natgillin/translations-raw huggingface dataset:
Temporary lowering of red blood cell count (anaemia), breakdown of red blood cells (haemolysis), decreased number of white blood cells (leukopenia), hypersensitivity, dizziness (including vertigo), high blood pressure (hypertension), flushing (including hot flush, hyperaemia), hypotension (including decreased blood pressure), breathlessness (dyspnoea including chest pain, chest discomfort, painful breathing), vomiting, loose stools (diarrhea), stomach pain, skin disorder (including rash, itching (pruritus), hives (urticaria), maculopapular rash, redness of the skin (erythema), peeling of the skin (skin exfoliation)), pain in the muscles (including muscle cramps and rigidity), tiredness (fatigue), physical weakness (asthenia), weakness in the muscles, .
(hemoliza), smanjenje broja bijelih krvnih stanica (leukopenija), preosjetljivost, omaglica (uključujući vrtoglavicu), visoki krvni tlak (hipertenzija), navale crvenila (uključujući valunge, hiperemiju), hipotenzija (uključujući sniženi krvni tlak), nedostatak zraka (dispneja, uključujući bol u prsištu, nelagodu u prsištu, bolno disanje, povraćanje, rijetka stolica (dijareja), bol u trbuhu, poremećaji kože (uključujući osip, svrbež (pruritus), koprivnjaču (urtikariju), makopapilarni osip, crvenilo kože (eritema), ljuštenje kože (eksfolijaciju kože)), bol u mišićima (uključujući grčeve i ukočenost), umor, fizička slabost (astenija), slabost u mišićima.
Sodium content Privigen is essentially sodium-free.
Sadržaj natrija Privigen u osnovi ne sadrži natrij.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
- Multifocal motor neuropathy (MMN)
- Multifokalna motorička neuropatija (MMN).
1.6 - 2 g/kg bw or in divided doses over 2 to 5 days in association with acetylsalicylic acid
1,6 - 2 g/kg TT ili u podijeljenim dozama tijekom 2 do 5 dana u kombinaciji s acetilsalicilatnom kiselinom2 g/kg TT u jednoj dozi u kombinaciji s acetilsalicilatnom kiselinom
Within each frequency grouping, undesirable effects are presented in order of decreasing frequency.
Unutar svake skupine učestalosti, nuspojave su prikazane u padajućem nizu prema učestalosti.
For obtaining an immunoglobulin solution of 50 mg/ml (5%), Privigen 100 mg/ml (10%) should be diluted with an equal volume of the glucose solution.
Za dobivanje otopine imunoglobulina od 50 mg/ml (5%), potrebno je razrijediti Privigen 100 mg/ml (10%) s jednakim volumenom otopine glukoze.
This is a chronic disease that is characterised by inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and upper limbs.
To je kronična bolest koju karakterizira upala perifernih živaca što uzrokuje slabost i/ili obamrlost mišića uglavnom u nogama i rukama. pacijenti s multifokalnom motoričkom neuropatijom (MMN).
Overdose is very unlikely to occur because Privigen is usually administered under medical supervision.
Privigen se obično primjenjuje pod liječničkim nadzorom, stoga je vrlo vjerojatno da do predoziranja neće doći.
Chronic inflammatory demyelinating polyneuropathy (CIDP)*
Kronična upalna demijelinizirajuća polineuropatija (KUDP)*
In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.
U slučaju neželjenih reakcija, potrebno je ili smanjiti brzinu infuzije ili u potpunosti obustaviti infuziju.
The overall median time to first MRC sum score response in PRIMA was 6 weeks (6 weeks in the IVIg-untreated and 3 weeks in the IVIg-pretreated) and 9.3 weeks in PATH.
Ukupni median vremena do prvog odgovora prema ukupnom rezultatu MRC-a u PRIMA-i bilo je 6 tjedana (6 tjedana u prethodno neliječenih i.v.
• temporary non-infectious meningitis (reversible aseptic meningitis), Tell your doctor or healthcare professional immediately if you have a stiff neck together with one or more of the following symptoms: fever, nausea, vomiting, headache, abnormal sensitivity to light, mental disturbances.
