natgillin/translations-raw huggingface dataset:
A titration pack composed of four triple packs is available for the titration period and the patient ’ s initial treatment with Betaferon.
Set za titriranje je sestavljen iz štirih tridelnih pakiranj, ki so namenjena za obdobje titriranja in začetno zdravljenje bolnikov z zdravilom Betaferon.
This package meets the patient ’ s needs for the first 12 injections.
Ta pakiranja zadostujejo za potrebe bolnika za prvih 12 injekcij.
The triple packs are highlighted in different colours (see section 6.5).
Tridelna pakiranja so označena z različnimi barvami (glejte poglavje 6. 5).
187.5 microgram
187, 5 mikrogramov
19, 21, 23 et seqq.
19, 21, 23 in naslednji
1.0 ml
1 ml
At the present time, it is not known for how long the patient should be treated.
Trenutno ni znano, kako dolgo naj traja zdravljenje (glejte poglavje 5. 1).
There are follow-up data under controlled clinical conditions for patients with relapsing-remitting MS for up to 5 years and for patients with secondary progressive MS for up to 3 years.
Za bolnike z recidivno - remitentno multiplo sklerozo obstajajo podatki o spremljanju v kontroliranih kliničnih pogojih za obdobje do 5 let, za bolnike s sekundarno progresivno multiplo sklerozo za obdobje do 3 let.
19 Gastrointestinal disorders
19 Bolezni prebavil
20 Renal and urinary disorders
20 Bolezni sečil
21 In the different controlled clinical trials, between 23% and 41% of the patients developed serum interferon beta-1b neutralising activity confirmed by at least two consecutive positive titres; of these patients, between 43% and 55% converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the respective study.
Pri 43 do 55% teh bolnikov je med poznejšim opazovalnim obdobjem v posameznih preskušanjih prišlo do konverzije v stabilni antigensko negativni status (na osnovi dveh zaporednih negativnih titrov).
The development of neutralising activity is associated with a reduction in clinical efficacy only with regard to relapse activity.
Pojav nevtralizirajoče aktivnosti je povezan z zmanjšanjem klinične učinkovitosti, ki se nanaša le na recidivno aktivnost.
22 • Women of child-bearing potential
22 • Ženske v rodni dobi
In patients with a high relapse rate before treatment started, the risk of a severe relapse following discontinuation of Betaferon in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
Pri bolnicah, pri katerih obstaja pred začetkom zdravljenja veliko tveganje za poslabšanje bolezenskih znakov, je treba pretehtati tveganje za resen relaps po prekinitvi zdravljenja z zdravilom Betaferon zaradi nosečnosti glede na povečano tveganje za spontani splav.
• Lactation
• Dojenje
23 Table 1 (adverse events and laboratory abnormalities with incidence rates ≥ 10% and the respective percentages under placebo; significantly associated side effects < 10%).
23 Preglednica 1 (neželeni učinki in nenormalni izvidi laboratorijskih preiskav s pogostnostjo ≥ 10% in ustrezni odstotki pri placebu; statistično značilno povezani neželeni učinki < 10%)
Multiple Sclerosis (BENEFIT) #
progresivna
Multiple Sclerosis
multipla
Betaferon Betaferon 250 250
neželeni učinek in
Betaferon 250 microgram
multipla
Betaferon 250
skleroza
microgram microgram
sklerozo
(Placebo) (Placebo)
(BENEFIT) # nenormalen izvid
n=317 (n=308)
(evropska
(Placebo)
(severno
Infections and infestations
laboratorijske preiskave
n=292 (n=176)
študija)
n=360 (n=358)
ameriška študija)
Metabolism and nutrition disorders Blood glucose decreased (< 55 mg/ dl) × Psychiatric disorders
Presnovne in prehranske motnje zmanjšana vrednost glukoze (< 55 mg/ dl) Psihiatrične motnje
Multiple Sclerosis (North American Study)
(severno
Multiple Sclerosis
laboratorijske
Cough increased Dyspnea * Gastrointestinal disorders
dispneja *
2% (2%) 0% (0%)
0% (0%)
5% (10%) 3% (2%)
3% (2%)
11% (15%) 8% (6%)
8% (6%)
31% (23%) 8% (2%)
8% (2%)
Diarrhoea Constipation Nausea Vomiting Λ Abdominal pain ° Hepatobiliary disorders
Bolezni prebavil driska
4% (2%) 1% (1%) 3% (4%) 5% (1%) 5% (3%)
1% (1%) 3% (4%)
7% (10%) 12% (12%) 13% (13%) 4% (6%) 11% (6%)
12% (12%) 13% (13%)
Alanine aminotransferase increased (SGPT > 5 times baseline) × Λ * °
Bolezni hepatobiliarnega sistema povečane vrednosti alanin aminotransferaze (SGPT > 5- kratna izhodiščna vrednost) × Λ * °
Aspartate aminotransferase increased (SGOT > 5 times baseline) × Λ * °
povečane vrednosti aspartat aminotransferaze (SGOT > 5- kratna izhodiščna vrednost) × Λ * ° Bolezni kože in podkožja
Skin and subcutaneous tissue disorders Skin disorder Λ
kožne spremembe Λ
Rash °
izpuščaj °
Metrorrhagia Impotence
metroragija impotenca
Flu-like symptoms *° Fever Λ * °
gripi podobni simptomi & Λ * °
Significantly associated with Betaferon treatment for patients with first event suggestive of MS, p < 0.05 * Significantly associated with Betaferon treatment for RRMS, p < 0.05 ° Significantly associated with Betaferon treatment for SPMS, p < 0.05 § Injection site reaction (various kinds) comprises all adverse events occurring at the injection site, i. e. the following terms: injection site hemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site edema, and injection site atrophy & “ Flu-like symptom complex ” denotes flu syndrome and/ or a combination of at least two AEs from fever, chills, myalgia, malaise, sweating. # During the third year of the BENEFIT study, no change of the known risk profile of Betaferon was observed.
nenormalen izvid laboratorijske preiskave Λ pomembno povezano z zdravljenjem z zdravilom Betaferon pri bolnikih s prvim kliničnim dogodkom, ki kaže na MS, p < 0, 05 * statistično značilno povezano z uporabo zdravila Betaferon pri RR- MS, p < 0, 05 ° statistično značilno povezano z uporabo zdravila Betaferon pri SP- MS, p < 0, 05 § reakcije na mestu injiciranja (različne vrste) sestavljajo vsi neželeni učinki na mestu injiciranja kot so krvavitev na mestu injiciranja, preobčutljivost na mestu injiciranja, vnetje na mestu injiciranja, hipertrofija na mestu injiciranja, nekroza na mestu injiciranja, bolečina na mestu injiciranja, reakcija na mestu injiciranja, edem na mestu injiciranja in atrofija na mestu injiciranja & "kompleks gripi podobnih simptomov" pomeni sindrom gripe in/ ali kombinacijo vsaj dveh izmed naslednjih neželenih učinkov: zvišana telesna temperatura, mrzlica, mialgija, občutek neugodja, potenje. # V tretjem letu študije BENEFIT niso ugotovili sprememb tveganja zaradi uporabe zdravila Betaferon.
26 Table 2 (reporting rates (very common ≥ 1/ 10, common ≥ 1/ 100 to < 1/ 10, uncommon ≥ 1/ 1,000 to < 1/ 100, rare ≥ 1/ 10,000 to < 1/ 1,000, very rare < 1/ 10,000) based on spontaneous adverse drug reaction reports).
26 Preglednica 2 (pogostnost navedb temelji na podatkih iz spontanih poročil o neželenih učinkih zdravila; zelo pogosto ≥ 1/ 10, pogosto ≥ 1/ 100 do < 1/ 10, občasno ≥ 1/ 1. 000 do < 1/ 100, redko ≥ 1/ 10. 000 do < 1/ 1. 000, zelo redko < 1/ 10. 000)
28 Clinical trials:
28 Posebnih študij o vplivu zdravila Betaferon na srce in ožilje, dihala in delovanje endokrinih organov niso izvedli.
Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
29 ustrezala bolnikovim znakom in simptomom.
