natgillin/translations-raw huggingface dataset:
The patient should be treated with increased FiO2 and/ or by reinstallment of therapy with inhaled nitric oxide.
Bolnika morate zdraviti s povečanim odmerkom FiO2 in/ ali ponovno začeti zdravljenje z vdihavanjem dušikovega oksida.
When possible, inhaled nitric oxide should be continued until the underlying disease has resolved.
Kadar je mogoče, nadaljujte vdihavanje dušikovega oksida, dokler ne odpravite osnovne bolezni.
5 NO2 rapidly forms in gas mixtures containing nitric oxide and O2, and NO2 may in this way cause airway inflammation and damage.
NO2 lahko na ta način povzroči vnetja in poškodbe dihalnih poti.
There are also animal data suggesting an increased susceptibility to airway infection upon exposure to low levels of NO2.
Obstajajo podatki raziskav na živalih, ki kažejo na povečano dovzetnost za okužbe dihalnih poti po izpostavljanju nizkim koncentracijam NO2.
In one clinical study (NINOS), treatment groups were similar with respect to the incidence and severity of intracranial haemorrhage, Grade IV haemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary haemorrhage, or gastrointestinal haemorrhage.
V eni od kliničnih študij (NINOS) je bila pri skupinah bolnikov, ki so prejemali zdravilo, podobna incidenca in intenzivnost intrakranialnih krvavitev, krvavitev 4. stopnje, periventrikularne levkomalacije, možganske kapi, epileptičnih napadov, ki so zahtevali zdravljenje z protikonvulzivnimi zdravili, pljučnih krvavitev in krvavitev v prebavilih.
The table below shows reactions that occurred in at least 5% of patients receiving INOmax in the CINRGI study.
Spodnja tabela prikazuje reakcije, ki so se pojavile pri vsaj 5% bolnikov, ki so v študiji CINRGI prejemali INOmax.
None of the differences in these adverse reactions were statistically significant when inhaled nitric oxide patients were compared to patients receiving placebo.
Ob primerjavi bolnikov, ki so vdihovali dušikov oksid, z bolniki, ki so prejemali placebo, nobena izmed razlik v teh neželenih reakcijah ni bila statistično značilna.
The reporting rate is classified as very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1,000 < 1/100), rare (> 1/10,000, < 1/ 1,000), very rare (< 1/ 10,000) including isolated reports.
Glede na pogostnost poročanja so neželeni učinki razvrščeni kot zelo pogosti (> 1/ 10), pogosti (> 1/ 100, < 1/ 10), občasni (> 1/ 1. 000, < 1/ 100), redki (> 1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000), vključno s posameznimi primeri.
Hyperbilirubinemia
Bolezni krvi in limfatičnega sistema Zelo pogosto: trombocitopenija Presnovne in prehranske motnje Pogosto: hipokaliemija Žilne bolezni Pogosto: hipotenzija Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosto: atelektaza Bolezni jeter, žolčnika in žolčevodov Pogosto: hiperbilirubinemija
Post Marketing Experience The following adverse reactions have been reported as part of the post-marketing surveillance: headaches associated with environmental exposure, hypotension associated with acute withdrawal of the drug, hypoxaemia associated with acute withdrawal of the drug, and dose errors associated with the delivery system.
Izkušnje po dajanju na trg Kot del spremljanja zdravila po dajanju na trg so poročali o naslednjih neželenih učinkih: glavoboli, povezani z vplivi iz okolja, hipotenzija, povezana z akutno odtegnitvijo zdravila, hipoksemija, povezana z akutno odtegnitvijo zdravila, in napake v odmerkih, povezane s sistemom za dovajanje zdravila.
In clinical studies, NO2 levels > 3 ppm or methaemoglobin levels > 7% were treated by reducing the dose of, or discontinuing, INOmax.
V kliničnih študijah so koncentracije NO2 > 3 ppm ali koncentracije methemoglobina > 7% zdravili z zmanjšanjem odmerka ali prekinitvijo zdravljenja z zdravilom INOmax.
It relaxes vascular smooth muscle by binding to the haeme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3’ ,5’ -monophosphate, which then leads to vasodilation.
Pri tem aktivira gvanilat- ciklazo in poveča znotrajcelične koncentracije cikličnega gvanozin- 3 ’, 5 ’ - monofosfata, kar pripelje do vazodilatacije.
When inhaled, nitric oxide produces pulmonary vasodilation.
