natgillin/translations-raw huggingface dataset:
After removing theNovoLet from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Potem, ko Mixtard NovoLet vzamete iz hladilnika, ga je priporočljivo pustiti, da doseže sobno temperaturo, preden insulin resuspendirate po navodilu za prvo uporabo.
Mixtard should not be disposed of via wastewater or household waste.
235 Zdravila Mixtard ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Please read the following instructions carefully before using your Mixtard 50 NovoLet.
Navodilo za uporabo Mixtard 50 NovoLet
Mixtard 50 NovoLet is a simple, compact pre-filled pen.
Mixtard 50 NovoLet je preprost, kompakten, napolnjen injekcijski peresnik.
Mixtard 50 NovoLet is designed to be used with NovoFine needles.
Mixtard 50 NovoLet je namenjen za uporabo z iglami NovoFine.
Getting started
237 Začetek
Check the label to make sure that your Mixtard 50 NovoLet contains the correct type of insulin.
Preverite nalepko in se prepričajte, da vaš Mixtard 50 NovoLet vsebuje pravo vrsto insulina.
Repeat this movement at
Če je preostalo manj kot 12 enot, uporabite nov peresnik Mixtard 50 NovoLet. • Peresnik premikajte gor in dol med položajema a in b ter nazaj (slika A), tako da se steklena kroglica premika z enega konca vložka na drugega.
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine needle • Screw the needle straight and tightly onto Mixtard 50 NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Premikanje je treba vedno ponavljati, dokler tekočina ni enakomerno bela in motna. • Po resuspendiranju brez odlašanja opravite vse ostale korake za injiciranje. • Dezinficirajte gumijasto membrano z medicinskim zložencem. • Za vsako injiciranje vedno uporabite novo iglo, da preprečite kontaminacijo. • Odstranite zaščitno nalepko z igle NovoFine. • Iglo naravnost in trdno privijte na Mixtard 50 NovoLet (slika B). • Snemite veliki zunanji pokrovček in notranji pokrovček igle.
To avoid injection of air and ensure proper dosing: • Hold Mixtard 50 NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Da boste preprečili injiciranje zraka in zagotovili pravilno odmerjanje: • Držite Mixtard 50 NovoLet tako, da je igla obrnjena navzgor.
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Mixtard 50 NovoLet horizontally.
Če ni, zasučite pokrovček, dokler ni potisni gumb povsem dol. • Držite Mixtard 50 NovoLet vodoravno.
To select 26 units:
239 Nastavitev 26 enot:
• Replace the big outer needle cap and unscrew the needle.
240 • Veliki zunanji pokrovček igle namestite nazaj in iglo odvijte.
Close your Mixtard 50 NovoLet fully with 0 next to the dosage indicator.
Mixtard 50 NovoLet povsem zaprite; 0 mora biti na kazalniku odmerka.
Dispose of your used Mixtard 50 NovoLet carefully without the needle attached.
Odrabljeni peresnik Mixtard 50 NovoLet pazljivo zavrzite; pazite, da boste pred tem z njega odstranili iglo.
Your Mixtard 50 NovoLet is designed to work accurately and safely.
Vaš Mixtard 50 NovoLet je izdelan za natančno in varno delovanje.
Do not refill Mixtard 50 NovoLet.
Peresnika Mixtard 50 NovoLet se ne sme znova polniti 50 NovoLet.
You can clean the exterior of your Mixtard 50 NovoLet by wiping it with a medicinal swab.
Zunanjost peresnika Mixtard 50 NovoLet lahko očistite tako, da ga obrišete z medicinskim zložencem.
INFORMATION FOR THE USER
241 NAVODILO ZA UPORABO
235 Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
242 Vaša potreba po insulinu se lahko spremeni, če uporabljate tudi: peroralna antidiabetična zdravila, zaviralce monoaminooksidaze (MAOI), zaviralce receptorjev beta, zaviralce ACE, acetilsalicilno kislino, anabolne steroide, sulfonamide, oralne kontraceptive, tiazide, glukokortikoide, zdravljenje s ščitničnimi hormoni, beta- simpatikomimetike, rastni hormon, danazol, oktreotid in lanreotid.