29 In the placebo-controlled phase, Betaferon delayed the progression from the first clinical event to clinically definite multiple sclerosis (CDMS) in a statistically significant and clinically meaningful manner, corresponding to a risk reduction of 47% (Hazard Ratio = 0.53, 95% confidence interval (0.39, 0.73), p < 0.0001).
Zmanjšanje tveganja je bilo 47% (razmerje ogroženosti = 0, 53, interval zaupanja = 95% (0, 39, 0, 73), p < 0, 0001).
Significant effects were also obtained in patients with less disseminated and less active disease at the time of the first event, the risk in two years for progression to CDMS in patients with monofocal onset was 47% for placebo and 24% for Betaferon, without gadolinium (Gd-) enhancement 41% and 20%, with less than 9 T2 lesions 39% and 18%.
Pomembne učinke so dosegli tudi pri bolnikih z manj diseminirano in manj aktivno boleznijo v času prvega kliničnega dogodka, tveganje do napredovanja do CDMS v dveh letih pri bolnikih z monofokalnim začetkom je bilo pri placebu 47% in 24% pri zdravilu Betaferon, brez ojačitve z gadolinijem (Gd) 41% in 20%, z manj kot 9 lezij T2 39% in 18%.
Therapy with Betaferon was well accepted in the study of patients with a single clinical event as indicated by a high rate of trial completion (92.8% in the Betaferon group).
30 Pri bolnikih z enim samim kliničnim dogodkom je bilo zdravljenje z zdravilom Betaferon dobro sprejeto, na kar kaže veliko število bolnikov, ki so zaključili preskušanje (92, 8% v skupini, ki je prejemala zdravilo Betaferon).
30 5.2 Pharmacokinetic properties
Farmakokinetične lastnosti
6.3 Shelf life
31 6. 3 Rok uporabnosti
31 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
Solvent (with sodium chloride solution 5.4 mg/ ml (0.54%):
Vehikel (z raztopino natrijevega klorida 5, 4 mg/ ml (0, 54%)) 2, 25 ml napolnjena injekcijska brizga (steklo tipa I) z 1, 2 ml vehikla
2.25 ml pre-filled syringe (type I glass) with 1.2 ml solvent.
brizgo z vehiklom, 1 adapter za vialo z iglo, 2 alkoholni blazinici, ali
Pack sizes − Pack with 5 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or − Pack with 15 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or − 3-month pack with 3x15 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or − 3-month pack with 3x14 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or − Titration pack for dose titration with 4 differently coloured and numbered triple packs:
injekcijsko brizgo z vehiklom, 1 adapter za vialo z iglo, 2 alkoholni blazinici ali − 3- mesečno pakiranje s 3 x 15 posameznimi pakiranji, od katerih vsako vsebuje 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo z vehiklom, 1 adapter za vialo z iglo, 2 alkoholni blazinici ali
- yellow, with the number “ 1” (treatment days 1, 3 and 5; 0.25- ml syringe marking),
- 3- mesečno pakiranje s 3 x 14 posameznimi pakiranji, vsako vsebuje 1 vialo s praškom, 1
- red, with number “ 2” (treatment days 7, 9 and 11; 0.5- ml syringe marking)
napolnjeno injekcijsko brizgo z vehiklom, 1 adapter za vialo z iglo, 2 alkoholni blazinici ali − set za titriranje za titriranje odmerka s štirimi različno obarvanimi in s številkami označenimi trojnimi pakiranji:
- green, with number “ 3” (treatment days 13, 15 and 17; 0.75- ml syringe marking)
rumeno, označeno s številko » 1 « (za 1., 3. in 5. dan zdravljenja; oznaka 0, 25ml na brizgi) rdeče, označeno s številko » 2 « (za 7., 9. in 11. dan zdravljenja; oznaka 0, 5 ml na brizgi) zeleno, označeno s številko » 3 « (za 13., 15. in 17. dan zdravljenja; oznaka 0, 75 ml na brizgi)
- blue, with number “ 4” (treatment days 19, 21 and 23; 0.25, 0.5, 0.75 and 1-ml syringe
modro, označeno s številko » 4 « (za 19., 21. in 23. dan zdravljenja; oznake 0, 25, 0, 5, 0, 75 in 1 ml na brizgi)
marking) Each triple pack contains 3 vials with powder, 3 pre-filled syringes with solvent, 3 vial adapters with pre-attached needle and 6 alcohol wipes for skin and vial cleaning.
