FrancophonIA/ELRC3.0 huggingface dataset:
English: Discard any unused product and all used administration supplies after administration in accordance with local requirements.
Croatian: Nakon primjene, sav neiskorišteni lijek i sav pribor korišten prilikom primjene potrebno je zbrinuti sukladno nacionalnim propisima.
English: 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.
Croatian: Sveukupno, broj infuzija bez ozbiljnih lokalnih reakcija naspram ukupnom broju infuzija
English: In isolated cases, infusion site ulcer or burning sensation may occur.
Croatian: U izoliranim slučajevima mogu se javiti čirevi na mjestu infuzije ili osjećaj žarenja.
English: Hizentra is for subcutaneous use only.
Croatian: Hizentra je namijenjena isključivo supkutanoj primjeni.
English: The following side effects are uncommon (affects 1 to 10 patients in 1,000):
Croatian: Sljedeće nuspojave su manje česte (javljaju se u 1 do 10 na 1000 bolesnika):
English: Human normal immunoglobulin 200 mg IgG .......................................... ≥ 98% IgA .......................... ≤ 50 micrograms
Croatian: Ljudski normalni imunoglobulin……… 200 mg IgG…………………...……… ≥ 98%
English: 25 ml/hour/site 50 ml/hour/site 75 ml/hour/site 100 ml/hour/site
Croatian: 2. brzine protoka kod primjene pumpom25 ml/sat/mjestu 50 ml/sat/mjestu 75 ml/sat/mjestu 100 ml/sat/mjestu
English: The same adverse reactions may occur in the elderly population.
Croatian: Iste nuspojave mogu se javiti i u starijoj populaciji.
English: Diarrhoea, Abdominal pain
Croatian: Proljev, bol u abdomenu
English: 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
Croatian: 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
English: Warnings and precautions Talk to your doctor or healthcare professional before using Hizentra.
Croatian: Obratite se svom liječniku ili zdravstvenom radniku prije nego primijenite Hizentru.
English: 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.
Croatian: 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.
English: Hizentra is also available in packs of 1, 10 or 20 vials.
Croatian: Hizentra je također dostupna u pakiranjima od 1, 10 ili 20 bočica.
English: 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.
Croatian: 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.
English: • Because the solution contains no preservative, you must use/infuse it as soon as possible after opening the vial.
Croatian: • Budući da otopina ne sadrži konzervans, mora se upotrijebiti/infundirati u najkraćem mogućem roku nakon otvaranja bočice.
English: No clinical studies have been performed with Hizentra in pregnant women.
Croatian: Klinička ispitivanja o primjeni Hizentre u trudnica nisu provedena.
English: No differences were seen in the pharmacodynamic properties between adult and paediatric study patients with PID.
Croatian: U ispitivanju nisu uočene razlike u farmakodinamičkim svojstvima između odraslih i pedijatrijskih bolesnika s PID-om.
English: Pack sizes Packs of 1, 10 or 20 vials
Croatian: Pakiranja od 1, 10 ili 20 bočica.
English: 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.
Croatian: 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.
English: Alcohol swabs, needles and other supplies or equipment are not contained in the pack.
Croatian: Pakiranje ne sadrži jastučiće od vate natopljene alkoholom, igle i ostali potrošni materijal ili opremu.
English: 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.
Croatian: centilni rezultat ostala je stabilna u usporedbi s početnom vrijednošću za pacijente koji nikada nisu imali relaps u nastavku ispitivanja.
English: Hizentra is also available in packs of 1 or 10 pre-filled syringes.
Croatian: Hizentra je također dostupna u pakiranjima od 1 ili 10 napunjenih štrcaljki.
English: Pre-filled syringe(s)
Croatian: Napunjena(e) štrcaljka(e)
English: • Hypersensitivity
Croatian: • Preosjetljivost
English: 1. manual push flow rates
Croatian: 1. brzine protoka kod ručnog potiskivanja štrcaljke
English: 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).
Croatian: 5, 10 ili 20 ml otopine u bočici (staklo tip I) i 50 ml otopine u bočici (staklo tip II), s čepom
English: Once a vial has been opened, use the solution immediately.
Croatian: Čim otvorite bočicu, odmah upotrijebite otopinu.
English: The recommended initial infusion rate is up to 20 ml/hour/site.
Croatian: Preporučena početna brzina infuzije je do 20 ml/sat/mjestu.
English: Infusion sites should be at least 5 cm apart.
Croatian: Mjesta primjene infuzije trebaju biti međusobno udaljena najmanje 5 cm.
English: Muscle spasm, Muscular weakness
Croatian: Mišićni spazam, mišićna slabost
English: Contact your doctor if you experience the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomitingafter receiving Hizentra.
Croatian: 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.
English: What Hizentra is used for
Croatian: Za što se Hizentra koristi
English: 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
Croatian: 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
English: Treatment of low immunoglobulin levels in patients pre- and post- allogeneic haematopoietic stem cell transplantation (HSCT).
Croatian: Liječenje niskih razina imunoglobulina kod bolesnika prije i poslije alogene transplantacije hematopoetskih matičnih stanica.
English: Your healthcare professional will avoid potential complications by ensuring: ►that you are not sensitive to human normal immunoglobulin.
Croatian: Vaš zdravstveni radnik će izbjeći potencijalne komplikacije tako što će osigurati:
English: Pack sizes
Croatian: Veličina pakiranja
English: 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.
Croatian: Hizentrom mogu se postaviti direktno na pumpu za štrcaljke ako veličina štrcaljke odgovara zahtjevima pumpe.
English: Hizentra is available in vials of 5, 10, 20 or 50 ml.
Croatian: Hizentra je dostupna u bočicama od 5, 10, 20 ili 50 ml.
English: Each infusion site should be at least 5 cm apart.
Croatian: Sva mjesta za infuziju bi trebala biti međusobno udaljena najmanje 5 cm.
English: How to store Hizentra
Croatian: Kako primjenjivati Hizentru
English: Clean the infusion site(s) using an antiseptic skin preparation, Allow each site to dry before proceeding.
Croatian: Očistite mjesto(a) za infuziju upotrebom antiseptika predviđenih za čišćenje kože.
English: CSL Behring AG Wankdorfstrasse 10 CH-3000 Bern 22 Switzerland
Croatian: CH-3000 Bern 22 Švicarska
English: • You may infuse Hizentra into sites such as abdomen, thigh, upper arm, and lateral hip.
Croatian: • Hizentru možete primijeniti infuzijom na mjesta kao što su trbuh, bedro, nadlaktica i bočna strana kuka.
English: Clinical experience with immunoglobulins suggests however that no harmful effects on the neonate are to be expected.
Croatian: Međutim, kliničko iskustvo s imunoglobulinima upućuje na to da nema očekivanih štetnih učinaka na novorođenčad.
English: 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).
Croatian: 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).
English: Attach the administration tubing or needle set to the syringe.
Croatian: Pričvrstite cijev za primjenu ili set s iglom na štrcaljku.
English: Patients should be sufficiently hydrated before use of immunoglobulins.
Croatian: Prije upotrebe imunoglobulina bolesnike se treba dostatno hidrirati.
English: Hizentra was evaluated in 68 paediatric subjects with PID aged 2 to <12 years and in 57 adolescents aged 12 to <18 years.
Croatian: 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.
English: Hizentra 200 mg/ml solution for subcutaneous injection Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe
Croatian: Hizentra 200 mg/ml otopina za supkutanu injekciju Hizentra 200 mg/ml otopina za supkutanu injekciju u napunjenoj štrcaljki
English: Manual push infusion:
Croatian: Infuzija pomoću pumpe za infuziju:
English: • Because the solution contains no preservative, you must use/infuse it as soon as possible after opening the blistered pre-filled syringe.
Croatian: • Budući da otopina ne sadrži konzervans, mora se upotrijebiti/infundirati u najkraćem mogućem roku nakon otvaranja napunjene štrcaljke u blisteru.
English: Hizentra is also available in vials of 5, 10, 20 and 50 ml.
Croatian: Hizentra je također dostupna u bočicama od 5, 10, 20 i 50 ml.
English: • Flu-like symptoms
Croatian: • Simptomi nalik gripi
English: • In the case, you will use a device-assisted infusion technique (e.g. pump-assisted infusion),
Croatian: • U slučaju primjene infuzije pomoću uređaja za infuziju (npr. pumpom za infuziju), istovremeno može biti primijenjeno više uređaja za infuziju.
English: What Hizentra looks like and contents of the pack Hizentra is a solution for subcutaneous injection (200 mg/ml).
Croatian: Hizentra je otopina za supkutanu injekciju (200 mg/ml).
English: Hizentra is available in pre-filled syringes of 5 or 10 ml.
Croatian: Hizentra je dostupna u napunjenim štrcaljkama od 5 ili 10 ml.
English: Pre-filled syringes EU/1/11/687/015 EU/1/11/687/016 EU/1/11/687/017 EU/1/11/687/018
Croatian: EU/1/11/687/015 EU/1/11/687/016 EU/1/11/687/017 EU/1/11/687/018
English: 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.
Croatian: - nisu osjetljivi na ljudski normalni imunoglobulin, polaganim injiciranjem lijeka na početku liječenja (vidjeti dio 4.2);
English: Hizentra is also available in pre-filled syringes of 5 and 10 ml.
Croatian: Hizentra je također dostupna u napunjenim štrcaljkama od 5 i 10 ml.
English: 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.
Croatian: IgG-u sukladno postiže kada je tjedna doza održavanja Hizentre podijeljena u nekoliko češćih doza (2 do 7 puta tjedno) u bolesnika s KUDP
English: Hizentra is also used in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a form of autoimmune disease.
Croatian: Hizentra se također koristi u bolesnika sa kroničnom upalnom demijelinizirajućom polineuropatijom
English: • Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Hizentru • Lijek čuvajte izvan pogleda i dohvata djece.
English: Immunomodulatory therapy in CIDP patients
Croatian: Imunomodulacijska terapija u bolesnika sa KUDP-om
English: The ability to drive and operate machines may be impaired by some adverse reactions associated with Hizentra.
Croatian: 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.
English: The primary efficacy endpoint was the percentage of subjects who had a CIDP relapse (defined as a ≥ 1 point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] score compared with baseline) or were withdrawn for any other reason in the Hizentra treatment period.
Croatian: Inflammatory Neuropathy Cause and Treatment) skora u odnosu na početnu vrijednost) ili koji su povučeni iz bilo kojeg drugog razloga u razdoblju liječenja Hizentrom.
English: EU/1/11/687/004 EU/1/11/687/005 EU/1/11/687/006 EU/1/11/687/010 EU/1/11/687/011 EU/1/11/687/012 EU/1/11/687/013 EU/1/11/687/014
Croatian: EU/1/11/687/001 EU/1/11/687/002 EU/1/11/687/003 EU/1/11/687/004 EU/1/11/687/005 EU/1/11/687/006 EU/1/11/687/010 EU/1/11/687/011 EU/1/11/687/012 EU/1/11/687/013 EU/1/11/687/014
English: Once a blistered pre-filled syringe has been opened, use the solution immediately.
Croatian: Čim otvorite napunjenu štrcaljku u blisteru, odmah upotrijebite otopinu.
English: No overall differences in safety or efficacy were observed between PID subjects >65 years and PID subjects 18 to 65 years of age.
Croatian: Nisu uočene razlike u sigurnosti ili djelotvornosti između PID ispitanika > 65 godina i PID ispitanika u dobi od 18 do 65 godina starosti.
English: EU/1/11/687/015 1 x 5 ml pre-filled syringe EU/1/11/687/016 10 x 5 ml pre-filled syringes EU/1/11/687/017 1 x 10 ml pre-filled syringe EU/1/11/687/018 10 x 10 ml pre-filled syringes
Croatian: EU/1/11/687/015 1 x 5 ml napunjena štrcaljka EU/1/11/687/016 10 x 5 ml napunjenih štrcaljki EU/1/11/687/017 1 x 10 ml napunjena štrcaljka EU/1/11/687/018 10 x 10 ml napunjenih štrcaljki
English: Hypogammaglobulinaemia in patients, pre- and post-allogeneic haematopoietic stem cell transplantation (HSCT).
Croatian: − Hipogamaglobulinemije kod bolesnika prije i poslije alogene transplantacije hematopoetskih matičnih stanica.
English: Immunomodulatory therapy in CIDP
Croatian: Imunomodulacijska terapija kod KUDP-a
English: As the dose is given by body weight and adjusted to the clinical outcome of the above mentioned conditions, the dose in the elderly population is not considered to be different from that in subjects 18 to 65 years of age.
Croatian: Doza u starijoj populaciji ne smatra se različitom od one u ispitanika od 18 do 65 godina budući da se daje na temelju tjelesne težine te je prilagođena kliničkom ishodu gore navedenih uvjeta.
English: Patients exhibiting signs and symptoms of AMS should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis.
Croatian: U bolesnika koji pokazuju znakove i simptome AMS-a potrebno je provesti temeljite neurološke pretrage,
English: They may occur even if you received human immunoglobulins previously and tolerated them well.
Croatian: Do alergijskih reakcija može doći čak i ako ste već primali i dobro podnosili ljudske imunoglobuline.
English: To assess the safety and tolerability of higher infusion rates applied via the manual push and pumpassisted administration, 49 PID subjects aged 2 to 75 years were enrolled in an open-label, multicentre, parallel-arm, nonrandomised phase IV HILO (Hizentra Label Optimization) study and treated with Hizentra for at least 12 weeks (11 paediatric patients aged 2 to <18, 35 adult patients aged 18 to 65, and 3 geriatric patients aged >65 years).
Croatian: Kako bi se procijenila sigurnost i podnošljivost većih brzina infuzije kod ručnog potiskivanja štrcaljke i primjene pomoću pumpe, 49 osoba s PID-om u dobi od 2 do 75 godina bilo je uključeno u nerandomizirano, otvoreno, multicentrično ispitivanje faze IV s paralelnim skupinama, naziva HILO (engl.
English: Your doctor will initiate therapy with Hizentra 1 week after your last intravenous immunoglobulin infusion by administrating under the skin (subcutaneously) with a weekly dose of 1.0 to 2.0 ml/kg of body weight.
Croatian: Hizentra se primjenjuje pod kožu (supkutano) s tjednom dozom od 1,0 do 2,0 ml/kg tjelesne težine.
English: ADRs (MedDRA Preferred Term, PT)
Croatian: Nuspojave (MedDRA preporučeni pojam)
English: 5 Preparation of Hizentra for infusion
Croatian: 5 Priprema Hizentre za infuziju Očistite čep bočice
English: 1 ml contains:
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 ml sadrži:
English: No overall differences in the pharmacokinetic parameters were observed between PID subjects >65 years and subjects 18 to 65 years of age.
Croatian: Nisu uočene razlike u farmakokinetičkim parametrima između PID ispitanika > 65 godina i ispitanika u dobi od 18 do 65 godina starosti.
English: Replacement therapy
Croatian: Nadomjesna terapija
English: The mean efficacy evaluation period was 125.8 days (range: 1-330) in the 0.2 g/kg, and 196.1 days (range: 1-330) in the 0.4 g/kg bw group.
Croatian: Srednja vrijednost perioda procjene djelotvornosti bila je 125,8 dana (raspon: 1-330)
English: Contact your doctor immediately if you experience signs and symptoms such as shortness of breath, chest pain, pain and swelling of a limb, weakness or numbness on one side of the body after receiving Hizentra.
Croatian: Ako osjetite znakove ili simptome kao što su nedostatak zraka, bol u prsnom košu, bol i oticanje udova, slabost ili obamrlost na jednoj strani tijela nakon uzimanja lijeka Hizentra, odmah obavijestite svog liječnika.
English: AMS has been reported with use of IVIg or SCIg.
Croatian: S upotrebom i.v.Ig ili s.c.Ig zabilježena je pojava AMS-a.
English: Accordingly, over the treatment period for up to 24 weeks Hizentra prevented relapse in 81 % and 67 % of subjects in the 0.4 g/kg bw and 0.2 g/kg bw group, respectively, while in the placebo group 44 % of subjects remained relapse-free.
Croatian: 0,4 g/kg tt i 67% ispitanika na 0,2 g/kg tt, dok u placebo skupini 44% ispitanika nije imalo relaps.
English: PRE-FILLED SYRINGE
Croatian: Napunjene štrcaljke
English: Keep the vial or the blistered pre-filled syringe in the outer carton in order to protect from light.
Croatian: Bočicu ili napunjenu štrcaljku u blisteru čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Vial(s)
Croatian: Bočica(e)
English: Summary of safety profile
Croatian: 4.8 Nuspojave Sažetak sigurnosnog profila
English: No overall differences in the pharmacokinetic parameters were observed between CIDP subjects >65 years and subjects 18 to 65 years of age.
Croatian: Nisu uočene razlike u farmakokinetičkim parametrima između KUDP ispitanika > 65 godina i ispitanika u dobi od 18 do 65 godina.
English: Infusion site ulcer
Croatian: Ulkus na mjestu infuzije
English: Hizentra has not been evaluated in clinical studies in paediatric patients with CIDP who are under the age of 18.
Croatian: Hizentra nije ocijenjivana u kliničkim ispitivanjima u pedijatrijskih bolesnika s KUDP-om koji su mlađi od 18 godina.
English: Secure the needle to the skin - If necessary, use gauze and tape or transparent dressing to hold the needle in place.
Croatian: - Ako je potrebno, upotrijebite gazu i traku ili prozirnu oblogu kako se igla ne bi pomicala.
English: Therefore, Hizentra should only be given with caution to breast-feeding mothers.
Croatian: Stoga se Hizentra treba dojiljama davati s oprezom.
English: Blood tests
Croatian: Krvožilni poremećaji
English: No overall differences in safety or efficacy were observed between CIDP subjects >65 years and CIDP subjects 18 to 65 years of age.
Croatian: Nisu uočene razlike u sigurnosti ili djelotvornosti između KUDP ispitanika > 65 godina i KUDP ispitanika u dobi od 18 do 65 godina starosti.
English: What Hizentra is and what it is used for What you need to know before you use Hizentra How to use Hizentra
Croatian: Što je Hizentra i za što se koristi Što je Hizentra
English: ► In isolated cases, you may get a bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light, which could be signs of AMS (aseptic meningitis sydrome), which is a temporary reversible non-infectious inflammation of the membranes surrounding the brain and the spinal cord.
Croatian: U izoliranim slučajevima, možete imati jaku glavobolju s mučninom, povraćanje, ukočen vrat, vrućica i osjetljivost na svjetlost mogu biti znakovi AMS-a (sindrom aseptičnog meningitisa),
English: Infusion rate(s)
Croatian: Brzina(e) infuzije
English: Patients should be closely monitored and carefully observed for any adverse events throughout the infusion period.
Croatian: Potrebno je pridržavati se preporučenih brzina infuzije navedenih u odjeljku 4.2. Bolesnike treba pažljivo pratiti i nadgledati kako bi se uočili eventualni simptomi tijekom razdoblja primjene infuzije.
English: Clean the vial stopper - Remove the protective cap from the vial to expose the central portion of the rubber stopper.
Croatian: - Uklonite zaštitni čep s bočice kako biste vidjeli središnji dio gumenog čepa.
English: Device-assisted infusion
Croatian: Infuzija pomoću uređaja za infuziju
English: • Keep the blistered pre-filled syringe in the outer carton in order to protect from light.
Croatian: • Čuvati napunjenu štrcaljku u blisteru u vanjskom pakiranju radi zaštite od svjetlosti.
English: • by manual push with a syringe.
Croatian: • ručnim potiskom štrcaljke.
English: ► In isolated cases, you may be allergic (hypersensitive) to immunoglobulins and allergic reactions such as a sudden fall in blood pressure or shock may occur (e.g. you may feel lightheaded, dizzy, faint on standing, cold in the hands and feet, sense an abnormal heart beat or chest pain, or have blurred vision).
Croatian: ► U izoliranim slučajevim, možete biti alergični (preosjetljivi) na imunoglobuline te je moguća pojava alergijske reakcije, kao što su nagli pad krvnog tlaka ili šok (npr. ošamućenost, omaglica,
English: CIDP
Croatian: Osip
English: Hizentra 200 mg/ml solution for subcutaneous injection human normal immunoglobulin (SCIg)
Croatian: Hizentra 200 mg/ml otopina za supkutanu injekciju ljudski normalni imunoglobulin (s.c.Ig)
English: Keep the blistered pre-filled syringe in the outer carton in order to protect from light.
Croatian: Napunjenu štrcaljku u blisteru čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe human normal immunoglobulin (SCIg)
Croatian: Hizentra 200 mg/ml otopina za supkutanu injekciju u napunjenoj štrcaljki ljudski normalni imunoglobulin (s.c.Ig)
English: If well-tolerated (see also section 4.4), the infusion rate can then gradually be increased to 35 ml/hour/site for the subsequent two infusions.
Croatian: Ako se dobro podnosi (vidjeti također dio 4.4), brzina infuzije postupno se može povećavati na