natgillin/translations-raw huggingface dataset:
The following side effects are common (affects 1 to 10 patients in 100):
Sljedeće nuspojave su česte (javljaju se u 1 do 10 na 100 bolesnika):
The mean duration of exposure was 118.9 days in the 0.2 g/kg bw and 129 days in the 0.4 g/kg bw Hizentra group (maximum exposure up to 167 and 166 days in each group, respectively).
dana za Hizentra skupinu liječenu s 0,2 g/kg tt i 129 dana za 0,4 g/kg tt (maksimalna izloženost do 167 odnosno 166 dana u svakoj grupi).
In the second patient group receiving Hizentra via pump-assisted administration (n=18), weekly Hizentra infusions were administered with 25, 50, 75 and 100 ml/hour/site flow rate.
U drugoj skupini bolesnika koja su primali lijek Hizentra pomoću pumpe (n = 18) primjenjivane su tjedne infuzije lijeka Hizentra s brzinom protoka od 25, 50, 75 i 100 ml/sat/mjestu.
When using multiple vials to achieve the desired dose, repeat this step.
Ako upotrebljavate nekoliko bočica kako biste postigli željenu dozu,
The solution is clear and pale-yellow or light-brown.
Otopina je bistra, blijedo žute ili svijetlo smeđe boje.
Data from prospective clinical trials on the use of human normal immunoglobulin in breast feeding women is limited.
Podaci iz prospektivnih kliničkih ispitivanja o primjeni ljudskog normalnog imunoglobulina u dojilja su ograničeni.
Replacement therapy The medicinal product should be administered via the subcutaneous route.
Lijek se treba primjenjivati supkutanim putem.
Caution should be exercised in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilization, severely hypovolemic patients, patients with diseases which increase blood viscosity).
hipertenzije, dijabetesa mellitusa i anamneze vaskularnih bolesti ili trombotskih epizoda, bolesnika sa stečenim ili naslijeđenim trombofilijskim poremećajima, bolesnici s produljenim razdobljima imobilizacije, bolesnika s teškom hipovolemijom, bolesnika s bolestima koje povećavaju viskoznost krvi).
• The active substance is human normal immunoglobulin.
• Djelatna tvar je ljudski normalni imunoglobulin.
The initial subcutaneous dose may be a 1:1 conversion from the previous IVIG dose (calculated as weekly dose).
Početna supkutana doza može se izračunati na temelju prethodne i.v.Ig doze uz omjer 1: 1 (ali je potrebno izračunati tjednu dozu).
Because the solution contains no preservative, Hizentra should be used/infused as soon as possible after opening the vial or blistered pre-filled syringe.
Budući da otopina ne sadrži konzervans, Hizentra se treba upotrijebiti/ubrizgati što je prije moguće nakon otvaranja bočice ili napunjene štrcaljke u blisteru.
1 x 5 ml 1 x 10 ml 1 x 20 ml 1 x 50 ml 10 x 5 ml 10 x 10 ml 10 x 20 ml 10 x 50 ml 20 x 5 ml 20 x 10 ml 20 x 20 ml
1 x 5 ml 1 x 10 ml 1 x 20 ml 1 x 50 ml 10 x 5 ml 10 x 10 ml 10 x 20 ml 10 x 50 ml 20 x 5 ml 20 x 10 ml
The recommended initial infusion rate is up to 0.5 ml/min/site (30 ml/hour/site).
Preporučena početna brzina infuzije je do 0,5 ml/min/mjestu (30 ml/sat/mjestu).
Marketing Authorisation Holder and Manufacturer CSL Behring GmbH
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač CSL Behring GmbH
For all patients who received 0.4 g/kg bw in the PATH extension study, 9.7 % (7/72 patients) had a relapse.
Svi bolesnici koji su primili 0,4 g/kg tt u nastavku PATH ispitivanja, njih 9,7% (7/72 bolesnika) je imalo relaps.
Immunomodulatory therapy
Imunomodulacijska terapija
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Unatoč tome, kod primjene lijekova dobivenih iz ljudske krvi ili plazme, mogućnost prijenosa infektivnih bolesti ne može biti potpuno isključena.
