje in upravljanja strojev zmanjšana zaradi utrujenosti in somnolence.
Most haematological adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5); the frequency of grade 3-4 laboratory findings is presented after each table.
Pogostnosti laboratorijskih izvidov 3. ali 4. stopnje jakosti je navedena za vsako preglednico.
Frequency groupings are defined according to the following convention:
Neželeni učinki so v preglednicah razvrščeni po organskih sistemih in pogostnosti.
Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100).
Pogostnost je opredeljena na naslednji način: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100).
97 Endocrine disorders Uncommon:
Bolezni endokrinega sistema
98 Respiratory, thoracic and mediastinal disorders Common:
Bolezni dihal, prsnega koša in mediastinalnega prostora
Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia
Bolezni kože in podkožja
Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
stomatitis, driska, trebušne bolečine, dispepsija, disfagija
Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
stomatitis, driska, dispepsija, disfagija, suha usta napihnjenost trebuha, inkontinenca blata, bolezni prebavil (NOS), gastroenteritis, hemoroidi
99 Common:
Občasni:
Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Ko so sešteli nenormalne
When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8% of the patients.
55 laboratorijske izvide in neželene sopojave iz faze sočasne terapije in faze monoterapije, so pri 8% bolnikov opažali anomalije nevtrofilcev 3. ali 4. stopnje, vključno z nevtropeničnimi sopojavi.
Headache Somnolence, dizziness, paresthesia
glavobol zaspanost, omotica, parestezije
Fatigue Fever, asthenia, rigors, malaise, pain, taste perversion
utrujenost zvišana telesna temperatura, astenija, mrzlica, slabo počutje, bolečine, motnje okusa
In a study of 288 subjects with newly– diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3% of female vs 0% of male subjects and Grade 4 thrombocytopenia in 1% of female vs 0% of male subjects in the first cycle of therapy.
V študiji pri 288 preiskovancih z novo diagnosticiranim glioblastomom multiforme se je v prvem ciklu terapije nevtropenija 4. stopnje pojavila pri 3% žensk in 0% moških, trombocitopenija 4. stopnje pa pri 1% žensk in 0% moških.
Temodal 2.5 mg/ml powder for solution for infusion delivers equivalent TMZ dose and exposure to both TMZ and its active metabolite MTIC as the corresponding Temodal hard capsules (see section 5.2).
Zdravilo Temodal 2, 5 mg/ ml prašek za raztopino za infundiranje dovaja enak odmerek TMZ in zagotavlja enako izpostavljenost TMZ in njegovem aktivnem presnovku, MTIK, kot ustrezne trde kapsule Temodal (glejte poglavje 5. 2).
Post -Marketing Experience
Postmarketinške izkušnje
Antineoplastic agents, and notably alkylating agents, have been associated with a potential risk of myelodysplastic syndrome (MDS) and secondary malignancies, including leukaemia.
Uporaba antineoplastičnih sredstev, še posebej alkilirajočih snovi, je bila povezana z možnim tveganjem za pojav mielodisplastičnega sindroma (MDS) in sekundarnih malignomov, vključno z levkemijo.
Cases of interstitial pneumonitis/pneumonitis have been reported very rarely.
Zelo redko so poročali o primerih intersticijskega pnevmonitisa ali pnevmonitisa.
101 5.1 Pharmacodynamic properties
57 5. 1 Farmakodinamične lastnosti
Antineoplastic agents - Other alkylating agents, ATC code:
Antineoplastična zdravila – drugi alkilirajoči citostatiki, oznaka ATC:
This was followed by monotherapy TMZ (150 - 200 mg/m2) on Days 1 - 5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Temu je sledila faza monoterapije s TMZ (od 150 do 200 mg/ m2) od 1. do 5. dne vsakega 28– dnevnega cikla, do največ 6 ciklov, ki se je začela 4 tedne po koncu RT.
TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
TMZ so bolniki jemali kot zadnji poskus terapije v fazi spremljanja pri 161 bolnikih od 282 (57%) v delu študije samo z RT in pri 62 bolnikih od 277 (22%) v delu študije s TMZ in RT.
Kaplan-Meier curves for overall survival (Intent to Treat population)
Kaplan- Meierjevi krivulji skupnega preživetja (populacija, ki so jo nameravali zdraviti)
1 4 .6
58
102 Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.
