SINORA 1 mg /Ml Concentrate

Contents of the leaflet

1. What is Sinora and what is it used for
2. Important information before taking Sinora
   1. When not to use Sinora:
   2. Warnings and precautions
   3. Before starting treatment with Sinora, you should discuss it with your doctor or pharmacist:
   4. Children and adolescents
   5. Sinora and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Sinora contains sodium
3. How to take Sinora
   1. Using a higher dose of Sinora than recommended
4. Possible side effects
   1. Reporting side effects
5. How to store Sinora
6. Contents of the packaging and other information
   1. What Sinora contains
   2. What Sinora looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Information intended for healthcare professionals only:
   6. Incompatibilities
   7. Instructions for dilution
   8. Shelf life after dilution

1. What is Sinora and what is it used for

Sinora is a medicine that belongs to the group of medicines that affect adrenergic and dopaminergic receptors.
Sinora is indicated for use in cases of sudden blood pressure drop (acute hypotension) in order to restore normal blood pressure.

2. Important information before taking Sinora

When not to use Sinora:

• If the patient is allergic to medicines containing noradrenaline or any of the other ingredients of this medicine (listed in section 6).
• If the patient has hypotension (low blood pressure) caused by hypovolemia (reduced blood volume).

Warnings and precautions

Before starting treatment with Sinora, you should discuss it with your doctor or pharmacist:

• if the patient has diabetes,
• if the patient has high blood pressure,
• if the patient has hyperthyroidism,
• if the patient has low oxygen levels in the blood,
• if the patient has high carbon dioxide levels in the blood,
• if the patient has blood clots or obstruction of blood vessels supplying blood to the heart, intestines, or other parts of the body,
• if the patient has low blood pressure after a heart attack,
• if the patient suffers from a type of angina (chest pain) called Prinzmetal's angina,
• if the patient is elderly,
• if the patient is at risk of extravasation (the risk that blood or lymph will leak from the vessels into the surrounding tissues),
• if the patient has severe left ventricular failure,
• if the patient has recently had a heart attack (myocardial infarction),
• if the patient has arrhythmias (too fast, slow, or irregular heartbeat), it may be necessary to reduce the dose.

During the infusion of noradrenaline, the doctor will constantly monitor blood pressure and heart rate.

Children and adolescents

The safety and efficacy of Sinora in children and adolescents have not been established.

Sinora and other medicines

You should tell your doctor or nurse about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
It has been confirmed that some medicines enhance the toxic effects of noradrenaline, including:

• monoamine oxidase inhibitors (antidepressants),
• tricyclic antidepressants,
• linezolid (antibiotic),
• anesthetics (especially inhaled),
• antidepressants that affect adrenergic and serotonergic receptors, e.g., used to treat asthma or heart disease.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or nurse before taking this medicine.
Noradrenaline may have harmful effects on the unborn child. The doctor will decide whether you should receive Sinora 1 mg/ml, concentrate for solution for infusion.

Driving and using machines

Not specified.

Sinora contains sodium

One ampoule containing 1 ml of concentrate contains less than 1 mmol of sodium (23 mg). This medicine contains less than 1 mmol of sodium (23 mg) per ampoule, which is essentially considered "sodium-free".
One ampoule containing 4 ml of concentrate contains less than 1 mmol of sodium (23 mg). This medicine contains less than 1 mmol of sodium (23 mg) per ampoule, which is essentially considered "sodium-free".
One ampoule containing 5 ml of concentrate contains less than 1 mmol of sodium (23 mg). This medicine contains less than 1 mmol of sodium (23 mg) per ampoule, which is essentially considered "sodium-free".
One ampoule containing 10 ml of concentrate contains 1.44 mmol of sodium (33 mg). This medicine contains 33 mg of sodium (the main component of table salt) per ampoule. This corresponds to 1.65% of the recommended maximum daily sodium intake for an adult.
Patients controlling their sodium intake should take this into account.

3. How to take Sinora

The doctor or nurse will administer Sinora to you in the hospital. The medicine is administered by intravenous infusion after prior dilution.
The initial dose of Sinora will depend on the patient's condition. Usually, a dose of 0.4 to 0.8 mg per hour of noradrenaline (0.8 mg to 1.6 mg per hour of noradrenaline hydrochloride) is used. The doctor will determine the appropriate dose for you. After the initial dose, the doctor will assess the patient's response and adjust the dose accordingly.

Using a higher dose of Sinora than recommended

Using a higher dose than recommended is unlikely, as you will receive the medicine in the hospital.
In case of any doubts, you should discuss it with your doctor or nurse.
Symptoms of overdose are: very high blood pressure, slow heartbeat, severe headache, sensitivity to light, chest pain, paleness, excessive sweating, and vomiting.
In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sinora can cause side effects, although not everybody gets them.
The frequency of side effects cannot be determined based on available data.

• . You should immediately inform your doctor if you experience any of the following conditions:
• slow heartbeat, fast heartbeat, palpitations, increased contractility of the heart muscle, acute heart failure,
• abnormal heart rhythm,
• breathing difficulties,
• anxiety, insomnia, confusion, weakness, psychotic state,
• headaches, tremors,
• high blood pressure (arterial hypertension), reduced oxygen supply to some organs (hypoxia),
• acute glaucoma,
• cold limbs,
• limb pain,
• nausea, vomiting,
• urinary retention,
• locally: possibility of irritation or necrosis (cell damage causing cell death in tissue) at the injection site.

In case of hypersensitivity or overdose, the following side effects may occur more frequently: arterial hypertension (high blood pressure), photophobia (intolerance to visual perception of light), chest pain, throat pain, paleness, excessive sweating, and vomiting.
The doctor will monitor blood pressure and blood volume.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl . By reporting side effects, you can help gather more information on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Sinora

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date {month/year} stated on the outer packaging and ampoule. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Do not freeze. Store in the original packaging to protect from light.
From a microbiological point of view, the product should be used immediately after dilution.
Medicines should not be disposed of via wastewater. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sinora contains

The active substance of the medicine is noradrenaline (Noradrenaline) in the form of noradrenaline hydrochloride.
1 ml of concentrate for solution for infusion contains 2 mg of noradrenaline hydrochloride, which corresponds to 1 mg of noradrenaline.
Sinora, 1 mg/1 ml
2 ml ampoule with 1 ml of concentrate for solution for infusion contains 2 mg of noradrenaline hydrochloride, which corresponds to 1 mg of noradrenaline.
Sinora, 4 mg/4 ml
5 ml ampoule with 4 ml of concentrate for solution for infusion contains 8 mg of noradrenaline hydrochloride, which corresponds to 4 mg of noradrenaline.
Sinora, 5 mg/5 ml
5 ml ampoule with 5 ml of concentrate for solution for infusion contains 10 mg of noradrenaline hydrochloride, which corresponds to 5 mg of noradrenaline.
Sinora, 10 mg/10 ml
10 ml ampoule with 10 ml of concentrate for solution for infusion contains 20 mg of noradrenaline hydrochloride, which corresponds to 10 mg of noradrenaline.
The other ingredients are: sodium chloride and water for injections.

What Sinora looks like and what the packaging contains

This medicinal product is a concentrate for solution for infusion. The solution is clear and colorless.
The medicinal product is available in packaging containing 10 ampoules x 1 ml, 10 ampoules x 4 ml, 10 ampoules x 5 ml, 10 ampoules x 10 ml of concentrate for solution for infusion.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany
Manufacturer / importer:
Sirton Pharmaceuticals Spa
Piazza XX Settembre, 2
22079 Villa Guardia (CO)
Italy
Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany
In order to obtain more detailed information, you should contact the local representative of the marketing authorization holder:
IMED Poland Sp. z o. o.
ul. Puławska 314, 02-819 Warsaw

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Germany:
Sinora 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Czech Republic, Poland:
Sinora
Hungary:
Sinora 1 mg/ml koncentrátum oldatos infúzióhoz
Slovakia:
Sinora 1 mg/ml infúzny koncentrát
Date of last revision of the leaflet:
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Information intended for healthcare professionals only:

Intravenous administration.
Dilute before administration.
Sinora, concentrate for solution for infusion for intravenous administration. To avoid ischemic necrosis (skin, limbs), an infusion catheter should be used, placed in a sufficiently large vein or central venous access.
The infusion rate should be controlled using an infusion pump, syringe pump, or drop counter.

Incompatibilities

Incompatibilities have been reported between noradrenaline hydrochloride infusion solutions and the following substances: alkaline agents or oxidizing agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, and streptomycin.

Instructions for dilution

Before administration, the product should be diluted in a 5% glucose solution or a 9 mg/ml (0.9%) sodium chloride solution, or a 9 mg/ml sodium chloride solution with 5% glucose solution.
In the case of administration using a syringe pump, 2 ml of concentrate should be added to 48 ml of 5% glucose solution (or 9 mg/ml sodium chloride solution or 9 mg/ml sodium chloride solution with 5% glucose solution). In the case of administration using a drop counter, 20 ml of concentrate should be added to 480 ml of 5% glucose solution (or 9 mg/ml sodium chloride solution or 9 mg/ml sodium chloride solution with 5% glucose solution). In both cases, the final concentration of the infusion solution is 40 mg/liter of noradrenaline (which corresponds to 80 mg/liter of noradrenaline hydrochloride). The product can also be diluted to concentrations other than 40 mg/liter of noradrenaline. In the case of dilution to a concentration other than 40 mg/liter of noradrenaline, the infusion rate should be carefully recalculated before starting treatment.
The medicinal product can be used with PVC infusion bags.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Shelf life after dilution

The chemical and physical stability of the solution after preparation is 24 hours at 25°C after dilution to 4 mg/liter and 40 mg/liter of noradrenaline in a 9 mg/ml (0.9%) sodium chloride solution or 5% glucose solution, or a 9 mg/ml sodium chloride solution with 5% glucose solution. However, from a microbiological point of view, the product should be used immediately. If the product is not administered immediately, the user is responsible for determining the storage conditions and period after preparation, which should not normally exceed 24 hours at a temperature of 2 to 8°C.