► In insulin infusion pumps ► If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Mixtard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
Ne uporabljajte zdravila Mixtard, v insulinskih infuzijskih črpalkah. ► če InnoLet pade, se poškoduje ali z njim kam udarite, ker obstaja nevarnost za puščanje ► insulina. če ni bilo shranjeno pravilno ali je zamrznilo (glejte poglavje 6.
236 unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
243 Če čutite, da se pojavlja hipa, si ne dajajte insulina.
237 Changes at the injection site (Lipodystrophy).
Spremembe na mestu injiciranja (lipodistrofija).
After removing the InnoLet from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Potem, ko Mixtard InnoLet vzamete iz hladilnika, ga je priporočljivo pustiti, da doseže sobno temperaturo, preden insulin resuspendirate po navodilu za prvo uporabo.
238 7.
245 7.
Not all packs may be marketed.
Izgled zdravila Mixtard in vsebina pakiranja Suspenzija za injiciranje je motna, bela, vodna suspenzija, opremljena v pakiranjih z 1, 5 ali 10 napolnjenih injekcijskih peresnikov po 3 ml vialami (na trgu lahko ni vseh navedenih pakiranj).
239 Information on how to use Mixtard 30 InnoLet
Navodilo za uporabo Mixtard 30 InnoLet
Please read the following instructions carefully before using your Mixtard 30 InnoLet.
Preden uporabite Mixtard 30 InnoLet, natančno preberite to navodilo.
Introduction
246 Uvod
Mixtard 30 InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Mixtard 30 InnoLet je preprost, kompakten, napolnjen injekcijski peresnik, s katerim je mogoče injicirati od 1 do 50 enot v korakih po 1 enoto.
Mixtard 30 InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
Mixtard 30 InnoLet je namenjen za uporabo z iglami NovoFine S, dolgimi 8 mm ali manj.
Preparing for injection
247 Priprava na injiciranje
Check the label to make sure that your Mixtard 30 InnoLet contains the correct type of insulin.
Preverite nalepko in se prepričajte, da vaš Mixtard 30 InnoLet vsebuje pravo vrsto insulina.
If there are less than 12 units left, use a new Mixtard 30 InnoLet • Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times.
Če je preostalo manj kot 12 enot, uporabite nov peresnik Mixtard 30 InnoLet. • Peresnik premikajte gor in dol med položajema A in B ter nazaj, tako da se steklena kroglica premika z enega konca vložka na drugega (slika 1A).
• Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine S needle • Screw the needle straight and tightly onto Mixtard 30 InnoLet (picture 1B) • Pull off the big outer needle cap and the inner needle cap.
• Dezinficirajte gumijasto membrano z medicinskim zložencem. • Za vsako injiciranje vedno uporabite novo iglo, da preprečite kontaminacijo. • Odstranite zaščitno nalepko z igle s kratkim pokrovčkom NovoFine S. • Iglo naravnost in trdno privijte na Mixtard 30 InnoLet (slika 1B). • Snemite veliki zunanji pokrovček in notranji pokrovček igle.
1B
248 1B
To avoid injection of air and ensure proper dosing: • Dial 2 units by turning the dose selector clockwise • Hold Mixtard 30 InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (picture 1C). • Keeping the needle upwards, press the push-button and the dose selector returns to zero • A drop of insulin must appear at the needle tip.
Da boste preprečili injiciranje zraka in zagotovili pravilno odmerjanje: • Nastavite 2 enoti z obračanjem izbirnika odmerka v smeri urnega kazalca. • Podržite Mixtard 30 InnoLet tako, da je igla obrnjena navzgor, in s prstom nekajkrat narahlo potrkajte po vložku, da se bodo zračni mehurčki zbrali na vrhu injekcijskega vložka (slika 1C). • Z iglo obrnjeno navzgor pritisnite potisni gumb in izbirnik odmerka se vrne na ničlo. • Na konici igle se mora pokazati kapljica insulina.