6 Prepare the tubing
6 Priprema cijevi
• Do not use this medicine after the expiry date which is stated on the outer carton and the pre filled syringe label after EXP.
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici na napunjenoj štrcaljki nakon oznake „Rok valjanosti“.
If you have any further questions on the use of this medicine, please ask your doctor or healthcare professional.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili zdravstvenom radniku.
Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus or the neonate are to be expected.
Kliničko iskustvo s imunoglobulinima upućuje na to da nema očekivanih štetnih učinaka na tijek trudnoće, ili na fetus i novorođenče.
Paediatric population The same interactions may occur in the paediatric population.
Jednake interakcije mogu se javiti i u pedijatrijskoj populaciji.
If well-tolerated, you may increase the infusion rate up to 2.0 ml/min/site (120 ml/hour/site) for subsequent infusions.
Ako se dobro podnosi, možete povećati brzinu infuzije do 2,0 ml/min/mjestu (120 ml/sat/mjestu) za sljedeće infuzije.
Treatmentof low immunoglobulin levels and recurrent bacterial infections in patients with chronic lymphocytic leukaemia(CLL), a certain kind of blood cancer, where prophylactic antibiotics have failed or are contra-indicated.
Liječenje niskih razina imunoglubulina i opetovanih bakterijskih infekcija kod bolesnika s kroničnom limfocitnom leukemijom (KLL), jednom vrstom raka krvi, gdje profilaktički antibiotici ne djeluju ili su kontraindicirani.
Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Kliničko iskustvo s imunoglobulinima upućuje na to da nema očekivanih štetnih učinaka na plodnost.
Once a vial or the blistered pre-filled syringe has been opened, the solution should be used immediately.
Nakon što se bočica ili napunjena štrcaljka u blisteru otvore, otopinu treba primijeniti odmah.
Hizentra may be infused into sites such as abdomen, thigh, upper arm, and / or lateral hip.
Hizentra može biti infundirana na mjesta kao što su abdomen, bedro, nadlaktica i lateralna strana kuka.
In clinical studies Hizentra was evaluated in 61 subjects with CIDP >65 years of age and no specific dose adjustments were necessary to achieve the desired clinical outcome.
Hizentra je ocijenjena u kliničkim ispitivanjima kod 61 ispitanika s KUDP-om u dobi od > 65 godina starosti i bez potrebe prilagodbe specifične doze za postizanje željenog kliničkog ishoda.
The initial infusion rate should not exceed 20 ml/hour/site.
Početna brzina infuzije ne smije prelaziti 20 ml/sat/mjestu.
If well-tolerated, you may gradually increase the infusion rate to 35 ml/hour/site for the subsequent two infusions.
U slučaju dobrog podnošenja, brzina infuzije postupno se može povećati na 35 ml/sat/mjestu za dvije sljedeće infuzije.
Frequency of Adverse Drug Reactions (ADR) associated with Hizentra obtained from clinical studies and post-marketing surveillance, reporting rate per patient or per infusion
Učestalost nuspojava povezanih s Hizentrom dobivena iz kliničkih ispitivanja i praćenja nakon stavljanja lijeka u promet, stopa prijava po bolesniku ili po infuziji.
In infants and children, infusion site may be changed every 5-15 ml.
Kod dojenčadi i djece, mjesto infuzije može se mijenjati svakih
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
A ili parvovirusa B19V putem imunoglobulina, a također se pretpostavlja da sadržaj protutijela čini važan doprinos virusnoj sigurnosti.
The weekly maintenance doses may be divided into smaller doses and administered as often as required during the week.
Tjedna doza održavanja može biti podijeljena na manje doze koje se primjenjuju u željenom rasporedu primjena tijekom tjedna.
Hizentra may impair the effect of some live virus vaccines such as measles, rubella, mumps and chicken pox.
Ovaj lijek može umanjiti učinak nekih živih virusnih cjepiva, kao što su ona za ospice, rubelu, zaušnjake i vodene kozice.
Hizentra comes as a ready-to-use solution in single-use vials or single-use pre-filled syringes.
Hizentra je dostupna kao otopina spremna za primjenu u jednokratnim bočicama ili jednokratnim napunjenim štrcaljkama.
