natgillin/translations-raw huggingface dataset:
In a follow-up study conducted in 74 children, approximately 2.5 to 3 years after the booster dose, 85.3% of the children were still seroprotected against hepatitis B and at least 95.7% were seroprotected against the three poliovirus types and PRP.
otrok še vedno serološko zaščitenih proti hepatitisu B in vsaj 95,7 % serološko zaščitenih proti trem vrstam poliovirusa in PRP.
Syringe
Brizga
Very common Appetite lost
Presnovne in prehranske motnje Zelo pogosti izguba apetita
10 vials and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 vial in 10 napolnjenih injekcijskih brizg + 20 igel 10 x 1 odmerek (0,5 ml)
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
• If your child misses an injection which is due, it is important that you make another appointment.
Če vaš otrok izpusti odmerek • Če vaš otrok zamudi predvideni odmerek, je pomembno, da ga prenaročite.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 50 (5 X 10) (OUTER WRAPPER LABEL TO BE APPLIED ON TRANSPARENT FOIL, INCLUDING BLUE BOX)
PAKIRANJE, KI VSEBUJE 5 POSAMEZNIH PAKIRANJ (5 X 10) (NALEPKA Z MODRIM OKENCEM NA ZUNANJI PROZORNI FOLIJI)
Post-dose 2
Po 2. odmerku
After a complete vaccination according to a 2-dose primary and booster schedule with Infanrix hexa, at least 97.9% of the subjects had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Po celotnem cepljenju s shemo 2 primarnih in enega obnovitvenega odmerka cepiva Infanrix hexa se je serološka zaščitna ali seropozitivna koncentracija protiteles proti vsakemu od antigenov v cepivu pojavila pri vsaj 97,9 % preiskovancev.
Fever ≥39.5°C was observed in 2.6% and 1.5% of infants receiving Infanrix hexa with or without Prevenar, respectively (see sections 4.4 and 4.5).
Zvišano telesno temperaturo ≥ 39,5 °C so zabeležili pri 2,6 % otrok, ki so dobili cepivo Infanrix hexa in cepivo Prevenar, ter pri 1,5 % otrok, ki so dobili samo cepivo Infanrix hexa (glejte poglavji 4.4 in 4.5).
A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Infanrix hexa.
Anamneze vročinskih krčev, družinske obremenjenosti s krči ali sindroma nenadne smrti dojenčka
1 vial and 1 pre-filled syringe 1 dose (0.5 ml)
1 viala in 1 napolnjena injekcijska brizga 1 odmerek (0,5 ml)
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very preterm infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Pri aplikaciji odmerkov primarne imunizacije veliko prezgodaj rojenim nedonošenčkom (rojenim pred ali v 28. tednu nosečnosti), še posebno tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48 do 72 urnem spremljanju pljučnega delovanja.
Haemophilus influenzae type b polysaccharide
32 D-antigenskih enot polisaharid hemofilusa influence tipa b
In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar (PCV7) as a booster (4th) dose of both vaccines, fever ≥ 38.0°C was reported in 43.4% of infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of infants receiving the hexavalent vaccine alone.
odmerek obeh cepiv, so poročali o zvišani telesni temperaturi ≥ 38,0 °C pri 43,4 % otrok, ki so obenem dobili cepivo Prevenar in cepivo Infanrix hexa, v primerjavi s 30,5 % otrok, ki so dobili samo heksavalentno cepivo.
• If additional injections (boosters) are necessary, the doctor will tell you.
• Zdravnik vam bo povedal, če so potrebni še dodatni ali "obnovitveni" odmerki.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH DTPA HBV IPV SUSPENSION
NAPOLNJENA INJEKCIJSKA BRIZGA S SUSPENZIJO (DTPA HBV IPV)
• If your child gets any side effects, talk to your doctor or pharmacist.
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES FOR MULTIPACK OF 50 (5 X 10) (WITHOUT BLUE BOX)
PAKIRANJE, KI VSEBUJE 5 POSAMEZNIH PAKIRANJ Z 10 VIALAMI IN 10 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI BREZ IGEL (5 X 10) (BREZ MODREGA OKENCA)
10 vials and 10 pre-filled syringes 10 x 1 dose (0.5 ml)
10 vial in 10 napolnjenih injekcijskih brizg 10 x 1 odmerek (0,5 ml)
Data from clinical studies indicate that, when Infanrix hexa is co-administered with pneumococcal conjugate vaccines, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone.
Podatki kliničnih študij kažejo, da je delež febrilnih reakcij večji, če je cepivo Infanrix hexa uporabljeno skupaj s konjugiranimi pnevmokoknimi cepivi, kot če je cepivo Infanrix hexa uporabljeno samo.
