URAPIDIL 25 mg Инъекционный Или Инфузионный Раствор

Содержание инструкции

1. Urapidil Kalceks 25 mg injectable solution/for infusion, 50 mg injectable solution/for infusion
   1. What is Urapidil Kalceks and what is it used for
   2. What you need to know before you receive Urapidil Kalceks
   3. How Urapidil Kalceks is administered
   4. Possible side effects
   5. How to store Urapidil Kalceks
   6. Contents of the pack and other information

Urapidil Kalceks 25 mg injectable solution/for infusion, 50 mg injectable solution/for infusion

Urapidil

Generic medicine

Read this leaflet carefully before using this medicine as 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 you experience any side effects, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What is Urapidil Kalceks and what is it used for

Urapidil Kalceks contains the active ingredient urapidil, a medicine that lowers blood
pressure (antihypertensive agent) belonging to a group of medicines called “alpha-blockers”.
This medicine exerts its action on blood vessels (i.e. arteries and veins). It reduces
blood pressure by relaxing the wall of blood vessels.
This medicine is used in adults:

• in case of emergency related to high blood pressure (e.g. sudden intense increase in blood pressure, called “hypertensive crisis”);
• for the treatment of severe to extremely severe forms of high blood pressure or of high blood pressure resistant to therapy;
• to reduce high blood pressure during and/or after a surgical intervention.

2. What you need to know before you receive Urapidil Kalceks

You must not receive Urapidil Kalceks

• if you are allergic to urapidil or any of the other ingredients of this medicine (listed in section 6);
• if you have a narrowing of the main artery (aortic stenosis) or an abnormality of the blood vessels called a “cardiac shunt” (except for cardiac shunt in people undergoing dialysis);
• if you are breastfeeding.

Warnings and precautions
If the blood pressure drops too quickly, a reduction in heart rate or cardiac arrest may occur.
Consult your doctor or nurse before receiving this medicine if you fall into any of the following cases, because special caution is required:

• if you have had diarrhea or vomiting (or any other cause of fluid loss in the body);
• patients with heart failure caused by mechanical obstruction, e.g. a narrowing of the heart valve (aortic or mitral stenosis);
• patients with a blockage of an artery in the lungs (pulmonary embolism);
• patients with impaired heart function caused by inflammation of the tissue sac surrounding the heart (pericardial disease);
• patients with liver disorders;
• patients with moderate to severe kidney disorders;
• elderly patients;
• patients who are taking cimetidine (a medicine to reduce stomach acid) at the same time. If you are not sure if you fall into any of the above cases, consult your doctor or nurse. If you are to undergo cataract surgery (clouding of the lens), inform the ophthalmologist before the operation that you are using or have previously used urapidil. This is because urapidil can cause complications during surgery, which can be managed if the specialist is prepared in advance.

If another medicine for lowering blood pressure has been administered to you before urapidil, the doctor will wait a sufficient time for the previous medicine to take effect. The doctor will reduce the dose of urapidil. A too rapid drop in blood pressure can cause a reduction in heart rate or cardiac arrest.

Children and adolescents
This medicine should not be used in children and adolescents.

Other medicines and Urapidil Kalceks
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Tell your doctor or nurse before receiving this medicine if you are taking any of the following medicines, because they may interact with Urapidil Kalceks by altering the effects of the medicines or making side effects more likely:

• alpha-blockers (medicines used to treat urinary disorders associated with prostate disease);
• any medicine for lowering blood pressure;
• cimetidine (used to inhibit acid production in the stomach);
• barbiturates (medicines used to treat epilepsy).

Urapidil Kalceks with alcohol
Alcohol may increase the effect of this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before receiving this medicine.
Adequate data are not available to assess the safety of urapidil in pregnant women. This medicine should not be used during pregnancy unless the woman's clinical condition makes it necessary. If high blood pressure develops during pregnancy that requires treatment with this medicine, the reduction in blood pressure must be gradual and always under medical supervision.
It is not known whether this medicine is excreted in human breast milk. For safety reasons, this medicine should not be used during breastfeeding.
This medicine is not recommended in women of childbearing potential who are not using contraceptive measures.
Studies in animals have shown that urapidil has an effect on fertility. However, the importance of this effect in humans is unknown.

Driving and operating machinery
This medicine can affect your ability to drive vehicles or operate machinery, especially at the beginning of treatment, if the dose is increased or the therapy is changed, or in association with alcohol.

Urapidil Kalceks contains propylene glycol (E1520) and sodium

Propylene glycol:

• This medicine contains 500 mg of propylene glycol per 5 ml of solution and 1,000 mg of propylene glycol per 10 ml of solution, equivalent to 100 mg/ml.
• If you are pregnant or breastfeeding, you should not receive this medicine unless recommended by your doctor. The doctor may perform further checks during treatment with this medicine.
• If you suffer from liver or kidney disease, you should not receive this medicine unless recommended by your doctor. The doctor may perform further checks during treatment with this medicine.
• Propylene glycol in this medicine can have the same effects as drinking alcohol and can increase the likelihood of side effects. Sodium:
• This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘sodium-free’.

3. How Urapidil Kalceks is administered

How this medicine is administered

• This medicine will be administered by a healthcare professional.
• This medicine will be administered as an injection or infusion into a vein. It can be administered as a single injection or repeated injections, or as continuous infusions. Injections may be combined (continued) with continuous infusions.
• During the administration of this medicine, you must be in a supine position.
• During treatment, blood pressure will be monitored constantly.

Dose
The doctor will decide the appropriate dose based on your condition.
Hypertensive crisis and severe to extremely severe forms of high blood pressure or blood pressure resistant to therapy

By intravenous injection
As an injection, 10-50 mg of urapidil is administered slowly, with continuous blood pressure monitoring. An effect of blood pressure reduction can be expected within 5 minutes of the injection. The urapidil injection can be repeated depending on the blood pressure response.

By intravenous infusion (with a drip or syringe pump)
For slow continuous infusion, 250 mg of urapidil is added to 500 ml of a compatible infusion solution (0.9% sodium chloride or 5% or 10% glucose solution).
If using a syringe pump, 100 mg of urapidil is drawn into a syringe pump and diluted to a volume of 50 ml with a compatible infusion solution (see above) (maximum 4 mg of urapidil per ml of infusion solution).
The initial infusion rate is 2 mg/min. The maintenance dose is on average 9 mg/hour. The extent of blood pressure reduction will be determined by the dose infused in the first 15 minutes.
Subsequently, the established blood pressure can be maintained with significantly lower doses.
Reduction of high blood pressure during and/or after surgery
To maintain the blood pressure level achieved with the injection, continuous infusion is used via a syringe pump or slow continuous infusion.

By intravenous injection
Initially, 25 mg of urapidil is administered. This dose will be repeated if sufficient blood pressure reduction is not achieved after 2 minutes. If, within 2 minutes after the second dose, the blood pressure reduction is still insufficient, 50 mg of urapidil will be administered.
If the blood pressure reduction after 2 minutes from the administered dose is sufficient, proceed to the maintenance dose.

By intravenous infusion (with a drip or syringe pump)
Initially, up to 6 mg will be administered over 1-2 minutes. The dose will then be reduced.

Special patient groups
In patients with liver and/or kidney disorders, it may be necessary to reduce the dose.
In the elderly, this medicine must be administered with caution. Lower doses will be administered at the beginning of treatment, as sensitivity to such medicines is often altered in these patients.

Duration of treatment
The duration of treatment with this medicine should not exceed 7 days.

If you receive more Urapidil Kalceks than you should
If you receive an excessive amount of this medicine, dizziness, lightheadedness or fainting when standing up, fatigue and slowed reaction time may occur. In this case, lie down with your legs raised. If the symptoms persist, immediately inform the doctor or nurse.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects described below are generally a consequence of a too
rapid reduction in blood pressure.
However, experience has shown that they resolve within a few minutes, even during
long-term infusions. The doctor will decide whether to interrupt treatment based on the severity of
the side effects.