2
249 2
Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.
250 delavci, sorodniki in drugi, ki skrbijo za vas, morajo upoštevati splošne previdnostne ukrepe za odstranjevanje in odlaganje igel, da ne bi prišlo do nehotenih vbodov z iglo.
Dispose of your used Mixtard 30 InnoLet carefully without the needle attached.
Odrabljeni peresnik Mixtard 30 InnoLet pazljivo zavrzite; pazite, da boste pred tem z njega odstranili iglo.
Your Mixtard 30 InnoLet is designed to work accurately and safely.
Vaš Mixtard 30 InnoLet je izdelan za natančno in varno delovanje.
Do not refill Mixtard 30 InnoLet.
Peresnika Mixtard 30 InnoLet se ne sme znova polniti.
You can clean your Mixtard 30 InnoLet by wiping it with a medicinal swab.
Zunanjost peresnika Mixtard 30 InnoLet lahko očistite tako, da ga obrišete z medicinskim zložencem.
INFORMATION FOR THE USER
251 NAVODILO ZA UPORABO
How to store Mixtard 7.
Shranjevanje zdravila Mixtard 30 FlexPen 7.
244 Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
252 Vaša potreba po insulinu se lahko spremeni, če uporabljate tudi: peroralna antidiabetična zdravila, zaviralce monoaminooksidaze (MAOI), zaviralce receptorjev beta, zaviralce ACE, acetilsalicilno kislino, anabolne steroide, sulfonamide, oralne kontraceptive, tiazide, glukokortikoide, zdravljenje s ščitničnimi hormoni, beta- simpatikomimetike, rastni hormon, danazol, oktreotid in lanreotid.
► In insulin infusion pumps ► If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Mixtard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
Ne uporabljajte zdravila Mixtard, v insulinskih infuzijskih črpalkah; ► če vložek FlexPen pade, se poškoduje ali z njim kam udarite, ker obstaja nevarnost in ► puščanje insulina; če ni bilo shranjeno pravilno ali je zamrznilo (glejte poglavje 6.
245 If you get any of these signs. eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Če se pojavi kateri od teh znakov, zaužijte tablete glukoze ali prigrizek, ki vsebuje veliko sladkorja (bonbone, piškote, sadni sok), in nato počivajte.
Don’ t take any insulin if you feel a hypo coming on.
253 Če čutite, da se pojavlja hipa, si ne dajajte insulina.
If you notice your skin pitting or
Če na mestu injiciranja opazite ugreznjenost ali izbočenost kože, morate to povedati zdravniku ali medicinski sestri.
246 thickening at the injection site, tell your doctor or nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
254 Takšne reakcije namreč lahko postanejo hujše ali spremenijo absorpcijo insulina, če ga injicirate na takšno mesto.
After removing theFlexPen from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Potem, ko Mixtard FlexPen vzamete iz hladilnika, ga je priporočljivo pustiti, da doseže sobno temperaturo, preden insulin resuspendirate po navodilu za prvo uporabo.
247 7.
255 7.
248 Introduction
Uvod
Please read the following instructions carefully before using your Mixtard 30 FlexPen.
Preden uporabite Mixtard 30 FlexPen, natančno preberite ta navodila
Your FlexPen is a unique dial-a-dose insulin pen.
256 Vaš FlexPen je edinstven insulinski peresnik z gumbom za nastavitev odmerka.
Mixtard 30 FlexPen Pen cap
Mixtard 30 FlexPen pokrovček peresnika
Preparing your Mixtard FlexPen
Priprava peresnika Mixtard 30 FlexPen
Pull off the pen cap.
257 Snemite pokrovček peresnika.
250 D
258 D
G
259 G
I
260 I
252 Turning the dose selector will not inject insulin.
Z vrtenjem izbirnika odmerka ne boste injicirali insulina.
