EBRANTIL 50 mg /10 Ml Инъекционный Раствор

Содержание инструкции

1. EBRANTIL 50 mg/10 ml injectable solution for intravenous use and for infusion
   1. What is EBRANTIL and what is it used for
   2. What you need to know before you are given EBRANTIL
   3. How EBRANTIL will be administered to you
   4. Possible side effects
   5. How to store EBRANTIL
   6. Contents of the pack and other information

EBRANTIL 50 mg/10 ml injectable solution for intravenous use and for infusion

Urapidil

Read this leaflet carefully before this medicine is administered to you
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What EBRANTIL is and what it is used for
• 2. What you need to know before EBRANTIL is administered to you
• 3. How EBRANTIL will be administered to you
• 4. Possible side effects
• 5. How to store EBRANTIL
• 6. Contents of the pack and other information

1. What is EBRANTIL and what is it used for

EBRANTIL is a medicine to lower blood pressure based on urapidil. It is used in

adultsto treat hypertensive urgencies and emergencies.

2. What you need to know before you are given EBRANTIL

You will not be given EBRANTIL

• if you are allergic to urapidil or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section 2 “Pregnancy, breastfeeding and fertility”);
• if you suffer from a narrowing of the aorta, the largest artery in the body (aortic isthmus stenosis) or have a communication between an artery and a vein (arterio-venous shunt).

Warnings and precautions
Talk to your doctor or nurse before you are given EBRANTIL.
Tell your doctor if you are in any of the following conditions:

• if you have previously been given another medicine to lower blood pressure and sufficient time has not elapsed for the effect to manifest;
• if you have a weakening of heart activity due to functional damage of mechanical origin (e.g. stenosis of the aortic or mitral valve), if you have an obstruction of the pulmonary artery, the vessel that carries blood from the heart to the lungs (pulmonary embolism) or a disease of the sac that surrounds the heart (pericardium);
• if you suffer from a liver disease;
• if you suffer from moderate to severe kidney disease;
• if you are an elderly person;
• if you are taking cimetidine, a medicine to treat stomach injuries (ulcers) (see section 2 “Other medicines and EBRANTIL”);
• if you have suffered a head injury (traumatic brain injury).

Children and adolescents
EBRANTIL should be administered with caution to children and adolescents.

Other medicines and EBRANTIL
Tell your doctor if you are taking, have recently taken or might take any other
medicine, in particular:

• medicines to lower high blood pressure (alpha-adrenergic receptor blockers, vasodilators, other antihypertensive drugs administered simultaneously, ACE inhibitors);
• cimetidine, a medicine to treat ulcers.

EBRANTIL with alcohol
Concomitant use with alcohol may enhance the antihypertensive action of EBRANTIL.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before you are given this medicine.
EBRANTIL should not be administered during pregnancy and in women of childbearing potential who are not using contraceptive methods, as there is insufficient experience in humans.
EBRANTIL should not be administered during breastfeeding.
It is not known whether EBRANTIL affects male or female fertility.

Driving and using machines
EBRANTIL may affect your ability to drive and use machines. This is particularly
true at the beginning of treatment, when changing the product or if you take it in combination with alcohol
(see section 2 “EBRANTIL with alcohol”).

EBRANTIL contains sodium and propylene glycol
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially “sodium-free”.
This medicine contains 1,000 mg of propylene glycol per 10 ml vial equivalent to 100 mg/ml.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise
recommended by your doctor.
Propylene glycol in this medicine may have the same effects as drinking alcohol and may
increase the likelihood of side effects.
Do not use this medicine in children under 5 years of age.
Use this medicine only if recommended by your doctor. The doctor may perform further checks during
therapy.

3. How EBRANTIL will be administered to you

This medicine will be administered to you in a vein (intravenously) under strict medical supervision.
If you have any doubts, consult your doctor.
The dose for controlled blood pressure reduction during and after surgery will be
determined by your doctor.
The treatment will have a maximum duration of 7 days. After this period, your doctor may prescribe
medicines to lower your blood pressure to be taken orally.
Elderly patients
If you are elderly, your doctor will administer lower doses, at least at the beginning of therapy.
Patients with kidney and/or liver diseases
If you suffer from kidney and/or liver diseases, your doctor may administer lower doses.

Use in children and adolescents
Usually EBRANTIL is not administered to children and adolescents. If this is
necessary, the dose for controlled blood pressure reduction during and after surgery will be
determined by your doctor.

If you are given too much EBRANTIL
In case of accidental ingestion/administration of an excessive dose of EBRANTIL, the doctor will adopt the
most appropriate therapy.
If you are administered high doses of EBRANTIL, you may experience:

• dizziness,
• reduction of blood pressure when standing up,
• fainting,
• fatigue and reduced reaction speed.

If you stop treatment with EBRANTIL
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Many of the following side effects are due to a sudden drop in blood pressure, but
according to experience they disappear within a few minutes, even during fast infusion. In relation
to the severity of the side effects, however, a suspension of treatment should also be considered.

Common (may affect up to 1 in 10 people)

• nausea,
• dizziness,
• headache. Uncommon (may affect up to 1 in 100 people)
• feeling of perceiving your heartbeat (palpitations),
• fast heartbeat (tachycardia),
• slow heartbeat (bradycardia),
• a feeling of oppression or pain in the chest (symptoms similar to angina pectoris) and shortness of breath (dyspnea),
• vomiting,
• fatigue, weakness (asthenia),
• irregular heartbeat,
• increased sweating,
• decrease in blood pressure when changing posture, e.g. when getting up (orthostatic dysregulation).

