NALPAIN Solution for injection Ref.[8190] Active ingredients: Nalbuphine

Adults

The usual recommended dose for adults is 10-20 mg for patients with 70 kg body weight, which is equivalent to 0.1–0.3 mg/kg body weight. This dose may be administered intravenously, intramuscularly or subcutaneously and may be repeated after 3 to 6 hours, if necessary. The maximum single dose in adults must not exceed 20 mg. The posology must be adapted to the intensity of pain and the physical status of the patient.

Children and adolescents

The usual recommended dose for children is 0,1-0,2 mg/kg body weight. This dose may be administered intravenously, intramuscularly or subcutaneously. Intramuscular as well as subcutaneous administration might be painful and should be avoided in children.

The dose may be repeated after 3 to 6 hours, if necessary. The single maximum dose is fixed with 0,2 mg nalbuphine hydrochloride per kilogram body weight.

There are no adequate data for the treatment of children younger than 1.5 years.

Elderly people

Due to increased bioavailability and decreased systemic clearance it is suggested to start with the lowest dose of nalbuphine hydrochloride.

Patients with hepatic/renal impairment

Patients with moderate and mild renal impairment may show an abnormal reaction upon standard dosages. Therefore, the product should be used with caution in these patients.

Nalbuphine hydrochloride is contraindicated in patients with hepatic disorders and severe renal impairment (see sections 4.3 and 4.4).

NALPAIN 10 mg/ml solution for injection is not suitable for long term treatment.

For further information see section 6.6.

Administration of high doses of nalbuphine hydrochloride (intramuscular or intravenous) produces several symptoms of overdose – like respiratory depression, sedation, sleepiness, unconsciousness and light uncomfortableness.

Naloxone hydrochloride can be used as a specific antidote to nalbuphine hydrochloride. However, primary attention should be given to respiratory and cardiovascular function. Symptomatic and supportive therapy is mostly sufficient for slight and moderate overdosage. Oxygen, plasma volume expanders and other auxiliaries may be used, if necessary.

Shelf life: 3 years.

The product has to be used immediately after opening.

Do not store above 25°C.

Keep the ampoules in the outer carton in order to protect from light.

Colourless glass, Type I.

Ampoules of 2 ml, in packages of 10 ampoules.

For single use only.

Only clear solutions practically free from particles should be used. The solution must be visually inspected prior to use.

Any unused solution should be disposed of in accordance with local requirements.