natgillin/translations-raw huggingface dataset:
There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95 % CI 0.76 - 1.00, p = 0.048)].
Telmisartan je bil podobno učinkovit kot ramipril pri vnaprej opredeljenem sekundarnem opazovanem dogodku, sestavljenem iz smrti zaradi srčnožilnega dogodka, neusodnega miokardnega infarkta in neusodne možganske kapi [0,99 (97,5-odstotni interval zaupanja 0,90 - 1,08), p (neinferiornost) =
Arthralgia, pain in extremetis, tendon pain (tendenitis like symptoms)
artralgija,bolečine v okončini, bolečina v kitah
The effect of Telmisartan Teva may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Učinek zdravila Telmisartan Teva se lahko zmanjša, če jemljete NSAID (nesteroidna protivnetna zdravila,
NAME OF THE MEDICINAL PRODUCT Telmisartan Teva 20 mg tablets telmisartan
Navodilo za uporabo Telmisartan Teva 20 mg tablete telmisartan
How to store Telmisartan Teva
Shranjevanje zdravila Telmisartan Teva
Metabolism and nutrition disorders Uncommon
Presnovne in prehranske motnje
Ear and labyrinth disorders Uncommon:
Ušesne bolezni, vključno z motnjami labirinta Občasni:
Each tablet contains 42.8 mg sorbitol (E420) For the full list of excipients, see section 6.1.
Ena tableta vsebuje 42,8 mg sorbitola (E420).
If you are intolerant to some sugars, contact your doctor before taking Telmisartan Teva.
Če vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred jemanjem zdravila
Magnesium stearate
Pretisni omot
Potassium sparing diuretics or potassium supplements
Diuretiki, ki zadržujejo kalij, ali kalijevi nadomestki
EU/1/09/610/002 Cartons of 28x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
EU/1/09/610/002 Škatla z 28x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo
Potassium sparing diuretics e.g. spironolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium.
kalijevi nadomestki ali nadomestki soli s kalijem, lahko močno povečajo raven kalija v serumu.
Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium,
Tveganje je lahko povečano pri kombiniranem zdravljenju z drugimi zdravili, ki lahko povzročijo hiperkaliemijo (nadomestki soli s kalijem, diuretiki, ki zadržujejo kalij,
Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis,
okužba sečil, tudi cistitis, okužba zgornjih dihal,
Telmisartan Teva 40 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Telmisartan Teva 40 mg tablete so bele do belkaste, ovalne tablete.
Telmisartan Teva 80 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Telmisartan Teva 80 mg tablete so bele do belkaste, ovalne tablete.
Telmisartan Teva 20 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Telmisartan Teva 20 mg tablete so bele do belkaste, ovalne tablete.
Uncommon:
Občasni:
EU/1/09/610/031 Cartons of 14x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/032 Cartons of 28x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/033 Cartons of 30x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/034 Cartons of 40x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/035 Cartons of 56x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/036 Cartons of 60x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/037 Cartons of 84x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/038 Cartons of 90x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/039 Cartons of 98x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/040 Cartons of 100x1 tablets in perforated unit-dose aluminium-aluminium blisters
EU/1/09/610/003 Škatla s 30x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/004 Škatla s 40x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/005 Škatla s 56x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/006 Škatla s 60x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/007 Škatla s 84x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/008 Škatla z 90x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/009 Škatla z 98x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/010 Škatla s 100x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/031 Škatla s 14x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/032 Škatla z 28x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/033 Škatla s 30x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/034 Škatla s 40x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/035 Škatla s 56x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/036 Škatla s 60x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/037 Škatla s 84x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/038 Škatla z 90x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/039 Škatla z 98x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/040 Škatla s 100x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih
EU/1/09/610/041 14x1 tablets EU/1/09/610/042 28x1 tablets EU/1/09/610/043 30x1 tablets EU/1/09/610/044 40x1 tablets EU/1/09/610/045 56x1 tablets EU/1/09/610/046 60x1 tablets EU/1/09/610/047 84x1 tablets EU/1/09/610/048 90x1 tablets EU/1/09/610/049 98x1 tablets EU/1/09/610/050
EU/1/09/610/041 14x1 tableta EU/1/09/610/042 28x1 tableta EU/1/09/610/043 30x1 tableta EU/1/09/610/044 40x1 tableta EU/1/09/610/045 56x1 tableta EU/1/09/610/046 60x1 tableta EU/1/09/610/047 84x1 tableta EU/1/09/610/048 90x1 tableta EU/1/09/610/049 98x1 tableta EU/1/09/610/050 100x1 tableta EU/1/09/610/050 30 tablet
Eye disorders Rare:
Srčne bolezni Občasni:
EU/1/09/610/004 Cartons of 40x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
EU/1/09/610/001 Škatla s 14x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo
EU/1/09/610/051 14x1 tablets EU/1/09/610/052 28x1 tablets EU/1/09/610/053 30x1 tablets EU/1/09/610/054 40x1 tablets EU/1/09/610/055 56x1 tablets EU/1/09/610/056 60x1 tablets EU/1/09/610/057 84x1 tablets EU/1/09/610/058 90x1 tablets EU/1/09/610/059 98x1 tablets EU/1/09/610/060
EU/1/09/610/051 14x1 tableta EU/1/09/610/052 28x1 tableta EU/1/09/610/053 30x1 tableta EU/1/09/610/054 40x1 tableta EU/1/09/610/055 56x1 tableta EU/1/09/610/056 60x1 tableta EU/1/09/610/057 84x1 tableta EU/1/09/610/058 90x1 tableta EU/1/09/610/059 98x1 tableta EU/1/09/610/060 100x1 tableta EU/1/09/610/062 30 tablet
EU/1/09/610/014 Cartons of 40x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
EU/1/09/610/011 Škatla s 14x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo
Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses: - Kidney disease or kidney transplant - Renal artery stenosis (narrowing of the blood vessels to one or both kidneys) - Liver disease - Heart trouble - Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals) - Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water)
jetrna bolezen težave s srcem če imate povečano raven aldosterona (zadrževanje vode in soli v telesu ter neravnovesje različnih mineralov v krvi)
Children and adolescents The use of Telmisartan Teva in children and adolescents up to the age of 18 years is not recommended.
Pediatrična populacija Varnost in učinkovitost zdravila Telmisartan Teva pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimesečju nosečnosti
EU/1/09/610/013 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
EU/1/09/610/031 Škatla s 14x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo
EU/1/09/610/041 Cartons of 14x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/042 Cartons of 28x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/043 Cartons of 30x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/044 Cartons of 40x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/045 Cartons of 56x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/046 Cartons of 60x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/047 Cartons of 84x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/048 Cartons of 90x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/049 Cartons of 98x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/050 Cartons of 100x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/061 Carton of 30 tablets in aluminium-aluminium blister
EU/1/09/610/012 Škatla z 28x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/013 Škatla s 30x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/014 Škatla s 40x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/015 Škatla s 56x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/016 Škatla s 60x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/017 Škatla s 84x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/018 Škatla z 90x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/019 Škatla z 98x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/020 Škatla s 100x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih z odstranljivo folijo EU/1/09/610/041 Škatla s 14x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/042 Škatla z 28x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/043 Škatla s 30x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/044 Škatla s 40x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/045 Škatla s 56x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/046 Škatla s 60x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/047 Škatla s 84x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/048 Škatla z 90x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/049 Škatla z 98x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/050 Škatla s 100x1 tableto v aluminij-aluminij perforiranih enoodmernih pretisnih omotih EU/1/09/610/061 Škatla s 30 tabletami v aluminij-aluminij pretisnem omotu
Other trials gave similar or higher results.
Drugi poskusi so dali podobne ali boljše rezultate.
Very rare (<1/10,000)
Zelo redki (<1/10.000)
Tell your doctor promptly about these symptoms.
Nemudoma obvestite svojega zdravnika o teh simptomih.
This vaccine has been prescribed for your child and you should not pass it on to others.
Cepivo je bilo predpisano za vašega otroka in ga ne smete dajati drugim.
If the condition persists or worsens, you may have to bring your child to the doctor.
Če stanje vztraja ali se poslabša, boste morda morali otroka odpeljati k zdravniku.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION October 23
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 23. oktober 2000
In rare instances, these cases were associated with swelling of the entire limb.
V redkih primerih so bili ti primeri povezani z otekanjem celotnega uda.
Official batch release: in accordance with Article 114 Directive 2001/83/EEC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: v skladu s členom 114 Direktive 2001/83/ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
Surveillance and antibody long term persistence studies are ongoing and will provide additional information in regards to the duration of protection.
Nadzorovanje in študije vztrajanja protiteles še potekajo in bodo zagotovile dodatne podatke o trajanju zaščite.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
• Post marketing experience
• Postmarketinške izkušnje
In such cases it is recommended to postpone the vaccination until the end of the disease or treatment.
V teh primerih je priporočljivo odložiti cepljenje do konca bolezni oz. zdravljenja.
