natgillin/translations-raw huggingface dataset:
Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of immunisation.
Zaradi dolge inkubacijske dobe hepatitisa B, je možno, da je v času cepljenja prisotna nezaznavna okužba z virusom hepatitisa B. V takšnih primerih cepivo ne more preprečiti okužbe z virusom hepatitisa B.
Side effects included injection-site reactions such as tenderness, redness, swelling and pain.
Med neželene učinke so spadale reakcije ne mestu vbrizganja, kot npr. občutljivost, rdečina, otekanje in bolečine.
96.6 % of infants ; the geometric mean titres (GMTs) were diminished compared to the control group.
Zaščitne ravni proti-HBs (ne manj kot 10 mi.e./ml) so bile dosežene pri 96,6 % dojenčkov; titri geometričnega povprečja (GMT) so bili zmanjšani v primerjavi s kontrolno skupino.
After a primary vaccination with 2 doses of HEXAVAC (e.g 3, 5 months), a booster dose must be given between 11 and 13 months of age; after a primary vaccination with 3 doses of Hexavac (e.g. 2, 3, 4 months; 2, 4, 6 months), a booster dose must be given between 12 and 18 months of age, according to official recommendations.
3. in 5. mesec) obnovitveno cepljenje izvesti med 11. in 13. mesecem življenja; po primarnem cepljenju s 3 odmerki HEXAVAC-a (npr. 2., 3. in 4. mesec; 2., 4. in 6. mesec) pa se mora obnovitveno cepljenje izvesti med 12. in 18. mesecem življenja.
Gastro-intestinal system disorders: Abdominal pain / Meteorism / Nausea.
Bolezni prebavil: bolečine v trebuhu / meteorizem / slabost.
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (chlorobromobutyl), with 1 or 2 separate needles - pack of 1 and 10.
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom na batu (klorobromobutil) in z 1 ali 2 priloženima iglama.
HEXAVAC Intramuscular use
Intramuskularna uporaba
Undesirable effects reported in clinical trials and the marketed use to date of Sanofi Pasteur MSD diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b and inactivated poliomyelitis adsorbed vaccine are included in the list of undesirable effects for HEXAVAC.
Poročali so tudi o neželenih učinkih po začetku splošne uporabe cepiv, ki so sorodna HEXAVAC-u. Neželeni učinki opaženi med kliničnimi poskusi in dosedanjim trženjem adsorbiranega cepiva Sanofi Pasteur MSD proti davici, tetanusu, oslovskemu kašlju (acelularnem), bakteriji Haemophilus influenzae tipa b in otroški ohromelosti (inaktiviranem) so vključeni v seznam neželenih učinkov HEXAVAC-a..
1 adjuvanted dose (0.5 ml) contains:
En 0,5 mililitrski odmerek adsorbiranega cepiva vsebuje:
HEXAVAC is an injectable vaccine in a 0.5 ml single dose syringe.
KAJ JE HEXAVAC IN ZA KAJ GA UPORABLJAMO HEXAVAC je cepivo za injiciranje v injekcijski brizgi z enkratnim odmerkom 0,5 ml.
Pharmacotherapeutic group: Bacterial and viral vaccines, combined, ATC code : J07CA
Farmakoterapevtska skupina: Kombinacije bakterijskih in virusnih cepiv.
Active substances:
Zdravilne učinkovine:
because as with other similar vaccines, cases of Haemophilus b disease may occur in the week after vaccination prior to the onset of the protective effects of the vaccine.
HEXAVAC naj se ne uporablja za odmerek ob rojstvu ali za kasnejše odmerke v prvem letu življenja pri otrocih ker se lahko (kot pri drugih podobnih cepivih) pojavi bolezen, ki jo povzroča bakterija Haemophilus b v tednu po cepljenju (preden se začnejo zaščitni učinki cepiva).
No increase in the number of undesirable reactions was noted between first, second and third doses of the primary series except for an increase in the rate of fever equal to or greater than 38 °C after the second dose in the primary series.
Opazili so le povečano stopnjo vročine ≥ 38 °C po drugem odmerku primarnega cepljenja.
