natgillin/translations-raw huggingface dataset:
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.
M-M-RVAXPRO powder for suspension for injection
M-M-RVAXPRO prašek za suspenzijo za injiciranje
After two doses, the seroprotection rates against measles were 94.6% when the first dose was given at 9 months compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective not met).
Po dveh odmerkih so bile stopnje serozaščite proti ošpicam 94,6 %, če so s prvim odmerkom cepili v starosti 9 mesecev, v primerjavi z 98,9 %, če so s prvim odmerkom cepili v starosti 12 mesecev (neinferiornost v študiji ni bila dokazana).
• Diarrhoea, vomiting.
• driska, bruhanje
Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues.
Povezan je bil z izolacijo persistentnega virusa in/ali virusnega antigena, izoliranega iz telesnih tkiv.
Do not use this vaccine after the expiry date which is stated on the outer carton after EXP.
Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini poleg oznake Uporabno do ali EXP. Rok uporabnosti cepiva se izteče na zadnji dan navedenega meseca.
• Seizures (fits) without fever; seizures (fits) with fever in children; walking unsteadily; dizziness; illnesses involving inflammation of the nervous system (brain and/or spinal cord).
• napadi krčev brez zvišane telesne temperature, napadi krčev z zvišano telesno temperaturo pri otrocih, nestabilna hoja, omotica, bolezni, ki vključujejo vnetje živčnega sistema (možganov in/ali hrbtenjače)
The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Pripravljenega cepiva ne smete uporabiti, če v njem opazite delce ali če se videz vehikla, praška ali pripravljenega cepiva razlikuje od prej opisanega.
Pregnancy Pregnant women should not be vaccinated with M-M-RVAXPRO.
Nosečnost Nosečnic se ne sme cepiti s cepivom M-M-RVAXPRO.
• Itching; inflammation of the fatty tissue under the skin; red or purple, flat, pinhead spots under the skin; hardened, raised area of the skin; serious illness with ulcers or blistering of the skin, mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
• srbenje, vnetje maščobnega tkiva pod kožo, rdeč ali škrlaten, neprivzdignjen, za bucikino glavico velik izpuščaj pod kožo, privzdignjena zatrdlina na koži, huda bolezen z razjedami in mehurji na koži, v ustih, očeh in/ali na spolovilih (Stevens-Johnsonov sindrom)
Post-exposure vaccination
Poekspozicijsko cepljenje
Pregnancy.
Nosečnost.
Therefore, inadvertent vaccination of unknowingly pregnant women with measles-, mumps-, or rubella-containing vaccines should not be a reason for termination of pregnancy.
Cepljenje žensk s cepivi proti ošpicam, mumpsu ali rdečkam, ki niso vedele, da so noseče, zato ne sme biti razlog za prekinitev nosečnosti.
The MAH presented an analysis of reports with PT (preferred term) “Crying” From the data provided by the MAH “crying” was reported during clinical trials, post marketing source and literature report in paediatric population as an ADR.
Iz podatkov, ki jih je predložil MAH, je bil "jok" pri pediatrični populaciji poročan kot neželeni učinek med kliničnimi preskušanji, v virih po začetku trženja in v poročilih iz literature.
• Cough; lung infection with or without fever.
• kašelj, okužba pljuč z zvišano telesno temperaturo ali brez
M-M-RVAXPRO can also be used in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated persons older than 9 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 osebah, starejših od 9 mesecev, ki so v stiku z nosečnico, dovzetno za okužbo, ter za osebe, verjetno dovzetne za mumps in rdečke.
What M-M-RVAXPRO looks like and contents of the pack
Izgled cepiva M-M-RVAXPRO in vsebina pakiranja
Based on clinical studies with the quadrivalent measles, mumps, rubella and varicella vaccine and with the previous formulation of the combined measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., M-M-RVAXPRO can be given simultaneously (but at separate injection sites) with Prevenar and/or hepatitis A vaccine.
Na podlagi kliničnih študij s štirivalentnim cepivom proti ošpicam, mumpsu, rdečkam in noricam ter s prejšnjo obliko kombiniranega cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc. se lahko cepivo M-M-RVAXPRO da sočasno s cepivom Prevenar in/ali cepivom proti hepatitisu
INSTRUCTIONS IN USE
NAVODILA ZA UPORABO
Pregnant women should not be vaccinated with M-M-RVAXPRO.
Nosečnic se ne sme cepiti s cepivom M-M-RVAXPRO.
The doctor will decide if M-M-RVAXPRO should be given.
Zdravnik se bo odločil, ali jih sme cepiti s cepivom M-M-RVAXPRO.
Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. is highly immunogenic and generally well tolerated.
Klinične študije pri 284 trojno seronegativnih otrocih, starih od 11 mesecev do 7 let, so pokazale veliko imunogenost in splošno dobro prenašanje prejšnje oblike cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc.
Rubella (titre ≥10 IU/mL)
Rdečke (titer ≥10 i.e./ml)
M-M-RVAXPRO should be given concomitantly at separate injection sites, or one month before or after administration of other live virus vaccines.
Cepivo M-M-RVAXPRO se lahko da sočasno z drugimi živimi cepivi, toda na drugo vbodno mesto, ali pa en mesec pred ali en mesec po cepljenju z drugimi živimi cepivi.
M-MRVAXPRO is not to be injected directly into any blood vessel.
Cepiva M-M-RVAXPRO se ne sme injicirati neposredno v katero koli žilo.
Blood and the lymphatic system disorders Regional lymphadenopathy, Thrombocytopenia
Bolezni krvi in limfatičnega sistema področna limfadenopatija, trombocitopenija neznana pogostnost
Studies have not been conducted with M-M-RVAXPRO in pregnant women.
Študij o cepljenju s cepivom M-M-RVAXPRO pri nosečnicah niso izvedli.
Store and transport refrigerated (2°C - 8°C).
Shranjujte in prevažajte na hladnem ( 2 °C - 8 °C).
Evaluation of immunogenicity and clinical efficacy A comparative study in 1279 subjects who received M-M-RVAXPRO or the previous formulation (manufactured with human serum albumin) of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrated similar immunogenicity and safety between the 2 products.
Primerjalna študija s 1279 osebami, ki so bile cepljene s cepivom M-M-RVAXPRO ali prejšnjo obliko cepiva (izdelano s humanim serumskim albuminom) proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc., je pokazala, da sta imunogenost in varnost teh 2 cepiv podobni.
Discard if reconstituted vaccine is not used within 8 hours.
Če pripravljenega cepiva ne uporabite v 8 urah, ga zavrzite.
The general safety profile of either administration routes were comparable, although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
Splošni profil varnosti po obeh načinih injiciranja je bil primerljiv, čeprav so bile reakcije na mestu vboda manj pogoste pri i.m.
Before mixing with the solvent, the powder is a light yellow compact crystalline cake.
Preden ga zmešamo z vehiklom, je prašek svetlo rumen kompakten kristalni skupek.
Immune globulin Immune globulin (IG) is not to be given concomitantly with M-M-RVAXPRO.
Imunoglobulini Sočasno s cepivom M-M-RVAXPRO ne dajajte imunoglobulinov (IG).
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 kadar koli pred cepljenjem s cepivom M-M-RVAXPRO, hkrati z njim ali 4 do 6 tednov po njem.
Anaphylactoid reaction, Anaphylaxis and related phenomenon such as Angioneurotic oedema, Facial oedema, and Peripheral oedema
Bolezni imunskega sistema anafilaktoidna reakcija, anafilaksija in povezani pojavi, kot so angionevrotični edem, obrazni edem in periferni edem neznana pogostnost
Individuals likely to be susceptible to mumps and rubella M-M-RVAXPRO is preferred for vaccination of persons likely to be susceptible to mumps and rubella.
Posamezniki, ki so verjetno dovzetni za mumps in rdečke Pri cepljenju oseb, ki so verjetno dovzetne za mumps in rdečke, ima prednost cepivo M-M-RVAXPRO.
Evaluation of immunogenicity in children from 9 to 12 months of age at the time of first dose A clinical study was conducted with the quadrivalent measles, mumps, rubella and varicella vaccine manufactured by Merck & Co., Inc., administered with a 2-dose schedule, the doses being given 3 months apart in 1,620 healthy subjects from 9 to 12 months of age at the time of first dose.
Ocena imunogenosti pri otrocih, ki so bili ob prejetju prvega odmerka stari od 9 do 12 mesecev Pri 1.620 zdravih osebah, ki so bile ob prejetju prvega odmerka, stare od 9 do 12 mesecev, so izvedli klinično študijo s štirivalentnim cepivom proti ošpicam, mumpsu, rdečkam in noricam izdelovalca Merck & Co., Inc., s katerim so cepili v 2 odmerkih, v razmiku 3 mesecev.
Encephalitis and Encephalopathy
Encefalitis in encefalopatija
M-M-RVAXPRO powder for suspension for injection in pre-filled syringe
M-M-RVAXPRO prašek za suspenzijo za injiciranje v napolnjeni injekcijski brizgi
Administration of a higher than recommended dose of M-M-RVAXPRO was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of M-M-RVAXPRO.
Profil neželenih učinkov je bil primerljiv s tistim, opaženim pri priporočenem odmerku cepiva M-M-RVAXPRO.
In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
Pri hudo imunsko oslabljenih posameznikih, ki so jih pomotoma cepili s cepivom, ki vsebuje virus ošpic, so poročali o ošpičnem encefalitisu z inkluzijskimi telesci, pnevmonitisu in smrti, kot neposredni posledici razsejane okužbe s cepilnim virusom ošpic.
Widespread use of a 2-dose vaccination schedule in the United States and countries such as Finland and Sweden has led to a >99% reduction in the incidence of each of the 3 targeted diseases.
Po svetu so med letoma 1978 in 2003 razdelili več kot 400 milijonov odmerkov cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc. Razširjena uporaba cepljenja z 2 odmerkoma v ZDA in državah, kot sta Finska in Švedska, je vodila v > 99-odstotno zmanjšanje pojavnosti vsake od teh 3 bolezni.
Individuals 12 months or older should receive one dose at an elected date.
V starosti nad 12 mesecev cepimo na izbrani dan z enim odmerkom cepiva.
Afebrile convulsions or seizures, Ataxia, Dizziness, Encephalitis
Bolezni živčevja nevročinski krči ali napadi, ataksija, vrtoglavica, encefalitis
Infections and infestations Nasopharyngitis, Upper respiratory tract infection or Viral infection
Infekcijske in parazitske bolezni nazofaringitis, okužba zgornjih dihal ali virusna okužba občasni aseptični meningitis
After reconstitution, the vaccine should be used immediately; however, in-use stability has been demonstrated for 8 hours when refrigerated at 2°C-8°C.
V primeru shranjevanja rekonstituiranega cepiva v hladilniku pri temperaturi od 2 C - 8 C je bila dokazana njegova 8-urna stabilnost.
Do not freeze the reconstituted vaccine.
Pripravljenega cepiva ne zamrzujte.
Inject the entire content of the pre-filled syringe into the vial containing the powder.
Izbrizgajte celotno vsebino iz napolnjene injekcijske brizge v vialo s praškom.
• Burning and/or stinging of short duration at the injection site; blisters and/or hives at the injection site.
• kratkotrajen pekoč občutek in/ali zbadanje na mestu injiciranja, mehurji in/ali koprivnica na mestu injiciranja
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 hidrogenkarbonat, klorovodikova kislina, natrijev hidroksid in voda za injekcije
Store and transport refrigerated (2°C- 8°C).
Shranjujte in prevažajte na hladnem (2 °C - 8 ºC).
Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and sex, being greatest in adult females and least in prepubertal children.
Artralgija in/ali artritis (običajno prehodna in redko kronična) ter polinevritis so značilni za okužbo z divjim sevom rdečk.
• Inflammation of the retina (in the eye) with changes in sight.
• vnetje očesne mrežnice s spremembami vida
Inject the entire content of the syringe into the vial containing the powder.
Izbrizgajte celotno vsebino brizge v vialo s praškom.
- If you get any of the side effects, talk to your doctor of pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
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 cepivo M-M-RVAXPRO vpliva na sposobnost vožnje ali upravljanja s stroji.
1 Jeryl Lynn™ [Level B] strain (live, attenuated)……...…not less than 12.5x10 3 CCID50*
1, sev Jeryl Lynn™ (nivo B) (živ, oslabljen) ...............najmanj 12,5 x 10 3 CCID50*
• Feeling sick (nausea).
• slabost (siljenje na bruhanje)
For use in measles outbreaks, or for post-exposure vaccination, or, for use in previously unvaccinated individuals older than 9 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 posameznikih, starejših od 9 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.
M-M-RVAXPRO - Powder in vial and solvent in vial- Pack of 1, 10
M-M-RVAXPRO - prašek v viali in vehikel v viali - pakiranje po 1, 10
Administration of measles, mumps, or rubella antibody-containing blood products, including immune globulin preparations, should be avoided within 1 month after a dose of M-M-RVAXPRO unless considered to be essential.
1 mesec po cepljenju s cepivom M-M-RVAXPRO se je treba izogibati dajanju krvnih pripravkov, ki vsebujejo protitelesa proti ošpicam, mumpsu ali rdečkam, vključno s pripravki imunoglobulinov, razen če je to nujno potrebno.
Solvent for M-M-RVAXPRO
Vehikel za M-M-RVAXPRO
DO NOT INJECT INTRAVASCULARLY.
CEPIVA NE INJICIRAJTE V ŽILO.
Dose 1 at 9 months / Dose 2 at 12 months
1. odmerek pri 9 mesecih / 2. odmerek pri 12 mesecih N = 527
In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported (see section 4.3); disseminated mumps and rubella vaccine virus infection has also been reported.
Pri hudo imunsko oslabljenih posameznikih, ki so jih pomotoma cepili s cepivom, ki vsebuje virus ošpic, so poročali o ošpičnem encefalitisu z inkluzijskimi telesci, pnevmonitisu in smrti kot neposredni posledici razsejane okužbe s cepilnim virusom ošpic (glejte poglavje 4.3).
• Nasal congestion and sore throat; upper respiratory tract infection or viral infection; runny nose.
• zamašen nos in vneto grlo, okužba v zgornjem delu dihal ali virusna okužba, izcedek iz nosu
Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.
Pri posameznikih s trombocitopenijo se lahko ta po cepljenju poslabša.
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, natrijev L-glutamat, neomicin, fenol rdeče, natrijev hidrogenkarbonat, klorovodikova kislina (za uravnavanje pH) in natrijev hidroksid (za uravnavanje pH)
Eye disorders Conjunctivitis, Retinitis
Očesne bolezni konjunktivitis, retinitis neznana pogostnost
Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent patients; therefore, some of these patients may acquire measles, mumps, or rubella in case of contact, despite appropriate vaccine administration.
Pri bolnikih z oslabelo imunostjo, ki nimajo kontraindikacij za cepljenje s tem cepivom (glejte poglavje 4.3), odziv morda ne bo tako dober kot pri imunsko sposobnih bolnikih.
Side effect
Neželeni učinek
Panniculitis, Pruritus, Purpura, Skin induration, Stevens-Johnson syndrome
Bolezni kože in podkožja ošpicam podoben izpuščaj ali drug izpuščaj pogosti urtikarija občasni panikulitis, pruritus, purpura, zatrdlina kože, Stevens-Johnsonov sindrom neznana pogostnost
Read the package leaflet before use.
intramuskularna ali subkutana uporaba Pred uporabo preberite priloženo navodilo!
How to use M-M-RVAXPRO
Kako uporabljati cepivo M-M-RVAXPRO
Warnings and precautions Talk to the doctor or pharmacist before you or your child receive M-M-RVAXPRO if you have experienced any of the following: - If you or your child have an allergic reaction to eggs or anything that contained egg - If you or your child have a history or family history of allergies or of convulsions (fits) - If you or your child have a side effect after vaccination with measles, mumps, or rubella vaccine (in a single component vaccine or a combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or M-M-RVAXPRO) that involved easy bruising or bleeding for longer than usual - If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not show symptoms of HIV disease.
Opozorila in previdnostni ukrepi Preden boste vi ali vaš otrok prejeli cepivo M-M-RVAXPRO, se posvetujte z zdravnikom ali s farmacevtom, če se je pri vas ali vašem otroku pojavilo kar koli od naštetega: - Če ste imeli vi ali vaš otrok alergijsko reakcijo na jajca ali na karkoli, kar vsebuje jajca.
The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.
Pri bolnikih s trombocitopenijo ali kakršnokoli drugo motnjo koagulacije je treba cepivo injicirati subkutano.
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), with one or two unattached needles, in pack size 1, 10 and 20.
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in pokrovčkom (stiren-butadienska guma), z eno ali dvema nepritrjenima iglama, v pakiranju po 1, 10 in 20.
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)
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
*50% cell culture infectious dose
* 50-odstotni infektivni odmerek na celični kulturi
The vaccine may be administered to persons 12 months of age or older.
Cepi se lahko v starosti od 12 mesecev dalje.
Bronchial spasm, Cough, Pneumonia, Pneumonitis (see section 4.3), Sore throat
Bolezni dihal, prsnega koša in mediastinalnega prostora izcedek iz nosu občasni bronhialni spazem, kašelj, pljučnica, pnevmonitis (glejte poglavje 4.3), bolečine v grlu neznana pogostnost
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with two unattached needlesPack 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
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)
In a clinical trial, 752 children received M-M-RVAXPRO, either intramuscularly or subcutaneously.
V kliničnem preskušanju je bilo s cepivom M-M-RVAXPRO intramuskularno (i.m.)
M-M-RVAXPRO is given as follows:
Pri uporabi cepiva M-M-RVAXPRO so poročali o naslednjih neželenih učinkih:
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without needle, in pack size 1, 10, and 20.
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in pokrovčkom (stiren-butadienska guma), brez igle, v pakiranju po 1, 10 in 20.
However, foetal damage has not been documented when measles or mumps vaccines have been given to pregnant women.
Pri nosečnicah, ki so jih cepili s cepivi proti ošpicam ali mumpsu, niso zabeležili okvare ploda.
Measles virus
Virus ošpic
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 shranjevali v hladilniku.
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with one unattached needlePack 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
How to use M-M-RVAXPRO 4.
Kako uporabljati cepivo M-M-RVAXPRO.
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
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
Tel: 8007 4433 (+356 99917558) malta_info@merck.com
Merck Sharp & Dohme Cyprus Limited., Tel: 8007 4433 (+356 99917558) malta_info@merck.com
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a vial (glass) with stopper (chlorobutyl rubber) in a pack size of 1 and 10.
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v viali (steklo) z zamaškom (klorobutilna guma) v pakiranju po 1 in 10.
• Injection-site bruising.
• izpuščaj na mestu injiciranja
Injection site pain, and Injection site swelling Injection site bruising
• rdečina na mestu injiciranja, bolečina na mestu injiciranja, oteklina na mestu injiciranja
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with attached needle with plunger stopper (chlorobutyl rubber) and needle-shield (natural rubber) in a pack size of 1 and 10.
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in z iglo z zaščito (iz naravne gume) v pakiranju po 1 in 10.
What M-M-RVAXPRO contains
Kaj vsebuje cepivo M-M-RVAXPRO
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