natgillin/translations-raw huggingface dataset:
En ml indeholder 15 millioner IE interferon alfa- 2b.
One ml contains 15 million IU of interferon alfa-2b.
Pennen er designet til at afgive sit indhold af 18 millioner IE i doser fra 1, 5 til 6 millioner IE.
The pen is designed to deliver its contents of 18 million IU in doses ranging from 1.5 to 6 million IU.
Pennen vil afgive maksimalt 12 doser á 1, 5 millioner IE over en periode, som ikke må overstige 4 uger.
The pen will deliver a maximum of 12 doses of 1.5 million IU over a period not to exceed 4 weeks.
Injektionsvæske, opløsning Opløsningen er klar og farveløs.
Solution for injection Solution is clear and colourless.
Behandling af voksne patienter med kronisk hepatitis B forbundet med tegn på hepatitis B virusreplikation (tilstedeværelse af HBV- DNA og HBeAg), forhøjet alaninaminotransferase ALAT og histologisk påvist aktiv leverinflammation og/ eller fibrose.
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.
233 Klinisk erfaring indikerer, at et hæmatologisk og cytogenetisk større/ mindre respons er opnåeligt hos størstedelen af behandlede patienter.
 233 Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated.
IntronA indgives subkutant i en dosis på 3 millioner IE tre gange om ugen (hver anden dag) til voksne patienter, både anvendt som monoterapi og i kombination med ribavirin.
IntronA is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with
234 Børn i alderen 3 år eller derover og unge:
 234 ribavirin.
Den anbefalede dosering er 2 millioner IE/ m2 givet subkutant tre gange om ugen (hver anden dag) for både splenektomerede og ikke splenektomerede patienter.
 235 most patients with Hairy Cell Leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
IntronA skal anvendes med forsigtighed hos patienter med invaliderende sygdom, som for eksempel patienter med tidligere lungesygdom (såsom kronisk obstruktiv lungesygdom) eller diabetes mellitus med tendens til ketoacidosis.
IntronA must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease) or diabetes mellitus prone  237 to ketoacidosis.
237 Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet observeret hos interferon- alfa behandlede patienter, inklusive de, som er behandlet med IntronA.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
238 Kronisk hepatitis C:
 238 Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation.
I kliniske undersøgelser med IntronA- behandling udviklede 2, 8% af patienterne unormal thyreoideafunktion.
In clinical trials using Intron A therapy, 2.8% patients overall developed thyroid abnormalities.
Indgift af IntronA i kombination med andre kemoterapeutika (såsom Ara- C, cyclophosphamid, doxorubicin, teniposid) kan føre til forøget risiko for toksicitet (sværhedsgrad og varighed), som kan være livstruende eller fatal som et resultat af det samtidigt indgivne lægemiddel.
 239 Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a result of the concomitantly administered medicinal product.
240 4. 6 Graviditet og amning
 240 (Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C).
241 Tabel 1.
Table 1.
Pharyngitis *, viral infektion * Bronkitis, sinuitis, herpes simplex (resistent), rhinitis Bakterieinfektion Lungebetændelse§, sepsis
Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis
Meget sjælden:
 Very rarely:
Hypertension Perifer iskæmi, hypotension§
242 Peripheral ischaemia, hypotension§
For eksempel var
Severity also increased with high dose therapy (WHO Grade 3 and 4, in 66% and 14% of
243 incidensen af træthed, feber, myalgi, neutropeni/ anæmi, anoreksi, kvalme og opkastning, diarré, kulderystelser, influenzalignende symptomer, depression, alopeci, smagsforstyrrelser og svimmelhed i en undersøgelse af højdosis adjuverende IntronA behandling hos patienter med melanom større end i hepatitis C undersøgelserne.
 243 patients, respectively), in comparison with the mild to moderate severity usually associated with lower doses.
Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper)
Blood and lymphatic system disorders
244
244
Anæmi, neutropeni Thrombocytopeni, lymphadenopati
Thrombocytopaenia, lymphadenopathy
245 Almene symptomer og reaktioner på administartionsstedet Meget almindelig:
Very common:
Meget almindelig:
 Very common:
Fald i væksthastighed (højde og/ eller vægtfald i forhold til alder) §
245 Growth rate decrease (height and/or weight decrease for age)§
246 inklusiv hæmning af virusreplikation i virusinficerede celler, suppression af celledeling og sådanne immunmodulerende aktiviteter som øgning af den fagocytære aktivitet af makrofager og øgning af den specifikke cytotoksicitet af lymfocytter på målcellerne.
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Skønt den nøjagtige antivirale virkningsmekanisme af rekombinant alfa- 2b er ukendt, synes det at ændre værtscellemetabolismen.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell  246 metabolism.
