TRAMADOL Solution for injection or infusion Ref.[7127] Active ingredients: Tramadol

Tramadol 50mg/ml Solution for Injection should not be administered for longer than absolutely necessary. If long-term pain treatment with Tramadol 50mg/ml Solution for Injection is necessary in view of the nature and severity of the illness, then careful regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether, and to what extent, further treatment is necessary.

The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily dose of 400mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances.

The tramadol solution is for parenteral injection either intramuscularly, by slow intravenous injection or diluted in solution (see Section 6.6 Special instructions for use and handling) for administration by infusion or patient controlled analgesia.

Adults and children 12 years and over

The usual dose is 50mg or 100mg 4 to 6 hourly by either intramuscular or intravenous routes. Intravenous injections must be given slowly over 2–3 minutes. The dose should be adjusted according to the severity of the pain and the response.

For post-operative pain, an initial bolus of 100mg is administered. During the 60 minutes following the initial bolus, further doses of 50mg may be given every 10-20 minutes, up to a total dose of 250mg including the initial bolus. Subsequent doses should be 50mg or 100mg 4-6 hourly up to a total daily dose of 400mg.

Geriatric patients

A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements.

Renal insufficiency/dialysis and hepatic impairment

In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient’s requirements.

Children under 12 years

Not recommended.

Symptoms

In principle, on intoxication with tramadol symptoms similar to those of other centrally acting analgesics (opioids) are to be expected. These include in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest.

Treatment

The general emergency measures apply. Keep open the respiratory tract (aspiration!), maintain respiration and circulation depending on the symptoms. The antidote for respiratory depression is naloxone. In animal experiments naloxone had no effect on convulsions. In such cases diazepam should be given intravenously.In case of intoxication orally, gastrointestinal decontamination with activated charcoal or by gastric lavage is only recommended within 2 hours after tramadol intake. Gastrointestinal decontamination at a later time point may be useful in case of intoxication with exceptionally large quantities.

Tramadol is minimally eliminated from the serum by haemodialysis or haemo-filtration. Therefore treatment of acute tramadol intoxication with haemodialysis or haemofiltration alone is not suitable for detoxification.

3 years.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Keep ampoule in the outer carton.

2ml neutral glass type I glass ampoules.

Box of 5 ampoules.

The prepared infusion solution should be made up immediately before use. Tramadol 50mg/ml Solution for Injection is physically and chemically compatible for up to:

• 24 hours with 4.2% sodium bicarbonate and Ringer’s solution.

Or up to 5 days with the following infusion solutions:

• 0.9% sodium chloride
• 0.18% sodium chloride and 4% glucose
• sodium lactate compound- 5% glucose