L
261 L
253
262
What is M-M-RVAXPRO?
Kaj je zdravilo M- M- RVAXPRO?
M-M-RVAXPRO is a vaccine against measles, mumps, and rubella (German measles).
Zdravilo M- M- RVAXPRO je cepivo proti ošpicam, mumpsu in rdečkam.
It is a powder and solvent to be made up into a suspension for injection.
Je v obliki praška in vehikla, iz katerih se pripravi suspenzija za injiciranje.
The active substances are attenuated (weakened) viruses for the diseases.
Zdravilne učinkovine so oslabljeni virusi za navedene bolezni.
What is M-M-RVAXPRO used for?
Za kaj se zdravilo M- M- RVAXPRO uporablja?
M-M-RVAXPRO is used to vaccinate against measles, mumps, and rubella, individuals 12 months or older.
Cepivo M- M- RVAXPRO se uporablja za cepljenje proti ošpicam, mumpsu in rdečkam v starosti od 12 mesecev dalje.
How is M-M-RVAXPRO used?
Kako se zdravilo M- M- RVAXPRO uporablja?
M-M-RVAXPRO is given by a doctor or nurse who will inject the suspension subcutaneously (just under the skin) into the upper arm or thigh.
Suspenzijo cepiva M- M- RVAXPRO injicira zdravnik ali medicinska sestra subkutano (tik pod kožo) v nadlaket ali stegno.
Individuals 12 months or older should receive one dose.
V starosti nad 12 mesecev cepimo z enim odmerkom cepiva.
A second dose may be given at least 4 weeks after the first dose.
Lahko se cepi še z drugim odmerkom najmanj 4 tedne po prvem cepljenju.
The second dose is intended for people who did not respond to the first dose for any reason.
Drugi odmerek je namenjen osebam, ki se iz kakršnegakoli vzroka niso odzvale na prvi odmerek.
There is no information on the safety and effectiveness of M-M-RVAXPRO in infants below 12 months.
Ni podatkov o varnosti in učinkovitosti cepiva M - M- RVAXPRO za uporabo pri otrocih, mlajših od 12 mesecev.
How does M-M-RVAXPRO work?
Kako zdravilo M- M- RVAXPRO deluje?
M-M-RVAXPRO is a vaccine.
Zdravilo M- M- RVAXPRO je cepivo.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) naučijo obrambe pred boleznijo.
M-M-RVAXPRO contains small amounts of weakened forms of the viruses that cause measles, mumps, and rubella.
Cepivo M- M- RVAXPRO vsebuje majhne količine oslabljenih oblik virusov, ki povzročajo ošpice, mumps in rdečke.
When a person is given the vaccine, the immune system recognises the weakened viruses as ‘ foreign’ and makes antibodies against them.
Ko cepimo, imunski sistem prepozna oslabljene viruse kot „ tuje “ in izdela protitelesa, usmerjena proti njim.
In the future, the immune system will be able to produce antibodies quicker when it is again exposed to the viruses.
Ob ponovni izpostavitvi virusom v prihodnosti bo imunski sistem izdelal protitelesa hitreje.
The antibodies will help to protect against diseases caused by these viruses.
Protitelesa bodo pripomogla pri zaščiti pred boleznim, ki jih povzročajo ti virusi.
M-M-RVAXPRO is very similar to another presentation of the measles, mumps and rubella vaccine already authorised (M-M-R II) but with a slight difference: where the existing presentation is manufactured with a protein, albumin, that is extracted from human serum (the liquid part of the blood); M-M-RVAXPRO is manufactured with the same protein, but made using ‘ recombinant DNA technology’ (a technique where a yeast is given a gene (DNA) that makes it able to produce human albumin).
