natgillin/translations-raw huggingface dataset:
• The CHMP considered the totality of the available non-clinical and clinical data to inform whether adrenaline administered via an auto-injector is delivered intramuscularly or subcutaneously, including submissions by marketing authorisation holders, consultations with healthcare professionals, experts and the Pharmacovigilance Risk Assessment Committee (PRAC).
• odbor CHMP je pretehtal vse razpoložljive neklinične in klinične podatke o intramuskularnem in subkutanem injiciranju adrenalina s samoinjektorji adrenalina, vključno z vlogami imetnikov dovoljenja za promet z zdravilom ter posveti z zdravstvenimi delavci, strokovnjaki in Odborom za oceno tveganja na področju farmakovigilance (PRAC);
• The CHMP considered that the preferred route of administration of adrenaline in an emergency situation has been established as IM, although intravenous administration may be indicated in severe cases.
• odbor CHMP je menil, da je prednostni način uporabe adrenalina v nujnih primerih intramuskularen, čeprav se lahko v hudih primerih uporabi intravensko injiciranje;
However, the CHMP was of the view that PK and PD studies in healthy volunteers representing the broad range of phenotypes, or imaging studies in healthy volunteers to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device could be considered.
Vendar je odbor CHMP menil, da je mogoče upoštevati FK- in FD-študije pri zdravih prostovoljcih, ki predstavljajo širok razpon fenotipov, ali študije s slikanjem pri zdravih prostovoljcih, ki pomagajo razumeti vpliv različnih dejavnikov na razporeditev, izpostavljenost in aktivnost adrenalina, kadar se daje s samoinjektorjem adrenalina.
Furthermore, the CHMP imposed a PK/PD study in order to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device and encouraged the possibility for a study to assess the effectiveness of the proposed risk minimisation measures and the conduct of an observational study to assess usage and incidence of lack of efficacy and device failure.
Poleg tega je odbor CHMP zahteval izvedbo FK-/FD-študije, s katero bi pojasnili vpliv različnih dejavnikov na porazdelitev, izpostavljenost in aktivnost adrenalina, kadar se daje s samoinjektorjem, in spodbudil možnost študije za ocenjevanje učinkovitosti predlaganih ukrepov za zmanjševanje tveganja ter opazovalne študije za ocenjevanje uporabe in primere pomanjkljive učinkovitosti in odpovedi pripomočka.
However, there is agreement that in general STMD is greater than the length of the needles of currently available adrenaline auto-injectors in many patients, both adult and child.
Vendar velja soglasje, da je STMD pri mnogih bolnikih (odraslih in otrocih) večji od dolžine igel trenutno razpoložljivih samoinjektorjev adrenalina.
• The CHMP considered that the efficacy of adrenaline in the treatment of anaphylaxis is wellsupported by anecdotal and retrospective evidence and that the safety of adrenaline is also well-established, and it has demonstrated a strong safety profile particularly with IM administration.
• odbor CHMP je menil, da je učinkovitost adrenalina pri zdravljenju anafilaksije dobro podprta z anekdotičnimi in retrospektivnimi dokazi ter da je varnost adrenalina prav tako dobro podprta.
The CHMP therefore recommended amendments to the product information, in order to reflect the uncertainties in whether a single administration would suffice for any given episode and advise that patients are prescribed two pens which they should carry at all times, to include a recommendation for immediate associates of patients to be trained to use the AAI and to include information on the needle length.
Odbor CHMP je zato priporočil spremembe informacij o zdravilih, tako da bodo odražale nejasnosti, ali je enkratna uporaba zadostna za vse epizode, in svetovale, naj zdravnik bolnikom predpiše dva peresnika, ki ju morajo imeti vedno pri sebi, prav tako pa vključile priporočilo za najbližje pomočnike bolnika, naj se usposobijo v uporabi samoinjektorjev adrenalina, in informacije o dolžini igle.
The CHMP concluded that the benefit-risk balance for adrenaline auto-injectors remains favourable subject to the conditions to the marketing authorisations and taking into account the amendments to the product information and other risk minimisation measures recommended.
Odbor CHMP je zaključil, da je razmerje med tveganji in koristmi samoinjektorjev adrenalina še naprej ugodno pod pogojem, da se upoštevajo pogoji dovoljenj za promet z zdravili ter spremembe informacij o zdravilu in drugi priporočeni ukrepi za zmanjšanje tveganja.
The CHMP agreed that there are many factors that may affect whether the adrenaline is delivered to the muscle or the subcutaneous tissue when an adrenaline auto-injector is used.
