natgillin/translations-raw huggingface dataset:
Do not use Preotact after the expiry date which is stated on the cartridge after EXP and on the carton after EXP.
Zdravila Preotact ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vložku za EXP in na škatlici za EXP.
Unused cartridge
Ne zamrzujte.
Do not freeze. • Keep the cartridges in the outer carton in order to protect them from light
22 • Vložke shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
Cartridge in use • A cartridge in use (in the Preotact pen) should be stored in a refrigerator (2-8°C).
Vložek, ki ga uporabljate: • Vložek, ki ga uporabljate (in je v peresu Preotact), shranjujte v hladilniku (2 °C - 8 °C).
Do not freeze. • A cartridge in use will keep for 28 days in refrigerator. • If for some reason you cannot store your Preotact pen (with the inserted cartridge) in a refrigerator for a number of days, it can be stored outside the refrigerator below 25°C - BUT ONLY FOR A TOTAL OF 7 DAYS during the 28-day use period. • If the Preotact solution in the cartridge is more than 28 days old, or if it has not been stored correctly, throw it away, even if the cartridge is not completely empty. • If the Preotact solution becomes cloudy or coloured throw the cartridge away.
Ne zamrzujte. • Vložek, ki ga uporabljate, bo uporaben 28 dni, če ga shranjujete v hladilniku. • Če zaradi kakršnegakoli razloga več dni ne morete shranjevati peresa Preotact (z vstavljenim vložkom) v hladilniku, ga lahko shranjujete izven hladilnika pri temperaturi do 25 °C, VENDAR NAJVEČ SKUPNO 7 DNI v 28- dnevnem obdobju uporabnosti. • Če je raztopina zdravila Preotact v vložku starejša od 28 dni ali če ta raztopina ni bila shranjena pravilno, jo zavrzite, čeprav vložek še ni popolnoma porabljen. • Če raztopina zdravila Preotact postane motna ali obarvana, vložek zavrzite.
What Preotact contains
Kaj vsebuje zdravilo Preotact
Preotact is supplied in a dual-chamber cartridge.
Zdravilo Preotact je na voljo v vložku z dvema komorama.
The first chamber contains the powder with the active substance and the second chamber contains the solvent.
Prva komora vsebuje prašek z zdravilno učinkovino, druga komora pa vsebuje vehikel.
• The active substance is parathyroid hormone.
• Zdravilna učinkovina je obščitnični hormon.
Each cartridge contains 1.61 mg parathyroid hormone.
Vsak vložek vsebuje 1, 61 mg obščitničnega hormona.
When the powder and the solvent have been mixed, the solution for injection contains parathyroid hormone at a concentration of 1.4 mg/ml.
Ko se prašek in vehikel zmešata, raztopina za injiciranje vsebuje obščitničnični hormon v koncentraciji 1, 4 mg/ ml. • Pomožne snovi:
The powder contains sodium chloride 0.4%, mannitol, citric acid monohydrate, hydrochloric acid, and sodium hydroxide.
Prašek vsebuje natrijev klorid 0, 4%, manitol, citronsko kislino monohidrat, klorovodikovo kislino in natrijev hidroksid.
The solvent contains metacresol and water for injections.
Vehikel vsebuje metakrezol in vodo za injekcije.
Preotact is a powder and solvent for solution for injection.
Zdravilo Preotact je prašek in vehikel za raztopino za injiciranje.
It is supplied in a dual-chamber cartridge which contains 1.61 mg parathyroid hormone as powder and 1.13 ml of solvent
Zdravilo je na voljo v vložku z dvema komorama, ki vsebuje 1, 61 mg obščitničničnega hormona v obliki praška in 1, 13 ml vehikla.
Preotact is available in packs of 2 and 6 cartridges.
Zdravilo je na voljo v pakiranju z 2 ali 6 vložki.
Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Tlf: +45 46 77 11 11 info@nycomed.com
Nycomed Danmark ApS Langebjerg 1 DK- 4000 Roskilde Tel: +45 46 77 11 11 info@ nycomed. com
23 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Prepandrix is a vaccine that is given by injection.
Zdravilo Prepandrix je cepivo, ki se daje z injiciranjem.
Prepandrix contains a flu strain called ‘ A/ VietNam/ 1194/ 2005 NIBRG-14’ (H5N1).
