1 mg injection solution
terlipressin acetate
1. What Glypressin is and what it is used for
Glypressin solution for injection contains the active substance terlipressin acetate.
Glypressin is used to treat bleeding esophageal varices.
Esophageal varices are dilated blood vessels that occur in the esophagus (esophagus) as a complication of liver disease. They can rupture and bleed, which is a serious and life-threatening condition.
When the active ingredient, terlipressin, is injected into the bloodstream, it is broken down and releases a substance called lysine vasopressin. This acts on the walls of the blood vessels and causes them to constrict, thereby impeding blood flow to the affected veins so that bleeding is reduced.
2. What you need to know before you use Glypressin
Do not use Glypressin
- if you are allergic (hypersensitive) to terlipressin acetate or any of the other ingredients of Glypressin (listed in section 6).
- if you are pregnant
Warnings and cautions
- if you have high blood pressure
- if you suffer from heart disease
- in the treatment of children and elderly patients as experience is limited in these age groups
- if you have septic shock ; septic shock is a serious condition that occurs when a severe infection leads to low blood pressure and low blood flow
Talk to your doctor before using Glypressin if any of these apply to you.
During treatment with Glypressin, blood pressure, heart rate, and fluid balance should be monitored continuously.
Other drugs and Glypressin
Tell your doctor or another healthcare professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is very important that you tell your doctor if you are taking any type of heart medicine (such as propofol or beta-blockers ) as these may increase if they are taken at the same time as Glypressin.
Pregnancy and breastfeeding
Glypressin should not be used during pregnancy.
Glypressin should not be used during breastfeeding as it is unknown whether Glypressin passes into breast milk.
Consult a doctor or healthcare professional before taking any medicine.
Driving and using machines
Not relevant. Glypressin is only used in hospitals.
Glypressin contains sodium
This medicine contains 1.33 mmol (30.7 mg) sodium per ampoule . Tell your doctor if you are on a low-salt diet.
3. How to use Glypressin
Glypressin is a medicine used in hospitals, and should only be given by qualified personnel.
The solution is injected intravenously (directly into the bloodstream).
The usual starting dose of Glypressin for sudden bleeding from esophageal varices is 2 mg. The additional dose is usually 1-2 mg every four hours until the bleeding has been under control for 24 hours. Treatment should not last more than 48 hours.
After starting dose can be dose-adjusted relative to body weight or any side effects.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (affects 1 to 10 users in 100):
- Headache
- Bradycardia (very low heart rate)
- Contraction of blood vessels (insufficient blood flow to tissue ) leading to pallor
- High blood pressure
- Transient abdominal pain
- Transient diarrhea
Uncommon (affects 1-10 users in 1000):
- Low sodium in blood if fluid is not monitored
- Uneven heart rate
- Increased heart rate
- Chest pain
- Myocardial infarction (heart attack)
- Pulmonary edema
- Torsade de pointes ( cardiac arrhythmia )
- Heart failure , symptoms are shortness of breath, fatigue and swollen ankles
- Insufficient blood flow to the intestines
- Peripheral cyanosis (bluish skin color due to low oxygen content in the blood)
- Hot flashes
- Shortness of breath and insufficiency (difficulty breathing)
- Transient nausea
- Transient vomiting
- Skin necrosis (tissue damage)
- Uterine contractions
- Reduced blood flow through the uterus
Rare (affects 1-10 of 10,000 users)
– Dyspnoea (difficulty breathing)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.
5. How to store Glypressin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C-8 ° C). Store the ampoules in their original packaging. Sensitive to light.
6. Contents of the packaging and other information
Content declaration
One ampoule of 8.5 ml contains 1 mg terlipressin acetate, equivalent to 0.85 mg terlipressin as an active substance.
1 ml solution contains 0.12 mg terlipressin acetate as an active substance.
The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate, water for injections.
What the medicine looks like and contents of the pack
The product is a clear colorless solution for injection.
Glypressin is supplied in a pack size:
5 ampoules are 8.5 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Ferring Läkemedel AB
Box 4041
203 11 Malmö
Manufacturer:
Ferring-Léčiva as
K Rybníku 475
252 42 Jesenice near Prague
Czech Republic
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany