Tigecycline noridem

Package leaflet: Information for the user

Tigecycline Noridem, 50 mg, powder for solution for infusion
Tigecyclinum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for the adult patient and for the child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Leaflet contents

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

1. What Tigecycline Noridem is and what it is used for

Tigecycline Noridem is an antibiotic belonging to the glycylcycline class, which works by
inhibiting the growth of bacteria causing infections.
Your doctor has prescribed this medicine for the adult patient or child aged at least 8 years to treat
one of the following serious infections:

• complicated skin and soft tissue infections (tissue beneath the skin), excluding diabetic foot infections,
• complicated intra-abdominal infections.

Tigecycline Noridem is used only when the doctor considers that other antibiotics are
inappropriate.

2. Important information before using Tigecycline Noridem

When not to use Tigecycline Noridem

• If the patient is allergic to tigecycline or to any of the other ingredients of this medicine (listed in section 6).
• Patients who have previously had an allergic reaction to tetracycline antibiotics (such as minocycline, doxycycline, etc.) may also be allergic to tigecycline.

Warnings and precautions
Before starting treatment with Tigecycline Noridem, discuss this with your doctor or
nurse:

• If the patient's wounds are healing poorly or slowly.

• If the patient has had diarrhoea before starting this medicine. If diarrhoea occurs during or after treatment, inform your doctor immediately. Do not take any anti-diarrhoeal medicines without first consulting your doctor.

• If the patient has ever had adverse reactions to tetracycline antibiotics (such as increased sensitivity to sunlight, tooth discolouration during tooth development, pancreatitis, or changes in certain laboratory test results used to assess blood coagulation).

• If the patient currently has or has previously had liver disease. Depending on the liver condition, the doctor may reduce the dose to avoid adverse effects.

• If the patient has biliary obstruction (blockage of the bile ducts).

• If the patient has blood clotting disorders or is being treated with anticoagulant medicines, because Tigecycline Noridem may interfere with blood clotting.

While being treated with Tigecycline Noridem:

• Contact your doctor immediately if symptoms of an allergic reaction occur.
• Contact your doctor immediately if severe abdominal pain, nausea, or vomiting occur. These may be symptoms of acute pancreatitis (inflammation of the pancreas, which may cause severe abdominal pain, nausea, and vomiting).
• In some severe infections, the doctor may consider administering Tigecycline Noridem together with other antibiotics.
• Your doctor will closely monitor whether another bacterial infection develops. If a new bacterial infection occurs, your doctor may prescribe another antibiotic specific to that type of infection.
• Although Tigecycline Noridem combats certain types of bacteria, other types of bacteria and fungi may continue to multiply. This phenomenon is known as superinfection. Your doctor will monitor the patient's condition to detect and treat any potential infection.

Children
Tigecycline Noridem must not be used in children under 8 years of age due to lack of safety and efficacy data in this age group and because it may cause permanent tooth damage, such as discolouration during tooth development.

Tigecycline Noridem and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Tigecycline Noridem may increase the values of certain parameters measured to assess blood coagulation. It is important that the patient informs the doctor if they are taking medicines to prevent excessive blood clotting (anticoagulants). In such cases, the doctor will closely monitor the patient's health status.
Tigecycline Noridem may enhance the effects of medicines used to suppress the immune system (such as tacrolimus or cyclosporine). It is important that the patient informs the doctor if they are taking these medicines so that the patient's condition can be monitored very closely.

Pregnancy and breastfeeding
Tigecycline Noridem may be harmful to the unborn child. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using Tigecycline Noridem.
It is not known whether Tigecycline Noridem passes into human milk. Consult your doctor before breastfeeding.

Driving and operating machinery
Tigecycline Noridem may cause undesirable effects such as dizziness, which may impair the ability to drive or operate machinery.

Tigecycline Noridem contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. this medicine is considered "sodium-free".

3. How to use Tigecycline Noridem

This medicine is administered by a doctor or nurse.
The recommended initial dose in adults is 100 mg, followed by 50 mg every 12 hours. The medicine is given by intravenous infusion (directly into the bloodstream) over a period of 30 to 60 minutes.

Use in children and adolescents

• The recommended dose in children aged 8 to <12 years is 1.2 mg/kg body weight, administered intravenously every 12 hours, up to a maximum dose of 50 mg every 12 hours.
• The recommended dose in adolescents aged 12 to <18 years is 50 mg every 12 hours.

Treatment usually lasts between 5 and 14 days. The duration of treatment will be determined by the doctor.

Use of a higher than recommended dose of Tigecycline Noridem
If the patient is concerned that they have received too high a dose of Tigecycline Noridem, they should immediately inform the doctor or nurse.

Missed dose of Tigecycline Noridem
If the patient is concerned that a dose of Tigecycline Noridem has been missed, they should immediately inform the doctor or nurse.

If there are any further doubts about the use of this medicine, consult the doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
During treatment with most antibiotics, including tigecycline, pseudomembranous colitis (swelling or inflammation of the large intestine) may occur. This is characterized by severe, persistent or bloody diarrhoea, accompanied by abdominal pain or fever, which may indicate a serious intestinal inflammation that can occur during or after completion of treatment.

Very common: (may affect more than 1 in 10 people)

• nausea, vomiting, diarrhoea.

Common: (may affect up to 1 in 10 people)

• abscess (collection of pus), infections,
• laboratory test results indicating reduced blood coagulation,
• dizziness,
• phlebitis (vein irritation) after injection, which may cause pain, inflammation, swelling, and blood clots,
• abdominal pain, dyspepsia (stomach discomfort), anorexia (loss of appetite), increased liver enzyme activity, hyperbilirubinemia (excess bile pigment in the blood),
• itching (pruritus), rash,
• poor or slow wound healing,
• headache,
• increased amylase activity (an enzyme found in the salivary glands and pancreas), increased blood urea nitrogen,
• pneumonia,
• low blood sugar levels,
• sepsis (a serious infection affecting the body and blood) or septic shock (a severe condition resulting from sepsis, which may lead to multi-organ dysfunction and death),
• injection site reaction (pain, redness, inflammation),
• low levels of protein in the blood.

Uncommon: (may affect up to 1 in 100 people)

• acute pancreatitis (inflammation of the pancreas, which may cause severe abdominal pain, nausea, and vomiting),
• jaundice (yellowing of the skin), hepatitis (liver inflammation),
• low platelet count (which may lead to increased tendency to bleed, bruising, or haemorrhages).

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

• low blood fibrinogen levels (a protein involved in blood clotting).

Frequency not known: (frequency cannot be estimated from available data)

• anaphylactic or pseudoanaphylactic reactions, which are severe allergic reactions that may be life-threatening. These may range from mild to severe, including sudden, generalized allergic reactions that may lead to life-threatening shock (such as difficulty breathing, low blood pressure, rapid heartbeat),
• liver failure,
• skin rash, which may lead to extensive blistering and peeling of the skin (Stevens-Johnson syndrome).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02 222 Warsaw,
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tigecycline Noridem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and the carton after:
(EXP). The expiry date refers to the last day of the specified month.
Store below 30°C.

Storage after reconstitution
After reconstitution:
The solution should be prepared from the powder and used immediately.

After dilution:
Chemical and physical in-use stability has been demonstrated after reconstitution and immediate dilution in an infusion bag or other container (e.g. glass bottle) for intravenous infusion as follows:

• For 6 hours at 23–27°C, both under artificial light and protected from light, when diluted in 9 mg/ml (0.9%) sodium chloride injection solution, 50 mg/ml (5%) glucose injection solution, or sodium lactate Ringer's injection solution, with a Tigecycline Noridem concentration of 0.476 mg/ml and 0.909 mg/ml.
• For 48 hours at 2–8°C protected from light, and for an additional 1 hour at 23–27°C under light exposure, when diluted in 9 mg/ml (0.9%) sodium chloride injection solution, 50 mg/ml (5%) glucose injection solution, or sodium lactate Ringer's injection solution, with a Tigecycline Noridem concentration of 0.476 mg/ml and 0.909 mg/ml.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage period and conditions prior to use, which generally should not exceed 24 hours at a temperature of 2–8°C, unless dilution occurred under controlled and validated aseptic conditions.