Uafhængigt af genotype havde patienter, som fik IntronA i kombination med ribavirin og fik  80% af deres behandling, et højere vedvarende respons 6 måneder efter 1 års behandling end dem, der anvendte < 80% af deres behandling (56% mod 32% i undersøgelse C/ I98- 580).
3 2% in trial C/I98-580).
247
Table 3
Tabel 3
Sustained
Genotype 1
 247 Genotype 1
248 Tabel 4
 248 Table 4
4. 1, 4. 4 og 4. 8).
 249, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Defineret som HCV RNA under detektionsgrænsen ved brug af en forskningsbaseret RT- PCR analyse ved afslutningen af behandlingen og under opfølgningsperioden
Defined as HCV-RNA below limit of detection using a research based R T-PCR assay at end of treatment and during follow-up period
Tabel 6.
 250 Table 6.
Dinatriumphosphat vandfri, Natriumdihydrogenphosphatmonohydrat, Natriumedetat, Natriumchlorid, M- cresol, Polysorbat 80, Sterilt vand q. s.
Disodium phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, Edetate disodium,
Fysisk- kemisk stabilitet under brug er vist i 27 dage ved 2C - 8C.
Chemical and physical in-use stability has been demonstrated for 27 days at 2ºC – 8ºC.
Fra et mikrobiologisk synspunkt kan produktet når det er åbnet opbevares i maksimalt 27 dage ved 2C - 8C.
From a microbiological point of view, once opened, the product may be stored for a maximum of 27 days at 2ºC – 8ºC.
251 Opbevares i køleskab (2°C - 8°C).
Store in a refrigerator (2°C – 8°C).
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
1.2 ml of solution (corresponding to 18 MIU) in a pen made of a cartridge (type I glass) sealed at one end with an cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber) with 12 injection needles and12 cleansing swabs Pack sizes of 1, 2 or 8 Not all pack sizes may be marketed.
IntronA injektionsvæske, opløsning, flerdosispen injiceres subkutant efter at en kanyle er påsat og den ordinerede dosis er indstillet.
IntronA, solution for injection, multidose pen is injected subcutaneously after attaching an injection needle and dialing the prescribed dose.
Detaljerede instruktioner til brug af præparatet følger med indlægsseddelen (se ” Hvordan injicerer De selv IntronA ”).
Detailed instructions for the use of the product is provided with the package leaflet (refer to “How to self inject IntronA”).
I lighed med alle parenterale lægemidler undersøges IntronA, injektionsvæske, opløsning visuelt for partikler og misfarvning før brugen.
 252 As with all parenteral medicinal products, prior to administration inspect IntronA, solution for injection, visually for particulate matter and discolouration.
IntronA 30 millioner IE injektionsvæske, opløsning, flerdosispen
IntronA 30 million IU solution for injection, multidose pen
En cylinderampul indeholder 30 millioner IE rekombinant interferon alfa- 2b, produceret i E. coli ved rekombinant DNA- teknologi, i 1, 2 ml.
One cartridge contains 30 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 1.2 ml.
En ml indeholder 25 millioner IE interferon alfa- 2b.
One ml contains 25 million IU of interferon alfa-2b.
Pennen er designet til at afgive sit indhold af 30 millioner IE i doser fra 2, 5 til 10 millioner IE.
The pen is designed to deliver its contents of 30 million IU in doses ranging from 2.5 to 10 million IU.
Pennen vil afgive maksimalt 12 doser á 2, 5 millioner IE over en periode, som ikke må overstige 4 uger.
The pen will deliver a maximum of 12 doses of 2.5 million IU over a period not to exceed 4 weeks.
LÆGEMIDDELFORM
PH ARMACEUTICAL FORM
254 Klinisk erfaring indikerer, at et hæmatologisk og cytogenetisk større/ mindre respons er opnåeligt hos størstedelen af behandlede patienter.
 254 Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated.
255 Kronisk hepatitis C:
 255 ribavirin.
Den anbefalede dosering er 2 millioner IE/ m2 givet subkutant tre gange om ugen (hver anden dag) for både splenektomerede og ikke splenektomerede patienter.
 256 most patients with Hairy Cell Leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
IntronA skal anvendes med forsigtighed hos patienter med invaliderende sygdom, som for eksempel patienter med tidligere lungesygdom (såsom kronisk obstruktiv lungesygdom) eller diabetes mellitus med tendens til ketoacidosis.
IntronA must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease) or diabetes mellitus prone  258 to ketoacidosis.
258 Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet observeret hos interferon- alfa behandlede patienter, inklusive de, som er behandlet med IntronA.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
259 Kronisk hepatitis C:
 259 Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation.
