vaccineswhich should therefore only be givenat least
3 weeks before or 3 months afteran injection of normal
immunoglobulin (this does not apply to yellow fever
vaccine since normal immunoglobulin does not contain
antibody to this virus).
OCTAGAM®Falsely elevated results with blood glucose
testing systems (contains maltose)
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonChills.diarrhoea.dizziness.
fatigue.gastrointestinal discomfort.headache.
hypotension.muscle complaints.nausea.pain.skin
reactions
▶UncommonParaesthesia
▶Rare or very rareArthralgia
▶Frequency not knownFever
SPECIFIC SIDE-EFFECTS
▶Common or very common
▶With subcutaneous useDrowsiness
▶Uncommon
▶With intramuscular useFeeling hot
▶Rare or very rare
▶With intramuscular useMusculoskeletal stiffness.peripheral
coldness.tremor
▶With intravenous useAcute kidney injury.meningitis
aseptic
▶Frequency not known
▶With intramuscular useChest discomfort.dyspnoea.facial
swelling.flushing.hyperhidrosis.hypertension.malaise.
oral paraesthesia.pallor.tachycardia.vomiting
▶With intravenous useEmbolism and thrombosis.haemolytic
anaemia.myocardial infarction.stroke
SIDE-EFFECTS, FURTHER INFORMATIONAdverse reactions
are more likely to occur in patients receiving normal
immunoglobulin for thefirst time, or following a
prolonged period between treatments, or when a different
brand of normal immunoglobulin is administered.
lMONITORING REQUIREMENTSMonitor for acute renal
failure; consider discontinuation if renal function
deteriorates. Intravenous preparations with added sucrose
have been associated with cases of renal dysfunction and
acute renal failure.
lDIRECTIONS FOR ADMINISTRATION
Preparations for subcutaneous useMay be administered by
intramuscular injection if subcutaneous route not
possible; intramuscular routenotfor patients with
thrombocytopenia or other bleeding disorders.
GAMUNEX®Use Glucose 5 % intravenous infusion if
dilution prior to infusion is required.
KIOVIG®Use Glucose 5 % intravenous infusion if dilution
prior to infusion is required.
lPRESCRIBING AND DISPENSING INFORMATIONAntibody
titres can vary widely between normal immunoglobulin
preparations from different manufacturers—formulations
arenot interchangeable; patients should be maintained
on the same formulation throughout long-term treatment
to avoid adverse effects.
▶With intramuscular useAvailable from the Centre for
Infections and other regional Public Health England
offices (for contacts and control of outbreaks only).
lHANDLING AND STORAGECare must be taken to store all
immunological products under the conditions
recommended in the product literature, otherwise the
preparation may become ineffective.Refrigerated
storageis usually necessary; many immunoglobulins need
to be stored at 2 – 8 °C and not allowed to freeze.
