natgillin/translations-raw huggingface dataset:
Your newborn may experience fever, rapid breathing (tachypnoea), jitteriness, muscular tremor vomiting, high blood levels of sugar (hyperglycemia), low blood levels of potassium (hypokalaemia), high blood levels of certain chemicals (urea), elevated number of certain cells (leukocyte) in blood and seizures if he/she receives more caffeine citrate than he/she should. 
Pri vašem novorojenčku se lahko pojavijo zvišana telesna temperatura, hitro dihanje (tahipneja), živčnost, trzanje mišic, bruhanje, visoke ravni sladkorja v krvi (hiperglikemija), nizke ravni kalija v krvi (hipokaliemija), visoke ravni nekaterih kemičnih substanc (sečnine) v krvi, zvišano število nekaterih celic (levkocitov) v krvi in epileptični napadi, če dobi več kofeinijevega citrata, kot bi smel.
Hepatic caffeine metabolism develops progressively in the weeks following birth and for the older infants, hepatic disease may indicate a need for monitoring caffeine plasma levels and may require dose adjustments (see sections 4.4 and 5.2). 
Presnova kofeina v jetrih se postopoma razvija v tednih po rojstvu in za starejše dojenčke lahko bolezen jeter kaže na potrebo po nadziranju ravni kofeina v plazmi in prilagoditev odmerka (glejte poglavji 4.4 in 5.2).
However, caffeine metabolism in preterm newborn infants is limited due to their immature hepatic enzyme systems. 
Vendar pa je presnova kofeina pri nedonošenih novorojenčkih omejena zaradi njihovih nezrelih jetrnih encimskih sistemov.
Treatment should be administered only in a neonatal intensive care unit in which adequate facilities are available for patient surveillance and monitoring. 
Zdravljenje mora potekati izključno na oddelku intenzivne nege za novorojenčke, kjer so na voljo ustrezni pripomočki za nadzor in spremljanje bolnika.
Solution for infusion Oral solution 10 ampoules 
raztopina za infundiranje peroralna raztopina 10 ampul
The recommended dose regimen in previously untreated infants is a loading dose of 20 mg caffeine citrate per kg body weight administered by slow intravenous infusion over 30 minutes, using a syringe infusion pump or other metered infusion device. 
Priporočeni režim odmerjanja predhodno nezdravljenih dojenčkov je začetni odmerek 20 mg kofeinijevega citrata na kg telesne mase, odmerjan s počasno 30-minutno intravensko infuzijo z infuzijsko črpalko na brizgo ali drugo odmerno infuzijsko napravo.
− infants with seizure disorders 
− dojenčki z epileptičnimi napadi
As bacterial overgrowth in the gut is associated with the development of necrotising enterocolitis, coadministration of caffeine citrate with medicinal products that suppress gastric acid secretion (antihistamine H2 receptor blockers or proton-pump inhibitors) may in theory increase the risk of necrotising enterocolitis (see section 4.4 and 4.8). 
Ker je razbohotenje bakterij v črevesju povezano z razvojem nekrotizirajočega enterokolitisa, lahko sočasna uporaba kofeinijevega citrata z zdravili, ki zavirajo izločanje želodčne kisline (zaviralci histaminskih receptorjev H2 ali zaviralci protonske črpalke), teoretično zvečajo tveganje nekrotizirajočega enterokolitisa (glejte poglavji 4.4 in 4.8).
The MAH shall agree with the National Competent Authorities the final text of a card suitable for display in neonatal intensive care units. 
Imetniki dovoljenja za promet z zdravilom se morajo dogovoriti z nacionalnimi pristojnimi organi glede besedila kartice, primerne za prikazovanje v enotah za intenzivno nego novorojenčkov.
Caffeine citrate should be used with caution in infants suffering gastro-oesophageal reflux, as the treatment may exacerbate this condition. 
Kofeinijev citrat je treba uporabljati previdno pri dojenčkih, ki imajo gastroezofagalni refluks, saj ga lahko zdravljenje poslabša.
