natgillin/translations-raw huggingface dataset:
13 Data on concomitant administration of Prevenar with Infanrix hexa (DTaP/ Hib(PRP-T)/ IPV/ HepB vaccine) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as a 3 dose primary vaccination.
Podatki o sočasni uporabi cepiva Infanrix hexa (DTaP/ Hib( PRP- T) / IPV/ HepB) s cepivom Prevenar kažejo, da ne pride do klinično pomembnih sprememb v tvorbi protiteles proti posameznim antigenom, če ga uporabimo kot osnovno cepljenje s tremi odmerki.
No consistent increased local or systemic reactions within repeated doses were seen throughout the primary series or with the booster dose, the exception being a higher rate of transient tenderness (36.5%) and tenderness that interfered with limb movement (18.5%) were seen with the booster dose.
Izjemi sta večja pogostnost prehodne občutljivosti (36, 5%) in občutljivosti, ki ovira gibanje uda (18, 5%), opaženi po poživitvenem odmerku.
In a post licensure study involving 115 children between 2-5 years of age, tenderness was reported in 39.1% of children; in 15.7% of children the tenderness interfered with limb movement.
V raziskavi, ki je bila opravljena po registraciji zdravila in je zajela 115 otrok, starih od 2 do 5 let, so občutljivost zabeležili pri 39, 1% otrok, pri 15, 7% otrok pa je občutljivost ovirala gibanje uda.
When Prevenar is co-administered with hexavalent vaccines (DTaP/ Hib(PRP-T)/ IPV/ HepB), fever ≥ 38 °C per dose was reported in 28.3% to 48.3% of infants in the group receiving Prevenar and the hexavalent vaccine at the same time as compared to 15.6% to 23.4% in the group receiving the hexavalent vaccine alone.
Če so Prevenar kombinirali s šestvalentnimi cepivi (DTaP/ Hib( PRP- T) IPV/ HepB), se je zvišana telesna temperatura ≥ 38 °C po enem odmerku pojavila pri 28, 3% do 48, 3% dojenčkov, medtem ko se je pri dojenčkih, ki so prejemali samo šestvalentno cepivo, ta pojavila samo pri 15, 6% do 23, 4%.
14 Undesirable effects reported in clinical trials or from the post-marketing experience are listed in the following table per body system and per frequency and this is for all age groups.
Navedeni so po lokalizaciji in po pogostnosti in vključujejo otroke vseh starostnih skupin.
Hypersensitivity reactions such as, anaphylactic/ anaphylactoid reactions including shock, angioneurotic oedema, bronchospasm, dyspnoea, face oedema.
preobčutljivostne reakcije kot je anafilaktična/ anafilaktoidna reakcija, vključno s šokom, angionevrotičnim edemom, bronhospazmom, oteženim dihanjem, edemom obraza
15 antibodies (measured by opsonophagocytosis) to all vaccine serotypes following the primary series.
Dokazali so tudi, da Prevenar po primarnem zaporedju spodbuja funkcionalna protitelesa (merjena z opsonofagocitozo) proti vsem v cepivo vključenim serotipom.
The immunogenicity of a two-dose primary series in infants plus a booster at about one year of age has been documented in several studies.
16 Imunogenost primarnega zaporedja dveh odmerkov pri dojenčkih in poživitvenega odmerka približno v starosti enega leta so dokumentirali v več študijah.
Most of the data have indicated that smaller proportions of infants achieved antibody concentrations ≥ 0.35 μ g/ mL (the reference antibody concentration recommended by WHO) 2 against serotypes 6B and 23F after two-dose primary series when directly or indirectly compared with three-dose primary series.
Podatki so večinoma pokazali, da je po primarnem zaporedju dveh odmerkov manjši del dojenčkov dosegel koncentracijo protiteles ≥ 0, 35 µg/ ml (referenčna koncentracija protiteles, ki jo priporoča SZO) 2 proti serotipoma 6B in 23F, če to neposredno ali posredno primerjamo s primarnim zaporedjem treh odmerkov.
The estimate of vaccine serotype specific efficacy was 94% (95% CI:
Ocena serotipično specifične učinkovitosti cepiva je bila 94% (95- odstotni interval zaupanja:
85, 100) in the per protocol (fully immunised) population (40 cases).
85, 100) v skupini otrok, ki so opravili vsa cepljenja skladno s protokolom cepljenja (40 primerov).