Immunoglobulins should be protected from light. Opened
multidose vials must be used within the period
recommended in the product literature.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for injection
ELECTROLYTES:May contain Sodium
▶Hizentra(CSL Behring UK Ltd)
Normal immunoglobulin human 200 mg per 1 mlHizentra 1 g/ 5 ml
solution for injection pre-filled syringes| 1 pre-filled disposable
injectionP£ 54. 00
Hizentra 2 g/ 10 ml solution for injection pre-filled syringes| 1 pre-
filled disposable injectionP£ 108. 00
▶Subgam(Bio Products Laboratory Ltd)
Normal immunoglobulin human 150 mg per 1 mlSubgam
750 mg/ 5 ml solution for injection vials| 1 vialP£ 37. 50
Subgam 1. 5 g/ 10 ml solution for injection vials| 1 vialP£ 75. 00
Solution for infusion
EXCIPIENTS:May contain Glucose, maltose, sorbitol, sucrose
▶Normal immunoglobulin (non-proprietary)A
Normal immunoglobulin human 100 mg per 1 mlNormal
immunoglobulin human 5 g/ 50 ml solution for infusion vials|
1 vialPs
Normal immunoglobulin human 2. 5 g/ 25 ml solution for infusion vials
| 1 vialPs
Normal immunoglobulin human 20 g/ 200 ml solution for infusion vials
| 1 vialPs
Normal immunoglobulin human 10 g/ 100 ml solution for infusion vials
| 1 vialPs
Normal immunoglobulin human 30 g/ 300 ml solution for infusion vials
| 1 vialPs
▶Flebogammadif(Grifols UK Ltd)
Normal immunoglobulin human 50 mg per 1 mlFlebogamma DIF
10 g/ 200 ml solution for infusion vials| 1 vialP£ 510. 00
Flebogamma DIF 2. 5 g/ 50 ml solution for infusion vials| 1 vialP
£ 127. 50
Flebogamma DIF 5 g/ 100 ml solution for infusion vials| 1 vialP
£ 255. 00
Flebogamma DIF 500 mg/ 10 ml solution for infusion vials| 1 vialP
£ 30. 00
Flebogamma DIF 20 g/ 400 ml solution for infusion vials| 1 vialP
£ 1 , 020. 00
▶Gammaplex(Bio Products Laboratory Ltd)
Normal immunoglobulin human 50 mg per 1 mlGammaplex
10 g/ 200 ml solution for infusion vials| 1 vialP£ 418. 00 (Hospital
only)
Gammaplex 5 g/ 100 ml solution for infusion vials| 1 vialP
£ 209. 00 (Hospital only)
Gammaplex 20 g/ 400 ml solution for infusion vials| 1 vialP
£ 836. 00 (Hospital only)
▶Gamunex(Grifols UK Ltd)
Normal immunoglobulin human 100 mg per 1 mlGamunex 10 %
1 g/ 10 ml solution for infusion vials| 1 vialP£ 42. 50
Gamunex 10 % 10 g/ 100 ml solution for infusion vials| 1 vialP
£ 425. 00
Gamunex 10 % 20 g/ 200 ml solution for infusion vials| 1 vialP
£ 850. 00
Gamunex 10 % 5 g/ 50 ml solution for infusion vials| 1 vialP
£ 212. 50
▶Hizentra(CSL Behring UK Ltd)
Normal immunoglobulin human 200 mg per 1 mlHizentra
2 g/ 10 ml solution for infusion vials| 1 vialP£ 108. 00
Hizentra 1 g/ 5 ml solution for infusion vials| 1 vialP£ 54. 00
Hizentra 4 g/ 20 ml solution for infusion vials| 1 vialP£ 216. 00
▶Kiovig(Baxalta UK Ltd)
Normal immunoglobulin human 100 mg per 1 mlKiovig 5 g/ 50 ml
solution for infusion vials| 1 vialP£ 245. 00
Kiovig 20 g/ 200 ml solution for infusion vials| 1 vialP£ 980. 00
Kiovig 10 g/ 100 ml solution for infusion vials| 1 vialP£ 490. 00
Kiovig 30 g/ 300 ml solution for infusion vials| 1 vialP£ 1 , 470. 00
Kiovig 2. 5 g/ 25 ml solution for infusion vials| 1 vialP£ 122. 50
Kiovig 1 g/ 10 ml solution for infusion vials| 1 vialP£ 49. 00
▶Octagam(Octapharma Ltd)
Normal immunoglobulin human 50 mg per 1 mlOctagam 5 %
10 g/ 200 ml solution for infusion bottles| 1 bottleP£ 480. 00
(Hospital only)
Octagam 5 % 5 g/ 100 ml solution for infusion bottles| 1 bottleP
£ 240. 00 (Hospital only)
Octagam 5 % 2. 5 g/ 50 ml solution for infusion bottles| 1 bottleP
£ 120. 00 (Hospital only)
Normal immunoglobulin human 100 mg per 1 mlOctagam 10 %
10 g/ 100 ml solution for infusion bottles| 1 bottleP£ 690. 00
(Hospital only)774 Immunoglobulin therapy BNFC 2018 – 2019
Vaccines14