natgillin/translations-raw huggingface dataset:
Unpredictable*** (LDH)
Albumin Alkalna fosfataza
interference after a 5 g dose
Laktat- dehidrogenaza (LDH)
Erythrocytes Haematocrit Mean corpuscular volume (MCV) Leucocytes Lymphocytes Monocytes Eosinophils Neutrophils Platelets
Eritrociti Hematokrit Povprečni volumen eritrocitov (MCV) Levkociti Limfociti Monociti Eozinofilci Nevtrofilci Trombociti
Haemoglobin (Hb) Mean corpuscular haemoglobin (MCH) Mean corpuscular haemoglobin concentration (MCHC)
Hemoglobin (Hb) Povprečna količina hemoglobina v eritrocitu (MCH) Povprečna koncentracija hemoglobina v eritrocitih (MCHC)
12-16 hours
12– 16 ur
Coagulation * ≥ 10% interference observed on at least one analyser ** Artificially decreased using the diazo method *** Inconsistent results
Koagulacija
Activated partial thromboplastin time (aPTT) Prothrombin time (PT) Quick or INR
Aktivirani parcialni tromboplastinski čas (aPTT) Protrombinski čas (PT) Quickov test ali INR
Analysers used:
Uporabljani analizatorji:
ACL Futura (Instrumentation Laboratory), Axsym/ Architect (Abbott), BM Coasys110 (Boehringer Mannheim), CellDyn 3700 (Abbott), Clinitek 500 (Bayer), Cobas Integra 700, 400 (Roche), Gen-S Coultronics, Hitachi 917, STA® Compact, Vitros 950 (Ortho Diagnostics)
ACL Futura (Instrumentation Laboratory), Axsym/ Architect (Abbott), BM Coasys110 (Boehringer Mannheim), CellDyn 3700 (Abbott), Clinitek 500 (Bayer), Cobas Integra 700, 400 (Roche), Gen- S Coultronics, Hitachi 917, STA® Compact, Vitros 950 (Ortho Diagnostics).
The effects on these tests typically last 48 hours after a 5 g dose, but may persist for longer periods.
Učinki na te teste navadno trajajo 48 ur po 5- gramskem odmerku, vendar lahko vztrajajo daljše obdobje.
The safety of administering other cyanide antidotes simultaneously with Cyanokit has not been established (see section 6.2).
Varnost sočasne uporabe drugih antidotov proti cianidu in zdravila Cyanokit ni ugotovljena (glejte poglavje 6. 2).
If the decision is made to administer another cyanide antidote with Cyanokit, these medicinal products must not be administered concurrently in the same intravenous line (see section 6.2).
Pri odločitvi za uporabo drugega antidota proti cianidu skupaj z zdravilom Cyanokit, se ta zdravila ne smejo dajati sočasno po isti intravenski liniji (glejte poglavje 6. 2).
Animal studies have shown teratogenic effects following daily exposure throughout organogenesis (see section 5.3).
Študije na živalih so pokazale teratogene učinke po dnevni izpostavljenosti ves čas trajanja organogeneze (glejte poglavje 5. 3).
- that no more than two injections of hydroxocobalamin are to be administered,
- uporabljeni ne bosta več kot dve injekciji hidroksokobalamina,
- the potentially life threatening condition,
- morebitnega smrtno nevarnega stanja,
- the lack of alternative treatment,
- pomanjkanja alternativnih zdravljenj,
hydroxocobalamin may be given to a pregnant woman.
hidroksokobalamin lahko da nosečnici.
In case of known pregnancy at the time of treatment with Cyanokit or in case that pregnancy becomes known after treatment with Cyanokit, health care professionals are requested to promptly report the exposure during pregnancy to the Market Authorisation Holder and to carefully follow-up on the pregnancy and its outcome.
V primeru znane nosečnosti v času zdravljenja z zdravilom Cyanokit ali v primeru, da postane nosečnost znana po zdravljenju z zdravilom Cyanokit, morajo zdravstveni delavci o izpostavljenosti med nosečnostjo takoj poročati imetniku dovoljenja za promet in skrbno spremljati nosečnost in njen izid.
5 Because hydroxocobalamin will be administered in potentially life-threatening situations, breast- feeding is not a contraindication to its use.
5 Ker se hidroksokobalamin uporablja v potencialno smrtno nevarnih primerih, dojenje ni kontraindikacija za njegovo uporabo.
No studies on the effects on the ability to drive or to use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
The following undesirable effects have been reported in association with Cyanokit use.
Pri uporabi zdravila Cyanokit so poročali o naslednjih neželenih učinkih.
Cyanokit may cause red discolouration of the plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters (see section 4.5).
Zdravilo Cyanokit lahko povzroči rdeče obarvanje plazme, ki lahko umetno zviša ali zniža ravni nekaterih laboratorijskih parametrov (glejte poglavje 4. 4).
Skin and subcutaneous tissue disorders
6 Bolezni kože in podkožja
6 Reversible red colouration of the skin and mucous membranes (see above).
Reverzibilno rdeče obarvanje kože in sluznic (glejte zgoraj).
Doses as high as 15 g have been administered without reported specific dose related adverse reactions.
Odmerke do 15 g so uporabljali so aplicirali brez specifičnih neželenih reakcij, odvisnih od odmerka.
Haemodialysis may be effective in such a circumstance, but is only indicated in the event of significant hydroxocobalamin- related toxicity.
V takšnih okoliščinah je hemodializa lahko učinkovita, vendar je indicirana le pri pomembni toksičnosti, povezani s hidroksokobalaminom.
Antidote, ATC code:
Antidoti, oznaka ATC:
Each hydroxocobalamin molecule can bind one cyanide ion by substituting the hydroxo ligand linked to the trivalent cobalt ion to form cyanocobalamin.
Vsaka molekula hidroksokobalamina lahko veže en cianidni ion ob substituciji hidrokso- liganda, ki je vezan na trivalentni kobaltov ion, pri čemer nastane cianokobalamin.
Dogs then received sodium chloride 9 mg/ ml, 75 mg/ kg or 150 mg/ kg hydroxocobalamin, administered intravenously over 7.5 minutes.
Nato so jim v 7, 5 minute intravensko dali 9 mg/ ml natrijevega klorida, 75 mg/ kg hidroksokobalamina ali 150 mg/ kg hidroksokobalamina.
The 75 mg/ kg and 150 mg/ kg doses are approximately equivalent to 5 g and 10 g of hydroxocobalamin, respectively, in humans, not only on a body weight basis but also on Cmax basis of hydroxocobalamin [total cobalamins-(III), see section 5.2].
Odmerek 75 mg/ kg približno ustreza odmerku 5 g hidroksokobalamina pri človeku, 150 mg/ kg pa 10 g hidroksokobalamina, ne le na podlagi telesne mase, ampak tudi na podlagi vrednosti Cmax [skupni kobalamini - (III), glejte poglavje 5. 2].
Survival at hour 4 and at day 14 was significantly greater in 75 mg/ kg and 150 mg/ kg hydroxocobalamin dose groups compared with dogs receiving sodium chloride 9 mg/ ml alone:
7 Preživetje po 4 urah in po 14 dnevu je bilo pri skupinah, ki so prejemale odmerke 75 mg/ kg hidroksokobalamina in 150 mg/ kg hidroksokobalamina, pomembno večje kot pri psih, ki so prejemali samo 9 mg/ ml natrijevega klorida:
7 Survival of cyanide-poisoned dogs
Preživetje psov, zastrupljenih s cianidom
9 mg/ ml
Natrijev klorid 9 mg/ ml
75 mg/ kg
Hidroksokobalamin 75 mg/ kg 150 mg/ kg
Parameter Survival at Hour 4, N (%) Survival at Day 14, N (%)
Parameter Preživetje po 4 urah, N (%) Preživetje po 14 dneh, N (%) < 0, 025
The incidence of brain lesions was markedly lower in dogs having received 150 mg/ kg hydroxocobalamin than in dogs having received 75 mg/ kg hydroxocobalamin or sodium chloride 9 mg/ ml.