Voksne patienter, som var i behandling med IntronA for kronisk hepatitis C, viste med mindre hyppighed unormal thyreoideafunktion, enten hypothyreoidisme eller hyperthyreoidisme.
Infrequently, adult patients treated for chronic hepatitis C with Intron A developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
Indgift af IntronA i kombination med andre kemoterapeutika (såsom Ara- C, cyclophosphamid, doxorubicin, teniposid) kan føre til forøget risiko for toksicitet (sværhedsgrad og varighed), som kan være livstruende eller fatal som et resultat af det samtidigt indgivne lægemiddel.
 260 Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a result of the concomitantly administered medicinal product.
261 4. 6 Graviditet og amning
 261 (Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C).
262 Tabel 1.
Table 1.
Sjælden:
Common:
Hypertension Perifer iskæmi, hypotension§
263 Peripheral ischaemia, hypotension§
264 incidensen af træthed, feber, myalgi, neutropeni/ anæmi, anoreksi, kvalme og opkastning, diarré, kulderystelser, influenzalignende symptomer, depression, alopeci, smagsforstyrrelser og svimmelhed i en undersøgelse af højdosis adjuverende IntronA behandling hos patienter med melanom større end i hepatitis C undersøgelserne.
 264 patients, respectively), in comparison with the mild to moderate severity usually associated with lower doses.
265
265
266 Almene symptomer og reaktioner på administartionsstedet Meget almindelig:
Very common:
Fald i væksthastighed (højde og/ eller vægtfald i forhold til alder) §
266 Growth rate decrease (height and/or weight decrease for age)§
267 inklusiv hæmning af virusreplikation i virusinficerede celler, suppression af celledeling og sådanne immunmodulerende aktiviteter som øgning af den fagocytære aktivitet af makrofager og øgning af den specifikke cytotoksicitet af lymfocytter på målcellerne.
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Skønt den nøjagtige antivirale virkningsmekanisme af rekombinant alfa- 2b er ukendt, synes det at ændre værtscellemetabolismen.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell  267 metabolism.
268
Table 3
Genotype 1
 268 Genotype 1
Behandlingsvarigheden var 48 uger med en opfølgningsperiode på 6 måneder med undtagelse af de patienter, der var inficeret med genotype 2 og 3 og viral load < 800. 000 IE/ ml (Amplicor), som blev behandlet i 24 uger med en opfølgningsperiode på 6 måneder.
The duration of thera py was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
269 Tabel 4
 269 Table 4
4. 1, 4. 4 og 4. 8).
 270, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Tabel 6.
 271 Table 6.
272 Opbevares i køleskab (2°C - 8°C).
Store in a refrigerator (2°C – 8°C).
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
1.2 ml of solution (corresponding to 30 MIU) in a pen made of a cartridge (type I glass) sealed at one end with an cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber) with 12 injection needles and12 cleansing swabs Pack sizes of 1, 2 or 8 Not all pack sizes may be marketed.
I lighed med alle parenterale lægemidler undersøges IntronA, injektionsvæske, opløsning visuelt for partikler og misfarvning før brugen.
 273 As with all parenteral medicinal products, prior to administration inspect IntronA, solution for injection, visually for particulate matter and discolouration.
273 8.
8.
IntronA 60 millioner IE injektionsvæske, opløsning, flerdosispen
IntronA 60 million IU solution for injection, multidose pen
En cylinderampul indeholder 60 millioner IE rekombinant interferon alfa- 2b, produceret i E. coli ved rekombinant DNA- teknologi, i 1, 2 ml.
One cartridge contains 60 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 1.2 ml.
En ml indeholder 50 millioner IE interferon alfa- 2b.
One ml contains 50 million IU of interferon alfa-2b.
275 Klinisk erfaring indikerer, at et hæmatologisk og cytogenetisk større/ mindre respons er opnåeligt hos størstedelen af behandlede patienter.
 275 Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated.
276 Børn i alderen 3 år eller derover og unge:
 276 ribavirin.
Den anbefalede dosering er 2 millioner IE/ m2 givet subkutant tre gange om ugen (hver anden dag) for både splenektomerede og ikke splenektomerede patienter.
 277 most patients with Hairy Cell Leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
Nogle patienter har vist at have gavn af IntronA 5 millioner IE/ m2 indgivet dagligt subkutant i forbindelse med cytarabin (Ara- C) 20 mg/ m2 indgivet dagligt subkutant i 10 dage per måned (op til en maksimal daglig dosis på 40 mg).
Some patients have been shown to benefit from IntronA 5 million IU/m2 administered daily subcutaneously in association with cytarabine (Ara -C) 20 mg/m2 administered daily subcutaneously for 10 days per month (up to a maximum daily dose of 40 mg).
