natgillin/translations-raw huggingface dataset:
After reconstitution the solution should be further diluted in the bag with the Savene diluent.
Po pripravi je treba raztopino dodatno redčiti v vrečo z vehiklom Savene.
(See section 6.6).
(Glejte poglavje 6. 6).
Paediatric patients Savene is not recommended for use in children due to a lack of data on safety and efficacy.
Otroci Zdravila Savene niso preučevali za otroke zaradi pomanjkanja podatkov o varnosti in učinkovitosti.
Patients with renal impairment Savene has not been studied in patients with impaired renal function and its use in such patients is not recommended (see section 4.4).
Bolniki z ledvično okvaro Zdravilo Savene ni preučeno pri bolnikih z okvaro ledvic, zato uporaba zdravila pri teh bolnikih ni priporočljiva (glejte poglavje 4. 4).
Patients with hepatic impairment Savene has not been studied in patients with impaired hepatic function and its use in such patients is not recommended (see section 4.4).
Bolniki z jetrno okvaro Zdravila Savene niso preučevali pri bolnikih z okvaro jeter, zato uporaba zdravila pri teh bolnikih ni priporočljiva (glejte poglavje 4. 4).
Elderly patients Safety and efficacy have not been evaluated in the elderly.
Starostniki Varnost in učinkovitost zdravila pri starostnikih niso preučevali.
Women of childbearing potential not using contraceptive measures (see section 4.4 and 4.6).
Ženske v rodni dobi, ki ne uporabljajo kontracepcije (glejte poglavji 4. 4 in 4. 6).
Concomitant vaccination with yellow fever vaccine (see section 4.5).
Sočasno cepljenje s cepivom proti rumeni mrzlici (glejte poglavje 4. 5).
Local examination should be performed on regular basis after treatment until resolution.
Po zdravljenju je treba prizadeto področje redno pregledovati, dokler stanje ne preneha.
If there is suspicion of extravasation by vesicant compounds other than anthracyclines through the same IV access, e. g. vincristine, mitomycin, and vinorelbine, Savene would not be effective against the reaction from these compounds.
Če obstaja sum na ekstravazacijo z vezikulacijskimi snovmi, ki niso antraciklini, skozi isti IV pristop (npr. vinkristin, mitomicin in vinorelbin), zdravilo Savene ne bo učinkovito proti reakciji zaradi teh snovi.
Savene will be administered to patients undergoing cytotoxic therapy with anthracycline containing chemotherapy and its cytotoxic potential (especially resulting in reversible haematological toxicity with a nadir occurring on days 11-12) will therefore be added to that of the other chemotherapy administered.
Ker se zdravilo Savene daje bolnikom, ki prejemajo citotoksično zdravljenje s kemoterapijo, ki vključuje antracikline, se citotoksični potencial zdravila (zlasti nastali reverzibilni hematološki toksikološki učinki z nadirjem 11. in 12. dan) prišteje citotoksičnemu potencialu drugih uporabljenih kemoterapevtikov.
Patients with neutropenia and thrombocytopenia > Common Toxicity Criteria (CTC) grade 1 have not been included in the clinical studies.
Bolniki z nevtropenijo in trombocitopenijo > kriterij toksičnosti (CTC - Common Toxicity Criteria) stopnje 1 niso bili vključeni v klinične študije.
Since liver dysfunction (increases in transaminases and bilirubin) may occur (especially after doses of above 1 000 mg/ m2 dexrazoxane), it is recommended that routine liver function tests are performed before each administration of dexrazoxane in patients with known liver function disorders.
Ker lahko pride do disfunkcije jeter (zvišane vrednosti transaminaz in bilirubina) (zlasti po odmerkih deksrazoksana nad 1000 mg/ m2), je pri bolnikih z dokazano okvaro jeter priporočljivo opraviti redne preiskave jetrne funkcije pred vsakim odmerkom deksrazoksana.
Since renal dysfunction may decrease the rate of elimination of dexrazoxane, patients with initial impaired renal function should be monitored for signs of haematological toxicity.
Ker lahko ledvična disfunkcija zmanjša hitrost izločanja deksrazoksana, je treba bolnike z začetno okvaro ledvic spremljati za znake hematološke toksičnosti.
As dexrazoxane possesses mutagenic activity, men being treated with dexrazoxane are advised not to father a child during and up to three months after treatment.