Dušikov oksid pri vdihavanju povzroča pljučno vazodilatacijo.
INOmax appears to increase the partial pressure of arterial oxygen (PaO2) by dilating pulmonary vessels in better ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/ perfusion (V/ Q) ratios toward regions with normal ratios.
Videti je, da zdravilo INOmax povečuje parcialni tlak kisika v arterijah (PaO2) tako, da razširi pljučne žile v bolj ventiliranih delih pljuč in tako preusmeri krvni pretok iz predelov pljuč z nizkim razmerjem ventilacija/ perfuzija proti predelom z normalnim razmerjem.
Persistent pulmonary hypertension of the newborn (PPHN) occurs as a primary developmental defect or as a condition secondary to other diseases such as meconium aspiration syndrome (MAS), pneumonia, sepsis, hyaline membrane disease, congenital diaphragmatic hernia (CDH), and pulmonary hypoplasia.
Kronična pulmonarna hipertenzija novorojenčka (PPHN – » pulmonary hypertension of the newborn «) se pojavlja kot primarna razvojna okvara ali kot posledica drugih bolezni, kot so mekonijski aspiracijski sindrom (MAS), pljučnica, sepsa, sindrom dihalne stiske pri novorojenčkih, prirojena diafragmalna hernija (CDH – » congenital diaphragmatic hernia «) in pljučna hipoplazija.
In these states, pulmonary vascular resistance (PVR) is high, which results in hypoxemia secondary to right-to-left shunting of blood through the patent ductus arteriosus and foramen ovale.
Pri teh boleznih je pljučni vaskularni upor (PVR – » pulmonary vascular resistance «) visok, kar povzroča hipoksemijo kot posledico obvoda krvi z desne na levo stran skozi ductus arteriosus in foramen ovale bolnika.
The efficacy of INOmax has been investigated in term and near-term newborns with hypoxic respiratory failure resulting from a variety of etiologies.
Učinkovitost zdravila INOmax so raziskovali pri novorojenčkih s hipoksično respiratorno odpovedjo kot posledico različnih etiologij, ki so se rodili v roku ali blizu roka.
In the NINOS trial, 235 neonates with hypoxic respiratory failure were randomised to receive 100% O2 with (n=114) or without (n=121) nitric oxide most with an initial concentration of 20 ppm with weaning as possible to lower doses with a median duration of exposure of 40 hours.
Večina je prejemala začetni odmerek 20 ppm, ki so ga zniževali, kolikor je bilo mogoče, z mediano trajanja izpostavitve 40 ur.
The objective of this double-blind, randomised, placebo controlled trial was to determine whether inhaled nitric oxide would reduce the occurrence of death and/ or initiation of extracorporeal membrane oxygenation (ECMO).
Namen tega dvojno slepega, randomiziranega, s placebom nadzorovanega preizkusa je bil določiti, ali vdihani dušikov oksid zniža smrtnost in/ ali potrebo po zdravljenju z zunajtelesno membransko oksigenacijo (ECMO – » extracorporeal membrane oxygenation «).
Neonates with less than a full response at 20ppm were evaluated for a response to 80ppm nitric oxide or control gas.
Pri novorojenčkih, ki se niso polno odzivali pri vrednosti 20 ppm, so ocenili odzivnost pri 80 ppm dušikovega oksida ali kontrolnega plina.
64%, p=0.006).
Kombinirana incidenca smrti in/ ali začetka zdravljenja z ECMO (vnaprej določen primarni rezultat) je pokazala značilno prednost pri skupini, ki so jo zdravili z dušikovim oksidom (46% proti 64%, p = 0, 006).
The adverse events collected occurred at similar incidence rates in both groups.
Pogostost neželenih učinkov je bila v obeh skupinah podobna.
Follow-up exams at 18-24 months of age were similar between the two groups with respect to mental, motor, audiologic, and neurologic evaluations.
Pregledi pri starosti 18- 24 mesecev so pokazali podobnosti v oceni duševnega, motoričnega, avdiološkega in nevrološkega stanja pri obeh skupinah.
In the CINRGI trial, 186 term- and near-term neonates with hypoxic respiratory failure were randomised to receive either INOmax (n=97) or nitrogen gas (placebo; n=89) with an initial dose of 20 ppm weaning to 5 ppm in 4 to 24 hours with median duration of exposure of 44 hours.
