natgillin/translations-raw huggingface dataset:
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1 point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] score compared with baseline) or were withdrawn for any other reason in the Hizentra treatment period.
Inflammatory Neuropathy Cause and Treatment) skora u odnosu na početnu vrijednost) ili koji su povučeni iz bilo kojeg drugog razloga u razdoblju liječenja Hizentrom.
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
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
Once a blistered pre-filled syringe has been opened, use the solution immediately.
Čim otvorite napunjenu štrcaljku u blisteru, odmah upotrijebite otopinu.
No overall differences in safety or efficacy were observed between PID subjects >65 years and PID subjects 18 to 65 years of age.
Nisu uočene razlike u sigurnosti ili djelotvornosti između PID ispitanika > 65 godina i PID ispitanika u dobi od 18 do 65 godina starosti.
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
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
Hypogammaglobulinaemia in patients, pre- and post-allogeneic haematopoietic stem cell transplantation (HSCT).
− Hipogamaglobulinemije kod bolesnika prije i poslije alogene transplantacije hematopoetskih matičnih stanica.
Immunomodulatory therapy in CIDP
Imunomodulacijska terapija kod KUDP-a
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.
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.
Patients exhibiting signs and symptoms of AMS should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis.
U bolesnika koji pokazuju znakove i simptome AMS-a potrebno je provesti temeljite neurološke pretrage,
They may occur even if you received human immunoglobulins previously and tolerated them well.
Do alergijskih reakcija može doći čak i ako ste već primali i dobro podnosili ljudske imunoglobuline.
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).
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.
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.
Hizentra se primjenjuje pod kožu (supkutano) s tjednom dozom od 1,0 do 2,0 ml/kg tjelesne težine.
ADRs (MedDRA Preferred Term, PT)
Nuspojave (MedDRA preporučeni pojam)
5 Preparation of Hizentra for infusion
5 Priprema Hizentre za infuziju Očistite čep bočice
1 ml contains:
NAVOĐENJE DJELATNE(IH) TVARI 1 ml sadrži:
No overall differences in the pharmacokinetic parameters were observed between PID subjects >65 years and subjects 18 to 65 years of age.
Nisu uočene razlike u farmakokinetičkim parametrima između PID ispitanika > 65 godina i ispitanika u dobi od 18 do 65 godina starosti.
Replacement therapy
Nadomjesna terapija
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.
Srednja vrijednost perioda procjene djelotvornosti bila je 125,8 dana (raspon: 1-330)
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.
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.
AMS has been reported with use of IVIg or SCIg.
S upotrebom i.v.Ig ili s.c.Ig zabilježena je pojava AMS-a.
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.
0,4 g/kg tt i 67% ispitanika na 0,2 g/kg tt, dok u placebo skupini 44% ispitanika nije imalo relaps.
PRE-FILLED SYRINGE
Napunjene štrcaljke
Keep the vial or the blistered pre-filled syringe in the outer carton in order to protect from light.
Bočicu ili napunjenu štrcaljku u blisteru čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
Vial(s)
Bočica(e)
Summary of safety profile
4.8 Nuspojave Sažetak sigurnosnog profila
No overall differences in the pharmacokinetic parameters were observed between CIDP subjects >65 years and subjects 18 to 65 years of age.
Nisu uočene razlike u farmakokinetičkim parametrima između KUDP ispitanika > 65 godina i ispitanika u dobi od 18 do 65 godina.
Infusion site ulcer
Ulkus na mjestu infuzije
Hizentra has not been evaluated in clinical studies in paediatric patients with CIDP who are under the age of 18.
Hizentra nije ocijenjivana u kliničkim ispitivanjima u pedijatrijskih bolesnika s KUDP-om koji su mlađi od 18 godina.
Secure the needle to the skin - If necessary, use gauze and tape or transparent dressing to hold the needle in place.
- Ako je potrebno, upotrijebite gazu i traku ili prozirnu oblogu kako se igla ne bi pomicala.
Therefore, Hizentra should only be given with caution to breast-feeding mothers.
Stoga se Hizentra treba dojiljama davati s oprezom.