Pogostnost možganskih lezij je bila pri psih, ki so prejemali 150 mg/ kg hidroksokobalamina, znatno manjša kot pri psih, ki so prejemali 75 mg/ kg hidroksokobalamina ali 9 mg/ ml natrijevega klorida.
Hydroxocobalamin reduced whole blood cyanide concentrations from about 120 nmol/ ml to 30-40 nmol/ ml by the end of the infusion compared with 70 nmol/ ml in dogs receiving sodium chloride 9 mg/ ml alone.
Hidroksokobalamin je ob koncu infundiranja zmanjšal celotno koncentracijo cianida v krvi s približno 120 nmol/ ml na 30– 40 nmol/ ml, pri psih, ki so prejemali samo 9 mg/ ml natrijevega klorida, pa je koncentracijo zmanjšal na 70 nmol/ ml.
Of the 213 patients in whom the outcome was known the survival was 58%.
Pri 213 bolnikih, pri katerih je izid bil znan, je bilo preživetje 58- odstotno.
Furthermore, in 34 patients with known cyanide concentrations above the lethal threshold (≥ 100 µmol/ l), 21 (62%) survived following treatment with hydroxocobalamin.
Od 34 bolnikov, pri katerih so bile koncentracije cianida nad pragom smrtnega odmerka (≥ 100 µmol/ l), jih je po zdravljenju s hidroksokobalaminom preživelo 21 (62%).
• Elderly
• Starejši bolniki
Documentation on efficacy is availablefor 54 paediatric patients.
Dokumentacija učinkovitosti je na voljo za 54 pediatričnih bolnikov.
The mean age of the paediatric patients was about six years and the mean dose of hydroxocobalamin was about 120 mg/ kg body weight.
Povprečna starost pediatričnih bolnikov je bila približno 6 let, povprečen odmerek hidroksokobalamina pa približno 120 mg/ kg telesne mase.
The survival rate of 41% depended very much on the clinical situation.
Stopnja preživetja, 41%, je bila v veliki meri odvisna od klinične situacije.
Out of the 20 paediatric patients without initial cardiac arrest, 18 (90%) survived, of whom 4 with sequelae.
Od 20 pediatričnih bolnikov, ki niso imeli srčnega zastoja, jih je preživelo 18 (90%), med njimi 4 s posledicami.
Following intravenous administration of Cyanokit, significant binding to plasma proteins and low molecular weight physiological compounds occurs, to form various cobalamin-(III) complexes by replacing the hydroxo ligand.
Po intravenski uporabi zdravila Cyanokit pride do pomembne vezave na beljakovine v plazmi in pojava fizioloških spojin z majhno molsko maso, ki s substitucijo hidrokso liganda tvorijo različne komplekse kobalamina - (III).
The low molecular weight cobalamins-(III) formed including
Nastali kobalamini - (III) z majhno molsko maso, vključno s hidroksokobalaminom, se imenujejo prosti kobalamini - (III).
8 hydroxocobalamin are termed free cobalamins-(III); the sum of free and protein-bound cobalamins is termed total cobalamins-(III).
Seštevek prostih kobalaminov in kobalaminov, vezanih na beljakovine, pa se imenuje skupni kobalamini - (III).
In order to reflect the exposure to the sum of all derivatives, pharmacokinetics of cobalamins-(III) were investigated instead of hydroxocobalamin, requiring the concentration unit µg eq/ ml (i. e. cobalamin-(III) entity without specific ligand).
Da bi ocenili izpostavljenost celotni količini vseh derivatov, so namesto farmakokinetike hidroksokobalamina raziskovali farmakokinetiko kobalaminov - (III), pri kateri so uporabili enoto koncentracije µg eq/ ml (tj. entiteto kobalamina - (III) brez specifičnega liganda).
