natgillin/translations-raw huggingface dataset:
• When the 50 ml syringe containing the diluted Removab solution for infusion is empty it is replaced with a 50 ml syringe containing 20 ml sodium chloride 9 mg/ml (0.9%) solution for injection until the end of the scheduled infusion time to clear the dead volume in the perfusion lead (approximately 2 ml) under unchanged conditions.
• Ko je 50 ml injekcijska brizga, ki vsebuje razredčeno zdravilo Removab raztopino za infundiranje prazna, se nadomesti s 50 ml injekcijsko brizgo, ki vsebuje 20 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) do konca načrtovanega časa infundiranja, da očistite mrtvi volumen v perfuzijskem vodu (približno 2 ml) pod nespremenjenimi pogoji.
Gastrointestinal reactions like abdominal pain, nausea, vomiting and diarrhoea are very common and occur mostly with CTCAE grade 1 or 2, but were also observed in higher grades, and respond to adequate symptomatic treatment.
Gastrointestinalne reakcije, kot so bolečina v trebuhu, navzea, bruhanje in driska so zelo pogoste in se običajno pojavijo s 1. ali 2. stopnjo po CTCAE, pri čemer so opazili tudi reakcije višje stopnje, in se odzivajo na ustrezno simptomatsko zdravljenje.
Treatment of these patients with Removab should only be considered after a thorough evaluation of benefit / risk (see section 4.4).
Pred zdravljenjem teh bolnikov z zdravilom Removab je treba izčrpno analizirati razmerje med možnimi koristmi in možnimi tveganji (glejte poglavje 4.4).
As secondary efficacy endpoint overall survival (Table 6) was assessed.
Kot sekundarni opazovani dogodek so ocenili celokupno preživetje (Preglednica 6).
You are required to have a BMI above 17 (after drainage of the ascites fluid) and a Karnofsky Index above 60 to use this medicine.
Za uporabo tega zdravila mora biti vaš BMI nad 17 (po drenaži ascitesa) in indeks po Karnofskem nad 60.
Treatment of these patients with Removab should only be considered after a thorough evaluation of benefit / risk.
Pred zdravljenjem teh bolnikov z zdravilom Removab je treba izčrpno analizirati razmerje med možnimi koristmi in možnimi tveganji.
Removab must be administered under the supervision of a physician experienced in the use of anti-neoplastic medicinal products.
Zdravilo Removab se mora aplicirati pod nadzorom zdravnika, ki ima izkušnje z uporabo antineoplastičnih zdravil.
Figure 2 Illustration of the transfer of Removab from the pre-filled syringe to the 50 ml syringe
Slika 2 Slika prenosa zdravila Removab iz napolnjene injekcijske brizge v 50 ml brizgo
The primary efficacy endpoint, puncture-free survival, was a composite endpoint defined as the time to first need for therapeutic ascites puncture or death, whichever occurred first (identical to the pivotal study).
Primarni opazovani dogodek učinkovitosti, preživetje brez punktiranja, je bil sestavljeni opazovani dogodek, opredeljen kot čas do prve potrebe po terapevtskem punktiranju ascitesa ali smrti, kar koli je nastopilo prej (identično s ključno študijo).
• An additional air buffer of at least 3 ml is included in the 50 ml syringe.
• 50 ml brizga vključuje vsaj dodatne 3 ml zračnega pufra.
Hypersensitivity to murine (rat and / or mouse) proteins.
Preobčutljivost za beljakovine glodavcev (podgan in/ali miši).
This is a precautionary measure to ensure that Removab is infused only via the intraperitoneal route of administration.
To je previdnostni ukrep, s katerim se zagotovi, da se zdravilo Removab infundira samo v obliki intraperitonealne infuzije.
Removab must be administered intraperitoneally over an infusion time of at least 3 hours via a constant infusion pump system as described below:
Zdravilo Removab se daje intraperitonealno v obliki vsaj 3-urne infuzije s sistemom stalne črpalke za infundiranje, kot je opisano spodaj:
The most common serious side effects of Removab are infusion-related side effects and side effects related to the gastrointestinal system (stomach and gut).
Najpogostejši resni neželeni učinki zdravila Removab so z infundiranjem povezani neželeni učinki in neželeni učinki, povezani s prebavili (želodec ali črevo).
• The catheter is kept closed until the next infusion.
• Do naslednje infuzije mora biti kateter zaprt.
Sodium Chloride 9 mg/ml (0.9%)
Natrijev klorid 9 mg/ml (0,9 %)
Uncommon Convulsion*.
Konvulzije*.
Anxiety, insomnia.
Anksioznost, nespečnost
Special populations No studies have been conducted.
Posebne skupine bolnikov Študij niso izvajali.
- The other ingredients are sodium citrate, citric acid monohydrate, polysorbate 80 and water for injections.
- Druge sestavine zdravila so natrijev citrat, citronska kislina monohidrat, polisorbat 80 in voda za injekcije.
Table 4 Overall survival of study IP-REM-AC-01 in post study phase Paracentesis + catumaxomab (N=170)
Preglednica 4 Celokupno preživetje študije IP-REM-AC-01 v fazi po študiji Paracenteza + katumaksomab (N = 170)
Back pain, myalgia, arthralgia.
Bolečine hrbta, mialgija, artralgija
Infection.
Okužba
Diluted Removab.
Razredčeno zdravilo Removab.
95% CI for median (days) p-value (log-rank test)
95 % IZ za mediano (dni) Vrednost p (test log-rank)
Pooled population (N=219)
Obe skupini bolnikov (N = 219)
Cytokine-release related reactions: SIRS a potentially life-threatening combination of tachycardia, fever and/or dyspnoea, can develop within 24 hours after a catumaxomab infusion and resolves under symptomatic treatment.
Reakcije, povezane s sproščanjem citokina: sindrom sistemskega vnetnega odziva (SIRS - Systemic Inflammatory Response Syndrome), potencialno življenje ogrožajoča kombinacija tahikardije, zvišane telesne temperature in/ali dispneje, se lahko razvije v roku 24 ur od infundiranja katumaksomaba in izzveni s simptomatskim zdravljenjem.
Ascites drainage
Drenaža ascitesa
A third functional binding site in the Fc-region of catumaxomab enables interaction with accessory immune cells via Fcγ receptors.
Tretja površina funkcionalne vezave na območju Fc katumaksomaba omogoča medsebojno delovanje z dodatnimi imunskimi celicami prek receptorjev
After the Removab infusion you will be observed as decided by your doctor.
Po infundiranju zdravila Removab se bo zdravnik odločil o načinu, na katerega bodo vaše stanje spremljali.
Catumaxomab + prednisolone (N=111)
Katumaksomab + prednizolon (N = 111)
An increased frequency of some adverse reactions was seen in relation to 3h administration including chills and hypotension (grades 1 / 2), diarrhoea (all grades) and fatigue (grade 1 / 2).
Opazili so povečano pogostnost nekaterih neželenih učinkov pri 3-urnem dajanju, vključno z mrzlicami in hipotenzijo (stopnje 1 / 2), drisko (vseh stopenj) in utrujenostjo (stopnje 1 / 2).
Patients with hepatic impairment of a higher severity grade than moderate and / or with more than 70% of the liver metastasised and / or portal vein thrombosis / obstruction have not been investigated.
Pri bolnikih z okvaro delovanja jeter, ki presega zmerno, in/ali pri katerih je vsaj 70 % jeter metastaziranih in/ali s trombozo/obstrukcijo vene porte, raziskav niso opravili.
• The connected perfusion tubing equipment of the precision pump is prefilled with the diluted Removab solution for infusion.
• Povezana oprema s perfuzijsko cevko natančne črpalke je napolnjena z razredčeno raztopino zdravila Removab za infundiranje.
*rat-mouse hybrid IgG2 monoclonal antibody produced in a rat-mouse hybrid-hybridoma cell line For the full list of excipients, see section 6.1.
*monoklonsko protitelo hibrida podgane-miši IgG2, proizvedeno v celični liniji hibrid-hibridoma podgane-miši
3 Perfusion Tubing (1 mm inner diameter, 150 cm length) 5 Perfusion Lead
infundiranje 3 Perfuzijska cev (1 mm notranji premer, 150 cm dolžine) 4 Infuzijski ventil
WARNING TEXT FOR PEELABLE STICKER TO BE ATTACHED TO 50ml SYRINGE CONTAINING THE DILUTED REMOVAB SOLUTION FOR INFUSION
OPOZORILNO BESEDILO ZA SAMOLEPILNO NALEPKO, KI SE PRILEPI NA 50 ml BRIZGO, KI VSEBUJE RAZREDČENO RAZTOPINO ZDRAVILA REMOVAB ZA INFUNDIRANJE
Removab is indicated for the intraperitoneal treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Zdravilo Removab je indicirano za intraperitonealno zdravljenje malignega ascitesa pri odraslih s karcinomi, pozitivnimi na EpCAM, kjer standardne terapije ni ali ni več smiselna.
