Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, A-3002, Purkersdorf, Austria
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
NALPAIN 10 mg/ml solution for injection may not be used as a substitute for heroin, methadone or other opioids in dependent persons. In these cases the withdrawal symptoms may be considerably intensified.
Withdrawal symptoms, including increased pain, can occur in patients with chronic pain treated with other μ-agonistic opioids e.g. morphine and fentanyl.
Abuse of NALPAIN 10 mg/ml solution for injection can lead to psychological and physical dependence. Special attention is required before treating emotionally unbalanced patients or patients with opioid-misuse in their medical history.
It is possible that potent analgesics may increase intracranial pressure and so cause respiratory depression. In case of head injury, inner head injury or already existing increased intracranial pressure this effect might be intensified. In addition, potent analgesics can cause effects that may mask the course of the disease in patients with head injury. Therefore, NALPAIN 10 mg/ml solution for injection must only be used if really necessary and with the utmost caution.
As NALPAIN 10 mg/ml solution for injection is metabolised in the liver and eliminated renally, nalbuphine hydrochloride is contraindicated in patients with hepatic disorders and severe renal impairment (see section 4.3). Patients with moderate and mild renal impairment may show abnormal reactions upon standard dosages. Caution is required in these patients.
Foetal and neonatal adverse effects reported following the administration of nalbuphine hydrochloride to the mother during labour include foetal bradycardia, respiratory depression at birth, apnoea, cyanosis, and hypotension. Some of these events have been life-threatening. Maternal administration of naloxone during labour has reversed these effects in some cases. Nalbuphine hydrochloride should only be used during labour and delivery if clearly indicated and if the potential benefit outweighs the risk to the infant. Newborns should be monitored for respiratory depression, apnoea, bradycardia and arrhythmias if Nalbuphine hydrochloride has been used.
10 mg NALPAIN 10 mg/ml solution for injection causes respiratory depression comparable to that caused by 10 mg morphine. Unlike morphine, there is a ceiling effect to the respiratory depressant effect of nalbuphine.
There is a ceiling for respiratory depression at a dose of approximately 30 mg, and an analgetic ceiling at approximately 50 mg administered during a short period. Patients with pain conditions who have a high opioid requirement should be offered an opioid with no analgetic ceiling.
Respiratory depression raised by NALPAIN 10 mg/ml solution for injection may be treated with naloxone hydrochloride, if necessary. NALPAIN 10 mg/ml solution for injection must be administered with great caution and in very small dosages to patients who suffer from impaired respiration (e.g. caused by other medical treatment, uremia, bronchial asthma, serious infections, cyanose or respiratory obstruction).
Nalbuphine hydrochloride should be used with caution in patients with heart insufficiency, paralytic ileus, biliary colic, epilepsy and hypothyroidism.
During administration, antagonist treatment should be available (naloxone).
+ Pure morphine agonists (such as morphine, pethidine, dextromoramide, dihydrocodeine, dextropropoxyphene, methadone, levacethylmethadol): Pure μ-agonists reduce analgesic effect due to competitive receptor blockage.
+ Alcohol: Alcohol potentiates the sedative effect of morphine-based analgesics. Alcoholic beverages and medicinal products containing alcohol must be avoided.
+ Other central nervous system suppressants, such as other morphine derivatives (analgesics and antitussives), sedative antidepressants, sedative H1 antihistamines, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: These substances may cause an increased risk of respiratory depression, potentially life threatening in case of overdose.
There is no information available regarding the potential for pharmacokinetic interactions between nalbuphine and other medicinal products. Caution is recommended when nalbuphine is combined with potent enzyme inhibitors or medicinal products with a narrow therapeutic range.
There are inadequate data regarding the use of nalbuphine hydrochloride in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk in humans is unknown. Pregnant women should only be treated with nalbuphine hydrochloride if the anticipated benefit to the mother exceeds the possible risk to the foetus.
As with all opioids, chronic use by the mother, particularly at the end of pregnancy may produce a withdrawal syndrome in the newborn, regardless of the dose.
As is the case with every opioid nalbuphine hydrochloride has not been studied in terms of efficacy and safety in premature labour or delivery.
When nalbuphine hydrochloride is administered to the mother directly before or during delivery, newborns should be monitored for respiratory depression, apnoea, bradycardia and arrhythmias (see section 4.4 and 4.8).
Nalbuphine hydrochloride is excreted in breast-milk. Lactation should be discontinued for 24 hours after treatment with NALPAIN 10 mg/ml solution for injection.
NALPAIN 10 mg/ml solution for injection reduces the ability to respond and has therefore a major influence on the ability to drive and use machines. These activities have to be avoided until the effects of nalbuphine hydrochloride have subsided.
The following undesirable effects are ranked according to system organ class and to their frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1.000 to <1/100), Rare (≥1/10.000 to <1/1.000), Very rare (<1/10.000).
Very common: Sedation
Common: Perspiration, Drowsiness, Vertigo, Dry mouth, Headache
Rare: Light numbness in the head, Nervousness, Tremor, Withdrawal symptoms, Paresthesia
Very rare: Euphoria
Common: Dysphoria
Very rare: Hallucination, Confusion, personality disorder trait
Rare: Respiratory difficulties
Very rare: Bradycardia, Tachycardia, Lung oedema
Very rare: Hypotension, Hypertension
Very rare: Watery eyes, Blurred vision
Very rare: Allergic reaction
Very rare: Pain in the puncture, Flushing
Very rare: Urticaria
Common: Vomiting, Nausea
Very rare: respiratory depression in newborn children, retarded circulation in newborn children
NALPAIN 10 mg/ml solution for injection can cause certain withdrawal symptoms if used in patients who exert opioids in an excessive way.
When NALPAIN 10 mg/ml solution for injection is used during delivery it can raise respiratory depression and/or retarded circulation in newborn children with deleterious consequences. In these cases naloxone hydrochloride must be kept available as an antidote.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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