40 IU / 2 mL concentrate for solution for infusion solution 
argipressin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Empressin is and what it is used for 
2. What you need to know before you use Empressin 
3. How to use Empressin 
4. Possible side effects 
5. How to store Empressin 
6. Contents of the packaging and other information 

1. What Empressin is and what it is used for

Empressin contains argipressin which is a synthetic substance that corresponds to the natural hormone et vasopressin. It regulates the body’s fluid balance and reduces urine excretion. Empressin 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 Empressin

  • if you are hypersensitive to argipressin or any of the other ingredients of Empressin (listed in section 6).

Warnings and cautions

Special precautions must be taken when using Empressin

  • if used to raise blood pressure in case of shock after using other blood pressure raising methods. Administration one must be performed under careful control of 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 the amount of fluid in the body poses a risk.
  • if you suffer from chronic nephritis (kidney inflammation).

Children and young people

The use of Empressin in children and newborns is not normally recommended.

Other medicines and Empressin

Empressin should be used with caution in combination with carbamazepine, chloropropamide, clofibrate, urea, fludrocortisone, or tricyclic antidepressants as these agents may potentiate the effect of Empressin. Empressin should be given with caution along with demeclocycline, norepinephrine lithium, heparin, or alcohol, as its effects may be reduced by these substances. Concomitant use of Empressin and blood pressure medication may increase or decrease the increase in blood 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

Empressin can cause uterine contractions and increased pressure in the uterus during pregnancy and may reduce blood flow in the uterus. Empressin should not be used during pregnancy unless clearly necessary.

It is not known whether Empressin 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 breast-feeding.

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, ie essentially ‘sodium-free’.

3. How to use Empressin

The empressin will be given to you by a doctor.

Empressin 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 is given as a long-term infusion 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, the use of 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. If you think you have been given too high a dose of this medicine, talk to your doctor immediately.

If you stop using Empressin

Discontinuation of this drug must be gradual, which means that 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.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Empressin can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people):

  • abnormal heartbeat
  • pressure over the chest
  • circulatory disorders in the heart muscle, in 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 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, strong dilution of the salinity in the body that can be life-threatening, diabetes insipidus a condition that, among other things, leads to large amounts of urine and constant thirst after treatment interruption.

5. How to store Empressin

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ° C – 8 ° C).

Do not use this medicine after the expiry date which is 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 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, water for injections.

What the medicine looks like and the contents of the pack

Empressin is a clear and colorless concentrate for 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 for the preparation of 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 concentrated 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

Muhammad Nadeem

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