3 Ker je deksrazoksan mutagen, moškim, ki se zdravijo z deksrazoksanom, odsvetujemo spočetje otroka med zdravljenjem in tri mesece po zdravljenju.
Women of childbearing potential must use contraceptive measures during treatment.
Ženske v rodni dobi morajo uporabljati kontracepcijo med zdravljenjem.
This product is generally not recommended in combination with live attenuated vaccines, or with phenytoin (see section 4.5).
To zdravilo se ne priporoča v kombinaciji z živimi oslabljenimi cepivi ali v kombinaciji s fenitoinom (glejte poglavje 4. 5).
3 Dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline-induced extravasation.
Pri bolnikih, ki prejemajo deksrazoksan, se za zdravljenje ekstravazacij, ki so jih povzročili antraciklini, ne sme uporabiti dimetilsulfoksid (DMSO).
As the Savene diluent contains potassium (98 mg/ 500 ml) the plasma potassium level of the patient must be closely monitored in patients at risk of hyperkalaemia.
Ker vehikel Savene vsebuje kalij (98 mg/ 500 ml), je treba pri bolnikih, pri katerih se lahko pojavi hiperkaliemija, natančno spremljati plazemske ravni kalija.
It also contains sodium (1.61 g/ 500 ml) which may be harmful to patients on a low sodium diet.
Vsebuje tudi natrij (1, 61 g/ 500 ml), ki je lahko škodljiv za bolnike, ki so na dieti z nadzorovanim vnosom natrija.
Interactions common to all cytotoxics:
Interakcije skupne vsem citostatikom:
Due to increase of thrombotic risk in patients with malignant diseases, the use of anticoagulants treatment is frequent.
Pri bolnikih z malignimi boleznimi je pogosto antikoagulacijsko zdravljenje zaradi nevarnosti trombotičnega dogodka.
Cytotoxic agents may interact with oral anticoagulants.
Lahko pride do interakcije med citotoksičnimi zdravili in peroralnimi antikoagulanti.
Patients treated with anticoagulant should be monitored more frequently.
Bolnike, ki se zdravijo z antikoagulanti, je treba pogosteje spremljati.
Yellow fever vaccine:
Cepivo proti rumeni mrzlici:
Risk of fatal generalised vaccinial disease (see section 4.3).
Tveganje smrtne generalizirane vakcinije (glejte poglavje 4. 3).
Live attenuated vaccines: risk of systemic, possible fatal disease.
Tveganje sistemske, možno smrtne bolezni.
This risk is increased in subjects who are already immunosuppressed by their underlying disease Phenytoin: concomitant use of cytotoxic medicinal products may reduce the absorption of phenytoin leading to an exacerbation of convulsions.
To tveganje je večje pri osebah, ki so že imunsko oslabljene zaradi obstoječe bolezni Fenitoin: sočasna uporaba citotoksičnega zdravila lahko zmanjša absorpcijo fenitoina, kar lahko poslabša krče.
Use an inactivated vaccine where this exists (poliomyelitis).
Uporaba inaktiviranega cepiva, kjer se uporablja (poliomielitis).
Concomitant use to take into consideration:
Sočasno uporabo je treba preučiti v naslednjih primerih:
Ciclosporine, Tacrolimus:
Ciklosporin, takrolimus:
Excessive immunosuppression with risk of lymphoproliferative disease.
Čezmerna imunska supresija s tveganjem limfoproliferativne bolezni.
CYP1A, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, none of these were inhibited by dexrazoxane.
Pri preskušanju petih glavnih izoencimov citokroma P450 (CYP1A, CYP2C9, CYP2C19, CYP2D6 in CYP3A4) niso odkrili inhibitornih učinkov deksrazoksana nanje.
Savene may add to the toxicity induced by the chemotherapy cycle during which the accident took place, requiring careful monitoring of haematological parameters.
Zaradi tega je potrebno natančnejše spremljanje hematoloških parametrov.
Savene may cause foetal harm when administered to pregnant women.
Uporaba zdravila Savene pri nosečnici lahko škoduje plodu.
Few pre-clinical data are available with respect to reproductive toxicity (see section 5.3).
O vplivu na sposobnost razmnoževanja je malo predkliničnih podatkov (glejte poglavje 5. 3).
Savene should not be administered to pregnant women unless clearly necessary.