Odbor CHMP se je strinjal, da lahko na injiciranje adrenalina v mišico ali podkožno tkivo ob uporabi samoinjektorja adrenalina vpliva več dejavnikov.
The preferred route of administration in an emergency situation has been established as IM, although intravenous administration may be indicated in severe cases.
Prednostni način uporabe v nujnih primerih je intramuskularen, čeprav se lahko v hudih primerih uporabi intravensko injiciranje.
It is widely accepted that IM delivery is superior to SC delivery in achieving the rate of rise and levels of plasma adrenaline that are most effective to treat anaphylaxis.
Na splošno velja, da je intramuskularna uporaba pri doseganju hitrega povišanja ravni adrenalina v plazmi, ki je najučinkovitejše za zdravljenje anafilaksije, boljša od subkutane uporabe.
• The CHMP noted that the product information for the different auto-injectors would benefit from an update to include warnings and precautions on uncertainties in whether a single administration would suffice for any given episode and advise that patients are prescribed two pens which they should carry at all times, training of immediate associates of patients and inclusion of information on the needle length.
• odbor CHMP je ugotovil, da bi bilo v informacije o zdravilu za različne samoinjektorje koristno vključiti opozorila in previdnostne ukrepe glede nejasnosti, ali je enkratna uporaba zadostna za vse epizode, in svetoval, naj zdravnik bolnikom predpiše dva peresnika, ki ju morajo imeti vedno pri sebi, prav tako pa bi bilo koristno vključiti priporočilo za usposabljanje najbližjih pomočnikov bolnikov in informacije o dolžini igle;
The CHMP concluded that the benefit-risk balance for adrenaline auto-injectors remains favourable subject to the agreed changes to the product information and the above-mentioned additional risk minimisation measures.
Odbor CHMP je zaključil, da je razmerje med tveganji in koristmi samoinjektorjev adrenalina še naprej ugodno, če se bodo uvedle dogovorjene spremembe informacij o zdravilu in vključili zgornji ukrepi za zmanjševanje tveganja.
The CHMP also concluded on the need for a PK/PD study to be conducted in order to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device.
• odbor CHMP je sklenil, da obstaja potreba za dodatne ukrepe za zmanjševanje tveganja, kot so izobraževalna gradiva, ki jih je treba predložiti in odobriti prek načrtov obvladovanja tveganja; odbor CHMP je prav tako sklenil, da je treba izvesti FK-/FD-študijo, s katero bi lahko pojasnili vpliv različnih dejavnikov na porazdelitev, izpostavljenost in aktivnost adrenalina, kadar se uporablja s samoinjektorjem adrenalina.
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagatelj v državah članicah
(Invented) Name
(Izmišljeno) Ime
The two new studies provided similar data.
Dve novi študiji sta dali podobne rezultate.
• if your child was born prematurely (before 37 weeks).
• če je bil otrok rojen prezgodaj (pred 37 tednom nosečnosti).
N= number of subjects with available results
N = število oseb z razpoložljivimi rezultati
Dispose of in accordance with local regulations.
Zavrzite v skladu z lokalnimi predpisi.
Efficacy and Safety conclusions
Zaključki o učinkovitosti in varnosti
Therefore the degree of protection that would be afforded is unknown.
Stopnja dosežene zaščite torej ni znana.
• Loss of appetite
• Izguba apetita.
Inject the entire contents of the vial.
Injicirajte celotno vsebino viale.
PACKAGE LEAFLET: INFORMATION FOR THE USER
NAVODILO ZA UPORABO: INFORMACIJE ZA UPORABNIKA
Vaccination is the best way to protect against diseases caused by these bacteria.
Cepljenje je najboljši način zaščite pred boleznimi, ki jih povzročajo te bakterije.
They may also cause severe blood infections and spread throughout the body.
Povzroči lahko tudi hudo okužbo krvi in se razširi po celem telesu.
Remember, however, that no vaccine can provide complete, life-long protection in all people vaccinated.
Zavedati pa se morate, da nobeno cepivo ne more zagotoviti popolne in doživljenjske zaščite pri vseh cepljenih osebah.
Using other medicines or vaccines
Uporaba drugih zdravil in cepiv
At present, the potential implications of these observations for the duration of protection are not known.
Možen vpliv teh ugotovitev na trajanje zaščite trenutno ni znan.
- This vaccine has been prescribed for your child. Do not pass it on to others.
- Cepivo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
If the symptoms start after you have left the clinic, you should get medical help as soon as possible (for example, go to the nearest accident and emergency department).
Če se simptomi pojavijo, ko zapustite ambulanto, morate čimprej poiskati zdravniško pomoč (na primer, pojdite na urgentni oddelek najbližje bolnišnice).