V preizkusu CINRGI so naključno razdelili 186 novorojenčkov s hipoksično respiratorno odpovedjo, rojenih v roku ali blizu roka, tako da so prejemali bodisi zdravilo INOmax (n = 97) ali dušik v plinasti obliki (placebo; n = 89) v začetnem odmerku 20 ppm, ki so ga zmanjševali do 5 ppm v 4 do 24 urah z mediano trajanja izpostavitve 44 ur.
Significantly fewer neonates in the INOmax group required ECMO compared to the control group (31% vs 57%, p < 0.001).
V skupini, ki je prejemala zdravilo INOmax, je ECMO potrebovalo značilno manjše število novorojenčkov kot v kontrolni skupini (31% proti 57%, p < 0, 001).
The INOmax group had significantly improved oxygenation as measured by PaO2, OI, and alveolar-arterial gradient (p < 0.001 for all parameters).
Skupina, ki je prejemala zdravilo INOmax, je imela značilno izboljšano oksigenacijo, ki so jo izmerili kot PaO2, OI (kisikov indeks) in alveolo- arterijski gradient (p < 0, 001 za vse parametre).
Of the 97 patients treated with INOmax, 2(2%) were withdrawn from study drug due to methaemoglobin levels > 4%.
Od 97 bolnikov, ki so jih zdravili z zdravilom INOmax, so 2 (2%) izključili iz študije zaradi koncentracij methemoglobina > 4%.
The frequency and number of adverse events were similar in the two study groups.
Pogostost in število neželenih učinkov sta bila v obeh skupinah podobna.
In biological tissue, nitric oxide may form peroxynitrite with superoxide (O2-), an unstable compound which may cause tissue damage through further redox reactions.
Dušikov oksid v tkivih lahko s superoksidom (O2 -) tvori peroksinitrit, nestabilno spojino, ki lahko z nadaljnjimi reakcijami 7 oksidacije in redukcije povzroči poškodbe tkiv.
In addition, nitric oxide has affinity to metalloproteins and may also react with SH-groups in protein forming nitrosyl compounds.
Poleg tega ima dušikov oksid afiniteto do metaloproteinov in lahko reagira tudi s skupinami - SH v beljakovinah ter tvori nitrozilne spojine.
The clinical significance of the
Klinična pomembnost kemične reaktivnosti dušikovega oksida v tkivih ni znana.
Most of it traverses the pulmonary capillary bed where it combines with haemoglobin that is 60% to 100% oxygen-saturated.
Večina ga prehaja skozi pljučne kapilare, kjer se veže na hemoglobin, ki je od 60% do 100% nasičen s kisikom.
Within the pulmonary system, nitric oxide can combine with oxygen and water to produce nitrogen dioxide and nitrite, respectively, which interact with oxyhaemoglobin to produce methaemoglobin and nitrate.
Dušikov dioksid in nitrit reagirata z oksihemoglobinom, pri čemer nastaneta methemoglobin in nitrat.
The mean methaemoglobin levels remained below 1% in the placebo group and in the 5 ppm and 20 ppm INOmax groups, but reached approximately 5% in the 80 ppm INOmax group.
V skupini, ki je prejemala 80 ppm zdravila INOmax, so dosegle približno 5%.
Methaemoglobin levels > 7% were attained only in patients receiving 80 ppm, where they comprised 35% of the group.
Koncentracije methemoglobina so bile > 7% le pri bolnikih, ki so prejemali 80 ppm, in sicer pri 35% bolnikov v skupini.
The average time to reach peak methaemoglobin was 10 ± 9 (SD) hours (median, 8 hours) in these 13 patients; but one patient did not exceed 7% until 40 hours.
Povprečen čas, potreben za doseganje najvišje koncentracije methemoglobina pri teh 13 bolnikih, je bil 10 ± 9 (SD) ur (mediana, 8 ur); en bolnik pa ni presegel 7% do 40 ur.
Nitrate has been identified as the predominant nitric oxide metabolite excreted in the urine, accounting for > 70% of the nitric oxide dose inhaled.
Kot prevladujoči presnovek dušikovega oksida, ki se izloča v urinu, so določili nitrat, ki ustreza > 70% odmerka vdihanega dušikovega oksida.
Single dose studies in rodents indicate that the lethal dose is around 300 ppm nitric oxide or greater.
Študije z enojnim odmerkom pri glodalcih so pokazale, da je smrtni odmerek dušikovega oksida približno 300 ppm ali več.
