GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.
MDR Number
MDR 191-03/22
Company name
GlaxoSmithKline UK Ltd
Product description
Zovirax I.V. 500 mg PL 00003/0159
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 9G4B | Jan 2026 | 1 x 5 vials* | 19 Jan 2022 |
| TC8E-A | Aug 2025 | 1 x 5 vials* | 15 Dec 2021 |
| 6V8W | Jan 2026 | 1 x 5 vials* | 15 Dec 2021 |
| B35J*** | Jan 2026 | 1 x 5 vials* | 19 Jan 2022** |
| GN8S*** | Jan 2026 | 1 x 5 vials* | 20 May 2022 |
| J69C*** | Jan 2026 | 1 x 5 vials* | 20 May 2022 |
Per correction by GlaxoSmithKline UK Ltd, an update was made on 20 May 2022 to reflect:
*clarification of pack size (1 x 5 vials)
**clarification of first distribution date for batch B35J
***GSK have confirmed further release of packs for batches B35J, GN8S and J69C on 20 May 2022. The newly released packs are provided with the correct PIL that is external to the original packaging. The incorrect PIL enclosed in the sealed packs should be discarded (see “Advice for healthcare professionals” below).
Active Pharmaceutical Ingredient: aciclovir
Brief description of the issue
GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.
The detailed differences between the incorrect and correct SmPC/PILs are listed in the Table below:
| Section | Unapproved text | Approved text |
|---|---|---|
| 4.2 Posology and method of administration – Dosage in adults | In obese patients dosed with intravenous aciclovir based on using ideal body weight, rather than actual body weight, higher plasma concentrations may be obtained (see SPC section 5.2 Pharmacokinetic properties). | In obese patients dosed with intravenous aciclovir based on their actual body weight, higher plasma concentrations may be obtained (see SPC section 5.2 Pharmacokinetic properties). |
| Section | Unapproved text | Approved text |
|---|---|---|
| 4.2 Posology and method of administration – Dosage in infants and children | The dose of Zovirax I.V. for infants and children aged between 3 months and 12 years is calculated on the basis of body weight. Infants and children 3 months of age or older with herpes simplex infections should be given Zovirax 20 mg / kg body weight IV every eight hours for 21 days for herpes encephalitis, or for 14 days for disease limited to skin and mucous membrane if renal function is not impaired. | The dose of Zovirax I.V. for infants and children aged between 3 months and 12 years is calculated on the basis of body surface area. Children 3 months of age or older with Herpes simplex (except herpes encephalitis) or Varicella zoster infections should be given Zovirax I.V. in doses of 250 mg per square metre of body surface area every 8 hours if renal function is not impaired. In immunocompromised children with Varicella zoster infections or children with herpes encephalitis, Zovirax I.V. should be given in doses of 500 mg per square metre body surface area every 8 hours if renal function is not impaired. |
Dosage in renal impairment – Dosage adjustments in infants and children:
| Creatinine Clearance | Dosage |
|---|---|
| 25 to 50 ml/min/1.73m2 | The dose recommended above (250 or 500 mg/m2 body surface area or 20 mg/kg body weight) should be given every 12 hours. |
| 10 to 25 ml/min/1.73m2 | The dose recommended above (250 or 500 mg/m2 body surface area or 20 mg/kg body weight) should be given every 24 hours. |
| 0 (anuric) to 10 ml/min/1.73m2 | In patients receiving continuous ambulatory peritoneal dialysis (CAPD) the dose recommended above (250 or 500 mg/m2 body surface area or 20 mg/kg body weight) should be halved and administered every 24 hours. In patients receiving haemodialysis the dose recommended above (250 or 500 mg/m2 body surface area or 20 mg/kg body weight) should be halved and administered every 24 hours and after dialysis |
Advice for healthcare professionals
Healthcare professionals prescribing and administering this product should refer to the corrected and approved Package Leaflet (accompanying future distribution) and discard the incorrect version inside the sealed packs. The impacted product is within product specification and there is no issue with product quality.
- Additional copies of the approved Package Leaflet can also be found online on the Electronic Medicines Compendium website at: https://www.medicines.org.uk/emc/product/7595/pil
- The approved Summary of Product Characteristics can be found online on the Electronic Medicines Compendium website at https://www.medicines.org.uk/emc/product/7595/smpc
The impacted product is within product specification and there is no issue with product quality. The MAH has confirmed that some batches remain on hold and due to the critical need for the product these will be distributed onwards, with an accompanying correct package leaflet.
Additionally, healthcare professionals should be aware of the following:
- There have been no report of effects to patients in terms of efficacy or adverse events due to dosing conversion.
- The benefit-risk profile of the impacted IV Zovirax remains favourable and unchanged. GSK UK Ltd has agreed to share copies of the printed PIL and will be sharing as part of the Direct Healthcare Professional Communication. Additional copies can be sourced on: https://www.medicines.org.uk/emc/product/7595/pil
Advice for patients
Zovirax I.V. 250mg and 500mg is administered under the supervision of a healthcare professional for the following indications:
- the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised
- prophylaxis of Herpes simplex infections in immunocompromised patients
- treatment of Varicella zoster infections or herpes encephalitis
- treatment of Herpes simplex infections in the neonate and infant up to 3 months of age
This notification informs healthcare professionals about the missing information. Patients should be given an updated Patient Information Leaflet.
Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
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