Following the widespread use of HEXAVAC, additional undesirable effects have been reported:
Po začetku splošne uporabe HEXAVAC-a so poročali o dodatnih neželenih učinkih:
Primary vaccination :
Primarno cepljenje :
if your child is allergic to any component of the vaccine.
če je vaš otrok alergičen na katerokoli sestavino cepiva.
Evaluation of pharmacokinetic properties is not required for vaccines.
Ovrednotenje farmakokinetičnih lastnosti ni predpisano za cepiva.
in case of newborns, adolescents or adults.
če gre za novorojenčka, mladostnika ali odraslo osebo.
If you have further questions, please ask your doctor or your pharmacist.
Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
This vaccine should not be used in newborns, adolescents or adults.
Tega cepiva ne uporabljajte za novorojenčke, mladostnike ali odrasle.
It has been shown that PTxd and FHA play a major role in protection against pertussis.
Dokazano je, da PTxd in FHA igrata poglavitno vlogo pri zaščiti proti oslovskemu kašlju.
Rare (>1/10,000 and <1/1,000) Body as a whole - General disorders: Prolonged or abnormal crying.
Redki (>1/10.000 in <1/1.000) Telo kot celota - splošne težave: trajajoč in nenormalen jok.
B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
For Hepatitis B surface antigen: Merck & Co. Inc.
Za hepatits B površinski antigen: Merck & Co., Inc.
These signs and symptoms usually occurred within 48 hours following the vaccination.
Ti znaki in simptomi so se ponavadi pojavili v 48 urah po cepljenju.
These reactions were mostly moderate (less than or equal to 39° C) and transient.
Te reakcije so bile večinoma zmerne (ne več kot 39°C) in prehodne.
The FHA is not detoxified.
FHA se ne razstruplja.
* As lower confidence limit (p = 0.95).
* Spodnja meja intervala zaupanja (p=0,95).
The 4-fold increase in post immunisation titres is considered a sign of seroconversion of which the clinical significance is unknown in the absence of a serological correlate of protection.
Štirikratno povečanje titrov po cepljenju se smatra kot znak serokonverzije, katerega klinični pomen je neznan v odsotnosti serološkega korelata zaščite.
Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause.
Temperatura ≥ 40,0 °C v 48 urah brez drugega vzroka.
^ Quantity of antigen in the final bulk product, according to W.H.O.
^ Količina antigena v končnem proizvodu po W.H.O.
Except in the case of immunosuppressive therapy (see 4.4 Special warnings and special precautions for use), no significant clinical interaction with other treatments or biological products has been documented.
Razen v primerih imunosupresivnega zdravljenja (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi) niso znane pomenljive klinične interakcije z drugimi zdravljenji ali biološkimi proizvodi.
If you forget to take HEXAVAC: Your doctor will decide when to give the missed dose.
Če ste pozabili cepiti otroka s HEXAVAC-om: Vaš zdravnik bo presodil, kdaj naj dobi zamujen odmerek.
HEXAVAC is available in packs of 1, 10, 25 and 50 with or without neddles.
HEXAVAC je na voljo v pakiranjih po 1, 10, 25 in 50 z ali brez igel.
(TRS 673, 1992) Or equivalent antigenic quantity determined by a suitable immunochemical method
(TRS 673, 1992) Ali enakovredna količina antigena določena s primerno imunokemijsko metodo
What HEXAVAC is and what it is used for 2.
Kaj je HEXAVAC in za kaj ga uporabljamo 2.
Adjuvanted on aluminium hydroxide (0.3 mg)
Adsorbirano na: aluminijev hidroksid (0,3 mg)
Vaccination should be postponed in the case of fever or acute disease.
Cepljenje je potrebno preložiti v primeru vročine ali akutnega obolenja.
In subjects who have a history of a severe reaction within 48 hours of a previous injection with a vaccine containing similar components, the course of vaccination should be carefully considered.
Pri osebah, ki imajo anamnezo hude reakcije v 48 urah po predhodni injekciji cepiva s podobno sestavo, je potrebno skrbno preučiti nadaljnji potek cepljenja.
A single bilateral oedematous reaction of the lower limbs and a single, hypotonic hyporesponsive episode have been reported.
Poročali so tudi o eni dvostranski edemski reakciji spodnjih udov in eni hipotonični hipoodzivni epizodi.
Known hypersensitivity to any component of the vaccine or severe reaction after previous administration of the vaccine.
Znana preobčutljivost na katerokoli sestavino cepiva ali huda reakcija po prejšnjem odmerku cepiva.
Storing HEXAVAC 6.
Shranjevanje HEXAVAC-a 6.
If your child is due to be vaccinated with HEXAVAC and other vaccines simultaneously, please ask your doctor for further information.
