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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: Irelandinfo@astrazeneca.com
Summary of Product Characteristics last updated on medicines.ie: 26/01/2011
SPC Bricanyl Injection 1ml

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 26/01/2011 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   13-Aug-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Section 4.5

 

Additional paragraph added at end of section, reads as,

 

“There are some data which indicate that there is a risk of interaction between monoamine oxidase inhibitors, tricyclic antidepressants and terbuatline.”

 

Section 10

13th August 2010
Updated on 15/02/2010 and displayed until 26/01/2011
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 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • 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:   25-Jan-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2

Addition of text:

1 ml also contains sodium (<1 mmol/ml), as sodium chloride.

Section 4.3

Addition of condition:

e.g. severe toxaemia, ante-partum haemorrhage, intra-uterine infection, severe pre-eclampsia, ablatio placentae, threatened abortion during the first and second trimesters or cord compression.

Addition of paragraph:

Bricanyl solution for injection 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.

Section 4.4

Replacement of section with:

As for all beta2-agonists caution should be observed in patients with thyrotoxicosis.

Cardiovascular effects may be seen with sympathomimetic drugs, including Bricanyl. There is some evidence from postmarketing data and published literature of myocardial ischaemia associated with beta agonists.

Due to the positive inotropic effect of the beta2-agonists, these drugs should not be used in patients with hypertrophic cardiomyopathy.

Tocolysis
Bricanyl 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. Bricanyl should not be used as a tocolytic agent in patients with significant risk factors for or pre-existing heart disease (see section 4.3).

In treatment of premature labour, hyperglycaemia and ketoacidosis have been found in pregnant women with diabetes after treatment with beta2-stimulants. It may therefore be necessary to adjust the insulin dose when beta2-stimulants are used in the treatment.

In premature labour in a patient with known or suspected cardiac disease a physician experienced in cardiology should assess the suitability of treatment before i.v. infusion with Bricanyl.

Increased tendency to uterine bleeding has been reported in connection with Caesarean section. However, this can be effectively stopped by propranolol 1 to 2 mg injected intravenously.

In order to minimise the risk of hypotension associated with tocolytic therapy, special care should be taken to avoid caval compression by keeping the patient in the left or right lateral positions throughout the infusion.

Respiratory indications
If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice. Consideration should be given to the requirements for additional therapy (including increased dosages of anti-inflammatory medication). Severe exacerbations of asthma should be treated as an emergency in the usual manner.

Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Bricanyl 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.

Due to the hyperglycaemic effects of beta2-agonists, additional blood glucose controls are recommended initially in diabetic patients.

Potentially serious hypokalaemia may result from beta2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalemic effect may be potentiated by concomitant treatments (see Interactions 4.5). It is recommended that serum potassium levels are monitored in such situations.


Section 4.8

Replacement of section with:

The intensity of the adverse reactions depends on dosage and route of administration. An initial dose titration will often reduce the adverse reactions. Most of the adverse reactions are characteristic of sympathomimetic amines. The majority of these effects have reversed spontaneously within the first 1-2 weeks of treatment.

Bronchial asthma. Chronic bronchitis, emphysema and other lung diseases where bronchospasm is a complicating factor.

Frequency Classification

Adverse Drug Reaction

 

System Organ Class (SOC)

Preferred term (PT)

Very Common (≥1/10)

Nervous System Disorders

Tremor

Headache

Common (<1/10 and ≥1/100)

Cardiac Disorders

 

Tachycardia

Palpitations

 

Musculoskeletal and Connective Tissue Disorders

 

Muscle spasms

 

Metabolism and Nutrition Disorders

 

Hypokalaemia

Unknown*

Cardiac Disorders

 

 

 

Arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia and extrasystoles

Myocardial ischaemia

 

Gastrointestinal Disorders

 

Nausea

 

Psychiatric Disorders

 

 

Sleep disorder and Behavioural disturbances, such as agitation and restlessness

 

Nervous System Disorders

Psychomotor hyperactivity

Skin and Subcutaneous Tissue Disorders

Urticaria

Rash

 


Preterm Labour

Frequency Classification

Adverse Drug Reaction

 

System Organ Class (SOC)

Preferred term (PT)

Very Common (≥1/10)

Cardiac Disorders

 

Tachycardia

 

Nervous System Disorders

 

Tremor

Headache

 

Gastrointestinal Disorders

Nausea

Common (<1/10 and ≥1/100)

Cardiac Disorders

 

Palpitations

 

Metabolism and Nutrition Disorders

Hypokalaemia

Unknown*

Blood and Lymphatic System Disorders

 

 

An increased tendency to bleeding in connection with caesarean section

 

Cardiac Disorders

 

 

 

 

Arrhythmias, e.g. atrial  fibrillation, supraventricular  tachycardia and extrasystoles

Myocardial ischaemia

 

Respiratory, Thoracic and Mediastinal Disorders

 

Symptoms of pulmonary oedema

Psychiatric Disorders

 

 

Sleep disorder and Behavioural disturbances, such as agitation and restlessness

 

Nervous System Disorders

Hyperactivity

Metabolism and Nutrition Disorders

 

Hyperglycaemia

Hyperlactacidaemia

 

Skin and Subcutaneous Tissue Disorders

 

Urticaria

Rash

 

Musculoskeletal and Connective Tissue Disorders

 

Muscle spasms

During treatment of preterm labour, when high doses of Bricanyl are used, diabetic mothers may develop hyperglycaemia and lactacidosis. In these patients glucose and acid-base balance should be carefully monitored. High doses of beta2-stimulants may cause hypokalaemia as a result of redistribution of potassium. Symptoms of pulmonary oedema have also been reported following treatment of preterm labour. An increased tendency to bleeding has been described in connection with caesarean section (give propranolol, 1-2 mg i.v.) in patients treated with Bricanyl for preterm labour

Section 5.3

Deletion of text:

Terbutaline is a well established active ingredient.
Terbutaline has been used extensively over many years for the relief of bronchospasm without identifying any areas of concern.

Section 6.4

Replacement of last sentence with:

Keep ampoules in the outer carton in order to protect from light.

Section 9

Change of date to:

1 April 1979 / 7 January 2004

Section 10

Change of date to:

25th January 2010
Updated on 27/03/2007 and displayed until 15/02/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 10/11/2006 and displayed until 27/03/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 -  In the section regarding special precautions for infusion (4th paragraph) the final sentence should read "Keep the infusion at this rate for 12 hours and then continue with appropriate oral maintenance therapy, if indicated."
 
Section 4.2 - In the section regarding special precautions for infusion  the sentence "Oral treatment may be continued for as long as the physician considers it desirable to prolong pregnancy" has been deleted.
 
Section 10 - The date of revision is updated to 2nd November 2006
Updated on 12/12/2005 and displayed until 10/11/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 22/03/2005 and displayed until 12/12/2005
Reasons for adding or 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 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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
Updated on 06/11/2003 and displayed until 22/03/2005
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Updated on 23/05/2003 and displayed until 06/11/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Terbutaline Sulphate