1 mg / ml concentrate for solution for infusion
Noradrenaline (as noradrenaline tartrate)
What Noradrenaline Pfizer is and what it is used for
Noradrenaline Pfizer is used in emergencies in healthcare to raise blood pressure to normal levels.
Noradrenaline contained in Noradrenaline Pfizer may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you are given Noradrenaline Pfizer
Do not use Noradrenaline Pfizer
- if you are allergic to norepinephrine or any of the other ingredients of this medicine (listed in section 6).
If the above applies to you, talk to a doctor before using this medicine.
Warnings and cautions
Talk to your doctor or pharmacist before using Noradrenaline Pfizer if you have:
- diabetes
- high blood pressure
- hyperthyroidism
- low levels of oxygen in the blood
- high levels of carbon dioxide in the blood
- blood clots or narrowing of the blood vessels that supply the heart, intestines or other parts of the body
- low blood pressure after a heart attack
- a type of angina (chest pain) called Prinzmetal’s angina
- is older
Other drugs and Noradrenaline Pfizer
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Several drugs are known to increase the toxic effect of norepinephrine. These are:
- MAO inhibitors (antidepressants)
- Tricyclic antidepressants
- Linezolid ( antibiotics )
- Anesthetics (especially anesthetic gases)
- Adrenergic-serotonergic drugs e.g. used in the treatment of asthma and heart disease.
- Guanetidine
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Noradrenaline Pfizer can harm your unborn baby. Your doctor will decide if you should be treated with Noradrenaline Pfizer.
Noradrenaline Pfizer contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per ampoule , ie essentially ‘sodium-free’. 2 ml ampoule one contains 6.7 mg sodium and 4 ml ampoule one contains 13.3 mg sodium . This medicine can be diluted with sodium-containing solutions. Take this into account if you have been prescribed a low-salt diet.
How to use Noradrenaline Pfizer
Noradrenaline Pfizer will be given in a hospital by a doctor or nurse. It is diluted first and then given via a vein.
The recommended dose of Noradrenaline Pfizer will depend on your medical condition. The usual dose is between 0.4 and 0.8 mg per hour. Your doctor will determine the right dose for you. After the first dose, your doctor will evaluate your response to the treatment and adjust the continued dose accordingly.
If you use more than one or have forgotten to use Noradrenaline Pfizer
It is unlikely that you will receive too much or too little of this medicine as it is only given in the hospital. But talk to your doctor or nurse if you have any thoughts.
Symptoms of overdose include severe high blood pressure, slow heart rate, severe headache, difficulty breathing due to fluid in the lungs, photosensitivity, chest pain, paleness, intense sweating, and vomiting.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience the following:
- Sudden itchy rash ( redness ), swollen hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), a feeling of fainting.
- Pain and / or swelling at the injection site
Tell your doctor as soon as possible if you experience the following:
- Slow heartbeat
- Abnormal heart rhythm
- Difficulty breathing
- Anxiety
- Headache
- Cold arms or legs
- Pain in arms or legs
Your doctor will monitor your blood pressure and blood volume.
How to store Noradrenaline Pfizer
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
From a microbiological point of view, the product should be used immediately after dilution.
Do not use this medicine if the solution is brown.
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.
Contents of the pack and other information
Content declaration
- The active substance is noradrenaline (as noradrenaline tartrate).
1 ml concentrate for solution for infusion contains 2 mg noradrenaline tartrate corresponding to 1 mg noradrenaline.
1 ampoule of 2 ml contains 4 mg noradrenaline tartrate corresponding to 2 mg noradrenaline.
1 ampoule of 4 ml contains 8 mg noradrenaline tartrate corresponding to 4 mg noradrenaline.
Other ingredients are:
- sodium chloride (see section 2 “Noradenaline Pfizer contains sodium”)
- hydrochloric acid (for pH adjustment)
- sodium hydroxide (for pH adjustment) (see section 2 “Noradenaline Pfizer contains sodium”)
- water for injections
What the medicine looks like and contents of the pack
This medicine is a concentrated solution for infusion. The solution is a clear colorless or yellowish solution.
Noradrenaline Pfizer may be available in packs of 5×2 ml ampoules or 5×4 ml ampoules.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Pfizer AB
191 90 Sollentuna
Phone: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Avara Liscate Pharmaceutical Services SpA
Via Fosse Ardeatine 2
20060 Liscate – Milano
Italy