Zdravilo M- M- RVAXPRO je zelo podobno drugi obliki cepiva proti ošpicam, mumpsu in rdečkam, ki je že odobreno (M- M- R II), vendar je nekoliko drugačno: obstoječa oblika je izdelana z beljakovino, albuminom, ki je izločen iz človeškega seruma (tekočega dela krvi); zdravilo M- M- RVAXPRO pa je izdelano z enako beljakovino, ki pa je izdelana s „ tehnologijo rekombinantne DNA “ (tehniko, kjer v kvasovko vnesemo gen (DNA), s katerim lahko tvori človeški albumin).
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V drugi raziskavi so pri drugih 1997 otrocih specifično 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The study measured the ability of the vaccine to make the immune system respond to the viruses.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged preverili eno sestavino cepiva (mumps), da bi ugotovili, ali je koncentracija sestavine v zdravilu M- M - RVAXPRO dovolj visoka, da zagotovi zadostno zaščito pred boleznijo.
What benefit has M-M-RVAXPRO shown during the studies?
Kakšne koristi je zdravilo M- M- RVAXPRO izkazalo med raziskavami?
M-M-RVAXPRO provided the same level of immune response as the measles, mumps, and rubella vaccine containing serum albumin.
Zdravilo M- M- RVAXPRO je povzročilo enako raven imunskega odziva kot cepivo proti ošpicam, mumpsu in rdečkam, ki vsebuje serumski albumin.
The response rates (measuring how the immune system had responded to the viruses) were:
Stopnje odziva (merilo odzivnosti imunskega sistema na viruse) so bile:
98.3% for measles, 99.4% for mumps and 99.6% for rubella.
98, 3% za ošpice, 99, 4% za mumps in 99, 6% za rdečke.
What is the risk associated with M-M-RVAXPRO?
Kakšna tveganja so povezana z zdravilom M- M- RVAXPRO?
The most common side effects in children who were given M-M-RVAXPRO were fever (38.5°C or higher), and injection site reactions (redness, pain, swelling).
Najpogostejša neželena učinka pri otrocih, ki so prejeli cepivo M- M- RVAXPRO, sta bila zvišana telesna temperatura (38, 5 °C ali višja) in reakcija na mestu injiciranja (pordelost, bolečina, oteklina).
For the full list of all side effects reported with M-M-VAXPRO, please see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi cepiva M- M- VAXPRO, najdete v Navodilih za uporabo.
M-M-RVAXPRO should not be used in people who may be hypersensitive (allergic) to any measles, mumps, or rubella vaccine, or to any of the ingredients, including neomycin (an antibiotic).
Cepivo M- M- RVAXPRO se ne sme uporabiti pri osebah, ki utegnejo biti preobčutljive za (alergične na) katerokoli cepivo proti ošpicam, mumpsu in rdečkam ali katerokoli drugo sestavino zdravila, vključno z neomicinom (antibiotik).
M-M-RVAXPRO should not be given during pregnancy, an illness with fever (over 38.5°C), active untreated tuberculosis (TB), or when the patient has any disease that affects their immune system.
Cepivo M- M- RVAXPRO se ne sme uporabiti med nosečnostjo, boleznijo z zvišano telesno temperaturo (nad 38, 5 °C), aktivno nezdravljeno tuberkulozo (TBC) ali če ima bolnik kakršnokoli bolezen, ki vpliva na imunski sistem.
Why has M-M-RVAXPRO been approved?
Zakaj je bilo zdravilo M- M- RVAXPRO odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that M-M-RVAXPRO’ s benefits are greater than its risks for the combined vaccination against measles, mumps, and rubella in individuals 12 months or older.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so za hkratno cepljenje proti ošpicam, mumpsu in rdečkam v starosti od 12 mesecev dalje, koristni učinki cepiva M- M- RVAXPRO večji od tveganja, povezanega z zdravilom.
They recommended that M-M-RVAXPRO be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom M- M- RVAXPRO.
What measures are being taken to ensure the safe use of M-M-RVAXPRO?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila M- M- RVAXPRO?
