ithdraw and discard 100 ml from a 1,000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
- withdraw 50 ml of ofatumumab from each of 2 vials and inject into the 1,000 ml bag;
- do not shake, mix diluted solution by gentle inversion.
• How to administer the diluted solution
Arzerra must not be administered as an intravenous push or bolus. Administer using an intravenous infusion pump, using the 0.2 micron in-line filter extension sets provided. The in-line filter must be used during the entire infusion.
The infusion must be completed within 24 hours after preparation. Discard any unused solution after this time.
Arzerra must not be mixed with, or administered as an infusion with other medicinal products or intravenous solutions. Flush line before and after ofatumumab administration with sodium chloride 9 mg/ml (0.9%) solution for injection to avoid this.
For the first and second infusion, administer over 6.5 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below:
Infusions 1 and 2: schedule
Time (minutes)
ml/hour
0 – 30
12
31 – 60
25
61 – 90
50
91 – 120
100
121 +
200
If the second infusion has been completed without a severe adverse reaction, the remaining infusions (3-12) should be administered over 4 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below:
Infusions 3 to 12: schedule
Time (minutes)
ml/hour
0 – 30
25
31 – 60
50
61 – 90
100
91 – 120
200
121 +
400
If any adverse reactions are observed, infusion rates should be reduced (see section 4.2).
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Glaxo Group Ltd
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex
UB6 0NN
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/10/625/003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19/04/2010
Date of last renewal: 21 April 2011
10. DATE OF REVISION OF THE TEXT
April 2011.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