Rare reported side effects (may affect up to 1 in 1,000 people) - allergic reactions 
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
Signs and symptoms reported in the literature after caffeine overdose in preterm infants include hyperglycaemia, hypokalaemia, fine tremor of the extremities, restlessness, hypertonia, opisthotonus, tonic clonic movements, seizures, tachypnoea, tachycardia, vomiting, gastric irritation, gastrointestinal haemorrhage, pyrexia, jitteriness, increased blood urea and increased white blood cell count, non-purposeful jaw and lip movements. 
Znaki in simptomi, o katerih poročajo v literaturi po prevelikem odmerjanju kofeina pri nedonošenčkih, vključujejo hiperglikemijo, hipokalemijo, rahel tremor okončin, nemir, hipertonijo, opistotonus, tonično-klonične gibe, epileptične napade, tahipnejo, tahikardijo, bruhanje, želodčno draženje, gastrointestinalne krvavitve, pireksijo, živčnost, zvišanje ravni sečnine v krvi in zvišanje števila levkocitov, nepotrebne gibe čeljusti in ustnic.
If you (the mother) are breast-feeding while your infant is treated with Peyona, you should not drink coffee or take any other high caffeine product as caffeine passes into breast milk. 
Če vi (mati) v času zdravljenja dojenčka z zdravilom Peyona dojite, ne smete piti kave ali jemati drugih izdelkov, ki vsebujejo kofein, saj kofein prehaja v mleko.
One case of caffeine overdose complicated by development of intraventricular haemorrhage and long-term neurological sequelae has been reported. 
Poročali so o enem primeru prevelikega odmerjanja kofeina z zapletom v razvoju intraventrikularne krvavitve in dolgoročnimi nevrološkimi posledicami.
The MAH shall agree the text of a Dear Healthcare Professional letter with the CHMP (and if necessary with the National Competent Authorities) prior to launch of the medicinal product and shall ensure that it is provided to all physicians experienced in neonatal intensive care prior to or at the launch of the medicinal product in each Member State. 
<vstavite lokalno ime in naslov družbe Chiesi Farmaceutici S.p.A.> Imetnik dovoljenja za promet z zdravilom se mora pred prihodom zdravila na trg glede uvodnega pisma za strokovno osebje dogovoriti z odborom CHMP (in po potrebi z nacionalnimi pristojnimi organi) in poskrbeti, da bodo pismo dobili vsi zdravniki, ki imajo izkušnje v intenzivnemu negovanju novorojenčkov pred ali ob prihodu zdravila na trg v vsaki državi članici.
What Peyona looks like and content of the pack 
Izgled zdravila Peyona in vsebina pakiranja
Citric acid monohydrate, sodium citrate, water for injections. 
monohidrat citronske kisline, natrijev citrat, voda za injekcije
Gastrointestinal disorders Regurgitation, increased gastric aspirate, necrotising enterocolitis 
Bolezni prebavil regurgitacija, zvišan želodčni aspirat, nekrotizirajoči enterokolitis neznana
0.25 ml/kg body weight 
0,25 ml/kg telesne mase
Peyona can be either used without dilution or diluted in sterile solutions for infusion such as glucose 50 mg/ml (5%) or sodium chloride 9 mg/ml (0.9%) or calcium gluconate 100 mg/ml (10%) immediately after withdrawal from the ampoule. 
Zdravilo Peyona se lahko uporablja nerazredčeno ali razredčeno v sterilni raztopini za infundiranje kot so glukoza 50 mg/ml (5 %), natrijev klorid 9 mg/ml (0,9 %) ali kalcijev glukonat 100 mg/ml (10 %) nemudoma po izvleku iz ampule.
Treatment should be initiated under supervision of a physician experienced in neonatal intensive care. 
Zdravljenje je treba začeti pod nadzorom zdravnika z izkušnjami v intenzivni negi novorojenčkov.
Peyona contains sodium 
Zdravilo Peyona vsebuje natrij
Infants randomised to caffeine citrate received an intravenous loading dose of 20 mg/kg, followed by a daily maintenance dose of 5 mg/kg. 
Dojenčki, randomizirani v skupino, ki je prejemala kofeinijev citrat, so dobili začetni intravenski odmerek 20 mg/kg, temu pa je sledil dnevni vzdrževalni odmerek 5 mg/kg.
