Medicinal Products

ENTONOX 170 bar gas for inhalation in bottle bottle (+ manodententeur) of 2 liters

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Nitrous oxide + Oxygen
laboratory: Linde France

Compressed medicinal gas
All forms

Indication

· Short-term analgesia of pain or mild to moderate pain in adults and children older than 1 month (eg, lumbar puncture, myelogram, minor superficial surgery, burn dressings, simple fracture reduction), reduction of certain peripheral dislocations, venipuncture, emergency medical assistance - trauma, burns, transport).

· Sedation in dental care, for children older than one month, anxious or disabled patients.

· In obstetrics, in hospital only, waiting for epidural analgesia or in case of refusal or impossibility to perform it.

Posology ENTONOX 170 bar gas for inhalation in bottle bottle (+ manodententeur) of 2 liters

· Short-term analgesia of pain or mild to moderate pain in adults and children older than 1 month (eg, lumbar puncture, myelogram, minor superficial surgery, burn dressings, simple fracture reduction), reduction of certain peripheral dislocations, venipuncture, emergency medical assistance - trauma, burns, transport).

· Sedation in dental care, for children older than one month, anxious or disabled patients.

· In obstetrics, in hospital only, waiting for epidural analgesia or in case of refusal or impossibility to perform it.

Against indications

· Patients requiring ventilation with pure oxygen.

· Intracranial hypertension.

· Any alteration of the state of consciousness, preventing the cooperation of the patient.

· Traumatic brain injury

· Pneumothorax.

· Emphysema bubbles.

· Gas embolism

· Diving accident.

· Abdominal gas distension.

· Patient who has recently received an ophthalmic gas (SF6, C3F8, C2F6) used in ocular surgery as long as a gas bubble persists inside the eye and at least for a period of 3 months. Serious post-operative complications may occur in connection with increased intraocular pressure.

· Known and unsubstituted deficiency of vitamin B12 or folic acid.

· Neurological abnormalities of recent onset and unexplained.

Adverse effects Entonox 170 Bar

The following side effects may occur during treatment and usually resolve within minutes of stopping inhalation of the mixture:

· Frequent (≥1 / 100 to <1/10):

Gastrointestinal disorders

Nausea, vomiting.

· Uncommon (≥1 / 1000 to <1/100):

Nervous system disorders

Paresthesia, excessive sedation, changes in sensory perception.

Psychiatric disorders

Agitation, anxiety, euphoria, dreams.

· Undetermined (can not be estimated on the basis of available data):

Affections of the ear and labyrinth

Dizzying sensations

After prolonged or repeated exposure:

Nervous system disorders

Abnormal movements have sometimes been observed, most often occurring in the context of hyperventilation or in patients with neurological disorders and myeleuropathies.

Blood and lymphatic system disorders

Megaloblastic anemias with leukopenia have been reported due to the inhibition of methionine synthetase involved in the synthesis of vitamin B12.

Psychiatric disorders

Cases of abuse and dependence.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals 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 Centers. www.ansm.sante.fr.

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