With regards to hepatitis B, seroprotective antibody concentrations (≥10 mIU/ml) following a 3-dose primary and booster schedule with Infanrix hexa have been shown to persist in ≥ 85% of subjects 4-5 years of age, in ≥72% of subjects 7-8 years of age, in ≥60% of subjects 12-13 years of age and in 53.7% of subjects 14-15 years of age.
preiskovancev v starosti od 4 do 5 let, pri ≥ 72 % preiskovancev v starosti od 7 do 8 let, pri ≥ 60 % preiskovancev v starosti od 12 do 13 let in pri 53,7 % preiskovancev v starosti od 14 do 15 let.
40, 8, 32 DU
Italija 2, 4, 6 mesecev
Infanrix hexa, Powder and suspension for suspension for injection in a pre-filled syringe Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)
Infanrix hexa - prašek in suspenzija za suspenzijo za injiciranje v napolnjeni injekcijski brizgi Adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju (brezcelično, pripravljeno iz antigenskih sestavin) (Pa), hepatitisu B (rekombinantno) (HBV), otroški ohromelosti (inaktivirano) (IPV) in hemofilusu influence tipa b (konjugirano) (Hib)
Uncommon Somnolence Rare
Občasni zaspanost
Component of a multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles
V pakiranju je 5 posameznih pakiranj z 10 vialami in 10 napolnjenimi injekcijskimi brizgami brez igel
Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 3-dose primary and booster vaccination with Infanrix hexa
Odstotek preiskovancev, pri katerih so titri protiteles kazali na serološko zaščito/seropozitivnost en mesec po primarnem cepljenju s 3 odmerki in obnovitvenem odmerku cepiva Infanrix hexa Protitelo (mejna vrednost)
Immunogenicity in preterm infants
Imunogenost pri nedonošenčkih
After booster vaccination (post-dose 4), at least 98.4% of children had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Po obnovitvenem cepljenju (po 4. odmerku) se je serološka zaščitna ali seropozitivna koncentracija protiteles proti vsakemu od antigenov v cepivu pojavila pri vsaj 98,4 % otrok.
Syringe cap
Občasni kašelj
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH HIB POWDER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines.
Preobčutljivost po predhodnem cepljenju s cepivi proti davici, tetanusu, oslovskemu kašlju, hepatitisu B, otroški ohromelosti ali boleznim, ki jih povzroča Hib.
Percentage of subjects with antibody titres indicative of seroprotection / seropositivity after primary and booster vaccination with Infanrix hexa
Odstotek preiskovancev, pri katerih so titri protiteles kazali na serološko zaščito/seropozitivnost po primarnem cepljenju in obnovitvenem odmerku cepiva Infanrix hexa Protitelo (mejna vrednost)
• fits - this may be when they have a fever These side effects have happened very rarely with Infanrix hexa as with other vaccines against whooping cough.
Ti neželeni učinki so se pojavili zelo redko pri cepljenju s cepivom Infanrix hexa, kot tudi pri drugih cepivih proti oslovskemu kašlju.
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a turbid white suspension.
Komponenta cepiva (DTPa-HBV-IPV) proti davici, tetanusu, oslovskemu kašlju (acelularno), hepatitisu B, otroški ohromelosti (inaktivirano) je motna bela suspenzija.
N = number of subjects † cut-off accepted as indicative of protection * Post booster, 94.4% of subjects in the 2-4-12 months schedule and 97.0% of subjects in the 3-5-11 months schedule had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection.
94,4 % preiskovancev, cepljenih po shemi 2-4-12 mesecev, in 97,0 % preiskovancev, cepljenih po shemi 3-5-11 mesecev.
Syringe plunger
Valj brizge
Lactose anhydrous
anafilaktoidne reakcije
After a 2-dose primary vaccination schedule, at least 84.3% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Po shemi osnovnega cepljenja z 2 odmerkoma se je serološka zaščitna ali seropozitivna koncentracija protiteles proti vsakemu od antigenov v cepivu pojavila pri vsaj 84,3 % dojenčkov.
After a 3-dose primary vaccination schedule, at least 95.7% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Po shemi osnovnega cepljenja s 3 odmerki se je serološka zaščitna ali seropozitivna koncentracija protiteles proti vsakemu od antigenov v cepivu pojavila pri vsaj 95,7 % dojenčkov.
redness
Opombe
What Infanrix hexa looks like and contents of the pack
5 Shranjevanje cepiva Infanrix hexa Vsebina pakiranja in dodatne informacije
What Infanrix hexa contains
Kaj vsebuje cepivo Infanrix hexa
Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju (brezcelično, pripravljeno iz antigenskih sestavin) (Pa), hepatitisu B (rekombinantno) (HBV), otroški ohromelosti (inaktivirano) (IPV) in hemofilusu influence tipa b (konjugirano) (Hib).
