Severe to strongest pain.
Intramuscular or subcutaneous use: A single dose of 15-30 mg is recommended.
Intravenous administration (when a particularly rapid effect is required): Slow intravenous administration (10 mg per minute): Single doses of 7.5-22.5 mg are recommended.
In elderly patients, patients with impaired liver function and patients with poor general health the dose should be reduced.
Intramuscular or subcutaneous use: A single dose of 0.05-0.2 mg per kg body weight for children is recommended.
Intravenous administration (when a particularly rapid effect is required): A single dose for children is 0.05-0.1 mg per kg body weight.
Further information on small children currently available is detailed in Section 5.2.
Piritramide can be used for single and repeated intramuscular, subcutaneous and intravenous administration.
Intramuscular, subcutaneous and intravenous single doses can usually be repeated after 6-8 hours if the effect is fading.
For instructions on dilution of the medicinal product before administration, see Section 6.6.
Piritramide is for single use only. Any unused solution from opened ampoules should be discarded.
Note: The dosage recommendations should serve as a general guidance for administration. In extreme pain states (e.g. tumour pain) the dose can be adjusted. Generally the dose should be sufficiently high and at the same time the smallest analgesic effective dose for the individual patient should be aimed for. For the therapy of chronic pain administration should preferably be performed according to a defined time schedule.
Typical symptoms are miosis and respiratory depression ranging through to respiratory arrest. Additionally, disturbance of consciousness ranging through to coma, low blood pressure, tachycardia and dizziness can occur. The parenteral dose at which severe respiratory depression may occur is 60-80 mg in non-predisposed adults and 1 mg/kg body weight in children.
These effects can be neutralised with administration of an opioid antagonist (e.g. naloxone), which is given cautiously in small repeated doses, because the duration of action of the opioid antagonist is shorter than that of piritramide (e.g. 0.4 mg naloxone every 2-3 minutes for adults).
Besides this, resuscitation measures (especially endotracheal intubation and artificial ventilation) must be introduced. Further, measures for protection of thermal loss and volume replacement should be employed as indicated.
Unopened ampoules: 3 years.
Piritramide [MAH] should be used immediately after first opening.
Chemical and physical in-use stability at 25°C and under light influence of the dilution has been demonstrated for 24 hours with sodium chloride 9 mg/ml (0.9%) solution and for 72 hours with glucose 50 mg/ml (5%) solution.
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 normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions. The NaCl 0.9% dilution should not be applied for more than 24 hours.
Do not store above 25°C. Do not freeze.
Keep the ampoules in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
1 ml, 2 ml and 6 ml ampoules made of colourless type I glass.
Box of 5, 10 or 50 (10x5 or 5x10) ampoules of 1 ml, 2 ml or 6 ml solution for injection.
Not all pack sizes may be marketed.
Immediately prior to administration of Piritramide [MAH] the prepared syringe or the diluted solution (e.g. infusion solution) should be inspected visually for visible particles; if particles are present the solution should be discarded.
Piritramide [MAH] should only be diluted with sodium chloride 9 mg/ml (0.9%) solution and glucose 50 mg/ml (5%) solution.
Any unused product or waste material should be disposed of in accordance with local requirements.
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