Zdravilo Prepandrix vsebuje sev gripe, imenovan „ A/ VietNam/ 1194/ 2005 NIBRG- 14 “ (H5N1).
Prepandrix is a vaccine for use in adults aged between 18 and 60 years to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Zdravilo Prepandrix je cepivo, namenjeno za uporabo pri odraslih v starosti od 18 do 60 let za zaščito proti gripi, ki jo povzroča sev (tip) H5N1 virusa gripe A.
Prepandrix is given according to official recommendations.
Cepivo Prepandrix se daje v skladu z uradnimi priporočili.
Prepandrix is given by injection into the upper arm muscle in two doses, at least three weeks apart.
Zdravilo Prepandrix se daje z injiciranjem v mišico nadlakti v dveh odmerkih v razmaku najmanj treh tednov.
Prepandrix is a ‘ prepandemic’ vaccine.
Zdravilo Prepandrix je „ prepandemično “ cepivo.
This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
To je posebna vrsta cepiva, namenjena za zaščito proti sevu virusa, ki utegne povzročiti pandemijo v prihodnosti.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it.
Pandemija gripe nastopi, ko se pojavi nova vrsta (sev) virusa gripe, ki se lahko brez težav širi s človeka na človeka, ker ljudje nanj niso imuni (zaščiteni proti njemu).
Prepandrix has been developed to provide protection against this strain, so that it can be used before or during a flu pandemic.
Zdravilo Prepandrix je bilo razvito z namenom, da bi nudilo zaščito proti temu sevu, tako da ga je mogoče uporabiti pred ali med pandemijo gripe.
Prepandrix contains small amounts of haemagglutinins (proteins from the surface) of the H5N1 virus.
Zdravilo Prepandrix vsebuje majhno količino hemaglutininov (beljakovin s površine) virusa H5N1.
This may help to protect against the disease caused by the virus.
To lahko prispeva k obrambi pred boleznijo, ki jo ta virus povzroča.
Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with an emulsion.
Pred uporabo se cepivo pripravi z mešanjem suspenzije, ki vsebuje delce virusa, in emulzije.
The effects of Prepandrix were first tested in experimental models before being studied in humans.
Učinki zdravila Prepandrix so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The main study of Prepandrix included 400 healthy adults and compared the ability of different doses of Prepandrix, with or without the adjuvant, to trigger the production of antibodies (‘ immunogenicity’).
V glavno študijo zdravila Prepandrix je bilo vključenih 400 zdravih odraslih.
The participants received two injections of Prepandrix containing one of four different doses of haemagglutinin.
V njej so primerjali učinkovitost različnih odmerkov zdravila Prepandrix, z adjuvansom ali brez njega, pri sprožanju tvorbe protiteles (imunogenosti).
The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Glavno merilo učinkovitosti je bila koncentracije protiteles proti virusu gripe v krvi ob treh različnih časih: pred cepljenjem, na dan drugega celjenja (21. dan) in 21 dni kasneje (na 42. dan).
The main study showed that Prepandrix containing 3.75 micrograms of haemagglutinin and the adjuvant produced an antibody response that met these criteria.
Glavna študija je pokazala, da zdravilo Prepandrix, vsebujoče 3, 75 mikrograma hemaglutinina in adjuvans, privede do protitelesnega odziva, ki zadovolji to merilo.
The most common side effects with Prepandrix (occurred with 1 in 10 doses or more of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Prepandrix (do katerih je prišlo pri 1 ali več odmerkih cepiva izmed 10) so glavobol, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah), reakcije na mestu injiciranja (zatrdlina, oteklina, bolečina, rdečina), zvišana telesna temperatura ter utrujenost.
For the full list of all side effects reported with Prepandrix, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Prepandrix, glejte navodilo za uporabo.
Prepandrix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Zdravila Prepandrix se ne sme dajati osebam, ki so imele v preteklosti anafilaktično reakcijo (resno alergijsko reakcijo) na katero koli izmed sestavin cepiva ali na katero koli od snovi, ki se v sledeh nahajajo v cepivu, kot npr. na jajca, piščančje beljakovine, ovalbumin (beljakovino v beljaku), formaldehid, gentamicinijev sulfat (antibiotik) in natrijev deoksiholat.
Vaccination with Prepandrix should be delayed in people who have a sudden fever.