IntronA skal anvendes med forsigtighed hos patienter med invaliderende sygdom, som for eksempel patienter med tidligere lungesygdom (såsom kronisk obstruktiv lungesygdom) eller diabetes mellitus med tendens til ketoacidosis.
IntronA must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease) or diabetes mellitus prone  279 to ketoacidosis.
279 Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet observeret hos interferon- alfa behandlede patienter, inklusive de, som er behandlet med IntronA.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
280 Kronisk hepatitis C:
 280 Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation.
Indgift af IntronA i kombination med andre kemoterapeutika (såsom Ara- C, cyclophosphamid, doxorubicin, teniposid) kan føre til forøget risiko for toksicitet (sværhedsgrad og varighed), som kan være livstruende eller fatal som et resultat af det samtidigt indgivne lægemiddel.
 281 Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a result of the concomitantly administered medicinal product.
282 4. 6 Graviditet og amning
 282 (Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C).
283 Tabel 1.
Table 1.
Hypertension Perifer iskæmi, hypotension§
284 Peripheral ischaemia, hypotension§
285 incidensen af træthed, feber, myalgi, neutropeni/ anæmi, anoreksi, kvalme og opkastning, diarré, kulderystelser, influenzalignende symptomer, depression, alopeci, smagsforstyrrelser og svimmelhed i en undersøgelse af højdosis adjuverende IntronA behandling hos patienter med melanom større end i hepatitis C undersøgelserne.
 285 patients, respectively), in comparison with the mild to moderate severity usually associated with lower doses.
4. 4).
Additional adverse events were reported rarely (> 1/10,000, < 1/1,000) or very rarely (< 1/10,000) Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
286
286
287 Almene symptomer og reaktioner på administartionsstedet Meget almindelig:
287
288 inklusiv hæmning af virusreplikation i virusinficerede celler, suppression af celledeling og sådanne immunmodulerende aktiviteter som øgning af den fagocytære aktivitet af makrofager og øgning af den specifikke cytotoksicitet af lymfocytter på målcellerne.
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Rekombinant interferon alfa- 2b hæmmer også viral replikation in vitro og in vivo.
 288 Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
289
Table 3
Alle genotyper
 289 All Genotypes
290 Tabel 4
 290 Table 4
4. 1, 4. 4 og 4. 8).
 291, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Genotype 2/ 3/ 4 (n=26) * Antal (%) patienter
Genotype 2/ 3/4 (n=26) *Number (%) of patients
Tabel 6.
 292 Table 6.
6. 4 Særlige opbevaringsforhold 293 Opbevares i køleskab (2°C - 8°C).
6.4 Special precautions for storage
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
1.2 ml of solution (corresponding to 60 MIU) in a pen made of a cartridge (type I glass) sealed at one end with an cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber) with 12 injection needles and12 cleansing swabs Pack sizes of 1, 2 or 8 Not all pack sizes may be marketed.
I lighed med alle parenterale lægemidler undersøges IntronA, injektionsvæske, opløsning visuelt for partikler og misfarvning før brugen.
 294 As with all parenteral medicinal products, prior to administration inspect IntronA, solution for injection, visually for particulate matter and discolouration.
294 8.
8.
295 BILAG II
 295 ANNEX II
Industriepark 30 B- 2220 Heist- op- den- Berg Belgien
Industriepark 30 B-2220 Heist-op-den-Berg Belgium
 BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE OF THE MEDICINAL PRODUCT
297 BILAG III
 297 ANNEX III
299 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
 299 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
IntronA 1 million IE/ ml pulver og solvens til injektionsvæske eller til infusionsvæske interferon alfa- 2b
IntronA 1 million IU/ml powder and solvent for solution for injection or infusion interferon alfa-2b
Et hætteglas med pulver indeholder 1 million IE interferon alfa- 2b og giver 1 million IE interferon alfa- 2b per ml efter tilberedning som anbefalet.
One vial of powder contains 1 million IU of interferon alfa-2b and provides 1 million IU per ml of interferon alfa-2b when reconstituted as recommended.
Hjælpestoffer: glycin, dinatriumphosphat vandfri, natriumdihydrogenphosphatmonohydrat og human albumin En ampul med solvens indeholder 1 ml vand til injektionsvæsker.
Excipients: glycine, disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, and human albumin solution One ampoule of solvent contains 1 ml of water for injections.
1 million IE/ ml pulver og solvens til injektionsvæske eller til infusionsvæske 1 hætteglas med pulver, 1 ampul med solvens, 1 injektionssprøjte, 2 kanyler og 1 renseserviet 12 hætteglas med pulver, 12 ampuller med solvens, 12 injektionssprøjter, 24 kanyler og 12 renseservietter
1 million IU/ml powder and solvent for solution for injection or infusion 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs