natgillin/translations-raw huggingface dataset:
if you are more than 3 months pregnant (it is also better to avoid Irbesartan Teva in early pregnancy - see pregnancy section).
• če ste noseči dlje kot tri mesece (Jemanju zdravila Irbesartan Teva se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti.
Not known: impaired renal function including cases of renal failure in patients at risk (see section 4.4) Reproductive system and breast disorders
motnje v delovanju ledvic, vključno s primeri odpovedi ledvic pri ogroženih bolnikih (glejte poglavje 4.4)
potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium
• dodatke kalija • nadomestke soli, ki vsebujejo kalij
Irbesartan Teva 75 mg film-coated tablets Irbesartan Teva 150 mg film-coated tablets Irbesartan Teva 300 mg film-coated tablets
Irbesartan Teva 75 mg filmsko obložene tablete Irbesartan Teva 150 mg filmsko obložene tablete Irbesartan Teva 300 mg filmsko obložene tablete
thrombocytopenia Immune system disorders Not known:
Bolezni imunskega sistema Neznana:
The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Hipertenzija in sladkorna bolezen tipa II z ledvično boleznijo Preskušanje irbesartana pri diabetični nefropatiji -“Irbesartan Diabetic Nephropathy Trial" (IDNT) kaže, da irbesartan pri bolnikih s kronično ledvično insuficienco in izraženo proteinurijo zmanjša napredovanje ledvične bolezni.
In particular, they appeared less favourable in women and non-white subjects (see section 5.1).
In sicer, so bili videti manj ugodni pri ženskah in pri nebelcih.
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Zdravilo Irbesartan Teva vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na filmsko obloženo tableto, kar v bistvu pomeni
Contents of the pack and other information What Irbesartan Teva contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Irbesartan Teva Zdravilna učinkovina je irbesartan.
White to off white capsule shaped, film coated tablet.
Bele do belkaste filmsko obložene tablete v obliki kapsule.
A limited accumulation of irbesartan (18 %) in plasma was observed upon repeated once daily dosing.
Po ponavljajočem odmerjanju enkrat na dan so ugotovili omejeno kopičenje irbesartana (18 %) v plazmi.
Irbesartan 75 mg film-coated tablets are white to off white capsule shaped, film coated tablet.
Irbesartan Teva 75 mg filmsko obložene tablete: bele do belkaste filmsko obložene tablete v obliki kapsule.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Pri sočasni uporabi litija in zaviralcev angiotenzinske konvertaze poročajo o reverzibilnem povečanju serumske koncentracije litija in o toksičnosti.
No dose adjustment is necessary in patients with impaired renal function.
Bolnikom s prizadeto ledvično funkcijo odmerka ni treba prilagajati.
• Each Irbesartan Teva 75 mg film-coated tablet contains 75 mg irbesartan.
Ena Irbesartan Teva 75 mg filmsko obložena tableta vsebuje 75 mg irbesartana.
Each film-coated tablet contains 75 mg irbesartan
Ena filmsko obložena tableta vsebuje 75 mg irbesartana.
You must tell your doctor if you think that you are (or might become) pregnant.
Zdravniku morate povedati, če mislite, da ste noseči (ali bi lahko zanosili).
• Each Irbesartan Teva 300 mg film-coated tablet contains 300 mg irbesartan.
Ena Irbesartan Teva 300 mg filmsko obložena tableta vsebuje 300 mg irbesartana.
Irbesartan Teva 75 mg film-coated tablets
Irbesartan Teva 75 mg filmsko obložene tablete
Pharmachemie B.V. Swensweg 5
Madžarska Pharmachemie B.V.
Irbesartan 150 mg film-coated tablets are white to off white capsule shaped, film coated tablet.
Irbesartan Teva 150 mg filmsko obložene tablete: bele do belkaste filmsko obložene tablete v obliki kapsule.
Uncommon: sexual dysfunction
motnje spolnosti
Irbesartan Teva 75 mg film-coated tablets Irbesartan
Irbesartan Teva 75 mg filmsko obložene tablete irbesartan
Irbesartan Teva is used in adult patients to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Irbesartan Teva uporabljamo pri odraslih bolnikih: • za zdravljenje visokega krvnega tlaka (esencialne hipertenzije).
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Pri bolnikih, ki imajo zmanjšan volumen krvi in/ali pomanjkanje natrija zaradi intenzivnega zdravljenja z diuretiki, omejevanja vnosa soli s hrano, driske ali bruhanja, se lahko pojavi simptomatska hipotenzija, zlasti po prvem odmerku.
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
• Each Irbesartan Teva 150 mg film-coated tablet contains 150 mg irbesartan.
Ena Irbesartan Teva 150 mg filmsko obložena tableta vsebuje 150 mg irbesartana.
Each film-coated tablet contains 300 mg irbesartan
Ena filmsko obložena tableta vsebuje 300 mg irbesartana.
Each film-coated tablet contains 150 mg irbesartan
Ena filmsko obložena tableta vsebuje 150 mg irbesartana.
The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo.
Zmanjšanje krvnega tlaka je odvisno od odmerka pri enkratnih dnevnih odmerkih in s tendenco doseganja platoja pri odmerkih večjih od 300 mg. Enkratni dnevni odmerki 150-300 mg v povprečju vseskozi (npr. 24 ur po odmerku)
Irbesartan Teva 150 mg film-coated tablets
Irbesartan Teva 150 mg filmsko obložene tablete
Irbesartan Teva 300 mg film-coated tablets
Irbesartan Teva 300 mg filmsko obložene tablete
Irbesartan Teva is unlikely to affect your ability to drive or use machines.
Verjetnost, da bi zdravilo Irbesartan Teva vplivalo na sposobnost upravljanja vozil ali stojev, je majhna.
After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented.
in N-nitrozodietilamin (NDEA) uvesti naslednje specifikacije za učinkovino: Po dveletnem prehodnem obdobju je treba za NDMA in NDEA uvesti mejo največ
Irbesartan
zlatenica
Mogilska 80
makrogol 4000
No dose adjustment is necessary in patients with mild to moderate hepatic impairment.
Bolnikom z lažjo do srednje težko jetrno okvaro odmerka ni treba prilagajati.
Other medicines and Irbesartan Teva
Možni neželeni učinki Shranjevanje zdravila Irbesartan Teva
Hypertensive patients with type 2 diabetes and renal disease The effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
Analiza rezultatov študije z bolniki z napredovalo ledvično boleznijo kaže, da učinki irbesartana tako na ledvične kot srčnožilne dogodke niso enotni znotraj podskupin.
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Renovaskularna hipertenzija Pri bolnikih z obojestransko stenozo ledvične arterije ali s stenozo arterije ene same delujoče ledvice,
EU/1/09/576/025 50 x 1 tablet (unit dose) EU/1/09/576/026 56 x 1 tablet (unit dose) EU/1/09/576/041 28 tablets (calendar pack)
EU/1/09/576/025 50 x 1 tablet (enkratno odmerjanje) EU/1/09/576/026 56 x 1 tablet (enkratno odmerjanje) EU/1/09/576/041 28 tablet (koledarsko pakiranje)
Irbesartan 300 mg film-coated tablets are white to off white capsule shaped, film coated tablet.
Izgled zdravila Irbesartan Teva in vsebina pakiranja Irbesartan Teva 300 mg filmsko obložene tablete: bele do belkaste filmsko obložene tablete v obliki kapsule.