What you need to know before your baby is given Peyona Do not use Peyona: 
Kaj morate vedeti, preden boste zdravilo Peyona uporabili pri otroku Ne uporabljajte zdravila Peyona:
In a post-authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic impairment appeared to be higher as compared to premature infants without organ impairment (see sections 4.2, 4.8 and 5.2). 
Študija o varnosti zdravila po pridobitvi dovoljenja za promet kaže, da je pogostnost neželenih učinkov, pri majhnem številu zelo zgodaj rojenih nedonošenčkov z okvaro jeter/ledvic višja, v primerjavi z nedonošenčki brez okvare organa (glejte poglavja 4.2, 4.8 in 5.2).
Caffeine readily crosses the placenta into the fetal circulation and is excreted into breast milk. 
Kofein hitro prehaja skozi placento v zarodkov obtok in se izloča v mleko.
After an interval of 24 hours, maintenance doses of 5 mg per kg body weight may be administered by slow intravenous infusion over 10 minutes every 24 hours. 
Po 24-urnem intervalu se lahko daje vzdrževalni odmerek 5 mg na kg telesne mase s počasnim intravenskim infundiranjem, ki traja vsakih 24 ur 10 minut.
The starting dose is 20 mg per kg body weight (equivalent to 1 ml per kg body weight). 
Začetni odmerek je 20 mg na kg telesne mase (kar ustreza 1 ml na kg telesne mase).
The protocol allowed infants to be “rescued” with open-label caffeine citrate treatment if their apnoea remained uncontrolled. 
Po protokolu je bilo dovoljeno razkriti in zdraviti dojenčke v odprtem zdravljenju s kofeinijevim citratom, če apneje ni bilo mogoče nadzirati.
A reduced daily maintenance dose of caffeine citrate is required and the dose should be guided by plasma caffeine measurements. 
Potrebno je zmanjšati dnevni vzdrževalni odmerek kofeinijevega citrata, odmerek pa se določi glede na izmerjeno raven kofeina v plazmi.
Urine output increased, urine sodium and calcium increased, haemoglobin decreased, thyroxine decreased 
Preiskave večje izločanje urina, zvišana natrij in kalcij v urinu, znižan hemoglobin, znižan tiroksin neznana
Caffeine concentrations in the cerebrospinal fluid of preterm newborn infants approximate to their plasma levels. 
Koncentracije kofeina v likvorju nedonošenih novorojenčkov so približno enake njihovim ravnem v plazmi.
Immune system disorders Hypersensitivity reaction 
Bolezni imunskega sistema preobčutljivostne reakcije redki
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characterisitcs, section 4.2). 
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Adverse reactions appeared to be more frequent in this subgroup with organ impairment than in other observed infants without organ impairment. 
Zdi se, da je pogostnost neželenih učinkov v podskupini z okvaro organa višja v primerjavi s skupino nedonošenčkov brez okvare organa.
In newborns previously treated with theophylline, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate because preterm infants metabolise theophylline to caffeine. 
Pri novorojenčkih, predhodno zdravljenih s teofilinom, je treba pred uvedbo zdravljenja s kofeinijevim citratom izmeriti izhodiščno vrednost koncentracije kofeina v plazmi, saj se pri nedonošenčkih teofilin presnavlja v kofein.
Alternatively, maintenance doses of 5 mg per kg body weight may be administered by oral administration, such as through a nasogastric tube every 24 hours. 
Alternativno se lahko daje vzdrževalni odmerek 5 mg na kg telesne mase peroralno, na primer skozi nazogastrično cevko vsakih 24 ur.
When given intravenously, caffeine citrate should be administered by controlled intravenous infusion, using a syringe infusion pump or other metered infusion device only. 
Pri intravenskem dajanju je treba kofeinijev citrat dati kot nadzirano intravensko infuzijo z uporabo injekcijske infuzijske črpalke ali druge odmerne infuzijske naprave.
Any unused portion left in the ampoule should be discarded. 
Neuporabljeno zdravilo, ki ostane v ampuli, zavrzite.
Treatment with caffeine citrate should be initiated under the supervision of a physician experienced in neonatal intensive care. 
Zdravljenje s kofeinijevim citratom je treba začeti pod nadzorom zdravnika z izkušnjami v intenzivni negi novorojenčkov.