Podatki o klinični učinkovitosti zdravila pri bolnikih z multiformnim glioblastomom (indeks kliničnega stanja po Karnofskyju [KPS – » Karnofsky performance status «] ≥ 70), ki napreduje ali se je ponovil po kirurškem posegu in RT, temeljijo na dveh kliničnih preskušanjih s peroralno uporabo TMZ.
In the non-comparative trial, the PFS at 6 months was 19%, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
V neprimerjalnem preskušanju je bil PFS po 6 mesecih 19%, mediana vrednost PFS 2, 1 meseca in mediana vrednost celotnega preživetja 5, 4 mesecev.
In the r andomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21% vs 8%, respectively – chi-square p = 0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p = 0.0063).
V randomiziranem, z učinkovino nadzorovanem preskušanju je bil PFS po 6 mesecih statistično značilno daljši pri TMZ kot pri prokarbazinu (21% v primerjavi z 8%, hi- kvadrat, p = 0, 008), z mediano vrednostjo PFS 2, 89 meseca za temozolomid in 1, 88 meseca za prokarbazin (test log. ranga p = 0, 0063).
In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46%.
V multicentričnem svetovnem prospektivnem preskušanju 2. faze za oceno varnosti in učinkovitosti peroralnega TMZ pri zdravljenju bolnikov z anaplastičnim astrocitomom ob prvem recidivu je bila 6 - mesečna vrednost (preživetje brez napredovanja bolezni) 46%.
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3- methyl(triazen-1-yl)imidazole-4-carboxamide (MTIC).
59 TMZ spontano hidrolizira pri fiziološki vrednosti pH predvsem do aktivnih presnovkov, 3- metil - (triazen- 1- il) imidazol- 4- karboksamida (MTIK).
MTIC is spontaneously hydrolyzed to 5amino-imidazole4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
MTIK pa spontano hidrolizira do 5- amino- imidazol- 4 - karboksamida (AIK), znanega intermediata v biosintezi purinov in nukleinskih kislin, ter metilhidrazina, za katerega menijo, da je aktivni alkilirajoči presnovek.
In an open-label, two-way crossover bioequivalence study of the pharmacokinetics of oral and intravenous TMZ in patients with primary CNS malignancies, Temodal 2.5 mg/ml powder for solution for infusion administered over 90 minutes was found to be bioequivalent for Cmax and AUC of TMZ and MTIC as compared to Temodal hard capsules, following administration of 150 mg/m2 dose.
V odprti, dvosmerni, navzkrižno zasnovani, bioekvivalenčni študiji farmakokinetike peroralnega in intravenskega TMZ pri bolnikih s primarnimi malignomi osrednjega živčevja so ugotovili, da je zdravilo Temodal 2, 5 mg/ ml prašek za raztopino za infundiranje, ki ga infundirajo 90 minut, biološko ekvivalentno glede vrednosti Cmax in AUC učinkovin TMZ in MTIK, kot zdravilo Temodal trde kapsule po uporabi odmerka 150 mg/ m2.
Mean Cmax values for TMZ and MTIC were 7.4 µg/ml and 320 ng/ml, respectively, following 90 minute intravenous infusion.
Po 90- minutnem intravenskem infundiranju je bila srednja vrednost Cmax za TMZ 7, 4 µg/ ml, za MTIK pa 320 ng/ ml.
Mean AUC (0 → ∞) values for TMZ and MTIC were 25 µg•h/ml and 1,004 ng•h/ml, respectively.
Srednja vrednost AUC (0 → ∞) za TMZ je bila 25 µg• h/ ml, za MTIK pa 1, 004 ng• h/ ml.
103 Absorption
Absorpcija
TMZ demonstrates low protein binding (10% to 20%), and thus it is not expected to interact with highly protein-bound substances.
TMZ se v majhni meri veže na beljakovine (10% do 20%), zato ni pričakovati, da bi medsebojno deloval z učinkovinami, ki se dobro vežejo na beljakovine.
CSF penetration was confirmed in one patient; CSF exposure based on AUC of TMZ was approximately 30% of that in plasma, which is consistent with animal data.
Izpostavljenost v CSF, določena na podlagi AUC za temozolomid, je bila približno 30% tiste v plazmi, kar je v skladu s podatki, ki so jih dobili na živalih.
Following oral administration, approximatively 5% to 10% of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4-carboxamide (AIC) or unidentified polar metabolites.
