Dear Doctor Letter about the possible vaccine leackage due to crack or defects on the plastic junction connecting the needle and syringe in vaccines with Readyject syringe for products FSME-IMMUN 0,25 ml Junior and FSME-IMMUN 0,5 ml
10.10.2013
The company Agmar d.o.o., the marketing authorisation holder for vaccines FSME-IMMUN 0,25 ml Junior, suspension for injection in pre-filled syringe, vaccine against tick-borne encephalitis, inactivated, is sending a letter on behalf of the manufacturer, Baxter, and in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) to doctors about an important information related to use of vaccines FSME-IMMUN 0.25 ml Junior and FSME-IMMUN 0,5 ml with Readyject syringe (pre-filled syringe with attached syringe).
Summary
- Baxter has received reports about the appearance of cracks or defects on the plastic junction connecting the needle with the syringe related to vaccines with Readyject syringe for certain manufactured batches of FSME-IMMUN vaccine for children and adults. The reporting frequency is very low (<1/10 000 dosages sold).
- When administering the product, these cracks and defects may cause a leakage of the vaccine suspension.
- In some cases, the vaccine leakage is discovered during the vaccine administration to patients, which could have led to insufficient vaccine dose. This insufficient dose may from the start cause an inappropriate protection or faster protection weakening of tick-borne encephalitis. In worst cases, it may come to serious infection with tick-borne encephalitis due to unsuccessful vaccination.
- Before use of these medicines, the syringe should be examined in order to discover visible defects or cracks on the plastic junction connecting the needle with the syringe.
- Should you discover cracks, defects or leakage, do not use the syringe with vaccine.
- Should a leakage be discovered when administering the vaccine, it is recommended to repeat the vaccination in order to obtain the appropriate immunologic response.
- If the vaccination has not been repeated, determination of antibody concentration 4 weeks after the last vaccination should be taken into account. A need for a repeated vaccination should be estimated based on those results.
- FSME-IMMUN vaccines for children and adults are indicated for active immunisation against thick-borne encephalitis. On the Croatian market is only the vaccine in pre-filled syringe with attached needle available (Readyject syringe) that this information refers to.
Here you may view the Dear Doctor Letter.
HALMED has not received any quality defect related to defects on the plastic junction connecting the needle with syringe. HALMED has neither received any adverse reaction report associated with an insufficient vaccine dose due to these defects. HALMED will continue to monitor the safe use of vaccines FSME-IMMUN 0.25 Junior i FSME-IMMUN 0.5 ml and will inform the public promptly about any new information.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
