TERBUTALINE VIATRIS 5 mg/2 ml S p inh/nébulis en récipient unidose 20unid/2ml

Solution for inhalation by nebuliser.

Terbutaline sulfate..........................................................................................................................................5,0 mg

For a vial of 2 mL.

Excipients:

• Symptomatic treatment of severe acute asthma attacks,
• Treatment of acute exacerbations of chronic obstructive pulmonary disease in adults,

in combination with continuous anti-inflammatory treatment such as inhaled corticosteroids or leukotriene receptor antagonists.

Remark : severe acute asthma requires hospitalization in an intensive care unit.

Oxygen therapy and systemic corticotherapy must be associated with the bronchodilator treatment.

Dosage

Adults: 5 mg to 10 mg, i.e. 1 to 2 doses of 2 mL per nebulisation.

Paediatric population (Child and infant) : 0,1 to 0,2 mg/kg per nebulization.

Any dose that has been started must be used within 24 hours.

The nebulisation may be repeated every 20 to 30 minutes depending on the clinical result and tolerance of the treatment.

Method of administration

This terbutaline solution must be administered by inhalation using a nebulization device (nebulizer).

DO NOT INJECT - DO NOT SWALLOW.

Follow the instructions for use of the device used.

Dilute the necessary quantity of terbutaline in physiological saline so as to obtain a total volume of 4 to 5 mL.

The resulting mixture is delivered in pulses by a flow of air or oxygen (6 to 8 litres/minute) for approximately 10 to 15 minutes, during which the patient breathes at their usual rate.

The technique of use by the patient must be checked regularly.

After inhalation, the unused solution remaining in the nebuliser reservoir must be discarded.

Intolerance to this medicine (occurrence of cough or bronchospasm after inhaling the product). In this case, treatment should be discontinued and other therapies or other forms of administration prescribed.

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

Special warnings

Administration of terbutaline via a nebuliser should be reserved for severe acute situations requiring inhalation of a high dose of the product by the inhaled route.

These situations require medical monitoring with the possibility of initiating resuscitation (venous access and respiratory support); oxygen therapy and systemic corticosteroid therapy should generally be associated with it.

It is necessary to combine continuous anti-inflammatory treatment, such as inhaled corticosteroids or leukotriene receptor antagonists, in patients with persistent asthma for whom continuous treatment with beta‑2‑mimetics is required. Patients must be informed that they must continue the basic anti-inflammatory treatment prescribed to them even if their symptoms and their use of TERBUTALINE VIATRIS decrease.

A decrease in the response usually obtained on symptoms with treatment is a sign of a possible worsening of asthma that requires a medical consultation in order to reassess asthma treatment.

Excessive use of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deterioration of asthma control, leading to an increased risk of severe asthma exacerbations and mortality.

If terbutaline is used as rescue treatment "on demand" more than twice a week, the background treatment must be reassessed and adjusted due to the risk of excessive use of terbutaline.

Athletes should be made aware that this product contains an active substance that may induce a positive reaction in tests carried out during anti-doping controls.

Cardiovascular effects may be observed with sympathomimetic medicines, including TERBUTALINE VIATRIS. Cases from the literature and post-marketing experience have revealed rare cases of myocardial ischemia related to the use of beta‑2‑mimetics. Patients treated with TERBUTALINE VIATRIS who have severe cardiac disorders (ischemic heart disease, arrhythmia or severe heart failure) must be informed to seek medical advice if they experience chest pain or any other symptom indicating worsening of their cardiac condition. Particular attention must be paid to symptoms such as dyspnea or chest pain, as these may be of respiratory or cardiac origin.

Precautions for use

In case of bronchial infection or abundant bronchorrhea, appropriate treatment is necessary in order to promote optimal distribution of the product in the airways.

This medicine must be administered with caution in cases of hyperthyroidism, in cases of cardiovascular disease, in particular obstructive cardiomyopathy, coronary disorders, rhythm disorders, arterial hypertension, and in cases of diabetes mellitus.

High doses of beta‑2‑mimetics may cause hypokalemia, which may favor the occurrence of cardiac rhythm disorders. Monitoring of kalemia is recommended where possible, in particular during simultaneous administration of hypokalemic therapies, in cases of hypoxia or in subjects in whom the risk of occurrence of torsades de pointes is increased (long QT or treatments likely to increase QTc).

Beta-blockers (including those in the form of eye drops) may partially or totally inhibit the effect of beta‑2‑stimulants.

Combinations not recommended

+ Halothane

In the event of obstetric intervention, increased uterine atony with risk of hemorrhage; furthermore, risk of occurrence of serious ventricular rhythm disorders, due to increased cardiac reactivity.

Discontinue treatment with beta‑2‑mimetics if anesthesia is to be performed under halothane.