(See sections 4.5 and 5.1)
(Glejte poglavji 4.5 in 5.1).
If it is not used within 24 hours, it should be discarded.
Če cepiva ne aplicirate v 24 urah, ga morate zavreči.
Experimental data show that the reconstituted vaccine could also be kept to 24 hours at ambient temperature (25°C).
Eksperimentalni podatki kažejo, da se lahko rekonstituirano cepivo shranjuje do 24 ur tudi pri sobni temperaturi (25 °C).
Finally, the post-marketing surveillance data from the UK are reassuring.
Nenazadnje pa kot zagotovilo služijo tudi podatki spremljanja po trženju iz Združenega kraljestva.
These issues were referred to the CHMP during the referral procedure under Article 29 of Directive 2001/83/EC, as amended, on 26 April
Ta vprašanja so 26. aprila 2007 posredovali CHMP med postopkom posvetovanja po 29. členu Direktive 2001/83/ES z vsemi spremembami.
• Other possible side effects:
• Drugi možni neželeni učinki:
SBA-MenC results are available for 177 subjects, anti-PRP results for 178 subjects.
Rezultati SBA-MenC so na voljo za 177 oseb, rezultati antiPRP pa za 178 oseb.
Primary vaccination in infants from 2 months up to 12 months of age:
Osnovno cepljenje otrok, starih od 2 do 12 mesecev:
Within one year of completion of the primary series, vaccine effectiveness in the infant cohort was estimated at 93% (95% confidence intervals 67-99%).
V enem letu po dokončanju osnovnega cepljenja, je bila učinkovitost cepiva v kohorti dojenčkov ocenjena na 93 % (95 % interval zaupanja; 67 - 99 %).
Adverse reactions occurring during these studies were mostly reported within 48 hours following vaccination.
V teh študijah so o pojavu neželenih učinkov večinoma poročali v 48 urah po cepljenju.
The conditions of the Marketing Authorisation are set out in Annex IV.
Pogoji dovoljenja za promet z zdravilom so navedeni v Dodatku IV.
Detailed information on this medicine is available on the web site of: [To be completed nationally]
Podrobne informacije o zdravilu so objavljene na spletni strani: [Izpolni država članica]
In line with these conclusions, the CHMP regarded Menitorix (GSK Bio) as acceptable for registration.
Skladno s temi zaključki je odbor CHMP menil, da je zdravilo Menitorix (GSK Bio) sprejemljivo za registracijo.
Immunisation with this vaccine does not substitute for routine tetanus immunisation.
Cepljenje s tem cepivom ni nadomestilo za rutinsko cepljenje proti tetanusu.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MENITORIX
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA MENITORIX
Other possible symptoms of a severe allergic reaction include a drop in blood pressure and unconsciousness.
Drugi možni simptomi hude alergijske reakcije vključujejo nenadno znižanje krvnega tlaka in nezavest.
Effectiveness in all other age groups (up to 18 years) primed with a single dose has so far remained around 90% or more within and more than one year after vaccination.
Učinkovitost pri osebah v vseh ostalih starostnih skupinah (do 18 leta starosti), ki so prejele enkratni odmerek, trenutno ostaja približno 90-odstotna ali večja v času enega leta po cepljenju ali kasneje.
However, more than one year after completion of the primary series, there was clear evidence of waning protection.
Vendar pa so več kot eno leto po dokončanem osnovnem cepljenju opazili pojemanje zaščite.
• if your child has a high temperature (38oC or above) or a severe infection.
• če ima zvišano telesno temperaturo (38 ºC ali višjo) ali hudo okužbo.
Severe allergic reactions can occur to any vaccine but they are very rare and are usually seen in less than 1 in 10,000 people who are vaccinated.
Po cepljenju s katerimkoli cepivom se lahko pojavijo hude alergijske reakcije, ki pa so običajno zelo redke in se pojavijo pri manj kot 1 od 10.000 cepljenih oseb.
The incidence of grade 3 unsolicited symptoms considered to be related to vaccination or booster vaccination in the previously submitted data was very low and similar between study groups.
Pojavnost 3. stopnje nenavedenih simptomov, za katere se meni, da so povezani s cepljenjem ali poživitvenim cepljenjem v prej podanih podatkih, je bila zelo nizka in podobna med skupinami študije.
Menitorix is not intended for use in adults.
Cepivo Menitorix ni namenjeno za uporabo pri odraslih.
Hib infection can also cause a life-threatening inflammation of the throat with severe swelling that can cause suffocation.
Posledica okužbe z bakterijo Hib je lahko tudi življenjsko nevarno vnetje žrela s hudo oteklino, ki lahko povzroči zadušitev.
Different injectable vaccines should always be given at different injection sites.
Različna cepiva za injiciranje je treba vedno injicirati na različna mesta.
5 micrograms conjugated to tetanus toxoid as carrier protein
5 mikrogramov konjugiran na tetanusni toksoid kot nosilni protein
2-3-4 month schedule
Shema 2-3-4 mesec
The presence of a minor infection is not a contraindication for vaccination.
Blažja okužba ni kontraindikacija za cepljenje.
The vaccine works by causing the body to produce its own protection (antibodies) against these bacteria.
Cepivo v telesu spodbudi lastno zaščito (tvorbo protiteles) proti tem bakterijam.
The timing of the booster dose should be in accordance with available official recommendations and should usually be from the age of 12 months onwards and before the age of 2 years.
Čas cepljenja z obnovitvenim odmerkom mora temeljiti na uradnih priporočilih in ga je običajno treba opraviti od starosti 12 mesecev dalje ter pred dopolnjenim drugim letom starosti.
Your child will receive three doses of Menitorix.
Otrok bo prejel tri odmerke cepiva Menitorix.
♦ Very common (in more than 1 per 10 doses of vaccine)
♦ Zelo pogosti (pri več kot 1 od 10 odmerkov cepiva)
WHAT MENITORIX IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO MENITORIX IN ZA KAJ GA UPORABLJAMO
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency as follows.
Neželeni učinki, ki bi vsaj lahko bili povezani s cepivom, so v nadaljevanju navedeni po pogostnosti.
Less commonly, the bacteria can infect other parts of the body, particularly the lungs (causing pneumonia) and the bones and joints.
Bakterija lahko redkeje prizadene druge dele telesa, predvsem pljuča (povzroči pljučnico) in kosti ter sklepe.
Menitorix has been used in UK since September 2006 and three 6-monthly PSURs have been issued to date, with reassuringly low reporting rates and no new safety concerns allowing the Applicant/MAH to conclude that the safety profile is adequately reflected in the Core Safety Information.
Zdravilo Menitorix je v uporabi v Združenem kraljestvu od septembra 2006, do današnjega dne pa so bila izdana tri šestmesečna poročila PSUR, ki potrjujejo nizko stopnjo poročanja in nobenih novih varnostnih zadržkov, zaradi česar predlagatelj/imetnik dovoljenja za promet z zdravilom lahko sklepa, da je varnostni profil primerno odražen v bistvenih informacijah o varnosti.
The revised Product Information (Summary of Product Characteristics, Labelling and Package Leaflet) is set out in Annex II of the Opinion.
Spremenjene informacije o zdravilu (Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo) so navedene v Dodatku II Mnenja.
Estimates of vaccine effectiveness from the UK's routine immunisation programme (using various quantities of three meningococcal group C conjugate vaccines) covering the period from introduction at the end of 1999 to March 2004 have demonstrated the need for a booster dose after completion of the primary series (three doses administered at 2, 3 and 4 months).
Ocene učinkovitosti cepiva iz programa rutinskega cepljenja v Veliki Britaniji (z uporabo različne količine treh konjugiranih cepiv proti meningokokom skupine C, ki pokrivajo obdobje od uvedbe konec leta 1999 do meseca marca 2004 kažejo na potrebnost obnovitvenega odmerka po dokončanju osnovnega cepljenja (cepljenje s tremi odmerki v starosti 2, 3 in 4 mesece).
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
Pred cepljenjem je treba preučiti anamnezo otroka (s poudarkom na predhodnih cepljenjih in morebitnih neželenih učinkih) in opraviti klinični pregled.
Hypersensitivity to the active substances, including tetanus toxoid, or to any of the excipients (see sections 2 and 6.1).
Preobčutljivost za zdravilne učinkovine, vključno s tetanusnim toksoidom, ali katerokoli pomožno snov (glejte poglavji 2 in 6.1).
A minor infection such as a cold should not be a problem but talk to your doctor or nurse first.
Blaga okužba, kot je prehlad, običajno ni težava, vendar se pred cepljenjem vseeno najprej posvetujte z otrokovim zdravnikom ali medicinsko sestro.
Information on the safety of the vaccine when used during pregnancy or lactation is not available.
Podatki o varnosti cepiva med nosečnostjo in dojenjem niso na voljo.
The Applicant/MAH submitted an application for a Marketing Authorisation through the mutual recognition procedure for Menitorix on the basis of the marketing authorisation granted by the UK.
