SINORA 0.1 mg/ml Solution

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER
   1. It is necessary to carefully read the contents of the leaflet before receiving the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Sinora and what is it used for
3. Important information before taking Sinora
   1. When not to use Sinora:
   2. Warnings and precautions
   3. Before starting Sinora, the doctor or pharmacist should be consulted:
   4. Sinora and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Children and adolescents
   7. Driving and using machines
   8. Important information about some components of Sinora
4. How to take Sinora
   1. Overdose of Sinora
5. Possible side effects
   1. Reporting side effects
6. How to store Sinora
7. 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. Importer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:
   7. Information intended for healthcare professionals only:
   8. Incompatibilities
   9. Special precautions for disposal and preparation of the medicinal product

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Sinora
0.1 mg/ml, solution for infusion
0.2 mg/ml, solution for infusion
Noradrenalinum(in the form of noradrenaline hydrochloride)

It is necessary to carefully read the contents of the leaflet before receiving the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sinora and what is it used for
• 2. Important information before taking Sinora
• 3. How to take Sinora
• 4. Possible side effects
• 5. How to store Sinora
• 6. Contents of the packaging and other information

1. What is Sinora and what is it used for

Sinora is a medicine belonging to the group of medicines that affect adrenergic and dopaminergic receptors.
Sinora is indicated for emergency restoration of blood pressure in cases of sudden drop in blood pressure (acute hypotension).

2. Important information before taking Sinora

When not to use Sinora:

• if the patient is allergic (hypersensitive) to products containing noradrenaline or any of the other components of this medicine (listed in section 6).
• if the patient has hypotension (low blood pressure) caused by hypovolemia (low blood volume).

Warnings and precautions

Before starting Sinora, the doctor or pharmacist should be consulted:

• 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 has a type of angina (chest pain) called Prinzmetal's angina,
• if the patient is elderly,
• if the patient is at risk of extravasation (risk that blood or lymph will leak from vessels into surrounding tissues),
• if the patient has severe left ventricular dysfunction,
• if the patient has recently had a myocardial infarction (heart attack),
• if the patient has arrhythmias (too fast, slow, or irregular heartbeat), the dose may need to be reduced.

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

Sinora and other medicines

The doctor or nurse should be informed about all medicines the patient is currently taking or has recently taken, including those available without a prescription.
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 the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor or nurse before taking any medicine.
Noradrenaline may have a harmful effect on the unborn child. The doctor will decide whether the patient should receive Sinora.

Children and adolescents

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

Driving and using machines

Not established

Important information about some components of Sinora

One vial containing 50 ml of solution for infusion contains 165.3 mg of sodium (main component of common salt).
This corresponds to 8.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Sinora

Sinora will be administered to the patient in the hospital by a doctor or nurse. The initial dose of Sinora will depend on the patient's condition. The usual dose is between 0.4 and 0.8 mg per hour of noradrenaline (between 0.8 mg per hour and 1.6 mg per hour of noradrenaline hydrochloride). The doctor will determine the appropriate dose for the patient. After administering the initial dose, the doctor will assess the patient's response and adjust the dose accordingly.

Overdose of Sinora

Administration of a higher dose than recommended is unlikely, as the patient will receive the medicine in the hospital.
In case of any doubts, the doctor or nurse should be consulted.
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, the doctor or pharmacist should be consulted.

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 from the available data.
The doctor should be informed immediately if the patient experiences 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 (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 tissues) at the injection site.

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

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist or nurse should be informed. 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
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Reporting side effects 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.
Sinora should not be used after the expiry date stated on the outer packaging and vial after the abbreviation EXP (Expiry Date).
The expiry date refers to the last day of the specified month.
Store in a temperature below 25°C. Do not freeze. Store in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.
The batch number is stated after the abbreviation Lot.

6. Contents of the packaging and other information

What Sinora contains

The active substance of Sinora is noradrenaline (Noradrenalinum) (in the form of noradrenaline hydrochloride).
Sinora, 0.1 mg/ml
Each ml of solution for infusion contains 0.2 mg of noradrenaline hydrochloride, which corresponds to 0.1 mg of noradrenaline.
Each vial of 50 ml of solution for infusion contains 10 mg of noradrenaline hydrochloride, which corresponds to 5 mg of noradrenaline.
Sinora, 0.2 mg/ml
Each ml of solution for infusion contains 0.4 mg of noradrenaline hydrochloride, which corresponds to 0.2 mg of noradrenaline.
Each vial of 50 ml of solution for infusion contains 20 mg of noradrenaline hydrochloride, which corresponds to 10 mg of noradrenaline.
The other ingredients are: sodium chloride, hydrochloric acid (to adjust pH), water for injections.

What Sinora looks like and what the packaging contains

The medicinal product is a solution for infusion. The solution is clear and colorless.
The medicinal product is available in a packaging containing 1 vial of 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

Importer:

Sirton Pharmaceuticals S.p.A
Piazza XX Settembre, 2
22079 Villa Guardia (CO)
Italy
Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany
To obtain more detailed information, the local representative of the marketing authorization holder should be contacted:
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:

Germany, Austria: Sinora 0.1 mg/ml Infusionslösung, Sinora 0.2 mg/ml Infusionslösung
Czech Republic, Poland: Sinora
Hungary: Sinora 0.1 mg/ml Oldatos infúzió, Sinora 0.2 mg/ml Oldatos infúzió
Slovakia: Sinora 0.1 mg/ml Infúzny roztok, Sinora 0.2 mg/ml Infúzny roztok

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

For intravenous administration.
Do not dilute before use: the medicine is supplied ready for use. Sinora solution for infusion is administered by intravenous infusion. To avoid ischemic necrosis (skin, limbs), the infusion should be administered through a cannula placed in a sufficiently large vein or a central venous access.
The infusion rate should be controlled using an infusion pump, infusion set, or drop counter.

Incompatibilities

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

Special precautions for disposal and preparation of the medicinal product

Any unused medicinal product or waste materials should be disposed of in accordance with local requirements.