Betaloc 1 mg/ml Solution for Injection

  • Name:

    Betaloc 1 mg/ml Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Metoprolol Tartrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/05/19

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Summary of Product Characteristics last updated on medicines.ie: 22/5/2019

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Recordati Ireland Limited

Recordati Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Betaloc 1 mg/ml Solution for Injection Active Ingredients Metoprolol Tartrate
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Medicine Name Lercaril 20 mg/10 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Lercaril 20 mg/20 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Phospho-soda 24.4g / 10.8g oral solution Active Ingredients Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate Dihydrate
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Medicine Name Reagila 3 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 4.5 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 6 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Urispas 200mg film-coated tablets Active Ingredients Flavoxate Hydrochloride, Lactose
Medicine Name Urorec capsules Active Ingredients Silodosin
Medicine Name Vitaros 3mg/g Cream Active Ingredients Alprostadil
Medicine Name Zanidip 10mg and 20mg Tablets Active Ingredients Lercanidipine Hydrochloride
Medicine Name Zanidip 10mg Tablets Active Ingredients Lercanidipine Hydrochloride
Medicine Name Zanidip 20mg Tablets Active Ingredients Lercanidipine Hydrochloride
1 - 0 of 18 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 22 May 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 May 2019 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 11 April 2017 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 April 2017 PIL

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 SmPC

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 PIL

Reasons for updating

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

Updated on 15 November 2013 SmPC

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 PIL

Reasons for updating

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

Updated on 7 December 2010 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 9 July 2010 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 4.9 - 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 7 July 2010 PIL

Reasons for updating

  • Change to storage instructions

Updated on 6 February 2007 PIL

Reasons for updating

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

Updated on 1 February 2007 SmPC

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 SmPC

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 9 December 2005 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to date of revision

Updated on 24 September 2004 SmPC

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 9 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 May 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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