PACKAGE LEAFLET: INFORMATION FOR THE USER
Nalbuphine Hydrochloride for injection 10mg/ml
Nalbuphine Hydrochloride for injection 20mg/ml
Read all of this leaflet carefully before you start using this medicine.
- 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.
In this leaflet:
- What Nalbuphine Hydrochloride 10 mg/ml solution for injection is and what it is used for
- Before you use Nalbuphine Hydrochloride 10 mg/ml solution for injection
- How to use Nalbuphine Hydrochloride 10 mg/ml solution for injection
- Possible side effects
- How to store Nalbuphine Hydrochloride 10 mg/ml solution for injection
- further information
- WHAT Nalbuphine Hydrochloride 10 MG/ML SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Nalbuphine Hydrochloride 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.
2. BEFORE YOU USE Nalbuphine Hydrochloride 10 MG/ML SOLUTION FOR INJECTION
Do not use Nalbuphine Hydrochloride 10 mg/ml solution for injection
- if you are allergic (hypersensitive) to nalbuphine hydrochloride or any of the other ingredients of Nalbuphine Hydrochloride 10 mg/ml solution for injection (see section6)
- if you have severe renal impairment
- if you have hepatic impairment
- if you use other opioids
Take special care with Nalbuphine Hydrochloride 10 mg/ml solution for injection
- if you suffer from a head injury, inner head injury or already existing increased intracranial pressure, Nalbuphine Hydrochloride 10 mg/ml solution for injection might intensify this. It is also possible that the use of Nalbuphine Hydrochloride 10 mg/ml solution for injection in patients with a head injury can disguise symptoms. if you suffer from a deranged kidney function, the dosage of Nalbuphine Hydrochloride 10 mg/ml solution for injection must then be reduced.
- if Nalbuphine Hydrochloride 10 mg/ml solution for injection is administered to the mother during labor and delivery. Newborns should be monitored for respiratory depression and arrhythmias if Nalbuphine Hydrochloride 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 from heart failure, paralyzed gut, gallbladder pains, epilepsy or reduced function of the thyroid.
- Abuse of Nalbuphine Hydrochloride 10 mg/ml solution for injection can lead to psychical and physical addiction and habituation.
- if you are addicted to heroin, methadone or other opioid substances. Nalbuphine Hydrochloride 10 mg/ml solution for injection cannot be used as a replacement. In these cases, 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.
Using other medicines
Other medicines can have an influence on the effect of Nalbuphine Hydrochloride 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.
- A combination of specific narcotics (opioids) is not indicated. The painkilling effect might be reduced.
- Alcohol and medicinal products containing alcohol must be avoided.
- The use of Nalbuphine Hydrochloride 10 mg/ml solution for injection in combination with other medicines that diminish fear and anxiety (anxiolytics) or the concurrent use of Nalbuphine Hydrochloride 10 mg/ml solution for injection with narcotic analgesics (pain killers), phenothiazines (medicines used for schizophrenia) or another 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 Nalbuphine Hydrochloride 10 mg/ml solution for injection or the other medicinal product.
Pregnancy and breast-feeding
There are insufficient data on the possible harmful effects in humans with the use of Nalbuphine Hydrochloride 10 mg/ml solution for injection in pregnancy. If Nalbuphine Hydrochloride 10 mg/ml solution for injection is administered to the mother during labor and delivery, newborns should be monitored for respiratory depression and arrhythmias (see section 4 possible side effects).
Nalbuphine Hydrochloride 10 mg/ml solution for injection is excreted in the breast-milk. Lactation should be discontinued for 24 hours during treatment with Nalbuphine Hydrochloride 10 mg/ml solution for injection.
Ask your doctor or nurse for advice before taking any medicine.
Driving and using machines
Nalbuphine Hydrochloride 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 Nalbuphine Hydrochloride 10 mg/ml solution for injection. Other side effects that may occur are listed in section4.
Important information about some of the ingredients of Nalbuphine Hydrochloride 10 mg/ml solution for injection
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially `salt-free?.
3. HOW TO USE Nalbuphine Hydrochloride 10 MG/ML SOLUTION FOR INJECTION
Nalbuphine Hydrochloride 10 mg/ml solution for injection is only used by the physician or nurse.
Posology
Adults
The commonly 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 Nalbuphine Hydrochloridehydrochloride per kilogram body weight.
Duration of treatment
The duration of treatment is specified by your doctor.
If you notice that the effect of Nalbuphine Hydrochloride 10 mg/ml solution for injection is too strong or even too weak, please ask your doctor or nurse for advice.
If you get more Nalbuphine Hydrochloride 10 mg/ml solution for injection than you should
The usage of a high dosage of Nalbuphine Hydrochloride 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nalbuphine Hydrochloride 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, a disturbing 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.
5. HOW TO STORE Nalbuphine Hydrochloride 10 MG/ML SOLUTION FOR INJECTION
Keep out of the reach and sight of children.
Do not use Nalbuphine Hydrochloride 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 the first opening.
This medicinal product is for single use only. Discard any unused solution.
Do not use Nalpain 10 mg/ml if you notice discoloration, cloudiness or particles in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Nalbuphine Hydrochloride 10 mg/ml solution for injection contains
- 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
sodium chloride
hydrochloric acid (for pH adjustment) water for injection
What Nalbuphine Hydrochloride 10 mg/ml solution for injection looks like and contents of the pack
One ampoule contains 2 ml of a clear and colorless solution for injection. Nalbuphine Hydrochloride 10 mg/ml solution for injection is available in packs with 10 ampoules.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222825)