natgillin/translations-raw huggingface dataset:
This medicinal product must not be allowed to come into contact with any calcium-containing solutions.
To zdravilo ne sme priti v stik z raztopinami, ki vsebujejo kalcij.
Frequency categories are defined using the following convention: very common ( 1/10); common ( 1/100 to <1/10); uncommon ( 1/1,000 to <1/100); rare ( 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
For storage conditions of the diluted solution for infusion, see section 6.3.
Za pogoje shranjevanja razredčene raztopine za infundiranje glejte poglavje 6.3.
In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Pri bolnikih z blago do zmerno okvaro ledvic so priporočeni nižji odmerki zoledronske kisline (glejte poglavje "Odmerjanje" zgoraj in poglavje 4.4).
The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 patients studied.
Ledvični očistek zoledronske kisline je bil postavljen v soodnosnost z očistkom kreatinina, ledvični očistek je predstavljal 75 ± 33 % očistka kreatinina, ki je pri 64 proučevanih bolnikih kazal povprečje 84 ± 29 ml/min (razpon od 22 do 143 ml/min).
− Sudden coldness with fainting, limpness or collapse.
− nenadni občutek mrazenja z izgubo zavesti, mlahavostjo ali kolapsom,
There was no accumulation of the active substance in plasma after multiple doses given every 28 days.
Po večkratnih odmerkih zdravila, danih vsakih 28 dni, se učinkovina ni kopičila v plazmi.
Caution is indicated when zoledronic acid is used with other potentially nephrotoxic medicinal products.
Kadar zoledronsko kislino dajemo z drugimi potencialno nefrotoksičnimi zdravili, je potrebna previdnost.
Table 1: Preparation of reduced doses of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Preglednica 1: Priprava zmanjšanih odmerkov zdravila Zoledronska kislina Hospira 4 mg/100 ml raztopina za infundiranje
In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/kg administered at 2-3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.
V študijah z intravenskim infundiranjem so dokazali ledvično prenosljivost za zoledronsko kislino pri podganah, ki so jim dajali odmerek 0,6 mg/kg v 15-minutnih infuzijah v 3-dnevnih presledkih (kumulativni odmerek je ustrezal ravnem AUC, ki so bile približno 6-krat večje od terapevtske izpostavljenosti pri človeku).
In the zoledronic acid treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
V skupini, zdravljeni z zoledronsko kislino, so v 4. tednu in vsako naslednjo časovno točko v študiji v primerjavi s placebom opazili statistično pomembno izboljšanje rezultata bolečine (z uporabo vprašalnika BPI (Brief Pain Inventory) (slika 1).
− Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
− v primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte s svojim zdravnikom.
The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone.
Difosfonati delujejo selektivno na kosti zaradi svoje velike afinitete do mineralizirane kosti.
Only clear solution free from particles and discoloration should be used.
Za uporabo je primerna samo bistra raztopina brez delcev in nespremenjene barve.
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml dose of Zoledronic Acid Hospira, i.e. essentially “sodium free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml odmerek zdravila Zoledronska kislina Hospira, kar v bistvu pomeni “brez natrija”.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema občasni anemija
− For single use only.
Samo za enkratno uporabo.
Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone
Rezultati kliničnih preskušanj glede preprečevanja z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti
The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
Ledvični očistek zoledronske kisline je bil postavljen v soodnosnost z očistkom kreatinina, ledvični očistek je predstavljal 75 ± 33 % očistka kreatinina, ki je pri 64 proučevanih bolnikih z rakom kazal povprečje 84 ± 29 ml/min (razpon od 22 do 143 ml/min).
Not known (frequency cannot be estimated from the available data) Pain in the mouth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, these could be signs of bone damage in the jaw (osteonecrosis).
Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov) Bolečine v ustih in/ali čeljusti, oteklina ali slabo celjenje ranic v ustni votlini ali čeljusti, vnetje, odrevenelost ali občutek pritiska v čeljusti ali majanje zoba - to so lahko znaki odmiranja kosti v čeljusti (osteonekroze).
In the single-dose dog infusion studies, 1.0 mg/kg (6 fold the recommended human therapeutic exposure based on AUC) administered over 15 minutes was well tolerated with no renal effects.
Psi, ki so jim v študijah infundirali enkratne odmerke, so dobro in brez učinkov na ledvice prenašali odmerek 1,0 mg/kg (6-kratna priporočena terapevtska izpostavljenost pri človeku na podlagi AUC), infundiran v času 15 minut.
Uncommon Hypertension, flushing Not known**
Žilne bolezni občasni hipertenzija, zardevanje pogostnost neznana**
Kidney disorders (e.g. decreased urine output) may occur.
Lahko pride do bolezni ledvic (na primer do zmanjšanega izločanja urina).
- Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
- Preobčutljivost na učinkovino, katerega od difosfonatov ali katerokoli pomožno snov, navedeno v poglavju 6.1.
In patients with mild to moderate renal impairment, reduced Zoledronic Acid Hospira doses are recommended (see section “Posology” above and section 4.4).
Pri bolnikih z blago do zmerno okvaro ledvic so priporočeni nižji odmerki zdravila Zoledronska kislina Hospira (glejte poglavje "Odmerjanje" zgoraj in poglavje 4.4).
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, non-healing of sores or discharge during treatment with zoledronic acid.
Vsem bolnikom je treba naročiti, naj v času zdravljenja z zoledronsko kislino skrbijo za dobro ustno higieno in redno hodijo na preglede k zobozdravniku, v primeru simptomov v ustni votlini, kot so majavost zob, bolečine, otekline ali neceljenje ustnih razjed ali vnetje, pa naj takoj obvestijo zdravnika.
Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
dehidracija zaradi simptomov po odmerjanju, kot so zvišana telesna temperatura, bruhanje in driska
Caution is advised when zoledronic acid is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Pri dajanju zoledronske kisline skupaj z zdravili, za katera je znano, da povzročajo hipokalciemijo, je potrebna previdnost, saj lahko delujejo sinergistično in povzročijo hudo hipokalciemijo (glejte poglavje 4.5).
Instructions for preparing reduced doses of Zoledronic Acid Hospira: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
Navodila za pripravo zmanjšanih odmerkov zdravila Zoledronska kislina Hospira: Odvzemite ustrezni volumen tekočega koncentrata, kot sledi:
Zoledronic Acid Hospira is contraindicated during pregnancy (see section 4.3).
Uporaba zdravila Zoledronska kislina Hospira v nosečnosti je kontraindicirana (glejte poglavje 4.3).
Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal products.
Zdravila Zoledronska kislina Hospira ne smete mešati ali dajati intravensko skupaj z drugimi zdravili.
The chance of experiencing these side effects decreases with subsequent doses of Zoledronic Acid Hospira.
Verjetnost, da pride do teh neželenih učinkov, se pri nadaljnjih odmerjanjih zdravila Zoledronska kislina Hospira zmanjšuje.
•Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1.
• Preobčutljivost na učinkovino, katerega od difosfonatov ali katerokoli pomožno snov, navedeno v poglavju 6.1.
Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Pred uporabo je treba 5,0 ml koncentrata iz ene viale oziroma ustrezni volumen odvzetega koncentrata dodatno razredčiti s 100 ml infuzijske raztopine, v kateri ni kalcija (9 mg/ml (0,9-odstotna) raztopina natrijevega klorida ali 5-odstotna m/v raztopina glukoze).
− Zoledronic Acid Hospira must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein (also referred to as ‘IV' administration).
− Zdravilo Zoledronska kislina Hospira vam sme dati samo zdravstveni delavec, ki je usposobljen za intravensko (kar pomeni v veno, uprablja se tudi izraz ‘i.v.'
Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 Class effects)
okvara ledvic; pri bolnikih s predhodno ledvično disfunkcijo ali z drugimi dejavniki tveganja, kot so višja starost bolnika, sočasna uporaba nefrotoksičnih zdravil, diuretičnega zdravljenja ali dehidracija v času po infuziji, so poročali o redkih primerih odpovedi ledvic, pri kateri je potrebna dializa, in redkih primerih s smrtnim izidom (glejte poglavji 4.4 in 4.8 odstavek Učinki po skupinah)
The percentage of patients who experienced adverse reactions was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against adverse reactions was used.
V manjši študiji, v kateri so uporabljali profilakso proti neželenim učinkom, je bil delež vseh bolnikov, pri katerih je prišlo do neželenih učinkov, nižji, in sicer po prvi infuziji 19,5 %, po drugi infuziji 10,4 %, po tretji infuziji pa 10,7%.
No interaction studies with other medicinal products have been performed with zoledronic acid.
Študij medsebojnega delovanja z zoledronsko kislino in drugimi zdravili niso izvedli.
CARTON FOR 1 BAG AS UNIT PACK
ŠKATLA ZA 1 VREČKO ZA POSAMIČNO PAKIRANJE
Caution is advised when Zoledronic Acid Hospira is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Pri uporabi zdravila Zoledronska kislina Hospira skupaj z antiangiogenimi zdravili je potrebna previdnost, saj so pri bolnikih, ki so sočasno prejemali navedena zdravila, opažali povečano incidenco osteonekroze čeljustnic.
Zoledronic Acid Hospira contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Zdravilo Zoledronska kislina Hospira vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar bistvu pomeni "brez natrija“.
Table 6: Proportion of complete responders by day in the combined TIH studies Day 4
Preglednica 6: Delež bolnikov s popolnim odzivom po dnevih v združenih raziskavah tumorsko povzročene hiperkalciemije (TIH)
In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded.