Predlagatelj/imetnik dovoljenja za promet z zdravilom je predložil prošnjo za odobritev dovoljenja za promet z zdravilom s postopkom medsebojnega priznavanja za zdravilo Menitorix na osnovi dovoljenja za promet z zdravilom, ki je bilo izdano v Združenem kraljestvu.
Pharmacotherapeutic group: bacterial vaccines ATC code: J07AG53
Farmakoterapevtska skupina: Bakterijska cepiva, oznaka ATC: J07AG53 Osnovno cepljenje
GlaxoSmithKline, S.A Severo Ochoa, 2 Tres Cantos, Madrid Spain
GlaxoSmithKline, S.ASevero Ochoa, 2 Tres Cantos, Madrid Španija
Estimates of effectiveness based on a small number of cases to date indicate that there may also be waning protection in children who received a single priming dose as toddlers.
Ocene učinkovitosti, ki danes temeljijo še na majhnem številu primerov kažejo, da lahko zaščita pojema tudi pri otrocih, ki so med osnovnim cepljenjem prejeli en sam odmerek.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Furthermore the CHMP considers that data on the persistence of SBA titres for up to 5 years after boosting with Menitorix alone cannot predict the longer-term protective effect of vaccination, which can only be estimated by detailed surveillance of disease and therefore agrees with the proposed revised SPC which accurately and comprehensively reflects the extensive body of data that has already been accumulated with respect to the immunity afforded by this vaccine.
Poleg tega CHMP meni, da podatki o obstoju titrov SBA do pet let po osnovnem cepljenju z zdravilom Menitorix samim ne morejo napovedati zaščitnega učinka cepljenja na daljši rok, ki ga je mogoče oceniti le s podrobnim spremljanjem bolezni, in se zato strinja s predlaganim spremenjenim Povzetkom glavnih značilnosti zdravila, ki natančno in izčrpno odseva obsežen korpus podatkov, ki so jih do sedaj zbrali glede imunosti, ki jo sproži to cepivo.
Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Obvestite svojega zdravnika, če otrok jemlje ali je pred kratkim jemal katerokoli zdravilo, tudi če ste ga dobili brez recepta..
After reconstitution, the vaccine should be administered promptly or kept in the refrigerator (2°C8°C).
Cepivo morate aplicirati takoj po rekonstituciji ali pa ga shraniti v hladilniku (2 °C - 8 °C).
The referral procedure was initiated with UK as the reference member state (RMS), due to concerns raised by the concerned member states Greece, Poland and Spain regarding major safety and efficacy issues and the immunological protection correlates, they considered the submitted clinical documentation insufficient to establish the clinical efficacy and safety of Menitorix, considering the product to be an entirely new conjugated, bivalent vaccine.
Posvetovalni postopek je bil sprožen z Združenim kraljestvom kot referenčno državo članico (RMS), zaradi zadržkov, ki so jih glede ključnih vprašanj varnosti in učinkovitosti ter imunološke zaščite korelatov izrazile države članice Grčija, Poljska in Španija, ki so menile, da je predložena klinična dokumentacija nezadostna za ugotavljanje klinične učinkovitosti in varnosti zdravila Menitorix ob upoštevanju, da je zdravilo povsem novo konjugirano dvovalentno cepivo.
• Irritability
• Razdražljivost.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, težko dihanje in otekanje obraza ali jezika.
Long-term immunogenicity data following the use of Menitorix as a primary and booster vaccination are not yet available (see section 5.1).
Podatki o dolgoročni imunogenosti po osnovnem ali obnovitvenem cepljenju s cepivom Menitorix še niso na voljo (glejte poglavje 5.1).
GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 Ireland
GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 Irska
If you have previously been told by your doctor that your child suffers from nephrotic syndrome (a kidney disease which may result in swelling, particularly around the face or eyes, protein in the urine making it appear frothy and/or weight gain) there may be an increased chance that this condition will reoccur within a few months after vaccination.
Če vam je zdravnik kdaj povedal, da ima otrok nefrotski sindrom (bolezen ledvic, ki ima lahko za posledico otekanje, še posebej obraza ali predela okrog oči, prisotnost beljakovin v urinu, kar povzroči penjenje urina in/ali povečanje telesne mase), se lahko to stanje pri otroku v nekaj mesecih po cepljenju ponovi.
• Neisseria meningitidis group C (MenC): Like Hib bacteria, MenC bacteria most frequently cause meningitis.
• Neisseria meningitidis skupine C (MenC): Podobno kot bakterija Hib tudi bakterija MenC najpogosteje povzroči meningitis.