m
infusion
time (min)
Patient
weight
(kg)
Dose
(mL)
Maximum
infusion
rate
(mL/h)
Minimum
infusion
time (min)
5 2.5 3 50 53 26.5 25 64
6 3 3.6 50 54 27 25 65
7 3.5 4.2 50 55 27.5 25 67
8 4 4.8 50 56 28 25 67
9 4.5 5.4 50 57 28.5 25 68
10 5 6 50 58 29 25 70
11 5.5 6.6 50 59 29.5 25 71
12 6 7.2 50 60 30 25 72
13 6.5 7.8 50 61 30.5 25 73
14 7 8.4 50 62 31 25 74
15 7.5 9 50 63 31.5 25 76
16 8 9.6 50 64 32 25 77
Patient
weight
(kg)
Dose
(mL)
Maximum
infusion
rate
(mL/h)
Minimum
infusion
time (min)
Patient
weight
(kg)
Dose
(mL)
Maximum
infusion
rate
(mL/h)
Minimum
infusion
time (min)
17 8.5 10.2 50 65 32.5 25 78
18 9 10.8 50 66 33 25 79
19 9.5 11.4 50 67 33.5 25 80
20 10 12 50 68 34 25 82
21 10.5 12.6 50 69 34.5 25 83
22 11 13.2 50 70 35 25 84
23 11.5 13.8 50 71 35.5 25 85
24 12 14.4 50 72 36 25 86
25 12.5 15 50 73 36.5 25 88
26 13 15.6 50 74 37 25 89
27 13.5 16.2 50 75 37.5 25 90
28 14 16.8 50 76 38 25 91
29 14.5 17.4 50 77 38.5 25 92
30 15 18 50 78 39 25 94
31 15.5 18.6 50 79 39.5 25 95
32 16 19.2 50 80 40 25 96
33 16.5 19.8 50 81 40.5 25 97
34 17 20.4 50 82 41 25 98
35 17.5 21 50 83 41.5 25 100
36 18 21.6 50 84 42 25 101
37 18.5 22.2 50 85 42.5 25 102
38 19 22.8 50 86 43 25 103
39 19.5 23.4 50 87 43.5 25 104
40 20 24 50 88 44 25 106
41 20.5 24.6 50 89 44.5 25 107
42 21 25 50 90 45 25 108
43 21.5 25 52 91 45.5 25 109
44 22 25 53 92 46 25 110
45 22.5 25 54 93 46.5 25 112
46 23 25 55 94 47 25 113
47 23.5 25 56 95 47.5 25 114
48 24 25 58 96 48 25 115
49 24.5 25 59 97 48.5 25 116
50 25 25 60 98 49 25 118
51 25.5 25 61 99 49.5 25 119
52 26 25 62
f) When the last syringe is empty, the dosage syringe is replaced with a 20 mL syringe filled withsodium chloride 9 mg/mL (0.9%) solution for injection. A volume of 10 mL sodium chloridesolution should be administered through the infusion system to infuse the remaining fraction ofLamzede in the line to the patient.
DisposalAny unused medicinal product or waste material should be disposed of in accordance with localrequirements.
7. MARKETING AUTHORISATION HOLDER
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy
8. MARKETING AUTHORISATION NUMBER
EU/1/17/1258/001
EU/1/17/1258/002
EU/1/17/1258/003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23/03/2018
10. DATE OF REVISION OF THE TEXT
{MM/YYYY}
Detailed information on this medicinal product is available on the website of the European Medicines
Agency http://www.ema.europa.e
ANNEX II
A. MANUFACTURER OF THE BIOLOGICAL ACTIVESUBSTANCE AND MANUFACTURER RESPONSIBLE FORBATCH RELEASE
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLYAND USE
C. OTHER CONDITIONS AND REQUIREMENTS OF THEMARKETING AUTHORISATION
D. CONDITIONS OR RESTRICTIONS WITH REGARD TOTHE SAFE AND EFFECTIVE USE OF THE MEDICINALPRODUCT
E. SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION
MEASURES FOR THE MARKETING
AUTHORISATION UNDER EXCEPTIONALCIRCUMSTANCES
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURER RESPONSIBLE FOR BATCH RELEASEName and address of the manufacturer of the biological active substance
Rentschler Biopharma SE
Erwin-Rentschler-Strasse 21
88471 Laupheim
Germany
Name and address of the manufacturer responsible for batch release
Chiesi Farmaceutici S.p.A.
Via San Leonardo, 96
43122 Parma
Italy
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Chara |
