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AstraZeneca Pharmaceuticals (Ireland) Ltd

AstraZeneca Pharmaceuticals (Ireland) Ltd
College Park House, 20 Nassau Street, Dublin 2,
Telephone: +353 1 609 7100
Fax: +353 1 679 6650
Medical Information e-mail: irelandproducts@astrazeneca.com
Summary of Product Characteristics last updated on medicines.ie: 07/08/2009
SPC Diprivan 1% Injection (Pre-Filled Syringe)

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.

Updated on 07/08/2009 and displayed until Current
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:   29-Jul-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 5.1
Additional sentence at the end of the 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
29th July 2009
Updated on 31/07/2008 and displayed until 07/08/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 2

Additional text:

Contains sodium 0.0018 mmol/ml.

Contains soya-bean oil, refined 100 mg/ml.

 

Section 4.3

Additional text:

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

 

 

Updated on 15/05/2007 and displayed until 31/07/2008
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

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.

 

Section 10

New Date of revision of text: 15 September 2006
Updated on 16/08/2006 and displayed until 15/05/2007
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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

Section 4.1

-   Children over 3 years has been changed to ‘children over one month of age’.

 

Section 4.2

-   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.

 

Section 4.3

-   ‘Diprivan is contraindicated for sedation in intensive care of patients of 16 years of age or younger’ has been added.

 

Section 4.4

-   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.

 

Section 4.8

-   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.

Updated on 26/07/2006 and displayed until 16/08/2006
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 2
The sentence: 'Each 20 ml pre‑filled syringe contains 200 mg propofol.' has been removed
 
Section 6.5
Reference to the 20ml syringe has been removed.
The statement: 'Not all pack sizes may be marketed.'has been removed.
Updated on 07/06/2006 and displayed until 26/07/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Propofol

Versions

 
07/08/2009 to Current
31/07/2008 to 07/08/2009
15/05/2007 to 31/07/2008
16/08/2006 to 15/05/2007
26/07/2006 to 16/08/2006
07/06/2006 to 26/07/2006
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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