FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects.
Slovenian: Priporočila za odmerjanje upoštevajo dostopne podatke o varnosti in imunogenosti iz kliničnih študij pri zdravih preiskovancih.
English: The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP
Slovenian: Cikel PSUR za zdravilo mora slediti polletnemu ciklu dokler CHMP ne odloči drugače.
English: Vaccination is not currently recommended in this age group.
Slovenian: Za to starostno skupino cepljenje trenutno ni priporočeno.
English: None of the ingredient in the vaccine can cause flu.
Slovenian: Sestavine cepiva ne morejo povzročiti gripe.
English: • The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the batch number.
Slovenian: • Minimalne podatkovne elemente, ki jih je treba sporočiti v vsakem poročilu, da se olajša vrednotenje in identifikacija uporabljenega cepiva pri posamezni osebi, vključno z imenom cepiva, izdelovalcem ter številko serije.
English: For the adjuvant, see section 2.
Slovenian: Za adjuvans glejte poglavje 2.
English: A protective response may not be elicited in all vaccinees (see section 5.1).
Slovenian: Zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah (glejte poglavje 5.1).
English: Although Focetria in multidose vials contains a preservative that inhibits microbial growth, minimisation of the risk of contamination of the multidose vial during withdrawal of each dose is the responsibility of the user.
Slovenian: Čeprav vsebuje cepivo Focetria v večodmerni viali konzervans, ki zavira rast mikrobov, je minimiranje tveganja onesnažitve večodmerne viale med odvzemom vsakega odmerka odgovornost uporabnika.
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, unexpected severe adverse reactions, adverse events of special interest (AESI).
Slovenian: • Neželene učinke, ki imajo pri prijavljanju prednost, tj. smrtne in življenje ogrožajoče neželene učinke, nepričakovane hude neželene učinke, neželene dogodke posebnega pomena (AESI).
English: 9.75 milligrams polysorbate 80
Slovenian: 9,75 miligramov polisorbat 80
English: The multidose vial should preferably be used within 24 hours after first withdrawal.
Slovenian: Najbolje je, da večodmerno vialo porabite v 24 urah po odvzemu prvega odmerka.
English: The vaccine will be injected into a muscle (usually in the upper arm).
Slovenian: Cepivo vam bodo injicirali v mišico (ponavadi v nadlaket).
English: Pharmacotherapeutic group: Vaccines.
Slovenian: Farmakoterapevtska skupina: cepiva.
English: What you need to know before you receive FOCETRIA
Slovenian: Kaj morate vedeti, preden boste prejeli cepivo FOCETRIA
English: Packs of 10.
Slovenian: Pakiranja po 10.
English: • If a specific notification system has been put in place, how to report adverse reactions.
Slovenian: • Način poročanja, če je vzpostavljen poseben sistem poročanja o neželenih učinkih.
English: It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
Slovenian: Na splošno velja, da je učinek adjuvansa, ki poveča imunogenost cepiva, povezan z nekoliko večjo pogostnostjo lokalnih reakcij (večinoma blagih bolečin) v primerjavi z običajnimi cepivi proti gripi brez adjuvansov.
English: • Official batch release In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: 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.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: You or your child will receive one dose of 0.5 ml vaccine.
Slovenian: Vi ali vaš otrok boste dobili en odmerek 0.5 ml cepiva.
English: * propagated in eggs ** expressed in microgram haemagglutinin.
Slovenian: * razmnožen v jajcih ** izraženo v mikrogramih hemaglutinina
English: Adjuvant MF59C.1 containing: squalene
Slovenian: Adjuvans MF59C.1 vsebuje: skvalen
English: Immunogenicity data obtained at three weeks after one dose of Focetria H1N1v suggest that a single dose may be sufficient.
Slovenian: Podatki o imunogenosti, dobljeni tri tedne po enem odmerku cepiva Focetria H1N1v kažejo, da en sam odmerek zadošča.