Zdravila Savene ne smete dajati nosečnicam, razen če je nujno potrebno.
Women of childbearing potential should use contraceptive measures during treatment and should inform their doctor immediately if they become pregnant.
Ženske v rodni dobi morajo med zdravljenjem uporabljati kontracepcijo in nemudoma obvestiti zdravnika, če zanosijo.
(See section 4.3) As dexrazoxane possesses mutagenic activity, male patients should use contraceptives during treatment and for 3 months after treatment with dexrazoxane has been concluded (see section 4.4).
(Glejte poglavje 4. 3) Ker je deksrazoksan mutagen, morajo moški bolniki uporabljati kontracepcijska sredstva med zdravljenjem in 3 mesece po zaključku zdravljenja z deksrazoksanom (glejte poglavje 4. 4).
Because of the potential for serious adverse reactions in nursing infants exposed to dexrazoxane, mothers should discontinue nursing during Savene therapy.
Zaradi potencialno resnih neželenih učinkov pri dojenih dojenčkih, ki so izpostavljeni deksrazoksanu, morajo matere prekiniti dojenje med zdravljenjem z zdravilom Savene.
(See section 4.3)
(Glejte poglavje 4. 3)
No studies on the effects on the ability to drive and use machines have been performed but it is unlikely that Savene will affect this function, as it has rarely been associated with any impairment of the central nervous system such as confusion.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli, vendar ni verjetno, da bi zdravilo Savene vplivalo na to funkcijo, saj je bilo redko povezano s kakršnokoli okvaro centralnega živčnega sistema, npr. zmedenostjo.
A number of published reports comprising more than 1000 patients have demonstrated a uniform pattern of dose dependant adverse reactions such as nausea/ vomiting, diarrhoea, stomatitis, bone marrow suppression (neutropenia, thrombocytopenia) and affected liver function (increased ALT/ AST).
Številna objavljena poročila, ki so obravnavala več kot 1000 bolnikov, so pokazala enakomeren vzorec neželenih reakcij, ki so odvisne od odmerka, npr. slabost/ bruhanje, driska, stomatitis, supresija kostnega mozga (nevtropenija, trombocitopenija) in okvarjena jetrna funkcija (zvišane vrednosti ALT/ AST).
All adverse reactions have been rapidly reversible.
Vse neželene reakcije so bile hitro reverzibilne.
The following information is based on two clinical studies, TT01 and TT02, of Savene administered to extravasation patients already receiving cycles of chemotherapeutic agents.
Naslednji podatki temeljijo na dveh kliničnih študijah (TT01 in TT02) zdravila Savene, ki so ga uporabili pri bolnikih z ekstravazacijo in ki so že prejemali cikle kemoterapevtikov.
The adverse reactions are those typically seen with standard chemotherapy and also with dexrazoxane:
Opazili so neželene reakcije, ki so tipične za standardno kemoterapijo in deksrazoksan:
Nausea/ vomiting in about one third of the patients, neutropenia and thrombocytopenia in about half of the patients, more rarely increased concentration of liver enzymes (ALT/ AST).
Slabost/ bruhanje so opazili pri približno tretjini bolnikov, nevtropenijo in trombocitopenijo pri približno polovici bolnikov, redkeje pa zvišane ravni jetrnih encimov (ALT/ AST).
The treatment related adverse events observed in the clinical studies are listed below.
Spodaj so našteti neželeni dogodki, ki so bili opaženi v kliničnih študijah in so povezani z zdravljenjem.
Incidence of adverse reactions (MedDRA) in studies TT01 and TT02 that are related or possible related to treatment.
Pojavnost neželenih reakcij (MedDRA), ki so povezane ali možno povezane z zdravljenjem v študijah TT01 in TT02.
(Note that numbers for Blood and Lymphatic System Disorders are described in a separate table of laboratory examinations) Adverse reactions described as very common were experienced in more than 1 in 10 patients (≥ 1/ 10).
(Številke za „ Bolezni krvi in limfatičnega sistema “ so navedene v ločeni tabeli laboratorijskih preiskav) Neželene reakcije, ki so opisane kot zelo pogoste, so opazili pri več kot 1 bolniku od 10 (≥1/ 10).
Adverse reactions described as common were experienced by up to 1 in 10 patients (> 1/ 100 to < 1/ 10).