The mean (SD) IgG trough concentration after Hizentra treatment in the 0.4 g/kg bw group was 20.4 (3.24) g/l and 15.4 (3.06) g/l in the 0.2 g/kg bw group.
Srednja vrijednost najniže koncentracije (SD) IgG nakon liječenja Hizentrom u skupini na 0,4 g/kg tt bila je 20,4 (3,24) g/l i 15,4
Elderly population The same interactions may occur in the elderly population.
Jednake interakcije mogu se javiti i u starijoj populaciji.
Pack sizes of 1, 10 or 20 vials: 1 g / 5 ml
Pakiranja od 1, 10 ili 20 bočica: 1 g / 5 ml
Hizentra was evaluated in 68 paediatric subjects with PID 2 to <12 years of age and in 57 paediatric subjects 12 to <18 years of age.
Hizentra je procjenjena kod 68 pedijatrijska ispitanika s PID-om u dobi od 2 do < 12 godina starosti i kod 57 pedijatrijskih ispitanika u dobi od 12 do < 18 godina starosti.
Local reactions at infusion sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash.
Lokalne reakcije na mjestima primjene: oticanje, bolnost, crvenilo, otvrdnuće, lokalni osjećaj topline,
Do not store above 25 °C.
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25 ° C.
Human normal immunoglobulin................................................................................................ 200 mg (purity: at least 98% is immunoglobulin type G (IgG))
Ljudski normalni imunoglobulin………………………….................................200 mg (čistoće: najmanje 98% imunoglobulina tipa G (IgG))
In clinical studies Hizentra was evaluated in 13 subjects with PID >65 years of age and no specific dose adjustments were necessary to achieve the desired serum IgG levels.
Hizentra je ocijenjena u kliničkim ispitivanjima kod 13 ispitanika s PID-om starijih od 65 godina i bez potrebe prilagodbe specifične doze za postizanje željene razine IgG u serumu.
Arterial and venous thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins.
S upotrebom imunoglobulina povezuju se arterijski i venski tromboembolijski događaji uključujući infarkt miokarda, moždani udar, duboku vensku trombozu i plućnu emboliju.
AMS is characterised by the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting.
AMS obilježavaju slijedeći znakovi i simptomi: jaka glavobolja, ukočenost u vratu, omamljenost, vrućica, fotofobija, mučnina i povraćanje.
4.2Posology and method of administration
4.2 Doziranje i način primjene
Side effects observed in controlled clinical studies are presented in order of decreasing frequency.
Nuspojave primijećene u kontroliranim kliničkim ispitivanjima navedene su slijedom od najčešćih prema najrjeđim.
• Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after EXP.
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici na bočici nakon oznake „Rok valjanosti“.
Home-treatment
Kućno liječenje
Patients with hyperprolinaemia type I or II.
Bolesnici s hiperprolinemijom tipa
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (bočica)
Tell your doctor or healthcare professional prior to treatment if you have experienced an intolerance against one of these components earlier.
Molimo obavijestite svog liječnika ili zdravstvenog radnika u slučaju ranijeg nepodnošenja bilo kojeg od navedenih sastojaka
Discard any unused product and all used administration supplies after administration in accordance with local requirements.
Nakon primjene, sav neiskorišteni lijek i sav pribor korišten prilikom primjene potrebno je zbrinuti sukladno nacionalnim propisima.
Overall, the number of infusions without severe local reactions versus the total number of infusions (tolerability) was ≥ 0.98 in all groups for all infusion parameters.
Sveukupno, broj infuzija bez ozbiljnih lokalnih reakcija naspram ukupnom broju infuzija
In isolated cases, infusion site ulcer or burning sensation may occur.
U izoliranim slučajevima mogu se javiti čirevi na mjestu infuzije ili osjećaj žarenja.
Hizentra is for subcutaneous use only.
Hizentra je namijenjena isključivo supkutanoj primjeni.
