NALPAIN Solution for injection (2011)
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Περιεχόμενα
Name of the medicinal product
NALPAIN 10 mg/ml solution for injection.
Qualitative and quantitative composition
1 ml solution for injection contains 10 mg nalbuphine hydrochloride. 1 ampoule of 2 ml contains 20 mg nalbuphine hydrochloride. Excipient: 1.6 mg sodium in a 2 ml ampoule. For a full list of excipients, ...
Pharmaceutical form
Solution for injection. The solution is clear and colourless. pH = 3.0-4.2, osmolarity = 0.3 Osmol/kg
Therapeutic indications
NALPAIN 10 mg/ml solution for injection is indicated for the short-term relief of moderate to severe pain. It can also be used for pre- and postoperative analgesia.
Posology and method of administration
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 ...
Contraindications
hypersensitivity to the active substance or to any of the excipients severe renal impairment hepatic impairment concomitant treatment with μ-agonistic opioids e.g. morphine and fentanyl (see section 4.5) ...
Special warnings and precautions for use
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium-free. Opioid dependence NALPAIN 10 mg/ml solution for injection may not be used as a substitute for heroin, ...
Interaction with other medicinal products and other forms of interaction
Contra-indicated combinations + Pure morphine agonists (such as morphine, pethidine, dextromoramide, dihydrocodeine, dextropropoxyphene, methadone, levacethylmethadol): Pure μ-agonists reduce analgesic ...
Pregnancy and lactation
Usage during pregnancy 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 ...
Effects on ability to drive and use machines
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 ...
Undesirable effects
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), ...
Overdose
Administration of high doses of nalbuphine hydrochloride (intramuscular or intravenous) produces several symptoms of overdose like respiratory depression, sedation, sleepiness, unconsciousness and light ...
Pharmacodynamic properties
Pharmacotherapeutic group: Opioids, Morphinane derivatives ATC code: N02AF02 Nalbuphine hydrochloride is an opioid with kappa-agonistic and mu-antagonistic properties. Beside the essential agonistic (analgesic) ...
Pharmacokinetic properties
In adults, the effect takes place 2 to 3 minutes after intravenous administration and less than 15 minutes after intramuscular or subcutaneous injection. The duration of action ranges from 3 to 6 hours.The ...
Preclinical safety data
Reproductive toxicity studies with parenterally administered nalbuphine were performed in rats and rabbits. In a pre- and postnatal study in rats, an increase in pre- and postnatal mortality and a decrease ...
List of excipients
Citric acid, anhydrous Sodium citrate Sodium chloride Hydrochloric acid (for pH adjustment) Water for injection
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years. The product has to be used immediately after opening.
Special precautions for storage
Do not store above 25°C. Keep the ampoules in the outer carton in order to protect from light.
Nature and contents of container
Colourless glass, Type I. Ampoules of 2 ml, in packages of 10 ampoules.
Special precautions for disposal
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 ...
Marketing authorization holder
Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, A-3002, Purkersdorf, Austria
Marketing authorization number(s)
PL 30414/0003
Date of first authorization / renewal of the authorization
21/02/2008 / 20/01/2011
Date of revision of the text
20/01/2011
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