Dose-proportional pharmacokinetics were observed following single dose intravenous administration of 2.5 to 10 g of Cyanokit in healthy volunteers.
Farmakokinetika po intravenski uporabi enkratnega odmerka 2, 5 do 10 g zdravila Cyanokit pri zdravih prostovoljcih je bila odvisna od odmerka.
Mean free and total cobalamins-(III) Cmax values of 113 and 579 µg eq/ ml, respectively, were determined following a dose of 5 g Cyanokit (the recommended initial dose).
Po 5- gramskem odmerku zdravila Cyanokit (priporočeni začetni odmerek) je bila povprečna vrednost Cmax prostih kobalaminov - (III) 113, skupnih kobalaminov - (III) pa 579 µg eq/ ml.
Similarly, mean free and total cobalamins-(III) Cmax values of 197 and 995 µg eq/ ml, respectively, were determined following the dose of 10 g Cyanokit.
Podobno je bila po 10- gramskem odmerku zdravila Cyanokit povprečna vrednost Cmax prostih kobalaminov - (III) 197, skupnih kobalaminov - (III) pa 995 µg eq/ ml.
The predominant mean half-life of free and total cobalamins-(III) was approximately 26 to 31 hours at the 5 and 10 g dose level.
Pri odmerkih 5 in 10 g je bil prevladujoč povprečni razpolovni čas prostih in skupnih kobalaminov - (III) približno 26 do 31 ur.
The mean total amount of cobalamins-(III) excreted in urine during the collection period of 72 hours was approximately 60% of a 5 g dose and approximately 50% of a 10 g dose of Cyanokit.
Povprečna skupna količina kobalaminov - (III), izločenih z urinom v 72- urnem obdobju zbiranja, je bila pri 5- gramskem odmerku zdravila Cyanokit približno 60%, pri 10- gramskem pa približno 50%.
When normalized for body weight, male and female subjects revealed no major differences in plasma and urinary pharmacokinetic parameters of free and total cobalamins-(III) following the administration of 5 g or 10 g Cyanokit.
Pri normalizaciji na telesno maso pri moških in ženskah ni bilo pomembnih razlik pri plazemskih in urinskih farmakokinetičnih parametrih prostih in skupnih kobalaminov - (III) po uporabi 5 g ali 10 g zdravila Cyanokit.
The pharmacokinetics of total cobalamins-(III) in this population may be affected by the body's cyanide load, since cyanocobalamin was reported to exhibit a 2-3 times lower half-life than total cobalamins-(III) in healthy volunteers.
Na farmakokinetiko skupnih kobalaminov - (III) pri teh bolnikih lahko vpliva obremenitev telesa s cianidom, saj so poročali, da je razpolovni čas cianokobalamina 2 - do 3- krat krajši kot razpolovni čas skupnih kobalaminov - (III) pri zdravih prostovoljcih.
No special hazard for humans was identified based on conventional studies of single and repeated dose toxicity and genotoxicity.
Običajne študije toksičnosti in genotoksičnosti pri enkratnih in ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
In particular, liver fibrosis was observed in dogs after administration of hydroxocobalamin for 4 weeks at 300 mg/ kg.
Pri psih, ki so 4 tedne prejemali po 300 mg/ kg hidroksokobalamina, so opazili predvsem fibrozo jeter.
Developmental toxicity, including teratogenicity, was observed in rats and rabbits at dose levels of 150 mg/ kg and higher administered daily throughout organogenesis.
Pri podganah in kuncih so pri odmerkih 150 mg/ kg in več, danih dnevno ves čas trajanja organogeneze, opazili toksičnost za razvoj, vključno s teratogenostjo.
The dose of 150 mg/ kg approximately corresponds to the maximum recommended human dose.
Odmerek 150 mg/ kg približno ustreza največjemu priporočenemu odmerku za ljudi.
