Nexium I.V. 40mg Powder for solution for injection/infusion

  • Name:

    Nexium I.V. 40mg Powder for solution for injection/infusion

  • Company:
    info
  • Active Ingredients:

    Esomeprazole sodium

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/12/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 16/1/2019

Click on this link to Download PDF directly

AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

Company Products

Medicine NameActive Ingredients
Medicine Name Alvesco 160 micrograms pressurised inhalation,solution Active Ingredients Ciclesonide
Medicine Name Alvesco 80 micrograms pressurised inhalation,solution Active Ingredients Ciclesonide
Medicine Name Arimidex Active Ingredients Anastrozole
Medicine Name Atacand 8mg 16mg Tablets Active Ingredients Candesartan Cilexetil
Medicine Name Atacand Plus 16/12.5mg Active Ingredients Candesartan Cilexetil, Hydrochlorothiazide
Medicine Name Bricanyl Turbohaler Active Ingredients Terbutaline sulfate
Medicine Name Brilique 60 mg film-coated tablets Active Ingredients Ticagrelor
Medicine Name Brilique 90 mg film coated tablets Active Ingredients Ticagrelor
Medicine Name Brilique 90 mg Orodispersible Tablets Active Ingredients Ticagrelor
Medicine Name Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen Active Ingredients Exenatide
Medicine Name Byetta 5 micrograms solution for injection, prefilled pen. Byetta 10 micrograms solution for injection, prefilled pen Active Ingredients Exenatide
Medicine Name Casodex 50mg Tablets Active Ingredients Bicalutamide
Medicine Name Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets Active Ingredients Rosuvastatin Calcium
Medicine Name Daxas 250 mcg Film-Coated Tablets Active Ingredients roflumilast
Medicine Name Daxas 500 mcg Film-coated Tablets Active Ingredients roflumilast
Medicine Name Fasenra 30 mg solution for injection in pre filled syringe Active Ingredients Benralizumab
Medicine Name Faslodex Active Ingredients Fulvestrant
Medicine Name Forxiga 10 mg Film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate
Medicine Name Forxiga 5 mg film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate
Medicine Name IMFINZI 50 mg/mL concentrate for solution for infusion Active Ingredients durvalumab
Medicine Name IRESSA 250 mg film-coated tablets Active Ingredients gefitinib
Medicine Name Komboglyze 2.5mg-1000mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
Medicine Name Komboglyze 2.5mg-850mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
Medicine Name Losec MUPS 10mg Gastro-resistant Tablets Active Ingredients omeprazole magnesium
Medicine Name Losec MUPS 20mg Gastro-resistant Tablets Active Ingredients omeprazole magnesium
1 - 0 of 54 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 3 December 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Removal of Malta adverse event reporting details and update to revision date

Updated on 15 November 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 15 November 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 16 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 16 January 2019 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 – Marketing Authorisation Holder details updated

Section 8 – Marketing Authorisation numbers updated

Section 10 – date of revision updated

Updated on 12 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 June 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 June 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2- Method of administration instructions updated

Section 4.8- ‘fundic gland polyps (benign)’ has been added as an Undesirable Effect

Section 6.2- Minor editorial update

Section 6.6- Minor editorial update

Section 10- Date of revision updated

Updated on 19 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 14 June 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 3 May 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 27 January 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: Additional information on PPI’s has been added under sub-section ‘Interference with laboratory tests’.

Section 5.1: Additional information on recommendation of Chromogranin A and PPI:S has been added.

Section 10: Date of revision of the text has been revised.

Updated on 26 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 28 April 2016 SmPC

Reasons for 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
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Change to section 4.2 – minor editorial changes to bring in line with QRD

Change to section 4.4 – Inclusion of paragraph regarding Subacute cutaneous lupus erythematosus (SCLE)

Change to section 4.8 – inclusion of the side effect SCLE

Change to section 5.2 – minor editorial changes to bring in line with QRD

Change to Section 10 – update to date of revision of text.

Updated on 27 April 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 10 October 2014 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 8 October 2014 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



 Multiple changes throughout the SmPC due to updating SmPC in line with QRD template.
section 10 - updated date of revision

Updated on 3 October 2014 PIL

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation

Updated on 6 March 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

- Section 10 date of revision  
- Section 4.8 addition of hypokalaemia to section under Metabolism and nutrition disorders

Updated on 9 October 2013 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Input of Chromogranin A

Section 4.5 - Input of pharmacokinetic (PK)/ pharmacodynamic (PD) interaction between clopidogrel and esomeprazole and interaction with Tacromilus

Section 4.8 - Renal and urinary disorders, renal failure added

Section 5.1 - More detail on interaction of Chromogranin A and tumours
Section 10 - Updated date of revision

Updated on 8 October 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 1 July 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8
Amend Renal and urinary disorders section to add: “
; in some patients renal failure has been reported concomitantly”

Section 10
Date of revision update to '14th June 2013'.

