Last Updated on eMC 06-06-2016 View medicine  | Janssen-Cilag Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:16-10-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4: addition of;

A reduced immune response is possible due to the subcutaneous injection.

Section 4.5: Addition of;

The concomitant administration of hepatitis A-specific immunoglobulins does not impair the seroconversion rate, but can lead to a reduction of hepatitis A antibody titers by approx. 20%.

In the case of concomitant administration with other vaccines, different syringes and separate injection sites should be chosen.

Section 4.6: Text changed to;

Pregnancy
Controlled studies have not been conducted with animals or pregnant women. As is the case with all inactivated viral vaccines, there is no obvious risk for the fetus. However, vaccinations should only be given during pregnancy if there is a high risk of infection.

Breast-feeding
Whether the vaccine passes into the milk of a lactating mother is unknown. Immunization during breast-feeding does not pose a risk for mothers or for their infants.

 

Section 4.7: Text changed to;
No adverse reactions are to be expected. However, some of the effects mentioned under section „Undesirable Effects“ may temporarily affect the ability to drive or use machines.

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO