Empressin 40 IU / 2 mL concentrate for solution for argipressin infusion solution.
1. What Empressin Is And What Is Empressin Used For
This medicine contains argipressin, a synthetic substance corresponding to the natural hormone et vasopressin. It regulates the body’s fluid balance and reduces urine excretion. This medicine is used in cases of septic shock when other methods of achieving the desired blood pressure, according to the attending physician, have not worked.
2. What You Need To Know Before Using Empressin
Do Not Use
- If you are hypersensitive to argipressin or any of the other ingredients of this (listed in section 6).
Warnings And Cautions
Special precautions must be taken when using it
- To raise blood pressure in case of shock after using other blood pressure-raising methods. The administration must carefully control vital parameters, e.g., heart rate and blood pressure.
- If you have cardiovascular disease.
- If you have
- Epilepsy
- Migraine
- Asthma
- Heart failure, or disease where a rapid increase in fluid in the body poses a risk.
- If you suffer from chronic nephritis (kidney inflammation).
Children And Young People
The use of this medicine in children and newborns is not normally recommended.
Other Medicines And Empressin
It should be used with caution in combination with
- Carbamazepine
- Chloropropamide
- Clofibrate, urea
- Fludrocortisone
- Tricyclic antidepressants, as these agents, may potentiate the effect of it. This medicine should be given with caution along with demeclocycline, norepinephrine lithium, heparin, or alcohol, as these substances may reduce their effects. Concomitant use of this medicine and blood pressure medication may increase or decrease the pressure induced by Empressin.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Empress With Food And Drink
Empress must not be used in combination with alcohol.
Pregnancy and breastfeeding
This medicine can cause uterine contractions and increased pressure in the uterus during pregnancy and may reduce blood flow in the uterus. This medicine should not be used during pregnancy unless necessary.
It is not known whether this medicine is excreted in human milk.
The use of Empressin during pregnancy and lactation is not recommended. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
Driving And Using Machines
No studies on the effects on the ability to drive and use machines have been performed.
Important Information About Some Of The Ingredients Of Empressin
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially ‘sodium-free.’
3. How To Use Empressin
- This will be given to you by a doctor.
- Empressin dosage should only be used as an adjunct to other treatments. Initially, 0.01 IU per minute is given as an infusion. This dose can be increased every 15-20 minutes by up to 0.03 IU per minute. Higher doses should only be used in an emergency.
- Empressin infusion is long-term and must be diluted with physiological saline.
Use For Children And Adolescents
Empressin has been used to treat certain shock conditions in infants, toddlers, and children in intensive care and during surgery. However, using Empressin in children and newborns is generally not recommended.
If You Use More Empressin Than You Should
This medicine will be given to you by a doctor. Talk to your doctor immediately if you think you have been given too high a dose of this medicine.
If you stop using Empressin
Discontinuation of this drug must be gradual, meaning treatment should not be stopped abruptly. If you think that the use of the medicine has been stopped too soon, talk to your doctor immediately.
Ask your doctor or nurse if you have further questions about using this product.
4. Possible Side Effects Of Empressin
This medicine can cause side effects like all medicines, although not everybody gets them.
Common side effects of empressin (may affect up to 1 in 10 people):
- Abnormal heartbeat
- Pressure over the chest
- Circulatory disorders in the heart muscle, the intestines, or fingertips
- Peripheral narrowing of blood vessels
- Necrosis
- Stomach cramps
- Pallor around the mouth
- Tissue death in the skin
Uncommon (may affect up to 1 in 100 people):
- Low levels of sodium in the blood
- Shaking
- Dizziness
- Headache
- Decreased circulating blood volume
- Life-threatening change in heart rhythm
- Cardiac arrest
- Respiratory distress caused by the narrowing of the airways
- Nausea
- Vomiting
- Gas in the stomach
- Tissue death in the intestine
- Sweating
- Rash
- Changes in certain laboratory values in the blood
Rare (may affect up to 1 in 1,000 people)
- Severe and life-threatening allergic reaction
Has been reported (occurs in an unknown number of people):
- Water poisoning
- A strong dilution of the salinity in the body can be life-threatening
- Diabetes insipidus is a condition that, among other things
- This leads to large amounts of urine and constant thirst after treatment interruption.
5. How To Store Empressin
- Keep this medicine out of sight and reach of children.
- Store in a refrigerator (2 ° C – 8 ° C).
- Do not use this medicine after the expiry date stated on the label and carton. The expiration date is the last day of the specified month.
- After opening, the drug should be diluted and used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. Contents Of The Packaging And Other Information
Content Declaration
- The active substance is argipressin.
- 1 ampoule with 2 ml concentrate for solution for infusion contains argipressin acetate equivalent to 40 IU argipressin (equivalent to 133 micrograms).
- The other ingredients are sodium chloride, concentrated acetic acid to adjust the pH, and water for injections.
What The Medicine Looks Like And The Contents Of The Pack
- Empressin is a clear and colourless concentrate solution for infusion.
- Each pack contains 5 or 10 ampoules.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85 / 1B
3002 Purkersdorf
Austria
Manufacturer
Amomed Pharma GmbH
Storchengasse 1
1150 Vienna
Austria
This medicinal product is authorized under the European Economic Area under the following names:
| Austria | Empesin 40 IU / 2 ml concentrate for the preparation of an infusion solution |
| Belgium | Reverage 40 IU / 2 ml concentrate for solution for infusion |
| Bulgaria | Емпресин 40 IU / 2ml Концентрат за инфузионен разтвор Empressin 40 IU / 2ml concentrate for infusion solution |
| Czech Republic | Embesin |
| Germany | Empress 40 IU / 2 ml concentrate on preparing an infusion solution. |
| Denmark | Empress |
| Estonia | Empesin |
| Greece | Empressin 40 IU / 2 ml Dilated glass with a double-edged glass |
| Spain | Empressin 40 IU / 2 ml concentrate for solution for perfusion |
| Finland | Empressin 40 IU / 2 ml infusion concentrate, liuosta varten |
| France | Reverpleg 40 UI / 2ml solution for dilution for perfusion |
| Hungary | Embesyn 40 NE / 2ml concentrate for infusion solution |
| Croatia | Empressin 40 IU / 2 ml concentrate for otopinu for infusion |
| Ireland | Embesin |
| Italy | Empressin 40 IU / 2 ml concentrate per solution for infusion |
| Lithuania | Empesin |
| Luxembourg | Empressin 40 IU / 2 ml dilution solution for perfusion |
| Latvia | Empesin 40 SV / 2 ml concentrated infusion solution |
| Netherlands | Empressin 40 IU / 2ml, concentrate for solution for infusion |
| Norway | Empress |
| Poland | Empesin |
| Portugal | Empressin 40 UI / 2ml concentrated for perfusion solution |
| Romania | Reverpleg |
| Slovenia | Empesin 40 IU / 2 ml concentrate for raztopino for infusion |
| Slovakia | Embesin 40 IU / 2 ml infusion concentrate |