The following side effects are uncommon (affects 1 to 10 patients in 1,000):
Sljedeće nuspojave su manje česte (javljaju se u 1 do 10 na 1000 bolesnika):
Human normal immunoglobulin 200 mg IgG .......................................... ≥ 98% IgA .......................... ≤ 50 micrograms
Ljudski normalni imunoglobulin……… 200 mg IgG…………………...……… ≥ 98%
25 ml/hour/site 50 ml/hour/site 75 ml/hour/site 100 ml/hour/site
2. brzine protoka kod primjene pumpom25 ml/sat/mjestu 50 ml/sat/mjestu 75 ml/sat/mjestu 100 ml/sat/mjestu
The same adverse reactions may occur in the elderly population.
Iste nuspojave mogu se javiti i u starijoj populaciji.
Diarrhoea, Abdominal pain
Proljev, bol u abdomenu
Each pre-filled syringe of 5 ml solution contains: 1 g human normal immunoglobulin Each pre-filled syringe of 10 ml solution contains: 2 g human normal immunoglobulin
Jedna napunjena štrcaljka s 5 ml otopine sadrži: 1 g ljudskog normalnog imunoglobulina Jedna napunjena štrcaljka s 10 ml otopine sadrži: 2 g ljudskog normalnog imunoglobulina
Warnings and precautions Talk to your doctor or healthcare professional before using Hizentra.
Obratite se svom liječniku ili zdravstvenom radniku prije nego primijenite Hizentru.
Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.
Živa atenuirana virusna cjepiva Primjena imunoglobulina može umanjiti djelotvornost živih atenuiranih virusnih cjepiva, kao što su ona protiv morbila, rubele, parotitisa, i varičela u periodu od najmanje 6 tjedana i do 3 mjeseca.
Hizentra is also available in packs of 1, 10 or 20 vials.
Hizentra je također dostupna u pakiranjima od 1, 10 ili 20 bočica.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped viruses HAV and parvovirus B19.
Poduzete mjere smatraju se učinkovitima za viruse s ovojnicom kao što su virus HIV-a, hepatitisa B i hepatitisa C te za viruse bez ovojnice kao što su virus hepatitisa A i parvovirus B19.
• Because the solution contains no preservative, you must use/infuse it as soon as possible after opening the vial.
• Budući da otopina ne sadrži konzervans, mora se upotrijebiti/infundirati u najkraćem mogućem roku nakon otvaranja bočice.
No clinical studies have been performed with Hizentra in pregnant women.
Klinička ispitivanja o primjeni Hizentre u trudnica nisu provedena.
No differences were seen in the pharmacodynamic properties between adult and paediatric study patients with PID.
U ispitivanju nisu uočene razlike u farmakodinamičkim svojstvima između odraslih i pedijatrijskih bolesnika s PID-om.
Pack sizes Packs of 1, 10 or 20 vials
Pakiranja od 1, 10 ili 20 bočica.
In the PATH study, subjects (n = 172) achieved sustained trough levels over a period of 24 weeks when receiving weekly doses of 0.2 g/kg bw and 0.4 g/kg bw, respectively.
U PATH ispitivanju, ispitanici (n=172) su imali održane najniže razine lijeka tijekom razdoblja od 24 tjedna kod primanja tjednih doza od 0,2 g/kg tt, odnosno 0,4 g/kg tt.
Alcohol swabs, needles and other supplies or equipment are not contained in the pack.
Pakiranje ne sadrži jastučiće od vate natopljene alkoholom, igle i ostali potrošni materijal ili opremu.
Grip strength, MRC sum score, and R-ODS centile score remained stable as compared to baseline for patients who never had a relapse in the extension study.
centilni rezultat ostala je stabilna u usporedbi s početnom vrijednošću za pacijente koji nikada nisu imali relaps u nastavku ispitivanja.
Hizentra is also available in packs of 1 or 10 pre-filled syringes.
Hizentra je također dostupna u pakiranjima od 1 ili 10 napunjenih štrcaljki.
Pre-filled syringe(s)
Napunjena(e) štrcaljka(e)
• Hypersensitivity
• Preosjetljivost
1. manual push flow rates
1. brzine protoka kod ručnog potiskivanja štrcaljke
5, 10 or 20 ml of solution in a vial (type I glass) and 50 ml of solution in a vial (type II glass), with a stopper (halobutyl), a cap (aluminium crimp) and a flip off disc (plastic).
5, 10 ili 20 ml otopine u bočici (staklo tip I) i 50 ml otopine u bočici (staklo tip II), s čepom
Once a vial has been opened, use the solution immediately.