Vsako tridelno pakiranje vsebuje 3 viale s praškom, 3 napolnjene injekcijske brizge z vehiklom, 3 adapterji za viale z iglami in 6 alkoholnih blazinic za čiščenje kože in vial.
Connect the pre-filled syringe with solvent to the vial adapter and inject the 1.2 ml of the solvent (sodium chloride solution, 5.4 mg/ ml (0.54% w/ v)) into the Betaferon vial.
Za pripravo liofiliziranega interferona beta- 1b za injiciranje je treba v vialo z zdravilom Betaferon s priloženo napolnjeno injekcijsko brizgo z vehiklom in iglo vbrizgati 1, 2 ml vehikla (raztopina natrijevega klorida, 5, 4 mg/ ml (0, 54% m/ v)).
After reconstitution, draw 1.0 ml from the vial into the syringe for the administration of 250 micrograms Betaferon.
32 Za odmerjanje 250 mikrogramov zdravila Betaferon, je treba po rekonstituciji potegniti 1 ml raztopine iz viale v brizgo.
For the dose titration at the start of treatment draw the respective volume as given in section 4.2 Dosage and administration.
Za titriranje odmerkov je treba na začetku zdravljenja potegniti ustrezno količino raztopine, kot je razloženo v poglavju 4. 2 Odmerjanje in način uporabe.
32 • Disposal
• Odstranjevanje
Bayer Schering Pharma AG D-13342 Berlin Germany
Bayer Schering Pharma AG D- 13342 Berlin Nemčija
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Boehringer Ingelheim Austria, Dr. -Boehringer-Gasse 5-11, A-1121 Vienna, Austria
Boehringer Ingelheim Austria, Dr. - Boehringer- Gasse 5- 11, A- 1121, Dunaj, Avstrija
5650 Hollis Street, Emeryville, CA 94608, USA
Bayer Healthcare Pharmaceuticals Inc., 5650 Hollis Street, Emeryville, CA 94608, ZDA
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serije v Evropskem gospodarskem prostoru (EEA).
37 PARTICULARS TO APPEAR ON THE OUTER PACKAGING (15 VIALs / 15 PRE-FILLED SYRINGES)
(15 VIAL / 15 NAPOLNJENIH INJEKCIJSKIH BRIZG)
Betaferon 250 microgram/ ml, Powder and solvent for solution for injection Interferon beta-1b
Betaferon 250 mikrogramov/ ml prašek in vehikel za raztopino za injiciranje Interferon beta- 1b
1 ml contains250 microgram (8 million IU) Interferon beta-1b when reconstituted.
1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta- 1b po rekonstituciji.
Human albumin, mannitol
Pomožne snovi: humani albumin, manitol.
1 vial with powder for solution for injection contains 300 microgram (9.6 million IU).
1 viala s praškom za raztopino za injiciranje vsebuje 300 mikrogramov (9, 6 milijonov i. e.).
After reconstitution 1 ml contains 250 microgram (8 million IU)Interferon beta-1b*
Po rekonstituciji 1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta 1- b *.
1 pre-filled syringe with 1.2 ml solvent for reconstitution contains: sodium chloride solution 5.4 mg/ ml.
1 napolnjena injekcijska brizga z 1, 2 ml vehikla za rekonstitucijo vsebuje raztopino natrijevega klorida 5, 4 mg/ ml.