In the Kaiser Permanente trial, efficacy was 87.5% (95% CI:
V študiji Kaiser Permanente je bila učinkovitost v preprečevanju pnevmokokne pljučnice, ki jo spremlja bakteriemija, proti serotipom bakterije S. pneumoniae, ki so bili vključeni v cepivo, 87, 5% (95- odstotni interval zaupanja:
2 WHO technical report No 927, 2005; Appendix serological criteria for calculation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.
Ker lahko k obremenitvi zaradi pljučnice pri otrocih
16 Effectiveness (no microbiological confirmation of diagnosis was performed) against non-bacteraemic pneumonia was also assessed.
927, 2005; Appendix serological criteria for calculation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.
As many pathogens other than pneumococcal serotypes represented in the vaccine may contribute to the burden of pneumonia in children, protection against all clinical pneumonia is expected to be lower than for invasive pneumococcal disease.
17 prispevajo številni patogeni, ne samo pnevmokokni serotipi, ki so prisotni v cepivu, pričakujemo, da bo zaščita pred vsemi kliničnimi pljučnicami slabša kot zaščita pred invazivno pnevmokokno pljučnico.
The effectiveness of Prevenar against IPD (i. e. comprising the protection afforded by vaccination and from herd immunity due to reduced transmission of vaccine serotypes in the population) has been evaluated in national immunisation programmes that employ three-dose or two-dose infant series, each with booster doses.
Učinkovitost cepiva Prevenar proti invazivnim pnevmokoknim boleznim( IPD), ki jo sestavljata zaščita, ki jo nudi cepljenje, in kolektivna zaščita v populaciji zaradi zmanjšanega prenašanja serotipov, ki so vključeni v cepivo, so ovrednotili v nacionalnih programih cepljenja, v katerih so uporabljali zaporedje treh odmerkov ali zaporedje dveh odmerkov za dojenčke, vedno tudi s poživitvenimi odmerki.
In the USA, generalised vaccination with Prevenar using a four-dose series in infants and a catch-up programme for children up to 5 years of age was introduced in 2000.
Učinkovitost cepiva proti
Vaccine effectiveness against IPD caused by vaccine serotypes was evaluated in 3- to 59-month old children within the first four years of the implementation of the programme.
18 IPD, povzročenim s serotipi, vključenimi v cepivo, so ovrednotili pri otrocih, starih od 3 mesece do 59 mesecev, v prvih štirih letih izvajanja programa.
17 94% reduction in vaccine type IPD in individuals under 5 years of age, compared to a pre-vaccine baseline (1998/ 99).
V ZDA so se v istem časovnem okviru IPD, povzročene s serotipi, ki so vključeni v cepivo, pri otrocih, mlajših od 5 let, v primerjavi z izhodiščem pred cepljenjem (1998/ 99) zmanjšale za 94%.
6.2 Incompatibilities
19 6. 2 Inkompatibilnosti
18 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
0.5 ml suspension for injection in pre-filled syringe (Type I glass) with a plunger rod (polypropylene) - pack size of 1 and 10 with or without needle, and multi pack of 5 packs of 10 pre-filled syringes without needle.
0, 5 ml suspenzije za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) s polipropilenskim batom - pakiranje s po 1 in 10 brizg z ali brez igle, in pakiranje s 5 seti s po 10 napolnjenimi injekcijskimi brizgami brez igel.
02/ 02/ 2001 Date of last renewal:
02/ 02/ 2001 Datum zadnje obnove:
CRM197, Activated Saccharides, and Conjugates Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 4300 Oak Park NC 27330, Sanford, USA
CRM197, Activated Saccharides, and Conjugates Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 4300 Oak Park NC 27330, Sanford, ZDA
Pneumococcal Polysaccharides Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 401 North Middletown Road NY 10965, Pearl River, USA
Pneumococcal Polysaccharides Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 401 North Middletown Road NY 10965, Pearl River, ZDA
• CONDITIONS AND RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
The Marketing Authorisation Holder must ensure that the system of pharmacovigilance, submitted on November 22, 2006 and presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo sistem farmakovigilance, predložen 22. novembra 2006 in predstavljen v modulu 1. 8. 1 dovoljenja za promet z zdravilom, vzpostavljen in bo deloval, preden bo dal zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The marketing Authorisation holder will continue to submit periodic safety update reports on a 2- year cycle.
