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DIPHTERIA ANTITOXIN, equine purified, 10.000IU/10ml, vial

https://unicat.msf.org/cat/product/72795
NST DVACADIP1V-

Valid Article

Former Code(s): DVACZFR0065
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
19.2 - Sera, immunoglobulins and monoclonal antibodies
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
J06AA01
Anatomical Therapeutic Chemical Classification according to WHOCC
P
The order of this product needs to be justified and is only acceptable under certain conditions.
0208
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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DIPHTERIA ANTITOXIN, equine purified - NST

With the increased use of the vaccine and the decline in the incidence of the disease, the supply of DAT has become increasingly complex. Most countries no longer produce the serum, and obtaining stocks and controlling quality is concern worldwide. It has been unavailable in many countries, including in Europe, since 2008.

Full Name

Diphtheria Anti-Toxin (DAT)

Therapeutic Action

Enzyme refined equine immunoglobulins.

Diphtheria antitoxin neutralises the free-circulating toxin before it can irreversibly bind to tissues and cause organ damage. Its effectiveness therefore decreases with the time elapsed since the onset of symptoms.

Indications

Treatment of diphtheria during an outbreak in patients meeting the diphtheria "suspect case" definition, including pregnant and lactating women, in combination with antibiotic treatment.

Not recommended for the prevention of diphtheria, as the protective effect of diphtheria antitoxin lasts only 1 to 2 weeks.

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Instructions for use

Each vial contains 10,0000 IU equivalent to 1,000IU/ml.

Two presentations are available:

  • liquid vial (DVACADIP1V-)
  • powder vial (DVACADIP1VD) to be reconstituted with the diluent supplied.

Must be given by IV infusion in 0.9% NaCl, as early as possible, as a single dose.

Dosage does not depend on the weight or age, but on clinical presentation.

Given the risk of allergic reactions, administer systematically antihistamines and corticoids as premedication.

Administer IV/PO antibiotics (azithromycin or erythromycin) in combination with diphtheria antitoxin to eliminate bacteria and toxin production, prevent further transmission and limit carriage, which may persist even after clinical recovery.

Treatment should be accompanied by isolation precautions.

After recovery, complete vaccination (tetanus-diphtheria vaccine).

Monitor close contacts for signs and symptoms for 10 days from the date of last contact with a suspected case. Antibiotic prophylaxis should be administered to close contacts for seven days.

Precautions for Use

As DAT is from equine origin, there is a risk of:

  • rare but severe anaphylactic reaction and frequent risk of mild reaction. DAT must be administered under close medical monitoring, in hospital settings equipped with ventilation and resuscitation equipment, Ringer lactate and epinephrine.
  • serum sickness weeks after administration. Ensure clinical follow-up.

Divided doses are not recommended as this increases risk of sensitivity reactions (see section on side effects). If in exceptional circumstances, the full dose cannot be given in a single administration, (e.g., in a small child), the maximum interval between the 2 split doses should not exceed 24 hours.

Storage

  • Liquid vial (DVACADIP1V-): keep refrigerated between 2ºC and 8ºC - Protect from sunlight
  • Powder vial (DVACADIP1VD): below 25ºC (does not require cold chain)
  • Do not freeze.

(Cf Introduction: Thermosensitive products)

Description updated and validated by Spinco and Vaccination WG on 28/02/2024.