natgillin/translations-raw huggingface dataset:
Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatine, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid, sodium hydroxide and water for injections.
Sorbitol, natrijev fosfat, kalijev fosfat, saharoza, hidrolizirana želatina, medij 199 s Hanksovimi solmi, MEM, natrijev L- glutamat, neomicin, fenol rdeče, natrijev bikarbonat, klorovodikova kislina, natrijev hidroksid in voda za injekcije
10 single dose vials (powder) and 10 single dose vials (solvent).
Prašek in vehikel za suspenzijo za injiciranje Ena enoodmerna viala (prašek) in ena enoodmerna viala (vehikel) 10 enoodmernih vial (prašek) in 10 enoodmernih vial s pritrjenimi iglami (vehikel)
Intramuscular (IM) or subcutaneous (SC) use.
Intramuskularna (i. m.) ali subkutana (s. c.) uporaba.
Store and transport refrigerated (2°C-8°C) Do not freeze Keep the vial of powder in the outer carton in order to protect from light After reconstitution, use immediately or within 8 hours if stored in a refrigerator
Po pripravi uporabite takoj ali v 8 urah, če ste hranili v hladilniku.
Please read the package leaflet for disposal of medicines no longer required
Za odstranjevanje cepiva, ki ga ne rabite več, prosimo, preberite navodilo za uporabo.
EU/ 1/ 06/ 337/ 001 – pack of 1 EU/ 1/ 06/ 337/ 002 – pack of 10
EU/ 1/ 06/ 337/ 001 - pakiranje po 1 EU/ 1/ 06/ 337/ 002 - pakiranje po 10
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
27 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
M-M-RVAXPRO Powder for suspension for injection.
M- M- RVAXPRO Prašek za suspenzijo za injiciranje
IM or SC use
i. m. ali s. c. uporaba
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
28 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Solvent for M-M-RVAXPRO Water for injections
Vehikel za M- M- RVAXPRO voda za injekcije
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
29 PODATKI NA ZUNANJI OVOJNINI
M-M-RVAXPRO - Powder in vial and solvent in prefilled syringe with attached needle - Pack of 1, 10
M- M- RVAXPRO – prašek v viali in vehikel v napolnjeni injekcijski brizgi s pritrjeno iglo – pakiranje po 1, 10
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps, and rubella vaccine (live)
M- M- RVAXPRO Prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti ošpicam, mumpsu in rdečkam (živo)
not less than 1x103 CCID50* not less than 12,5 x103 CCID50* not less than 1 x103 CCID50*
* 50- odstotni infektivni odmerek na celični kulturi
Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid, sodium hydroxide and water for injections.
Sorbitol, natrijev fosfat, kalijev fosfat, saharoza, hidrolizirana želatina, medij 199 s Hanksovimi solmi, MEM, natrijev L- glutamat, neomicin, fenol rdeče, natrijev bikarbonat, klorovodikova kislina, natrijev hidroksid in voda za injekcije
10 single dose vials (powder) and 10 single dose prefilled syringes with attached needle (solvent).
Prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi Ena enoodmerna viala (prašek) in ena enoodmerna napolnjena injekcijska brizga s pritrjeno iglo (vehikel) 10 enoodmernih vial (prašek) in 10 enoodmernih napolnjenih injekcijskih brizg s pritrjenimi iglami (vehikel)
EU/ 1/ 06/ 337/ 003 – pack of 1 EU/ 1/ 06/ 337/ 004 – pack of 10
EU/ 1/ 06/ 337/ 003 - pakiranje po 1 EU/ 1/ 06/ 337/ 004 - pakiranje po 10
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
31 PODATKI NA ZUNANJI OVOJNINI
M-M-RVAXPRO - Powder in vial and solvent in prefilled syringe without needle - Pack of 1, 10, 20
M- M- RVAXPRO – prašek v viali in vehikel v napolnjeni injekcijski brizgi brez igle – pakiranje po 1, 10, 20
Measles virus Enders’ Edmonston strain (live attenuated) Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) Rubella virus Wistar RA 27/ 3 strain (live attenuated)
Po pripravi cepiva en odmerek (0, 5 ml) vsebuje: najmanj 1 x 103 TCID50 * Virus ošpic, sev Enders ’ Edmonston (živ, oslabljen) najmanj 12, 5 x 103 TCID50 Virus mumpsa, sev Jeryl Lynn™ [nivo B] (živ, oslabljen) najmanj 1 x 103 TCID50 Virus rdečk, sev Wistar RA 27/ 3 (živ, oslabljen)
not less than 1 x103 CCID50* not less than 12,5 x103 CCID50* not less than 1 x103 CCID50*
* 50- odstotni infektivni odmerek na tkivni kulturi
20 single dose vials (powder) and 20 single dose prefilled syringes without needle (solvent).
Prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi Ena enoodmerna viala (prašek) in ena enoodmerna napolnjena injekcijska brizga brez igle (vehikel) 10 enoodmernih vial (prašek) in 10 enoodmernih napolnjenih injekcijskih brizg brez igel (vehikel) 20 enoodmernih vial (prašek) in 20 enoodmernih napolnjenih injekcijskih brizg brez igel (vehikel)
EU/ 1/ 06/ 337/ 005 – pack of 1 EU/ 1/ 06/ 337/ 006 – pack of 10 EU/ 1/ 06/ 337/ 007 – pack of 20
EU/ 1/ 06/ 337/ 005 - pakiranje po 1 EU/ 1/ 06/ 337/ 006 - pakiranje po 10 EU/ 1/ 06/ 337/ 007 - pakiranje po 20
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
33 PODATKI NA ZUNANJI OVOJNINI
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with one unattached needle – Pack of 1, 10, 20
M- M- RVAXPRO – prašek v viali in vehikel v napolnjeni injekcijski brizgi z eno nepritrjeno iglo – pakiranje po 1, 10, 20
10 single dose vials (powder) and 10 single dose prefilled syringes with one unattached needle (solvent).
Prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi Ena enoodmerna viala (prašek) in ena enoodmerna napolnjena injekcijska brizga z eno nepritrjeno iglo (vehikel) 10 enoodmernih vial (prašek) in 10 enoodmernih napolnjenih injekcijskih brizg z eno nepritrjeno iglo (vehikel).
20 single dose vials (powder) and 20 single dose prefilled syringes with one unattached needle (solvent).
20 enoodmernih vial (prašek) in 20 enoodmernih napolnjenih injekcijskih brizg z eno nepritrjeno iglo (vehikel).
EU/ 1/ 06/ 337/ 008 – pack of 1 EU/ 1/ 06/ 337/ 009 – pack of 10 EU/ 1/ 06/ 337/ 010 – pack of 20
EU/ 1/ 06/ 337/ 008 - pakiranje po 1 EU/ 1/ 06/ 337/ 009 - pakiranje po 10 EU/ 1/ 06/ 337/ 010 - pakiranje po 20
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
35 PODATKI NA ZUNANJI OVOJNINI
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with two unattached needles - Pack of 1, 10, 20
M- M- RVAXPRO – prašek v viali in vehikel v napolnjeni injekcijski brizgi z dvema nepritrjenima iglama – pakiranje po 1, 10, 20
10 single dose vials (powder) and 10 single dose pre-filled syringes with two unattached needles (solvent).
Prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi Ena enoodmerna viala (prašek) in ena enoodmerna napolnjena injekcijska brizga z dvema nepritrjenima iglama (vehikel) 10 enoodmernih vial (prašek) in 10 enoodmernih napolnjenih injekcijskih brizg z dvema nepritrjenima iglama (vehikel).
20 single dose vials (powder) and 20 single dose pre-filled syringes with two unattached needles (solvent).
20 enoodmernih vial (prašek) in 20 enoodmernih napolnjenih injekcijskih brizg z dvema nepritrjenima iglama (vehikel).