Odmah obavijestite svog liječnika ili zdravstvenog radnika ako imate ukočen vrat skupa s jednim ili više od sljedećih simptoma: vrućicu, mučninu, povraćanje, glavobolju, nenormalnu osjetljivost na svjetlost, mentalne poremećaje.
• In very rare cases transfusion-related acute lung injury (TRALI) can occur after receiving immunoglobulins including Privigen.
• U vrlo rijetkim slučajevima se nakon primitka imunoglobulina uključujući Privigen može pojaviti akutna ozljeda pluća povezana s transfuzijom.
• You are diabetic.
• Ako imate šećernu bolest.
CSL Behring GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Germany
CSL Behring GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg
Hypertension, flushing (including hot flush, hyperaemia), hypotension
Hipertenzija, navala crvenila (uključujući valunge, hiperemiju), hipotenzija
For obtaining an immunoglobulin solution of 50 mg/ml (5%), Privigen 100 mg/ml (10%) should be diluted with an equal volume of the 5% glucose solution.
Za dobivanje otopine imunoglobulina od 50 mg/ml (5%) potrebno je razrijediti Privigen 100 mg/ml (10%) s jednakim volumenom 5% -tne otopine glukoze.
Headache (including sinus headache, migraine, head discomfort, tension headache)
Glavobolja (uključujući sinusnu glavobolju, migrenu, nelagodu u glavi, tenzijsku glavobolju),
Temporary non-infectious meningitis (reversible aseptic meningitis), irregularity of red blood cell shape (microscopic finding), presence of high platelet counts in the blood (thrombocytosis), sleepiness, shiver (tremor), palpitations, tachycardia, thromboembolic events, lack of blood supply to the lower extremities causing e.g. pain when walking (peripheral vascular disorder), presence of an excess of serum proteins in the urine (proteinuria including increased blood creatinine), injection site pain
Prolazni neinfekcijski meningitis (reverzibilni aseptički meningitis), nepravilni oblici crvenih krvnih stanica (mikroskopski nalazi), prisustvo visokog broja trombocita u krvi (trombocitoza), pospanost, drhtanje (tremor), palpitacije (osjećaj lupanja srca), tahikardija (ubrzan rad srca), tromboembolijski događaji, pomanjkanje opskrbe krvlju donjih udova što uzrokuje npr. bol kod hodanja (periferni vaskularni poremećaj), povišeni serumski proteini u mokraći (proteinurija, uključujući povišenu razinu kratinina u krvi), bol na mjestu injekcije.
TRALI may be managed using oxygen therapy with adequate ventilatory support.
Akutna ozljeda pluća povezana s transfuzijom zbrinjava se terapijom kisikom s odgovarajućom mehaničkom ventilacijom.
If dilution is desired, 5% glucose solution should be used.
Ako se lijek želi razrijediti, potrebno je koristiti 5%-tnu otopinu glukoze.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because antibodies against these infections, which are contained in the product, are protective.
A ili infekcijama parvovirusom B19 možda i zbog toga jer su protutijela na te infekcije koja se nalaze u ovom lijeka ujedno i zaštitna.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus and parvovirus B19.
Poduzete mjere smatraju se djelotvornim protiv virusa s ovojnicom kao što su virus humane imunodeficijencije (HIV), virus hepatitis B i C te za viruse bez ovojnice kao što su virus hepatitisa
This is an acute disease that is characterised by inflammation of the peripheral nerves that causes severe muscle weakness mainly in the legs and upper limbs.
To je akutna bolest koju karakterizira upala perifernih živaca koja uzrokuje tešku slabost mišića uglavnom u nogama i rukama. bolesnici s Kawasakijevom bolešću.
Human normal immunoglobulin (IVIg)
Ljudski normalni imunoglobulin (i.v.Ig)
In most cases risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or age over 65.
šećerna bolest, hipovolemija, prekomjerna težina, istodobna terapija nefrotoksičnim lijekovima ili dob iznad 65 godina.