Imetnik dovoljenja za promet z zdravilom bo še naprej predlagal periodična poročila o varnosti zdravila na 2 leti.
Official batch release: in accordance with Article 114 of Council Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: v skladu s 114. členom dopolnjene in spremenjene Direktive 2001/ 83/ ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
22 Official Medicines Control Laboratory (OMCL) Agence Française de Sécurité Sanitaire des Produits de Santé Direction des laboratoires et des contrôles Avenue Jean Jaurès, 321 F - 69007 Lyon France
Uradni kontrolni laboratorij za zdravila (Official Medicines Control Laboratory - OMCL) Agence Française de Sécurité Sanitaire des Produits de Santé Direction des laboratoires et des contrôles Avenue Jean Jaurès, 321 F - 69007 Lyon Francija
25 Prevenar- single-dose vial x 1 pack
24 Prevenar - enoodmerna viala x pakiranje po 1
Each 0.5 ml dose contains 2 micrograms of saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 micrograms of serotype 6B per dose (16 micrograms total saccharide) conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg).
Vsak odmerek po 0, 5 ml vsebuje po 2 mikrograma saharidov serotipov 4, 9V, 14, 18C, 19F in 23F in 4 mikrograme serotipa 6B (vseh saharidov je 16 mikrogramov), konjugiranih na CRM197 nosilni protein in adsorbiranih na aluminijev fosfat (0, 5 mg).
1 single-dose (0.5 ml) vial.
1 enoodmerna (0, 5 ml) viala.
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
26 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT
BESEDILO NA VIALI
Prevenar suspension for injection Pneumococcal saccharide conjugated vaccine, adsorbed Intramuscular use.
Prevenar suspenzija za injiciranje konjugirano pnevmokokno saharidno cepivo, adsorbirano Intramuskularna uporaba.
28 Prevenar- single-dose vial x 10 pack
27 Prevenar - enoodmerna viala x pakiranje po 10
10 single-dose (0.5 ml) vials.
10 enoodmernih (0, 5 ml) vial.
30 Prevenar- single-dose pre-filled syringe without needle x 1 pack
29 Prevenar - enoodmerna napolnjena injekcijska brizga brez igle x pakiranje po 1
1 single-dose (0.5 ml) pre-filled syringe without needle.
1 enoodmerna (0, 5 ml) napolnjena injekcijska brizga brez igle.
32 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
31 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
PRE-FILLED SYRINGE TEXT
BESEDILO NA NAPOLNJENI INJEKCIJSKI BRIZGI
Prevenar suspension for injection in pre-filled syringe Pneumococcal saccharide conjugated vaccine, adsorbed.
Prevenar suspenzija za injiciranje v napolnjeni injekcijski brizgi konjugirano pnevmokokno saharidno cepivo, adsorbirano.
METHOD OF ADMINISTRATION Shake well before use.
Pred uporabo dobro pretresite.
33 Prevenar - single-dose pre-filled syringes without needle x 10 pack
32 Prevenar - enoodmerna napolnjena injekcijska brizga brez igle x pakiranje po 10
10 single-dose (0.5 ml) pre-filled syringes without needle.
10 enoodmernih (0, 5 ml) napolnjenih injekcijskih brizg brez igle.
METHOD AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT( I) UPORABE
35 Prevenar- single-dose vial x 1 pack with syringe/ needles
34 Prevenar - enoodmerna viala x 1 pakiranje z brizgo/ iglama
1 separate syringe.
1 brizga.
2 separate needles.
2 ločeni igli.
37 Prevenar- single-dose pre-filled syringe with separate needle x 1 pack
36 Prevenar - enoodmerna napolnjena injekcijska brizga z ločeno iglo x pakiranje po 1
1 single-dose (0.5 ml) pre-filled syringe with separate needle.
1 enoodmerna (0, 5 ml) napolnjena injekcijska brizga z ločeno iglo.
39 Prevenar - single-dose pre-filled syringes with separate needle x 10 pack
38 Prevenar - enoodmerna napolnjena injekcijska brizga z ločeno iglo x pakiranje po 10
10 single-dose (0.5 ml) pre-filled syringes with separate needle.
10 enoodmernih (0, 5 ml) napolnjenih injekcijskih brizg z ločeno iglo.