- That the dose of caffeine expressed as caffeine base is one half the dose of caffeine expressed as caffeine citrate (20mg caffeine citrate is equivalent to 10mg caffeine base) and that prescriptions should clearly indicate that caffeine citrate is to be administered. 
- Podatek, da je odmerek kofeina, izražen kot kofein, ena polovica odmerka kofeina, izraženega kot kofeinijev citrat (20 mg kofeinijevega citrata je enakovredno 10 mg kofeina) in da morajo recepti jasno navajati, da je treba uporabiti kofeinijev citrat.
Infections and infestations Sepsis 
Infekcijske in parazitske bolezni sepsa neznana
Dose of caffeine citrate (Volume) 
Odmerek kofeinijevega citrata (volumen)
In premature infants with cholestatic hepatitis a prolonged caffeine elimination half-life with an increase of plasma levels above the normal limit of variation has been found suggesting a particular caution in the dosage of these patients (see sections 4.2 and 4.4). 
Pri nedonošenčkih s holestatičnim hepatitisom so ugotovili podaljšani razpolovni čas izločanja kofeina z zvišanimi ravnmi v plazmi nad normalnimi mejami odstopanja, kar kaže, da je potrebna posebna previdnost pri odmerjanju tem bolnikom (glejte poglavji 4.2 in 4.4).
− infants receiving co-administration of medicinal products known to interfere with caffeine metabolism (see section 4.5) 
− dojenčki, ki sočasno dobivajo zdravila, za katera je znano, da ovirajo presnovo kofeina (glejte poglavje 4.5)
Peyona will be infused by controlled intravenous infusion, using a syringe infusion pump or other metered infusion device. 
Zdravilo Peyona se infundira kot nadzirana intravenska infuzija z injekcijsko infuzijsko črpalko ali z drugo odmerno infuzijsko napravo.
Undiluted and diluted parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration. 
Nerazredčene ali razredčen parenteralne raztopine je treba pred uporabo vizualno pregledati glede delcev in obarvanja.
As for all preterm infants, those treated with caffeine citrate should be carefully monitored for the development of necrotising enterocolitis (see section 4.8). 
Kot pri vseh nedonošenčkih je treba tudi pri tistih, zdravljenih s kofeinijevim citratom, skrbno nadzirati razvoj nekrotizirajočega enterokolitisa (glejte poglavje 4.8).
Peyona should only be used in a neonatal intensive care unit in which adequate facilities are available for patient surveillance and monitoring. 
Zdravljenje z zdravilom Peyona mora potekati izključno na oddelku intenzivne nege za novorojenčke, kjer so na voljo ustrezni pripomočki za nadzor in spremljanje bolnika.
− infants whose mothers may have ingested large quantities of caffeine prior to delivery (see section 
− dojenčkih, katerih matere so pred porodom zaužile velike količine kofeina (glejte poglavje 4.4)
The medicinal product must be used immediately after diluting by aseptic technique 
Zdravilo je treba po redčenju z uporabo aseptične tehnike uporabiti takoj.
Endotracheal tube 
endotrahealna cevka
If your newborn gets any side effects, talk to your baby's doctor. 
Če opazite pri svojem novorojenčku kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom.
Effects described include central nervous system (CNS) stimulation such as convulsion, irritability, restlessness and jitteriness, cardiac effects such as tachycardia, arrhythmia, hypertension and increased stroke volume, metabolism and nutrition disorders such as hyperglycaemia. 
Opisani učinki vključujejo spodbujanje osrednjega živčnega sistema (OŽS) kot so konvulzije, razdražljivost, nemir in živčnost, srčne učinke kot so tahikardija, aritmija,
Caffeine's main action is as a CNS stimulant. 
Farmakodinamični učinki Glavni učinek kofeina je spodbujanje OŽC.
These active substances should not be used concurrently. 
Teh zdravilnih učinkovin ne uporabljajte sočasno.
It may be needed that your baby's doctor decides to check the levels of caffeine in a blood test periodically throughout treatment to avoid toxicity. 
Morda bo moral otrokov zdravnik v izogib toksičnosti ves čas zdravljenja s testi redno določati ravni kofeina v krvi.