Repeat dose studies show that rodents can survive nitric oxide exposures until sustained levels approaching 250 ppm nitric oxide are achieved.
Študije s ponavljajočimi se odmerki so pokazale, da glodalci lahko preživijo izpostavitev dušikovemu oksidu, dokler se vzdrževana koncentracija ne približa vrednosti 250 ppm.
Deaths are secondary to anoxia resulting from elevated methaemoglobin levels.
Smrt je posledica anoksije, do katere pride zaradi povečanih koncentracij methemoglobina.
Methaemoglobin levels of greater than 30% were recorded in animals dying from nitric oxide exposure.
Pri živalih, ki so poginile zaradi izpostavitve dušikovemu oksidu, so zaznali koncentracije methemoglobina, večje od 30%.
Recovery from methaemoglobinaemia is rapid; full recovery is recorded in less than 24 hours.
Opažali so popolno okrevanje v manj kot 24 urah.
At levels of 80 ppm there were ‘ no observable’ effects from nitric oxide exposure.
Pri koncentraciji 80 ppm » ni bilo vidnih « učinkov izpostavitve dušikovemu oksidu.
From studies in dogs it can be deduced that the lethal concentration is around 640 ppm nitric oxide for 4 hours, whereas, exposures of 320 ppm nitric oxide are non-lethal.
Iz študij na psih lahko sklepamo, da je smrtna koncentracija približno 640 ppm dušikovega oksida v 4 urah, medtem ko izpostavitev koncentraciji 320 ppm dušikovega oksida ni smrtna.
No reproduction toxicity and carcinogenicity studies have been conducted.
V omejeni raziskavi na kuncih in ljudeh so ugotovili, da vdihani dušikov oksid približno podvoji čas krvavitve.
As described in section 5.1, some of this toxicity may be mediated by peroxynitrite.
Študije vpliva na sposobnost razmnoževanja in kancerogenosti niso bile izvedene.
8 6.
8 Mutagenost.
From a corrosion point of view the supply system can be divided into two zones:
S stališča rjavenja lahko sistem za dovajanje razdelimo na dva dela:
1) From the gas cylinder valve to the humidifier (dry gas) and 2) From the humidifier to outlet (moist gas which may contain NO2).
1) Od ventila jeklenke do vlažilca (suhi plin) in 2) Od vlažilca do izhoda (vlažni plin, ki lahko vsebuje NO2).
Among metallic construction materials, only stainless steel can be recommended.
Med kovinskimi materiali se priporoča le nerjaveče jeklo.
Tested polymers which can be used in nitric oxide administration systems include polyethylene (PE) and polypropylene (PP).
Med preizkušene polimere, ki jih lahko uporabimo pri sistemih za dovajanje dušikovega oksida, sodita polietilen (PE) in polipropilen (PP).
Polytrifluorochloroethylene, hexafluoropropene-vinyliden copolymer and polytetraflourethylene have been used extensively with pure nitric oxide and other corrosive gases.
S čistim dušikovim oksidom in drugimi jedkimi plini so pogosto uporabljali politrifluorokloroetilen, heksafluoropropen - viniliden kopolimer in politetrafluoretilen.
Storage in the pharmacy departmentThe gas cylinders should be stored in an airy, clean and locked place, for storage of medicinal gas only.
Shranjevanje v lekarnah Jeklenke shranjujte v zračnih, čistih in zaklenjenih prostorih, namenjenih le shranjevanju plinov za medicinske namene.
Storage in the medical department The gas cylinder should be put in an equipped site with appropriate material in order to hold the gas cylinder vertically.
Shranjevanje v medicinskih oddelkih Jeklenko morate namestiti v prostor, opremljen z ustreznimi materiali, ki omogočajo, da je jeklenka postavljena pokončno.
Transport of gas cylinders The gas cylinders should be transported with appropriate material in order to protect them from risks of shocks and falls.
Prevoz jeklenk Jeklenke morate prevažati z ustrezno opremo, da bi jih zaščitili pred nevarnostjo padcev in udarcev.
9 6.5 Nature and contents of container
9 Med premeščanjem bolnikov, ki prejemajo zdravilo INOmax, znotraj bolnišnice ali med bolnišnicami morajo biti jeklenke trdno nameščene v pokončen položaj, da bi preprečili padce ali neprimerno spremembo dovajanja.
2 litre aluminium gas cylinder 10 litre aluminium gas cylinder
2 - litrska aluminijasta jeklenka 10- litrska aluminijasta jeklenka
A 2 litre and 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection.
2- litrska in 10- litrska aluminijasta jeklenka (prepoznate jo po zelenomodrem vratu in belem telesu), napolnjena pod tlakom 155 bar, opremljena z nadtlačnim (presežnotlačnim) ventilom iz nerjavečega jekla s specifičnim izhodnim priključkom.
Instructions for use/ handling INOmax
Navodila za pripravo / ravnanje z zdravilom INOmax
- the good condition of the material should be checked before use
- pred uporabo preverite, ali je oprema v dobrem stanju
- the gas cylinders should be fixedly stowed away in order to avoid untimely fall
- jeklenke morajo biti pritrjene, da preprečite padce
- the valve should not be violently opened
- ventila ne odpirajte na silo
- a gas cylinder whose valve is not protected by a cap or a shell should not be used
- jeklenke ne uporabljajte, če ventil ni zaščiten z zaporko ali plaščem
- a specific connection, with a 30 mm thread which is designated for medical use, complying with
- uporabljajte specifično povezavo s 30- milimetrskim navojem za uporabo v medicinske namene,
ISO 5145 and a pressure regulator which admits a pressure at least equal to 1.5 the maximum operating pressure (155 bar) of the gas cylinder should be used
skladnim s standardom ISO 5145, in regulator tlaka, ki dopušča tlak vsaj do 150% največjega obratovalnega tlaka jeklenke (155 bar)
- the pressure regulator should be purged by the nitrogen-nitric oxide mixture before each new use
- pred vsako uporabo regulator tlaka očistite z mešanico dušika in dušikovega oksida, da bi
in order to preclude nitrogen dioxide inhalation
preprečili vdihovanje dušikovega dioksida
- a defective valve should not be repaired
- okvarjenega ventila ne smete popravljati
- the pressure regulator should not be tightened with pliers, at the risk of crushing the gasket
- regulatorja tlaka ne smete privijati s kleščami, da ne zdrobite tesnila
Instruction for Disposal of Gas Cylinder
Navodila za odstranjevanje jeklenke
When the gas cylinder is empty, do not discard.
Ko je jeklenka prazna, je ne zavrzite.
INO Therapeutics AB SE-181 81 Lidingö Sweden
INO Therapeutics AB SE- 181 81 Lidingö Švedska
1 August 2001 Date of last renewal:
1. avgust 2001 Datum zadnje obnove:
AGA Medical Zone Industrielle de Limay Porcheville 3, avenue Ozanne 78440 Gargenville France
AGA Medical Zone Industrielle de Limay Porcheville 3, avenue Ozanne 78440 Gargenville Francija
• OTHER CONDITIONS
Navedba smiselno ni potrebna.
14 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
14 PODATKI NA PRIMARNI OVOJNINI 2 litra
INOmax 400 ppm mol/ mol inhalation gas Nitric oxide.
Zdravilo INOmax INOmax 400 ppm mol/ mol plin za inhaliranje dušikov oksid
INOmax contains nitric oxide 400 ppm mol/ mol.
INOmax vsebuje dušikov oksid 400 ppm mol/ mol.
Endotracheopulmonary use.
Endotraheopulmonalna uporaba.
Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo 6.
Expiry date:
Uporabno do:
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
ŠTEVILKA( E) DOVOLJENJA( DOVOLJENJ) ZA PROMET
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
16 PODATKI NA PRIMARNI OVOJNINI 10 litrov
INOmax 400 ppm mol/ mol inhalation gas Nitric oxide.
INOmax 400 ppm mol/ mol plin za inhaliranje dušikov oksid
EU/ 1/ 01/ 194/ 001
EU/ 1/ 00/ 194/ 001
INOmax 400 ppm mol/ mol inhalation gas Nitric ooxide
INOmax 400 ppm mol/ mol plin za inhaliranje dušikov oksid
- If you have any further questions, ask your baby ’ s doctor
- Če imate dodatna vprašanja, se posvetujte z zdravnikom svojega dojenčka.
please tell your baby ’ s doctor.
omenjen v tem navodilu, obvestite zdravnika svojega dojenčka.
What INOmax is and what it is used for 2.
Kaj je zdravilo INOmax in za kaj ga uporabljamo 2.