Po peroralni uporabi se v 24 urah s sečem v nespremenjeni obliki izloči približno 5% do 10% odmerka, preostanek pa se izloči v obliki temozolomidske kisline, 5- aminoimidazol- 4- karboksamida (AIC) ali neopredeljenih polarnih presnovkov.
Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m2 per cycle both in children and in adults.
Pri otrocih je bila vrednost AUC večja kot pri odraslih, medtem ko je bil največji odmerek, ki so ga bolniki še prenašali (MTD – » maximum tolerated dose «), pri obeh skupinah 1. 000 mg/ m2 na cikel.
104 Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Rezultati testa Ames/ Salmonella in testa kromosomskih aberacij v človeških limfocitih iz periferne krvi (HPBL – » Human Peripheral Blood Lymphocyte «) so pokazali pozitiven mutageni odziv.
Mannitol (E421) Threonine Polysorbate 80 Sodium citrate (for pH adjustment) Hydrochloric acid concentrated (for pH adjustment)
Manitol (E421) Treonin Polisorbat 80 Natrijev citrat (za uravnavanje pH) Koncentrirana klorovodikova kislina (za uravnavanje pH).
Reconstituted solution: after reconstitution the chemical and physical in-use stability has been demonstrated for 14 hours at 25°C, including infusion time.
Po rekonstituciji ostane raztopina kemično in fizično stabilna 14 ur, vključno s časom infundiranja, če je shranjena pri temperaturi 25 °C.
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 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če ni porabljeno takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo, ti pa ne bi smeli trajati dlje kot 24 ur pri 2 do 8 °C, razen če se je rekonstitucija opravila v nadzorovanih in preverjeno aseptičnih pogojih.
Store in a refrigerator (2 °C – 8 °C).
Shranjujte v hladilniku (2 °C– 8 °C).
Clear type I glass vial sealed with bromobutyl rubber stopper and aluminium overseal with peach-coloured flip-off bonnet.
61 Viala iz prozornega stekla vrste I, zamašena z zamaškom iz bromobutilne gume in aluminijastim tesnilom z rožnatim pokrovčkom flip- off.
Temodal 2.5 mg/ml is supplied as a pack of 1 vial.
Zdravilo Temodal 2, 5 mg/ ml je na voljo v pakiranjih po 1 vialo.
Caution must be exercised in handling Temodal 2.5 mg/ml powder for solution for infusion.
Pri ravnanju z zdravilom Temodal 2, 5 mg/ ml prašek za raztopino za infundiranje je potrebna previdnost.
If Temodal 2.5 mg/ml comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Če zdravilo Temodal 2, 5 mg/ ml pride v stik s kožo ali sluznico, ga je treba takoj temeljito izprati z milom in vodo.
The resulting solution contains 2.5 mg/ml TMZ.
Tako pridobljena raztopina vsebuje 2, 5 mg/ ml TMZ.
A volume up to 40 ml reconstituted solution should be withdrawn, according to the total prescribed dose and transferred into
Odvzeti je treba do 40 ml rekonstituirane raztopine, glede na skupni predpisani odmerek, in jo prenesti v prazno 250- mililitrsko vrečko za infundiranje iz PVC.
Studies with non-PVC bags have not been conducted.
Študij z vrečkami iz drugih materialov niso izvedli.
Temodal 2.5 mg/ml must be administered by intravenous infustion only over a period of 90 minutes.
Zdravilo Temodal 2, 5 mg/ ml se sme intravensko infundirati samo v obdobju 90 minut.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or infused simultaneously through the same intravenous line.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, ali ga sočasno infundirati po isti intravenski liniji.
SP Europe Rue de Stalle 73 B-1180 Bruxelles Belgium
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106 ANNEX II
62 DODATEK II
107 A.
63 A.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2. 0, predstavljeni v Modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, uveljavljen in deluje, preden da zdravilo v promet in ves čas ko je zdravilo na trgu.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 2. 0 Načrta za obvladovanje tveganja (RMP), predstavljenega v Modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s Smernico CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini je treba predložiti posodobljen RMP istočasno z naslednjim Periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted
Dodatno je treba predložiti posodobljen RMP:
- When new information is received that may impact on the current Safety Specification,
- ob prejemu novih informacij, ki bi lahko vplivale na veljavne Varnostne specifikacije, Načrt
Pharmacovigilance Plan or risk minimisation activities
farmakovigilance ali na dejavnosti za zmanjševanje tveganja na najmanjšo možno mero,