natgillin/translations-raw huggingface dataset:
Clinical trials were conducted with a version of Celvapan containing a H5N1 vaccine strain (see section 5.1) in approximately 3700 subjects (ranging in age from 18 to 60 years and above), and in special risk groups of approximately 300 subjects each, consisting of immune-compromised subjects and patients with chronic disease conditions.
Klinična preskušanja z različico cepiva Celvapan, ki vsebuje sev cepiva proti H5N1 (glejte poglavje 5.1) so opravili pri približno 3700 osebah (v starosti med 18. in 60. letom in več) ter pri skupinah s posebnim tveganjem s po približno 300 preiskovanci, in sicer pri imunsko kompromitiranih osebah in bolnikih s kroničnimi boleznimi.
This is a multidose container.
V enem pakiranju je več odmerkov.
Clinical Adverse Reactions (H1N1)v Studies System Organ Class (SOC)
Neželeni učinki, ki so jih ugotovili v kliničnih preskušanjih cepiva (H1N1)v Organski sistem (SOC)
MN
Test MN
The vaccine should be allowed to reach room temperature before use.
Pred cepljenjem počakajte, da cepivo doseže sobno temperaturo.
An updated RMP should be submitted: • At the request of the European Medicines Agency;
Posodobljen RMP je treba predložiti:
Clinical studies in which a version of Celvapan containing HA derived from A/Vietnam/1203/2004 (H5N1) was administered at day 0 and at day 21 provide:
Klinične študije, v katerih so na dan 0 in dan 21 uporabili različico cepiva Celvapan s HA iz seva A/Vietnam/1203/2004 (H5N1), dajejo naslednje informacije:
However, if co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Če pa menite, da je hkratno cepljenje z drugimi cepivi potrebno, je treba cepiva injicirati v različni okončini.
(A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not indicate direct or indirect harmful effects with respect to female fertility, pregnancy, embryonal/foetal development, parturition or post-natal
Študije vpliva na sposobnost razmnoževanja in razvoja pri živalih z uporabo cepiv s sevom H5N1 (A/Vietnam/1203/2004 in A/Indonesia/05/2005) niso pokazale neposrednih ali posrednih škodljivih učinkov na plodnost samic, brejost, razvoj zarodka/ploda, kotitev ali postnatalni razvoj
The side effects listed below have occurred with Celvapan (H1N1)v in clinical studies in adults, including older people.
Spodaj navedeni neželeni učinki so se pojavljali pri uporabi cepiva Celvapan (H1N1)v v kliničnih študijah pri odraslih, vključno s starostniki.
The seroprotection rates, seroconversion rates and seroconversion factors reported in adults and older subjects were comparable with Celvapan (H1N1)v.
Odstotek serozaščite, odstotek serokonverzije in faktor serokonverzije, poročani pri odraslih in starejših osebah so bili primerljivi s cepivom Celvapam (H1N1)v.
• severe stabbing or throbbing pain along one or more nerves • low blood platelet count which can result in bleeding or bruising
• huda zbadajoča ali pulzirajoča bolečina vzdolž enega ali več živcev,
Vasculitis with transient renal involvement.
Vaskulitis s prehodno prizadetostjo ledvic.
Clinical studies with Celvapan (H1N1)v currently provide:
Klinične študije s cepivom Celvapan (H1N1)v trenutno dajejo naslednje informacije:
METABOLISM AND NUTRITION DISORDERS
PRESNOVNE IN PREHRANSKE MOTNJE
Side effects from the Pandemic Observational Study with CELVAPAN (H1N1)v Results from a clinical study done on marketed vaccine confirmed the safety profile as observed in the clinical studies.
Rezultati klinične študije, opravljene s cepivom, ki je bilo na trgu, so potrdili varnostni profil, ugotovljen v kliničnih študijah.
• if you previously had a sudden life-threatening allergic reaction to any ingredient of Celvapan or to any of the substances that may be present in trace amounts as follows: formaldehyde,
• če ste v preteklosti imeli nenadno, življenjsko ogrožujočo alergijsko reakcijo na katerokoli sestavino cepiva Celvapan ali katerokoli od naslednjih snovi, ki so lahko prisotne v sledeh v cepivu: formaldehid, Benzonaza, saharoza.
Children and adolescents aged 5 to 17 years:
Otroci in mladostniki od 5 do 17 let:
Possible side effects Like all medicines, Celvapan can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi cepivo Celvapan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
1st Dose
1. odmerku
Children aged 6 to 35 months
Otroci, stari od 6 do 35 mesecev
Pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm)
Vaš zdravnik ve, da do tega lahko pride, in bolečine v rokah in/ali nogah (v večini primerov so poročali o bolečinah v roki, v katero je
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
• neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome
• nevrološke motnje, kot je encefalomielitis (vnetje osrednjega živčevja), nevritis (vnetje živcev)
The immunogenicity of the vaccine containing 7.5 μg non-adjuvanted HA derived from strain A/California/07/2009 (H1N1)v has been evaluated in clinical studies in adults aged 18 years and older (N = 200), in children and adolescents aged 3 to 17 years (N = 102), and in infants and young children aged 6 to 35 months (N = 68) following a 0, 21 day schedule.
Imunogenost cepiva, ki vsebuje 7,5 μg HA iz seva A/California/07/2009 (H1N1)v brez adjuvansa, so ovrednotili v kliničnih preskušanjih pri odraslih osebah, starih vsaj 18 let (N=200), pri otrocih in mladostnikih, starih od 3 do 17 let (N=102) ter pri dojenčkih in majhnih otrocih, starih od 6 do 35 mesecev (N=68), z režimom na dan 0 in 21.
Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
cepivo proti gripi (H1N1)v (s celimi inaktiviranimi virusi, pridobljenimi iz celic Vero)
SPECIAL STORAGE CONDITIONS Store in refrigerator.
POSEBNA NAVODILA ZA SHRANJEVANJE
CELVAPAN suspension for injection Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
CELVAPAN suspenzija za injiciranje cepivo proti gripi (H1N1)v (s celimi inaktiviranimi virusi, pridobljenimi iz celic Vero)
Infants and children aged 6-35 months
Dojenčki in otroci, stari od 6 do 35 mesecev
Non-Clinical data obtained with Celvapan containing a H5N1 vaccine strain demonstrated alterations in liver enzymes and calcium levels in repeat dose toxicity studies in rats.
V študiji toksičnosti večkratnih odmerkov, ki je bila izvedena na podganah, so predklinični podatki, dobljeni s cepivom Celvapan, ki vsebuje sev cepiva proti H5N1, pokazali spremembe v vrednostih jetrnih encimov in koncentraciji kalcija.
There are no data on co-administration of Celvapan with other vaccines.
Podatkov o sočasni uporabi cepiva Celvapan z drugimi cepivi ni.
Adverse reactions from pediatric clinical trials with CELVAPAN (H1N1)v are listed in the table below.
Neželeni učinki, ki so jih ugotovili v pediatričnih kliničnih preskušanjih cepiva CELVAPAN (H1N1)v, so navedeni v spodnji preglednici.
Adverse reactions from clinical trials with Celvapan (H1N1)v in a healthy adult and older people are listed in the table below.
Neželeni učinki, ki so jih ugotovili v kliničnih preskušanjih cepiva Celvapan (H1N1)v pri zdravih odraslih osebah in starostnikih, so navedeni v spodnji preglednici.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Pri bolnikih z endogeno ali jatrogeno zmanjšanim imunskim odzivom je protitelesni odziv
One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Škatla s po 20 večodmernimi vialami (iz stekla vrste I) po 5 ml suspenzije (10 odmerkov po 0,5 ml)
Frequency 9 - 17 years 3 - 8 years 6 - 35 months
3 - 8 let 6 - 35 mesecev
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance(s), to any of the excipients and to trace residues e.g. formaldehyde, benzonase, or sucrose.
Pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) na zdravilno učinkovino, katerokoli pomožno snov ali ostanke v sledeh, npr. formaldehid, benzonazo ali saharozo, je treba
Children and adolescents 3 to 17 years of age
Otroci in mladostniki od 3 do 17 let starosti
Celvapan is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus When a person is given the vaccine, the immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease.
Po cepljenju imunski sistem (naravni obrambni sistem telesa) ustvari lastno zaščito (protitelesa) proti bolezni.
Children and adolescents 6 months to 17 years of age In a clinical study the frequency and type of side effects after the first and second injection were basically similar to that seen in the adult and older population using Celvapan.
V klinični študiji so bile pogostnosti in vrste neželenih učinkov po prvem in drugem odmerku cepiva v osnovi podobne kot pri odraslih in starostnikih, ki so prejeli cepivo Celvapan.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Celvapan suspension for injection
IME ZDRAVILA IN POT(I) UPORABE
Uncommon:
Izdelovalec:
See section 6.5 for the number of doses per vial.
Število odmerkov na vialo je navedeno v poglavju 6.5.
If you get any of the side effects talk to your doctor.
Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom.
Children and adolescents aged 6 months to 17 years of age:
Otroci in mladostniki, stari od 6 mesecev do 17 let:
Immune response against a version of Celvapan containing A/H5N1 vaccine strains The immunogenicity of the vaccine containing 7.5 µg non-adjuvanted HA derived from strain A/Vietnam/1203/2004 has been evaluated in two clinical studies in adults aged 18 - 59 years (N = 312) and in older subjects aged 60 years and older (N = 272) following a 0, 21 day schedule.
Imunogenost cepiva, ki vsebuje 7,5 µg HA brez adjuvansa, izdelanega s sevom A/Vietnam/1203/2004, je bila ocenjena v dveh kliničnih študijah pri odraslih, starih od 18 do 59 let (n=312), in pri starejših osebah, starih 60 let ali več (n=272), in sicer po shemi cepljenja na prvi in 21. dan.
In a clinical study the 7.5 µg dose of Celvapan (H1N1)v was administered to adults aged 18 to 59 years (N = 101) and older people over 60 years of age (N = 101).
• Klinična preskušanja cepiva Celvapan (H1N1)v V klinični študiji so odmerek 7,5 µg cepiva Celvapan (H1N1)v dajali odraslim osebam, starim od 18 do 59 let (N= 101) in starostnikom, starejšim od 60 let (N=101).
In the clinical studies, most side effects were mild in nature and short term.
V kliničnih študijah je bila večina neželenih učinkov
• you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to formaldehyde, benzonase, or to sucrose.
• če ste imeli kdaj v preteklosti kakršnokoli drugo alergijsko reakcijo (poleg nenadne, življenjsko ogrožajoče alergijske reakcije) na katerokoli sestavino cepiva, formaldehid, Benzonazo ali saharozo (glejte poglavje 6.
The following adverse reactions were reported at a higher frequency category than in the
Naslednji neželeni učinki so bili opaženi z večjo pogostnostjo kot v drugih kliničnih študijah:
This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
V okviru teh ukrepov lahko imetnik dovoljenja za promet z zdravilom zagotovi nalepke z imenom cepiva in številko serije.
Persistence of anti-HA antibodies 180 days and 360 days after the first vaccination as measured by single radial hemolysis (SRH) and microneutralization assay (MN) in infants and young children aged 6 to 35 months was as follows:
Perzistenca protiteles proti HA 180 dni in 360 dni po prvem odmerku cepiva, izmerjena z enkratno radialno hemolizo (SRH) in testom mikronevtralizacije (MN) po cepljenju dojenčkov in majhnih otrok, starih med 6 in 35 mesecev je bila naslednja:
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
If you get any side effects, talk to your doctor or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
• Injection site erythema
• eritem na mestu injiciranja
None of the ingredients in the vaccine can
Sestavine cepiva ne morejo povzročiti gripe.
Seronegative subjects at baseline (≤ 4mm 21 Days After nd
Seronegativni preiskovanci v izhodišču (≤4 mm 21 dni po 1. odmerku 2. odmerku 1. odmerku 2. odmerku N=33
18 to 59 years
9 - 17 let
The seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in children aged 6 to 35 months were as follows:
Odstotek serozaščite, odstotek serokonverzije in faktor serokonverzije, izmerjeni z enkratno radialno hemolizo (SRH) za protitelesa proti HA po cepljenju otrok, starih med 6 in 35 mesecev, so bili naslednji:
Persistence of anti-HA antibodies 180 days after the first vaccination as measured by single radial haemolysis (SRH) and microneutralisation assay (MN) in adults aged 18 to 59 years and in older subjects aged 60 years and above was as follows:
Perzistenca protiteles proti HA 180 dni po prvem odmerku cepiva, izmerjena z enkratno radialno hemolizo (SRH, single radial haemolysis) in testom mikronevtralizacije (MN) po cepljenju odraslih, starih med 18 in 59 let, ter starejših oseb, starih 60 let in več, so bili naslednji:
* SRH area > 25 mm² ** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm² *** geometric mean increase
* površina SRH >25 mm² ** bodisi površina SRH > 25 mm² (če je osnovni vzorec negativen) bodisi 50-odstotno povečanje površine SRH, če je začetni vzorec >4 mm² *** geometrična sredina povečanja
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR 10-DOSE VIAL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (e.g. formaldehyde, benzonase, sucrose) of this vaccine.
Anafilaktična reakcija v anamnezi (npr. življenjsko nevarna) zaradi preobčutljivosti na katerokoli sestavino cepiva ali ostanke v sledeh (npr. formaldehid, benzonaza, saharoza).