EU/ 1/ 06/ 337/ 011 – pack of 1 EU/ 1/ 06/ 337/ 012 – pack of 10 EU/ 1/ 06/ 337/ 013 – pack of 20
EU/ 1/ 06/ 337/ 011 - pakiranje po 1 EU/ 1/ 06/ 337/ 012 - pakiranje po 10 EU/ 1/ 06/ 337/ 013 - pakiranje po 20
44 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
37 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
M-M-RVAXPRO Powder for suspension for injection in pre-filled syringe
M- M- RVAXPRO Prašek za suspenzijo za injiciranje v napolnjeni injekcijski brizgi
IM or SC use
i. m. ali s. c. uporaba.
45 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
M-M-RVAXPRO Powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live)
M- M- RVAXPRO Prašek in vehikel za suspenzijo za injiciranje cepivo proti ošpicam, mumpsu in rdečkam (živo)
Read all of this leaflet before you or your child is vaccinated.
Preden bo vaš otrok cepljen, natančno preberite navodilo!
- This vaccine has been prescribed for you or your child.
- To cepivo je bilo predpisano samo vašemu otroku.
Do not pass it on to others.
Ne smete ga dati drugim.
What M-M-RVAXPRO is and what it is used for 2.
Kaj je cepivo M- M- RVAXPRO in za kaj ga uporabljamo 2.
Before you use M-M-RVAXPRO 3.
Kaj morate vedeti, preden boste uporabili cepivo M- M- RVAXPRO 3.
How to use M-M-RVAXPRO 4.
Kako uporabljati cepivo M- M- RVAXPRO 4.
How to store M-M-RVAXPRO 6.
Shranjevanje cepiva M- M- RVAXPRO 6.
WHAT M-M-RVAXPRO IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO M- M- RVAXPRO IN ZA KAJ GA UPORABLJAMO
M-M-RVAXPRO is a vaccine containing measles, mumps, and rubella viruses that have been weakened.
M- M- RVAXPRO je cepivo, ki vsebuje oslabljene viruse ošpic, mumpsa in rdečk.
M-M-RVAXPRO is given to help protect you or your child against measles, mumps, and rubella.
Cepljenje s cepivom M- M- RVAXPRO pomaga zaščititi vašega otroka pred ošpicami, mumpsom in rdečkami.
The vaccine may be administered to persons 12 months or older.
Cepimo lahko v starosti od 12 mesecev dalje.
M-M-RVAXPRO can also be used 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.
Cepivo M- M- RVAXPRO lahko uporabljamo tudi za cepljenje med izbruhom ošpic ali za cepljenje po izpostavljenosti ošpicam ter pri predhodno necepljenih otrok, starejših od 12 mesecev, ki so v stiku z nosečnico, dovzetno za okužbo, ter za osebe, verjetno dovzetne za mumps in rdečke.
Although M-M-RVAXPRO contains live viruses, they are too weak to cause measles, mumps, or rubella in healthy people.
Čeprav M- M- RVAXPRO vsebuje žive viruse, so ti prešibki, da bi povzročili ošpice, mumps ali rdečke pri zdravih ljudeh.
BEFORE YOU USE M-M-RVAXPRO
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI CEPIVO M- M- RVAXPRO
Do not use M-M-RVAXPRO
Ne uporabljajte M- M- RVAXPRO:
- If you or your child are allergic (hypersensitive) to any of the components of
- Če ste vi ali vaš otrok alergični na (preobčutljivi za) katerokoli sestavino cepiva M- M -
See section 6.
RVAXPRO (vključno z neomicinom ali katerokoli sestavino, navedeno pod "pomožne snovi" – glejte poglavje 6.
Further information)
Dodatne informacije).
after vaccination, see Pregnancy)
- Če ste vi ali vaš otrok noseči (poleg tega je 3 mesece po cepljenju potrebna zaščita pred
- If you or your child have active untreated tuberculosis
zanositvijo, glejte poglavje Nosečnost in dojenje).
48
- Če imate vi ali vaš otrok aktivno nezdravljeno tuberkulozo.
- If you or your child are receiving treatment or taking medicines that may weaken the
- Če vi ali vaš otrok prejemate terapijo ali jemlje zdravila, ki lahko oslabijo imunski sistem (razen
immune system (except low-dose corticosteroid therapy for asthma or replacement therapy)
majhnih odmerkov glukokortikoidov pri astmi ali kot nadomestno zdravljenje).