Čim otvorite bočicu, odmah upotrijebite otopinu.
The recommended initial infusion rate is up to 20 ml/hour/site.
Preporučena početna brzina infuzije je do 20 ml/sat/mjestu.
Infusion sites should be at least 5 cm apart.
Mjesta primjene infuzije trebaju biti međusobno udaljena najmanje 5 cm.
Muscle spasm, Muscular weakness
Mišićni spazam, mišićna slabost
Contact your doctor if you experience the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomitingafter receiving Hizentra.
Obratite se svom liječniku ako primijetite slijedeće znakove i simptome: jaka glavobolja, ukočenost u vratu, omamljenost, vrućica, fotofobija, mučnina i povraćanje nakon uzimanja lijeka Hizentra.
What Hizentra is used for
Za što se Hizentra koristi
EU/1/11/687/001 1 x 5 ml vial EU/1/11/687/002 10 x 5 ml vials EU/1/11/687/003 20 x 5 ml vials EU/1/11/687/004 1 x 10 ml vial EU/1/11/687/005 10 x 10 ml vials EU/1/11/687/006 20 x 10 ml vials EU/1/11/687/010 1 x 20 ml vial EU/1/11/687/011 10 x 20 ml vials EU/1/11/687/012 20 x 20 ml vials EU/1/11/687/013 1 x 50 ml vial EU/1/11/687/014 10 x 50 ml vials
EU/1/11/687/001 1 x 5 ml bočica EU/1/11/687/002 10 x 5 ml bočice EU/1/11/687/003 20 x 5 ml bočice EU/1/11/687/004 1 x 10 ml bočica EU/1/11/687/005 10 x 10 ml bočice EU/1/11/687/006 20 x 10 ml bočice EU/1/11/687/010 1 x 20 ml bočica EU/1/11/687/011 10 x 20 ml bočice EU/1/11/687/012 20 x 20 ml bočice EU/1/11/687/013 1 x 50 ml bočica EU/1/11/687/014 10 x 50 ml bočice
Treatment of low immunoglobulin levels in patients pre- and post- allogeneic haematopoietic stem cell transplantation (HSCT).
Liječenje niskih razina imunoglobulina kod bolesnika prije i poslije alogene transplantacije hematopoetskih matičnih stanica.
Your healthcare professional will avoid potential complications by ensuring: ►that you are not sensitive to human normal immunoglobulin.
Vaš zdravstveni radnik će izbjeći potencijalne komplikacije tako što će osigurati:
Pack sizes
Veličina pakiranja
If you are using a syringe pump, Hizentra pre-filled syringes can be placed directly in the syringe pump if the syringe size matches the pump requirements.
Hizentrom mogu se postaviti direktno na pumpu za štrcaljke ako veličina štrcaljke odgovara zahtjevima pumpe.
Hizentra is available in vials of 5, 10, 20 or 50 ml.
Hizentra je dostupna u bočicama od 5, 10, 20 ili 50 ml.
Each infusion site should be at least 5 cm apart.
Sva mjesta za infuziju bi trebala biti međusobno udaljena najmanje 5 cm.
How to store Hizentra
Kako primjenjivati Hizentru
Clean the infusion site(s) using an antiseptic skin preparation, Allow each site to dry before proceeding.
Očistite mjesto(a) za infuziju upotrebom antiseptika predviđenih za čišćenje kože.
CSL Behring AG Wankdorfstrasse 10 CH-3000 Bern 22 Switzerland
CH-3000 Bern 22 Švicarska
• You may infuse Hizentra into sites such as abdomen, thigh, upper arm, and lateral hip.
• Hizentru možete primijeniti infuzijom na mjesta kao što su trbuh, bedro, nadlaktica i bočna strana kuka.
Clinical experience with immunoglobulins suggests however that no harmful effects on the neonate are to be expected.
Međutim, kliničko iskustvo s imunoglobulinima upućuje na to da nema očekivanih štetnih učinaka na novorođenčad.
A statistically significant lower percentage of subjects treated with Hizentra, 32.8 % for 0.4 g/kg bw and 38.6 % for 0.2 g/kg bw, had CIDP relapse or was withdrawn for other reasons compared with 63.2 % subjects treated with placebo (p < 0.001 or p = 0.007, respectively).