*Betaferon is formulated to contain a calculated overfill of 20%.
* Betaferon vsebuje izračunan 20% presežek.
For subcutaneous injection after reconstitution with 1.2 ml of solvent.
Po rekonstituciji z 1, 2 ml vehikla zdravilo injicirajte subkutano. za enkratno uporabo Pred uporabo preberite priloženo navodilo.
Read the package leaflet before use.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Zdravilo shranjujte nedosegljivo otrokom!
Keep out of the reach and sight of children
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
OTHER SPECIAL WARNING(S), IF NECESSARY
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXPIRY DATE
38 Zdravilo je priporočljivo uporabiti takoj po pripravi.
LOT
Serija {številka}
1 ml contains 250 microgram (8 million IU) Interferon beta-1b when reconstituted.
1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta- 1b po rekonstituciji.
Multipack comprising 15 single packs, each containing:
Škatla z več pakiranji iz 15 posameznih pakiranj, vsako vsebuje:
After reconstitution 1 ml contains 250 microgram (8 million IU) Interferon beta-1b*.
Po rekonstituciji 1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta 1- b *.
1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ ml.
1 napolnjena injekcijska brizga z 1, 2 ml vehikla za rekonstitucijo vsebuje raztopino natrijevega klorida 5, 4 mg/ ml.
Read the package leaflet before use.
Po rekonstituciji z 1, 2 ml vehikla zdravilo injicirajte subkutano. za enkratno uporabo Pred uporabo preberite priloženo navodilo.
EXP {MM/ YYYY}
Uporabno do{ MM/ LLLL}
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING (5 VIALs / 5 PRE-FILLED SYRINGES (1.2 ml))
(5 VIAL / 5 NAPOLNJENIH INJEKCIJSKIH BRIZG (1, 2 ml))
1 vial with powder for solution for injection contains 300 microgram (9.6 million IU).
1 viala s praškom za raztopino za injiciranje vsebuje 300 mikrogramov (9. 6 milijonov i. e.).
After reconstitution 1 ml contains 250 microgram (8 million IU)Interferon beta-1b*
Po rekonstituciji 1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta- 1b *.
1 pre-filled syringe with 1.2 ml solvent for reconstitution contains: sodium chloride solution 5.4 mg/ ml.
1 napolnjena injekcijska brizga z 1, 2 ml vehikla za rekonstituiranje vsebuje raztopino natrijevega klorida 5, 4 mg/ ml
*Betaferon is formulated to contain a calculated overfill of 20%.
* Ena viala Betaferona vsebuje izračunan 20% presežek.
EXPIRY DATE
42 Zdravilo je priporočljivo uporabiti takoj po pripravi.
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF MULTIPACKS (5x1 SINGLE PACK) (INCLUDING BLUE BOX)
43 PODATKI NA ZUNANJI OVOJNINI
Multipack comprising 5 single packs, each containing:
Škatla z več pakiranji iz 5 posameznih pakiranj, vsako vsebuje:
1 pre-filled syringe with solvent for reconstitution contains 1.2 ml sodium chloride solution 5.4 mg/ ml.
1 napolnjena injekcijska brizga z 1, 2 ml vehikla za rekonstitucijo vsebuje raztopino natrijevega klorida 5, 4 mg/ ml.
EXPIRY DATE
44 Uporabno do{ MM/ LLLL}
CARTON OF 45 (3x 15) SINGLE PACKS (INCLUDING BLUE BOX)
ŠKATLA S PO 45 (3 x 15) POSAMEZNIMI PAKIRANJI (VKLJUČUJE BLUEBOX)
Betaferon 250 microgram/ ml powder and solvent for solution for injection Interferon beta-1b
Betaferon 250 mikrogramov/ ml prašek in vehikel za raztopino za injiciranje Interferon beta- 1b
3-month pack comprising 45 (3x15) single packs, each containing:
3- mesečno pakiranje vsebuje 45 (3 x 15) posameznih pakiranj, od katerih vsako vsebuje:
Keep out of the reach and sight of children.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
EXPIRY DATE
46 Uporabno do {MM/ LLLL}
CARTON OF 42 (3x 14) SINGLE PACKS (INCLUDING BLUE BOX)
ŠKATLA S PO 42 (3 x 14) POSAMEZNIMI PAKIRANJI (VKLJUČUJE BLUE BOX)
Betaferon 250 microgram/ ml powder and solvent for solution for injection Interferon beta-1b
Betaferon 250 milrogramov/ ml prašek in vehikel za raztopino za injiciranje Interferon beta- 1b
3-month pack comprising 42 (3x14) single packs, each containing:
3- mesečno pakiranje vsebuje 42 (3 x 14) posameznih pakiranj, od katerih vsako vsebuje:
1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ ml.
1 napolnjena injekcijska brizga z 1, 2 ml vehikla za rekostitucijo vsebuje raztopino natrijevega klorida 5, 4 mg/ ml.
48 8.
48
49 PARTICULARS TO APPEAR ON THE OUTER PACKAKING CARTON WITH 15 SINGLE PACKS, PART OF A CARTON WITH 45 (3 x 15) SINGLE PACKS (INCLUDING BLUE BOX)
ŠKATLA S 15 POSAMEZNIMI PAKIRANJI, DEL ŠKATLE S 45 (3 x 15) POSAMEZNIMI PAKIRANJI (VKLJUČUJE BLUEBOX)
Pack comprising 15 single packs, part of a 3-month pack containing 45 (3 x 15) single packs.
Pakiranje vsebuje 15 posameznih pakiranj, del 3- mesečnega pakiranja, ki vsebuje 45 (3 x 15) posameznih pakiranj.
51 PARTICULARS TO APPEAR ON THE OUTER PACKAKING CARTON WITH 14 SINGLE PACKS, PART OF A CARTON WITH 42 (3 x 14) SINGLE PACKS (INCLUDING BLUE BOX)
ŠKATLA S 14 POSAMEZNIMI PAKIRANJI, DEL ŠKATLE S 42 (3 x 14) POSAMEZNIMI PAKIRANJI (VKLJUČUJE BLUEBOX)
Pack comprising 14 single packs, part of a 3-month pack containing 42 (3 x 14) single packs.
Pakiranje vsebuje 14 posameznih pakiranj, del 3- mesečnega pakiranja, ki vsebuje 42 (3 x 14) posameznih pakiranj.
EXPIRY DATE
Uporabno do
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 1 SINGLE PACK (1VIAL/ 1PFS), PART OF A CARTON WITH 15 SINGLE PACKS IN A CARTON OF 3x15 SINGLE PACKS
ŠKATLA Z ENIM POSAMEZNIM PAKIRANJEM (1 VIALA/ 1 NAPOLNJENA INJEKCIJSKA BRIZGA), DEL ŠKATLE S 15 POSAMEZNIMI PAKIRANJI V KARTONU S PO 3 X 15 POSAMEZNIMI PAKIRANJI
Part of a pack containing 15 single packs in a 3-month pack of 3x15 single packs.
Del pakiranja vsebuje 15 posameznih pakiranj v 3- mesečnem pakiranju s po 3 x 15 posameznimi pakiranji.
1 vial with powder:
1 viala s praškom:
300 microgram (9.6 mio IU) per vial.
300 mikrogramov (9, 6 milijonov i. e.) na vialo.
When reconstituted 250 microgram/ ml (8 mio IU/ ml) Interferon beta-1b.
Po rekonstituciji 1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta- 1b *.
1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ ml, 1 vial adapter with needle + 2 alcohol wipes
1 napolnjena injekcijska brizga z 1, 2 ml vehikla: natrijev klorid 5, 4 mg/ ml, 1 adapter za vialo z iglo + 2 alkoholni blazinici
Read the package leaflet before use.
Po rekonstituciji zdravilo injicirajte subkutano. za enkratno uporabo Pred uporabo preberite priloženo navodilo.
54 9.