- If you or your child have a weakened immune system because of a disease (including
- Če imate vi ali vaš otrok zaradi bolezni oslabljen imunski sistem (vključno z aidsom).
AIDS)
- Če imate vi ali vaš otrok bolezen krvi ali katerokoli vrsto raka, ki vpliva na imunski sistem.
- If you or your child have a blood disorder or any type of cancer that affects the immune
- Če imate vi ali vaš otrok v družini prirojeno ali dedno imunsko pomanjkljivost, razen če nimate
- If you or your child have a family history of congenital or hereditary immunodeficiency,
41
unless the immune competence of you or your child is demonstrated.
- Če imate vi ali vaš otrok kakršnokoli bolezen z zvišano telesno temperaturo nad 38, 5° C; malo
- If you or your child have any illness with fever higher than 38.5°C; however, low-grade
zvišana telesna temperatura pa sama po sebi ni vzrok, da bi cepljenje odložili.
fever itself is not a reason to delay vaccination
Bodite posebno pozorni pri uporabi M- M- RVAXPRO
Take special care with M-M-RVAXPRO If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist before M-M-RVAXPRO is given:
Če je pri osebi, ki naj bi bila cepljena, prišlo do kateregakoli od naštetih pojavov, o tem pred cepljenjem s cepivom M- M- RVAXPRO povejte zdravniku ali farmacevtu:
- If you or your child have an allergic reaction to eggs or anything that contained egg
- Če ste imeli vi ali vaš otrok alergijsko reakcijo na jajca ali na karkoli, kar vsebuje jajca.
- If you or your child have a history or family history of allergies or of convulsions (fits)
- Če ste imeli vi ali vaš otrok ali kdo drug iz vaše družine kdaj alergijo ali konvulzije (krče).
- If you or your child have a side effect after vaccination with measles, mumps, or rubella
- Če ste imeli vi ali vaš otrok kdaj neželen učinek po cepljenju proti ošpicam, mumpsu ali
vaccine (in a single component vaccine or a combination vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.) that involved easy bruising or bleeding for longer than usual
rdečkam (pri cepljenju z enovalentnim ali kombiniranim cepivom, kot je cepivo proti ošpicam, mumpsu in rdečkam proizvajalca Merck & Co., Inc.), pri katerem so se hitreje pojavljale modrice ali je krvavitev trajala dlje kot ponavadi.
- If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not
- Če ste vi ali vaš otrok okužen s človeškim virusom imunske pomanjkljivosti (HIV), a ne kažete
show symptoms of HIV disease.
znakov bolezni HIV.
You or your child should be monitored closely for measles, mumps, and rubella because vaccination may be less effective than for uninfected persons (see section Do not use M-M-RVAXPRO).
Vas ali vašega otroka je treba skrbno spremljati zaradi noric, mumpsa in rdečk, ker je lahko cepljenje manj učinkovito kot pri neokuženih osebah (glejte poglavje Ne uporabljajte M- M- RVAXPRO).
As with other vaccines, M-M-RVAXPRO may not completely protect all persons who are vaccinated.
Tako kot druga cepiva, tudi M- M- RVAXPRO ne pomeni popolne zaščite vseh cepljenih oseb.
Also, if the person who is to be vaccinated has already been exposed to the measles, mumps, or rubella virus but is not yet ill, M-M-RVAXPRO may not be able to prevent the illness from appearing.
Če je bila oseba, ki bo cepljena, že izpostavljena virusu ošpic, mumpsa ali rdečk, ni pa še zbolela, M- M- RVAXPRO morda ne bo mogel preprečiti pojava bolezni.
M-M-RVAXPRO can be given to persons who have been in recent (within 3 days) contact with a case of measles and may be incubating the disease.
S cepivom M- M- RVAXPRO se sme cepiti osebe, ki so bile pred nedavnim (v zadnjih 3 dneh) v stiku z bolnikom z ošpicami in so lahko v obdobju inkubacije.
However, M-M-RVAXPRO may not always be able to prevent measles developing in these cases.
Vendar pa M- M- RVAXPRO v teh primerih ne more vedno preprečiti pojava ošpic.