Infants born of hepatitis B virus surface antigen (HBsAg)-positive mothers should receive Hepatitis B Immune Globulin (HBIG) and Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
Novorojenčki mater pozitivnih za površinski antigen virusa hepatitisa B (HBsAg) naj ob rojstvu prejmejo imunoglobulin proti virusu hepatitisa B (HBIG) in rekombinantno cepivo proti hepatitisu B, nato pa dokončajo zaporedje cepljenj proti hepatitisu B. Dajanje HEXAVAC-a za dokončanje zaporedja cepljenj proti hepatitisu B pri novorojenčkih mater pozitivnih za HBsAg, ki so prejeli HBIG, in pri novorojenčkih mater neznanega statusa ni preučeno.
Febrile convulsion and high-pitched crying have been reported rarely.
Redko so poročali o vročinskih krčih in joku z visokim glasom.
Respiratory system disorders: Dyspnoea or Stridor inspiratory.
Bolezni dihal: oteženo dihanje ali škripavo vdihovanje.
if your child has a thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
če je vaš otrok preobčutljiv za neomicin, streptomicin in polimiksin B, ker so bile te snovi če ima vaš otrok trombocitopenijo ali motnjo krvavitve, saj se lahko v teh primerih razvije krvavitev kot posledica intramuskularnega dajanja.
A mean 7.4 and 4.3-fold rise in antibody titres to PT and FHA respectively was achieved and all toddlers developed protective antibody titres against poliovirus types 1, 2 and 3.
Vsi so razvili zaščitne titre protiteles proti poliovirusom tipov 1, 2 in 3.
METHOD OF ADMINISTRATION Store at 2 °C - 8 °C
POSTOPEK UPORABE Shranjujte pri temperaturi med 2°C - 8 °C Ne zamrzujte
Not applicable.
Navedba smiselno ni potrebna
Purified diphtheria toxoid ....................................................... equal to or greater than 20 IU* (30 Lf) Purified tetanus toxoid............................................................ equal to or greater than 40 IU* (10 Lf) Purified pertussis toxoid ......................................................... 25 micrograms Purified pertussis filamentous haemagglutinin ...................... 25 micrograms Hepatitis B surface antigen **................................................ 5.0 micrograms Inactivated type 1 poliovirus (Mahoney)................................ D antigen^: 40 units Inactivated type 2 poliovirus (MEF 1) ................................... D antigen^: 8 units Inactivated type 3 poliovirus (Saukett)................................... D antigen^: 32 units Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 12 micrograms conjugated to tetanus toxoid (24 micrograms)
Prečiščen davični toksoid ....................................................... ne manj kot 20 i.e.* (30 Lf) Prečiščen tetanusni toksoid..................................................... ne manj kot 40 i.e.* (10 Lf) Prečiščen toksoid bordetele pertusis....................................... 25 mikrogramov Prečiščen filamentozni hemaglutinin bordetele pertusis ........ 25 mikrogramov Površinski antigen virusa hepatitisa B **............................... 5,0 mikrogramov Inaktiviran poliovirus tipa 1 (Mahoney)................................. antigen D^: 40 enot Inaktiviran poliovirus tipa 2 (MEF 1) .................................... antigen D^: 8 enot Inaktiviran poliovirus tipa 3 (Saukett).................................... antigen D^: 32 enot Polisaharid Haemophilus influenzae tipa b (poliribozilribitol fosfat) 12 mikrogramov, konjugiran na tetanusni toksoid (24 mikrogramov)
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
After booster, GMTs increased to 16.7 µg/ml and 23.0 µg/ml in each group respectively, indicating a strong anamnestic response.
Po obnovitvenem odmerku so se GMT povečali na 16,7 µg/ml oz.
The following additional undesirable effects have been reported following the widespread use of HEXAVAC.
O spodaj navedenih neželenih učinkih so poročali po začetku splošne uporabe HEXAVAC-a, Pogosti (>1/100 in <1/10)
BEFORE YOU USE HEXAVAC
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI HEXAVAC
Formulation contains aluminium hydroxide and a buffer solution of disodium phosphate, monopotassium phosphate, sodium carbonate, sodium bicarbonate, trometamol, sucrose, medium 199 (complex blend of amino acids, mineral salts, vitamins and other ingredients) and water for injections.
Pripravek vsebuje aluminijev hidroksid in pufrsko raztopino natrijevega hidrogenfosfata, kalijevega dihidrogenfosfata, natrijevega karbonata, natrijevega hidrogenkarbonata, trometamola, saharoze, gojišča 199 (kompleksne mešanice aminokislin, mineralnih soli, vitaminov in drugih sestavin) in vodo za injekcije.
PHARMACEUTICAL FORM AND CONTENTS 10 single doses 0.5 ml pre-filled syringes with 1 separate needle (for each syringe).
FARMACEVTSKA OBLIKA IN VSEBINA 10 posameznih odmerkov po 0,5 ml v napolnjenih injekcijskih brizgah z 1 priloženo iglo (za vsako injekcijsko brizgo) .
Excipients: aluminium hydroxide and a buffer solution of disodium phosphate, monopotassium phosphate, sodium carbonate, sodium bicarbonate, trometamol, sucrose, medium 199 (complex blend of amino acids, mineral salts, vitamins and other ingredients) and water for injections.
Pomožne snovi: aluminijev hidroksid in pufrska raztopina natrijevega hidrogenfosfata, kalijevega dihidrogenfosfata, natrijevega karbonata, natrijevega hidrogenkarbonata, trometamola, saharoze, gojišča 199 (kompleksne mešanice aminokislin, mineralnih soli, vitaminov in drugih sestavin) in vode za injekcije.
PHARMACEUTICAL FORM AND CONTENTS 10 single doses 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) Suspension for injection in pre-filled syringe
FARMACEVTSKA OBLIKA IN VSEBINA 10 posameznih odmerkov po 0,5 ml v napolnjenih injekcijskih brizgah z 2 priloženima iglama (za vsako injekcijsko brizgo).
The other ingredients are: aluminium hydroxide and a buffer solution of disodium phosphate, monopotassium phosphate, sodium carbonate, sodium bicarbonate, trometamol, sucrose, medium 199 (complex blend of amino acids, mineral salts, vitamins and other ingredients) and water for injections.
Pomožne snovi so: aluminijev hidroksid in pufrska raztopina natrijevega hidrogenfosfata, kalijevega dihidrogenfosfata, natrijevega karbonata, natrijevega hidrogenkarbonata, trometamola, saharoze, gojišča 199 (kompleksne mešanice aminokislin, mineralnih soli, vitaminov in drugih sestavin) in vodo za injekcije.
HEXAVAC suspension for injection in pre-filled syringe Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted.
HEXAVAC Suspenzija za injiciranje v napolnjeni injekcijski brizgi Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju(acelularno), otroški ohromelosti(inaktivirano), hepatitisu B-rekombinantno in proti hemofilusu tipa b(konjugirano).
Purified diphtheria toxoid .......................................................................≥ 20 IU Purified tetanus toxoid............................................................................≥ 40 IU Purified pertussis toxoid .........................................................................25 µg Purified pertussis filamentous haemagglutinin.......................................25 µg Hepatitis B surface antigen.....................................................................5.0 µg Inactivated type 1 poliovirus ..................................................................40 D units Inactivated type 2 poliovirus ..................................................................8 D units Inactivated type 3 poliovirus ..................................................................32 D units Haemophilus influenzae type b conjugated to tetanus toxoid.................12 µg
Prečiščen toksoid davice.........................................................................≥20 i.e Prečiščen toksoid tetanusa ......................................................................≥40 i.e. Prečiščen toksoid pertusisa .....................................................................25 µg Prečiščen filamentozni hemaglutinin pertusisa.......................................25 µg Površinski antigen virusa hepatitisa B ....................................................5,0 µg Inaktiviran poliovirus tipa 1....................................................................40 enot D Inaktiviran poliovirus tipa 2....................................................................8 enot D Inaktiviran poliovirus tipa 3....................................................................32 enot D Haemophilus influenzae tipa b konjugiran na tetanusni toksoid ............12 µg
HEXAVAC - single dose pre-filled syringe without needle - Pack of 25
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi brez igle - Pakiranje po 25
NAME OF THE MEDICINAL PRODUCT HEXAVAC suspension for injection in pre-filled syringe Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted.
HEXAVAC Suspenzija za injiciranje v napolnjeni injekcijski brizgi Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno), otroški ohromelosti (inaktivirano), hepatitisu B (rekombinantno) in proti hemofilusu tipa b (konjugirano).
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (chlorobromobutyl) without needle - pack of 1, 10, 25 and 50.
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom na batu (klorobromobutil) in brez igle.