No data are available on male and female fertility as well as on peri- and postnatal development.
Podatkov o plodnosti pri samcih in samicah ter o peri - in postnatalnem razvoju ni.
9 6.2 Incompatibilities
Klorovodikova kislina
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6. 2 Inkompatibilnosti
Physical incompatibility (particle formation) was observed with the mixture of hydroxocobalamin in solution and the following medicinal products: diazepam, dobutamine, dopamine, fentanyl, nitroglycerin, pentobarbital, phenytoin sodium, propofol and thiopental.
Fizikalno inkompatibilnost (nastanek delcev) so opazili pri mešanju raztopine hidroksokobalamina in naslednjih zdravil: diazepam, dobutamin, dopamin, fentanil, nitroglicerin, pentobarbital, natrijev fenitoin, propofol in tiopental.
Chemical incompatibility was observed with sodium thiosulfate, sodium nitrite, and has been reported with ascorbic acid.
Kemijsko inkompatibilnost so opazili pri natrijevem tiosulfatu, natrijevem nitritu, o njej pa so poročali pri askorbinski kislini.
Consequently, these medicinal products must not be administered simultaneously through the same intravenous line as hydroxocobalamin.
Zato se ta zdravila ne smejo dajati sočasno po isti intravenski liniji kot hidroksokobalamin.
Simultaneous administration of hydroxocobalamin and blood products (whole blood, packed red cells, platelet concentrate and fresh frozen plasma) through the same intravenous line is not recommended (see section 6.6).
Sočasna uporaba hidroksokobalamina in krvnih izdelkov (polne krvi, koncentrata eritrocitov, koncentrata trombocitov in sveže zamrznjene plazme) po isti intravenski liniji ni priporočena (glejte poglavje 6. 6).
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 6 hours at a temperature between 2°C and 40°C.
Dokazano je bilo, da je rekonstituirana raztopina pri temperaturi med 2 °C in 40 °C kemijsko in fizikalno stabilna 6 ur.
For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of usual transport (15 days submitted to temperatures ranging from 5°C to 40°C), transport in the desert (4 days submitted to temperatures ranging from 5°C to 60°C) and freezing/ defrosting cycles (15 days submitted to temperatures ranging from -20°C to 40°C).
Pri ambulantni uporabi se lahko zdravilo Cyanokit kratek čas izpostavlja temperaturnim odstopanjem pri običajnem transportu (15 dni temperaturam od 5 °C do 40 °C), transportu v puščavi (4 dni temperaturam od 5 °C do 60 °C) in ciklom zamrzovanja/ odmrzovanja (15 dni temperaturam od – 20 °C do 40 °C).
For storage conditions of the reconstituted medicinal product, see section 6.3.
Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6. 3.
Type II colourless 250 ml glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid.
250- mililitrska viala iz brezbarvnega stekla vrste II, zaprta z zamaškom iz bromobutilne gume in aluminijasto zaporko s plastičnim pokrovčkom.
Each vial contains 2.5 g powder for solution for infusion.
Vsaka viala vsebuje 2, 5 g praška za raztopino za infundiranje.
Each carton contains two glass vials (each glass vial packed in one cardboard box), two sterile transfer devices, one sterile intravenous infusion set and one sterile short catheter for administration to children.
V vsaki škatli sta po dve stekleni viali (vsaka steklena viala je pakirana v kartonsko škatlo), dve sterilni napravi za prenos, en sterilen komplet za intravensko infundiranje in en sterilen kratek kateter za uporabo pri otrocih.
Each vial is to be reconstituted with 100 ml of diluent using the supplied sterile transfer device.
S priloženo sterilno napravo za prenos je treba vsako vialo rekonstituirati s 100 ml topila.
Sodium chloride 9 mg/ ml (0.9%) solution for injection is the recommended diluent.
Priporočeno topilo je natrijev klorid 9 mg/ ml (0, 9%) raztopina za injiciranje.