MM/YYYY 
{MM/LLLL}
After oral administration of 10 mg caffeine base/kg body weight to preterm newborn infants, the peak plasma caffeine concentration (Cmax) ranged from 6 to 10 mg/l and the mean time to reach peak concentration (tmax) ranged from 30 min to 2 h. The extent of absorption is not affected by formula feeding but tmax may be prolonged. 
Po peroralnem dajanju 10 mg kofeina/kg telesne mase nedonošenega novorojenčka je bil razpon najvišje koncentracije kofeina v plazmi (Cmax) od 6 do 10 mg/l in razpon povprečnega časa do dosežene najvišje koncentracije (tmax) od 30 minut do 2 uri.
Ampoules of all parenteral solutions must be inspected visually for particulate matter prior to administration. 
Vse ampule s parenteralno raztopino je treba pred uporabo vizualno pregledati zaradi delcev.
Rare 
enkratno
Caffeine citrate should be administered with caution in preterm newborn infants with impaired renal or hepatic function. 
Kofeinijev citrat je treba dajati previdno pri nedonošenih novorojenčkih z okvarjenim delovanjem ledvic ali jeter.
Type I clear glass 1 ml ampoule Type I clear glass 3 ml ampoule Pack size of 10 ampoules. 
1 ml ampula iz prosojnega stekla vrste I 3 ml ampula iz prosojnega stekla vrste I
Dose of caffeine citrate (mg/kg body weight) 
Odmerek kofeinijevega citrata (mg/kg telesne mase)
In newborn infants born to mothers who consumed large quantities of caffeine prior to delivery, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate, since caffeine readily crosses the placenta into the foetal circulation (see sections 4.2 and 5.2). 
Pri novorojenčkih, rojenim materam, ki so pred porodom zaužile velike količine kofeina, je treba pred uvedbo zdravljenja s kofeinijevim citratom izmeriti izhodiščne koncentracije kofeina v plazmi, saj kofein hitro prehaja skozi placento v plodov obtok (glejte poglavji 4.2 in 5.2).
The active substance is caffeine citrate. 
Zdravilna učinkovina je kofeinijev citrat.
5 mg/kg body weight Intravenous infusion (over 10 minutes) or by oral administration 
5 mg/kg telesne mase intravenska infuzija (10-minutna) ali peroralno dajanje vsakih 24 ur*
In newborn infants born to mothers who consumed large quantities of caffeine prior to delivery, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate (see section 4.4). 
Pri novorojenčkih, rojenih materam, ki so pred porodom zaužile veliko količino kofeina, je treba pred uvedbo zdravljenja s kofeinijevim citratom izmeriti izhodiščno vrednost koncentracije kofeina v plazmi (glejte poglavje 4.4).
These effects are not relevant with regard to short term administration in the preterm infant population (see section 
Ti učinki niso pomembni zaradi kratkega obdobja dajanja v skupini nedonošenčkov (glejte poglavje 5.3).
Caffeine citrate readily dissociates in aqueous solution. 
Kofeinijev citrat v vodni raztopini hitro disociira.
Contents of the pack and other information 
Shranjevanje zdravila Peyona Vsebina pakiranja in dodatne informacije
The dose expressed as caffeine base is one-half the dose when expressed as caffeine citrate (20 mg caffeine citrate are equivalent to 10 mg caffeine base). 
Odmerek, izražen kot kofein, je polovica odmerka, če je izražen kot kofeinijev citrat (20 mg kofeinijevega citrata je enakovredno 10 mg kofeina).
Peyona should be inspected visually for particulate matter and discoloration prior to administration. 
Zdravilo Peyona je treba pred uporabo vizualno pregledati glede delcev in obarvanja.
Peyona is a solution for infusion and oral solution. 
Zdravilo Peyona je raztopina za infundiranje in peroralna raztopina.
Loading dose 1.0 ml/kg body weight 
1,0 ml/kg telesne mase
The solution must not be used if it is discoloured or foreign particulate matter is present. 
Raztopine ne smete uporabljati, če je obarvana ali v njej plavajo delci.