Rare (may affect up to 1 in 1,000 people)

• persistent and painful erection (priapism),
• blocked nose (nasal congestion),
• allergic reactions such as itching, redness of the skin, rash with pustules, blisters and bubbles (exanthema). Very rare (may affect up to 1 in 10,000 people)
• reduction in the number of platelets in the blood,
• agitation,
• sleep disorders,
• increased need to urinate or worsening of the inability to retain urine (urinary incontinence), nocturnal enuresis (loss of urine during sleep). Frequency not known (the frequency cannot be estimated from the available data)
• swelling of the face, mouth, tongue, throat, but also of other mucous membranes (angioedema),
• itchy rash (urticaria).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store EBRANTIL

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 label after Scad.
The expiry date refers to the last day of that month
Do not store at a temperature above 30°C.
Keep the vials in the outer packaging to protect the medicine from light.
Solutions for continuous intravenous infusion should be prepared at the time of use. Any remaining solution
must not be reused.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What EBRANTIL contains

• The active ingredient is urapidil. Each vial contains 50 mg of urapidil.
• The other ingredients are propylene glycol, monobasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, water for injections (see section 2 “EBRANTIL contains sodium and propylene glycol”).

Description of the appearance of EBRANTIL and contents of the pack
EBRANTIL is presented as an injectable solution for intravenous use and for infusion.
It is available in a pack of 5 vials of 10 ml.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer
Takeda Austria GmbH St. Peter Strasse 25 - A-4020 Linz, Austria
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The following information is intended exclusively for doctors or healthcare professionals:

Warnings and precautions
If another antihypertensive drug has already been administered previously, EBRANTIL should not
be used until sufficient time has elapsed to allow the action of the previously administered drug(s) to establish itself. The dosage of EBRANTIL should then
be appropriately reduced.
An excessively rapid decrease in blood pressure can cause bradycardia or cardiac arrest .
For intravenous bolus injection, 10-50 mg of EBRANTIL can be administered. The hypotensive effect usually manifests within 5-10 minutes. The injection of EBRANTIL can be repeated in
relation to the trend of blood pressure, according to the dosage scheme reported in section
“Dosage and administration”.

Preparation of the diluted solution
For continuous intravenous infusion, dilute 200-250 mg of EBRANTIL (4-5 vials of
EBRANTIL 50 mg/10 ml injectable solution) in 500 ml of a compatible infusion solution:
physiological saline solution, 5% or 10% glucose solution, 5% levulose solution, 40% dextran solution with 0.9% sodium chloride. The maximum compatible concentration of EBRANTIL per
ml is 4 mg.
The infusion rate of the initial dose should not exceed 2 mg/min. The maintenance dose (average 9 mg/h) and the duration of the infusion (no more than 7 days) should be appropriately adjusted to the pressor response.
The extent of the reduction in blood pressure is determined by the dose infused in the first 15 minutes.
Subsequently, stabilization of blood pressure can be achieved with considerably lower doses.
The infusion solution to maintain the blood pressure level obtained with bolus injection
is prepared as follows: in 500 ml of a compatible infusion solution, for example physiological
saline solution, 5% or 10% glucose solution, 5% levulose solution, 40% dextran solution with
0.9% sodium chloride, generally 100-200 mg of EBRANTIL (2-4 vials of
EBRANTIL 50 mg/10 ml injectable solution) are diluted.
The maximum compatible concentration is 4 mg of EBRANTIL per ml of infusion solution.
When using a perfuser to administer the maintenance dose, 20 ml of EBRANTIL equal to
100 mg of active ingredient are placed in a perfuser syringe and diluted to a volume of 50 ml
with a compatible infusion solution (see above).
The EBRANTIL injectable solution must not be mixed with other injectable products or alkaline infusion solutions, as turbidity or flocculation may occur due to the
acidic properties of the solution itself.

Dosage and administration
The recommended dose for controlled reduction of blood pressure in hypertensive patients during
and after surgical interventions is:

A)AdministrationB)Stabilization of blood
pressurebycontinuous
infusion
Intravenous injection of 25 mg of EBRANTIL
= 5 ml of injectable solution

in bolus
blood pressure reduction
after 2 minutes
after
2 minutes
no change in
blood pressure
Initially up
to 6 mg in 1-2
minutes, then
reduce the
dose based on
pressor response
Intravenous injection of 25 mg of EBRANTIL
= 5 ml of injectable solution
blood pressure reduction
after 2 minutes
after
2 minutes
no change in
blood pressure
Slow intravenous injection of 50 mg of
EBRANTIL
= 10 ml of injectable solution
blood pressure reduction
after 2 minutes
Treatment duration: not more than 7 days.
The EBRANTIL injectable solution can be administered intravenously in bolus or
by continuous infusion to a supine patient.
Unless otherwise prescribed by a doctor, both single or repeated bolus administrations and continuous intravenous infusion are possible in the proposed indications. It is possible to switch from acute parenteral therapy to maintenance therapy with oral antihypertensives.
Elderly
In elderly patients, antihypertensive drugs should be used with caution and initially at lower doses, because sensitivity to these types of preparations is often altered in these patients.
Patients with renal and/or hepatic impairment
In patients with reduced renal and/or hepatic function, it may be necessary to reduce the dosage.

Overdosage
Treatment
Excessive blood pressure drop can be relieved by raising the legs with the patient maintained in
a supine position or by restoring blood volume. If these measures are inadequate, a
vasoconstrictor drug should be administered slowly intravenously, monitoring blood pressure.
In very rare cases, intravenous administration of catecholamines (e.g. adrenaline 0.5 – 1.0 mg
diluted to 10 ml with isotonic saline solution) is necessary.