Only when sodium chloride 9 mg/ ml (0.9%) solution for injection is not available, Lactated Ringer solution or 5% glucose can also be used.
Če natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje ni na voljo, se lahko uporabi raztopina Ringerjevega laktata ali 5 - odstotna raztopina glukoze.
The Cyanokit vial is to be rocked or inverted for at least 30 seconds to mix the solution.
10 Vialo z zdravilom Cyanokit je treba zibati ali obračati vsaj 30 sekund, da se raztopina premeša.
The intravenous infusion set provided in the kit must then be used as it includes an appropriate filter 10 and is to be primed with the reconstituted solution.
Uporabiti je treba priložen komplet za intravensko infundiranje, ker vsebuje ustrezen filter, komplet za intravensko infundiranje pa je treba napolniti z rekonstituirano raztopino.
If blood products (whole blood, packed red cells, platelet concentrate and fresh frozen plasma) and hydroxocobalamin are administered simultaneously, use of separate intravenous lines (preferably on contralateral extremities) is recommended (see section 6.2).
Če sočasno uporabljate krvne izdelke (polno kri, koncentrat eritrocitov, koncentrat trombocitov in sveže zamrznjeno plazmo) in hidroksokobalamin, je priporočena uporaba ločenih intravenskih linij (po možnosti na nasprotnih okončinah) (glejte poglavje 6. 2).
37, rue Saint-Romain 69379 Lyon Cedex 08 France
37, rue Saint- Romain 69379 Lyon Cedex 08 Francija
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. eu. int /
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Centre de production de Semoy 2, rue du Pressoir Vert FR-45400 Semoy France
Centre de production de Semoy 2, rue du Pressoir Vert FR- 45400 Semoy Francija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3. 0, predstavljen v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, pred da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 6.0 dated 21 October 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne dejavnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 6. 0 (21. oktober 2008) načrta za obvladovanje tveganja (RMP, Risk Management Plan), predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša odbor 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 odbora CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini, je treba posodobljen RMP predložiti sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR, Periodic Safety Update Report).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljen RMP predložiti • ob prejemu novih informacij, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja; • v 60 dneh po tem, ko je dosežen pomemben mejnik (pri farmakovigilanci ali zmanjševanju tveganja); • na zahtevo Evropske agencije za zdravila (EMEA).
Cyanokit 2.5 g powder for solution for infusion Hydroxocobalamin
Cyanokit 2, 5 g prašek za raztopino za infundiranje hidroksokobalamin
Hydrochloric acid.
Pomožna snov: klorovodikova kislina.
Two vials, each containing 2.5 g of powder for solution for infusion.
Dve viali, vsaka vsebuje 2, 5 g praška za raztopino za infundiranje.
Read the leaflet for storage conditions in ambulatory use.
Pogoji shranjevanja pri ambulantni uporabi so v navodilih za uporabo.
One vial containing 2.5 g of powder for solution for infusion.
Ena viala z 2, 5 g praška za raztopino za infundiranje.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 18 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
19 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
19 PODATKI NA PRIMARNI OVOJNINI
Powder for solution for infusion containing 2.5 g of hydroxocobalamin.
Prašek za raztopino za infundiranje, ki vsebuje 2, 5 g hidroksokobalamina.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 20 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
21 MEDICAL OR HEALTHCARE PROFESSIONALS EDUCATIONAL STICKER
21 INFORMATIVNANALEPKA ZA ZDRAVNIKE ALI ZDRAVSTVENO OSEBJE
“ To be attached to the patient ’ s medical record:
“ V bolnikovo zdravstveno kartoteko je treba priložiti naslednje:
Cyanokit may interfere with burn assessment (red coloration of the skin) and laboratory tests (see SPC) .”
Zdravilo Cyanokit lahko moti ocenjevanje stopnje opeklin (povzroči rdeče obarvanje kože) in rezultate laboratorijskih preiskav (glejte povezetek glavnih značilnosti zdravila). ”