Using other medicines and other vaccines The doctor may delay your or your child’ s vaccination for at least 3 months following blood or plasma transfusions, or immune globulin (known as IG).
Zdravnik lahko odloži cepljenje za vsaj 3 mesece po transfuziji krvi ali plazme ali po prejemu imunoglobulinov.
After vaccination with M-M-RVAXPRO, IG should not be given for 1 month, unless your doctor tells you otherwise.
Po cepljenju s cepivom M- M- RVAXPRO vi ali vaš otrok 1 mesec ne smete dobiti imunoglobulinov, razen če se zdravnik ne odloči drugače.
If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, or 4 to 6 weeks after vaccination with M-M-RVAXPRO.
Če je potreben tuberkulinski test, ga je treba opraviti kadarkoli pred cepljenjem s cepivom M- M- RVAXPRO, hkrati z njim ali 4 do 6 tednov po njem.
M-M-RVAXPRO may be given with some routine childhood vaccines that may be due to be given at the same time.
Cepljenje s cepivom M- M- RVAXPRO se lahko opravi hkrati z nekaterimi običajnimi otroškimi cepljenji.
For vaccines that cannot be given at the same time, M-M-RVAXPRO should be given 1 month before or after administration of those vaccines.
Pri cepivih, ki se ne smejo uporabljati hkrati z M- M- RVAXPRO, je treba cepljenje s cepivom M- M- RVAXPRO opraviti 1 mesec pred ali 1 mesec po cepljenju s temi cepivi.
Please tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines), including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če vi ali vaš otrok jemljete ali ste pred kratkim jemali katerokoli zdravilo (ali drugo cepivo), tudi če ste ga dobili brez recepta.
49 Pregnancy and breast-feeding M-M-RVAXPRO must not be given to pregnant females.
Nosečnost in dojenje Nosečnic se ne sme cepiti s cepivom M- M- RVAXPRO.
Females of child-bearing age should take the necessary precautions to avoid pregnancy for 3 months, or according to doctor’ s recommendation, after they have been given the vaccine.
Ženske v rodni dobi morajo 3 mesece po cepljenju, oziroma po navodilu zdravnika, ustrezno poskrbeti, da ne zanosijo.
The doctor will decide if M-M-RVAXPRO should be given.
Zdravnik se bo odločil, ali jih sme cepiti s cepivom M- M- RVAXPRO.
Driving and using machines There is no information to suggest that M-M-RVAXPRO affects the ability to drive or operate machinery.
Vpliv na sposobnost upravljanja vozil in strojev Ni podatkov, ki bi kazali, da M- M- RVAXPRO vpliva na sposobnost vožnje ali upravljanja s stroji.
HOW TO USE M-M-RVAXPRO
KAKO UPORABLJATI CEPIVO M- M- RVAXPRO
M-M-RVAXPRO should be injected into the muscle or under the skin either in the area of the outer thigh or of the upper arm.
M- M- RVAXPRO se z injekcijo injicira v mišico ali pod kožo v predel zunanje strani stegna ali nadlakti.
Usually for injections into the muscle the thigh area is preferred in young children whereas for older individuals the upper arm area is the preferred injection site.
Ponavadi je predel stegna najprimernješe mesto za injiciranje pri mlajših otrocih, pri starejših posameznikih pa nadlaket.
M-M-RVAXPRO is not to be injected directly into any blood vessel.
Cepiva M- M- RVAXPRO se ne sme injicirati neposredno v katerokoli žilo.
M-M-RVAXPRO is given as follows:
S cepivom M- M- RVAXPRO se cepi po naslednji shemi:
One dose is given at an elected date.
- V starosti 12 mesecev ali več na izbrani dan cepimo z enim odmerkom.
- For persons vaccinated at 12 months or older, an additional dose is usually recommended
- Za osebe, cepljene v starosti 12 mesecev ali več, običajno priporočamo dodaten odmerek vsaj 4
at least 4 weeks after the first dose according to your doctor’ s recommendation.
tedne po prvem, v skladu z navodilom zdravnika.
