Ventolin Concentrate for IV Infusion

  • Name:

    Ventolin Concentrate for IV Infusion

  • Company:
    info
  • Active Ingredients:

    Salbutamol sulfate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/11/18

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Summary of Product Characteristics last updated on medicines.ie: 15/5/2018
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 0 of 136 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 20 November 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 15 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 January 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 January 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • 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 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 4.1

Simplified indication and added:

It provides short acting bronchodilation in reversible airways obstruction due to asthma and chronic obstructive pulmonary disease (COPD) such as chronic bronchitis and emphysema.

 

Section 4.2:

Regarding the delay in childbirth of up to 48 hours following tocolytic therapy, the administration of glucocoricoids is added to the description of measures known to improve perinatal health.

 

Replaced the text ‘The dose must be individually titrated, with reference to suppression of contractions, increase in pulse rate and changes in blood pressure, which are limiting factors’ with ‘The dose must be individually titrated. Careful attention should be given to cardio-respiratory function, including increases in pulse rate and changes in blood pressure

 

Strengthened the advice that ‘Treatment should be discontinued should signs of pulmonary oedema or myocardial ischaemia develop

 

Section 4.4:

Updated the warning ‘Bronchodilators should not be the only or main treatment in patients with persistent asthma...’, to read:

 

Rewording of  following  warning ‘In the treatment of premature labour, before salbutamol parenteral preparations are given to any patient with known or suspected heart disease, an adequate assessment of the patient's cardiovascular status should be made by a physician experienced in cardiology’   

Regarding Pulmonary oedema, added advice to monitor by ECG.

 

Section 4.6:

Included subheadings ‘Pregnancy’, ‘Breast-feeding’ and ‘Fertility’, and added the following statement regarding Fertility: ‘There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals (see section 5.3)’.

 

Section 4.9:

Added statement regarding Lactic acidosis

Regarding the treatment of overdose, the updated statement ‘Further management should be as clinically indicated or as recommended by the national poisons centre, where available

 

Section 5.1:

Updated the following statement to include duration of affect and indication and to remove the statement ‘with little or no action on the beta-1 adrenoceptors of the heart’, to read: ‘Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors of bronchial muscle providing short acting (4 to 6 hour) bronchodilation in reversible airways obstruction’.

 

Section 5.3:

Added ‘Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of salbutamol up to 50 mg/kg’.

 

Section 6.6:

Removed ‘0.3% Potassium Chloride’ from the list of infusion fluids.

 

Editorial updates and amendment of  the spelling of ‘sulphate’ to ‘sulfate’ and to re-position texts in following sections 2, 4.4, 4.8, 5.2 and 9

Updated on 4 January 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 January 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 21 July 2015 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Update to MA holder contact details - Address change

Updated on 21 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 27 April 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 7 - removal of trading as Allen and Hanbury from Marketing Authorisation Holder.

Updated on 16 April 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.1 - Simplified indication statement. Added following statement - For the short term management of uncomplicated premature labour

Section 4.2 - Updated the instructions regarding use in short term management of uncomplicated premature labour.

Section 4.3 - Contraindications more clearly stated as Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Updated with specific contraindications in relation to use in obstetrics.

Section 4.4 - Paradoxical bronchodilator warning added. Updated and grouped warnings regarding use in obstetrics under the subheading ‘Tocolysis’.

Section 4.5 - Updated with subheadings and associated statements for ‘Halogenated anaesthetics’, ‘Corticosteroids’, ‘Anti-diabetics’ and ‘Potassium depleting agents’.

Section 4.6 - Added subheading, updated fertility statement
Section 4.7 - Added statement on no negligible influence on ability to drive or operate machinery
Section 4.8 - Side effects and their frequencies were updated to specify whether they were reported when used for respiratory or obstetric indication. AE reporting details updated.
Section 4.9 - Removed instructions on treatment of overdose. Added statement on lactic acidosis
Section 5.1 - Updated ATC Code
Section 5.3 - Added preclinical study data
Section 6.4 - Added protect from frost and sunlight
Section 6.6 - No special requirements for disposal

Updated on 15 April 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Improved electronic presentation

Updated on 3 September 2013 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Changes to:

Section 4.1 -Therapeutic indications,
Section 4.2 - Posology and method of administration

Updated on 30 August 2013 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 16 November 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 10 November 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 10 November 2009 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions
  • Change of special precautions for disposal

Updated on 28 October 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 1 September 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 15 April 2008 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 1 October 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 14 August 2007 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • 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)

Free text change information supplied by the pharmaceutical company

4.9       Overdose

 

The preferred antidote for overdosage with salbutamol is a cardioselective â-blocking agent. However,

 

 

 

Symptoms and Signs

The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events (see Special Warnings and Precautions for Use and Undesirable Effects).

