natgillin/translations-raw huggingface dataset:
The osmotic gradient promotes water absorption from the renal tubules resulting in increased extracellular fluid volume, leading to blood volume expansion, improved venous return to the heart, and increased cardiac output.
Osmotski gradient spodbuja absorpcijo vode iz ledvičnih tubulov, kar povzroči povečan zunajcelični tekočinski volumen, zato se volumen krvi poveča, izboljša se vračanje venske krvi v srce in večji je minutni volumen srca.
In case of accidental spillage onto the skin or eyes, wash the affected area with water.
V primeru nenamernega razlitja po koži ali v oči prizadeti predel takoj izperite z vodo.
Zycortal is intended for long term administration at intervals and doses dependent upon individual response.
Zdravilo Zycortal je indicirano za dolgotrajno dajanje v intervalih in odmerkih, ki so odvisni od individualnega odziva.
Dogs with combined glucocorticoid and mineralocorticoid deficiency should also receive a glucocorticoid such as prednisolone in accordance with standard texts.
Psi s kombiniranim glukokortikoidnim in mineralokortikoidnim pomanjkanjem morajo dobiti tudi glukokortikoid, kot je prednizolon, v skladu s standardnimi navodili.
In a clinical trial, very common adverse reactions were polydipsia (excessive drinking) and polyuria (excessive urination).
V kliničnih preskušanjih sta bila zelo pogosta neželena učinka polidipsija (pretirano pitje) in poliurija (pretirano uriniranje).
Desoxycortone is a corticosteroid with primarily mineralocorticoid activity, similar to aldosterone.
Dezoksikorton je kortikosteroid s primarno mineralokortikoidno aktivnostjo, podobno aldosteronu.
Type I glass vial (containing 4 ml) with a coated chlorobutyl rubber stopper and aluminium seal with a plastic flip-off cap.
Viala iz stekla tipa I (vsebuje 4 ml) z obloženim klorobutilnim gumijastim zamaškom in aluminijasto zaporko s plastičnim pokrovčkom.
Initial dose of Zycortal: The initial dose is 2.2 mg/kg body weight, administered by subcutaneous injection.
Začetni odmerek zdravila Zycortal: Začetni odmerek je 2,2 mg/kg telesne teže, aplicirano v obliki subkutane injekcije.
Any dog presenting with severe hypovolaemia, dehydration, prerenal azotaemia and inadequate tissue perfusion (also known as “Addisonian crisis”) must be rehydrated with intravenous fluid (saline) therapy before starting treatment with the veterinary medicinal product.
Vsakega psa, pri katerem se pojavljajo huda hipovolemija, dehidracija, prerenalna azotemija in neustrezna perfuzija tkiv (znano tudi kot "Addisonska kriza") je treba pred začetkom zdravljenja z zdravilom rehidrirati z intravensko tekočino (fiziološko raztopino).
Tailor the dose of Zycortal and the concurrently administered glucocorticoid replacement therapy to the individual dog based on clinical response and normalization of Na⁺ and K⁺ serum concentrations.
Odmerek zdravila Zycortal in sočasno aplicirano nadomestno glukokortikoidno zdravljenje je treba prilagoditi na individualne potrebe psa na podlagi kliničnega odziva in normalizacije koncentracije Na⁺ in K⁺ v serumu.
Pancreas disorders have been reported very rarely following use of Zycortal.
Po uporabi zdravila Zycortal so zelo redko poročali o motnjah trebušne slinavke.
25 days after the first dose, administer Zycortal, as follows: Decrease dose to: 2.0 mg/kg body weight
25 dni po prvem odmerku dajte zdravilo Zycortal kot sledi: Zmanjšajte odmerek na: 2,0 mg/kg telesne teže
• Clinical signs of polyuria/polydipsia: Decrease the glucocorticoid dose first.
• Klinični znaki poliurije/polidipsije: Najprej zmanjšajte odmerek glukokortikoida.
Shelf life after first opening the container: 120 days.
Rok uporabnosti po prvem odpiranju vsebnika: 120 dni.