• The peelable sticker, which is provided on the inner side of the Removab carton box, displaying the text “Diluted Removab.
• Samolepilno nalepko na notranji strani škatle zdravila Removab z besedilom „Razredčeno zdravilo Removab.
Dyspnoea*, pleural effusion*, cough.
Dispneja*, plevralna efuzija*, kašelj
What you need to know before you use Removab
Kaj morate vedeti, preden boste uporabili zdravilo Removab Ne uporabljajte zdravila Removab
Table 7 Preparation of Removab solution for intraperitoneal infusion Number of infusion / Dose
Preglednica 7 Priprava raztopine zdravila Removab za intraperitonealno infundiranje
Before you start using Removab your doctor will check your: - Body Mass Index (BMI), which depends on your height and weight - Karnofsky Index, a measure of your general performance status.
- vaš indeks telesne mase (BMI - Body Mass Index ), ki je odvisen od vaše višine in telesne mase, - indeks po Karnofskem, ki je merilo za vašo splošno sposobnost.
Systemic Inflammatory Response Syndrome (SIRS) In 3.8% of the patients symptoms of SIRS were observed within 24 hours after catumaxomab infusion.
Pri 3,8 % bolnikov so v 24 urah po infundiranju katumaksomaba opazili simptome SIRS.
Uncommon Pulmonary embolism*, hypoxia*.
Pljučni embolizem*, hipoksija*
Table 5 Efficacy results (puncture-free survival and time to first need for therapeutic ascites puncture) of study IP-CAT-AC-03
Preglednica 5 Rezultati učinkovitosti (preživetje brez punktiranja in čas do prve potrebe po terapevtskem punktiranju ascitesa) študije IP-CAT-AC-03
Removab has to be administered as constant rate intraperitoneal infusion with an infusion time of at least 3 hours.
Zdravilo Removab se daje kot intraperitonealna infuzija s stalno hitrostjo s trajanjem infuzije vsaj 3 ure.
Figure 1 Kaplan-Meier estimates of time to first need for therapeutic ascites puncture of study IP-REM-AC-01
Slika 1 Ocena po Kaplan-Meierju za čas do prve potrebe po terapevtskem punktiranju ascitesa v študiji IP-REM-AC-01
Uncommon Extravasation*, application site inflammation*.
Ekstravazacija*, vnetje mesta aplikacije*
Intraperitoneal use only.” must be attached to the 50 ml syringe containing the diluted Removab solution for intraperitoneal infusion.
Samo za intraperitonealno uporabo.“ nalepite na 50 ml brizgo, ki vsebuje razredčeno raztopino zdravila Removab za intraperitonealno infundiranje.
Catumaxomab was administered as four 3-hour constant-rate i.p.
Katumaksomab so dajali v obliki štirih 3-urnih i.p.
Headache, dizziness.
Glavobol, omotičnost.
Anaemia*, lymphopenia, leukocytosis, neutrophilia.
Anemija*, limfopenija, levkocitoza, nevtrofilija
Hypotension*, hypertension*, flushing.
Hipotenzija*, hipertenzija*, oblivanje
Uncommon Gastrointestinal haemorrhage*, intestinal obstruction*.
Gastrointestinalne krvavitve*, obstrukcija črevesja*
This confirmatory two-arm, randomized, open label, phase IIIb study in 219 epithelial cancer patients with symptomatic malignant ascites requiring therapeutic ascites puncture investigated treatment with catumaxomab plus 25 mg prednisolone premedication vs. catumaxomab alone.
V tej potrditveni, dvokraki, randomizirani, odprti študiji faze IIIb z 219 bolniki z epitelnim rakom s simptomatičnim malignim ascitesom, ki so potrebovali terapevtsko punktiranje ascitesa, so raziskovali zdravljenje s premedikacijo s katumaksomabom in 25 mg prednizolona v primerjavi s samim katumaksomabom.
Removab has minor to moderate influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Removab ima blag do zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Hepatic impairment or portal vein thrombosis / obstruction Patients with hepatic impairment of a higher severity grade than moderate and / or with more than 70% of the liver metastasised and / or portal vein thrombosis / obstruction have not been investigated.