Bolnike s serumskim kreatininom > 400 μmol/l ali > 4,5 mg/dl so izključili iz kliničnih študij.
This resulted in exaggerated pharmacological effects considered related to the compound's inhibition of skeletal calcium mobilisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Prišlo je do poudarjenega farmakološkega delovanja, domnevno zaradi zaviranja mobilizacije kalcija iz kosti, ki je v obdobju okrog poroda povzročalo hipokalciemijo (kar je značilno za celotno skupino difosfonatov), distocijo in predčasno prekinitev študije.
− The active substance of Zoledronic Acid Hospira is zoledronic acid.
− Učinkovina v zdravilu Zoledronska kislina Hospira je zoledronska kislina.
Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Analiza večkratnih dogodkov je pokazala za 36 % zmanjšano tveganje za razvoj SREs v skupini, ki je prejemala zoledronsko kislino 4 mg, v primerjavi s placebom.
Caution is indicated when zoledronic acid is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4).
Kadar uporabljamo zoledronsko kislino skupaj z zdravili, ki lahko znatno vplivajo na delovanje ledvic (npr. z aminoglikozidi ali diuretiki, ki lahko povzročijo dehidracijo), je potrebna previdnost (glejte poglavje 4.4).
Patients treated with zoledronic acid should be given the package leaflet and the patient reminder card.
Bolnikom, ki se zdravijo z zoledronsko kislino, je treba izročiti navodilo za uporabo in opozorilno kartico za bolnika.
It also contains mannitol, sodium citrate, water for injections and sodium chloride.
Vsebuje tudi manitol, natrijev citrat, vodo za injekcije in natrijev klorid.
The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Odvzeto količino koncentrata morate razredčiti v 100 ml sterilne 9 mg/ml (0,9-odstotne) raztopine natrijevega klorida za injiciranje ali 5-odstotne m/v raztopine glukoze.
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
O osteonekrozi čeljustnic so poročali predvsem pri bolnikih z rakom, zdravljenih z zdravili, ki zavirajo resorpcijo kosti, kot je zoledronska kislina (glejte poglavje 4.4).
Prevention of skeletal related events in patients with advanced malignancies involving bone:
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti:
If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Če je bila raztopina zdravila shranjena v hladilniku, pustite, da se pred uporabo segreje na sobno temperaturo.
Zoledronic Acid Hospira 4 mg/5 ml sterile concentrate IV
Zoledronska kislina Hospira 4 mg/5 ml sterilni koncentrat i.v.
Remove the following amount of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion (ml)
Odstranite naslednjo količino zdravila Zoledronska kislina Hospira 4 mg/100 ml raztopina za infundiranje (ml)
Mannitol, sodium citrate and water for injections.
Manitol, natrijev citrat in voda za injekcije.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw.
Zdravnika in zobozdravnika morate obvestiti takoj, če pride do kakršnihkoli težav v ustih oziroma z zobmi, na primer do majanja zoba, bolečin ali otekline, neceljenja ran ali vnetja, saj so to lahko znaki stanja, ki ga imenujemo osteonekroza čeljustnic.
Renal impairment has been observed in patients after a single administration, renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.
Pri bolnikih s predhodno okvaro ledvic ali s katerim od zgoraj navedenih dejavnikov tveganja je redko prišlo do ledvične odpovedi, zaradi katere bi bila potrebna dializa ali bi se končala s smrtnim izzidom.
Vomiting, nausea
anksioznost, motnje spanja
After dilution: From a microbiological point of view, the diluted solution for infusion should be used immediately.
Po redčenju: z mikrobiološkega vidika je treba razredčeno raztopino za infundiranje uporabiti takoj.
Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Pred uporabo zoledronske kisline moramo bolnike pregledati, da zagotovimo, da so ustrezno hidrirani.
The efficacy of one infusion of 5 mg zoledronic acid versus daily doses of 30 mg risedronate for 2 months was demonstrated in two 6-month comparative trials.
V dveh 6-mesečnih primerjalnih preskusih se je ena infuzija 5 mg zoledronske kisline izkazala za bolj učinkovito kot dvomesečna uporaba 30 mg risedronata na dan.
Zoledronic Acid Hospira is supplied as packs containing 1 bag.
Zdravilo Zoledronska kislina Hospira je na voljo v pakiranjih, ki vsebujejo 1 vrečo.
− From a microbiological point of view, the diluted solution for infusion should be used immediately.
− Z mikrobiološkega stališča je razredčeno raztopino za infundiranje najbolje uporabiti takoj.
To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Da ne bi prišlo do možnih inkompatibilnosti, mora biti infuzijska raztopina, ki se uporablja za razredčenje, bodisi 9 mg/ml (0,9-odstotna) raztopina natrijevega klorida bodisi 5-odstotna m/v raztopina glukoze.