Neželene reakcije, ki so opisane kot pogoste, niso opazili pri več kot 1 bolniku od 10 (> 1/ 100 do < 1/ 10).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti..
(Number of patients = 80) System Organ Classes (SOC)
(Število bolnikov = 80) Organski sistemi (SOC -
Preferred Terms (PT)
Priporočeni izrazi (PT -
Grade 3+4
Stopnji 3+4
Gastrointestinal Very common disorders
Bolezni prebavil Zelo pogosti
Vomiting Diarrhoea Stomatitis Dry mouth
Bruhanje Driska Stomatitis Suha usta
General Very common disorders and
Splošne težave in spremembe
Pyrexia Injection site phlebitis
Pireksija Flebitis na mestu injiciranja
3 (3.8%)
Eritem na mestu 3 injiciranja
Injection site induration
Zatrdlina na mestu injiciranja
Injection site swelling
Otekanje na mestu injiciranja
Infections and Very common infestations
Priporočeni izrazi (PT -
Postoperative infection
Infekcijske in parazitske
Infection Neutropenic infection
Okužba Nevtropenična okužba
Injury, Common poisoning and procedural complications
Pogosti
Wound complication
Zaplet v zvezi z rano
Investigations Common
Pogosti
Weight decreased
Zmanjšana telesna masa
5 System Organ Classes (SOC)
Presnovne in prehranske motnje
Dizziness Sensory loss Syncope Tremor
Omotica Izguba čutov Sinkopa Tremor
Vaginal haemorrhage
Krvavitev iz nožnice
Alopecia Pruritus
Alopecija Srbečica
Phlebitis Thrombophlebit is superficial
Flebitis Površinski tromboflebitis
Venous thrombosis limb
Venska tromboza okončine
Incidence of laboratory abnormalities (all patients) in TT01 and TT02
Pojavnost nenormalnosti rezultatov laboratorijskih preiskav (vsi bolniki) v TT01 in TT02
No of pts with post
Laboratorijska
CTC grade 3-4
CTC stopnja 3- 4
Lab test
preiskava
baseline value
izhodiščni vrednosti
WBC Neutrophils Platelets Sodium (Hypo) Potassium (Hypo) Potassium (Hyper) Alkaline Phosphatase Bilirubin AST ALT Creatinine LDH Calcium Total (Hypo)
Kalij (hipo) Kalij (hiper) Alkalna fosfataza Bilirubin AST ALT Kreatinin LDH Skupni kalcij (hipo)
80 78 80 79 79 79 77 77 57 71 76 78 28
79 79 77 77 57 71 76 78 28
36 36 17 5 2 0 0 1 2 3 2 0 2
2 0 0 1 2 3 2 0 2
45.0% 46.2% 21.3% 6.3% 2.5% 0.0% 0.0% 1.3% 3.5% 3.9% 2.6% 0.0% 7.1%
2, 5% 0, 0% 0, 0% 1, 3% 3, 5% 3, 9% 2, 6% 0, 0% 7, 1%
Detoxifying agents for antineoplastic agents, ATC code:
Zdravila za zaščito organizma pred toksičnostjo citostatikov, oznaka ATC:
Two pharmacodynamic properties of dexrazoxane, its antineoplastic effect and its use in the prevention of anthracycline cardiotoxicity, are described in the literature.
Farmakodinamični lastnosti deksrazoksana (antineoplastični učinek in preprečevanje antraciklinske kardiotoksičnosti) sta opisani v literaturi.
Mechanism of action Dexrazoxane has two major mechanisms of action:
Mehanizem delovanja Deksrazoksan ima dva glavna mehanizma delovanja:
Prevention of anthracycline cardiotoxicity: chelation of iron especially through its ring-opened metabolite reduces the iron-dependant free radical oxidative stress associated with anthracycline- induced cardiotoxicity.
Preprečevanje antraciklinske kardiotoksičnosti: kelacija železa, zlasti preko odprtega presnovka z obročem, zmanjša od železa odvisni oksidativni stres prostih radikalov, povezan s kardiotoksičnostjo, ki so jih povzročili antraciklini.
Antineoplastic effect: inhibition of topoisomerase II.
Antineoplastični učinek: zaviranje topoizomeraze II.
It is not known to which extent each of these mechanisms contributes to the protective effect of tissue destruction following anthracycline extravasation.