English: Focetria should be used in accordance with Official Guidance.
Slovenian: Cepivo Focetria je treba uporabljati v skladu z uradnimi priporočili.
English: In the clinical studies with the vaccine, most side effects were mild in nature and short term.
Slovenian: V kliničnih študijah s cepivom je bila večina neželenih učinkov blagih in kratkotrajnih.
English: Health care providers need to assess the benefits and potential risks of administering Focetria vaccine to pregnant women, taking into consideration official recommendations.
Slovenian: Zdravstveni delavci morajo oceniti koristi in morebitna tveganja dajanja cepiva Focetria nosečnicam in pri tem upoštevati uradna priporočila.
English: • The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Focetria.
Slovenian: • Imetnik dovoljenja za promet z zdravilom se bo dogovoril z državami članicami o mehanizmih, ki bodo bolnikom in zdravnikom omogočali stalen dostop do posodobljenih informacij o cepivu Focetria.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Slovenian: Kot pri vseh cepivih, ki se injicirajo, morata biti ustrezno zdravljenje in zdravstveni nadzor vedno na voljo za primer redkih anafilaktičnih reakcij po uporabi cepiva.
English: These side effects usually disappear within 1-2 days without treatment.
Slovenian: Ti neželeni učinki navadno izginejo v 1 do 2 dneh brez zdravljenja.
English: • The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Slovenian: • Imetnik dovoljenja za promet z zdravilom se bo dogovoril z državami članicami o ukrepih za lažjo identifikacijo in sledljivost cepiva proti virusu A/H1N1, ki se bo uporabilo pri posameznem bolniku, da bi se zmanjšale napake pri uporabi zdravila ter v pomoč bolnikom in zdravnikom pri poročanju o neželenih učinkih.
English: The physician should inform you about the possibility to experience convulsion, in particular if you have had previous history of epilepsy.
Slovenian: Zdravnik vas mora obvestiti o možnosti, da boste doživeli krče, zlasti, če imate (ali ste v preteklosti imeli) epilepsijo.
English: Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescriptionor have recently been given any other vaccine.
Slovenian: Obvestite svojega zdravnika ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta, ali če ste se pred kratkim cepili z drugim cepivom.
English: This vaccine in a multi-dose vial contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Slovenian: To cepivo v večodmernem vsebniku vsebuje tiomersal kot konzervans in obstaja možnost, da se pri vas pojavi alergijska reakcija.
English: One dose of 0.5 ml at an elected date.
Slovenian: En odmerek 0,5 ml se uporabi na izbrani datum.
English: The side effects listed below have occurred in the days or weeks after vaccination with Focetria.
Slovenian: Spodaj navedeni neželeni učinki so se pojavili v dneh ali tednih po cepljenju s cepivom Focetria.
English: You should discuss with your doctor whether you should receive Focetria taking into consideration official recommendation based on post-marketing reported adverse events during second and third trimesters of pregnancy.
Slovenian: Posvetujte se s svojim zdravnikom, ali se lahko cepite s cepivom Focetria, pri čemer je treba upoštevati uradna priporočila na osnovi neželenih učinkov, o katerih so poročali v obdobju trženja zdravila, v drugem in tretjem trimesečju nosečnosti.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: In the event that a second dose is to be administered it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Focetria with other H1N1v vaccines.
Slovenian: V kolikor se daje drugi odmerek cepiva, se je treba zavedati, da ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi potrjevali zamenljivost cepiva Focetria z drugimi cepivi proti H1N1v.
English: The common reactions usually disappear within 1-2 days without treatment.
Slovenian: Pogosti neželeni učinki navadno izginejo v 1-2 dneh brez zdravljenja.
English: Safety data after the first and second dose in children and adolescents suggest a comparable safety profile with that reported for the H5N1 mock-up vaccine formulation.