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, reduced Zoledronic Acid Hospira doses are recommended (see also section 4.4).
Pri bolnikih z zasevki v kosteh, ki imajo pred začetkom zdravljenja blago do zmerno okvaro ledvic (opredeljeno za to skupino bolnikov kot CLcr 30-60 ml/min), priporočajo naslednji zmanjšani odmerek zdravila Zoledronska kislina Hospira (glejte tudi poglavje 4.4):
− Zoledronic Acid Hospira must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
− Zdravilo Zoledronska kislina Hospira vam sme dati samo zdravstveni delavec, ki je usposobljen za intravensko (kar pomeni v veno) dajanje difosfonatov.
Talk to your doctor before you are given Zoledronic Acid Hospira: - if you are being treated with any medicine containing zoledronic acid, which is also the active substance of Zoledronic Acid Hospira (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium).
− če se zdravite s katerim od zdravil, ki vsebuje zoledronsko kislino, ki je učinkovina tudi v zdravilu Zoledronska kislina Hospira (zoledronsko kislino uporabljamo za preprečevanje zapletov na kosteh ali za zmanjševanje količine kalcija pri odraslih bolnikih, ki imajo določene vrste raka),
- if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Hospira and inform your doctor about your dental treatment.
- če vam zobozdravnik zdravi zobe ali boste imeli zobozdravstveno operacijo, mu povejte, da prejemate zdravilo Zoledronska kislina Hospira in obvestite svojega zdravnika o zdravljenju zob.
• Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each Zoledronic Acid Hospira dose.
• Pred vsakim odmerjanjem zdravila Zoledronska kislina Hospira je treba izračunati očistek kreatinina glede na dejansko telesno maso po Cockcroft-Gaultovi formuli.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Zdravnika in zobozdravnika morate obvestiti takoj, če pride do kakršnihkoli težav v ustih oziroma z zobmi, na primer do majanja zoba, bolečin ali otekline, slabega celjenja ustnih razjed ali vnetja, saj so to lahko znaki osteonekroze čeljustnic.
Cases of osteonecrosis of the jaw have been reported; predominantly in cancer patients treated with medicinal products that inhibit bone resorption, including zoledronic acid (see section 4.4).
O osteonekrozi čeljusti so poročali predvsem pri bolnikih z rakom, zdravljenih z zdravili, ki zavirajo resorpcijo kosti, vključno z zoledronsko kislino (glejte poglavje 4.4).
Uncommon: Blurred vision, scleritis and orbital inflammation Rare
zamegljen vid, skleritis in vnetje orbite
Skeletal morbidity rate p-value
stopnja obolevnosti skeleta vrednost p 0,005
Headache Uncommon: Dizziness, paraesthesia, dysgusia, hypoaesthesia, hyperaesthesia, tremor,
omotica, parestezija, disgevzija, hipestezija, hiperestezija, tremor,
− Do not use Zoledronic Acid Hospira after the expiry date stated on the pack.
− Zdravila Zoledronska kislina Hospira ne smete uporabljati po datumu izteka roka uporabnosti,
− The unopened vial does not require any specific storage conditions.
− Za shranjevanje neodprtih vial niso potrebna posebna navodila.
This uptake into bone is common for all bisphosphonates and is presumably a consequence of the structural analogy to pyrophosphate.
V kostno tkivo se vežejo vsi difosfonati, verjetno zaradi svoje zgradbe, ki je podobna pirofosfatu.
Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal product and must be given through a separate infusion line at a constant infusion rate.
Zdravila Zoledronska kislina Hospira ne smete mešati ali dajati intravensko z drugim zdravilom, dajati ga morate po ločenem infuzijskem sistemu s stalno hitrostjo infundiranja.
Zoledronic Acid Hospira is supplied as packs containing 1 vial.
Zdravilo Zoledronska kislina Hospira je na voljo v pakiranjih, ki vsebujejo 1 vialo.
Prevention of skeletal related events in patients with advanced malignancies involving bone
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti
Patients treated with Zoledronic Acid Hospira should be given the package leaflet and the patient reminder card
Bolnikom, ki se zdravijo z zdravilom Zoledronska kislina Hospira, je treba izročiti navodilo za uporabo in opozorilno kartico za bolnika.
- From a microbiological point of view, the product should be used immediately.
− Z mikrobiološkega vidika je treba zdravilo uporabiti takoj.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodiumfree”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni “brez natrija“.
This medicinal product must not be allowed to come into contact with any calcium-containing solutions and it must not be mixed or given intravenously with any other medicinal product in the same infusion line.
Tega zdravila ne smemo mešati ali dajati intravensko skupaj z drugimi zdravili po isti infuzijski cevki.
somnolence
somnolenca