If the dog develops abnormal clinical signs or Na⁺ or K⁺ serum concentrations, use the following guidelines for subsequent doses:
Če se pri psu razvijejo nenormalni klinični znaki ali koncentracije Na⁺ ali K⁺ v serumu, uporabite za nadaljnje odmerke naslednje smernice:
Evaluate the electrolytes every 5-9 days until the Na⁺/K⁺ ratio is < 32, and then administer 2.2 mg/kg of Zycortal.
Ocenite elektrolite vsakih 5-9 dni, dokler ni razmerje Na⁺/K⁺ < 32, nato pa dajte zdravilo Zycortal v odmerku 2,2 mg/kg.
Manufacturer responsible for batch release: Dales Pharmaceuticals Limited Snaygill Industrial Estate Keighley Road
Proizvajalec odgovoren za sproščanje serij: Dales Pharmaceuticals Limited Snaygill Industrial Estate Keighley Road
Prolonging the dosing interval:
Podaljšanje intervala odmerjanja:
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso omenjeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
Use an appropriately graduated syringe to accurately administer the required dose volume.
Za pravilno dajanje potrebne količine odmerka uporabite ustrezno graduirano injekcijsko brizgo.
5531 AE Bladel The Netherlands
5531 AE Bladel Nīderlande
In the kidney, desoxycortone causes sodium and chloride ion retention, and hydrogen and potassium ion excretion, creating an osmotic gradient.
V ledvicah povzroči dezoksikorton zastajanje natrija in kloridnega iona ter izločanje vodikovega in kalijevega iona, kar ustvari osmotski gradient.
Continue 2.2 mg/kg body weight
Nadaljujte z 2,2 mg/kg telesne teže
• If the dog is both clinically normal and has a normal Na
• Če je pes klinično normalen in ima na 25. dan normalno razmerje Na
Polyuria and polydipsia may be observed.
Opaziti je možno poliurijo in polidipsijo.
Hypertension has been observed in dogs receiving 20 mg/kg of desoxycortone pivalate.
Hipertenzijo so opazili pri psih, ki so dobili 20 mg/kg dezoksikorton pivalata.
When given to dogs at three to five times the recommended dose, injection site reactions characterised by erythema and oedema occurred.
Pri dajanju tri- do štirikratnega priporočenega odmerka psom so se pojavile reakcije na mestu injiciranja kot eritem in edem.
Use caution when administering Zycortal concurrently with medicinal products which affect either serum sodium or potassium concentrations, or cellular transportation of sodium or potassium, for example: trimethoprim, amphotericin B, or digoxin or insulin.
Previdnost je potrebna, ko se zdravilo Zycortal uporablja sočasno z zdravili, ki vplivajo na koncentracije natrija ali kalija v serumu ali na celični prenos natrija ali kalija, na primer: trimetoprim, amfotericin B, digoksin ali insulin.
Increase dose to: 2.3 mg/kg body weight Increase dose to: 2.4 mg/kg body weight
Povečajte odmerek na: 2,3 mg/kg telesne teže Povečajte odmerek na: 2,4 mg/kg telesne teže
If the polyuria/polydipsia persists and the Na⁺/K⁺ ratio is >32, then decrease the dose of Zycortal without changing the dosing interval.
Če poliurija/polidipsija vztraja in je razmerje Na⁺/K⁺ > 32, odmerek zdravila Zycortal zmanjšajte brez spreminjanja intervala odmerjanja.
Prolonged-release suspension for injection.
Suspenzija s podaljšanim sproščanjem za injiciranje.
Prior to use, gently shake the vial to resuspend the product.
Pred uporabo vialo nežno pretresite, da se zdravilo resuspendira.
As expected from the pharmacodynamic effects, escalating doses of desoxycortone are associated with a dose-related trend for increased serum sodium, and decreased blood urea nitrogen, serum potassium and urine specific gravity.
Kot se pričakuje zaradi farmakodinamičnega učinka je večanje odmerkov dezoksikortona povezano z od odmerka odvisnim trendom povečanega natrija v serumu in zmanjšanja sečninskega dušika v krvi, kalija v serumu in specifične teže urina.