38,6% u skupini na 0,2 g/kg tt, imao je KUDP relaps ili je povučen iz drugih razloga u usporedbi s 63,2% ispitanika s placebom (p <0,001 odnosno p = 0,007).
Attach the administration tubing or needle set to the syringe.
Pričvrstite cijev za primjenu ili set s iglom na štrcaljku.
Patients should be sufficiently hydrated before use of immunoglobulins.
Prije upotrebe imunoglobulina bolesnike se treba dostatno hidrirati.
Hizentra was evaluated in 68 paediatric subjects with PID aged 2 to <12 years and in 57 adolescents aged 12 to <18 years.
Hizentra je ocijenjena u 68 pedijatrijskih ispitanika sa sindromom primarne imunodeficijencije (PID) u dobi od 2 do < 12 godina i kod 57 adolescenata u dobi od 12 do < 18 godina.
Hizentra 200 mg/ml solution for subcutaneous injection Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe
Hizentra 200 mg/ml otopina za supkutanu injekciju Hizentra 200 mg/ml otopina za supkutanu injekciju u napunjenoj štrcaljki
Manual push infusion:
Infuzija pomoću pumpe za infuziju:
• Because the solution contains no preservative, you must use/infuse it as soon as possible after opening the blistered pre-filled syringe.
• Budući da otopina ne sadrži konzervans, mora se upotrijebiti/infundirati u najkraćem mogućem roku nakon otvaranja napunjene štrcaljke u blisteru.
Hizentra is also available in vials of 5, 10, 20 and 50 ml.
Hizentra je također dostupna u bočicama od 5, 10, 20 i 50 ml.
• Flu-like symptoms
• Simptomi nalik gripi
• In the case, you will use a device-assisted infusion technique (e.g. pump-assisted infusion),
• U slučaju primjene infuzije pomoću uređaja za infuziju (npr. pumpom za infuziju), istovremeno može biti primijenjeno više uređaja za infuziju.
What Hizentra looks like and contents of the pack Hizentra is a solution for subcutaneous injection (200 mg/ml).
Hizentra je otopina za supkutanu injekciju (200 mg/ml).
Hizentra is available in pre-filled syringes of 5 or 10 ml.
Hizentra je dostupna u napunjenim štrcaljkama od 5 ili 10 ml.
Pre-filled syringes EU/1/11/687/015 EU/1/11/687/016 EU/1/11/687/017 EU/1/11/687/018
EU/1/11/687/015 EU/1/11/687/016 EU/1/11/687/017 EU/1/11/687/018
Potential complications can often be avoided by ensuring that patients: are not sensitive to human normal immunoglobulin, by initially injecting the product slowly (see section 4.2); are carefully monitored for any symptoms throughout the infusion period.
- nisu osjetljivi na ljudski normalni imunoglobulin, polaganim injiciranjem lijeka na početku liječenja (vidjeti dio 4.2);
Hizentra is also available in pre-filled syringes of 5 and 10 ml.
Hizentra je također dostupna u napunjenim štrcaljkama od 5 i 10 ml.
These simulations further suggest that a comparable IgG exposure is correspondingly achieved when the weekly maintenance dose of Hizentra is divided in several, more frequent doses (2 to 7 times per week) in the CIDP patients` population.
IgG-u sukladno postiže kada je tjedna doza održavanja Hizentre podijeljena u nekoliko češćih doza (2 do 7 puta tjedno) u bolesnika s KUDP
Hizentra is also used in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a form of autoimmune disease.
Hizentra se također koristi u bolesnika sa kroničnom upalnom demijelinizirajućom polineuropatijom
• Keep this medicine out of the sight and reach of children.
Kako čuvati Hizentru • Lijek čuvajte izvan pogleda i dohvata djece.
Immunomodulatory therapy in CIDP patients
Imunomodulacijska terapija u bolesnika sa KUDP-om
The ability to drive and operate machines may be impaired by some adverse reactions associated with Hizentra.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Sposobnost upravljanja vozilima i rada na strojevima može biti smanjena pojavom nekih nuspojava povezanih s Hizentrom.