The Company that makes M-M-RVAXPRO will continue to monitor the side effects to see if using recombinant albumin in the manufacturing process of M-M-RVAXPRO leads to side effects such as allergic reactions.
Podjetje, ki izdeluje cepivo M- M- RVAXPRO bo spremljalo neželene učinke, da se ugotovi, ali uporaba rekombinantnega albumina v postopku izdelave cepiva M- M- RVAXPRO povzroča neželene učinke, kot so alergijske reakcije.
Other information about M-M-RVAXPRO:
Druge informacije o zdravilu M- M- RVAXPRO?
The European Commission granted a marketing authorisation valid throughout the European Union for M-M-RVAXPRO to Sanofi Pasteur MSD SNC on 5 May 2006.
Evropska Komisija je dovoljenje za promet z zdravilom M- M- RVAXPRO, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pasteur MSD SNC dne 5. maja 2006.
The full EPAR for M-M-RVAXPRO is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo M- M- RVAXPRO je na voljo tukaj.
Powder and solvent for suspension for injection
Prašek in vehikel za suspenzijo za injiciranje
1 vial + 1 pre-filled syringe with attached needle
1 viala + 1 napolnjena injekcijska brizga z nameščeno iglo
10 vials + 10 pre-filled syringes with attached needle
10 vial + 10 napolnjenih injekcijskih brizg z nameščenimi iglami
EU/ 1/ 06/ 337/ 012
1/ 2 EU/ 1/ 06/ 337/ 012
Measles, mumps, and rubella vaccine (live).
M- M- RVAXPRO prašek in vehikel za suspenzijo za injiciranje cepivo proti ošpicam, mumpsu in rdečkam (živo)
After reconstitution, one dose (0.5 ml) contains:
Po pripravi cepiva en odmerek (0, 5 ml) vsebuje:
Measles virus1 Enders’ Edmonston strain (live, attenuated)......... not less than 1x103 CCID50* Mumps virus1 Jeryl Lynn™ [Level B] strain (live, attenuated).... not less than 12.5x103 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)............... not less than 1x103 CCID50*
Virus ošpic1, sev Enders ’ Edmonston (živ, oslabljen)................... najmanj 1 x 103 CCID50 * Virus mumpsa1, sev Jeryl Lynn™ [nivo B] (živ, oslabljen).......... najmanj 12, 5 x 103 CCID50 * Virus rdečk2, sev Wistar RA 27/ 3 (živ, oslabljen)......................... najmanj 1 x 103 CCID50 *
*50% cell culture infectious dose 1 produced in chick embryo cells.
* 50- odstotni infektivni odmerek na celični kulturi (CCID – » cell culture infectious dose «) 1 Pridobljen iz celic piščančjih zarodkov.
2 produced in WI-38 human diploid lung fibroblasts.
2 Pridobljen iz človeških diploidnih pljučnih (WI- 38) fibroblastov.
Powder and solvent for suspension for injection.
Prašek in vehikel za suspenzijo za injiciranje
Before reconstitution, the powder is a light yellow compact crystalline cake and the solvent is a clear colourless fluid.
Pred pripravo je prašek svetlo rumen kompakten kristalni skupek, vehikel pa je bistra, brezbarvna tekočina.
M-M-RVAXPRO is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months or older (see section 4.2).
M- M- RVAXPRO je indiciran za hkratno cepljenje proti ošpicam, mumpsu in rdečkam v starosti od 12 mesecev dalje (glejte poglavje 4. 2).
For use in measles outbreaks, or for post-exposure vaccination, or, for use in previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella, see section 5.1.
Uporaba pri izbruhih ošpic ali za poekspozicijsko cepljenje (cepljenje po izpostavitvi bolezni) ali uporaba pri predhodno necepljenih otrocih, starejših od 12 mesecev, ki so v stiku z nosečnicami, dovzetnimi za ošpice, ter osebah, ki so verjetno dovzetne za mumps in rdečke, je opisana v poglavju 5. 1.