Tramalgin 100 mg – Ampoule

Composition

Each 2 mL ampoule contains:

• Tramadol Hydrochloride: 100 mg.
• Excipient: S.Q. for ampoule of 2 mL.

Indications

Moderate to severe pain.

Dosage & Administration

The following, guidelines apply, unless your doctor has prescribed Tramalgin 100 mg solution for injection otherwise.

How much of Tramalgin 100 mg solution for injection should be administered?

How often is Tramalgin 100 mg solution for injection administered?

The dosage should be adjusted to the intensity of the pain and the sensitivity of the individual patient.

In moderate pain adults and adolescents above 14 years of age receive 1 ml Tramalgin 100 mg solution for injection (50 mg tramadol hydrochloride) as a single dose. If there is no pain-relieving effect after 30 – 60 minutes, a further 1 ml can be administered.

If in severe pain a higher dose is necessary, 2 ml Tramalgin 100 mg solution for injection (100 mg tramadol hydrochloride) are administered as a single dose.

For the treatment of severe pain after operations, on-demand pain relief may require even higher doses in the first few hours. In general, over 24 hours more than the normal daily doses of tramadol are not necessary.

Depending on the pain, the effect lasts for 4 to 8 hours. In general, 8 ml Tramalgin 100 mg solution for injection (400 mg tramadol hydrochloride) per day need not to be exceeded. However, for the treatment of cancer pain much higher doses may be necessary.

Dosage for Children:

Children aged 1 to 13 years receive 1-2 mg tramadol hydrochloride per kg body weight as a single dose.

In this case Tramalgin 100 mg solution for injection is diluted in water for injection.

The following table shows which concentrations are achieved (1 mL Tramalgin 100 mg solution for injection contains 50 mg tramadol hydrochloride).

Diluting Tramalgin 100 mg solution for injection in

Example:

The doctor would like to give 1.5 mg tramadol hydrochloride per kg body weight to a child weighing 45 kg. This requires 67.5mg tramadol hydrochloride.

Therefore 2ml Tramalgin 100 mg solution for injection are diluted in 4 ml water for injection. These results in a concentration of 16.7mg tramadol hydrochloride per ml. 4ml (approx. 67 mg tramadol hydrochloride) of the diluted solution are then administered.

Dose adjustment when the duration of action is prolonged:

When kidney or liver function is impaired, it is not necessary to adjust the dose of Tramalgin 100 mg solution for injection in acute pain conditions, because the preparation is only given once or occasionally.

In chronic (long-lasting) pain, however, the intervals between doses should be extended on account of the risk of accumulation (concentration of tramadol in the body) due to delayed excretion.

Even if there is no recognizable restriction of liver or kidney function, excretion may be delayed in elderly patients (over 75 years of age), and therefore the intervals between doses may have to be extended.

Note:

The recommended dosages are guidelines. In principle, the lowest pain-relieving dose should be selected. In the treatment of chronic (long-lasting) pain a fixed dosage schedule is recommended.

How is Tramalgin 100 mg solution for injection administered?

Tramalgin 100 mg solution for injection is administered intravenously, intra-muscularly or subcutaneously (on intravenous injection Tramalgin 100 mg solution for injection is mostly injected into a surface blood vessel of the arm, on intramuscular injection into the buttocks and on subcutaneous injection under the skin). Intravenous injection is carried out slowly, injecting 1ml Tramalgin 100 mg solution for injection (50 mg tramadol hydrochloride) per minute.

How long is Tramalgin 100 mg solution for injection administered?

Tramalgin 100 mg solution for injection must not be administered for longer than absolutely necessary. If long-term treatment is necessary, your doctor should check at regular short intervals as to whether and with what dose Tramalgin 100 mg solution for injection should be continued (if necessary, with breaks in treatment).