Infanrix hexa will confer an anti-PRP immune response (cut-off ≥ 0.15µg/ml) in at least 84% of the infants.
≥ 0,15 µg/ml) pri vsaj 84 % dojenčkov.
• Keep this vaccine out of the sight and reach of children.
• Cepivo shranjujte nedosegljivo otrokom!
Uncommon Diffuse swelling of the injected limb, sometimes involving the adjacent joint1
Občasni difuzna oteklina okončine, v katero je bilo cepivo injicirano,
Swelling of the entire injected limb1, 2, extensive swelling reactions2, injection site mass2, injection site vesicles2 1 Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines.
1 Pri otrocih, ki so bili osnovno cepljeni z acelularnim cepivom proti oslovskemu kašlju, je verjetneje, da se bo po obnovitvenem cepljenju pojavila reakcija v obliki otekline kot pa pri otrocih, ki so bili osnovno cepljeni s cepivom proti oslovskemu kašlju, ki je vsebovalo celotno celico.
25 micrograms
25 mikrogramov pertaktin1
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hib for Infanrix hexa
IME ZDRAVILA IN POT(I) UPORABE Hib za Infanrix hexa prašek za suspenzijo za injiciranje i.m.
Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Infanrix hexa and Prevenar 13 (see section
Pri sočasni uporabi cepiva Infanrix hexa in cepiva Prevenar 13 so opazili povečano pogostnost poročanja o konvulzijah (z ali brez vročine) in hipotonično-hiporesponzivni epizodi (glejte poglavje 4.8).
Bordetella pertussis antigens (Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1)
antigeni Bordetella pertussis (toksoid Bordetella pertussis1, filamentozni hemaglutinin1, pertaktin1) 25, 25, 8 mikrogramov površinski antigen virusa hepatitisa B2,
25, 25, 8 micrograms
Nemčija 3, 4, 5 mesecev
• Experience in co-administration:
• Izkušnje s sočasno uporabo dveh cepiv:
STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml): Diphtheria toxoid1
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 odmerek (0,5 ml) po rekonstituciji:
Anti-Polio type 2 (1/8 dilution)
Antipolio tip 2
3-5-11 months of age N=530 (4 studies)
N = 530 (4 študije)
• if your child is allergic to: - Infanrix hexa or any of the ingredients of this vaccine (listed in section 6).
- cepivo Infanrix hexa ali katero koli sestavino tega cepiva (navedeno v poglavju 6); - formaldehid; - neomicin ali polimiksin (antibiotika).
Anti-Polio type 3 (1/8 dilution)
Antipolio tip 3
IPV) component is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).
poliomielitis (inaktivirani) je bela, rahlo mlečna tekočina v napolnjeni injekcijski brizgi
2-4-12 months of age N=223 (1 study)
N = 223 (1 študija)
Lymphadenopathy2, thrombocytopenia2
Redki limfadenopatija2, trombocitopenija2
Infanrix hexa should not be given if any of the above apply to your child.
Če karkoli od navedenega velja za vašega otroka, ne sme prejeti cepiva Infanrix hexa.
1 vial and 1 pre-filled syringe + 2 needles
1 viala in 1 napolnjena injekcijska brizga + 2 igli 1 odmerek (0,5 ml)
Film-Coated Tablet Oral Use
Eurefin filmsko obložena tableta
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for fenspiride containing medicinal products
Priloga I Seznam zdravil in oblik
Oral Drops, Solution Oral Use
Litva peroralne kapljice, raztopina
These changes usually resolve over time.
Spremembe običajno izzvenijo s časom.
The study protocol should be submitted within 3 months of the EC decision.
Protokol študije je treba predložiti v roku treh mesecev od odločbe EK.
Each course lasts one month.
Vsak cikel traja en mesec.
The clinical study report should be submitted by
Poročilo o klinični študiji je treba predložiti do
The terminal halflife was estimated at 10 (+ 6) days.
Razpolovni čas je bil ocenjen na 10 (+6) dni.
However, the presence of HACA appears to increase the clearance of dinutuximab by approximately 60%.
Vendar se zdi, da prisotnost HACA poveča izločanje dinutuksimaba za približno 60 %.