Če naj bi se vaš otrok sočasno cepil s HEXAVAC-om in drugim cepivom, se posvetujte z zdravnikom.
Psychiatric disorders: Agitation / Sleep disorder.
Psihiatrične motnje: razburjenje / motnje spanja.
Preclinical data including single-dose, repeated dose and local tolerance studies revealed no unexpected findings and no target organ toxicity.
Predklinični podatki o varnosti vključno s študijami enkratnega odmerka, večkratnih odmerkov in lokalne tolerance niso pokazali nepričakovanih rezultatov in strupenosti za tarčne organe.
Convulsions with or without fever, occurring within 3 days of vaccination.
Krči z ali brez vročine, ki se pojavijo v 3 dneh po cepljenju.
FURTHER INFORMATION
Dodatne informacije
As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established.
Kot pri drugih cepivih proti hepatitisu B, v veliko primerih vzročna povezava s cepivom ni bila dokazana.
In these circumstances the vaccination course should be continued with vaccine not containing a pertussis component.
V teh primerih je potrebno program cepljenja nadaljevati s cepivom, ki ne vsebuje komponente proti oslovskemu kašlju.
Do not use after the expiry date stated on the label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
HEXAVAC should under no circumstances be administered intravascularly.
HEXAVAC se v nobenem primeru ne sme dajati v žilo.
METHOD AND, IF NECESSARY, ROUTE(S) OF ADMINISTRATION Shake well before use.
POSTOPEK IN (ČE JE POTREBNO) POT(I) UPORABE ZDRAVILA Pred uporabo dobro pretresti.
When administered alone PRP induces a serological response, but it is weakly immunogenic in infants.
PRP sam po sebi sicer sproži serološki odziv, vendar je šibko imunogen pri dojenčkih.
In addition, tell your doctor if your child experiences any symptoms that suggest an allergic reaction such as rash, redness, itching, pallor or oedema after any dose in the vaccination series.
Poleg tega svojega zdravnika obvestite, če ima vaš otrok kakršnekoli simptome, ki nakazujejo alergijsko reakcijo, kot so: izpuščaj, rdečina, srbečica, bledica ali edem, po kateremkoli odmerku cepiva.
Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
Trajajoč in neutolažljiv jok, ki traja ≥ 3 ure in se pojavi v 48 urah po cepljenju.
• Clinical trials experience
• Izkušnje iz kliničnih poskusov
For needle free syringes, the needle should be pushed firmly on to the end of the prefilled syringe and rotated through 90 degrees.
Pri injekcijskih brizgah brez igle je treba iglo trdno nasaditi na konec injekcijske brizge in jo zavrteti za 90 stopinj.
As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of vaccine.
Kot pri vseh cepivih, ki se injicirajo, mora biti na voljo primerno zdravljenje in zdravniški nadzor za takojšnje ukrepanje za primer razvoja redke anafilaktične reakcije po cepljenju .
Immune response after primary vaccination
Imunski odziv po primarnem cepljenju
Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the antibody response might be limited.
Vendar pa je cepljenje oseb s kronično imunsko pomanjkljivostjo (npr. okužbo s HIV) priporočljivo navkljub morebitnemu omejenemu protitelesnemu odzivu.
• Potential undesirable effects
• Možni neželeni učinki
For excipients, see 6.1
Za pomožne snovi glejte 6.1.
In clinical trials, more than 3,900 infants and 4,400 toddlers (from 12 to 20 months of age) have received HEXAVAC.
V kliničnih poskusih je prejelo HEXAVAC več kot 3.900 dojenčkov in 4.400 malčkov (med 12. in 20. mesecem starosti).
Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination.
Kolaps ali šokovno stanje (hipotoničnost-hipoodzivnost) v 48 urah po cepljenju.
For any information about this medicinal product, 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.
They were mostly mild, generally lasting for up to 72 hours and resolved spontaneously.
Večinoma so bili blagi in običajno niso trajali dlje kot 72 ur ter so izzveneli sami od sebe.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose = 0.5 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek = 0,5 ml
After a 3, 5, 12 months schedule, immune responses were compatible with the sought clinical protection and of the same magnitude as those reported previously for HEXAVAC or other licensed combination vaccines during the second year of life
Po programu cepljenja v 3., 5. in 12. mesecu so bili imunski odzivi skladni z iskano klinično zaščito in enakega obsega, kot tisti poročani za HEXAVAC ali druga odobrena kombinirana cepiva v drugem letu življenja.
Not all pack sizes may be marketed.
Ni nujno, da so v prometu vsa pakiranja.