- Children first vaccinated between 6 months and less than 12 months should be revaccinated
- Otroke, ki so bili prvič cepljeni v starosti 6 do 12 mesecev, je treba v starosti 12 do 15 mesecev
at 12 to 15 months followed by an additional dose according to your doctor’ s recommendation.
ponovno cepiti, nato pa je potreben še en odmerek, v skladu z navodilom vašega zdravnika.
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet.
Navodila za pripravo, namenjena zdravstvenemu osebju, so navedena na koncu navodila.
Like all medicines, M-M-RVAXPRO can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi M- M- RVAXPRO neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Approximately 1 out of 10 patients reported the following side effects with the use of M-M-RVAXPRO: fever (38.5°C or higher), injection site redness, and injection site pain and swelling.
Približno 1 od 10 bolnikov je poročal o naslednjih neželenih učinkih: zvišana telesna temperatura (38, 5 ºC ali več), rdečina na mestu injiciranja, bolečinain oteklina na mestu injiciranja.
Injection site bruising was reported in approximately 1 out of 100 patients.
O modrici na mestu injiciranja je poročal 1 od 100 bolnikov.
Other side effects have been reported with the use of either the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. or of its monovalent (single) components: burning and/ or stinging of short duration at the injection site, joint pain and/ or swelling (which could be transient or chronic), rash, unusual bleeding or bruising under the skin, and swelling of the testicles.
O drugih neželenih učinkih so poročali pri cepljenju bodisi s cepivom proti ošpicam, mumpsu in rdečkam proizvajalca Merck & Co., Inc., ali pri cepljenju z enovalentnimi komponentami tega cepiva: kratkotrajno pečenje in/ ali zbadanje na mestu injiciranja, bolečine v sklepih in/ ali otekanje sklepov (kar je lahko prehodno ali kronično), izpuščaj, nenavadna krvavitev ali modrice na koži, otekla moda.
Other less common side effects have been reported and some of these were serious.
Poročali so tudi o drugih manj pogostih neželenih učinkih in nekateri od njih so bili resni.
These included: allergic reactions, seizures (fits), and inflammation of the brain (encephalitis).
Ti vključujejo: alergijske reakcije, krče in vnetje možganov (encefalitis).
50 The doctor has a more complete list of side effects for M-M-RVAXPRO.
Zdravnik ima podrobnejši seznam neželenih učinkov cepiva M- M- RVAXPRO.
If the condition persists or worsens, seek medical attention.
Če se stanje ne popravi ali če se slabša, poiščite zdravniško pomoč.
HOW TO STORE M-M-RVAXPRO
SHRANJEVANJE M- M- RVAXPRO
Store and transport refrigerated (2°C- 8°C).
Hranite in prevažajte v hladilniku (2 °C – 8 ºC).
Keep the vial of powder in the outer carton in order to protect from light.
Vialo s praškom hranite v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Do not use M-M-RVAXPRO after the expiry date which is stated on the outer carton after EXP.
Cepiva M- M- RVAXPRO ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini poleg oznake EXP.
Once the vaccine has been mixed with the solvent supplied, it should be either used immediately or stored in the refrigerator and used within eight hours.
Ko je cepivo zmešano s priloženim vehiklom, ga je treba uporabiti takoj ali pa shraniti v hladilnik in uporabiti v osmih dneh.
What M-M-RVAXPRO contains
Kaj vsebuje M- M- RVAXPRO
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.
Powder: sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)
Prašek Sorbitol, natrijev fosfat, kalijev fosfat, saharoza, hidrolizirana želatina, medij 199 s Hanksovimi solmi, MEM, mononatrijev L- glutamat, neomicin, fenol rdeče, natrijev bikarbonat, klorovodikova kislina (za prilagodotev pH) in natrijev hidroksid (za prilagoditev pH).
Solvent: water for injections
Vehikel Voda za injekcije
51 What M-M-RVAXPRO looks like and contents of the pack
Izgled M- M- RVAXPRO in vsebina pakiranja
The powder is a light yellow compact crystalline cake.
Prašek je bledo rumen kompakten kristalni skupek.
M-M-RVAXPRO is available in packs of 1 and 10.
M- M- RVAXPRO je na voljo v pakiranjih po 1, 10 in 20.
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, 69007 Lyon, Francija