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

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with tramadol in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

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 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances.

Unless otherwise prescribed, Tramadol hydrochloride 50 mg/ml solution for injection or infusion should be administered as follows:

Adults and adolescents above the age of 12 years

The usual dose is 50 or 100mg 4-6 hourly by the intravenous or intramuscular route. Dosage should be adjusted according to pain severity and response.

Intravenous injections must be given slowly over 2-3 minutes.

For post-operative pain administer an initial bolus of 100mg. 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.

Children

Tramadol hydrochloride 50 mg/ml solution for injection or infusion is not suitable for children below the age of 12 years.

Geriatric patients

A dose adjustment is not usually necessary in elderly 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 Insufficiency

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.

Method of administration

Tramadol hydrochloride 50 mg/ml solution for injection or infusion may be administered intramuscularly, by slow intravenous injection, or diluted in solution (see Section 6.6) for administration by infusion or patient controlled analgesia.

Duration of administration

Tramadol hydrochloride 50 mg/ml solution for injection or infusion should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Tramadol hydrochloride 50 mg/ml solution for injection or infusion 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.

Symptoms

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

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.

Serotonin syndrome has also been reported.

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 intoxication with Tramadol hydrochloride 50 mg/ml solution for injection or infusion with haemodialysis or haemofiltration alone is not suitable for detoxification.

36 months. From a microbiological point of view, the product should be used immediately. If not used-immediately, inuse storage times and conditions prior to use are the responsibility of the user.

Do not store above 30°C.

Colourless glass ampoule containing either 1 ml or 2 ml of injection solution. Ampoules are contained in a pre-fabricated blister strip, which is enclosed in a cardboard outer carton. Cartons contain either 1, 5 or 10 ampoules.

Based on described observations Tramadol 50 mg/ml solution for injection or infusion is physically and chemically compatible for up to 24 hours with water for injections (WFI), sodium chloride solution for injection 0.9% and glucose solution for injection 5% at given concentrations. Obtained results show no necessity for cold storage.

The prepared infusion solution should be made immediately before use.