Prolonged-release suspension for injection
Suspenzija s podaljšanim sproščanjem za injiciranje
After subcutaneous administration of desoxycortone pivalate at a dosage of 11 mg/kg body weight (five times the recommended dosage), the plasma half-life (mean ± standard deviation) is approximately 17 ± 7 days, with a maximum concentration (Cmax) of 13.2 ± 5 ng/ml, and time to maximum concentration (Tmax) of 10 ± 3.5 days.
Po subkutani aplikaciji dezoksikortonpivalata v odmerku 11 mg/kg telesne teže (petkratni priporočeni odmerek) je razpolovni čas v plazmi (povprečje ± standardni odklon) približno 17 ± 7 dni, z največjo koncentracijo (Cmax) 13,2 ± 5 ng/ml, in čas do največje koncentracije (Tmax) je 10 ± 3,5 dni.
Polyuria, polydipsia may be observed.
Opaziti je možno poliurijo, polidipsijo.
• Hyperkalaemia, hyponatremia or Na⁺/K⁺ ratio < 27: Decrease the Zycortal dosing interval by 2-3 days or increase the dose.
• Hiperkaliemija, hiponatriemija ali razmerje Na⁺/K⁺ < 27: Zmanjšajte interval odmerjanja zdravila Zycortal za 2-3 dni ali povečajte odmerek.
At approximately 25 days after the first dose, re-evaluate the dog and measure the Na⁺/K⁺ ratio.
Približno 25 dni po prvem odmerku ponovno ocenite psa in izmerite razmerje Na⁺/K⁺.
EXP {month/year} Once broached, use by __/__/__
EXP {mesec/leto} Načeto zdravilo uporabite do __/__/__
If the dog is clinically normal and the Day 25 Na⁺/K⁺ ratio is > 32, it is possible to prolong the dosing interval instead of adjusting the dose as described in Table 1.
Če je pes klinično normalen in je 25. dne razmerje Na⁺/K⁺ > 32, lahko interval odmerjanja podaljšate, namesto da bi prilagodili odmerek, kot je opisano v preglednici 1.
Common reactions were inappropriate urination, lethargy, alopecia, panting, vomiting, decreased appetite, anorexia, decreased activity, depression, diarrhoea, polyphagia, shaking, tiredness and urinary tract infections.
Pogosti neželeni učinki so bili neprimerno uriniranje, letargija, alopecija, sopenje, bruhanje, zmanjšan apetit, anoreksija, zmanjšana aktivnost, depresija, driska, polifagija, tresenje, utrujenost in okužbe sečil.
Use with caution in dogs with congestive heart disease, severe renal disease, primary hepatic failure or oedema.
Pri psih s kongestivno srčno boleznijo, hudim ledvičnim obolenjem, primarno jetrno odpovedjo ali edemom zdravilo uporabljajte previdno.
Pack size of 1.
Pakiranje vsebuje 1 vialo.
Common reactions were inappropriate urination, lethargy, alopecia (hair loss), panting, vomiting, decreased appetite, anorexia, decreased activity, depression, diarrhoea, polyphagia (excessive eating), shaking, tiredness and urinary tract infections.
Pogosti neželeni učinki so bili neprimerno uriniranje, letargija, alopecija (izpadanje dlake), sopenje, bruhanje, zmanjšan apetit, anoreksija, zmanjšana aktivnost, depresija, driska, polifagija (pretirana ješčost), tresenje, utrujenost in okužbe sečil.
Decrease dose to: 2.1 mg/kg body weight
Zmanjšajte odmerek na: 2,1 mg/kg telesne teže
Shelf life after first opening the immediate packaging: 120 days.
Rok uporabnosti po prvem odpiranju stične ovojnine: 120 dni.
In a clinical trial, very common adverse reactions were polydipsia and polyuria.
V kliničnih preskušanjih sta bila zelo pogosta neželena učinka polidipsija in poliurija.
If irritation occurs, seek medical advice immediately and show the package leaflet or the label to the physician.
Če se pojavi draženje, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Excipients: Chlorocresol 1 mg/ml
Pomožna snov: klorokrezol 1 mg/ml
Second dose of Zycortal: At approximately 25 days after the first dose, re-evaluate the dog and measure the Na⁺/K⁺ ratio.
Drugi odmerek zdravila Zycortal: Približno 25 dni po prvem odmerku ponovno ocenite psa in izmerite razmerje Na⁺/K⁺.
ratio (i.e. 27 to 32) on Day 25, adjust the dose based on the Day 10 Na⁺/K⁺ ratio using the guidelines in Table 1, below.
(tj. 27 do 32), prilagodite odmerek na podlagi razmerja Na⁺/K⁺ na 10. dan s pomočjo smernic v spodnji Preglednici 1.
Table 1: Day 25: Administering the Second Dose of Zycortal If the Day 10 Na⁺/K⁺ ratio is:
Preglednica 1: 25. dan: dajanje drugega odmerka zdravila Zycortal Če je 10. dan razmerje Na⁺/K⁺:
In the clinical trial, the mean final dose of Zycortal was 1.9 mg/kg (range 1.2-2.5 mg/kg) and the mean final dosing interval was 38.7 ± 12.7 days (range 20-99 days) with the majority of dogs having a dosing interval between 20 and 46 days.
V kliničnih preskušanjih je bil srednji končni odmerek zdravila Zycortal 1,9 mg/kg (razpon 1,22,5 mg/kg) in srednji končni interval odmerjanja 38,7 ± 12,7 dni (razpon 20-99 dni), pri čemer je bil interval odmerjanja pri večini psov med 20 in 46 dni.
• Hypokalaemia, hypernatremia or Na⁺/K⁺ ratio > 32: Decrease the Zycortal dose.
• Hipokaliemija, hipernatriemija ali razmerje Na⁺/K⁺ > 32: Zmanjšajte odmerek zdravila Zycortal.
In the clinical trial, the mean final dose of desoxycortone pivalate was 1.9 mg/kg (range 1.22.5 mg/kg) and the mean final dosing interval was 38.7 ± 12.7 days (range 20-99 days) with the majority of dogs having a dosing interval between 20 and 46 days.
V kliničnih preskušanjih je bil srednji končni odmerek dezoksikortonpivalata 1,9 mg/kg (razpon 1,22,5 mg/kg) in srednji končni interval odmerjanja 38,7 ± 12,7 dni (razpon 20-99 dni), pri čemer je bil interval odmerjanja pri večini psov med 20 in 46 dni.
• If the dog is either not clinically normal or if the Na⁺/K⁺ ratio is abnormal on Day 25, adjust the dose of glucocorticoid or Zycortal (see Subsequent doses and long term management).
• Če pes ni klinično normalen ali če je na 25. dan razmerje Na⁺/K⁺ nenormalno, prilagodite odmerek glukokortikoida ali zdravila Zycortal (glejte Naslednji odmerki in dolgotrajno upravljanje).
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERI
• If the dog is clinically normal and has a Na⁺/K⁺ ratio > 32 on Day 25, either adjust the dose based on the Day 10 Na⁺/K⁺ ratio according to Table 1 or delay the dose (see Prolonging the dosing interval).
• Če je pes klinično normalen in ima na 25. dan razmerje Na⁺/K⁺ > 32, prilagodite odmerek na podlagi razmerja Na⁺/K⁺ na 10. dan v skladu s preglednico ali odmerek zamaknite (glejte Podaljšanje intervala odmerjanja).
Pregnant and breast-feeding women should avoid administration of this product.
Tega zdravila naj ne dajejo nosečnice in ženske, ki dojijo.
This product may cause pain and swelling at the injection site if accidentally self-administered.
V primeru nenamernega samo-injiciranja lahko to zdravilo povzroči bolečino in oteklino na mestu injiciranja.
Methylcellulose Sodium carboxymethylcellulose Polysorbate 60
6.1 Seznam pomožnih snovi metilceluloza natrijeva karboksimetilceluloza polisorbat 60 natrijev klorid klorokrezol voda za injekcije
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
Zycortal 25 mg/ml suspenzija s podaljšanim sproščanjem za injiciranje za pse
Zycortal 25 mg/ml prolonged-release suspension for injection desoxycortone pivalate
Zycortal 25 mg/ml suspenzija s podaljšanim sproščanjem za injiciranje dezoksikortonpivalat
PACKAGE LEAFLET: Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
NAVODILO ZA UPORABO Zycortal 25 mg/ml suspenzija s podaljšanim sproščanjem za injiciranje za pse
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs Desoxycortone pivalate
Zycortal 25 mg/ml suspenzija s podaljšanim sproščanjem za injiciranje za pse dezoksikortonpivalat
Active substance: Desoxycortone pivalate 25 mg/ml
Učinkovina: dezoksikortonpivalat 25 mg/ml
Re-evaluate the dog and measure the serum sodium/potassium ratio (Na⁺/K⁺ ratio) approximately 10 days after the first dose (which is the time to maximum concentration (Tmax) of desoxycortone).
Približno 10 dni po prvem odmerku (to je čas najvišje koncentracije (Tmax) dezoksikortona) je treba pri psu ponovno oceniti razmerje natrija/kalija v serumu (razmerje Na⁺/K⁺).
Desoxycortone pivalate 25 mg/ml
dezoksikortonpivalat 25 mg/ml
desoxycortone pivalate 25 mg/ml
dezoksikortonepivalat 25 mg/ml
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Preprečite stik z očmi in kožo.
Invented name Strength Pharmaceutical form
Farmacevtska oblika Pot uporabe
Fifty of the patients in this study survived.
Petdeset bolnikov v tej študiji je preživelo.
The European Commission granted a marketing authorisation valid throughout the European Union for Cyanokit on 31 November 2007.
Evropska komisija je dovoljenje za promet z zdravilom Cyanokit, veljavno po vsej Evropski uniji, izdala 31. novembra 2007.
The information on these patients was obtained from their medical notes, as recorded in databases at two French hospitals.
Podatke o teh bolnikih so pridobili iz njihovih zdravniških podatkov, kakor so zabeleženi v zbirkah podatkov v dveh francoskih bolnišnicah.
The response was unknown in the remaining 13 patients.
V preostalih 13 primerih je bil odziv neznan.
Symptoms of brain damage resolved in 38 of 66 patients.
Simptomi možganske poškodbe so izzveneli pri 38 od 66 bolnikov.
The second dose is given over a period of between 15 minutes and two hours, depending on the patient's condition.
Drugi odmerek se infundira od 15 minut do 2 uri, odvisno od stanja bolnika.
It is given as an infusion over 15 minutes.
Daje se v obliki infuzije, ki traja 15 minut.
The maximum total dose is 10 g for adults, and 140 mg/kg in children up to a maximum of 10 g.
Največji odmerek za odrasle je 10 g, za otroke pa 140 mg/kg do največ 10 g.
The full EPAR for Cyanokit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cyanokit je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Hydroxocobalamin (vitamin B12a) has been used as a vitamin supplement since the 1950s.
Hidroksokobalamin (vitamin B12a) se uporablja kot vitaminsko dopolnilo že od petdesetih let prejšnjega stoletja.
This is a summary of the European public assessment report (EPAR) for Cyanokit.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cyanokit.
What measures are being taken to ensure the safe and effective use of Cyanokit?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cyanokit?
In the study of smoke inhalation, the response to Cyanokit was assessed as ‘positive' in 31 patients (45%), ‘partial' in 15 (22%) and ‘absent' in 10 (15%).
V študiji vdihavanja dima so odziv na zdravilo Cyanokit pri 31 (45 %) bolnikih ocenili kot „pozitiven“, pri 15 (22 %) bolnikih kot „delen“ in pri 10 (15 %) bolnikih kot „odsoten“.
The use of Cyanokit can interfere with the assessment of burns and with laboratory test results.
Uporaba zdravila Cyanokit lahko vpliva na ocenjevanje opeklin in rezultate laboratorijskih preiskav.
Cyanokit is given as an emergency treatment as soon as possible after poisoning.
Zdravilo Cyanokit se uporablja kot nujno zdravljenje čim prej po zastrupitvi.
This can be attached to the patient's notes so that hospital staff are made aware of these effects of the medicine.
