Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars
hyperlipidaemia (5)               6.1 List of excipients
Psychiatric         Not known (9)    Euphoric mood.                    Soybean oil, glycerol, egg lecithin, oleic acid, disorders                            Drug abuse and drug
dependence (8)                    sodium hydroxide and water for injection.
Nervous system      Common           Headache during recovery          6.2 Incompatibilities disorders                            phase
The neuromuscular blocking agent, atracurium,
Rare             Epileptiform movements,           should not be given through the same intravenous including convulsions
and opisthotonus during           line as Diprofol 1% without prior flushing.
induction, maintenance
and recovery                      6.3 Shelf life
Very rare        Postoperative                     The expiry date of the product is indicated on the unconsciousness                   packaging materials.
Not known (9)    Involuntary movements             Shelf life after dilution Cardiac disorders   Common           Bradycardia (1)                   Use of diluted Diprofol 1% must begin immediately Very rare        Pulmonary oedema                  following dilution.
Not known (9)    Cardiac arrhythmia (5),           6.4 Special precautions for storage cardiac failure (5), (7)
Protect from light.
Vascular            Common           Hypotension (2)                   Store below 25°C. Do not freeze.
disorders
Ampoules and vials that their contents have been
Uncommon         Thrombosis and phlebitis
frozen can no longer be used.
Respiratory,        Common           Transient apnoea during
thoracic and                         induction                         6.5 Nature and contents of container mediastinal
disorders                                                              Diprofol 10 mg/ml: Glass ampoules of 20 ml Not known (9)    Respiratory depression                               Glass vials of 50 ml (dose dependent)
6.6 Special precautions for disposal and other
Gastrointestinal    Common           Nausea and vomiting                   handling In-use precautions disorders                            during recovery phase
Very rare        Pancreatitis
The ampoules and vials must be shaken before use.
Hepatobiliary       Not known (9)    Hepatomegaly (5)                  Parts of the contents left over after use must be disorders                                                              destroyed.
Musculoskeletal     Not known (9)    Rhabdomyolysis (3), (5)           Diprofol 1% should not be mixed prior to administration and connective                                                         with injections or infusion fluids other than 5% tissue disorders
Dextrose or Lidocaine Injection (see Section 4.2.5).
Renal and urinary Very rare          Discolouration of urine
disorders                            following prolonged               7. Manufacturer administration
Synthon Hispania S.L., Barcelona, Spain
Not known (9)    Renal failure (5)
Reproductive        Very rare        Sexual disinhibition