EU/1/09/576/038 50 x 1 tablet (unit dose) EU/1/09/576/039 56 x 1 tablet (unit dose) EU/1/09/576/042 28 tablets (calendar pack)
EU/1/09/576/038 50 x 1 tablet (enkratno odmerjanje) EU/1/09/576/039 56 x 1 tablet (enkratno odmerjanje) EU/1/09/576/042 28 tablet (koledarsko pakiranje)
Package leaflet: information for the user Irbesartan Teva 150 mg Film-Coated Tablets
PODATKI V BRAILLOVI PISAVI Irbesartan Teva 150 mg filmsko obložene tablete
Package leaflet: information for the user Irbesartan Teva 300 mg Film-Coated Tablets
PODATKI V BRAILLOVI PISAVI Irbesartan Teva 300 mg filmsko obložene tablete
For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance:
Imetnik dovoljenja za promet z zdravilom mora za N-nitrozodimetilamin (NDMA)
Therefore, the use of irbesartan is not recommended.
V zgodnjem obdobju nosečnosti uporaba zdravila Irbesartan Teva ni priporočljiva.
Povidone
Preiskave
Respiratory, thoracic and mediastinal disorders Uncommon: cough
Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni:
In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 zdravilo Irbesartan Teva upočasni pešanje delovanja ledvic.
Package leaflet: information for the user Irbesartan Teva 75 mg Film-Coated Tablets
PODATKI V BRAILLOVI PISAVI Irbesartan Teva 75 mg filmsko obložene tablete
Because no information is available regarding the use of irbersartan during breast-feeding, irbesartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Priporočajo se alternativni načini zdravljenja s potrjeno varnostjo pri doječih materah, še zlasti pri dojenju novorojenčkov ali nedonošenčkov.
EU/1/09/576/012 50 x 1 tablet (unit dose) EU/1/09/576/013 56 x 1 tablet (unit dose) EU/1/09/576/040 28 tablets (calendar pack)
EU/1/09/576/012 50 x 1 tablet (enkratno odmerjanje) EU/1/09/576/013 56 x 1 tablet (enkratno odmerjanje)
Common (may affect up to 1in 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Krvne preiskave lahko pokažejo zvišanje vrednosti encima, ki kaže na delovanje mišic in srca (encim kreatin-kinaza).
hyperkalaemia Nervous system disorders Common:
Bolezni živčevja Pogosti:
Your doctor will advise you.
Zdravnik vam bo svetoval.
The dose is 0.5 ml.
Odmerek je 0,5 ml.
Adolescents and adults
Mladostniki in odrasli
After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Po odločbi komisije bodo pristojni organi držav članic v povezavi z referenčno državo članico posodobili informacije o zdravilu, kot bo potrebno.
In controlled clinical studies, signs and symptoms were actively monitored during a 42-day follow-up period.
V nadzorovanih kliničnih študijah so znake in simptome aktivno spremljali med 42-dnevnim opazovalnim obdobjem.
Because these adverse reactions were reported spontaneously, it is not possible to reliably estimate their frequency.
Ker so o teh dogodkih poročali spontano, njihove pogostnosti ni mogoče zanesljivo oceniti.
Your doctor will advise if additional doses of vaccine are needed.
Vaš zdravnik vam bo svetoval, ali so potrebni dodatni odmerki cepiva.
A second dose should be given according to official recommendations.
Drugi odmerek je treba dati v skladu z uradnimi priporočili.
Inject the entire content of the vial.
Injicirajte celotno vsebino viale.
The vaccinees were also requested to report any clinical events during the study period.
Cepljene osebe so tudi prosili, da med obdobjem študije poročajo o vsakem kliničnem dogodku.
• loss of appetite
• izguba apetita;
Dispose of in accordance with local regulations
Odstranite v skladu z lokalnimi predpisi.
Immediate measures depend on the severity of the reaction (see section 4.4).
Takojšnje ukrepanje je odvisno od resnosti reakcije (glejte poglavje 4.4).
The appropriate time and number of injections that will be given to you or your child will be determined by your doctor on the basis of appropriate official recommendations.
Odločitev o primernem času in številu odmerkov, ki jih boste vi ali vaš otrok prejeli, bo sprejel zdravnik na podlagi ustreznih uradnih priporočil.