Okvara delovanja jeter ali tromboza/obstrukcija vene porte Pri bolnikih z okvaro delovanja jeter, ki presega zmerno, in/ali pri katerih je vsaj 70 % jeter metastaziranih in/ali s trombozo/obstrukcijo vene porte, raziskav niso opravili.
sinus tachycardia.
s sinusno tahikardijo
0.1 ml concentrate for solution for infusion in a pre-filled syringe (type I glass, siliconised) with plunger stopper (bromobutyl rubber) and luer lock system (polypropylene siliconised and polycarbonate) with tip cap (styrene butadiene rubber) with a cannula; pack size of 1.
0,1 ml koncentrata za raztopino za infundiranje v napolnjeni injekcijski brizgi (steklo vrste I, silikonizirano) zamašek (bromobutilna guma) in sistem za zapiranje luer lock (silikoniziran polipropilen in polikarbonat) s pokrovom za konico (stiren-butadienska guma) s kanilo; velikost pakiranja po 1.
The remaining sodium chloride 9 mg/ml (0.9%) solution for injection can be discarded.
Preostanek natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje lahko zavržete.
As release of pro-inflammatory and cytotoxic cytokines is initiated by the binding of catumaxomab to immune and tumour cells, cytokine release related clinical symptoms such as fever, nausea, vomiting and chills have been very commonly reported during and after the Removab administration (see section 4.8).
Ker povzroči vezava katumaksomaba na imunske celice in celice tumorja sproščanje vnetnih in citotoksičnih citokinov, so med in po uporabi zdravila Removab zelo pogosto poročali o kliničnih simptomih, povezanih s sproščanjem citokina, kot so zvišana telesna temperatura, navzea, bruhanje in mrzlice (glejte poglavje 4.8).
The following definitions of CTCAE criteria of the US National Cancer Institute (version 4.0) apply: CTCAE grade 1 = mild, CTCAE grade 2 = moderate, CTCAE grade 3 = severe, CTCAE grade 4 = life-threatening
1. stopnje po CTCAE = blago, 2. stopnje po CTCAE = zmerno, 3. stopnje po CTCAE = resno,
0.5 ml concentrate for solution for infusion in a pre-filled syringe (type I glass, siliconised) with plunger stopper (bromobutyl rubber) and luer lock system (polypropylene siliconised and polycarbonate) with tip cap (styrene butadiene rubber) with a cannula; pack size of 1.
0,5 ml koncentrata za raztopino za infundiranje v napolnjeni injekcijski brizgi (steklo vrste I, silikonizirano) zamašek (bromobutilna guma) in sistem za zapiranje luer lock (silikoniziran polipropilen in polikarbonat) s pokrovom za konico (stiren-butadienska guma) s kanilo; velikost pakiranja po 1.
In presence of factors interfering with the immune system, in particular acute infections, the administration of Removab is not recommended.
V prisotnosti dejavnikov, ki vplivajo na imunski sistem, še zlasti akutnih okužb, se uporaba zdravila
LIST OF EXCIPIENTS Sodium citrate, citric acid monohydrate, polysorbate 80, water for injections
Natrijev citrat, citronska kislina monohidrat, polisorbat 80, voda za injekcije
4th infusion 150 micrograms
4. infuzija 150 mikrogramov
What Removab looks like and contents of the pack Removab is presented as a clear and colourless concentrate for solution for infusion in a pre-filled syringe with a cannula.
Zdravilo Removab je bister in brezbarven koncentrat za raztopino za infundiranje v napolnjeni brizgi s kanilo.
Table 1 Adverse reactions reported from patients receiving catumaxomab treatment Infections and infestations
Preglednica 1 Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih s katumaksomabom
The safety profile of catumaxomab using a 3h versus a 6h infusion time is in general comparable in regards to nature, frequency and severity.
Varnostni profil katumaksomaba je po narav, pogostnosti in resnosti pri 3-urnem infundiranju primerljivi s 6-urnim.
Kaplan Meier estimates for time to first need for therapeutic ascites puncture are given in Figure 1.
Meierju za čas do prve potrebe po terapevtskem punktiranju ascitesa so predstavljene v Sliki 1.
A catheter will be placed in your abdominal space (intraperitoneal) for the whole treatment period, until the day after your last infusion.
Za ves čas trajanja postopka zdravljenja se v trebušno votlino (intraperitonealno) namesti kateter, do dneva zadnjega infundiranja.
Time to first need for therapeutic ascites puncture Median time to first need for therapeutic ascites puncture (days) 95% CI for median (days) p-value (log-rank test)
Čas od prve potrebe po terapevtskem punktiranju ascitesa Mediani čas do prve potrebe po terapevtskem punktiranju ascitesa (dni) 95 % IZ za mediano (dni) Vrednost p (test log-rank) Razmerje tveganja (RT) 95 % IZ za RT
Cytokine release related symptoms
Simptomi, povezani s sproščanjem citokina
2nd infusion 20 micrograms
2. infuzija 20 mikrogramov
20 micrograms on day 3
2. odmerek 20 mikrogramov na dan 3
50 micrograms on day 7
3. odmerek 50 mikrogramov na dan 7
A solid performance status expressed as Body Mass Index (BMI) > 17 (to be assessed after drainage of ascites fluid) and Karnofsky Index > 60 is required prior to Removab therapy.
izražen kot indeks telesne mase (BMI - Body Mass Index) (oceni se po drenaži ascitesa) in > 17 indeks po Karnofskem > 60.
Table 3 Efficacy results (puncture-free survival and time to first need for therapeutic ascites puncture) of study IP-REM-AC-01
Preglednica 3 Rezultati učinkovitosti (preživetje brez punktiranja in čas do prve potrebe po terapevtskem punktiranju ascitesa) študije IP-REM-AC-01
• Parallel to each Removab application 250 ml sodium chloride 9 mg/ml (0.9%) solution for injection are infused via an infusion valve / Y connection in the perfusion lead of the catheter.
• Vzporedno z vsako aplikacijo zdravila Removab infundirajte še 250 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) skozi infuzijski ventil/spoj Y v perfuzijski vod katetra.
Other cytokine-release related reactions such as fever, chills, nausea, and vomiting are very commonly reported reactions in intensity of CTCAE grade 1 and 2 (US National Cancer Institute, version 4.0).
Zelo pogosto poročajo o drugih reakcijah, povezanih s sproščanjem citokina, kot so zvišana telesna temperatura, mrzlice, navzea in bruhanje, z intenzivnostjo 1. in 2. stopnje po Terminološko poenotenih kriterijih za neželene učinke (CTCAECommon Terminology Criteria for Adverse Events US National Cancer Institute, različica 4.0).
1st infusion 10 micrograms
1. infuzija 10 mikrogramov
Removab dosing schedule comprises the following four intraperitoneal infusions: 1st dose
Režim odmerjanja zdravila Removab sestavljajo naslednje štiri intraperitonealne infuzije:
150 micrograms on day 10
4. odmerek 150 mikrogramov na dan 10
Rash*, erythaema*, hyperhidrosis, pruritus.
Izpuščaj*, eritem*, hiperhidroza, pruritus
• polyurethane, polyurethane silicon coated catheters
• katetri iz poliuretana s silikonsko oblogo ali brez
infusions in doses of 10, 20, 50 and 150 micrograms on day 0, 3, 7 and 10, respectively, in both groups.
infundiranj s stalno hitrostjo v odmerkih z 10 mikrogrami na dan 0, 20 mikrogrami na dan 3, 50 mikrogrami na dan 7 in 150 mikrogrami na dan 10 v obeh skupinah.
A pivotal, two-arm, randomised, open-label, phase II/III clinical trial in 258 patients with symptomatic malignant ascites due to EpCAM-positive carcinomas of whom 170 were randomised to catumaxomab treatment.
Ključno, dvokrako, randomizirano, odprto klinično preskušanje faze II/III z 258 bolniki s simptomatičnim malignim ascitesom zaradi karcinoma, pozitivnega na EpCAM, od katerih jih je bilo 170 naključno razvrščeno za zdravljenje s katumaksomabom v randomiziranem delu študije.
Uncommon Thrombocytopenia*, coagulopathy*.
Trombocitopenija*, koagulopatija*
Conditions such as hypovolaemia, hypoproteinaemia, hypotension, circulatory decompensation and acute renal impairment must be resolved prior to each Removab infusion.
Pred vsakim infundiranjem zdravila Removab je treba odpraviti stanja kot so hipovolemija, hipoproteinemija, hipotenzija, cirkulatorna dekompenzacija in okvara delovanja ledvic.
Endometrial *= lobular breast cancer
*= lobularni rak dojke
Catumaxomab was administered as four intraperitoneal infusions with increased doses of 10, 20, 50 and 150 micrograms on day 0, 3, 7 and 10, respectively (see section 4.2).