Updated on 26 November 2012 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 10

Last revision date modified to reflect IMB issued SmPC.

Updated on 22 October 2012 SmPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4

PhVWP wording included regarding hypomagnesaemia and risk of fracture.


Section 4.8

Frequency of hypomagnesaemia changed from “very rare” to “not known” and fracture of the hip, wrist or spine added as uncommon, as per PhVWP wording.


Section 10

Updated to 10th October 2012.

Updated on 18 October 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 3 July 2012 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4

 

Addition of information about vitamin B12 absorption.

 

 

Section 4.5

 

Revision of information about ‘gastric acid suppression (initial paragraph).

 

Addition of information under sub-heading ‘Unknown mechanism’ – related to methotrexate.

 

 

Section 4.8

 

Further information provided about ADR hypomagnesaemia – under ‘Metabolism and nutrition disorders’.

 

Addition of ADR microscopic colitis – under ‘Gastrointestinal disorders’.  

 

 

Section 5.1


Addition of information about paediatric GORD patients receiving long-term PPI treatment.

 

 

Section 10


Date of revision updated to 20th June 2012

Updated on 28 June 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 23 May 2012 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5

 

Addition of information about about esomeprazole interaction with cilostazol.

 

 

Section 5.1

 

Addition of information about risk of Clostridium difficile infection in hospitalised patients.

 

 

Section 10

 

Date of revision changed to 11th May 2012.

Updated on 21 May 2012 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 5 October 2011 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Information added re about ‘Interference with laboratory tests’

 

Section 4.5 - Information added about interaction with St John’s wort, rifampicin and digoxin

 

Section 5.1 - Information added about the increased levels of Chromogranin A

Updated on 5 October 2011 PIL

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision

Updated on 1 August 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.1: New GORD Paediatric Indication

Section 4.2: New GORD Paediatric Indication posology


Section 4.5: Addition of statement to indicate that interaction studies have been performed in Adults only


Section 4.8: Details added for Paediatric population


Section 5.1: Pharmacodynamic properties updated to reflect addition of Paediatric population


Section 5.1: Pharmacokinetic properties updated to reflect addition of Paediatric population


 
Section 6.5: Revision of Litres abbreviation from L to l


Section 6.6: Revision of reconstitution details

Section 10: Change to date of revision to 18th July 2011 

Updated on 26 July 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 24 March 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Nexium IV 40mg Powder for inj/inf

 

Section 2

Now reads as,

 

Each vial contains esomeprazole 40 mg (as sodium salt).

Each vial contains <1 mmol sodium.

 

For a full list of excipients see section 6.1.”

 

 

Section 4.4

Additional last paragraph added, reads as,

 

” Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole (see section 4.5). The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.”

 

Section 4.5

Additional eighth paragraph, reads as,

 

“In a crossover clinical study, clopidogrel (300 mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered together. Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24 hours) and 30% (Day 5) when clopidogrel and omeprazole were administered together. In another study it was shown that administering clopidogrel and omeprazole at different times did not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19. Inconsistent data on the clinical implications of this PK/PD interaction in terms of major cardiovascular events have been reported from observational and clinical studies.”

 

 

Section 4.8

Text changes to first paragraph, now reads as,

“The following adverse drug reactions have been identified or suspected in the clinical trials programme for esomeprazole and post-marketing. None was found to be dose-related. The reactions are classified according to frequency very common > 1/10; common >1/100 to <1/10; uncommon >1/1,000 to <1/100; rare >1/10,000 to <1/1,000; very rare <1/10,000; not known (cannot be estimated from the available data
).”

Change to Metabolism and nutrition disorders, now reads as,

Metabolism and nutrition disorders

Uncommon: Peripheral oedema

Rare: Hyponatraemia

Very rare: Hypomagnesaemia”


Section 6.1

Text change, now reads as,

 

Disodium edetate

Sodium hydroxide (for pH adjustment)

 

Section 9

Now reads as,

 

Date of first authorisation: 10 March 2005

Date of latest renewal: 10 March 2010”

 

Section 10

25 February 2011

Updated on 22 March 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 23 October 2009 PIL

Reasons for updating

  • Change to drug interactions
  • Change to name of manufacturer

Updated on 20 October 2009 SmPC

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.3

Replacement of last sentence with:

Esomeprazole should not be used concomitantly with nelfinavir (See section 4.5).

Section 4.4

Addition of last paragraph:

Co-administration of esomeprazole with atazanavir is not recommended (see section 4.5). If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded.

Section 4.5

Addition of text under the heading 'Medicinal products with pH dependent absorption':

Omeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms behind these reported interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the protease inhibitors. Other possible interaction mechanisms are via inhibition of CYP2C19. For atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended.

and

The co-administration of omeprazole (20 mg qd) with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30% in the atazanavir exposure as compared with the exposure observed with atazanavir 300 mg/ritonavir 100 mg qd without omeprazole 20 mg qd. Co-administration of omeprazole (40 mg qd) reduced mean nelfinavir AUC, Cmax and Cmin by 36–39 % and mean AUC, Cmax and Cmin for the pharmacologically active metabolite M8 was reduced by 75-92%. For saquinavir (with concomitant ritonavir), increased serum levels (80-100%) have been reported during concomitant omeprazole treatment (40 mg qd). Treatment with omeprazole 20 mg qd had no effect on the exposure of darunavir (with concomitant ritonavir) and amprenavir (with concomitant ritonavir). Treatment with esomeprazole 20 mg qd had no effect on the exposure of amprenavir (with and without concomitant ritonavir). Treatment with omeprazole 40 mg qd had no effect on the exposure of lopinavir (with concomitant ritonavir). Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration with esomeprazole and atazanavir is not recommended and concomitant administration with esomeprazole and nelfinavir is contraindicated.

Section 10

Change of date to:

3rd September 2009

Updated on 3 August 2009 PIL

Reasons for updating

  • Change to MA holder contact details
  • Change to dosage and administration

Updated on 9 June 2009 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.1

Change to text after last bullet point:

prevention of rebleeding following therapeutic endoscopy for actue bleeding gastric or duodenal ulcers.

 

Section 4.2

Addition of heading:

Gastric antisecretory treatment when the oral route is not possible.

Addition of paragraph:

Prevention of rebleeding of gastric and duodenal ulcers.
Following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers, 80 mg should be administered as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/h given over 3 days (72 hours).

 

Change of sentence at end of section to:

The parenteral treatment period should be followed by oral acid-suppression therapy.

 

Addition of paragraph under heading ‘Infusion’:

80 mg bolus dose

The reconstituted solution should be given as a continuous intravenous infusion over 30 minutes.

8 mg/h dose

The reconstituted solution should be given as a continuous intravenous infusion over a period of 71.5 hours (calculated rate of infusion of 8 mg/h. See section 6.3 for shelf-life of the reconstituted solution).

 

Addition of paragraph under heading ‘Impaired hepatic function’:

Bleeding ulcers: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, following an initial bolus dose of 80 mg Nexium for infusion, a continuous intravenous infusion dose of 4 mg/h for 71.5 hours may be sufficient (see section 5.2).

 

Section 4.4

Addition of paragraph:

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter (see section 5.1).

 

Section 4.5

Addition of paragraph:

No in vivo interaction studies have been performed with the high dose IV regimen (80 mg + 8 mg/h). The effect of esomeprazole on drugs metabolised by CYP2C19 may be more pronounced during this regimen, and patients should be monitored closely for adverse effects during the 3-day IV treatment period.

 

Section 4.8

Addition of side effect under ‘Skin and subcutaneous tissue disorders’:

Common: Administration site reactions*

 

*Administration site reactions have mainly been observed in a study with high-dose exposure over 3 days (72 hours). See section 5.3.

 

Deletion of paragraph:

In the non-clinical program for esomeprazole intravenous formulation there was no evidence of vaso-irritation but a slight tissue inflammatory reaction at the injection site after subcutaneous (paravenous) injection was noted.  The non-clinical findings somewhat indicated that the clinical tissue irritation was concentration related.

 

Section 4.9

Change of sentence to:

Single oral doses of 80 mg esomeprazole and intravenous doses of 308 mg esomeprazole over 24 hours were uneventful.

 

Section 5.1

Addition of paragraph:

During intravenous administration of 80 mg esomeprazole as a bolus infusion over 30 minutes followed by a continuous intravenous infusion of 8 mg/h for 23.5 hours, intragastric pH above 4, and pH above 6 was maintained for a mean time of 21 hours and 11-13 hours, respectively, over 24 hours in healthy subjects.

 

Addition of paragraph:

In a randomised, double blind, placebo-controlled clinical study, patients with endoscopically confirmed peptic ulcer bleeding characterised as Forrest Ia, Ib, IIa or IIb (9%, 43%, 38% and 10% respectively) were randomised to receive Nexium solution for infusion (n=375) or placebo (n=389). Following endoscopic haemostasis, patients received either 80 mg esomeprazole as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg per hour or placebo for 72 hours. After the initial 72 hour period, all patients received open-label 40 mg oral Nexium for 27 days for acid suppression. The occurrence of rebleeding within 3 days was 5.9% in the Nexium treated group compared to 10.3% for the placebo group. At 30 days post-treatment, the occurrence of rebleeding in the Nexium treated versus the placebo treated group was 7.7% vs 13.6%

 

Section 5.2

Addition of paragraph:

There is a dose-linear increase in total exposure following intravenous administration of esomeprazole as a 30-minute infusion (40 mg, 80 mg or 120 mg) followed by a continuous infusion (4 mg/h or 8 mg/h) over 23.5 hours.

 

Change of percentage under ‘Special Patient Populations’ to:

Approximately 2.9 ±1.5% of the population lack a functional CYP2C19 enzyme and are called poor metabolisers.

 

Addition of text in penultimate paragraph:

For patients with bleeding ulcers and severe liver impairment, following an initial bolus dose of 80 mg, a maximum continuous intravenous infusion dose of 4 mg/h for 71.5 hours may be sufficient.

 

Section 5.3

Addition of text at end of section:

In the non-clinical program for esomeprazole intravenous formulation there was no evidence of vaso-irritation but a slight tissue inflammatory reaction at the injection site after subcutaneous (paravenous) injection was noted. See section 4.8.

 

Section 6.6

Addition of paragraph at end of section:

Infusion 80 mg

A solution for infusion is prepared by dissolving the content of two vials of esomeprazole 40 mg in up to 100 ml of 0.9% sodium chloride for intravenous use.

 

Section 10:

Change of date:

26th May 2009

Updated on 3 June 2009 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to dosage and administration

Updated on 20 January 2009 SmPC

Reasons for updating

  • 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
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4

 

Addition of paragraph 6:

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter (see section 5.1).

 

Section 5.1

 

Addition of paragraph 4 under heading Other effects related to acid inhibition:

Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter

 

Section 5.2

 

Change of text in paragraph 3 under heading Special patient populations to:

Approximately 2.9 1.5% of the population lack a functional CYP2C19 enzyme and are called poor metabolisers.

 

Section 10

 

Change of date:

21st November 2008

Updated on 8 January 2009 PIL

Reasons for updating

  • Change to appearance of the medicine
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change due to user-testing of patient information

Updated on 19 September 2007 PIL

Reasons for updating

  • Change to drug interactions

Updated on 17 August 2007 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5

 

Following new sub heading added to 1st paragraph:

Medicinal products with pH dependent absorption

Also in 1st paragraph Nexium IV changed to esomeprazole

 

Following new text added as 2nd paragraph:

Co-administration of omeprazole (40 mg once daily) with atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 75% decrease in AUC, Cmax and Cmin). Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. PPIs including esomeprazole should not be co-administered with atazanavir (see section 4.3).

 

Following new sub heading added to 3rd paragraph:

Drugs metabolised by CYP2C19

And following new sentence added to end of paragraph 3: Omeprazole (40 mg once daily) increased voriconazole (a CYP2C19 substrate) Cmax and AUCt by 15% and 41%, respectively.

 

Following text deleted 6th paragraph:

Co-administration of omeprazole (40 mg once daily) with atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 75% decrease in AUC, Cmax and Cmin). Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. PPIs, including esomeprazole, should not be co-administered with atazanavir (see section 4.3). 

 

Following new text added to last paragraph in section 4.5:

Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP 3A4 may result in more than doubling of the esomeprazole exposure. The CYP2C19 and CYP3A4 inhibitor voriconazole increased omeprazole AUCt  by 280%. A dose adjustment of esomeprazole is not regularly required in either of these situations. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.

 

Also following last sentence deleted:

Dose adjustment of esomeprazole is not required.

 

 

Section 10

Date changed to 30th July 2007

Updated on 24 July 2007 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.1

The following sentence was removed: “Nexium for injection and infusion is indicated as an alternative to oral therapy when oral intake is not appropriate.” And replaced with the following new text: “Nexium for injection and infusion is indicated for gastric antisecretory treatment when the oral route is not possible, such as:”

 

Also the word “for” was deleted from the beginning of each bullet point.

 

Section 4.5

End of paragraph 3 the text “Concomitant treatment” was deleted and replaced with: “Concomitant esomeprazole treatment during treatment with warfarin or other coumarine derivatives”

 

 

Section 10

Date changed to 28th June 2007

Updated on 4 July 2007 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 31 May 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 25 May 2006 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to instructions about missed dose
  • Change to date of revision

Updated on 22 May 2006 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 April 2006 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 November 2005 PIL

Reasons for updating

  • Change from the BAN of the active substance to the rINN
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision

Updated on 4 November 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 29 July 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 February 2004 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)