Temperature excursion
Temperature excursion
Temperature
excursion
What should I do if the product is left out at room temperature or below 2°C?
Almost all products from AJ Vaccines A/S must be stored at range 2-8°C. Vaccines stored outside this temperature range can cause the vaccine to lose its potency. Once a vaccine loses its potency, it cannot be regained or restored. AJ Vaccines has performed studies that shows it is acceptable for some vaccines and other products to be outside the temperature range of 2-8°C for a shorter defined period. Please find your AJ Vaccines product listed below and follow the recommendations to storage times and temperatures.
Unknown max. temperature or period
If the maximum temperature is unknown, AJ Vaccines recommend the product to be discarded
If the period is unknown, AJ Vaccines recommend the product to be discarded
VVM label
Please note, only use specified products if the VVM label is still active
General
It is common policy that AJ Vaccines do not hand out our studies.
The company policy at AJ Vaccines is that we do not give general temperature statements on products, only issues regarding specific temperature deviations outside the approved 2-8°C.
In case of temperature excursion when shipped from AJ Vaccines to the first recipient please contact QAcompliance@ajvaccines.com.
When the incident occurs after receipt at the first recipient (e.g. at the end-user/healthcare facility/clinic/hospital) please check the instructions below.
In case of doubt Please contact AJ Vaccines.
Guideline
If it is not possible to find the answer in this table, please see additional text for each product or use the below information.
Product | 2-8°C | 8-25°C | Above 25°C or unknown | Below 2°C → -20°C | Other |
|---|---|---|---|---|---|
Until expired date | 12 hours | Discarded | 120 hours | – | |
Until expired date | 4 hours | Discarded | – | ||
– | – | – | – | Only if the VVM label is still active | |
· Before first use | Until expired date | Discarded | Discarded | – | |
· After first use | 28 days | Discarded | Discarded | Discarded | – |
Until expired date | Discarded | Discarded | – | ||
Until expired date | 72 hours | Discarded | Discarded | – | |
Until expired date | 72 hours | Discarded | Discarded | – | |
Until expired date | Until expired date | 25-30°C: See Contact | Discarded | – |
Contact
For any contact regarding temperature excursions, where information cannot be found on this site, please contact QA-temperatur@ajvaccines.com. Following information must be included:
Batch number
Contact information
Temperature duration
Max or min. temperature outside the range for the product – information can be found by each product on this site
In case of a product that has been exposed to more than 8°C has been administered to a patient please contact drugsafety@ajvaccines.com.
BCG Vaccine“AJ Vaccines”
8-25°C
BCG Vaccine “AJ Vaccines” can be used until expiration date if not exposed to more than +25°C for maximum 12 hours – accumulated.
>25°C
BCG Vaccine “AJ Vaccines” stored above 25°C must be discarded regardless the time.
<2°C
BCG Vaccine “AJ Vaccines” is a freeze-dried vaccine and can be used until expiration date if not exposed to less than -20°C for maximum 120 hours continuously.
VesiCulture(BCG Culture)
8-25°C
VesiCulture (BCG Culture) can be used until expiration date if not exposed to more than +25°C for maximum 4 hours – accumulated.
>25°C
VesiCulture (BCG Culture) stored above 25°C must be discarded regardless the time.
Diluted Sauton
8-25°C
Diluted Sauton can be used until expiration date if not exposed to more than +25°C.
25-30°C
Please contact AJ Vaccines
30°C
Diluted Sauton stored above 30°C must be discarded regardless the time.
<2°C
Diluted Sauton must be discarded if exposed to less than +2°C regardless the time.
Picovax®(Inactivated Polio Vaccine)
8-25°C – BEFORE first use:
Please contact AJ Vaccines
>25°C
Picovax (Inactivated Polio Vaccine) stored above 25°C must be discarded regardless the time.
<2°C
Picovax (Inactivated Polio Vaccine) must be discarded if exposed to less than +2°C regardless the time.
AFTER first use:
28 days at 2-8°C.
TuberculinPPD RT23
8-25°C
Please contact AJ Vaccines
>25°C
Tuberculin PPD RT23 stored above 25°C must be discarded regardless the time.
<2°C
Tuberculin PPD RT23 must be discarded if exposed to less than +2°C regardless the time
diTeBooster(Td Vaccine)
8-25°C
diTeBooster (Td Vaccine) can be used until expiration date if not exposed to more than +25°C for maximum 72 hours – accumulated.
>25°C
diTeBooster (Td Vaccine) stored above 25°C must be discarded regardless the time.
<2°C
diTeBooster (Td Vaccine) stored below +2°C must be discarded regardless the time.
diTeKiBooster(TdaP Vaccine)
8-25°C
diTekiBooster (TdaP Vaccine) can be used until expiration date if not exposed to more than +25°C for maximum 72 hours – accumulated.
>25°C
diTekiBooster (TdaP Vaccine) stored above 25°C must be discarded regardless the time.
<2°C
diTekiBooster (TdaP Vaccine) stored below +2°C must be discarded regardless the time.