Before your baby begins treatment with INOmax 3.
Kaj morate vedeti, preden vaš dojenček začne zdravljenje z zdravilo INOmax 3.
How your baby is treated with INOmax 4.
Kako bo vaš dojenček zdravljen z zdravilom INOmax 4.
How to store INOmax 6.
Shranjevanje zdravila INOmax 6.
WHAT INOmax IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO INOmax IN ZA KAJ GA UPORABLJAMO
INOmax is a gas mixture for inhalation.
Zdravilo INOmax je mešanica plina za inhaliranje.
INOmax is for the treatment of newborn babies with lung failure associated with high blood pressure in the lungs, a condition known as hypoxic respiratory failure.
Zdravilo INOmax se uporablja za zdravljenje novorojenčkov s pljučno odpovedjo, povezano z visokim tlakom v pljučih, stanje, ki ga poznamo kot hipoksično respiratorno odpoved.
When inhaled, nitric oxide can improve the flow of blood through the lungs, which may help to increase the amount of oxygen that reaches your baby ’ s blood.
Vdihavanje dušikovega oksida lahko izboljša pretok krvi skozi pljuča, kar pripomore k povečanju količine kisika, ki pride v dojenčkovo kri.
BEFORE YOUR BABY BEGINS TREATMENT WITH INOmax
KAJ MORATE VEDETI, PREDEN VAŠ DOJENČEK PRIČNE ZDRAVLJENJE Z ZDRAVILOM INOmax
Do not use INOmax
Ne uporabljajte zdravila INOmax
- If your baby is allergic (hypersensitive) to nitric oxide or any other ingredients of INOmax.
- če je vaš otrok alergičen na (preobčutljivi za) dušikov oksid ali katerokoli sestavino zdravila
- INOmax is not to be given to babies who have an abnormal circulation within the heart.
- Zdravila INOmax ne smete dajati dojenčkom, ki imajo nenormalno cirkulacijo v srcu.
The doctor will decide when to treat your baby with INOmax and with other medicines, and will carefully supervise the treatment.
Zdravnik se bo odločil, kdaj naj vaš dojenček prejema zdravilo INOmax in druga zdravila in bo pozorno spremljal zdravljenje.
Some medicines can affect the ability of blood to carry oxygen.
Nekatera zdravila lahko vplivajo na sposobnost krvi za prenašanje kisika.
INOmax 400 ppm gas should be given with some medicines called “ nitric oxide donors” only if care is taken to make sure that the blood can carry enough oxygen.
Plin INOmax 400 ppm se sme uporabljati z zdravili, imenovanimi "donorji dušikovega oksida" le, če je zagotovljeno, da kri lahko prenaša dovolj kisika.
This need for care is present whether the medicines are administered by mouth, by injection, or even when applied as a cream to the skin.
Ta skrb je potrebna bodisi, če se takšno zdravilo pogoltne, da z injekcijo ali če se ga nanese v obliki kreme na kožo.
For example, care should be taken when INOmax is given at the same time as other medicines containing prilocaine.
Na primer, pozorni moramo biti kadar se zdravilo INOmax daje hkrati z zdravili, ki vsebujejo prilokain.
Please tell your doctor if your baby is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika, če vaš dojenček jemlje ali je pred kratkim jemal katerokoli zdravilo, tudi če ste ga dobili brez recepta.
HOW INOmax IS ADMINISTERED
KAKO BO VAŠ DOJENČEK ZDRAVLJEN Z ZDRAVILOM INOmax
Your doctor will decide the correct dose of INOmax and will administer INOmax to your baby ’ s lungs through a system designed for delivering nitric oxide.
Vaš zdravnik se bo odločil, kolikšen je ustrezni odmerek zdravila INOmax, in bo dovajal zdravilo INOmax v pljuča vašega dojenčka skozi sistem za dovajanje dušikovega oksida.
This delivery system will ensure that the correct
Ta sistem za dovajanje bo zagotovil, da bo dojenček prejel ustrezno količino dušikovega oksida.
The amount of nitrogen dioxide and oxygen delivered will be constantly monitored.
Količino dovedenega dušikovega oksida in kisika je treba nenehno nadzorovati.
INOmax is administered to your baby using an approved (CE-marked) delivery system designed to deliver nitric oxide.
Vaš dojenček bo prejemal zdravilo INOmax prek odobrenega (z oznako CE) sistema za dovajanje dušikovega oksida.