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Remestyp 0.2 mg. 2 ml. 5 ampules

€19

REMESTYP solution for injection contains the active substance terlipressin.

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WHAT A REMESTIP IS AND WHAT IT IS USED FOR

REMESTIP solution for injection contains the active substance terlipressin.

When injected into the bloodstream, the active substance, terlipressin, is broken down and released a substance called lysine-vasopressin. It affects the walls of blood vessels and causes them to constrict, thus reducing blood flow to the affected veins and thus reducing bleeding.

This product is used in the treatment of:

Bleeding from the gastrointestinal and urogenital system - such as bleeding from esophageal varices, gastric and duodenal ulcers, functional and similar types of uterine bleeding, childbirth, abortion and others.

Bleeding as a result of surgery, especially in the abdomen and pelvis.

Topical application in gynecological operations, such as cervical.

2. BEFORE YOU USE REMESTIP

Do not use REMESTIP

if you are allergic (hypersensitive) to terlipressin acetate or any of the other ingredients of REMESTIP;

if you are pregnant;

Take special care with REMESTIP

if you have high blood pressure;

if you have heart disease;

in children and elderly patients, as experience in these groups is limited;

if you have septic shock. Septic shock is a serious condition that occurs when severe inflammation leads to low blood pressure and poor circulation.

Tell your doctor if any of the above apply to you.

Your blood pressure, heart rate and fluid balance should be monitored constantly during treatment with REMESTIP.

Use of other drugs

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is important that you tell your doctor if you are taking any medicine for the heart (eg, propofol or beta-blockers), as their effect may be increased if they are used at the same time as REMESTIP.

Pregnancy and lactation

REMESTIP should not be used during pregnancy.

REMESTIP should not be used during breast-feeding, as it is not known whether REMESTIP is excreted in human milk.

Ask your doctor for advice before taking any medicine.

Driving and using machines

Not applicable.

3. HOW TO USE REMESTIP

REMESTIP is a medicine that is mainly used in hospitals and should only be used by qualified personnel.

The usual starting dose of REMESTIP for sudden bleeding from esophageal varices is 2 mg. Subsequent doses are usually 1-2 mg every 4 hours until the bleeding is controlled for 24 hours. The treatment should last for a maximum of 48 hours. After the initial dose, your dose may be adjusted according to your body weight or if you have side effects.

Bleeding from esophageal varices: The usual starting dose of REMESTIP for sudden bleeding from esophageal varices is 2 mg. Subsequent doses are usually 1-2 mg every 4 hours, while bleeding is monitored for 24 hours. The treatment should last for a maximum of 48 hours. After the initial dose, your dose may be adjusted depending on your body weight or if you have side effects.

Other types of gastrointestinal bleeding: 1.0 mg (1000 μg) every 4-6 hours. The product can be used as a first aid in cases of clinically suspected upper gastrointestinal bleeding.

Bleeding from the splanchnic area in children: the usual dose varies from 8 to 20 μg / kg body weight, distributed at intervals of 4 to 8 hours. The administration should be continued throughout the bleeding period, and it is generally recommended that it be continued as in the case of adult bleeding. For sclerosed esophageal varices, a single dose of 20 μg / kg body weight given as a bolus injection is given.

Genitourinary bleeding: the dosage range is too wide and this is due to the different activity of plasma and tissue endopeptidases. Therefore, the dosage will vary from 0.2 to 1.0 mg (200 - 1000 μg) every 4-6 hours. Doses of 5 to 20 μg / kg body weight are recommended for juvenile metrorrhagia.

The application should be intravenous.

Topical application in gynecological operations: Add saline to a dose of 0.4 mg (400 μg) to obtain a volume of 10 ml and administer intracervically or paracervically. The effect of this method of administration of the drug can be established after approximately 5-10 minutes. If necessary, the dose should be increased or repeated.

4. POSSIBLE SIDE EFFECTS

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

Commonly reported side effects (affecting between 1 and 10 in every 100 patients treated):

headache;

bradycardia (very slow heart rate);

increased blood pressure;

peripheral constriction of blood vessels (insufficient blood circulation to the tissues), which

respiratory distress and respiratory failure (difficulty breathing);

transient nausea;

transient vomiting;

skin necrosis (tissue damage) at the injection site.

Rarely reported side effects (affects between 1 and 10 in every 10,000 patients treated):

Dyspnoea (difficulty breathing)

Not known (cannot be determined from the available data)

Heart failure. Symptoms include shortness of breath, fatigue and swollen ankles.

Torsade depoinles (acute cardiac event)

Skin necrosis (tissue damage)

Uterine contractions (uterine contractions) Decreased blood supply to the uterus

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 other healthcare professional.

5. HOW TO STORE REMESTIP

Keep out of reach of children.

Store in a refrigerator (2 ° C - 8 ° C). Keep the ampoules in the outer carton in order to protect from light. Do not freeze.

The product can be stored below 25 ° C for a period of one month (eg in an outpatient setting).

Do not use REMESGIP after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

6. ADDITIONAL INFORMATION

What REMESTIP contains

The active substance is terlipressin. 1 ml of solution for injection contains 0.1 mg terlipressin.

The other ingredients are: sodium chloride, acetic acid, sodium acetate, water for injections.

What REMESTIP looks like and contents of the pack

The product is a clear, colorless solution for injection.

REMESTIP is available in the following packages:

Remestip 0.1 mg / ml - 2 ml x 5 ampoules; 10 ml x 5 ampoules

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