54 Zdravilo je priporočljivo uporabiti takoj po pripravi.
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 1 SINGLE PACK (1VIAL/ 1PFS), PART OF A CARTON WITH 14 SINGLE PACKS IN A CARTON OF 3x14 SINGLE PACKS
ŠKATLA Z 1 POSAMEZNIM PAKIRANJEM (1 VIALA/ 1 VEHIKEL), DEL ŠKATLE S 14 POSAMEZNIMI PAKIRANJI V KARTONU S PO 3 x 14 POSAMEZNIMI PAKIRANJI
Part of a pack containing 14 single packs in a 3-month pack of 3x14 single packs.
Del pakiranja vsebuje 14 posameznih pakiranj v 3- mesečnem pakiranju s po 3 x 14 posameznimi pakiranji.
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING (TITRATION PACK WITH 4x1 TRIPLE PACK (3 VIALS/ 3 PRE-FILLED SYRINGES)), FOR FIRST 12 INJECTIONS/ TREATMENT DAYS
SET ZA TITRIRANJE S 4 x 1 TRIDELNIM PAKIRANJEM (3 VIALE/ 3 NAPOLNJENE INJEKCIJSKE BRIZGE), ZA PRVIH 12 INJICIRANJ/ DNEVOV ZDRAVLJENJA
Titration pack comprising 4 triple packs, each containing:
Set za titriranje Vsebuje 4 tridelna pakiranja, ki vsebujejo
3 Vials with powder for solution for injection, each containing 300 microgram (9.6 million IU).
3 viale s praškom za raztopino za injiciranje, vsaka vsebuje 300 mikrogramov (9, 6 milijonov i. e.) na vialo.
After reconstitution 1 ml contains 250 microgram (8 million IU) Interferon beta-1b*.
Po rekonstituciji 1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta- 1b *.
3 Pre-filled syringes with solvent for reconstitution, each containing 1.2 ml sodium chloride solution, 5.4 mg/ ml.
3 napolnjene injekcijske brizge z vehiklom za rekonstitucijo; vsaka vsebuje 1, 2 ml natrijevega klorida, 5, 4 mg/ ml, III.
For subcutaneous injection after reconstitution with 1.2 ml of solvent.
Po rekonstituciji z 1, 2 ml raztopine zdravilo injicirajte subkutano. za enkratno uporabo Pred uporabo preberite priloženo navodilo.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Zdravilo shranjujte nedosegljivo otrokom.
EXPIRY DATE
58 Uporabno do {MM/ LLLL}
1 for treatment days 1, 3 and 5 Use red triple pack No.
Uporabite rumeno tridelno pakiranje 1 za 1., 3. in 5. dan zdravljenja.
2 for treatment days 7, 9 and 11 Use green triple pack No.
Uporabite rdeče tridelno pakiranje 2 za 7., 9. in 11. dan zdravljenja.
3 for treatment days 13, 15 and 17 Use blue triple pack No.
Uporabite zeleno tridelno pakiranje 3 za 13., 15. in 17. dan zdravljenja.
4 for treatment days 19, 21 and 23
Uporabite modro tridelno pakiranje 4 za 19., 21. in 23. dan zdravljenja.
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 1 SINGLE PACK (1VIAL/ 1PFS) AS AN INTERMEDIATE PACK OF A MULTIPACK OF 15 PACKS (WITHOUT BLUE BOX)
ŠKATLA Z ENIM POSAMEZNIM PAKIRANJEM (1 VIALA/ 1 NAPOLNJENA INJEKCIJSKA BRIZGA), KOT ENOTA V ŠKATLI S 15 PAKIRANJI (BREZ BLUEBOXA)
No individual sale of single packs.
Posamezna pakiranja niso v prodaji.
300 mcg (9.6 mio IU) per vial.
300 mikrogramov (9, 6 milijonov i. e.).
When reconstituted 250 mcg/ ml (8 mio IU/ ml) Interferon beta-1b.
Po rekonstituciji 250 mikrogramov (8 milijonov i. e.) interferona beta 1- b.