• 0.8 to 1g/kg bw given on day 1; this dose may be repeated once within 3 days
0,8 - 1 g/kg TT ili prvi dan, može se ponoviti još jednom unutar 3 dana
In patients at risk for thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
U bolesnika s rizikom za tromboembolijske događaje i.v.IG lijekove potrebno je primijeniti minimalnom provedivom brzinom infuzije i provedivom dozom.
Hepatobiliary disorders Hyperbilirubinaemia
Hiperbilirubinemija
Privigen is used for the treatment of adults and children (0-18 years) in the following situations:
Imunomodulacija u odraslih,djece i adolescenata (0-18 godina) kod:
No differences were seen in the pharmacokinetic parameters between adult and paediatric study patients with PID.
Nisu uočene razlike u farmakokinetičkim parametrima između odraslih osoba i djece oboljele od PID-a u ispitivanju.
How to store Privigen
Kako primjenjivati Privigen
Your doctor will decide whether you can receive Privigen during your pregnancy or while you are breast-feeding.
Vaš liječnik će odlučiti možete li uzimati Privigen u vrijeme trudnoće ili dok dojite.
The solution is clear or slightly opalescent and colourless to pale yellow.
Otopina je bistra ili blago opalescentna i bezbojna do blijedo žute boje.
TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever.
plućni edem, hipoksemija, normalna funkcija lijeve klijetke i vrućica.
In patients defined as INCAT non-responders, muscle strength improved by 5.5 points (95% confidence interval [0.6, 10.2]) as compared to INCAT responders (7.4 points (95% confidence interval [4.0, 11.7])
U bolesnika koji su definirani kao oni koji prema ljestvici INCAT ne reagiraju na liječenje, snaga mišića poboljšala se za 5,5 bodova (interval pouzdanosti 95% [0,6; 10,2] u usporedbi s INCAT
If well tolerated, the rate of administration may gradually be increased to a maximum of 4.8 ml/kg bw/hr.
Ako se dobro podnosi, brzinu primjene moguće je postupno povećati na maksimalno 4,8 ml/kg TT po satu.
1.6 to 2.0 g/kg bw should be administered in divided doses over 2 to 5 days or 2.0 g/kg bw as a single dose.
Ukupnu dozu od 1,6 do 2,0 g/kg TT treba primijeniti u podijeljenim dozama kroz 2 do 5 dana ili primijeniti jednokratnu dozu od 2,0 g/kg TT.
Anisocytosis (including microcytosis), thrombocytosis
Anizocitoza (uključujući mikrocitozu),
Dyspnoea (including chest pain, chest discomfort, painful respiration)
Dispneja (uključujući bol u prsištu, nelagodu u prsištu, bolno disanje)
Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment including Privigen (see section 4.4).
Privigen razvije hemolitička anemija koja zahtijeva transfuziju (vidjeti dio 4.4).
If well tolerated (see section 4.4), the rate of administration may gradually be increased to a maximum of 4.8 ml/kg bw/hr.
U slučaju dobrog podnošenja (vidjeti dio 4.4), primijenjena doza postupno se može povećati na najviše 4,8 ml/kg TT/sat.
Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
- budu pažljivo nadzirani u svrhu uočavanja eventualnih simptoma tijekom razdoblja primjene infuzije.
1 ml contains: Human normal immunoglobulin 100 mg. IgG purity ≥ 98%.
1 ml sadrži: Ljudski normalni imunoglobulin 100 mg
In case of renal impairment, IVIg discontinuation should be considered.
U slučaju oštećenja bubrežne funkcije treba razmotriti prekid i.v.Ig terapije.
Monitor patients for pulmonary adverse reactions.
Bolesnike pratiti u slučaju plućnih nuspojava.
No differences were seen in the pharmacodynamic properties between adult and paediatric study patients.
Nisu uočene razlike u farmakodinamičkim svojstvima između odraslih osoba i djece u ispitivanjima.
In patients at risk of acute renal failure, IVIg products should be administered at the minimum rate of infusion and dose practicable.
U bolesnika pod rizikom za akutno zatajenje bubrega i.v.Ig lijekove treba primijeniti minimalnom provedivom brzinom infuzije i dozom.
- Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.
- Sekundarne imunodeficijencije (SID) u bolesnika s teškim ili rekurentnim infekcijama, onih u kojih antimikrobno liječenje nije bilo učinkovito te s dokazanim nedostatkom stvaranja specifičnog antitijela (PSAF)* ili s koncentracijom IgG-a u serumu <4 g/l. * PSAF = (engl. proven specific antibody failure) = nemogućnost postići barem dvostruki porast titra IgG antitijela na polisaharidne i polipeptidne antigene u pneumkoknim cjepivima.
Privigen is presented as a solution for infusion.
Privigen je otopina za infuziju.
• transient decrease in red blood cells (reversible haemolytic anaemia/haemolysis), anaemia, leukopenia, anisocytosis (including microcytosis).
• prolazni pad crvenih krvnih stanica (reverzibilna hemolitička anemija/hemoliza), anemija,
Other side effects presented in order of decreasing frequency:
Druge nuspojave prikazane su prema opadajućoj učestalosti:
Blood tests Tell your doctor about your treatment with Privigen prior to having any blood tests.
Prije obavljanja krvnih pretraga obavijestite svog liječnika o uzimanju Privigena.
• It is strongly recommended that every time you are given a dose of Privigen the name and batch number of the product are recorded in order to maintain a record of the batches used.
• Preporučuje se bilježenje naziva i broja serije proizvoda pri svakoj primjeni Privigena kako bi se mogle pratili primijenjene serije lijeka.
Skin disorder (including rash, pruritus, urticaria, maculo-papular rash, erythema, skin exfoliation)
urtikariju, makulopapularni osip, eritem, eksfolijaciju kože)
(e.g. you may feel light-headed, dizzy, faint on standing, cold in the hands and feet, sense an abnormal heart beat or chest pain, or have blurred vision) even when you have shown no hypersensitivity on previous infusions, Tell your doctor or healthcare professional immediately if you notice such signs during the infusion of Privigen.
možete osjećati ošamućenost, omaglicu, nesvjesticu prilikom ustajanja, hladnoću u šakama ili stopalima, osjećaj abnormalnih srčanih otkucaja ili bolove u prsištu ili zamagljen vid) čak i ako niste imali preosjetljivost kod prethodnih infuzija,
The solution should be clear or slightly opalescent and colourless or pale yellow.
Otopina treba biti bistra ili blago opalescentna te bezbojna ili blijedo žuta.
Tel: +386 1 25 71 496
MediSanus d.o.o. Tel: +386 1 25 71 496
Pain (including back pain, pain in extremity, arthralgia, neck pain, facial pain) pyrexia (including chills), influenza like illness (including nasopharyngitis, pharyngolaryngeal pain, oropharyngeal blistering, throat tightness)
(artralgija), bol u vratu, bol u licu), vrućica (uključujući zimicu), bolest nalik gripi (uključujući curenje nosa (nazofaringitis), grlobolju (faringolaringealna bol), mjehurići na sluznici usne šupljine i grla
200 or 400 ml of solution in a single vial (type II glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
200 ili 400 ml otopine u jednoj bočici (staklo tipa II), s čepom (elastomer), zaštitnim zatvaračem
- Chronic inflammatory demyelinating polyneuropathy (CIDP).
- Kronične upalne demijelinizirajuće polineuropatije (KUDP).
Cases of acute renal failure have been reported in patients receiving IVIg therapy.
U bolesnika koji primaju terapiju i.v.Ig-om zabilježeni su slučajevi akutnog zatajenja bubrega.
Dizziness (including vertigo)
Omaglica (uključujući vrtoglavicu)
The pharmacokinetic parameters for Privigen were determined in a clinical study in PID patients (see section 5.1).
Farmakokinetički parametri za Privigen utvrđeni su u kliničkom ispitivanju u
Aseptic technique must be strictly observed during the dilution of Privigen.