41 Prevenar - single-dose pre-filled syringes without needle x 10: pack for multi pack presentation 5 x 10 without blue box
40 Prevenar - enoodmerna napolnjena injekcijska brizga brez igle x 10: pakiranje z več zavitki 5 x 10 brez modre škatle
Component of a multipack comprising 5 packs, each containing 10 single-dose (0.5 ml) pre-filled syringes without needle.
Sestavni del zavitka s 5 zavitki, od katerih vsak vsebuje 10 enoodmernih (0, 5 ml) napolnjenih injekcijskih brizg brez igle.
Each individual pack can’ t be sold separately.
Posamezni zavitki se ne smejo prodajati ločeno.
43 Prevenar – Outer wrapper label to be applied on the transparent foil for multi pack presentation 5 x 10, including the blue box
42 Prevenar – nalepka zunanjega ovoja, ki bo nalepljena na prozorni foliji pakiranja z več zavitki 5 x 10, vključno z modro škatlo
LABEL TEXT
BESEDILO NA NALEPKI
Multipack comprising 5 packs, each containing 10 single-dose (0.5 ml) pre-filled syringes without needle.
Zavitek s 5 zavitki, od katerih vsak vsebuje 10 enoodmernih (0, 5 ml) napolnjenih injekcijskih brizg brez igle.
PACKAGE LEAFLET
45 NAVODILO ZA UPORABO
What Prevenar is and what it is used for 2.
Kaj je cepivo Prevenar in za kaj ga uporabljamo 2.
Before you use Prevenar 3.
Kaj morate vedeti, preden boste uporabili cepivo Prevenar 3.
How to use Prevenar 4.
Kako uporabljati cepivo Prevenar 4.
How to store Prevenar 6.
Shranjevanje cepiva Prevenar 6.
Prevenar helps protect your child against diseases such as: meningitis, sepsis or bacteraemia (bacteria in blood stream), pneumonia and ear infection caused by seven types of the bacteria Streptococcus pneumoniae.
Prevenar pomaga zaščititi vašega otroka pred boleznimi kot so: meningitis, sepsa ali bakteriemija (bakterije v krvi), pljučnica in okužbe ušesa, ki jih povzroča sedem tipov bakterije Streptococcus pneumoniae.
BEFORE YOU USE PREVENAR
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI CEPIVO PREVENAR
Do not use Prevenar:
Ne uporabljajte cepiva Prevenar:
diphtheria toxoid.
cepiva ali na toksoid davice.
Take special care with Prevenar:
Bodite posebno pozorni pri uporabi cepiva Prevenar:
- if your child has any present or past medical problems after any dose of Prevenar.
- če ima ali je imel vaš otrok zdravstvene težave po uporabi cepiva Prevenar;
- if your child has any bleeding problems.
- če ima vaš otrok težave s krvavitvami;
- if your child is sick with a high fever.
- če je vaš otrok bolan in ima visoko telesno temperaturo.
Using other medicines/ vaccines:
Uporaba drugih zdravil ali cepiv:
HOW TO USE PREVENAR
KAKO UPORABLJATI CEPIVO PREVENAR
The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine.
Zdravnik ali sestra bo otroku injiciral priporočeni odmerek cepiva (0, 5 ml).
Prevenar should not be mixed with any other vaccines in the same syringe.
Cepiva Prevenar se ne sme mešati v isti brizgi z drugimi cepivi.
Prevenar will be injected into your child's muscle.
46 Cepivo Prevenar bo otrok dobil v mišico.
Typically, your child should receive four doses of the vaccine.
Običajno dobi otrok štiri odmerke cepiva.
Each dose will be given on a separate occasion.
Vsak odmerek bo dobil ob različnem času.
It is important to follow the instructions from the doctor/ nurse so that your child completes the course of injections.
Pomembno je, da se držite navodil zdravnika ali sestre tako, da bo otrok prejel vse predpisane odmerke.
The meaning of the terms used to describe the frequency of side effects is as follows:
Pomen izrazov, s katerimi opisujemo pogostost neželenih učinkov, je sledeč
Very Rare: side effects which may occur in less than 1 of 10,000 patients.
zelo pogosti: neželeni učinki, ki se pojavljajo pri več kot 1 od 10 bolnikov; pogosti: neželeni učinki, ki se pojavljajo pri manj kot 1 od 10 bolnikov; občasni: neželeni učinki, ki se pojavljajo pri manj kot 1 od 100 bolnikov; redki: neželeni učinki, ki se pojavljajo pri manj kot 1 od 1. 000 bolnikov; zelo redki: neželeni učinki, ki se pojavljajo pri manj kot 1 od 10. 000 bolnikov.
• Blood and lymphatic system disorders
• Bolezni krvi in limfatičnega sistema:
enlarged lymph nodes (lymphadenopathy) in the region of the injection site
povečanje bezgavk (limfadenopatija) v predelu mesta injiciranja
• Nervous System Reactions
• Bolezni živčevja:
Rare: seizures, seizures associated with fever
krči, vključno z vročinskimi krči
• Gastrointestinal Reactions
• Bolezni prebavil:
decreased appetite, vomiting, diarrhoea
zmanjšan apetit, bruhanje, driska
• Skin Reactions
• Reakcije na koži:
Very rare:
občasni: zelo redki:
rash/ hives (urticaria) erythema multiforme
izpuščaj/ koprivnica (urtikarija) multiformni eritem.
• Injection Site Reactions and General Reactions
• Splošne težave in spremembe na mestu aplikacije:
pain, tenderness, redness, swelling, or hardness at the injection site; fever of 38 °C or higher, irritability, crying, drowsiness, restless sleep
bolečina, občutljivost, rdečina, oteklina ali zatrdlina na mestu injiciranja; zvišana telesna temperatura 38 °C ali višja, razdražljivost, jok, zaspanost, nemiren spanec
redness, swelling, or hardness at the injection site greater than 2.4 cm; tenderness at the injection site interfering with movement; fever of 39 °C or higher
rdečina, oteklina ali zatrdlina na mestu injiciranja, večja od 2, 4 cm; bolečina na mestu injiciranja, ki ovira gibljivost okončine, zvišana telesna temperatura 39 °C ali višja
48
redki:
Rare: injection site hypersensitivity reactions like rash/ hives (urticaria) or itching at the injection site; hypotonic hyporesponsive episode (collapse or shock-like state)
preobčutljivostne reakcije na mestu injiciranja kot so izpuščaj, koprivnica (urtikarija) ali srbenje; epizoda hipotonije in zmanjšane odzivnosti (kolaps ali šoku podobno stanje)
• Immune System Reactions:
• Bolezni imunskega sistema:
Rare: severe hypersensitivity/ allergic reactions, which may include swelling of the face and/ or lips, difficulty in breathing, and/ or shock (cardiovascular collapse)
hude preobčutljivostne/ alergijske reakcije z otekanjem obraza in/ ali ustnic, oteženo dihanje in/ ali šok (kardiovaskularni kolaps)
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
47 Pri zelo nedonošenih dojenčkih (rojenih po 28 tednih gestacije ali prej) se lahko pojavijo daljši premori med vdihi dva do tri dni po cepljenju.
Please speak with your doctor or pharmacist should you have any questions or concerns.
Če imate kakršnakoli vprašanja ali ste zaskrbljeni, se posvetujte z zdravnikom ali s farmacevtom.
HOW TO STORE PREVENAR
SHRANJEVANJE CEPIVA PREVENAR
What Prevenar contains
Kaj vsebuje cepivo Prevenar
Pneumococcal polysaccharide serotype 4* Pneumococcal polysaccharide serotype 6B* Pneumococcal polysaccharide serotype 9V* Pneumococcal polysaccharide serotype 14* Pneumococcal oligosaccharide serotype 18C* Pneumococcal polysaccharide serotype 19F* Pneumococcal polysaccharide serotype 23F*
Zdravilne učinkovine Vsak odmerek po 0, 5 ml vsebuje: pnevmokokni polisaharid serotip 4 * pnevmokokni polisaharid serotip 6B * pnevmokokni polisaharid serotip 9V * pnevmokokni polisaharid serotip 14 * pnevmokokni oligosaharid serotip 18C * pnevmokokni polisaharid serotip 19F * pnevmokokni polisaharid serotip 23F *
* Conjugated to the CRM197 carrier protein and adsorbed on
* vezan na CRM197 nosilni protein in adsorbiran na aluminijev fosfat (0, 5 mg)
The vaccine is a suspension for injection and provided in a single-dose vial (0.5 ml).
Prevenar je cepivo v obliki suspenzije za injiciranje; v vsaki viali je en odmerek (0, 5 ml).
