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Ranibizumab

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Topics: BiosimilarsCCG commissioned new medicinesEyes and vision · New MedicinesPatent expiriesPre-registration new medicines (UK/EU)RanibizumabSafety in BreastfeedingStability outside the fridge ·
Contents
  1. dm+d
  2. Articles
  3. Refrigerated Storage
    1. Lucentis · Novartis Pharmaceuticals
    2. Ongavia · Bioeq/Midas. UK Sales and Marketing: Teva
  4. Lactation Safety Information

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Articles

Preparing to use ranibizumab biosimilar

29 June 2022Ranibizumab biosimilar needs planning. Ensure you are familiar with the area and then develop an implementation plan working with the multidisciplinary team

Good governance when implementing ranibizumab biosimilar

29 June 2022Governance should consider processes for approval; procurement and supply; prescribing and administration; monitoring; and pharmacovigilance

The licence and supporting evidence for ranibizumab biosimilar

29 June 2022Three licensed ranibizumab biosimilars are available: Byooviz, Ongavia and Ximluci. Learn about the licensed indications and supporting evidence

Safety in Lactation: Subfoveal choroidal neovascularisation

21 September 2020VEGF inhibitors are used for age-related macular degeneration, administered by intravitreal injection. They are also large molecules with a high molecular weight. These factors will…
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Refrigerated Storage

LucentisNovartis Pharmaceuticals

Novartis Pharmaceuticals
Lucentis
10 mg/mL solution for injection (vial and pre-filled syringe)

In the event of an inadvertent temperature excursion the following data may be used:

Prior to use, the unopened product may be kept at room temperature (25°C) for up to 24 hours.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

26 January 2022
London MI Service

OngaviaBioeq/Midas. UK Sales and Marketing: Teva

Bioeq/Midas. UK Sales and Marketing: Teva
Ongavia
10mg/mL solution for injection (vial)

In the event of an inadvertent temperature excursion the following data may be used:

The following temperature excursions are considered non-critical:

  • Between 8°C and 25°C for a maximum duration of 16 hours
  • Between 25°C and 30°C for a maximum duration of 4 hours
  • Between -10°C and 2°C for a maximum duration of 24 hours

Prior to use, the unopened product may be kept at room temperature (25°C) for up to 24 hours.
Contact Teva in cases where additional stability data is required. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and manufacturer’s product literature.

5 July 2022
London MI Service

Lactation Safety Information

Yes
Very limited published evidence of safety
Negligible levels anticipated in milk due to the drug’s properties
Safety in Lactation: Subfoveal choroidal neovascularisation
16 September 2020
LactMed