Dilution must be carried out under aseptic conditions.
Redčenje je treba izvesti v aseptičnih pogojih.
Grade 3 (sensory changes for more than 2 weeks, objective motor weakness) or Grade 4
Stopnja 3 (senzorične spremembe za več kot 2 tedna, objektivna motorična oslabelost) ali stopnja 4
As with all therapeutic proteins, there is potential for immunogenicity.
Kot za vse terapevtske proteine obstaja možnost imunogenosti.
United Therapeutics Corporation 1040 Spring Street Silver Spring, Maryland 20910 USA
United Therapeutics Corporation 1040 Spring Street Silver Spring, Maryland 20910 ZDA
You will not be given all of the medicines in every course.
V posameznih ciklih ne boste prejemali vseh zdravil.
Classical biotransformation studies have not been performed.
Klasične študije o biotransformaciji niso bile izvedene.
Non-clinical data reveal no special hazard for humans based on conventional studies conducted to date.
Neklinični podatki ne kažejo nobenih posebnih nevarnosti za ljudi na podlagi konvencionalnih študij,
You will be given an anti-histamine medicine which helps to prevent allergic reactions.
Prejeli boste antihistaminsko zdravilo, ki pomaga pri preprečevanju alergijskih reakcij.
The safety and efficacy of Unituxin in children aged less than 12 months have not yet been established.
Varnost in učinkovitost zdravila Unituxin pri otrocih, mlajših od 12 mesecev, še nista dokazani.
Your doctor or nurse will check you during and after the infusion.
Vaš zdravnik ali medicinska sestra vas bo kontroliral pred in po infuziji.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1022/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1022/001
Your doctor will work out your dose based on your body surface area.
Vaš zdravnik bo izračunal primeren odmerek za vas na podlagi površine vašega telesa.
In addition to the above criteria, clinician judgement must be exercised in the evaluation of the patient's cardiovascular functions.
Poleg zgoraj navedenih kriterijev je za presojanje bolnikovih kardiovaskularnih funkcij potrebno klinično mnenje.
• Administer supportive measures.
• Nudite podporne ukrepe.
No direct effects on electrocardiogram parameters or on the respiratory system were observed.
Neposredni učinki na parametre elektrokardiograma ali na dihalni sistem niso bili opaženi.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če pripravljene raztopine ne uporabite takoj, so čas shranjevanja pripravljene raztopine in pogoji odgovornost uporabnika.
• You will only be given isotretinoin to take by mouth.
• Jemali boste samo izotretinoin skozi usta.
Grade 4(life-threatening) - < 120 mmol/L despite appropriate fluid management
Stopnja 4 (življenje ogrožajoča) - < 120 mmol/l kljub primernemu upravljanju tekočin
Serious anaphylactic/allergic reactions were reported in 14% of patients.
Resne anafilaktične/alergijske reakcije so se pojavile pri 14 % bolnikov.
Occasionally a young person who is taking this medicne may be reading the package leaflet, but usually it will be a parent/carer.
Občasno se zgodi, da mlada oseba, ki jemlje to zdravilo, sama prebere navodilo za uporabo, vendar pa ga običajno preberejo starši ali skrbnik.
It belongs to a group of medicines called ‘monoclonal antibodies'.
Ta sodi v skupino zdravil, imenovanih »monoklonska protitelesa«.
You will be given pain relieving medicines (such as paracetamol, ibuprofen and morphine) to help prevent and reduce the pain.
Prejeli boste zdravila proti bolečinam (kot npr. paracetamol, ibuprofen, morfin) za preprečevanje in lajšanje bolečin.
Reporting of suspected adverse reactions that occur after authorisation of the medicinal product is important.
Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
Do not take Unituxin if - you are allergic to dinutuximab or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Unituxin, - če ste alergični na dinutuksimab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
High-risk neuroblastomas are more likely to come back again after treatment.
Nevroblastomi z visokim tveganjem se po zdravljenju pogosto ponovno pojavijo.
A risk for interactions with concomitantly used medicinal products cannot be excluded.
Tveganja za medsebojno delovanje v primeru sočasne uporabe drugih zdravil ni mogoče izključiti.
To reduce the risk of side effects, your doctor may increase the time allowed for the Unituxin infusion up to 20 hours.
Za zmanjšanje tveganja neželenih učinkov bo vaš zdravnik lahko podaljšal dovoljeni čas infuzije zdravila Unituxin do 20 ur.
There was no apparent correlation between the development of these antibodies and allergic reactions.
Med razvojem teh protiteles in alergijskimi reakcijami ni bilo nobene očitne povezave.
United Kingdom Tel: +44 (0)1932 664884 Fax: +44 (0)1932 573800 E-mail: druginfo@unither.com
Tel: +44 (0)1932 664884 Faks: +44 (0)1932 573800 E-pošta: druginfo@unither.com
This means it is essentially ‘sodiumfree'.
To pomeni, da je v bistvu »brez natrija«.
The infusion must be terminated after 20 hours, even if the full dose cannot be delivered within this timeframe.
Infuzijo je treba prekiniti po 20 urah, tudi če znotraj tega časovnega obdobja ni mogoče dati celotnega odmerka.
Some neuroblastomas are classed as ‘high risk' if the cancer has spread to various parts of the body and contains certain types of cells.
Nekateri nevroblastomi sodijo v razred »visokega tveganja«, če se rak širi po raznih delih telesa in vsebuje določene vrste celic.
The diluted solution for infusion must be used within 24 hours of preparation.
Pripravljeno raztopino za infuzijo je treba uporabiti v roku 24 ur po pripravi.
Day IL-21
Dan IL-21
Driving and using machines
Vožnja in upravljanje strojev
• Obligation to conduct post-authorisation measures
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Opis
Neuroblastoma is a type of cancer that grows from abnormal nerve cells in the body.
Nevroblastom je vrsta raka, ki se razvija iz abnormalnih živčnih celic v telesu.
The effects of dinutuximab on fertility in humans are unknown.
Učinki dinutuksimaba na plodnost pri ljudeh niso znani.
High-risk neuroblastoma was based on the patient age (greater than 12 months) and tumour stage at diagnosis and / or the presence of biological risk factors, such as MYCN amplification.
Nevroblastom z visokim tveganjem je temeljil na bolnikovi starosti (več kot 12 mesecev) in stopnji tumorja ob diagnozi in/ali prisotnosti bioloških faktorjev tveganja, kot npr. amplifikacija MYCN.
In particular, tell your doctor or nurse if you have recently received: - medicines called ‘corticosteroids' - these can affect the activity of your immune system which is important for Unituxin to work.
Obvestite svojega zdravnika ali medicinsko sestro še posebno, če ste pred kratkim jemali: - zdravila, imenovana »kortikosteroidi« - ti lahko vplivajo na delovanje imunskega sistema, kar je pomembno za učinkovanje zdravila Unituxin.
• You will be given isotretinoin to take by mouth for the last 14 days of each course.
• Izotretinoin boste jemali skozi usta zadnjih 14 dni posameznega cikla.
• Problems with your eyes - tell your doctor or nurse if you notice any problems with your eyes or changes to your vision.
• Težave z očmi - obvestite svojega zdravnika ali medicinsko sestro, če opazite katere koli težave z očmi ali spremembe vida.
Unituxin is used to treat ‘high-risk neuroblastoma' in babies, children and adolescents aged 12 months to 17 years old.
Zdravilo Unituxin uporabljamo za zdravljenje »nevroblastoma z visokim tveganjem« pri dojenčkih, otrocih in mladostnikih, starih od 12 mesecev do 17 let.
No interaction studies have been performed.
Študij interakcij niso izvedli.
Originally reported terms have been coded to preferred terms (using the Medical Dictionary for Regulatory Activities [MedDRA]).
Prvotno uporabljeni izrazi so bili zamenjani s priporočenimi izrazi v skladu z medicinskim slovarjem za regulatorne aktivnosti [MedDRA]).
Prior to starting each treatment course, refer to Table 3 for a list of criteria that must be evaluated.
Preden začnete posamezni terapevtski cikel, upoštevajte Preglednico 3 za seznam kriterijev, ki jih je treba oceniti.
From a microbiological point of view, the product should be used immediately.
Iz mikrobiološkega vidika je treba zdravilo uporabiti takoj.
When Unituxin attaches to the GD2 on the cancer cells, the patient's immune system starts to attack these cells and kill them.
Ko se zdravilo Unituxin pritrdi na GD2 rakastih celic, začne imunski sistem bolnika napadati te celice in jih pobije.
Additional adverse reactions characteristic of an allergic response were also reported - including anaphylactic reaction (18 %) and bronchospasm (4 %).
Navedeni so bili tudi dodatni neželeni učinki v obliki alergijskih reakcij, vključno z anafilaktičnimi reakcijami (18 %) in bronhospazmom (4 %).
No clinical signs of CNS toxicity were observed.
Znaki CNS toksičnosti niso bili opaženi.
• Administer supportive measures (see section 4.4).
• Nudite podporne ukrepe (glejte poglavje 4.4).