Katumaksomab so dajali kot štiri intraperitonealne infuzije z zvišanjem odmerkov z 10 mikrogrami na dan 0, 20 mikrogrami na dan 3, 50 mikrogrami na dan 7 in 150 mikrogrami na dan 10 (glejte poglavje 4.2).
• The 50 ml syringe containing the diluted Removab solution for infusion is installed in the precision pump.
• Namestite 50 ml brizgo, ki vsebuje razredčeno raztopino zdravila Removab za infundiranje, v natančno črpalko.
• Based on the dose, the appropriate amount of sodium chloride 9 mg/ml (0.9%) solution for injection is extracted with a 50 ml syringe (Table 7).
• Glede na odmerek izvlecite ustrezno količino raztopine natrijevega klorida 9 mg/ml (0,9 %) za injekciranje v 50 ml brizgo (Preglednica 7).
In 43.7% of patients abdominal pain was reported as an adverse reaction reaching grade 3 in 8.2 % of patients, but it resolved under symptomatic treatment.
3. stopnjo pri 8,2 % bolnikov, vendar so s simptomatskim zdravljenjem izzvenele.
• The 50 ml syringe is closed with a cap and shaken gently to mix the solution.
• 50 ml brizgo zaprite s pokrovom in zmešajte raztopino z nežnim pretresanjem.
Instructions for dilution prior to administration
Navodila za redčenje pred uporabo
In Table 1, adverse reactions are listed by organ class.
Seznam neželenih učinkov v obliki preglednice V Preglednici 1 so neželeni učinki našteti po organskih sistemih.
2nd dose
PRILOGA II
Standard therapy or premedication, e.g. analgesic / antipyretic / nonsteroidal antiphlogistic is appropriate to limit the risk.
Za omejitev tveganja je ustrezna standardna terapija ali premedikacija, npr. z analgetiki/antipiretiki/nesteroidnimi antiflogistiki.
Abdominal pain was commonly reported as an adverse reaction.
Bolečina v trebuhu je neželeni učinek, o katerem so pogosto poročali.
The diluted Removab solution for infusion is administered intraperitoneally as constant rate infusion using an adequate pump system.
Razredčena raztopina se nato uporabi intraperitonealno z enakomerno hitrostjo infundiranja in s pomočjo ustreznega sistema črpalke.
• The 50 ml syringe is inserted in the infusion pump.
• 50 ml brizgo vstavite v črpalko za infundiranje.
Very common serious side effects (may affect more than 1 in 10 people): - Tiredness
Pogosti neželeni učinki (prizadenejo lahko do 1 od 10 bolnikov):
infusion cycle consisting of 10, 20, 50 and 150 micrograms of catumaxomab in 8 patients with malignant ascites due to carcinoma (IP-CAT-AC-04)
infundiranj, sestavljenem iz odmerkov z 10, 20, 50 in 150 mikrogrami katumaksomaba pri 8 bolnikih z malignim ascitesom zaradi karcinoma, (IP-CAT-AC-04), je bila adenozin deaminaza (ADA) pri presejalnem testiranju zaznavna v vseh razpoložljivih vzorcih ascitesa in plazme.
The infusion must be administered at constant rate with duration time of at least 3 hours.
Infuzijo se mora dajati s stalno hitrostjo s trajanjem infuzije vsaj
It is important to tell your doctor if you have any of the following: - undrained fluid in your abdominal cavity - cold hands and feet, light headedness, difficulty passing urine, increased heart rate, and weakness (symptoms of low blood volume) - weight gain, weakness, shortness of breath and fluid retention (symptoms of low blood protein levels) - feeling dizzy and faint (symptoms of low blood pressure) - problems with your heart and circulation - kidney or liver problems - an infection.
Pomembno je, da zdravnika obvestite, če imate katerega od znakov v nadaljevanju: - obstoječa tekočina v trebušni votlini, - hladne roke ali noge, omotica, težave pri uriniranju, zvišan srčni utrip, oslabelost (simptomi slabokrvnosti),
Precautions to be taken before administering the medicinal product Before administration of Removab the concentrate for solution for infusion is diluted in sodium chloride 9 mg/ml (0.9%) solution for injection.
Previdnostni ukrepi potrebni pred dajanjem zdravila Pred dajanjem se zdravilo Removab koncentrat za raztopino za infundiranje razredči v raztopini natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.