Pack sizes of 1 and 10 vials without syringe/ needles.
Pakiranji s po 1 vialo in s po 10 vialami brez brizge/ igel.
49 Marketing Authorization Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom in izdelovalec
Manufacturing Authorisation Holder responsible for batch release:
48 Imetnik dovoljenja za promet z zdravilom, odgovoren za sproščanje serije:
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH-UK United Kingdom
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH- UK Velika Britanija
Nederland Wyeth Pharmaceuticals B. V.
Nederland Danmark Wyeth Pharmaceuticals B. V.
Tel: + 31 23 5672567 Fax: + 31 23 567 2599
Wyeth Danmark Tel: + 31 23 5672567 Tlf: + 45 44 88 88 05 Fax: + 31 23 567 2599 Fax: + 45 44 88 88 06
Deutschland Wyeth-Pharma GmbH Tel: + 49 1802 299 384 Fax: + 49 251 204 1128
Norge Deutschland Wyeth Wyeth- Pharma GmbH Tlf. + 47 40 00 23 40 Tel: + 49 1802 299 384 Fax: + 47 40 00 23 41 Fax: + 49 251 204 1128
Tel: +48 22 457 1000 Fax: + 48 22 457 1001
Tel: + 48 22 457 1000 Fax: + 48 22 457 1001
Tel: + 34 91 334 65 65 Fax: + 34 91 663 65 53
Portugal España Wyeth Lederle Portugal (Farma), Lda.
Portugal Wyeth Lederle Portugal (Farma), Lda.
Wyeth Farma, S. A.
Tel: + 351 21 412 82 00 Fax: + 351 21 412 01 11
Tel: + 351 21 412 82 00 Tel: + 34 91 334 65 65 Fax: + 351 21 412 01 11 Fax: + 34 91 663 65 53
France Wyeth Pharmaceuticals France Tél: + 33 1 41 02 70 00 Fax: + 33 1 41 02 70 10
România France Wyeth- Lederle Pharma GmbH Wyeth Pharmaceuticals France Tel: + 43 1 89 1140 Tél: + 33 1 41 02 70 00 Fax: + 43 1 89 114600 Fax: + 33 1 41 02 70 10
Ireland Wyeth Vaccines Tel: + 353 1 449 3500 Fax: + 353 1 679 3773
49 Slovenská Republika Ireland Wyeth Whitehall Export GmbH, organizačná Wyeth Vaccines zložka Tel: + 353 1 449 3500 Tel: + 42 1 2 654 128 16 Fax: + 353 1 679 3773 Fax: + 42 1 2 654 128 17
Ísland Icepharma hf, Tel: + 354 540 8000 Fax: + 354 540 8001
Slovenija Ísland Wyeth- Lederle Pharma GmbH Icepharma hf, Tel: + 43 1 89 1140 Tel: + 354 540 8000 Faks: + 43 1 89 114600 Fax: + 354 540 8001
Kύπρος Wyeth Hellas (Cyprus Branch) AEBE Tηλ: +357 22 817690 Φαξ: + 357 22 751855
Kύπρος Wyeth Hellas (Cyprus Branch) AEBE Tηλ: + 357 22 817690 Φαξ: + 357 22 751855
Tél: + 32 10 49 4711 Fax: +32 10 49 48 70
Tél: + 32 10 49 4711 Fax: + 32 10 49 48 70
The vaccine should be well shaken to obtain a homogeneous white suspension and be inspected visually for any particulate matter and/ or variation of physical aspect prior to administration.
Cepivo je treba pred uporabo dobro pretresti, da nastane bela homogena suspenzija, in ga pred uporabo dobro pregledati, da ne vsebuje delcev in/ ali ni drugačnega fizikalnega videza.
51 This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.
Cepiva ne dajemo dojenčkom ali otrokom s trombocitopenijo ali kako drugo motnjo strjevanja krvi, pri kateri je intramuskularna aplikacija kontraindicirana, razen v primerih, ko je korist cepljenja očitno večja od potencialnega tveganja.
Infants age 2 - 6 months: the primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Dojenčki od 2. do 6. meseca starosti: primarno zaporedje za dojenčke sestavljajo trije odmerki po 0, 5 ml; prvi odmerek damo običajno pri 2 mesecih starosti; med naslednjima odmerkoma mora biti najmanj enomesečni presledek.