6.6 Special precautions for disposal and other handling
6.4 Posebna navodila za shranjevanje
In a clinical trial 51 children and adolescents aged 9 to 17 years and 51 children aged 3 to 8 years were administered the 7.5 µg dose of Celvapan (H1N1)v. The incidence and nature of symptoms after the first and second vaccination were similar to that observed in the adult and older population using
V kliničnem preskušanju so 51 otrokom in mladostnikom, starim od 9 do 17 let, ter 51 otrokom, starim od 3 do 8 let, dali odmerek cepiva Celvapan (H1N1)v 7,5 µg.
After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in children and adolescents aged 3 to 17 years were as follows:
Odstotek oseb, ki imajo titer nevtralizirajočih protiteles ≥ 40, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju otrok in mladostnikov, starih od 3 do 17 let, so bili naslednji:
After vaccination the seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Odstotek serozaščite, odstotek serokonverzije in faktor serokonverzije, izmerjeni z enkratno radialno hemolizo (SRH, single radial haemolysis) za protitelesa proti HA po cepljenju odraslih, starih med 18 in 59 let, ter starejših oseb, starih 60 let in več, so bili naslednji:
The seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in children and adolescents aged 3 to 17 years were as
Odstotek serozaščite, odstotek serokonverzije in faktor serokonverzije, izmerjeni z enkratno radialno hemolizo (SRH) za protitelesa proti HA po cepljenju otrok in mladostnikov, starih med 3 in 17 let, so
Very common: Injection site redness, drowsiness, irritability, loss of appetite, crying
Otroci, stari od 6 mesecev do 5 let: Zelo pogosti: pordelost na mestu injiciranja, zaspanost, razdražljivost, zmanjšan apetit, jok
After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Odstotek oseb, ki imajo titer nevtralizirajočih protiteles ≥ 40, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju odraslih, starih od 18 do 59 let, in starostnikov, starih 60 let ali več, so bili naslednji:
Antibody persistence
Perzistenca protiteles
• Injection site induration
• zatrdlina na mestu injiciranja
INFECTIONS AND INFESTATIONS Nasopharyngitis
INFEKCIJSKE IN PARAZITSKE BOLEZNI
Celvapan may be used in lactating women.
Cepivo Celvapan se lahko uporablja tudi pri doječih materah.
Seroprotection / Seroneutralization rate*
Odstotek serozaščite /
Persistence of anti-HA antibodies 180 days and 360 days after the first vaccination as measured by single radial hemolysis (SRH) and microneutralization (MN) assay in children and adolescents
Perzistenca protiteles proti HA 180 dni in 360 dni po prvem odmerku cepiva, izmerjena z enkratno radialno hemolizo (SRH) in testom mikronevtralizacije (MN) po cepljenju otrok in mladostnikov, starih med 3 in 17 let je bila naslednja:
Pharyngolaryngeal pain
nazofaringitis pogosti
• Injection site pain
• bolečine na mestu injiciranja
The following information is intended for medical or health care professionals only: Prior to administration, the vaccine should be allowed to reach room temperature and the vial should
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pred cepljenjem počakajte, da cepivo doseže sobno temperaturo.
Seronegative subjects at baseline 21 Days After nd
Seronegativni preiskovanci v izhodišču (<1:10) 21 dni po 1. odmerku
** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm²; > 4-fold increase in MN titer;
** bodisi površina SRH > 25 mm² (če je osnovni vzorec negativen) bodisi 50-odstotno povečanje površine SRH, če je začetni vzorec >4 mm²; >4-kratno povečanje titra MN;
Pain in extremity (in the majority of cases reported as pain in the injection site arm) General disorders and administration site conditions:
Bolezni mišično-skeletnega sistema in vezivnega tkiva Bolečine v udu (v večini zabeleženih primerov bolečina v roki, v katero je bilo vneseno cepivo)
• Pain, redness, swelling or a hard lump where the injection was given, reduced movement in the Side effects from clinical studies in children
• zvišana telesna temperatura, mrzlica, slabo počutje, • bolečine, rdečina, oteklina ali zatrdlina na mestu injiciranja, zmanjšana gibljivost roke, v katero
The following additional adverse reactions have been reported in the post-marketing experience in adults and children receiving Celvapan (H1N1)v.
Izkušnje v obdobju trženja pri odraslih osebah in otrocih, ki so prejeli cepivo Celvapan (H1N1)v so pokazale naslednje dodatne neželene učinke.
The side effects listed below have occurred with Celvapan (H1N1)v in adults and children during the
Spodaj navedeni neželeni učinki so se pojavljali pri uporabi cepiva Celvapan (H1N1)v pri odraslih osebah in otrocih v programu cepljenja proti pandemski gripi.
After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in children aged 6 to 35 months
Odstotek oseb, ki imajo titer nevtralizirajočih protiteles ≥ 40, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju otrok in mladostnikov, starih od 6 do 35 mesecev, so bili naslednji:
** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline
** bodisi površina SRH > 25 mm² (če je osnovni vzorec negativen) bodisi 50-odstotno povečanje površine SRH, če je začetni vzorec >4 mm²
See section 4.
Navodilo shranite.
There are no data with Celvapan using the subcutaneous route.
Ni podatkov o subkutanem injiciranju cepiva Celvapan.
** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm²; > 4-fold increase in MN titre;
** bodisi površina SRH > 25 mm² (če je osnovni vzorec negativen) bodisi 50-odstotno povečanje površine SRH, če je začetni vzorec >4 mm²; >4-kratno povečanje titra MN; *** geometrična sredina povečanja
<Content (concentration)>
<Vsebina (koncentracija)>
(Invented) name Strength Pharmaceutical form
(Izmišljeno) ime Jakost Farmacevtska oblika
<EMA procedure number> <MA (EU) number>
<Številka postopka EMA> <Številka (EU) dovoljenja za promet>
powder: 90 mg; solvent: 2 ml
prašek: 90 mg; vehikel: 2 ml
60 vials powder + 60 vials solvent + 60 3 ml syringes + 60 1 ml syringes + 180 alcohol swabs
60 vial praška + 60 vial vehikla + 60 3-ml injekcijskih brizg + 60 1-ml injekcijskih brizg +
Subcutaneous use powder: vial (glass); solvent: vial (glass)
Fuzeon mg/ml prašek in vehikel za raztopino za injiciranje subkutana uporaba prašek: viala (steklo); vehikel: viala (steklo)
Pack size
alkoholnih blazinic
Open the bottle.
Odprite stekleničko.
These effects should however decrease over time.
Vendar se ti učinki sčasoma zmanjšajo.
The mechanism of this risk is not known.
Mehanizem tega tveganja ni znan.
Food and alcohol
Hrana in alkohol
Date of first authorisation: 5 December 2011 Date of latest renewal: 08 August 2016
Datum prve odobritve: 5. december 2011 Datum zadnjega podaljšanja: 8. avgust 2016
After first opening: 7 months
3 leta Po prvem odprtju: 7 mesecev
Age also had an influence on both parameters.
Na oba parametra je vplivala tudi starost.
In the elderly, the half-life is increased by about 40% (10 to 11 hours).
Pri starejših se razpolovni čas podaljša za približno 40 % (10 do 11 ur).
The elimination half-life was approximately 5 hours.
Eliminacijski razpolovni čas je bil približno 5 ur.
This leaflet was last revised in {month/YYYY}.
Navodilo je bilo nazadnje revidirano {mesec/LLLL}.
Duration of treatment:
Trajanje zdravljenja:
No clinical data are available, potential risk for human is unknown.
Kliničnih podatkov ni in potencialno tveganje za človeka ni znano.
Tell your doctor immediately, or go to your nearest emergency department, if you experience:
Takoj obvestite zdravnika ali pojdite do najbližje urgence, če opazite:
In such case, the lowest effective dose is recommended.
V tem primeru se priporoča najmanjši učinkovit odmerek.
This decrease is more pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy).
To znižanje je izrazitejše v tretjem trimesečju (do 60 % izhodiščne koncentracije pred nosečnostjo).
BG-5600 Troyan Bulgaria
BG-5600 Troyan Bolgarija
These could be symptoms of an encephalopathy.
To so lahko znaki encefalopatije.
• encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
• encefalopatija (glejte podpoglavje »Takoj obvestite zdravnika« za podroben opis simptomov)
This is more likely at the beginning of treatment or after an increase in the dose.
To je verjetneje na začetku zdravljenja in po povečanju odmerka.
However, current epidemiological studies (on about 100 children) do not suggest an increased risk of neurodevelopmental disorders or delays.
Vendar pa trenutne epidemiološke študije (pri približno 100 otrocih) ne kažejo na povečano tveganje za nevrološko razvojne motnje ali zaostalosti.
Available data in children did not suggest impact on growth and puberty.
Podatki, ki so na voljo za otroke, ne kažejo vpliva na rast in puberteto.