When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Additional text:
Contains sodium 0.0018 mmol/ml.
Contains soya-bean oil, refined 100 mg/ml.
Section 4.3
Diprivan contains soya oil and should not be used in patients who are hypersensitive to peanut or soya.
Section 4.4
At end of section there are Additional precautions
Section 6.6
Text for Additional precautions moved to section 4.4
Section 9
Renewal of authorisation: 6 November 2007
Section 10
Revision date of text: 4 July 2008
Section 4.6
Current text:
Pregnancy: Diprivan should not be used in pregnancy. Diprivan has been used, however, during termination of pregnancy in first trimester.
Obstetrics: Diprivan crosses the placenta and may be associated with neonatal depression. It should not be used for obstetric anaesthesia.
Lactation: Safety to the neonate following the use of Diprivan in mothers who are breast‑feeding has not been established.
New text:
Pregnancy: The safety of Diprivan during pregnancy has not been established. Therefore, Diprivan should not be used in pregnant women unless clearly necessary. Propofol crosses the placenta and may be associated with neonatal depression. High doses (more than 2.5 mg/kg for induction or 6 mg/kg/h for maintenance of anaesthesia) should be avoided.
Lactation: Safety to the neonate following the use of Diprivan in mothers who are breast‑feeding has not been established. Studies in breast‑feeding women showed that propofol is excreted in small amounts into the milk. Therefore, mothers should stop breast‑feeding and discard breast milk for 24 hours after administration of propofol.
- Children over 3 years has been changed to ‘children over one month of age’.
- The heading ‘Sedation During Intensive Care’ has changed to ‘Sedation of Ventilated Patient in the Intensive Care Unit’.
- The sentence ‘Diprivan is not indicated for sedation in intensive care of patients of 16 years of age or younger’ has been added.
- Heading ‘C) Children’ now states that Diprivan is not recommended for use in children less than one month of age. Also added is ‘Diprivan 2% is not recommended for induction and maintenance of anaesthesia in children between 1 month and 3 years of age’.
- Under the heading ‘Maintenance of General Anaesthesia’ a sentence on dosage requirements for younger children 1 month to 3 years has been added.
- ‘Diprivan is contraindicated for sedation in intensive care of patients of 16 years of age or younger’ has been added.
- Two paragraphs have been added on the safety and efficacy of Diprivan for (background) sedation in children younger than 16 years of age as reported during unlicensed use.
- The sentence ‘In very rare cases rhabdomyolysis, metabolic acidosis, hyperkalaemia or cardiac failure, sometimes with fatal outcome, have been observed when Diprivan was administered at dosages in excess of 4 mg/kg/h for sedation in the intensive care unit’ has been added.