Slovenian: Varnostni podatki po prvem in drugem odmerku za otroke in mladostnike kažejo varnostni profil, ki je primerljiv z varnostnim profilom modelnega cepiva H5N1.
English: The MAH shall perform the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet in vseh nadaljnih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Slovenian: Zato mora zdravnik oceniti koristi in možna tveganja uporabe cepiva pri osebah s trombocitopenijo ali kakršno koli motnjo strjevanja krvi, ki bi bila kontraindikacija za intramuskularno injiciranje, razen če možna korist odtehta tveganje krvavitve.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: • Safety and immunogenicity data obtained after administration of a one or two doses of Focetria
Slovenian: • Podatki o varnosti in imunogenosti, dobljeni po uporabi enega ali dveh odmerkov cepiva
English: Children aged less than 6 months:
Slovenian: Otroci, mlajši od 6 mesecev:
English: These transitory false positive results may be due to IgM production in response to the vaccine.
Slovenian: Prehodno lažno pozitivni rezultati so lahko posledica nastajanja protiteles IgM kot odziv na cepivo.
English: Immunisation should be postponed in patients with severe febrile illness or acute infection.
Slovenian: Cepljenje pri bolnikih s hudo febrilno boleznijo ali akutno okužbo naj se preloži.
English: Thiomersal:
Slovenian: Tiomersal:
English: • Studies in adults and elderly:
Slovenian: • Študije z odraslimi in starostniki:
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Slovenian: To zdravilo vsebuje tiomersal (živosrebrova organska spojina) kot konzervans, zato lahko pride do senzibilizacije (glejte poglavje 4.4).
English: Side effects from clinical studies in children
Slovenian: Neželeni učinki v kliničnih preskušanjih z otroki
English: This medicinal contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium free.
Slovenian: To cepivo vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek 0,5 ml, kar pomeni, da je v bistvu brez natrija in kalija.
English: There is a further immune response to a second dose of 0.5 ml administered after an interval of three weeks.
Slovenian: Obstaja dodatni imunski odziv na drugi odmerek 0,5 ml, uporabljen po presledku 3 tednov.
English: Other medicines and Focetria
Slovenian: Druga zdravila in cepivo Focetria
English: - Via Fiorentina, 1 - Siena, Italy.
Slovenian: - Via Fiorentina, 1 - Siena, Italija.
English: Therefore, the relevant SmPC wording currently stating the limited availability of clinical data in pregnant women, is recommended to be changed to reflect the newly available information.
Slovenian: Zato se priporoča sprememba besedila SmPC, ki opisuje omejeno razpoložljivost kliničnih podatkov o nosečnicah, da bo odražalo nove podatke.
English: Additional information is available from the studies conducted with a vaccine similar in composition to Focetria but containing antigen derived from H5N1 viruses.
Slovenian: Dodatne informacije so na voljo iz študij, izvedenih s cepivom podobne sestave, kot je sestava cepiva focetria, a z antigenom, pridobljenim iz virusov H5N1.
English: • The MAH shall agree with Member States on the provision of a targeted communication to healthcare professionals which should address the following:
Slovenian: • Imetnik dovoljenja za promet z zdravilom se bo dogovoril z državami članicami o zagotavljanju ciljanega obveščanja za zdravnike, ki mora obravnavati naslednje:
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the marketing authorisation, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet vzpostavljen in deluje, preden začne tržiti cepivo in ves čas trženja cepiva.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Slovenian: Cepljenje je treba opraviti z intramuskularnim injiciranjem po možnosti v deltoidno mišico ali v anterolateralni predel stegna (odvisno od mišične mase).
English: Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C (36° and 46° F).
Slovenian: Med uporabami shranjujte večodmerno vialo pod priporočenimi pogoji shranjevanja med 2 °C in 8 °C.
English: Like all medicines, Focetria can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi cepivo Focetria neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Record date and time of the first dose withdrawal on the vial label.