HEXAVAC - single dose pre-filled syringe without needle - Pack of 1
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi brez igle - Pakiranje po 1
HEXAVAC - single dose pre-filled syringe with 2 separate needles - Pack of 1
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi z 2 priloženima iglama - Pakiranje po 1
HEXAVAC - single dose pre-filled syringe with attached needle - Pack of 50
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi z iglo - Pakiranje po 50
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/008
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/008
HEXAVAC - single dose pre-filled syringe with attached needle - Pack of 25
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi z iglo - Pakiranje po 25
Purified diphtheria toxoid ....................................................... equal to or greater than 20 IU* (30 Lf) Purified tetanus toxoid............................................................ equal to or greater than 40 IU* (10 Lf) Purified pertussis toxoid ......................................................... 25 micrograms Purified pertussis filamentous haemagglutinin ...................... 25 micrograms Hepatitis B surface antigen **................................................ 5.0 micrograms Inactivated type 1 poliovirus (Mahoney)................................ D antigen^: 40 units Inactivated type 2 poliovirus (MEF 1) ................................... D antigen^: 8 units Inactivated type 3 poliovirus (Saukett)................................... D antigen^: 32 units Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 12 micrograms conjugated to tetanus toxoid (24 micrograms) for one adjuvanted dose of 0.5 ml
Prečiščen davični toksoid ......................................................................≥20 i.e. Prečiščentetanusni toksoid......................................................................≥40 i.e. Prečiščen toksoid bordetele pertusis.......................................................25 µg Prečiščen filamentozni hemaglutinin bordetele pertusis.........................25 µg Površinski antigen virusa hepatitisa B ....................................................5,0 µg Inaktiviran poliovirus tipa 1....................................................................40 enot D Inaktiviran poliovirus tipa 2....................................................................8 enot D Inaktiviran poliovirus tipa 3....................................................................32 enot D Haemophilus influenzae tipa b konjugiran na tetanusni toksoid ............12 µg
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/001- 012
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/001-012
HEXAVAC - single dose pre-filled syringe without needle - Pack of 10
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi brez igle - Pakiranje po 10
HEXAVAC - single dose pre-filled syringe without needle - Pack of 50
HEXAVAC- enkratni odmerek v napolnjeni injekcijski brizgi brez igle - Pakiranje po 50
MARKETING AUTHORISATION HOLDER Sanofi Pasteur MSD SNC
IMETNIK DOVOLJENJA ZA PROMET Sanofi Pasteur MSD SNC 8, rue Jonas Salk
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/012
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/012
PHARMACEUTICAL FORM AND CONTENTS 25 single doses 0.5 ml pre-filled syringes with attached needle.
FARMACEVTSKA OBLIKA IN VSEBINA 25 posameznih odmerkov po 0,5 ml v napolnjenih injekcijskih brizgah z iglo.
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/011
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/011
BATCH NUMBER Batch
Oznaka ATC: J07CA
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/010
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/010
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (chlorobromobutyl) with attached needle - pack of 1, 10, 25 and 50.
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom na batu (klorobromobutil) in z iglo.
HEXAVAC should be injected into the quadriceps or deltoid muscle preferably at alternating sites for subsequent injections.
HEXAVAC se daje intramuskularno v četveroglavo stegensko mišico ali ramensko mišico.
HEXAVAC - single dose pre-filled syringe with attached needle - Pack of 10
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi z iglo - Pakiranje po 10
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/006
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/006
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/005
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/005
PHARMACEUTICAL FORM AND CONTENTS 25 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
FARMACEVTSKA OBLIKA IN VSEBINA 25 posameznih odmerkov po 0,5 ml v napolnjenih injekcijskih brizgah brez igle.
HEXAVAC - single dose pre-filled syringe with attached needle - Pack of 1
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi z iglo - Pakiranje po 1
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/009
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/009
PHARMACEUTICAL FORM AND CONTENTS 1 single dose 0.5 ml pre-filled syringe with 2 separate needles Suspension for injection in pre-filled syringe
FARMACEVTSKA OBLIKA IN VSEBINA Enkratni odmerek 0,5 ml v napolnjeni injekcijski brizgi z 2 priloženima iglama.
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/002
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/002
HEXAVAC - single dose pre-filled syringe with 1 separate needle - Pack of 10
HEXAVAC- enkratni odmerek v napolnjeni injekcijski brizgi z 1 priloženo iglo - Pakiranje po 10
PHARMACEUTICAL FORM AND CONTENTS 50 single doses 0.5 ml pre-filled syringes with attached needle.
