Login

Betaloc 1 mg/ml Solution for Injection

*
Pharmacy Only: Prescription

  • Company:

    Recordati Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Metoprolol Tartrate

    *Additional information is available within the SPC or upon request to the company

Updated on 19 February 2024

File name

ie-betaloc-spc.pdf

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.3                Shelf life

Unopened pack: 5 years.

The product should be used immediately after opening.


10.         Date of revision of the text

 February 2024

Updated on 19 February 2024

File name

ie-betaloc-pil.pdf

Reasons for updating

  • Change to storage instructions

Free text change information supplied by the pharmaceutical company

6.3      Shelf life

Unopened pack: 5 years.

The product should be used immediately after opening.


This leaflet was last revised in February 2024

Updated on 17 February 2023

File name

ie-pl-betaloc.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 17 February 2023

File name

spc-ie-betaloc-march2020.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 March 2020

File name

pl-ie-betaloc.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to information for healthcare professionals
  • Change to improve clarity and readability

Updated on 27 March 2020

File name

spc-ie-betaloc.pdf

Reasons for updating

  • Change due to harmonisation of SPC

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 May 2019

File name

1.3.1 leaflet-ie.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 May 2019

File name

spc-ie-Betaloc.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 11 April 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 11 April 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2- Editorial changes to bring in line with QRD template

Section 4.2- Editorial changes to bring in line with QRD template

Section 4.4- correction in spelling of haemodynamic

Section 4.6 Editorial changes to bring in line with QRD template

Section 5.1 Correction in spelling of pharmacotherapeutic

Section 9 Editorial changes to bring in line with QRD template

Section 10 Change to revision date

Updated on 10 April 2017

File name

PIL_8030_809.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 April 2017

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 28 October 2014

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

- QRD update – editorial changes to number of sections in the SmPC

 

- Section 4.6 updated in line with QRD template, addition of following: ‘In general, beta-blockers reduce placental perfusion, which has been associated has been associated with growth retardation, intrauterine death, abortion and early labour. It is therefore suggested that appropriate maternofoetal monitoring be performed in pregnant women treated with Betaloc’

 

-section 4.8 ADR wording updated with correct address for HPRA

 

-section 10 updated date of revision

Updated on 27 October 2014

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Improved electronic presentation

Updated on 15 November 2013

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.3 addition of ‘unless a permanent pacemaker is in place’ after sick sinus syndrome and formatting changes

Section 4.8 Addition of adverse event reporting statement

Section 4.9 Amendment to symptoms and management text for overdose

Section 10 – Update to "Date of Revision"

Updated on 13 November 2013

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 07 December 2010

Reasons for updating

  • Correction of spelling/typing errors

Updated on 09 July 2010

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 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities
  • 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2

Additional text:

Each ml of solution contains metoprolol tartrate 1 mg. Each ampoule contains 5 mg/5 ml metoprolol tartrate.

Each ml of solution contains 3.6 mg sodium, as sodium chloride. Each 5 ml ampoule contains 17.8 mg sodium, as sodium chloride.

 

Section 4.4

Additional text  2nd bullet point:

Acute initiation of high-dose metoprolol to patients undergoing non-cardiac surgery should be avoided, since it has been associated with bradycardia, hypotension and stroke including fatal outcome in patients with cardiovascular risk factors.

 

Section 4.9

Change of text to whole of section:

The symptoms of overdose may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.

General treatment should include:

Close supervision, treatment in an intensive care ward and the use of plasma or plasma substitutes to treat hypotension and shock.

Excessive bradycardia can be countered with atropine 1-2 mg intravenously and/or a cardiac pacemaker.  If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously.  If required, this may be repeated or followed by an intravenous infusion of glucagon 1-10 mg/hour depending on response.  If no response to glucagon occurs or if glucagon is unavailable, a beta adrenoceptor stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by intravenous infusion may be given. 

Dobutamine, because of its positive inotropic effect could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta blockade if a large overdose has been taken.  The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient.

Administration of calcium ions may also be considered. Bronchospasm can usually be reversed by bronchodilators.

 

Section 6.2

Change of text to section:

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

 

Section 6.6

Change of text to section:

For single use only. Discard any unused contents.

 

Section 9

Renewal authorisation:

2nd May 2008

 

Section 10

New revision date of text: 19th May 2010

Updated on 07 July 2010

Reasons for updating

  • Change to storage instructions

Updated on 06 February 2007

Reasons for updating

  • Change to side-effects
  • Change from the BAN of the active substance to the rINN

Updated on 01 February 2007

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5- 3rd Paragraph- Addition of text
"Digitalis glycosides, in association with beta‑blockers, may increase atrioventricular conduction time and may induce bradycardia".
 
Section 4.8-Cardiovascular system-uncommon-Addition of text:
"cardiogenic shock in patients with acute myocardial infarction"*,
 
Section 4.8-Cardiovascular system-Replacement of original word.
The word pericordial replaced by the word precordial
 
Section 4.8-Cardiovascular System-Addition of extra paragraph at end of list.
*Excess frequency of 0.4% compared with placebo in a study of 46,000 patients with acute myocardial infarction where the frequency of cardiogenic shock was 2.3% in the metoprolol group and 1.9% in the placebo group in the subset of patients with low shock risk index. The shock risk index was based on the absolute risk of shock in each individual patient derived from age, sex, time delay, Killip class, blood pressure, heart rate, ECG abnormality, and prior history of hypertension. The patient group with low shock risk index corresponds to the patients in which metoprolol is recommended for use in acute myocardial infarction.
 
Section 4.9-Overdose-Last Paragraph-Addition of nex text which replaces the old text
Betaloc cannot be effectively removed by haemodialysis.
 
Section 10-Change to date of the revision of the text:
4th December 2006
 

Updated on 31 January 2007

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5- 6th & 7th paragraph

 

Current Text:

The administration of adrenaline to patients undergoing beta‑blockade can result in an increase in blood pressure and bradycardia although this is less likely to occur with beta1‑selective drugs.

 

Betaloc Injection may impair the elimination of lignocaine

New Text:
The administration of adrenaline (epinephrine) to patients undergoing beta‑blockade can result in an increase in blood pressure and bradycardia although this is less likely to occur with beta1‑selective drugs.

Betaloc Injection may impair the elimination of lidocaine.
 
Section 4.9-Additional word:  noradrenaline [norepinephrine],

Section 10: New revision of text date;  12th September 2006

 

 

Updated on 09 December 2005

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 23 November 2005

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 - 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 25 January 2005

Reasons for updating

  • Change to date of revision

Updated on 24 September 2004

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 May 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)