Common(may affect up to 1 in 10 people)
Dizziness, headache, nausea.

Uncommon(may affect up to 1 in 100 people)
Sleep disturbances, palpitations, increase or decrease in heart rate, feeling of
oppression or chest pain (like angina pectoris), difficulty breathing, lowering of
blood pressure when getting up from a sitting or lying position (orthostatic
dysregulation), vomiting, diarrhea, dry mouth, sweating, fatigue, irregular
heartbeat.

Rare(may affect up to 1 in 1,000 people)
Nasal congestion, allergic reactions (itching, skin redness, rash), prolonged and painful
erection.

Very rare(may affect up to 1 in 10,000 people)
Restlessness, increased need to urinate, increased urinary incontinence, reduced
number of platelets (blood cells that contribute to the formation of clots to stop
bleeding).

Not known(frequency cannot be estimated from available data)
Urticaria, severe allergic reaction with swelling of the face, lips, tongue and throat.

Reporting of side effects
If you get any side effects, talk to 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 Urapidil Kalceks

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
After dilution
Chemical and physical stability in use has been demonstrated for 50 hours at a temperature of 25 °C and of
2 °C - 8 °C with dilution in sodium chloride 9 mg/ml (0.9%), glucose
50 mg/ml (5%) or glucose 100 mg/ml (10%) infusion solution.
From a microbiological point of view, the diluted solution must be used immediately. If not
used immediately, the in-use storage times and storage conditions before
use are the responsibility of the user and should generally not exceed 24 hours at
2 °C – 8 °C, unless the dilution has been carried out under controlled and
validated aseptic conditions.
Do not use this medicine after the expiry date which is stated on the pack and vial after
Expiry./EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Urapidil Kalceks contains

• The active substance is urapidil. 1 ml of solution contains 5 mg of urapidil. Each vial of 5 ml of solution contains 25 mg of urapidil. Each vial of 10 ml of solution contains 50 mg of urapidil.
• The other ingredients are concentrated hydrochloric acid, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, propylene glycol (E1520), sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of Urapidil Kalceks and contents of the pack
Clear, colorless solution, free from visible particles.
Transparent glass vials of 5 ml or 10 ml with OPC pre-breaking system.
5 vials are packaged in a blister pack. The blister pack is packaged in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AS KALCEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]

Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Estonia, Czech Republic, Italy, Portugal: Urapidil Kalceks
Austria Urapidil Kalceks 25 mg, 50 mg Injektions-/Infusionslösung
France URAPIDIL KALCEKS 25 mg/5 ml, solution injectable/pour perfusion
URAPIDIL KALCEKS 50 mg/10 ml, solution injectable/pour perfusion
Germany Urapidil Ethypharm 25 mg, 50 mg Injektions-/Infusionslösung
Hungary Urapidil Kalceks 25 mg, 50 mg oldatos injekció vagy infúzió
Latvia Urapidil Kalceks 25 mg, 50 mg šķīdums injekcijām/infūzijām
Poland Urapidil KALCEKS
Romania Urapidil Kalceks 25 mg, 50 mg soluție injectabilă/perfuzabilă
Slovakia Urapidil Kalceks 25 mg, 50 mg injekčný/infúzny roztok
Spain Urapidil Kalceks 5 mg/ml solución inyectable y para perfusion
Netherlands Urapidil Kalceks 25 mg, 50 mg oplossing voor injectie/infusie
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The following information is intended for physicians or healthcare professionals:

Dosage

Hypertensive emergency, severe and extremely severe forms of hypertension and resistant hypertension

for treatment

• Intravenous injectionAs an injection, 10-50 mg of urapidil are administered slowly, intravenously with continuous monitoring of blood pressure. The onset of the hypotensive effect occurs within 5 minutes of the injection. The injection of urapidil can be repeated depending on the response of blood pressure.
• Slow continuous intravenous infusion or continuous infusion via a syringe pumpSlow continuous infusion or a syringe pump is used to maintain the blood pressure level achieved with the injection. For instructions on how to prepare the diluted solution, see “Instructions for use and disposal” and “Preparation of the diluted solution” below. The maximum compatible amount is 4 mg of urapidil per ml of infusion solution.

Rate of administration
The infusion rate should be based on the individual pressor response.
Recommended initial rate: 2 mg/min.
The extent of blood pressure reduction is determined by the dose infused in the first 15 minutes.
Subsequently, the established blood pressure can be maintained with significantly
lower doses.
Maintenance dose: on average 9 mg/hour, based on 250 mg of urapidil added to 500 ml of
infusion solution, equivalent to 1 mg = 44 drops = 2.2 ml.

Controlled reduction of blood pressure in hypertension during and/or after surgery

surgical intervention
To maintain the blood pressure level achieved with the injection, continuous
infusion via a syringe pump or slow continuous infusion is used.

Dosage
If a
reduction in blood
pressure occurs
Intravenous injection
of 25 mg of urapidil
(= 5 ml of injectable/for
infusion solution)
after 2 min
Blood pressure
stabilized
by infusion
Initially,
up to 6 mg
over
1-2 min,
then reduce
no pressor
response
after 2 min
If a
reduction in blood
pressure occurs
after 2 min
Intravenous injection
of 25 mg of urapidil
(= 5 ml of injectable/for
infusion solution)
after 2 min
no pressor
response
If a
reduction in blood
pressure occurs
after 2 min
Slow intravenous
injection of 50 mg of urapidil
(= 10 ml of injectable/for
infusion solution)

Special patient groups
In patients with hepatic and/or renal dysfunction, it may be necessary to reduce the dose of urapidil.
In the elderly, antihypertensive agents should be administered with due caution and at lower doses at the beginning of treatment, as sensitivity to these medicines is often
altered in these patients.

Paediatric population
The safety and efficacy of urapidil in children and adolescents have not been established. No data
are available.

Route of administration
Intravenous use.
Urapidil Kalceks is administered intravenously as an injection or infusion, to patients
in the supine position.
Both single injections and repeated injections, as well as continuous infusions, can be administered.
Injections can be followed by subsequent continuous infusions.
In addition to acute parenteral therapy, a transition to maintenance therapy with orally administered antihypertensives is possible.
To avoid toxic effects, a treatment period of more than 7 days should not be exceeded, which
also represents the generally applicable term for parenteral antihypertensive therapy. Parenteral treatment can be repeated in case of recurrence of hypertension.

Contraindications
This medicine should not be mixed with alkaline injectable or infusion solutions, as
turbidity or flocculation may occur due to the acidic properties of the solution.
This medicine should not be mixed with other medicines except those listed below.

Instructions for use and disposal
For single use only.
Use immediately after opening the vial. Dispose of any unused portion.
The medicine must be visually inspected before use. Only clear solutions, free from particles, must be used.
Preparation of the diluted solution

• Slow intravenous infusion: add 250 mg of urapidil to 500 ml of one of the compatible infusion solutions (see below).
• Syringe pump:20 ml of injectable/infusion solution (= 100 mg of urapidil) are drawn into a syringe pump and diluted to a volume of 50 ml with one of the compatible infusion solutions (see below).

Dilution can be performed with:

• sodium chloride 9 mg/ml (0.9%) infusion solution;
• glucose 50 mg/ml (5%) infusion solution;
• glucose 100 mg/ml (10%) infusion solution.

Instructions for opening the vial

• 1) Turn the vial with the colored tip upwards. If there is solution in the upper part of the vial, gently tap with your finger to bring all the solution to the bottom of the vial.
• 2) Use both hands to open; holding the bottom of the vial in one hand, break off the top of the vial with the other hand in the opposite direction to the colored point (see figures below).

Unused medicine and waste materials from this medicine must be disposed of in accordance with
current local regulations.