FARMACEVTSKA OBLIKA IN VSEBINA 50 posameznih odmerkov po 0,5 ml v napolnjenih injekcijskih brizgah z iglo.
PHARMACEUTICAL FORM AND CONTENTS 10 single doses 0.5 ml pre-filled syringes with attached needle.
FARMACEVTSKA OBLIKA IN VSEBINA Enkratni odmerek 0,5 ml v napolnjeni injekcijski brizgi z 1 priloženo iglo.
HEXAVAC - single dose pre-filled syringe with 1 separate needle - Pack of 1
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi z eno priloženo iglo - Pakiranje po 1
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/004
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/004
PHARMACEUTICAL FORM AND CONTENTS 1 single dose 0.5 ml pre-filled syringe without needle Suspension for injection in pre-filled syringe
FARMACEVTSKA OBLIKA IN VSEBINA Enkratni odmerek 0,5 ml v napolnjeni injekcijski brizgi brez igle.
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/001
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NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/007
ŠTEVILKA(E) V REGISTRU ZDRAVIL SKUPNOSTI EU/1/00/147/007
PHARMACEUTICAL FORM AND CONTENTS 10 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
FARMACEVTSKA OBLIKA IN VSEBINA 10 posameznih odmerkov po 0,5 ml v napolnjenih injekcijskih brizgah brez igle.
If any of the following events are known to have occurred in temporal relation to receipt of the vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:
Če se je pojavil katerikoli od naslednjih znakov v časovni povezavi s cepljenjem, je potrebno skrbno pretehtati nadaljevanje cepljenja s cepivi, ki vsebujejo komponento proti oslovskemu kašlju: Temperatura ≥ 40,0 °C v 48 urah brez drugega vzroka.
PHARMACEUTICAL FORM AND CONTENTS 50 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
FARMACEVTSKA OBLIKA IN VSEBINA 50 posameznih odmerkov po 0,5 ml v napolnjenih injekcijskih brizgah brez igle.
HEXAVAC - single dose pre-filled syringe with 2 separate needles - Pack of 10
HEXAVAC- enkratni odmerek v napolnjeni injekcijski brizgi z 2 priloženima iglama - Pakiranje po
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/003
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GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN
In patients with Fabry disease, this enzyme does not work properly.
Pri bolnikih s Fabryjevo boleznijo ta encim ne deluje pravilno.
What measures are being taken to ensure the safe and effective use of Galafold?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Galafold?
Galafold is available as capsules (123 mg).
Zdravilo Galafold je na voljo v obliki kapsul (123 mg).
The main measure of effectiveness was the change in patients' kidney function after 18 months of treatment.
Glavno merilo učinkovitosti je bila sprememba v delovanju ledvic bolnikov po 18 mesecih zdravljenja.
The most common side effect with Galafold (which may affect around 1 in 10 people) is headache.
Najpogostejši neželeni učinek zdravila Galafold (ki lahko prizadene približno 1 osebo od 10) je glavobol.
This allows the enzyme to be transported into areas of the cell where it can break down GL-3.
To omogoča encimu, da se razmešča v območja v celici, kjer lahko razgradi GL-3.
This is a summary of the European public assessment report (EPAR) for Galafold.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Galafold.
As a result, GL-3 cannot be broken down and it builds up in various cells in the body, including in the heart and kidneys.
Posledično se GL-3 ne razgradi, ampak se kopiči v različnih celicah v telesu, med drugim v srcu in ledvicah.
Galafold has been investigated in two main studies involving a total of 127 patients with Fabry disease.
Zdravilo Galafold so raziskovali v dveh glavnih študijah, ki so vključevale skupno 127 bolnikov s Fabryjevo boleznijo.
The recommended dose of Galafold is one capsule every other day, taken by mouth at least 2 hours before or after food.
Priporočeni odmerek zdravila Galafold je ena kapsula vsak drugi dan, ki se vzame peroralno vsaj dve uri pred jedjo ali po njej.
The Committee noted that Galafold was studied in a limited number of patients, however the available evidence is considered sufficient for such a rare disease.
Odbor je opozoril, da je bilo zdravilo Galafold raziskano pri omejenem številu bolnikov, vendar so se razpoložljivi dokazi šteli kot zadostni za tako redko bolezen.