Tijekom razrjeđivanja Privigena potrebno je strogo se pridržavati aseptičke tehnike.
EXP
KUDP
The mean improvement at the end of the treatment period compared to reference visit was 1.4 points in the PRIMA (1.8 points in IVIg pretreated subjects) and 1.2 points in PATH study.
PRIMA (1,8 bodova u ispitanika prethodno liječenih i.v.Ig-om) i 1,2 boda u PATH ispitivanju.
Patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
bolesnici s kroničnom upalnom demijelinizirajućom polineuropatijom.
The MRC responder rate, an increase of at least 3 points, was 84.8% which was similar in previously treated (81.5% [58.95, 100.00]) and untreated (86.7% [69.46, 100.00]) patients.
Stopa bolesnika koji su odgovorili na liječenje prema MRC, odnosno porast od barem tri boda iznosio je 84,8% što je slično u prethodno liječenih (81,5% [58,95; 100,00]) i neliječenih bolesnika (86,7% [69,46; 100,00]).
Replacement therapy in primary immunodeficiency (PID) syndromes The dose regimen should achieve a trough IgG level (measured before the next infusion) of at least 5 to 6 g/l.
Režimom doziranja se treba postići najniža IgG razina (izmjereno prije svake infuzije) od najmanje
Primary immune thrombocytopenia (ITP)
Primarna imunotrombocitopenija (ITP)
If you get any side effects, talk to your doctor or healthcare professional.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili zdravstvenog radnika.
Thromboembolism
Tromboembolije
Frequency of injections
Učestalost ubrizgavanja
• acute renal failure,
• akutno zatajenje bubrega,
• formation of blood clots which may be carried off in the blood circulation (thromboembolic reactions) and which may result e.g. in myocardial infarction (e.g. when you have sudden chest pain or shortness of breath), stroke (e.g. when you have a sudden onset of muscle weakness, have loss of sensation and/or balance, decreased alertness or difficulty in speaking), blood clots in the arteries of the lungs (e.g. when you have chest pain, difficulty in breathing or are coughing up blood), deep vein thrombosis (e.g. when you have redness, feel warmth, pain, tenderness, or have a swelling of one or both legs),
• formiranje krvnih ugrušaka koji se mogu prenositi kroz cirkulaciju krvi (tromboembolijske reakcije) i mogu uzrokovati npr. srčani udar (primjerice, kada osjetite iznenadnu bol u prsištu ili nedostatak zraka), moždani udar (primjerice kada osjetite iznenadan nastanak mišićne slabosti,
0.4 g/kg bw/d for 5 days
0,4 g/kg TT/dan tijekom 5 dana
2 g/kg bw every 4 to 8 weeks over 2 to 5 days
preko 2 do 5 uzastopnih dana svaka 2 do 4 tjedna ili svakih 4 do 8 tjedana preko 2 do 5 dana
CSL Behring s.r.o.
CSL Behring B.V.
0.4 g/kg bw/d for 2 to 5 days
0,4 g/kg TT/dan tijekom 2 do 5 dana
25 ml of solution in a single vial (type I glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
25 ml otopine u jednoj bočici (staklo tipa I), s čepom (elastomer), zaštitnim zatvaračem (aluminij),
MedDRA System Organ Class (SOC)
Klasifikacija organskih sustava prema MEDRA-i
In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
U ovim slučajevima bolesnike treba nadzirati tijekom primanja prve infuzije i jedan sat nakom primanja prve infuzije, a u svrhu otkrivanja mogućih nuspojava.
Affected are vaccinations with live attenuated virus vaccines such as vaccinations against measles, mumps, rubella and varicella.
Umanjena je uglavnom djelotvornost živih atenuiranih virusnih cjepiva kao što su ona za ospice, zaušnjake, rubeolu i vodene kozice.
starting dose: 2 g/kg bw in divided doses over 2 to 5 days maintenance dose: 1 g/kg bw every 3 weeks over 1 to 2 days
u podijeljenim dozama kroz 2 - 5 dana doza održavanja: 1 g/kg TT
Noncardiogenic pulmonary edema may very rarely occur following treatment with IVIg products, including Privigen.