Ta nalepka se lahko nalepi v bolnikovo kartoteko, da je zdravstveno osebje obveščeno o teh učinkih zdravila.
For more information about treatment with Cyanokit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Cyanokit preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For adults, the initial dose is 5 g. For children, it is 70 mg per kilogram body weight up to a maximum dose of 5 g. A second dose can be given, depending on how severe the poisoning is and how well the patient is responding.
Začetni odmerek za odrasle je 5 g, za otroke pa 70 mg na kilogram telesne mase do največ 5 g. Glede na resnost zastrupitve in odziv bolnika se lahko da še en odmerek.
This helps to reduce the effects of cyanide poisoning.
S tem se zmanjšajo učinki zastrupitve s cianidom.
Other information about Cyanokit
Druge informacije o zdravilu Cyanokit:
Because hydroxocobalamin has an intense red colour, most patients will have dark red colouring of the skin and mucous membranes for up to 15 days and of the urine for up to 35 days after receiving Cyanokit.
Ker ima hidroksokobalamin intenzivno rdečo barvo, se pri večini bolnikov po prejemu zdravila Cyanokit temno rdeče obarvajo koža in sluznice (do 15 dni) ter seč (do 35 dni).
A risk management plan has been developed to ensure that Cyanokit is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Cyanokit je bil pripravljen načrt obvladovanja tveganj.
What benefit has Cyanokit shown during the studies?
Kakšne koristi je zdravilo Cyanokit izkazalo med študijami?
Therefore, the CHMP decided that Cyanokit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je odbor CHMP zaključil, da so koristi zdravila Cyanokit večje od z njim povezanih tveganj in priporočil, da se zanj izda dovoljenje za promet.
Information on its effectiveness was obtained in 83 patients who had been admitted to hospital with suspected cyanide poisoning and who received Cyanokit.
Učinkovitost so ugotavljali pri 83 bolnikih, ki so bili sprejeti v bolnišnico s sumom zastrupitve s cianidom in ki so prejeli zdravilo Cyanokit.
In this study, the patients' condition at the accident scene was compared with that at the end of the infusion of Cyanokit and over the following three days.
V tej študiji so primerjali stanje bolnikov na mestu nezgode s stanjem po koncu infundiranja zdravila Cyanokit ter stanjem v naslednjih treh dneh.
Cyanide poisoning usually results from exposure to smoke from fire, from breathing or swallowing cyanide, or from getting it onto the skin or mucous membranes (moist body surfaces, such as the lining of the mouth).
Zastrupitev s cianidom je navadno posledica izpostavljenosti dimu pri požarih, vdihavanja ali zaužitja cianida ali stika z njim prek kože ali sluznice (vlažne površine telesa, npr. v ustih).
It contains the active substance hydroxocobalamin (vitamin B12a).
Vsebuje zdravilno učinkovino hidroksokobalamin (vitamin B12a).
Cyanokit is given along with other appropriate decontamination and supportive measures, including providing oxygen for the patient to breathe.
Zdravilo Cyanokit se uporablja skupaj z ustreznimi ukrepi za dekontaminacijo in oskrbo bolnika, vključno z dovajanjem kisika za dihanje.
This lowers cyanide levels in the body and stops the cyanide fixing itself to an enzyme in cells called cytochrome oxidase, which is important for providing energy in cells.
S tem se znižajo ravni cianida v telesu in prepreči vezava cianida na celični encim citokrom-oksidazo, ki je pomemben za zagotavljanje energije v celicah.
Survival was more likely in those who received Cyanokit before their hearts had stopped, who had less severe symptoms of brain damage and who had lower blood cyanide levels.
Preživetje je bilo bolj verjetno pri bolnikih, ki so prejeli zdravilo Cyanokit, preden se jim je ustavilo srce, pri bolnikih, ki so imeli blažje simptome možganske poškodbe in ki so imeli nižje ravni cianida v krvi.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cyanokit.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cyanokit, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Two patients survived despite their hearts having stopped before receiving Cyanokit.
Dva bolnika sta preživela, čeprav je prišlo do zastoja srca pred prejemom zdravila Cyanokit.