Ni znano, v kakšni meri opisana mehanizma prispevata k zaščitnemu učinki pri uničevanju tkiva po antraciklinski ekstravazaciji.
The following efficacy data relate to Savene used as treatment of anthracycline extravasation.
Naslednji podatki o učinkovitosti se nanašajo na uporabo zdravila Savene za zdravljenje antraciklinske ekstravazacije.
The clinical programme for Savene (dexrazoxane) included two open, single arm, multicentre studies.
Klinični program za zdravilo Savene (deksrazoksan) je obsegal dve odprti multicentrični študija brez primerjalne skupine.
Due to the rarity of the condition only historical data could be used for comparison (demonstrating surgical rates of 35-50%, in one country 100% in biopsy proven cases) In both studies, the dosage regimen was the same.
Zaradi redkosti stanja je bilo možno za primerjavo uporabiti le zgodovinske podatke (ki kažejo stopnjo uporabe kirurškega posega 35- 50%, v eni državi 100% v primerih, dokazanih z biopsijo) V obeh študijah je bil režim odmerjanja enak.
The first and second doses were at 1000 mg/ m2 and the third was 500 mg/ m2.
Prvi in drugi odmerek sta bila 1000 mg/ m2, tretji pa je bil 500 mg/ m2.
Patients with neutropenia and thrombocytopenia > CTC grade 1 have not been included in the clinical studies.
7 Bolniki z nevtropenijo in trombocitopenijo > kriterij toksičnosti (CTC) stopnje 1 niso bili vključeni v klinične študije.
In study TT01 23 patients were entered and received treatment with Savene.
V študiji TT01 so vključili 23 bolnikov, ki so prejeli zdravilo Savene.
Overall, the most commonly received anthracycline was epirubicin (56% of the patients).
Najpogosteje so bolniki prejeli antraciklin epirubicin (56% bolnikov).
Patients with extravasations from a central venous access device (CVAD) were not included in the efficacy evaluation.
V vrednotenje učinkovitosti niso vključili bolnikov, ki so imeli ekstravazacije iz pripomočka za centralni venski pristop (CVAD - central venous access device).
In both studies dexrazoxane treatment prevented the development of necrosis, allowed cancer treatment to continue as scheduled in the majority of patients, and reduced the occurrence of sequelae (only few and mild long-term sequelae were observed).
V obeh študijah je zdravljenje z deksrazoksanom preprečilo razvoj nekroze in pri večini bolnikov omogočilo nadaljevanje zdravljenja raka po režimu in zmanjšalo pojavnost posledic (opazili so le nekaj blagih dolgoročnih posledic).
Savene is only administered intravenously.
Zdravilo Savene se daje le intravensko.
The apparent volumes of
Podatki v literaturi kažejo, da serumska kinetika deksrazoksana pri intravenskem dajanju sledi odprtemu modelu dveh kompartmentov neodvisno od režima in odmerka.
7 distribution are 0.13-1.3 l/ kg (median 0.49 l/ kg).
Navidezni volumen porazdelitve je 0, 13 - 1, 3 l/ kg (mediana 0, 49 l/ kg).
About 2% of dexrazoxane is protein-bound.
Na beljakovine je vezano 2% deksrazoksana.
Dexrazoxane undergoes intracellular hydrolysis first to its two one-ring open intermediates (B and C) and then to the two-ring opened form (ADR-925) which has a structure similar to EDTA and is a strong chelator of iron and divalent cations as calcium ions.
Deksrazoksan se znotrajcelično najprej hidrolizira v odprta intermediata z enim obročem (B in C) in nato v odprto obliko z dvema obročema (ADR- 925), ki je po strukturi podobna EDTA in je močen kelator železa in dvovalentnih kationov (npr. kalcijevih ionov).
Initial elimination half lives (alpha) are 0.18-1 h (median 0.34 h) and terminal elimination half lives 1.9-9.1 h (median 2.8 h).
Začetni razpolovni časi izločanja (alfa) so 0, 18 - 1 h (mediana 0, 34 h), končni razpolovni časi izločanja pa 1, 9- 9, 1 h (mediana 2, 8 h).
Total urinary recovery of unchanged dexrazoxane is 34%-60%.
Skupni izplen nespremenjenega deksrazoksana v urinu je 34% - 60%.
The mean elimination half-lives of the one-ring opened metabolite B and metabolite C are 0.9-3.9 h (n=5) and 0.5-0.8 h (n=3), respectively.
Povprečni razpolovni čas izločanja je za odprti intermediat z enim obročem B 0, 9- 3, 9 h (n=5), za odprti intermediat z enim obročem C pa 0, 5- 0, 8 h (n=3).
ADR-925 is reported to increase three-fold within 15 min after infusion of 1500 mg/ m2 and remain relatively constant on a plateau for 4 hours and then decreased to about half at 24 h.
Ugotovili so, da se raven ADR- 925 v 15 min po infuziji 1500 mg/ m2 zviša na trikratno raven, nato ostane relativno konstantna na platoju 4 ure, zatem pa se zniža na približno polovico po 24 h.
In vitro studies on dexrazoxane when tested in human microsomes have shown high stability of dexrazoxane indicating that major metabolism via cytochrome P450 is unlikely
V študijah deksrazoksana in vitro na človeških mikrosomih so dokazali visoko stabilnost deksrazorsana, kar kaže, da se v večji meri ne presnavlja preko citokroma P450
Inter- and intraindividual pharmacokinetic variabilities have not been studied systematically.
Variabilnost znotraj posameznika in med posamezniki ni bila sistematično preučena.
Based on a limited number of patients, interindividual variability calculated as the coefficient of variation (CV%), was estimated to be approximately 30% for the main pharmacokinetic parameters.
Na osnovi omejenega števila bolnikov, je bila variabilnost med posamezniki za glavne farmakokinetične parametre, izračunana kot koeficient variacije (CV - coefficient of variation%), ocenjena na približno 30%.
Dexrazoxane has been shown to possess mutagenic activity.
8 Dokazano je bilo, da je deksrazoksan mutagen.
The carcinogenic potential of dexrazoxane has not been investigated, however, razoxane, (the racemic mixture of dexrazoxane and levrazoxane), has been reported to be associated with the development of secondary malignancies in mice (lymphoid neoplasms) and rats (uterine carcinomas) after administration for a prolonged period of time.
Karcinogenega potenciala deksrazoksana še niso raziskali, vendar je dolgoročno dajanje razoksana (racemno zmes deksrazoksana in levrazoksana) povezano s pojavom sekundarnih malignih tvorb pri miših (limfatične neoplazme) in podganah (maternični karcinomi).
The apparent effects were greater during chronic administration than acute.
Zabeleženi učinki so bili pri kroničnem dajanju obsežnejši kot pri akutni izpostavitvi.
When mice with experimental daunorubicin extravasation were treated with dexrazoxane systemically combined with topical treatment with DMSO on the daunorubicin-affected skin area, 67% of the mice developed small skin wounds, whereas dexrazoxane treatment alone completely prevented the daunorubicin induced skin necrosis in another group of mice, Thus, DMSO should not be used in patients treated with dexrazoxane to prevent anthracycline extravasation.
Zato se DMSO ne sme uporabiti pri bolnikih, ki se zdravijo z deksrazoksanom za preprečevanje antraciklinske ekstravazacije.
Savene powder Hydrochloric acid
Prašek Savene Klorovodikova kislina
8 Savene diluent Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Water for injections
Vehikel Savene Natrijev klorid Kalijev klorid Magnezijev klorid heksahidrat Natrijev acetat trihidrat Natrijev glukonat Natrijev hidroksid Voda za injekcije
Vials and bags:
Viale in vreče:
Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8°C.
Dokazana je bilo da, je pripravljena raztopina pri temperaturi 2 do 8 °C kemijsko in fizikalno stabilana 4 ure.
From a microbiological point of view the product should be used immediately.
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren uporabnik, pri čemer shranjevanje praviloma ne sme biti daljše od 4 ur pri 2 do 8 °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 4 hours at 2 to 8°C.
6. 4 Posebna navodila za shranjevanje
Store below 25°C.
9 Shranjujte pri temperaturi do 25 °C.
Keep the vials and bags in the outer carton in order to protect from light.
Viale in vreče shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Amber coloured glass type I vial with rubber stopper made of chlorobutyl and a flip- off or tear off cap.
Viala iz stekla tipa I jantarne barve z gumastim zamaškom iz klorobutila in izvlečno ali potezno zaporko.