natgillin/translations-raw huggingface dataset:
The efficacy and safety of empagliflozin as add-on to multiple daily insulin with or without concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 52 weeks duration.
Empagliflozin kot dodatno zdravljenje k večkratnim dnevim odmerkom insulina Učinkovitost in varnost empagliflozina kot dodatno zdravljenje k večkratnim dnevnim odmerkom insulina s sočasnim zdravljenjem z metforminom ali brez njega so ocenili v dvojno slepem, s placebom nadzorovanem 52-tedenskem preskušanju.
Jardiance should not be initiated in patients with an eGFR below 60 ml/min/1.73 m2 or
Zdravila Jardiance se ne sme uvesti pri bolnikih z eGFR pod 60 ml/min/1,73 m2 ali CrCl < 60 ml/min.
Body Weight (kg) at week 522
Telesna masa (kg) v 52. tednu2
Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Bolniki (%), ki so dosegli vrednost HbA1c < 7 % z izhodiščno vrednostjo
N SBP (mmHg)2
N Vrednost SBP (mmHg)2
Boehringer Ingelheim International GmbH Binger Strasse 173
Imetnik dovoljenja za promet z zdravilom Boehringer Ingelheim International GmbH Binger Strasse 173
12 phase 2 and 3 clinical studies involving 10,036 patients with type 2 diabetes, empagliflozin did not increase cardiovascular risk.
V prospektivni, vnaprej specificirani metaanalizi neodvisno ovrednotenih srčno-žilnih dogodkov v 12 kliničnih študija 2. in 3. faze, ki so zajele 10.036 bolnikov s sladkorno boleznijo tipa 2,
Urine laboratory assessments
Laboratorijska ocena seča
Empagliflozin should not be initiated in patients with an eGFR <60 ml/min/1.73 m or
Empagliflozina se ne sme uvesti pri bolnikih z eGFR < 60 ml/min/1,73 m2 ali CrCl < 60 ml/min.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters (perforated)
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU pretisni omot (perforiran)
At week 18, empagliflozin provided statistically significant improvement in HbA1c (Table 6).
V 18. tednu je pri empagliflozinu prišlo do statistično značilnega izboljšanja vrednosti HbA1c
Jardiance 10 mg film-coated tablets
Jardiance 10 mg filmsko obložene tablete
There were no clinically relevant differences in empagliflozin pharmacokinetics between healthy volunteers and patients with type 2 diabetes.
Med zdravimi prostovoljci in bolniki s sladkorno boleznijo tipa 2 ni bilo klinično pomembnih razlik v farmakokinetiki empagliflozina.
Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
To so znaki diabetične ketoacidoze (glejte tudi poglavje 2 »Opozorila in previdnostni ukrepi«): - povišane ravni “ketonskih teles” v urinu ali krvi - hitra izguba telesne mase - slabost ali bruhanje
Jardiance 25 mg film-coated tablets
Jardiance 25 mg filmsko obložene tablete
1 Mean adjusted for baseline value
1 Povprečje, prilagojeno za izhodiščne vrednosti
5 Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001
2 Povprečje, prilagojeno za vrednost HbA1c ob izhodišču, vrednost eGFR ob izhodišču, geografsko regijo in število antihipertenzivnih zdravil
The efficacy and safety of empagliflozin as monotherapy was evaluated in a double-blind, placebo- and active-controlled study of 24 weeks duration in treatment-naïve patients.
Učinkovitost in varnost empagliflozina pri samostojnem zdravljenju so pri predhodno še nezdravljenih bolnikih ocenili v dvojno slepi, s placebom in zdravilno učinkovino nadzorovani študiji, ki je trajala 24 tednov.
4 LOCF, values after antihypertensive rescue censored
3 95-odstotni IZ 4 LOCF, vrednosti po cenzuriranju antihipertenzivnega reševanja
No dose adjustment is required for patients with an eGFR ≥60 ml/min/1.73 m2 or CrCl ≥60 ml/min.
Pri bolnikih z eGFR ≥60 ml/min/1,73 m2 ali CrCl ≥60 ml/min prilagoditev odmerka ni potrebna.
Difference from glimepiride1 (97.5% CI)
Razlika glede na glimepirid1 (97,5-odstotni IZ) N Vrednost SBP (mmHg)2
HbA1c (%) at week 522
Vrednost HbA1c (%) v 78. tednu
In a pre-specified pooled analysis of 4 placebo-controlled studies, treatment with empagliflozin resulted in a reduction in systolic blood pressure (empagliflozin 10 mg: -3.9 mmHg; empagliflozin 25 mg: -4.3 mmHg) compared with placebo (-0.5 mmHg) and in diastolic blood pressure (empagliflozin 10 mg: -1.8 mmHg; empagliflozin 25 mg: -2.0 mmHg) compared with placebo (-0.5 mmHg) at week 24 that were maintained up to week 52.
empagliflozin 25 mg: -4,3 mmHg) v primerjavi s placebom (-0,5 mmHg) in diastoličnega krvnega tlaka (empagliflozin 10 mg: -1,8 mmHg; empagliflozin 25 mg: -2,0 mmHg) v primerjavi s placebom (-0,5 mmHg) v 24. tednu, kar se je ohranilo do 52. tedna.
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Jardiance ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
Following administration of an oral [14C]-empagliflozin solution to healthy volunteers, the red blood cell partitioning was approximately 37% and plasma protein binding was
Navidezni volumen porazdelitve v stanju dinamičnega ravnovesja je bil na podlagi populacijske farmakokinetične analize ocenjen na 73,8 l. Po peroralnemu zaužitju raztopine [14C]-empagliflozina je bila pri zdravih prostovoljcih porazdelitev v eritrocite približno 37 %, vezava na beljakovine v plazmi pa 86 %.
Interstitial cell tumours in the testes were observed with a higher incidence in rats at 300 mg/kg/day and above, but not at 100 mg/kg/day which corresponds to approximately 18-times the maximal clinical exposure to empagliflozin.
300 mg/kg/dan in več, ne pa tudi pri 100 mg/kg/dan, kar ustreza približno 18-kratni največji klinični izpostavljenosti empagliflozinu.
Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets empagliflozin
Jardiance 10 mg filmsko obložene tablete Jardiance 25 mg filmsko obložene tablete
At Week 52, treatment with empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared with placebo and a reduction in FPG and body weight.
HbA1c in varčevanje z insulinom v primerjavi s placebom in zmanjšanje vrednosti FPG in telesne mase.
With once-daily dosing, steady-state plasma concentrations of empagliflozin were reached by the fifth dose.
Koncentracije v plazmi v stanju dinamičnega ravnovesja so bile pri odmerjanju enkrat na dan dosežene s petim odmerkom.
Hypoglycaemia (when used with sulphonylurea or insulin)a
Presnovne in prehranske motnje hipoglikemija (pri uporabi s sulfonilsečnino ali insulinom)a diabetična ketoacidoza
Your blood sugar levels may increase when you stop taking Jardiance.
Če boste zdravilo Jardiance prenehali jemati, se bodo ravni krvnega sladkorja morda povišale.
* p-value <0.0001
* vrednost p < 0,0001
Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post-marketing in patients treated with SGLT2 inhibitors, including empagliflozin.
vključno z empagliflozinom poročali o redkih primerih diabetične ketoacidoze (DKA), vključno z življenje ogrožujočimi.
Treatment with empagliflozin provided reductions in seated SBP and DBP.
Zdravljenje z empagliflozinom je povzročilo zmanjšanje sistoličnega in diastoličnega krvnega tlaka merjenega sede.
Interaction studies conducted in healthy volunteers suggest that the pharmacokinetics of empagliflozin were not influenced by co-administration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
glimepirida, pioglitazona, sitagliptina, linagliptina, varfarina, verapamila, ramiprila, simvastatina, torazemida in hidroklorotiazida ni vplivala na farmakokinetiko empagliflozina.
Do not drive or use any tools or machines, if you feel dizzy while taking Jardiance.
Če ste med jemanjem zdravila Jardiance omotični, ne vozite in ne upravljajte z orodji ali stroji.
Dysuria a see subsections below for additional information b derived from postmarketing experience * see section 4.4
Bolezni sečil pogostejše uriniranje a disurija a za dodatne informacije glejte spodnja podpoglavja b izhaja iz izkušenj v obdobju trženja
Volume depletion
Zmanjšanje volumna
Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1
Vrednost ŞBP (mmHg)3 Izhodišče (povprečje) Sprememba od izhodišča1
What Jardiance looks like and contents of the pack Jardiance 10 mg film-coated tablets are round, pale yellow, biconvex and bevel-edged.
Zdravilo Jardiance 10 mg filmsko obložene tablete so okrogle, svetlorumene, bikonveksne tablete s poševnim robom.
Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
Če se pojavi kateri koli od naslednjih neželenih učinkov, se nemudoma posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico:
Add-on to metformin and a sulphonylurea therapy Placebo
Dodatno zdravljenje k metforminu s sulfonilsečnino placebo zdravilo Jardiance 10 mg
Symptoms
ZDRAVILA
In four placebo-controlled studies, treatment with empagliflozin as monotherapy or add-on therapy to metformin, pioglitazone, or metformin plus a sulfonylurea resulted in mean changes from baseline in
V štirih s placebom nadzorovanih študijah je zdravljenje z empagliflozinom kot samostojno zdravljenje ali dodatno zdravljenje k metforminu, pioglitazonu ali metforminu s sulfonilsečnino povzročilo povprečno spremembo od izhodiščne vrednosti glede na placebo (7,4 mg/dl [0,41 mmol/l])
In male rats, treatment-related benign vascular proliferative lesions (haemangiomas) of the mesenteric lymph node were observed at the highest dose, but not at 300 mg/kg/day, which corresponds to approximately 26-times the maximal clinical exposure to empagliflozin.
Pri podganjih samcih so pri najvišjih odmerkih, ne pa tudi pri 300 mg/kg/dan, kar ustreza približno 26-kratni največji klinični izpostavljenosti empagliflozinu, opazili z zdravljenjem povezane benigne vaskularne proliferativne lezije (hemangiome) mezentrialnih bezgavk.
N HbA1c (%) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2 N Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N SBP (mmHg)2 Baseline (mean) Change from baseline1 Difference from placebo1 (95% CI)
Razlika glede na placebo1 (95odstotni IZ) N Bolniki (%), ki so dosegli vrednost HbA1c < 7 % z izhodiščno vrednostjo HbA1c ≥ 7 %2
Placebo Empagliflozin 25 mg eGFR ≥60 to <90 ml/min/1.73 m²
Vrednost eGFR ≥ 45 do < 60 ml/min/1,73 m²
<7% with baseline
< 7 % z izhodiščno vrednostjo HbA1c
Infections and infestations
Opozorila in previdnostni ukrepi
An increased frequency was noted when given as add-on to metformin and a sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5%, placebo: 8.4%), and as add-on to insulin with or without metformin and with or without a sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 27.1%, placebo: 20.6% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 36.1%, empagliflozin 25 mg: 34.8%, placebo 35.3% over the 78-week trial).
11,5 %, placebo: 8,4 %) in kot dodatno zdravljenje z insulinom z metforminom ali brez njega ali s sulfonilsečnino ali brez nje (empagliflozin 10 mg: 19,5 %, empagliflozin 25 mg: 27,1 %, placebo:
(95% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy
a Niz celotne analize (FAS, full analysis set) - osebe, ki so študijo dokončale, z uporabo zadnjega opazovanja prenesenega naprej (LOCF, last observation carried forward) pred uporabo reševalnega zdravljenja za ureditev glikemije
The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) was similar in patients treated with empagliflozin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.3%) and placebo (0.3%).
hipovolemija, ortostatska hipotenzija in sinkopa) je bila podobna pri bolnikih, zdravljenih z empagliflozinom (empagliflozin 10 mg: 0,5 %, empagliflozin 25 mg: 0,3 %) in placebom (0,3 %).
Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently in patients treated with empagliflozin (empagliflozin 10 mg: 4.1%, empagliflozin 25 mg: 3.7%) compared to placebo (0.9%).
V primerjavi s placebom (0,9 %) so o nožnični kandidozi, vulvovaginitisu, balanitisu in drugih okužbah spolovil pogosteje poročali pri bolnikih, zdravljenih z empagliflozinom (empagliflozin
Empagliflozin
Diuretiki
Urinary tract infection, seen commonly (may affect up to 1 in 10 people) The signs of urinary tract infection are:
Okužbe sečil, pojavijo se pogosto (pojavi se lahko pri največ 1 od 10 bolnikov)
Complicated urinary tract infection (e.g. pyelonephritis or urosepsis) occurred at a similar frequency in patients treated with empagliflozin compared to placebo.
so se pri bolnikih, zdravljenih z empagliflozinom, pojavile s podobno pogostnostjo kot pri placebu.
NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg film-coated tablets Empagliflozin
Jardiance 25 mg filmsko obložene tablete empagliflozin
• itching
• moten urin
NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets Empagliflozin
Jardiance 10 mg filmsko obložene tablete empagliflozin
(97.5% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy
Razlika glede na placebo1 (95odstotni IZ) a Niz celotne analize (FAS, full analysis set) z uporabo zadnjega opazovanja prenesenega naprej (LOCF, last observation carried forward) pred uporabo reševalnega zdravljenja za ureditev glikemije
Add-on combination therapy
Dodatno kombinirano zdravljenje
SBP (mmHg)3
Vrednost SBP (mmHg)
Patients (%)
Izhodišče (povprečje)
(95% CI) a Full analysis set (FAS)
Razlika glede na placebo1 (95-odstotni IZ) a Niz celotne analize (FAS, full analysis set) z uporabo zadnjega opazovanja prenesenega naprej
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Glimepirideb
• srbečica
Cardiovascular safety
Varnost za srce in ožilje
The study was conducted in North America, Latin America, Asia Pacific and Europe.
