Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom
Human Tetanus Immunoglobulin, 100 IU/ml sterile solution.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear or slightly opalescent, colourless or pale yellow sterile solution. |
Human tetanus immunoglobulin.
Human protein content: 40-180 g/l, of which at least 95% is IgG.
Each vial contains nominally 250 IU of human tetanus immunoglobulin.
One ml contains at least 100 IU of human tetanus immunoglobulin.
The potency of this biological medicinal product may vary between batches, therefore the specific human tetanus immunoglobulin potency (IU/ml) is overprinted in the vial label. Also printed on the label, ‘Dose (ml)’ is the actual volume required, even at the end of shelf-life, to ensure that the patient receives 250 IU.
Distribution of IgG subclasses (approximate values):
IgG1 64%
IgG2 29%
IgG3 6%
IgG4 1%
The maximum IgA content is 0.3% w/w.
Produced from the plasma of human donors.
Excipient with known effect:
This medicinal product contains approximately 0.36 mmol (8.3 mg) sodium per 250 IU vial.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tetanus immunoglobulin |
Human tetanus immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against the toxin produced by the bacteria clostridium tetanus. |
| List of Excipients |
|---|
|
Sodium chloride |
Vials are for single use only.
5 ml glass vial (Type I Ph.Eur.) with stopper (halobutyl rubber), with an overseal (aluminium) and tamper-evident cap (polypropylene).
Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom
PL 08801/0011
Date of first authorisation: 18 June 1991
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