Sulfur hexafluoride

No clinical data on exposed pregnancies are available. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of sulfur hexafluoride during pregnancy.

It is not known if sulphur hexafluoride is excreted in human milk. However, based on its rapid elimination from the body via the expired air, it is considered that the breastfeeding can be resumed two to three hours after administration of sulphur hexafluoride.

Fertility

No clinical data are available. Animal studies do not indicate harmful effects on fertility.

Sulfur hexafluoride has no or negligible influence on the ability to drive and use machines.

Adult population – Intravenous use

The safety of sulfur hexafluoride after intravenous administration was evaluated in 4653 adult patients who participated in 58 clinical trials. The undesirable effects reported with sulfur hexafluoride after intravenous administration were, in general, non-serious, transient and resolved spontaneously without residual effects. In clinical trials, the most commonly reported adverse reactions after intravenous administration are: headache, injection site reaction, and nausea.

The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders

Rare: Hypersensitivity*

Nervous system disorders

Uncommon: Headache, paraesthesia, dizziness, dysgeusia

Not known: Vasovagal reaction

Eye disorders

Rare: Vision blurred

Cardiac disorders

Not known: Myocardial infarction**, Myocardial ischemia**, Kounis syndrome***

Vascular disorders

Uncommon: Flushing

Rare: Hypotension

Gastrointestinal disorders

Uncommon: Nausea, Abdominal pain

Not known: Vomiting

Skin and subcutaneous tissue disorders

Uncommon: Rash

Rare: Pruritus

Musculoskeletal, connective tissue and bone disorders

Rare: Back pain

General disorders and administration site conditions

Uncommon: Chest discomfort, injection site reaction, feeling hot

Rare: Chest pain, pain, fatigue

* Cases suggestive of hypersensitivity may include: skin erythema, bradycardia, hypotension, dyspnoea, loss of consciousness, cardiac/cardio-respiratory arrest, anaphylactic reaction, anaphylactic shock.
** In some of the cases of hypersensitivity, in patients with underlying coronary artery disease, myocardial ischemia and/or myocardial infarctions were also reported.
*** Allergic acute coronary syndrome

In very rare cases, fatal outcomes have been reported in temporal association with the use of sulfur hexafluoride. In all these patients there was a high underlying risk for major cardiac complications, which could have led to the fatal outcome.

Paediatric population – Intravesical use

The safety of sulfur hexafluoride after intravesical administration was based on evaluation of published literature involving use of sulfur hexafluoride in over 6000 paediatric patients (age range 2 days to 18 years). No adverse reactions were reported.