Blood tests
Krvožilni poremećaji
No overall differences in safety or efficacy were observed between CIDP subjects >65 years and CIDP subjects 18 to 65 years of age.
Nisu uočene razlike u sigurnosti ili djelotvornosti između KUDP ispitanika > 65 godina i KUDP ispitanika u dobi od 18 do 65 godina starosti.
What Hizentra is and what it is used for What you need to know before you use Hizentra How to use Hizentra
Što je Hizentra i za što se koristi Što je Hizentra
► 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.
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),
Infusion rate(s)
Brzina(e) infuzije
Patients should be closely monitored and carefully observed for any adverse events throughout the infusion period.
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.
Clean the vial stopper - Remove the protective cap from the vial to expose the central portion of the rubber stopper.
- Uklonite zaštitni čep s bočice kako biste vidjeli središnji dio gumenog čepa.
Device-assisted infusion
Infuzija pomoću uređaja za infuziju
• Keep the blistered pre-filled syringe in the outer carton in order to protect from light.
• Čuvati napunjenu štrcaljku u blisteru u vanjskom pakiranju radi zaštite od svjetlosti.
• by manual push with a syringe.
• ručnim potiskom štrcaljke.
► 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).
► 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,
CIDP
Osip
Hizentra 200 mg/ml solution for subcutaneous injection human normal immunoglobulin (SCIg)
Hizentra 200 mg/ml otopina za supkutanu injekciju ljudski normalni imunoglobulin (s.c.Ig)
Keep the blistered pre-filled syringe in the outer carton in order to protect from light.
Napunjenu štrcaljku u blisteru čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe human normal immunoglobulin (SCIg)
Hizentra 200 mg/ml otopina za supkutanu injekciju u napunjenoj štrcaljki ljudski normalni imunoglobulin (s.c.Ig)
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.
Ako se dobro podnosi (vidjeti također dio 4.4), brzina infuzije postupno se može povećavati na
Patients who completed the pivotal PATH study without relapse on 0.4 g/kg bw dose and initially received this dose in the extension study had a relapse rate of 5.6 % (1/18 patients).
kod 0,2 g/kg i 196,1 dana (raspon: 1-330) u skupini 0,4 g/kg tt. Bolesnici koji su završili pivotalno PATH ispitivanje bez relapsa na dozu od 0,4 g/kg tt i početno su primili ovu dozu u nastavku ispitivanja, imali su relaps stopu od 5,6% (1/18 bolesnika).
• Flushing
• Omaglica
The approximate percentage of IgG subclasses is as follows:
Približan postotak IgG podvrste je kako slijedi: IgG1……….69%
Hizentra 200 mg/ml solution for subcutaneous injection human normal immunoglobulin (SCIg) For subcutaneous use only.
Hizentra 200 mg/ml otopina za supkutanu injekciju ljudski normalni imunoglobulin (s.c.Ig) Samo za supkutanu primjenu.
Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe human normal immunoglobulin (SCIg) For subcutaneous use only.
Hizentra 200 mg/ml otopina za supkutanu injekciju u napunjenoj štrcaljki ljudski normalni imunoglobulin (s.c.Ig) Samo za supkutanu primjenu.
United Kingdom CSL Behring UK Ltd. Tel: +44 (0)1444 447405
Tel: +44 (0)1444 447405
Burning sensation
Osjećaj pečenja
Magyarország CSL Behring Kft.
United Kingdom CSL Behring UK Ltd.
Infusion rate
Mjesto infuzije
You may reduce possible side effects if you infuse Hizentra slowly.
Spora primjena infuzije Hizentre može smanjiti pojavu nuspojava.
OUTER BOX (pre-filled syringe)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (napunjena štrcaljka)
CSL Behring GmbH D-35041 Marburg Germany
D-35041 Marburg Njemačka
3 Thoroughly wash and dry hands 4 Check Vials Visually inspect Hizentra for particles in the solution or discoloration as well as expiry date before administering Hizentra.
Prije primjene Hizentre, otopinu treba vizualno pregledati na prisutnost vidljivih čestica ili promjenu boje, kao i rok valjanosti.
Sodium content Hizentra is essentially sodium free.
Sadržaj natrija Hizentra sadrži zanemarive količine natrija.
4 g / 20 ml
20 x 20 ml
If you get any side effects talk to your healthcare professional.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti zdravstvenog radnika.
Tell your doctor or healthcare professional prior to treatment if you have an immunoglobulin type A (IgA) deficiency.
Molimo obavijestite svog liječnika ili zdravstvenog radnika u slučaju ranijeg nepodnošenja bilo kojeg od navedenih sastojaka ► ako patite od hiperprolinemije (genetski poremećaj koji uzrokuje visoke razine aminokiseline prolina u krvi).
See section 4.
Pogledajte dio 4. Što se nalazi u ovoj uputi:
Simulations with population-pharmacokinetic models in the PATH study suggest that a comparable IgG exposure (Cmax, AUC0-14days, Cmin, 14 days) is achieved when the double weekly Hizentra dose is administered every two weeks in the CIDP subjects.
(3,06) g/l u skupini na 0,2 g/kg tt. Simulacije s populacijskim farmakokinetičkim modelima u ispitivanju PATH upućuju na to da je usporediva izloženost IgG-u (Cmax, AUC0-14 dana, Cmin, 14 dana)
1 g/5 ml 2 g/10 ml
1 g / 5 ml
No paediatric-specific dose adjustments were necessary to achieve the desired serum IgG levels.
Za dostizanje željene razine IgG u serumu nije bilo potrebno posebno prilagođavanje pedijatrijske doze.
Weight in kilograms
Težina u kilogramima
Ask your pharmacist how to throw away the medicines you no longer use.
Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
Different organs are affected at different ages.
Različiti organi su zahvaćeni u različitoj dobi.
After opening do not store above 25°C.
Nakon otvaranja ne čuvati na temperaturi iznad 25°C.
Do not increase or decrease the amount of medicine without your doctor's approval.
Nemojte povećavati ili smanjivati količinu lijeka bez odobrenja svog liječnika.
Examine your skin while taking this medicine.
Pregledavajte svoju kožu tijekom uzimanja ovog lijeka.
This will help lessen the chance of loss of eyesight.
To će smanjiti šansu za gubitak vida.
The entire amount of the mixture should be eaten.
Mora se pojesti cjelokupna količina smjese.
The recommended dose for you or your child will depend on your or your child's age and weight.
Preporučena doza za Vas ili Vaše dijete ovisi o Vašoj dobi i težini ili dobi i težini Vašeg djeteta.
The potential risk for humans is unknown.
Nije poznat potencijalni rizik u ljudi.
Date of latest renewal: 26 July 2018
Datum posljednje obnove odobrenja: 26 Srpanj 2018
You may become drowsy.
Možete postati omamljeni.
It is important to take these supplements exactly as instructed.
Važno je uzimati te dodatke točno kako su Vas uputili.
Discard the open bottle and use a new bottle.
Bacite otvorenu bocu i upotrijebite novu.
The Safety Checklist should highlight the following:
Popis za provjeru sigurnosti treba istaknuti sljedeće:
You should not use this medicine if you are pregnant, particularly during the first trimester.
Ne smijete uzimati ovaj lijek ako ste trudni, osobito tijekom prvog tromjesečja.
Recommended dose in mg Every 12 hours*
Preporučena doza u mg Svakih 12 sati*
This is a condition where there is high pressure in the fluid around the brain.
To je stanje u kojem je visok pritisak tekućine oko mozga.
These mainly involve the gastrointestinal and central nervous systems.
One uglavnom uključuju gastrointestinalni i središnji živčani sustav.
Take this medicine two times a day, every 12 hours.
Uzimajte ovaj lijek dva puta dnevno, svakih 12 sati.
Do not double the dose.
Ne uzimajte dvostruku dozu.
Tell your doctor if you have these symptoms.
Obratite se svom liječniku ako imate te simptome.
Do not take this medicine if the foil seal has been open for more than 30 days.
Nemojte uzimati ovaj lijek ako je zaštitna folija zatvarača otvorena duže od 30 dana.
Method of administration You should take this medicine only by mouth.
Način primjene Ovaj lijek smijete uzimati samo kroz usta.
PROCYSBI with food and drink
PROCYSBI s hranom i pićem
Patients with poor tolerability
Bolesnici sa slabijom podnošljivosti
Patients on dialysis or post-transplantation
Bolesnici na dijalizi ili nakon transplantacije
The consequence of this for the clinical use of the drug is unknown.
Nije poznata posljedica toga na kliničku uporabu lijeka.
Your doctor will monitor you for this.
Vaš liječnik će Vas pratiti radi toga.
Warnings and precautions Talk to your doctor or pharmacist before taking PROCYSBI.
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete PROCYSBI.
The terminal half-life of cysteamine bitartrate is approximately 4 hours.
Terminalni poluvijek cisteaminhidrogentartarata iznosi približno 4 sata.
The education pack is aimed at strengthening awareness of important identified and potential risks as well as appropriate patient selection, the need for dose titration and patient monitoring.
Cilj edukativnog paketa je ojačati svijest o važnosti identificiranih i potencijalnih rizika kao i o odgovarajućem odabiru bolesnika, o potrebi za titracijom doze i nadzoru bolesnika.
When starting therapy, you should not drive, use machines, or engage in other dangerous activities until you know how the medicine affects you.
Pri započinjanju liječenja ne smijete voziti, upravljati strojevima niti obavljati nikakve druge opasne aktivnosti sve dok ne znate kako lijek djeluje na Vas.
Central Nervous System (CNS)
Središnji živčani sustav (SŽS)
As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy.
Kao mjera opreza, neobični abdominalni simptomi ili promjene abdominalnih simptoma moraju se medicinski procijeniti kako bi se isključila mogućnost fibrozirajuće kolonopatije.
When these reactions appear at the initiation of cysteamine therapy, temporary suspension and gradual reintroduction of treatment may be effective in improving tolerance.
Kad se ove reakcije pojave na početku liječenja cisteaminom, privremeni prestanak i postupno ponovno uvođenje liječenja mogu biti učinkoviti u poboljšanju podnošljivosti.
Measurement timing: PROCYSBI should be administered every 12 hours.
Vrijeme mjerenja: PROCYSBI treba primjenjivati svakih 12 sati.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Učestalost nuspojava definirana je sukladno sljedećoj konvenciji: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
Do not give gastro-resistant hard capsules to children under 6 years of age because they may not be able to swallow them and they may choke.
Nemojte davati tvrde želučanootporne kapsule djeci mlađoj od 6 godina jer ih ona možda neće moći progutati i mogu se ugušiti.
Two cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation.
Prijavljena su dva slučaja nefrotskog sindroma unutar 6 mjeseci od početka liječenja s progresivnim oporavkom nakon prekida liječenja.
If you are allergic to penicillamine.
Ako ste alergični na penicilamin.
Newly diagnosed adult patients
Novodijagnosticirani odrasli bolesnici
Do not use this medicine if you are breastfeeding (see section 2 under “Do not use PROCYSBI”).
Nemojte uzimati ovaj lijek ako dojite (pogledajte dio 2. pod ,,Nemojte uzimati PROCYSBI“).
Therefore, cysteamine bitartrate should not be used during pregnancy, particularly during the first trimester, unless clearly necessary (see section 4.4).
Stoga se cisteaminhidrogentartarat ne smije primjenjivati tijekom trudnoće, osobito tijekom prvog tromjesečja, osim ako to nije izričito potrebno (vidjeti dio 4.4).
Do not take PROCYSBI:
Nemojte uzimati PROCYSBI:
Thirty-nine (39) patients were included in the final primary per protocol efficacy analysis.
Trideset devet (39) ispitanika je uključeno u finalnu primarnu analizu djelotvornosti prema planu ispitivanja.
Keep the container tightly closed in order to protect from light and moisture.
Spremnik čuvati čvrsto zatvoren radi zaštite od svjetlosti i vlage.
Talk to your doctor if you have any unusual stomach symptoms or changes in stomach symptoms.
Obratite se svom liječniku ako imate bilo kakve neobične želučane simptome ili promjene želučanih simptoma.
If you missed a dose of medicine, you should take it as soon as possible.
Ako ste propustili dozu lijeka, morate ju uzeti što prije.
Report any changes to your doctor.
Obavijestite svog liječnika o svim promjenama.
If several doses of the supplements are missed or weakness or drowsiness develops, call your doctor for instructions.
Ako ste izostavili nekoliko doza nadomjestaka ili se razvije slabost ili omamljenost, nazovite svog liječnika za upute.
Since some of these side effects are serious, ask your doctor to explain their warning signs.
Obzirom da su neke od ovih nuspojava ozbiljne, pitajte svog liječnika da Vam objasni znakove koji upozoravaju na njih.
Your doctor will monitor you with eye examinations to find and treat this problem early.
Vaš liječnik će Vas nadzirati u očnim pregledima kako bi rano ustanovio i liječio taj problem.
Your doctor will monitor you for these problems.
Vaš liječnik će Vas pratiti za te probleme.
Do not crush or chew capsules or capsule contents.
Nemojte drobiti niti žvakati kapsule ili njihov sadržaj.
A white plastic bottle contains 60 capsules.
Bijela plastična boca sadrži 60 kapsula.
What PROCYSBI is and what it is used for
Što je PROCYSBI i za što se koristi
Consult your child's doctor for complete directions.
Posavjetujte se sa svojim liječnikom za cjelovite upute.
Experience has occasionally shown that some forms of cysteamine are less well tolerated (i.e. leading to more adverse events) when patients are on dialysis.
Iskustvo je pokazalo da se povremeno pojedini oblici cisteamina slabije podnose (tj. dovode do više štetnih događaja) kad su bolesnici na dijalizi.
If such symptoms develop, tell your doctor who will adjust your dose.
Ako se razviju takvi simptomi, obratite se svom liječniku koji će prilagoditi Vašu dozu.
If a dose is missed, it should be taken as soon as possible.
Ako se doza propusti, mora se uzeti što prije.
CYP2A6 and CYP3A4 were not involved in the metabolism of cysteamine bitartrate under the experimental conditions.
CYP2A6 i CYP3A4 nisu uključeni u metabolizam cisteaminhidrogentartarata u eksperimentalnim uvjetima.
The relative bioavailability is about 125% as compared to immediate-release cysteamine.
Relativna bioraspoloživost je oko 125% u usporedbi s cisteaminom s trenutnim oslobađanjem.
Skin rash: Tell the doctor right away if you get a skin rash.
Kožni osip: Odmah se javite liječniku ako dobijete kožni osip.
If the rash is severe, your doctor may discontinue cysteamine treatment.
Ako je osip težak, Vaš liječnik može prekinuti liječenje cisteaminom.
Physicians should remain alert for signs of ulceration and bleeding and should inform patients and/or guardians about the signs and symptoms of serious GI toxicity and what steps to take if they occur.
Liječnici moraju pripaziti na znakove ulceracija i krvarenja te trebaju obavijestiti bolesnike i/ili skrbnike o znakovima i simptomima ozbiljne GI toksičnosti te koje korake poduzeti ako se pojave.
Open Date:
Datum otvaranja:
Your doctor will routinely monitor your blood counts and liver function.
Vaš liječnik će rutinski pratiti Vaše krvnu sliku i jetrenu funkciju.
If you are allergic to cysteamine (also known as mercaptamine) or any of the other ingredients of this medicine (listed in section 6).
Ako ste alergični na cisteamin (poznat i kao merkaptamin) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
At this dose, weight gain and survival of the offspring during lactation was also reduced.
Pri toj je dozi bilo smanjeno dobivanje na težini i preživljavanje potomaka tijekom laktacije.
In clinical studies with healthy volunteers, the most frequent adverse reactions were very common GI symptoms (16%) and occurred primarily as single episodes that were mild or moderate in severity.
U kliničkim ispitivanjima sa zdravim dobrovoljcima najčešće nuspojave su bili vrlo uobičajeni GI simptomi (16%) i pojavili su se primarno kao samostalne epizode koje su bile blage ili umjerene težine.
The effect on pregnancy of untreated cystinosis is also unknown.
Učinak neliječene cistinoze na trudnoću također nije poznat.
No specific antidote is known.
Nije poznat specifični protulijek.