Slovenian: Datum in čas odvzema prvega odmerka zabeležite na nalepki viale.
English: 1.175 milligrams
Slovenian: 1,175 miligramov
English: Rare: Low blood platelet count which can result in bleeding or bruising.
Slovenian: Redki: Zmanjšano število trombocitov v krvi, kar lahko povzroči krvavitve ali modrice.
English: GMR (95% CI)
Slovenian: GMR (95-% IZ)
English: 1.175 milligrams sorbitan trioleate
Slovenian: 1,175 miligramov sorbitantrioleat
English: Elderly (>60 years):
Slovenian: Starostniki (>60 let):
English: Paediatric population Children and adolescents 6 months to 17 years of age
Slovenian: Pediatrična populacija Otroci in mladostniki, stari od 6 mesecev do 17 let
English: Postmarketing spontaneously reported adverse events, an interventional study and large observational studies do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Slovenian: Neželeni učinki, o katerih so spontano poročali v obdobju trženja zdravila, intervencijska študija in velike opazovalne študije ne kažejo na neposredne ali posredne škodljive učinke izpostavljenosti cepiva Focetria na nosečnost.
English: A second dose of vaccine should be given after an interval of at least three weeks.
Slovenian: Drugi odmerek cepiva se uporabi po presledku vsaj 3 tednov.
English: Tell the doctor requesting these tests that you have recently been given Focetria.
Slovenian: Obvestite zdravnika, ki vas je napotil na takšne preiskave, da ste se pred nedavnim cepili s cepivom Focetria.
English: Rare: Transient thrombocytopenia.
Slovenian: Redki: Prehodna trombocitopenija.
English: What Focetria is and what it is used for What you need to know before you receive Focetria How Focetria is given
Slovenian: Kaj je cepivo Focetria in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Focetria Kako boste prejeli cepivo Focetria Možni neželeni učinki
English: Adverse reactions from clinical trials with the mock-up vaccine are listed below.
Slovenian: Neželeni učinki v kliničnih preskušanjih z modelnim cepivom so navedeni spodaj.
English: Adults (18-60 years):
Slovenian: Odrasli (18-60 let):
English: What Focetria looks like and contents of the pack Focetria is a milky-white liquid.
Slovenian: Videz cepiva Focetria in vsebina pakiranja Cepivo Focetria je mlečno bela tekočina.
English: The safety profile of Focetria was similar to that of the H5N1 mock up vaccines.
Slovenian: Varnostni profil cepiva Focetria je bil podoben varnostnemu profilu modelnih H5N1 cepiv.
English: The side-effects are generally similar to those related to the seasonal flu vaccine.
Slovenian: Neželeni učinki so bili na splošno podobni kot pri cepivu proti sezonski gripi.
English: The incidence of symptoms observed in subjects over 60 years of age was generally lower as compared to the 18-60 years old population.
Slovenian: Pogostnost simptomov, ki so jih opazili pri osebah, starih več kot 60 let, je bila na splošno manjša kot pri populaciji oseb, starih od 18 do 60 let.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: MF59C.1 is an oil/water emulsion containing 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg sorbitan trioleate in a citrate buffer.
Slovenian: MF59C.1 je emulzija iz olja in vode, ki vsebuje 9,75 mg skvalena, 1,175 mg polisorbata 80 in 1,175 mg sorbitantrioleata v citratnem pufru.
English: 7.5 micrograms** per 0.5 ml dose
Slovenian: 7,5 mikrogramov** na odmerek 0,5 ml
English: Do not receive Focetria:
Slovenian: Cepiva Focetria ne smete prejeti:
English: It is recommended that subjects who receive a first dose of Focetria, should complete the vaccination course with Focetria H1N1v (see section 4.4).
Slovenian: Priporočljivo je, da osebe, ki so prejele prvi odmerek cepiva Focetria, cepljenje tudi zaključijo s cepivom Focetria H1N1v (glejte poglavje 4.4).
English: 10 x 10 doses of 0.5 ml vaccine (5 ml)
Slovenian: 10 x 10 odmerkov cepiva z 0,5 ml (5 ml)
English: Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Slovenian: Alergijske reakcije, ki so lahko vključevale kratko sapo, sopenje, oteklost grla ali alergijske reakcije, ki povzročijo nevarno znižanje krvnega tlaka, ki lahko, če stanje ni zdravljeno, povzročijo šok.
English: Available clinical data suggest that a single dose may be sufficient.
Slovenian: Klinični podatki, ki so na voljo kažejo, da lahko zadošča en sam odmerek.
English: Particular attention should be given to subjects suffering from epilepsy and the physician should inform the subjects (or parents) about the possibility to experience convulsion.
Slovenian: Posebno pozornost je treba posvetiti osebam, ki imajo epilepsijo, zdravnik pa mora osebe (ali starše) obvestiti o možnosti nastanka konvulzij (glejte poglavje 4.8).
English: Prophylaxis of influenza caused by A (H1N1v) 2009 virus (see section 4.4).
Slovenian: Preprečevanje gripe, ki jo povzroča virus A(H1N1v) 2009 (glejte poglavje 4.4).
English: Some cases were observed in subjects with a history of epilepsy.
Slovenian: Nekatere primere so opazili pri osebah z epilepsijo v anamnezi.
English: Clinical data suggest that a single dose may be sufficient.
Slovenian: Klinični podatki kažejo, da lahko zadošča en sam odmerek.
English: Quantities are expressed per 0.5 ml vaccine dose.
Slovenian: Količine so izražene na 0,5 ml odmerek cepiva.
English: In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Focetria H1N1v:
Slovenian: Poleg neželenih učinkov, o katerih so poročali v kliničnih preskušanjih, so iz izkušenj v obdobju trženja zdravila poročali o naslednjih neželenih učinkih s cepivom Focetria H1N1v:
English: Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Slovenian: Po cepljenju proti gripi so poročali o lažno pozitivnih rezultatih seroloških testov z metodo ELISA za odkrivanje protiteles proti virusu humane imunske pomanjkljivosti 1 (HIV-1), virusu hepatitisa C in zlasti proti virusu HTLV-1.
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-like strains.
Slovenian: Pričakuje se, da cepivo ščiti le pred gripo, ki jo povzročijo sevi, podobni A/California/07/2009 (H1N1)v.
English: Any adverse reaction Local
Slovenian: Kateri koli neželeni učinek Lokalni
English: - The active substance is:
Slovenian: - Zdravilna učinkovina je:
English: The incidence of symptoms observed in subjects over 60 years of age was lower as compared to the 18-60 years old population.
Slovenian: Pogostnost simptomov, ki so jih opazili pri osebah, starih več kot 60 let, je bila manjša kot pri populaciji oseb, starih od 18 do 60 let.
English: Non-clinical data obtained with the mock-up vaccine (MF59C.1-adjuvanted H5N1 vaccine) and with seasonal vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of efficacy, repeated dose toxicity, and reproductive and developmental toxicity.
Slovenian: Neklinični podatki, pridobljeni z modelnim cepivom (cepivo H5N1 z adjuvansom MF59C.1) in sezonskim cepivom, ki je vsebovalo adjuvans MF59C.1, na osnovi običajnih študij učinkovitosti, toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in razvoj ne kažejo posebnih tveganj za človeka.
English: Further, data from vaccinations with seasonal interpandemic inactivated trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Slovenian: Tudi podatki o cepljenjih nosečnic s sezonskimi interpandemičnimi trivalentnimi cepivi ne kažejo, da bi bili neželeni izidi pri plodu in materi lahko posledice cepiva.
English: Do not use Focetria after the expiry date which is stated on the carton and the label.
Slovenian: Cepiva Focetria ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in ovojnini.