 

Hypokalaemia may occur following overdose with salbutamol.  Serum potassium levels should be monitored.

 

Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.

 

Treatment

Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). 

 

Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.

 

 

6.6     Instructions for Use and Handling

 

No special requirements.

 

Salbutamol syrup may be diluted with Purified Water BP (50% v/v).  The resulting mixture should be protected from light and used within 28 days.

 

A 50% v/v dilution of salbutamol syrup has been shown to be adequately preserved against microbial contamination.

 

Admixture of salbutamol syrup with other liquid preparation is not recommended.

Updated on 9 July 2007 PIL

Reasons for updating

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

Updated on 9 July 2007 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.3 Contraindications

 

Salbutamol should not be used as a tocolytic agent in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease.

 

4.4 Special Warnings and Precautions for Use

 

Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with salbutamol.

 

Tocolysis

Salbutamol should be used with caution in tocolysis and supervision of cardiorespiratory function, including ECG monitoring, should be considered.  Treatment should be discontinued if signs of myocardial ischaemia (such as chest pain or ECG changes) develop.  Salbutamol should not be used as a tocolytic agent in patients with significant risk factors for or pre-existing heart disease (see section 4.3).

 

Respiratory indications

Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

 

4.8 Undesirable Effects

 

Respiratory indications

Unknown: Myocardial ischaemia* (see section 4.4)

* reported spontaneously in post-marketing data therefore frequency regarded as unknown

 

Obstetric indications

Uncommon: Myocardial ischaemia*.

*In the management of pre-term labour with salbutamol injection/solution for infusion.

Updated on 25 September 2006 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

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

Free text change information supplied by the pharmaceutical company

4.2 Posology and Method of Administration

etc……

For premature labour (or to control contractions or counteract overdosage of oxytocics):

Intravenous Infusion:-

Infusion rates of 10 – 45 micrograms per minute are generally adequate. A starting rate of 10 micrograms per minute is recommended, increasing the rate until there is evidence of patient response.

Careful attention should be given to cardio-respiratory function and fluid balance monitoring. The maternal pulse rate should be monitored regularly and should not be allowed exceed 140 bpm. Treatment discontinuation should be considered should signs of pulmonary oedema or myocardial ischaemia develop. (see section 4.4 ‘Special Warnings and Precautions for Use’ and section 4.8 ‘Undesirable Effects’)

Once uterine contractions have ceased the infusion rate should be maintained at the same level for one hour and then reduced by 50% decrements at 6 hourly intervals. Treatment may be continued orally.

Children:-

At present there is insufficient evidence to recommend a dosage regimen for routine use in children.

.....etc

4.4 Special Warnings and Precautions for Use

etc........

Diabetic patients and those concurrently receiving corticosteroids should be monitored frequently during intravenous infusion of Ventolin so that remedial steps (e.g. an increase in insulin dosage) can be taken to counter any metabolic change occurring. For these patients Ventolin Concentrate Solution for Intravenous Infusion should be diluted with Sodium Chloride Injection BP, rather than Sodium Chloride and Dextrose Injection BP.

Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Adverse Reaction section). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.

Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output. Caution should be used in patients with angina, severe tachycardia or thyrotoxicosis.

As maternal pulmonary oedema has and myocardial ischaemia have been reported during or following treatment of premature labour with ß2 agonists, careful attention should be given to fluid balance and cardio-respiratory function, including ECG, should be monitored. If signs of pulmonary oedema or myocardial ischaemia develop, discontinuation of treatment should be considered. (See section 4.2 ‘Posology and Method of Administration’ and section 4.8 ‘Undesirable Effects’).

…..etc

4.8 Undesirable Effects

etc.....

Metabolism and nutrition disorders

Rare: Hypokalaemia

Potentially serious hypokalaemia may result from beta-2-agonist therapy.

Very rare: Lactic acidosis

Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the treatment of acute exacerbation.