Študija je potekala v Severni Ameriki, Latinski Ameriki, azijsko-pacifiški regiji in Evropi.
Duration of protection has not fully been established.
Trajanje zaščite trenutno še ni povsem določeno.
However, do not drive or use any machines if you are feeling unwell.
Vendar ne vozite ali upravljajte strojev, če se ne počutite dobro.
• if you have a severe infection with a high temperature.
• če imate hudo okužbo z visoko telesno temperaturo.
If you are between 9 and 14 years old
Če ste stari med 9 in 14 let
Use with other vaccines
Uporaba z drugimi cepivi
Paediatric population (children < 9 years of age)
Pediatrična populacija (otroci, mlajši od 9 let)
For storage after first opening, see section 6.3.
Za podatke o shranjevanju po prvem odprtju glejte poglavje 6.3.
If not used within 6 hours it should be discarded.
Če ni uporabljeno v 6 urah, ga morate zavreči.
These reactions will usually occur before leaving the doctor's surgery.
Ti učinki se po navadi pojavijo, še preden zapustite zdravnikovo ordinacijo.
Functional antibodies were not determined.
Funkcijskih protiteles niso določili.
The clinical relevance of this observation is unknown.
Klinični pomen tega opažanja ni znan.
This does not constitute a sign of deterioration.
To ni znak kvarjenja.
Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
Zato je še naprej treba upoštevati ustrezne previdnostne ukrepe proti spolno prenosljivim boleznim.
The limits of the confidence interval around the vaccine efficacy were calculated.
Izračunane so bile meje intervala zaupanja okrog učinkovitosti cepiva.
Final analysis was performed at study conclusion, 7 years after 1st vaccination.
Končna analiza je bila narejena ob dokončanju študije, 7 let po prvem cepljenju.
Duration of the immune response in women aged 26 years and older
Trajanje imunskega odziva pri ženskah, starih 26 let in več
Therefore tell the doctor or nurse if you or your child fainted with a previous injection.
Zato morate zdravniku ali medicinski sestri povedati, če ste vi ali vaš otrok omedleli pri kakšni predhodni injekciji.
However, stability has been demonstrated when stored outside the refrigerator for up to 3 days at temperatures between 8°C and 25°C or for up to 1 day at temperatures between 25°C and 37°C.
Vendar je bila stabilnost dokazana, tudi če je bilo shranjeno zunaj hladilnika, in sicer do 3 dni pri temperaturi od 8 °C do 25 °C ali do 1 dan pri temperaturi od 25 °C do 37 °C.
• if you are allergic to any of the active substances or any of the other ingredients of this vaccine (listed in section 6).
• če ste alergični na učinkovino ali katero koli sestavino tega cepiva (navedeno v poglavju 6).
Animal studies have shown that the efficacy of L1 VLP vaccines is largely mediated by the development of a humoral immune response.
Študije na živalih kažejo, da je učinkovitost L1 VLP cepiv v veliki meri posledica razvoja humoralnega imunskega odziva.
When the value zero is included, i.e. when the lower limit of the CI is <0, the efficacy is not considered statistically significant.
Če interval vključuje vrednost nič, tj. če je spodnja meja intervala zaupanja < 0, učinkovitost ne velja za statistično značilno.
Cervarix should be administered as soon as possible after being removed from the refrigerator.
Cepivo Cervarix je potrebno uporabiti čim prej po tem, ko ga vzamete iz hladilnika.
BATCH NUMBER LOT:
ŠTEVILKA SERIJE LOT:
The need for a booster dose has not been established (see section 5.1).
Potrebnost obnovitvenega odmerka ni bila dokazana (glejte poglavje 5.1).
Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you.
Pred začetkom cepljenja natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
If you miss a dose
Če ste izpustili odmerek
Specific studies of the vaccine in pregnant women were not conducted.
Posebne študije o uporabi cepiva pri nosečnicah niso bile izvedene.
Inclusion of this subset allowed assessment of prophylactic efficacy in a population that is thought to reflect a real-world setting, as adult women are the age group generally targeted for cervical screening.
