Nalpain 10 Mg/Ml Solution For Injection
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
NALPAIN 10 mg/ml solution for injection is a medicinal product that belongs to a group of pain killers (analgesics) with opioid properties.
It is used for short-term treatment of moderate to severe pain. It can also be used before or after an operation.
- if you are allergic (hypersensitive) to nalbuphine hydrochloride or any of the other ingredients of NALPAIN 10 mg/ml solution for injection (see section 6)
- if you have severe renal impairment
- if you have hepatic impairment
- if you use other opioids
- if you suffer from head injury, inner head injury or already existing increased intracranial pressure, NALPAIN 10 mg/ml solution for injection might intensify this. It is also possible that the use of NALPAIN 10 mg/ml solution for injection in patients with head injury can disguise symptoms. if you suffer from a deranged kidney function, the dosage of NALPAIN 10 mg/ml solution for injection must then be reduced.
- if NALPAIN 10 mg/ml solution for injection is administered to the mother during labour and delivery. Newborns should be monitored for respiratory depression and arrhythmias if NALPAIN 10 mg/ml solution for injection has been used.if you suffer from impaired breathing or if you get difficulties with your breathing during the treatment, your doctor may have to monitor you closely.
- if you suffer with heart failure, paralysed gut, gallbladder pains, epilepsy or reduced function of the thyroid.
- Abuse of NALPAIN 10 mg/ml solution for injection can lead to psychical and physical addiction and habituation.
- if you are addicted on heroine, methadone or other opioid substances. NALPAIN 10 mg/ml solution for injection cannot be used as a replacement. In these cases the acute withdrawal symptoms can be considerably intensified.
Ask your doctor, if one of the above mentioned warnings applies to you or has applied to you in the past.
Other medicines can have an influence on the effect of NALPAIN 10 mg/ml solution for injection.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines or natural products.
- Combination with specific narcotics (opioids) is not indicated. The painkilling effect might be reduced.
- Alcohol and medicinal products containing alcohol must be avoided.
- The use of NALPAIN 10 mg/ml solution for injection in combination with other medicines that diminish fear and anxiety (anxiolytics) or the concurrent use of NALPAIN 10 mg/ml solution for injection with narcotic analgesics (pain killers), phenothiazines (medicines used for schizophrenia) or other sedative, sleep enhancing or similar medication that affect the central nervous system can show worsening of the side effects. Your doctor must adapt the dosage of NALPAIN 10 mg/ml solution for injection or the other medicinal product.
There are insufficient data on the possible harmful effects in humans with the use of NALPAIN 10 mg/ml solution for injection in pregnancy. If NALPAIN 10 mg/ml solution for injection is administered to the mother during labour and delivery, newsborns should be monitored for respiratory depression and arrhythmias (see section 4 possible side effects).
NALPAIN 10 mg/ml solution for injection is excreted in the breast-milk. Lactation should be discontinued for 24 hours during treatment with NALPAIN 10 mg/ml solution for injection.
Ask your doctor or nurse for advice before taking any medicine.
NALPAIN 10 mg/ml solution for injection reduces your ability to react quickly. You should therefore avoid driving and using machines while you are treated with NALPAIN 10 mg/ml solution for injection. Other side effects that may occur are listed in section 4.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially 'salt-free'.
NALPAIN 10 mg/ml solution for injection is only used by the physician or nurse.
The common used dose for adults is 10 to 20 mg for persons with 70 kg body weight: intravenous, intramuscular or subcutaneous administration. This dose can be repeated after 3 to 6 hours, if necessary. The dosage must be adapted according to the intensity of the pain and the condition of the patient.
Children and adolescents
The usual dosage for children is 0,1 to 0,2 mg/kg body weight: intravenous, intramuscular or subcutaneous administration. This dose can be repeated after 3 to 6 hours, if necessary. The single maximum dose is defined with 0,2 mg NALPAIN hydrochloride per kilogram body weight.
The duration of treatment is specified by your doctor.
If you notice that the effect of NALPAIN 10 mg/ml solution for injection is too strong or even too weak, please ask your doctor or nurse for advice.
The usage of a high dosage of NALPAIN 10 mg/ml solution for injection can cause symptoms such as respiratory depression, drowsiness or unconsciousness.
As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too much.
If you have any further questions on the use of this product, ask your doctor or nurse.
Like all medicines, NALPAIN 10 mg/ml solution for injection can cause side effects, although not everybody gets them.
The possible side effects are ranked according to their frequency: very common (more than 1 out of 10 persons)
common (more than 1 out of 100 persons and less than 1 out of 10 persons) uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons) rare (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons) very rare (less than 1 out of 10,000 persons)
The following side effects may appear:
Very common: Sedation
Common: Sweating, sleepiness, dizziness, Dry mouth, Headache, Vomiting, sickness, decreased feeling of happiness
Rare: Light numbness in the head, nervousness, shiver, Withdrawal symptoms, disturbed feeling of the skin, Respiratory difficulties
Very rare: illusions, n, personality disorder trait, slow heartbeat, rapid heartbeat, fluid retention in the Lung, increased feeling of happiness, low blood pressure, high blood pressure, Watery eyes, Blurred vision, Allergic reaction, Pain in the puncture, reddened skin, nettle-rash, respiratory depression in newborn children, retarded circulation in newborn children
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use NALPAIN 10 mg/ml solution for injection after the expiry date which is stated on the ampoule and carton.The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the ampoules in the outer carton, in order to protect from light.
The product has to be used immediately after first opening.
This medicinal product is for single use only. Discard any unused solution.
Do not use Nalpain 10 mg/ml if you notice discolouration, cloudiness or particles in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment.
- The active substance is nalbuphine hydrochloride.
1 ml of solution contains 10 mg nalbuphine hydrochloride.
1 ampoule of 2 ml contains 20 mg nalbuphine hydrochloride.
- The other ingredients are citric acid, anhydrous sodium citrate
hydrochloric acid (for pH adjustment) water for injection
One ampoule contains 2 ml of a clear and colourless solution for injection.
NALPAIN 10 mg/ml solution for injection is available in packs with 10 ampoules.
Orpha-Devel Handels und Vertriebs GmbH Wintergasse 85/1B 3002 Purkersdorf Austria
HIKMA Italia S.P.A.
G.L. Pharma GmbH Austria
Amomed Pharma GmbH Austria
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium: PAINAFIN 10 mg/ml oplossing voor injectie Czech Republic: Nalbuphin OrPha 10 mg/ml injekcm roztok
Denmark: NALPAIN 10 mg/ml injektionsopl0sning
Germany: NALPAIN 10 mg/ml Injektionslosung
Estonia: NALPAIN 10 mg/ml sustelahus
Finland: NALPAIN 10 mg/ml injektioneste, liuos
France: NALPAIN 20 mg/2 ml solution injectable
Greece: NALPAIN 10 mg/ml eveaipo SiaAupa
Hungary: NALPAIN 10 mg/ml oldatos injekcio
Ireland: LAPAINOL 10 mg/ml solution for injection
Italy: NALPAIN 10 mg/ml soluzione iniettabile
Latvia: NALPAIN 10 mg/ml injekcinis tirpalas
Lithuania: NALPAIN 10 mg/ml injekcinis tirpalas
Luxemburg: NALPAIN 10 mg/ml solution injectable
Netherlands: Nalbufine HCl OrPha 10 mg/ml oplossing voor injectie
Poland: NALPAIN 10 mg/ml roztwor do iniekcji
Sweden: NALPAIN 10 mg/ml injektionsvatska, losning
Slovenia: NALPAIN 10 mg/ml raztopina za injiciranje
UK: NALPAIN 10 mg/ml solution for injection