Nervous system disorders

.....etc

etc……

Cardiac disorders

Very common: Tachycardia, palpitations

Uncommon: Myocardial ischaemia *

* In the management of pre-term labour with salbutamol injection/solution for infusion

Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.

…..etc.

Updated on 1 September 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 10 July 2006 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

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

Free text change information supplied by the pharmaceutical company

4.2 Posology and Method of Administration

 

ETC……………….

For premature labour (or to control contractions or counteract overdosage of oxytocics):

Intravenous Infusion:-

Infusion rates of 10-45 micrograms per minute are generally adequate. A starting rate of 10 micrograms per minute is recommended, increasing the rate until there is evidence of patient response.

Careful attention should be given to cardio-respiratory function and fluid balance monitoring.

The maternal pulse rate should be monitored regularly and should not be allowed exceed 140 bpm. Treatment discontinuation should be considered should signs of pulmonary oedema develop. (see section 4.4 ‘Special Warnings and Precautions for Use’ and section 4.8 ‘Undesirable Effects’)

Once uterine contractions have ceased the infusion rate should be maintained at the same level for one hour and then reduced by 50% decrements at 6-hourly intervals. Treatment may be continued orally.

Children:-

At present there is insufficient evidence to recommend a dosage regimen for routine use in children.

4.4 Special warnings and precautions for use

ETC……………..

Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output. Caution should be used in patients with angina, severe tachycardia or thyrotoxicosis.

As maternal pulmonary oedema has been reported during or following treatment of premature labour with ß2 agonists, careful attention should be given to fluid balance and cardio-respiratory function should be monitored. If signs of pulmonary oedema develop, discontinuation of treatment should be considered. (See section 4.2 ‘Posology and Method of Administration’ and section 4.8 ‘Undesirable Effects’).

In the treatment of premature labour by intravenous infusion of salbutamol increases in maternal heart rate of the order 20 to 50 beats per minute usually accompany the infusion. The maternal pulse rate should be monitored and not normally allowed to exceed a steady rate of 140 beats per minute.

………………ETC

4.8 Undesirable Effects

Enhancement of physiological tremor may occur with Ventolin. This effect is caused by a direct action on skeletal muscle and is common to all ß-adrenergic stimulants.

Occasionally headaches have been reported.

Ventolin parenteral preparations may dilate some peripheral arterioles leading to a small reduction in arterial pressure and a compensatory increase in cardiac rate. Increases in heart rate are more likely to occur in patients with normal heart rates and these increases are dose-dependent. In patients with pre-existing sinus tachycardia, especially those in status asthmaticus, the heart rate tends to fall as the condition of the patient improves.

Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.

There have been very rare reports of muscle cramps.

Potentially serious hypokalaemia may result from ß2 -agonist therapy.

As with other ß2 -agonists, hyperactivity has been reported rarely in children.

Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) may occur, usually in susceptible patients.

Tachycardia may occur in some patients.

In the management of premature labour, intravenous infusion of Ventolin has occasionally been associated with nausea and vomiting.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common and common events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data.

Immune system disorders

Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.

Metabolism and nutrition disorders

Rare: Hypokalaemia.

Potentially serious hypokalaemia may result from beta-2 agonist therapy.

Nervous system disorders

Very common: Tremor.

Common: Headache.

Very rare: Hyperactivity.

Cardiac disorders

Very common: Tachycardia, palpitations.

Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.

Vascular disorders:

Rare: Peripheral vasodilatation.

Respiratory, thoracic and mediastinal disorders:

Uncommon: Pulmonary oedema.

In the management of pre-term labour, salbutamol injection/solution for infusion have uncommonly been associated with pulmonary oedema. Patients with predisposing factors including multiple pregnancies, fluid overload, maternal infection and pre-eclampsia may have an increased risk of developing pulmonary oedema.

Gastrointestinal disorders

Very rare: Nausea, vomiting.

In the management of premature labour, intravenous infusion of salbutamol has very rarely been associated with nausea and vomiting.

Musculoskeletal and connective tissue disorders

Common: Muscle cramps.

Injury, poisoning and procedural complications

Very rare: Slight pain or stinging on i.m. use of undiluted injection.

 

Updated on 3 July 2006 PIL

Reasons for updating

  • Change to side-effects

Updated on 31 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 February 2004 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life

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

Updated on 4 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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