Vključitev te podskupine je omogočila oceno učinkovitosti profilakse v populaciji, za katero se smatra, da odraža realno svetovno situacijo; odrasle ženske so starostna skupina, predvidena za pregled materničnega vratu.
However, if your child gets any of these symptoms you should contact a doctor urgently.
Toda če se otroku pojavi katerikoli od teh simptomov, se morate nujno posvetovati z zdravnikom.
When using a multidose vial, each 0.5 ml dose should be withdrawn using a sterile needle and syringe; precautions should be taken to avoid contamination of the contents.
Pri uporabi večodmerne viale je treba vsak 0,5 ml odmerek izvleči s sterilno iglo in brizgo; upoštevati je treba previdnostne ukrepe, da ne pride do onesnaženja vsebine.
Do not use this vaccine after the expiry date which is stated on the carton.
Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
EXP After first opening, use immediately or within 6 hours if stored in a refrigerator
Cepivo uporabite takoj po prvem odprtju ali v šestih urah, če je shranjeno v hladilniku.
Cervarix should only be used during breast-feeding when the possible advantages outweigh the possible risks.
Cepivo Cervarix se sme med dojenjem uporabljati le, če možne koristi prevladajo nad možnimi tveganji.
The GMTs appeared to be lower in the HIV infected group (non overlapping 95% confidence interval).
Geometrična sredina titrov je bila v skupini, okuženi s HIV, nižja (neprekrivajoči 95 % interval zaupanja).
The vaccine has not been shown to have a therapeutic effect.
Ni bilo dokazano, da bi imelo terapevtski učinek.
A similar kinetic profile was observed with the neutralising antibodies.
Podoben kinetični profil so opažali z nevtralizirajočimi protitelesi.
In study 008, immunogenicity up to month 48 was similar to the response observed in study 001.
V študiji 008 je bila imunogenost do 48. meseca podobna odzivu, opaženem v študiji 001.
Evidence of Anamnestic (Immune Memory) Response
Dokazi o anamnestičnem odzivu (imunski spomin)
0.5 milligrams Al3+ in total
0,5 miligrama Al3+ v celoti
In accordance with Article 114 of Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
V skladu s 114. členom Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
To lahko spremljajo različni nevrološki znaki, npr. prehodna motnja vida, parestezije in tonično-klonični gibi udov med okrevanjem.
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100)
Pogostnost je navedena kot: Zelo pogosti (≥ 1/10) Pogosti (≥ 1/100 do < 1/10) Občasni (≥ 1/1.000 do < 1/100)
The study was not powered to assess efficacy against disease caused by individual HPV types.
Moč študije ni bila izračunana za oceno učinkovitosti proti bolezni, povzročeni s posameznim tipom HPV.
This cohort included women with normal or low-grade cytology at baseline and excluded only women with high-grade cytology (0.5% of the total population).
Ta kohorta je vključila ženske z izhodiščno normalno ali nizkostopenjsko citologijo in je izključila le ženske z visokostopenjsko citologijo (0,5 % celotne populacije).
If you do not finish the complete vaccination course (two or three injections depending on your age at vaccination), you may not get the best response and protection from the vaccination.
Če niste prejeli vseh predvidenih odmerkov cepiva (dva ali tri odmerke, odvisno od vaše starosti v času cepljenja), sta odziv na cepljenje in zaščita lahko slabša.
Cross-protective efficacy
Učinkovitost navzkrižne zaščite
However, during the clinical development program, a total of 10,476 pregnancies were reported including 5,387 in women who had received Cervarix.
Vendar so v času kliničnega razvojnega programa poročali o 10.476 primerih nosečnosti, vključno s 5.387 ženskami, ki so bile cepljene s cepivom Cervarix.
4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive or use machines have been performed.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
Other oncogenic HPV types can also cause ano-genital cancers (approximately 30%).
Drugi onkogeni tipi HPV prav tako lahko povzročijo anogenitalne oblike raka (približno 30 %).
Turbid white suspension.
Motna bela suspenzija.
The use of Cervarix should be in accordance with official recommendations.
Cepivo Cervarix je treba uporabljati v skladu z uradnimi priporočili.
It is important that procedures are in place to avoid injury from faints.
Pomembno je zagotoviti ukrepe za preprečitev poškodb v primeru omedlevice.
The total number of injections you will receive depends on your age at the time of the first injection.
Skupno število odmerkov, ki jih boste prejeli je odvisno od vaše starosti, ko boste prejeli prvi odmerek.
% Efficacy (95% CI)
% učinkovitosti (95 % IZ)
What Cervarix is and what it is used for
Kaj je cepivo Cervarix in za kaj ga uporabljamo