Sinora

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sinora
0.1 mg/ml, solution for infusion
0.2 mg/ml, solution for infusion
Noradrenaline (as noradrenaline tartrate)
Please read this leaflet carefully before receiving this medicine, as it contains important information
for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Leaflet contents

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

1. What Sinora is and what it is used for

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

2. Important information before receiving Sinora

When not to use Sinora:

• if the patient is allergic (hypersensitive) to products containing noradrenaline or to any of the other ingredients 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 treatment with Sinora, discuss 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 blood oxygen levels,
• if the patient has high blood carbon dioxide levels,
• if the patient has blood clots or blocked 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 blood vessels into surrounding tissues),
• if the patient has severe left ventricular dysfunction,
• if the patient recently suffered a myocardial infarction (heart attack),
• if the patient has cardiac arrhythmias (too fast, too slow, or irregular heartbeat), a reduced dose will be necessary.

During noradrenaline infusion, the doctor will continuously monitor blood pressure and heart rate (heart
beats).
Sinora with other medicines
You must tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
It has been confirmed that certain medicines enhance the toxic effects of noradrenaline, including:

• monoamine oxidase inhibitors (antidepressants),
• tricyclic antidepressants,
• linezolid (an antibiotic),
• anesthetic agents (especially inhalational anesthetics),
• antidepressants affecting adrenergic and serotonergic receptors, e.g. used in the treatment of asthma or heart diseases.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or nurse before using any medicine.
Noradrenaline may have harmful effects on the unborn child. The doctor will decide whether the patient should receive Sinora.
Children and adolescents
The safety and efficacy in children and adolescents have not been established.
Driving and operating machinery
Not applicable
Important information about some of the ingredients of Sinora
One vial containing 50 ml of infusion solution contains 165.3 mg of sodium (main component of table salt).
This corresponds to 8.3% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Sinora

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

Overdose of Sinora
Taking more than the recommended dose is unlikely, as the patient will receive the medicine in hospital. If in doubt, discuss this with the doctor or nurse.
Symptoms of overdose include very high blood pressure, slow heartbeat, severe headache, light sensitivity, chest pain, pallor, excessive sweating, and vomiting.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, the Sinora medicine may cause adverse reactions, although not everyone experiences them.
The frequency of occurrence of adverse reactions cannot be determined based on the available data.
Immediately inform the physician if the patient develops any of the following conditions:

• slow heartbeat, rapid heartbeat, palpitations, increased myocardial contractility, acute heart failure,
• irregular heartbeat,
• breathing difficulties,
• anxiety, insomnia, confusion, weakness, psychotic state,
• headache, tremor,
• high blood pressure (arterial hypertension), reduced oxygen delivery to certain organs (hypoxia),
• acute glaucoma,
• cold extremities,
• limb pain,
• nausea, vomiting,
• urinary retention,
• locally: possibility of irritation or necrosis (cell injury leading to cell death in tissues) at the injection site.

In case of hypersensitivity or overdose, the following adverse reactions may occur more frequently:
arterial hypertension (high blood pressure), photophobia (intolerance to visual perception of light), retrosternal pain (chest pain), oral and pharyngeal pain (sore throat), pallor, excessive sweating, and vomiting.
The physician will monitor blood pressure and blood volume.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions enables the collection of further information on the safety of the medicine's use. Adverse reactions may also be reported to the marketing authorization holder.

5. How to store the medicine Sinora

Keep the medicine out of the sight and reach of children.
Do not use the medicine Sinora after the expiry date stated on the outer packaging and on the vial
following the abbreviation EXP (Expiry date).
The expiry date refers to the last day of the stated month.
Store below 25°C. Do not freeze. Keep in the original outer packaging to protect from light.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.
The batch number is indicated following the abbreviation Lot.

6. Contents of the pack and other information

What Sinora contains
The active substance is noradrenaline (Noradrenalinum) (in the form of noradrenaline tartrate).
Sinora, 0.1 mg/ml
Each ml of infusion solution contains 0.2 mg of noradrenaline tartrate, equivalent to 0.1 mg of noradrenaline.
Each 50 ml vial of infusion solution contains 10 mg of noradrenaline tartrate, equivalent to 5 mg of noradrenaline.
Sinora, 0.2 mg/ml
Each ml of infusion solution contains 0.4 mg of noradrenaline tartrate, equivalent to 0.2 mg of noradrenaline.
Each 50 ml vial of infusion solution contains 20 mg of noradrenaline tartrate, equivalent to 10 mg of noradrenaline.
The other components are: sodium chloride, hydrochloric acid concentrated (for pH adjustment), water for injections.

What Sinora looks like and contents of the pack
The medicinal product is a solution for infusion. The solution is clear and colourless.
The medicinal product is available in packaging containing 1 vial of infusion solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information, please contact the local representative of the Marketing Authorisation Holder:
IMED Poland Sp. z o.o.
ul. Puławska 314, 02-819 Warszawa

This medicinal product is authorised in the European Economic Area countries 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

Information intended exclusively for healthcare professionals:

For intravenous use.
Do not dilute before use: the medicinal product is supplied ready for use. The medicinal product Sinora solution for infusion is administered by intravenous infusion. To avoid ischemic necrosis (skin, limbs), the infusion should be given through a catheter placed in a sufficiently large vein or via central venous access.
The infusion rate should be controlled using a syringe pump, infusion pump, or drop counter.
Pharmaceutical incompatibilities
Pharmaceutical incompatibilities have been reported for infusion solutions containing noradrenaline bitartrate with the following substances: alkaline agents or agents with oxidizing properties, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin.
Special precautions for disposal and preparation of the medicinal product for administration
Any unused portions of the medicinal product or waste materials should be disposed of in accordance with local regulations.