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Safety in Lactation: Immunoglobulins

21 September 2020Immunoglobulins are considered to be compatible with breastfeeding and may contribute to the transfer of protective antibodies to the neonate.
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Refrigerated Storage

SubgamBio Product Laboratory

Bio Product Laboratory
Subgam
solution for injection

In the event of an inadvertent temperature excursion the product is stable for up to 1 week at 25°C.

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

No under conditions described above
Yes under conditions described above

There is no data to support the use of a product that has more than one cycle of exposure to room temperature. For best practice it is suggested to identify the vials left out of the fridge in order they can be used first.

29 April 2019
London MI Service

KiovigBaxter

Baxter
Kiovig
100 mg/mL solution for infusion

Contact Baxter with the following information in all cases where a deviation from the recommended storage conditions has occurred:- Copy of the fridge recordings or log of fridge temperature recordings- Quantity of product affected- Batch numbers- Expiry dates- Length of the temperature excursionRefer to the current BNF for company contact details.

London MI Service

VigamBio Products Laboratory Ltd

Bio Products Laboratory Ltd
Vigam
Solution for infusion (IV) 50 g/L

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

This product is stable for up to 3 months at 25°C within the shelf life period.

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

No alteration required under the storage conditions described above
Yes under the storage conditions described above.

There is no data to support the use of a product that has more than one cycle of exposure to room temperature. For best practice it is suggested to identify the vials left out of the fridge in order they can be used first.

30 October 2019
London MI Service

Gammanorm®Octapharma Limited

Octapharma Limited
Gammanorm®
Solution for injection

In the event of an inadvertent temperature excursion the following data may be used:
The product may be removed from the refrigerator for a single period of up to 6 months (without exceeding the original expiry date) and stored at a temperature below 25°C. At the end of this period, the product should not be refrigerated again and should be disposed of. The date at which the product was taken out of the refrigerator should be recorded on the outer carton.

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

Contact Octapharma Limited in all cases where a deviation from the recommended storage conditions has occurred.

6 months as described above
No
9 May 2020
London MI Service

Octagam®Octapharma Ltd

Octapharma Ltd
Octagam®
10% Solution for infusion

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

The product may be removed from the refrigerator for a single period of up to 9 months (without exceeding the expiry date) and stored at a temperature below 25°C. At the end of this period, the product should not be refrigerated again and should be disposed of. The date at which the product was taken out of the refrigerator should be recorded on the outer carton.

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

Contact Octapharma Limited in all cases where a deviation from the recommended storage conditions has occurred.

9 months as described above
No
9 July 2020
London MI Service

GamunexGrifols

Grifols
Gamunex
100 mg/mL solution for infusion

In the event of an inadvertent temperature excursion the following data may be used:
The product may be stored in its outer carton for a one-off period of up to 6 months at room temperature (not above 25°C). Subsequent refrigeration or freezing is not possible.

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

Contact Grifols UK Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Reduce the shelf-life to 6 months as soon you take the product out of the fridge. The new expiry date must be noted on the outer carton and the vial label. The new expiry date must be no later than the printed expiry date. Thereafter, it must be used or destroyed.
No
12 October 2020
London Medicines Information Service

Lactation Safety Information

HNIG; Immune globulin

HNIG; Immune globulin
Yes
Normal component of breast-milk
16 September 2020

New Medicines

Primary immunodeficiency

Information

New formulation
Biotest
Biotest

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Next generation polyvalent human normal immunoglobulin, manufactured using an innovative production process
In the UK over 4,300 people with PIDs have been registered on the UK Primary Immune Deficiency Registry to date. At present doctors estimate that about 5,000 people may be affected by a PID in the UK. The exact figure is unknown because there is no national screening programme for PIDs at birth [1].
Primary immunodeficiency
Intravenous infusion

HyQvia Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Information

HyQvia
Licence extension / variation
Takeda
Takeda

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes

Category

Liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies
CIDP is the most common chronic acquired demyelinating polyneuropathy. Prevalence rates vary between 1 and 7 per 100,000 people, but this may be an underestimation since the clinical presentation can be rather diverse, leading to under diagnosis [1].
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Subcutaneous infusion