Prilikom liječenja s i.v.Ig lijekovima, uključujući Privigen, vrlo rijetko se pojavljuje nekardiogeni plućni edem.
starting dose: 0.4 - 0.8 g/kg bw maintenance dose: 0.2 - 0.8 g/kg bw every 3 to 4 weeks to obtain IgG trough levels of at least 5 - 6 g/l
0,4 - 0,8 g/kg TT doza održavanja: 0,2 - 0,8 g/kg TT
In all patients, IVIg administration requires: - adequate hydration prior to the initiation of the infusion of IVIg - monitoring of urine output - monitoring of serum creatinine levels - avoidance of concomitant use of loop diuretics.
- kontrolu diureze - praćenje razine kreatinina u serumu - izbjegavanje istodobne primjene diuretika Henleove petlje.
Vaccinations Tell your vaccinating doctor prior to a vaccination about your treatment with Privigen.
Prije cijepljenja, obavijestite svog liječnika o svom liječenju Privigenom.
Tel: +385 1 631 1833
PharmaSwiss d.o.o. Tel: +385 1 631 1833
Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially infusing the product slowly (0.3 ml/kg bw/hr); - are carefully monitored for any symptoms throughout the infusion period.
- nisu osjetljivi na ljudski normalni imunoglobulin, polaganom infuzijom lijeka na početku primjene (0,3 ml/kg TT/sat);
For intravenous use only.
Samo za primjenu u venu.
Reversible haemolytic reactions have been observed in patients, especially those with non-O blood groups in immunomodulatory treatment.
Reverzibilne hemolitičke reakcije tijekom imunomodulatornog liječenja opažene su u bolesnika,
Pregnancy
Cjepljenje
Secondary immunodeficiencies (as defined in 4.1) The recommended dose is 0.2 - 0.4 g/kg every three to four weeks.
Preporučena doza je 0,2 - 0,4 g/kg svaka tri do četiri tjedna.
3 years
godine.
Solutions that are cloudy or have deposits should not be used.
Ne koristiti otopine koje su mutne ili sadrže talog.
The median doses administered for the 3-week and 4-week treatment schedules were almost identical to each other (428.3 vs. 440.6 mg IgG/ kg bw).The PID extension study included a total of 55 patients aged between 4 and 81 years old.
Medijani doza primijenjenih prema 3-tjednom i 4-tjednom rasporedu bili su gotovo identični (428,3 naspram 440,6
The ability to drive and operate machines may be impaired by some adverse reactions associated with Privigen.
Neke nuspojave povezane s lijekom Privigen mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
These include: careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, the testing of each donation and pools of plasma for signs of virus/infections, the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
• uključivanje koraka u obradi krvi ili plazme koji mogu inaktivirati ili ukloniti viruse.
A total of 43 of the 207 patients achieved a better CIDP status as assessed by the adjusted INCAT score compared to their CIDP status at study entry.
Ukupno 43 od 207 bolesnika postiglo je bolji status
Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally in connection with intravenous administration of human immunoglobulin including Privigen.
Nuspojave kao što su zimica, glavobolja, omaglica, vrućica, povraćanje, alergijske reakcije, mučnina,
A vented infusion line should be used for the administration of Privigen.
Za primjenu Privigena treba koristiti ventilirani sustav za infuziju.
In the second ITP study, 57 patients with ITP (baseline platelet counts ≤ 30×109 / l) aged between 18
U drugom ITP ispitivanju 57 je bolesnika (broj trombocita na početku ispitivanja ≤30x109/1) u dobi između 18 i 65 godina liječeno Privigenom u dozi od 1 g/kg TT.
The recommended infusion rate given under section 4.2 must be closely followed.
Nužno je pridržavati se preporučene brzine infuzije navedene u dijelu 4.2. Bolesnike se mora pomno pratiti i pažljivo nadzirati kako bi se uočili eventualni simptomi tijekom razdoblja primjene infuzije.