The diluted Tigecycline Noridem solution should be clear and range in colour from yellow to orange; otherwise, it should be discarded.

Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Tigecycline Noridem contains

• The active substance is tigecycline. Each vial contains 50 mg of tigecycline. After reconstitution, the solution contains 10 mg of tigecycline per 1 ml.
• The other components are: monohydrate lactose, concentrated hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

What Tigecycline Noridem looks like and contents of the pack
Tigecycline Noridem is supplied as a powder for solution for infusion in a 6 ml vial made of colourless type I glass, with a grey bromobutyl rubber stopper type I, aluminium seal and a yellow polypropylene flip-off cap. Before dilution, it is an orange powder.
This medicinal product is supplied in packages containing either 1 vial or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Noridem Enterprises Limited, Evagorou & Makariou,
Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus
T: +30 210 8161802, F: +30 2108161587.
Manufacturer
DEMO S.A. PHARMACEUTICAL INDUSTRY,
21st km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece,
This medicinal product is authorised for marketing in the European Economic Area countries
under the following names:

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Information intended exclusively for healthcare professionals:

Instructions for preparation of the medicinal product for administration (see also section 3. How to use the medicine Tigecycline Noridem in this leaflet).
To obtain a tigecycline solution at a concentration of 10 mg/ml, the powder should be reconstituted with 5.3 ml of 0.9% (9 mg/ml) sodium chloride injection solution, 5% (50 mg/ml) glucose injection solution, or sodium lactate Ringer's injection solution. The vial should be gently rotated until the active substance is completely dissolved. Immediately thereafter, 5 ml of the prepared solution should be withdrawn from the vial and added to 100 ml of an intravenous infusion bag or another suitable container (e.g. a glass bottle).
To prepare a 100 mg dose, the powder from two vials should be reconstituted and added to 100 ml of an intravenous infusion bag or another suitable container (e.g. a glass bottle).
Note: Each vial contains a 6% excess of the active substance; therefore, 5 ml of the reconstituted solution corresponds to 50 mg of active substance. After reconstitution, the solution should be yellow to orange in color and free from visible particulate matter or signs of contamination; if not, the solution must be discarded. Prior to administration of parenteral medicinal products, inspect the solution visually for any visible solid particles or discoloration (e.g. to green or black).
The ready-to-use infusion solution should be administered intravenously through a dedicated infusion line or via a Y-type connector. If multiple active substances are administered sequentially through the same intravenous infusion line, the line must be flushed before and after the tigecycline infusion with 0.9% (9 mg/ml) sodium chloride injection solution or 5% (50 mg/ml) glucose injection solution. Only infusion solutions compatible with tigecycline and other medicinal products should be administered through the same infusion line.
Compatible intravenous solutions: 0.9% (9 mg/ml) sodium chloride injection solution, 5% (50 mg/ml) glucose injection solution, and sodium lactate Ringer's injection solution.
Compatibility of tigecycline solution administered via a Y-type connector, after dilution in 9 mg/ml (0.9%) sodium chloride injection solution, has been demonstrated with the following medicinal products or diluents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, sodium lactate Ringer's solution, lidocaine hydrochloride, metoclopramide, noradrenaline, piperacillin with tazobactam, potassium chloride, propofol, theophylline, and tobramycin.
Tigecycline Noridem must not be mixed with other medicinal products for which compatibility data are not available.
For single use only – any unused solution must be discarded.