- That Peyona is for the treatment of primary apnoea - That treatment with Peyona must be provided in a neonatal intensive care unit and initiated and supervised by a physician experienced in neonatal intensive care - Details of the loading and maintenance dosages and that caffeine may accumulate in premature newborn infants because of its long half-life. 
- Zdravljenje z zdravilom Peyona je treba nuditi v enoti za intenzivno nego novorojenčkov, začeti in nadzorovati pa ga mora zdravnik, izkušen v intenzivni negi novorojenčkov.
− infants whose mothers consume caffeine while providing breast milk for feeding. 
− dojenčki, katerih matere uživajo kofein in dajejo mleko za prehranjevanje Priporočljivo je izmeriti izhodiščne vrednosti kofeina pri:
Caffeine has a prolonged half-life in premature newborn infants and there is potential for accumulation which may necessitate monitoring infants treated for an extended period (see section 
Razpolovna doba kofeina pri nedonošenčkih je podaljšana, zato obstaja možnost kopičenja, zaradi katerega je morda treba nadzirati dojenčke, ki zdravilo dobivajo dalj časa (glejte poglavje 5.2).
The following other side effects may also be considered serious by your baby's doctor in the context of the global clinical evaluation. 
- resna bolezen črevesja s krvavim blatom (nekrotizirajoči enterokolitis) V kontekstu celotne klinične ocene lahko zdravnik tudi naslednje neželene učinke obravnava kot resne.
However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease. 
Vendar pa je te neželene učinke težko ločiti od pogostih zapletov, ki se pojavljajo pri nedonošenčkih,
Peyona 20 mg/ml solution for infusion and oral solution Caffeine citrate (equivalent to 10 mg/ml of caffeine base) IV/oral use 
Peyona 20 mg/ml raztopina za infundiranje in peroralna raztopina kofeinijev citrat (ustreza 10 mg/ml kofeina) i.v./peroralna uporaba
Hepatic cytochrome P450 1A2 (CYP1A2) is involved in caffeine biotransformation in older individuals. 
(CYP1A2) sodeluje v biološki transformaciji kofeina pri starejših osebah.
Other causes of apnoea (e.g., central nervous system disorders, primary lung disease, anaemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnoea) should be ruled out or properly treated prior to initiation of treatment with caffeine citrate. 
Pred začetkom zdravljenja s kofeinijevim citratom je treba izključiti ali ustrezno zdraviti druge vzroke za apnejo (npr. bolezen osrednjega živčnega sistema, primarna bolezen pljuč, anemija, sepsa, motnje presnove,
As for all preterm infants, those treated with caffeine citrate should be carefully monitored for the development of necrotising enterocolitis (see section 
Kot pri vseh nedonošenčkih je treba tudi pri tistih, zdravljenih s kofeinijevim citratom, skrbno nadzirati razvoj nekrotizirajočega enterokolitisa (glejte poglavje 4.4).
After opening the ampoules, the medicinal product should be used immediately. 
Zdravilo je treba po odprtju ampule porabiti takoj.
Caffeine citrate can be administered by intravenous infusion and by the oral route. 
Kofeinijev citrat se lahko daje kot intravenska infuzija ali peroralno.
Peyona 20 mg/ml solution for infusion and oral solution Caffeine citrate (equivalent to 10 mg/ml of caffeine base) 
Peyona 20 mg/ml raztopina za infundiranje in peroralna raztopina kofeinijev citrat (ustreza 10 mg/ml kofeina)
Infants received 20 mg/kg caffeine citrate loading dose intravenously. 
Dojenčkom so intravensko dali začetni odmerek 20 mg/kg kofeinijevega citrata.
Peyona 20 mg/ml solution for infusion and oral solution 
Peyona 20 mg/ml raztopina za infundiranje in peroralna raztopina
Caffeine citrate can be either used without dilution or diluted in sterile solutions for infusion such as glucose 50 mg/ml (5%), or sodium chloride 9 mg/ml (0.9%) or calcium gluconate 100 mg/ml (10%) immediately after withdrawal from the ampoule (see section 6.6). 
natrijev klorid 9 mg/ml (0,9 %) ali kalcijev glukonat 100 mg/ml (10 %) nemudoma po izvleku iz ampule (glejte poglavje 6.6).