Saphnelo 300 mg concentrate for solution for infusion

Section 4.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

Malta

ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

United Kingdom (Northern Ireland)

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store 

Section 6.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

 Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC

Tel: +353 1609 7100

Malta

Associated Drug Co. Ltd

Tel: +356 2277 8000

United Kingdom (Northern Ireland)

AstraZeneca UK Ltd

Tel: +44 1582 836 836

information to HCPs

Administration

1.         It is recommended that the solution for infusion be administered immediately after preparation. If the solution for infusion has been stored in a refrigerator, allow it to reach room temperature (15°C to 25°C) prior to administration.

2.         Administer the infusion solution intravenously over 30 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or to 15 micron in-line or add-on filter.

4.2 Posology and method of administration

Method of administration

For intravenous use.

Saphnelo must not be administered as an intravenous push or bolus injection.

Following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, Saphnelo is administered as an infusion over 30 minutes through an intravenous infusion line containing a sterile, low-protein binding 0.2 or to 15 micron in-line or add-on filter.

4.8 Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

Malta

ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

United Kingdom (Northern Ireland)

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store