Pri osebah, ki imajo nenadno zvišano telesno temperaturo, je treba cepljenje z zdravilom Prepandrix odložiti.
The CHMP decided that Prepandrix’ s benefits are greater than its risks for active immunisation against H5N1 subtype of influenza A virus.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Prepandrix pri aktivni imunizaciji proti podtipu H5N1 virusa gripe A večje od z njim povezanih tveganj.
The Committee recommended that Prepandrix be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Prepandrix odobri dovoljenje za promet.
Other information about Prepandrix:
Druge informacije o zdravilu Prepandrix:
The European Commission granted a marketing authorisation valid throughout the European Union for Prepandrix to GlaxoSmithKline Biologicals s. a. on 14 May 2008.
Evropska komisija je dovoljenje za promet z zdravilom Prepandrix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s. a. dne 14. maja 2008.
The full EPAR for Prepandrix can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Prepandrix je na voljo tukaj.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Prepandrix suspenzija in emulzija za emulzijo za injiciranje prepandemično cepivo proti gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
2 For further information, see section 5.1.
2 Način uporabe
Method of administration
Cepivo je treba injicirati v mišico.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues ((egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaksijske reakcije) za zdravilno učinkovino, katerokoli pomožno snov, tiomersal ali zaostanke (jajčne ali piščančje proteine, ovalbumin, formaldehid, gentamicinijev sulfat ali natrijev deoksiholat).
Prepandrix should under no circumstances be administered intravascularly or intradermally.
Cepiva Prepandrix se v nobenem primeru ne sme injicirati v žilo ali v kožo.
No data have been generated in pregnant women with Prepandrix or with any other vaccine that contains the AS03 adjuvant.
O uporabi cepiva Prepandrix ali kateregakoli drugega cepiva z adjuvansom AS03 pri nosečnicah ni podatkov.
There are no data regarding the use of Prepandrix during lactation.
O uporabi cepiva Prepandrix med dojenjem ni podatkov.
The potential benefits to the mother and risks to the infant should be considered before administering Prepandrix during lactation.
Pred cepljenjem doječe matere s cepivom Prepandrix je treba presoditi o možnih koristih za mater in tveganjih za dojenega otroka.
4 Generalised skin reactions including urticaria
4 Generalizirane kožne reakcije, vključno z urtikarijo.
Immune response against vaccine strain contained in Prepandrix:
Imunski odziv proti cepilnemu sevu, ki ga vsebuje cepivo Prepandrix:
In a consistency study, more than 900 subjects aged 18-60 years received Prepandrix following a 0, 21 days schedule.
V študiji konsistentnosti je cepivo Prepandrix po shemi 0. in 21. dan prejelo več kot 900 oseb, starih od 18 do 60 let.
21 days
21 dni po
after 1st dose 44.5% 42.5% 4.1
prvem odmerku 44, 5% 42, 5% 4, 1
The seroprotection rates, seroconversion rates and seroconversion factors for anti-haemagglutinin (anti-HA) antibody at day 42 (post dose 2) and day 180 (persistence) were as follows:
Deleži serološke zaščite, deleži serokonverzije in faktorji serokonverzije za antihemaglutininska (anti- HA) protitelesa 42.
anti-HA antibody Seroprotection rate*†
(po prejemu 2. odmerka) in 180. dan (persistenca) so bili naslednji:
Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
anti- HA protitelesa Delež serološke zaščite * † Delež serokonverzije † Faktor serokonverzije † * anti- HA ≥ 1: 40
82% 27.9
42. dan 84% 82% 27, 9 5
52% 4.4
180. dan 54% 52% 4, 4
Twenty one days after the second dose, a 4-fold increase in serum neutralising antibody titres was obtained in 77.1% of subjects against the A/ Indonesia/ 5/ 2005 strain, in 75.0% of subjects against A/ Anhui/ 01/ 2005 and in 85.0% of subjects against A/ Turkey/ Turkey/ 1/ 2005.
Enaindvajset dni po cepljenju z drugim odmerkom so 4- kraten porast titrov nevtralizirajočih protiteles v serumu proti sevu A/ Indonesia/ 5/ 2005 ugotovili pri 77, 1% oseb, proti A/ Anhui/ 01/ 2005 pri 75, 0% oseb in proti A/ Turkey/ Turkey/ 1/ 2005 pri 85, 0% oseb.
6 In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/ A/ Vietnam/ 1194/ 04 (NIBRG-14).
V vsakem poskusu so štiri skupine s šestimi živalmi intramuskularno cepili s cepivom, ki je imelo kot adjuvans AS03 in je vsebovalo HA, pridobljen iz H5N1/ A/ Vietnam/ 1194/ 04 (NIBRG- 14).
Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Kontrolne skupine so vključevale dihurje, ki so prejeli samo adjuvans, cepivo brez adjuvansa (15 mikrogramov 6 HA) ali fiziološko raztopino fosfatnega pufra.
7 After mixing, the vaccine should be used within 24 hours.
18 mesecev Po mešanju morate cepivo uporabiti v 24 urah.
Do not freeze.
7 Ne zamrzujte.
Prepandrix consists of two containers:
Cepivo Prepandrix je na voljo v dveh vsebnikih:
The volume of Prepandrix (5 ml) after mixing corresponds to 10 doses of vaccine.
Količina cepiva Prepandrix po mešanju (5 ml) ustreza 10 odmerkom cepiva.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
CONDITIONS OF THE MARKETING AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
Name and address of the manufacturer of the biological active substance
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv3 (dated 31 January 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici RMPv3 (z dne 31. januarja 2008) načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
11 PSURs
10 Periodična poročila o varnosti zdravila (PSUR)
PSUR submission when Prepandrix is used during the influenza pandemic:
Predložitev periodičnega poročila o varnosti zdravila pri uporabi cepiva Prepandrix med pandemijo gripe:
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the prepandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:
Imetnik dovoljenja za promet z zdravilom mora zato takoj po razglasitvi pandemije (faza 6 globalnega načrta SZO o pripravljenosti na gripo) in začetku uporabe pandemičnega cepiva periodična poročila o varnosti zdravila predajati s pogostnostjo in v obliki, kot sledi:
- Serious expected reactions will be reviewed by the MAH as part of their signal
- Resne pričakovane neželene učinke bo obravnaval imetnik dovoljenja za promet z
detection procedures and will only form part of the report if an issue of concern arises.
zdravilom v sklopu lastnih postopkov ugotavljanja razmerja med koristjo in tveganjem (“ signal detection ”) in bodo vključeni v poročilo le, če se bo stopnja zaskrbljenosti povečala.
- In Tables 1 to 5, numbers will be provided for events received during the reporting
- V tabelah od 1 do 5 bodo predstavljene številke o dogodkih med obdobjem poročanja in
period and cumulatively.
kumulativno.
Product-specific
- Vse tabele bodo temeljile na generičnih podatkih in ne na za zdravilo specifičnih podatkih.
data can be evaluated during signal work-up.
Za zdravilo specifične podatke se lahko ovrednoti med obravnavanjem znakov.
necessary.
Seznami niso potrebni – ti se po potrebi lahko zagotovijo v poročilih o vrednotenju znakov.
All 12 signal evaluation reports should be provided, including those that were subsequently not identified as being signals.
Zagotovljena morajo biti vsa poročila o vrednotenju znakov, tudi tistih, ki kasneje niso bili identificirani kot znaki.
A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in:
Vključen mora biti tudi povzetek o prometu s cepivom, ki mora zagotavljati podrobnosti o številu odmerkov v prometu v:
Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Prepandrix suspenzija in emulzija za emulzijo za injiciranje prepandemično cepivo proti gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
16 Intramuscular use Shake before use Read the package leaflet before use
Pred uporabo preberite priloženo navodilo.
Medicinal product subject to medical prescription.
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
INSTRUCTIONS ON USE
17 PODATKI NA ZUNANJI OVOJNINI
Prepandrix suspension for emulsion for injection Prepandemic influenza vaccine (H5N1)
Prepandrix suspenzija za emulzijo za injiciranje prepandemično cepivo proti gripi (H5N1)
Suspension to be exclusively mixed with emulsion before administration 19 8.
Suspenzijo morate pred uporabo zmešati izključno z emulzijo.
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
19 PODATKI NA ZUNANJI OVOJNINI
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL
21 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Vial A Prepandrix suspension for emulsion for injection IM
Viala A Prepandrix suspenzija za emulzijo za injiciranje
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS EMULSION VIAL
22 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Vial B Emulsion for emulsion for injection for Prepandrix
Viala B Emulzija za emulzijo za injiciranje za Prepandrix
What Prepandrix is and what it is used for 2.
Kaj je cepivo Prepandrix in za kaj ga uporabljamo 2.
Before you receive Prepandrix 3.
Kaj morate vedeti, preden boste cepljeni s cepivom Prepandrix 3.
How Prepandrix is given 4.
Kako uporabljati cepivo Prepandrix 4.
How to store Prepandrix 6.
Shranjevanje cepiva Prepandrix 6.
WHAT PREPANDRIX IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO PREPANDRIX IN ZA KAJ GA UPORABLJAMO
Prepandrix is a vaccine for use in adults from 18 to 60 years old.
Cepivo Prepandrix uporabljamo pri odraslih, starih od 18 do 60 let.
BEFORE YOU RECEIVE PREPANDRIX
KAJ MORATE VEDETI, PREDEN BOSTE CEPLJENI S CEPIVOM PREPANDRIX
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Prepandrix (these are listed at the end of this leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
• če se je pri vas kdaj pojavila nenadna, smrtno nevarna alergijska reakcija na katerokoli sestavino cepiva Prepandrix (navedena so na koncu tega navodila) ali na katerokoli od naslednjih snovi, ki so lahko prisotne v manjših količinah: jajčne ali piščančje proteine, ovalbumin, formaldehid, gentamicinijev sulfat (antibiotik) ali natrijev deoksiholat.
A minor infection such as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Prepandrix.
Blažja okužba, npr. prehlad, ne bi smela biti težava, vendar se pred cepljenjem s cepivom Prepandrix o tem vseeno posvetujte s svojim zdravnikom.
Take special care with Prepandrix:
25 Bodite posebno pozorni pri cepljenju s cepivom Prepandrix:
• if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin
• če se je pri vas kdaj pojavila kakršnakoli alergijska reakcija (poleg nenadne, smrtno nevarne alergijske reakcije) na katerokoli sestavino cepiva, tiomersal, jajčne ali piščančje proteine, ovalbumin, formaldehid, gentamicinijev sulfat (antibiotik) ali natrijev deoksiholat (glejte poglavje 6, Dodatne informacije). • če imate težave z imunskim sistemom.
Therefore, Prepandrix is not intended to be given at the same time as other vaccines.
O sočasnem cepljenju s cepivom Prepandrix in drugimi cepivi ni podatkov, zato cepivo Prepandrix ni namenjeno za uporabo skupaj z drugimi cepivi.
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandrix can still be given but your response to the vaccine may be poor.
Če jemljete katerokoli zdravilo, ki zmanjšuje imunost proti okužbam, ali se zdravite s katerokoli drugo obliko zdravljenja, ki vpliva na imunski sistem (npr. obsevanje), ste s cepivom Prepandrix lahko cepljeni, vendar pa je odziv na cepivo lahko slabši.
Pregnancy and breast-feeding There is no information on the use of Prepandrix in pregnant or breast-feeding women.
Nosečnost in dojenje O uporabi cepiva Prepandrix med nosečnostjo in dojenjem ni podatkov.
Important information about some of the ingredients of Prepandrix Thiomersal (preservative) is present in this product, and it is possible that you may experience an allergic reaction.
Pomembne informacije o nekaterih sestavinah cepiva Prepandrix Cepivo vsebuje tiomersal (konzervans), ki lahko povzroči alergijsko reakcijo.
HOW PREPANDRIX IS GIVEN
KAKO UPORABLJATI CEPIVO PREPANDRIX
You will receive two doses of Prepandrix.
Prejeli boste dva odmerka cepiva Prepandrix.
The doctor or nurse will give Prepandrix as an injection into your upper arm muscle.
Cepivo Prepandrix vam bo zdravnik ali medicinska sestra dal/ dala v obliki injekcije v mišico nadlakti.
Like all medicines, Prepandrix can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi cepivo Prepandrix neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
♦ Very common (these may occur with 1 in 10 doses or more of the vaccine):
♦ Zelo pogosti (pojavijo se lahko pri 1 od 10 odmerkov cepiva ali pogosteje): • utrujenost. • glavobol. • bolečina, rdečina, oteklina ali zatrdlina na mestu injiciranja. • zvišana telesna temperatura. • bolečine v mišicah, bolečine v sklepih.