Associations requiring precautions for use

+ Antidiabetics

Elevation of blood glucose due to beta-stimulant effect.

Reinforce blood and urine monitoring. Possibly switch to insulin.

+ Agents causing potassium depletion

Due to the hypokalemic effect of beta‑2‑mimetics, concomitant administration of agents causing potassium depletion known to aggravate the risk of hypokalemia, such as diuretics, digoxin, methylxanthines and corticosteroids, must be carried out with caution after careful evaluation of benefits and risks, with particular attention to the increased risk of cardiac arrhythmias resulting from hypokalemia (see section Warnings and precautions). Hypokalaemia also predisposes to digoxin toxicity.

Pregnancy

Clinically, there is substantial experience, with a sufficient number of documented pregnancies, to conclude on the safety of terbutaline during pregnancy.

Consequently, inhaled terbutaline may be administered during pregnancy.

When administered during pregnancy :

An acceleration of fetal heart rate may be observed in parallel with maternal tachycardia. It is exceptional for it to persist at birth.

Similarly, post-natal blood glucose values are only exceptionally disturbed.

TERBUTALINE VIATRIS 5 mg/2 mL, solution for inhalation by nebulizer in single-dose container, used in the treatment of asthma and other pulmonary diseases, is a tocolytic agent and must therefore be used with caution at the end of pregnancy.

In case of administration before delivery, take into account the peripheral vasodilator effect of beta‑2‑mimetics.

Breast-feeding

Beta-2-mimetics pass into breast milk.

The severity of adverse effects depends on the dosage and route of administration. Terbutaline prescribed by inhalation is unlikely to produce significant systemic effects when administered at the recommended doses. Most of these effects are characteristic of sympathomimetic amines. The majority of these effects were spontaneously reversible during the first two weeks of treatment.

Frequency	System Organ Class	Adverse effects
Very common (> 1/10)	Nervous system disorders	Headache Tremor of the extremities
Common (< 1/1000 and ≥ 1/100)	Cardiac disorders	Tachycardia Palpitations
	Musculoskeletal and systemic disorders	Muscle cramps
	Metabolism and nutrition disorders	Hypokalaemia, increased blood glucose
Rare (< 1/1 000 and ≥ 1/10 000)	Metabolism and nutrition disorders	Lactic acidosis
Undetermined*	Cardiac disorders	Heart rhythm disorders, in particular atrial fibrillation, supraventricular tachycardia and atrial or ventricular extrasystoles, myocardial ischaemia
	Gastrointestinal disorders	Nausea
	Psychiatric disorders	Sleep disorders and behavioural disorders: agitation, nervousness, hyperactivity
	Respiratory, thoracic and mediastinal disorders	Bronchospasm**, cough**
	Skin and subcutaneous tissue disorders	Erythematous rash, urticaria, exanthema

* Reported spontaneously in post-marketing data; the frequency is therefore considered not determinable.

** As with other inhaled products, cough and, rarely, paradoxical bronchospasm may occur following inhalation of the product. In this case, this treatment should be discontinued and other therapies or another form of administration should be prescribed.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/

In case of overdose: the risk of tachycardia and cardiac arrhythmia, blood pressure changes, tremors, sweating, agitation, nausea, hypokalaemia are increased.

Pharmacotherapeutic class: SELECTIVE BETA‑2‑ADRENERGIC AGONISTS, ATC code: R03AC03.

Broncho-dilator beta‑2‑mimetic fast-acting and short-acting by inhalation route.

Terbutaline is a selective beta‑2 receptor agonist.

After inhalation, terbutaline exerts a stimulating action on the beta‑2 receptors of bronchial smooth muscle, thus ensuring rapid bronchodilation, significant within a few minutes, persisting for 4 to 6 hours.

After repeated nebulisations, the plasma concentrations observed at therapeutic doses are not negligible but remain lower than those observed orally or by injection.

There is no correlation between the blood level and the efficacy curve.

After pulmonary absorption, terbutaline is weakly bound to plasma proteins. It is metabolised in the liver into sulpho and conjugated derivatives, eliminated in the urine.

2 years.

Store in the original package, protected from light.

No special requirements.

List I
Prescription restricted to specialists in paediatrics and pneumology.
Medicine reserved for use in emergency situations.
Medicinal product that may be administered within the framework of a mobile medical assistance or health repatriation structure (Art R.5121-96 of the CSP).

Marketing authorisation (AMM)

CIP 3400926887100 (20unit/2ml). CIP 3400926887339 (50Unit/2ml).

Price:

4,21 euros (20unit/2ml). 10,28 euros (50Unit/2ml).

Social Security reimbursement at 65% (20unit/2ml) in the indications:

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree (20unit/2ml)

Social Security reimbursement at 65% (50Unit/2ml).
Collection.