Last Updated on eMC 07-12-2017 View medicine  | Aspen 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:04-12-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text

Text strikethrough = deleted text

 

 

4.5       Interaction with other medicinal products and other forms of interaction

 

A need for lower propofol doses has been observed in patients taking valproate. When used concomitantly, a dose reduction of propofol may be considered.

 

 

 

10.       DATE OF REVISION OF THE TEXT

31/01/2017 04/12/2017

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:31-01-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text

 

 

Marketing Authorisation holder

Aspen Pharma Trading Limited,

3016 Lake Drive,

Citywest Business Campus,

Dublin 24

 

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU, UK.

 

 

 

Marketing authorisation number(s)

PL 17901/0007 39699/0074

 

 

Date of revision of the text

27th February 2015

31/01/2017

 

 

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC:27-02-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2: updates in line with QRD

Section 4.1: updates in line with QRD

Section 4.2: updates in line with QRD, amended of text to include that an alternative effect-site mode of administration may be accessible on some Diprifusors, but its safety and efficacy have not yet been established.

Section 4.2: deletion of historical text (sedation during intensive care)

Section 4.3: QRD update and update in line with CSP update

Section 4.4: addition of dependence on in line with CSP update

section 4.4 text on blood lipid level monitoring in patients at risk of fat overload (in line with CSP) moved lower down

section 4.4. qrd update

-section 4.4 addition of text on propofol not being used in patients of 16 years or younger for sedation for intensive care (in line with CSP)

Section 4.4 removal of text regarding safety and efficacy of diprivan in children younger than 16 years(in line with CSP)

Section 4.4 addition of text regarding use of propfol emulsion infusions for ICU sedation associated with metabolic derangements and organ system failures may result in death(in line with CSP)

Section 4.4 additional text added in reference to propofol infusion syndrome (CSP update)

Section 4.4 text added to take caution in patients with fat metabolism disorders(in line with CSP)

Section 4.4 additional precaution text added regarding caution when treating patients with mitochondrial disease(in line with CSP)

Section 4.5 – treatment with rifampicin – profound hypotension reported following anaesthesia with propofol(in line with CSP)

Section 4.6 – updated in line with QRD

Section 4.7 – updated in line with QRD

Section 4.8- addition of drug dependence in undesireable effects (psychiatric disorders) (in line with CSP)

Section 4.8 –addition of respiratory depression as an undesireable effect (not known frequency) (in line with CSP)

Section 4.8 – addtion of tissue necrosis and local pain, swelling to undesireable effects (very rare and not known respectively) (in line with CSP)

Section 4.8 – addition of ADR wording

Section 5.1 – updated in line with QRD

Section 5.2 – updated in line with QRD

Section 5.3 – updated in line with QRD

Section 6.1 – updated in line with QRD

Section 6.3 – updated in line with QRD

Section 6.4 – updated in line with QRD

Section 6.5 – updated in line with QRD

Section 6.6 – updated in line with QRD

Section 9 – updated in line with QRD

Section 10 – update to date of revision

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:19-01-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4

 

Several amendments to Special Warning and Precautions for Use

 

Section 4.6

 

Pregnancy and Lactation sections updated

 

Section 4.7

 

Additional text

 

Diprivan 1% induced impairment is not generally detectable beyond 12 hours (Section 4.4).

  

Section 4.8

 

Table and text updated. Footnotes to table updated

 

Section 10

 

Date of Revision changed to 19th January 2012

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties

Date of revision of text on the SPC:07-09-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SPC Changes Diprivan 1% Amps, Vials & PFS PAI 10 0039

 

Section 4.1

Additional text and deleted text throughout section, now reads as,

 

“Diprivan 1% is a short-acting intravenous general anaesthetic for:

·              Induction and maintenance of general anaesthesia in adults and children >1 month.

·              Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children >1 month.

·              Sedation of ventilated patients >16 years of age in the intensive care unit.”

 

Section 4.2.1, Children

New second paragraph, updated third paragraph, section now reads as,

“Diprivan 1% is not recommended for induction of anaesthesia in children aged less than 1 month.

 

For induction of anaesthesia in children over 1 month of age, Diprivan 1% should be titrated slowly until clinical signs show the onset of anaesthesia. The dose should be adjusted according to age and/or body weight. Most patients over 8 years of age require approximately 2.5 mg/kg body weight of Diprivan 1% for induction of anaesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher (2.5–4 mg/kg body weight).

 

For ASA 3 and 4 patients lower doses are recommended (see also Section 4.4).

 

Administration of Diprivan 1% by a ‘Diprifusor’ TCI system is not recommended for induction of general anaesthesia in children.”

 

Section 4.2.2, Children
Changes to second and third paragraphs, section now reads as,

Diprivan 1% is not recommended for maintenance of anaesthesia in children aged less than 1 month.

 

Anaesthesia can be maintained in children over 1 month of age by administering Diprivan 1% by infusion or repeated bolus injection to maintain the depth of anaesthesia required. The required rate of administration varies considerably between patients, but rates in the region of 9–15 mg/kg/h usually achieve satisfactory anaesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher.

 

For ASA 3 and 4 patients lower doses are recommended (see also Section 4.4).

 

Administration of Diprivan 1% by a 'Diprifusor' TCI system is not recommended for maintenance of general anaesthesia in children.”

Section 4.2.4, Children

New first paragraph and changes to second paragraph, section now reads as,

Diprivan 1% is not recommended for surgical and diagnostic procedures in children aged less than 1 month.

 

In children over 1 month of age, doses and adminisation rates should be adjusted according to the required depth of sedation and the clinical response. Most paediatric patients require 1–2 mg/kg body weight of Diprivan 1% for onset of sedation. Maintenance of sedation may be accomplished by titrating Diprivan 1% infusion to the desired level of sedation. Most patients require 1.5–9 mg/kg/h Diprivan 1%. The infusion may be supplemented by bolus administration of up to 1 mg/kg body weight if a rapid increase of depth of sedation is required.

 

In ASA 3 and 4 patients lower doses may be required.”


Section 4.3

Changed text to second paragraph, now reads as,

Diprivan 1% must not be used in patients of 16 years of age or younger for sedation in intensive care (See 4.4 Special warnings and precautions for use).”

Section 4.4

Changed text to 12th paragraph, now reads as,

 

As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic, elderly or debilitated patients. Propofol clearance is blood flow dependent, therefore, concomitant medication that reduces cardiac output will also reduce propofol clearance.”

 

Changed text to 18th paragraph, now reads as,

 

“The use of Diprivan 1% is not recommended for newborn infants for induction and maintenance of anaesthesia as this patient population has not been fully investigated. Pharmacokinetic data (see Section 5.2) indicate that clearance is considerably reduced in neonates with a very high inter-individual variability. Relative overdose could occur administering doses recommended for older children resulting in severe cardiovascular depression.”

 

Section 5.1

New final paragraph, reads as,

“Limited studies on the duration of propofol based anaesthesia in children indicate safety and efficacy is unchanged up to duration of 4 hours. Literature evidence of use in children documents use for prolonged procedures without changes in safety or efficacy.”

 

Section 5.2

Changes to second paragraph and additional 4th and 5th paragraphs, section now reads as,

“The decline in propofol concentrations following a bolus dose or following the termination of an infusion can be described by a three compartment open model with very rapid distribution (half-life 2 –4 minutes), rapid elimination (half-life 30 – 60 minutes), and a slower final phase, representative of redistribution of propofol from poorly perfused tissue.

Propofol is extensively distributed and rapidly cleared from the body (total body clearance 1.5–2 litres/minute). Clearance occurs by metabolic processes, mainly in the liver where it is blood flow dependent, to form inactive conjugates of propofol and its corresponding quinol, which are excreted in urine.

 

When Diprivan 1% is used to maintain anaesthesia, blood concentrations asymptotically approach the steady-state value for the given administration rate. The pharmacokinetics are linear over the recommended range of infusion rates of Diprivan 1%.

 

After a single dose of 3 mg/kg intravenously, propofol clearance/kg body weight increased with age as follows: Median clearance was considerably lower in neonates <1 month old (n=25) (20 ml/kg/min) compared to older children (n= 36, age range 4 months–7 years). Additionally inter-individual variability was considerable in neonates (range 3.7–78 ml/kg/min). Due to this limited trial data that indicates a large variability, no dose recommendations can be given for this age group.

 

Median propofol clearance in older aged children after a single 3 mg/kg bolus was 37.5 ml/min/kg (4-24 months) (n=8), 38.7 ml/min/kg (11–43 months) (n=6), 48 ml/min/kg (1–3 years)(n=12), 28.2 ml/min/kg (4–7 years)(n=10) as compared with 23.6 ml/min/kg in adults (n=6).”

 

Section 10

7th September 2010

 

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:28-07-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 5.1 Pharmacodynamic Properties

Additional wording at end of first paragraph:
"However, propofol is thought to produce its sedative/anaesthetic effects by the positive modulation of the inhibitory function of the neurotransmitter GABA through the ligand-gated GABAA receptors."

Section 10
"28th July 2009"

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6.1 - List of Excipients

Date of revision of text on the SPC:21-08-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4

Additional text:

 

EDTA is a chelator of metal ions, including zinc. The need for supplemental zinc should be considered during prolonged administration of Diprivan, particularly in patients who are predisposed to zinc deficiency, such as those with burns, diarrhoea and/or major sepsis.

 

Section  6.1

Additional excipient:

Disodium Edetate Ph Eur

 

Section 6.3

Change of text:

 

When diluted, ‘Diprivan’ 1% must be used within 6 hours of preparation. Use of diluted Diprivan must begin immediately following dilution.

 

Section 10

Date of revision of text: 21 August 2008

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-02-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2

In section 4.2.2 under the heading ‘Children’

Amendment to recommendation for the maintenance of general anaesthesia, and to extend use to children aged 1 month to 3 years.

 

Section 10

date of revision of text: 5 feb 2008

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-05-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1

Change of name from Diprivan 1% to

Diprivan 10 mg/ml (1%) emulsion for injection or infusion.

 

Section 3

Current text - Oil in water emulsion for intravenous injection.

New text –

Emulsion for injection or infusion.

White aqueous isotonic oil-in-water emulsion.

 

Section 4.3

Current text:

Known hypersensitivity for any of the components of Diprivan 1% or Diprivan 2%.

 

Diprivan 1% is contraindicated for sedation in intensive care of patients of 16 years of age or younger (See 4.4 Special warnings and precautions for use).

 

New text:

Diprivan is contraindicated in patients with a known hypersensitivity to propofol or any of the excipients.

 

Diprivan 1% is contraindicated for sedation in intensive care of patients of 16 years of age or younger (See 4.4 Special warnings and precautions for use).

 

Diprivan 1% contains soya oil and should not be used in patients who are hypersensitive to peanut or soya.

 

Section 4.4

New additional sentence last paragraph before heading “Additional Precautions”

Diprivan 1% contains 0.0018 mmol sodium per ml.

 

Section 6.1

Addition of the word “Refined” in the Soya-bean Oil excipient

 

Section 10

New revision date of text: 14th May 2007

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change from BAN to rINN

Date of revision of text on the SPC:01-02-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8
Add sentence to 3rd last paragraph: 
 
Dystonia/dyskinesia have been reported.
 
Section 10
New revision date of text - 21 February 2007

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Reasons for adding or updating:

  • No reasons supplied