You or your child should be closely monitored as the responses to the vaccines may not be sufficient to ensure a protection against the illness (see section 2).
Potreben bo skrbni nadzor vas ali vašega otroka, saj odziv na cepiva morda ne bo zadosten, da bi bila zagotovljena zaščita proti boleznim (glejte poglavje 2).
Children vaccinated in their first year of life may not be fully protected.
Otroci, cepljeni v prvem letu življenja, morda ne bodo popolnoma zaščiteni.
The vaccine contains 9 mg of sorbitol, see section 4.4.
Cepivo vsebuje 9 mg sorbitola, glejte poglavje 4.4.
There are no data to support the use of PRIORIX with any other vaccines.
Ni podatkov, ki bi podpirali uporabo cepiva PRIORIX s kakšnimi drugimi cepivi.
Limited protection against measles may be obtained by vaccination up to 72 hours after exposure to natural measles.
Omejena zaščita proti ošpicam je lahko dosežena s cepljenjem do 72 ur po izpostavljenosti naravnim ošpicam.
Tell your doctor if you or your child is taking, has recently taken or might take any other medicines (or other vaccines).
Obvestite svojega zdravnika, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali boste morda začeli jemati katerokoli drugo zdravilo (ali drugo cepivo).
However, some field studies report that the effectiveness against mumps may be lower than the observed seroconversion rates to mumps.
Toda nekatere terenske študije navajajo, da je učinkovitost proti mumpsu morda manjša, kot je zabeleženi delež serokonverzije za mumps.
Under no circumstances should the interval between doses be less than four weeks (see sections 4.4 and 5.1).
Nikakor pa presledek med odmerkoma ne sme biti krajši od štirih tednov (glejte poglavji 4.4 in 5.1).
What Priorix is and what it is used for
Kaj je cepivo Priorix in za kaj ga uporabljamo
Arthralgia, arthritis
Artralgija, artritis
Pharmaco-therapeutic group: Viral vaccine, ATC code J07BD52
Farmakoterapevtska skupina: Virusna cepiva, oznaka ATC: J07BD52
A history of contact dermatitis to neomycin is not a contraindication.
Kontaktni dermatitis na neomicin v anamnezi ni kontraindikacija.
Priorix contains sorbitol.
Cepivo Priorix vsebuje sorbitol.
Patients with rare hereditary problems of fructose intolerance should not be vaccinated with PRIORIX since it contains sorbitol.
Bolniki z redko dedno intoleranco na fruktozo ne smejo biti cepljeni s cepivom PRIORIX, ker vsebuje sorbitol.
If this is not possible, it must be stored in the refrigerator (2C - 8C) and used within 8 hours of reconstitution.
Če to ni možno, ga shranite v hladilniku (2 ºC do 8 ºC) in uporabite v 8 urah po rekonstituciji.
For hypersensitivity reactions to egg proteins, see section 4.4.
Za preobčutljivostne reakcije na jajčne proteine, glejte poglavje 4.4.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or neomycin.
Preobčutljivost na zdravilne učinkovine ali katerokoli pomožno snov, navedeno v poglavju 6.1 ali na neomicin.
• if you or your child is allergic against any of the components of this vaccine (listed in section 6).
• če ste vi ali vaš otrok alergični na katerokoli sestavino tega cepiva (navedeno v poglavju 6).
EXP: After reconstitution, use promptly or within 8 hours if stored in a refrigerator
EXP: Cepivo je treba uporabiti takoj po rekonstituciji ali v 8 urah, če je shranjeno v hladilniku.
An evaluation of pharmacokinetics in vaccines is not necessary.
Vrednotenje farmakokinetičnih lastnosti za cepiva ni zahtevano.
Although there are no data available concerning the protective efficacy of PRIORIX, immunogenicity is accepted as an indication of protective efficacy.
Podatkov o zaščitni učinkovitosti cepiva PRIORIX sicer ni, vendar imunogenost velja za kazalnik zaščitne učinkovitosti.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue;
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, težave z dihanjem in oteklino obraza ali jezika;
Only in the event the child is confirmed or suspected to be immunodeficient, risks and benefits of vaccinating the mother should be evaluated (see section 4.3).
Samo v primeru, da ima otrok ugotovljeno imunsko pomanjkljivost ali da obstaja sum nanjo, je treba pretehtati koristi in tveganja cepljenja matere (glejte poglavje 4.3).
In case an epidemiological situation requires vaccinating infants in their first year of life (e.g. outbreak or travel to endemic regions), a second dose of PRIORIX should be given in the second year of life, preferably within three months after the first dose.
Če epidemiološke okoliščine zahtevajo cepljenje dojenčkov v prvem letu življenja (npr. zaradi izbruha bolezni ali potovanja v endemska območja), mora otrok dobiti drugi odmerek cepiva PRIORIX v drugem letu življenja, po možnosti v treh mesecih po prvem odmerku.
Infants in their first year of life may not respond sufficiently to the components of the vaccines.
Pri dojenčkih v prvem letu življenja je možno, da se ne odzovejo dovolj na sestavine cepiv.
Accidental intravascular administration may give rise to severe reactions or even shock.
Nenamerno injiciranje cepiva v žilo ima lahko za posledico hude reakcije ali celo šok.
The risk of encephalitis following administration of the vaccine is far below the risk of encephalitis caused by natural diseases (measles: 1 in 1000 to 2000 cases; mumps: 2-4 in 1000 cases; rubella: approximately 1 in 6000 cases).
Tveganje za pojav encefalitisa po cepljenju s tem cepivom je veliko manjše od tveganja za pojav encefalitisa pri naravni okužbi (ošpice: 1 na 1.000 do 2.000 primerov; mumps: 2 do 4 na 1.000 primerov, rdečke: približno 1 na 6.000 primerov).
• if you or your child has ever had a severe allergic reaction to egg protein.
• če ste vi ali vaš otrok kdaj imeli alergijsko reakcijo na jajčne beljakovine;
The measles and mumps components of the vaccine are produced in chick embryo cell culture and may therefore contain traces of egg protein.
Komponenti cepiva proti ošpicam in mumpsu sta pridobljeni na kulturi piščančjih embrionalnih celic in lahko zato vsebujeta jajčne proteine v sledeh.
Whether you or your child receives the vaccine will depend upon the level of your immune defenses.
Odločitev, ali boste vi ali vaš otrok prejeli cepivo bo temeljila na nivoju vašega imunskega odziva.
PRIORIX has no or negligible influence on the ability to drive and use machines.
Cepivo PRIORIX nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
The exception to this was pain at the injection site which was “Common” after the first vaccine dose and “Very common” after the second vaccine dose.
Izjema je bila le bolečina na mestu injiciranja, ki je bila po cepljenju s prvim odmerkom “pogosta”, po cepljenju z drugim odmerkom pa “zelo pogosta”.
QUALITATIVE AND QUANTITATIVE COMPOSITION To be completed nationally
KAKOVOSTNA IN KOLIČINSKA SESTAVA [izpolni država članica]
* Encephalitis has been reported with a frequency below 1 per 10 million doses.
*Pogostnost encefalitisa je bila manjša od 1 na 10 milijonov odmerkov.
PRIORIX is contraindicated during pregnancy (see section 4.3).
Cepivo PRIORIX je med nosečnostjo kontraindicirano (glejte poglavje 4.3).
Humoral or cellular immune deficiency (primary or acquired), including hypogammaglobulinaemia, dysgammaglobulinaemia and AIDS or symptomatic HIV infection or an age-specific CD4+ Tlymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4).
Humoralna ali celična imunska pomanjkljivost (primarna ali pridobljena), vključno z hipogamaglobulinemijo, disgamaglobulinemijo in aidsom ali simptomatsko okužbo HIV, ali za starost specifični odstotek T-limfocitov CD4+ pri otrocih do 12 mesecev: CD4+ < 25 %, pri otrocih od 12 do 35 mesecev: CD4+ < 20 % oz. pri otrocih od 36 do 59 mesecev: CD4+ < 15 % (glejte poglavje 4.4).
WITH 2 SEPARATE NEEDLES: PACK OF 1, 10, 25, 100 WITHOUT NEEDLE: PACK OF 1, 10, 20, 25, 40, 100
Z 2 LOČENIMA IGLAMA: PAKIRANJE PO 1, 10, 25, 100 BREZ IGLE: PAKIRANJE PO 1, 10, 20, 25, 40, 100
Other medicines and Priorix
Druga zdravila in cepivo Priorix
The safety profile presented below is based on a total of approximately 12,000 subjects administered PRIORIX in clinical trials.
V nadaljevanju predstavljen profil varnosti temelji na podatkih približno 12.000 oseb, ki so cepivo PRIORIX prejele v kliničnih preskušanjih.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali s farmacevtom, preden boste cepljeni s tem cepivom.
PRIORIX has not been evaluated in fertility studies.
Cepiva PRIORIX niso ocenili v študijah plodnosti.
Pregnancy (see section 4.6).
Nosečnost (glejte poglavje 4.6)
In case of high fever following vaccination please consult your doctor promptly;
V primeru zvišane telesne temperature po cepljenju se nemudoma posvetujte s svojim zdravnikom;
General disorders and administration site conditions: Kawasaki syndrome
Splošne težave in spremembe na mestu aplikacije: Kawasakijev sindrom
• abnormal crying
• neobičajen jok;
• fever of 38°C or higher
• zvišana telesna temperatura 38 °C ali višja).
A known contact dermatitis (skin rash when the skin is in direct contact with allergens such as neomycin) should not be a problem but talk to your doctor first;
Znani kontaktni dermatitis (pojav kožnega izpuščaja po neposrednem stiku kože z alergeni, kot je neomicin) ne bi smel biti težava, vendar se pred cepljenjem kljub temu najprej posvetujte s svojim zdravnikom;
Therefore a second dose of PRIORIX should be given within three months to provide optimal immune responses.
Zato je treba za zagotovitev optimalnega imunskega odziva drugi odmerek cepiva PRIORIX dati v treh mesecih.
• if you or your child has a weakened immune defenses (e.g. because of an HIV infection.
• če imate vi ali vaš otrok oslabljeno imunsko obrambo (npr. zaradi okužbe s HIV).
Note: This SmPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Opomba: Ta povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so različice, veljavne ob izdaji Odločbe komisije.
• fever higher than 39.5°C
• zvišana telesna temperatura (višja od 39,5 °C);
• if you or your child is known to be allergic to neomycin (an antibiotic agent).
• če ste vi ali vaš otrok alergični na neomicin (antibiotik).
Due to minor variation of its pH, the reconstituted vaccine may vary in colour from clear peach to fuchsia pink without deterioration of the vaccine potency.
Zaradi manjših odstopanj pH-ja lahko barva rekonstituiranega cepiva variira od svetle breskove do fuksijsko rožnate, kar ne zmanjša učinkovitosti cepiva.
The safety and efficacy of PRIORIX in infants under 9 months of age has not been established.
Varnost in učinkovitost cepiva PRIORIX pri dojenčkih, mlajših od 9 mesecev nista bili dokazani.
• if you or your child has any illness or takes any medicine that weakens the immune system such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).
• če imate vi ali vaš otrok katerokoli bolezen ali jemljete zdravilo, ki oslabi imunski sistem, npr. virus imunske pomanjkljivosti (HIV) ali sindrom pridobljene imunske pomanjkljivosti (AIDS).