The SPC has been updated as follows:

* Section 10: DATE OF REVISION OF THE TEXT has been updated

The SPC has been updated as follows:

* Section 10: DATE OF REVISION OF THE TEXT has been updated

The SPC has been updated as follows:

Section 10: DATE OF REVISION OF THE TEXT has been updated

The SPC has been updated as follows:

1.         Update to the MAH (section 7):

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Belgium

2.         Editorial changes (sections 1, 2, 4.2, 6.5 and 8)

• Updates to the SmPC in line with QRD template 9 and 10

Changes to Malta local representative in the PIL

The SPC has been updated as follows:

Section 4.4, Special Warnings and precautions for Use, inclusion of: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.  More severe cases have been observed with long-acting epoetins.

At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.  If signs and symptoms suggestive of these reactions appear, Retacrit should be withdrawn immediately and an alternative treatment considered.

If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Retacrit, treatment with Retacrit must not be restarted in this patient at any time.

Section 4.8, Undesirable effects, inclusion of: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life threatening or fatal, have been reported in association with epoetin treatment (see section 4.4).

Section 10, Revision date up Text: Updated

Section 4.4, Special Warnings and precautions for Use, inclusion of: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.  More severe cases have been observed with long-acting epoetins.

At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.  If signs and symptoms suggestive of these reactions appear, Retacrit should be withdrawn immediately and an alternative treatment considered.

If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Retacrit, treatment with Retacrit must not be restarted in this patient at any time.

Section 4.8, Undesirable effects, inclusion of: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life threatening or fatal, have been reported in association with epoetin treatment (see section 4.4).

Section 10, Revision date up Text: Updated

Section 4.4, Special Warnings and precautions for Use, inclusion of: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.  More severe cases have been observed with long-acting epoetins.

At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.  If signs and symptoms suggestive of these reactions appear, Retacrit should be withdrawn immediately and an alternative treatment considered.

If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Retacrit, treatment with Retacrit must not be restarted in this patient at any time.

Section 4.8, Undesirable effects, inclusion of: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life threatening or fatal, have been reported in association with epoetin treatment (see section 4.4).

The SPC has been updated as follows:

Section 4.4, Special Warnings and precautions for Use, inclusion of: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.  More severe cases have been observed with long-acting epoetins.

At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.  If signs and symptoms suggestive of these reactions appear, Retacrit should be withdrawn immediately and an alternative treatment considered.

If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Retacrit, treatment with Retacrit must not be restarted in this patient at any time.

Section 4.8, Undesirable effects, inclusion of: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life threatening or fatal, have been reported in association with epoetin treatment (see section 4.4).