TIGECYCLINE NORAMEDA

Patient Information Leaflet

Tigecycline Norameda, 50 mg, powder for solution for infusion.
Tigecyclinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents

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

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

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

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

Tigecycline Norameda is used only when your doctor considers other antibiotics to be inappropriate.

2. Important information before using Tigecycline Norameda

• When not to use Tigecycline Norameda
  Do not use this medicine if the patient is allergic to tigecycline or to any of the other ingredients of this medicine (listed in section 6). If the patient is allergic to tetracycline antibiotics (e.g. minocycline, doxycycline, etc.), they may also be allergic to tigecycline.

Warnings and precautions
Before starting treatment with Tigecycline Norameda, discuss the following with the doctor or
nurse:

• If the patient has wounds that are healing poorly or slowly.
• If the patient has had diarrhoea before starting treatment with Tigecycline Norameda. If diarrhoea occurs during or after completion of treatment, inform the doctor immediately. Do not use any anti-diarrhoeal medicines without first consulting the doctor.
• If the patient has ever had adverse reactions to tetracycline antibiotics (e.g. skin photosensitivity, tooth discoloration during tooth development, pancreatitis, or changes in certain laboratory test results used to assess blood coagulation), either currently or in the past.
• If the patient currently has or has previously had liver function disorders. Depending on the patient's liver condition, the doctor may reduce the dose to avoid potential adverse effects.
• If the patient has biliary obstruction (cholestasis).
• If the patient has coagulation disorders or is taking anticoagulant medicines, as this medicine may affect blood coagulation.

During treatment with Tigecycline Norameda

• Inform the doctor immediately if symptoms of an allergic reaction occur.
• Inform the 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).
• For certain severe infections, the doctor may consider administering Tigecycline Norameda in combination with other antibiotics.
• The doctor will closely monitor whether the patient develops any additional bacterial infections. If another bacterial infection occurs, the doctor may prescribe a different antibiotic specific to that type of infection.
• Although antibiotics, including Tigecycline Norameda, combat certain types of bacteria, other types of bacteria and fungi may continue to multiply. This phenomenon is known as superinfection. The doctor will closely monitor the patient's condition to detect and treat any such infections if necessary.

Children
Tigecycline Norameda must not be used in children under 8 years of age due to lack of data on safety and efficacy in this age group, and because it may cause permanent tooth damage, such as discoloration of developing teeth.

Tigecycline Norameda and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Tigecycline Norameda 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 used to prevent excessive blood clotting (called anticoagulants). In such cases, the doctor will closely monitor the patient's health status.
Tigecycline Norameda may reduce the effectiveness of oral contraceptives (birth control pills). The patient should discuss with the doctor whether an additional method of contraception is needed during treatment with Tigecycline Norameda.
Tigecycline Norameda 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 close monitoring can be ensured.

Pregnancy and breastfeeding
Tigecycline Norameda may harm 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 the doctor before taking Tigecycline Norameda.
It is not known whether Tigecycline Norameda passes into human milk. Consult the doctor before starting breastfeeding.

Driving and operating machinery
Tigecycline Norameda may cause adverse effects such as dizziness. These symptoms may impair the ability to drive or operate machinery.

Tigecycline Norameda contains sodium
Tigecycline Norameda contains less than 1 mmol (23 mg) of sodium per 5 mL of solution, meaning the medicine is considered "sodium-free".

3. How to use Tigecycline Norameda

Tigecycline Norameda 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.
The recommended dose for 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 for adolescents aged 12 to <18 years is 50 mg every 12 hours.
Treatment usually lasts from 5 to 14 days. The duration of treatment will be determined by the doctor.
Use of a higher than recommended dose of Tigecycline Norameda
If the patient is concerned that they have received too high a dose of Tigecycline Norameda, they should immediately inform the doctor or nurse.
Missed dose of Tigecycline Norameda
If the patient is concerned that a dose of the medicine has been missed, they should immediately inform 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 Norameda, pseudomembranous colitis may occur.
This is characterised 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 adverse reactions (may affect more than 1 in 10 people):

• nausea, vomiting, diarrhoea.

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

• abscess (collection of pus), infections;
• laboratory test results indicating reduced blood coagulation;
• dizziness;
• phlebitis at injection site, which may cause pain, inflammation, swelling and thrombus formation;
• abdominal pain, dyspepsia (stomach pain and indigestion), anorexia (loss of appetite);
• increased liver enzyme activity, hyperbilirubinemia (excess bile pigment in the blood);
• itching, rash;
• poor or slow wound healing;
• headache;
• increased amylase activity—an enzyme present in the salivary glands and pancreas—increased blood urea nitrogen (BUN) concentration;
• pneumonia;
• low blood sugar levels;
• sepsis (severe systemic and blood infection) and (or) septic shock (a severe condition resulting from sepsis, potentially leading to multi-organ dysfunction and death);
• injection site reaction (pain, redness, inflammation);
• low levels of proteins in the blood.

Uncommon adverse reactions (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;
• low platelet count (which may lead to increased tendency to bleeding and development of bruises and/or haematomas).

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

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

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• anaphylactic and/or pseudo-anaphylactic reactions (ranging from mild to severe, including sudden, generalized allergic reactions which may lead to life-threatening shock [e.g. breathing difficulties, drop in blood pressure, rapid heartbeat]);
• liver failure;
• skin rash which may lead to formation of extensive blisters and skin peeling (Stevens-Johnson syndrome).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Tigecycline Norameda

Keep this medicine out of the sight and reach of children.
There are no special storage requirements for unopened vials of the medicine.
Do not use this medicine after the expiry date stated on the vial and carton after EXP. The expiry date refers to the last day of the stated month.
Storage after reconstitution
Chemical and physical in-use stability has been demonstrated for the reconstituted and diluted medicine for 1 hour at a temperature up to 25°C. From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the medicinal product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions prior to use.
The Tigecycline Norameda solution, after reconstitution, should be orange in colour; otherwise, it should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Tigecycline Norameda contains

• The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
• The other ingredients are arginine and hydrochloric acid, concentrated.

What Tigecycline Norameda looks like and contents of the pack
Tigecycline Norameda is supplied as a powder for solution for infusion in a vial. Before reconstitution, it is an orange powder.
The pack contains 10 vials in a cardboard box.

Marketing Authorisation Holder:
UAB Norameda
Meistrų g. 8A
Vilnius 02189
Lithuania
[email protected]

Manufacturer:
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo,
28760 Tres Cantos – Madrid
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia - Tigecycline Norameda
Finland - Tigecycline Norameda 50 mg infuusiokuiva-aine, liuosta varten
Lithuania - Tigecycline Norameda 50 mg milteliai infuziniam tirpalui
Latvia - Tigecycline Norameda 50 mg pulveris infūziju šķīduma pagatavošanai
Poland - Tigecycline Norameda 50 mg proszek do sporządzania roztworu do infuzji

Information intended exclusively for medical professionals:

Instructions for use and handling of the medicinal product (see also section 3. How to use Tigecycline Norameda in this leaflet)
The powder must be dissolved in 5.3 mL of 9 mg/mL (0.9%) sodium chloride injection solution, 50 mg/mL (5%) glucose injection solution, or lactated Ringer's injection solution to obtain a tigecycline solution with a concentration of 10 mg/mL. The vial should be gently swirled until the medicinal product is completely dissolved. Then, 5 mL of the prepared solution should be immediately 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, solutions from two vials should be prepared and combined into 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 prepared solution corresponds to 50 mg of active substance. After preparation, the solution should be orange in color; if not, it must be discarded. Before administration of parenteral products, visually inspect the solution for particulate matter and discoloration (e.g. to green or black).
Tigecycline must be administered intravenously via a separate infusion line or 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 9 mg/mL (0.9%) sodium chloride injection solution or 50 mg/mL (5%) glucose injection solution. Only infusion solutions compatible with tigecycline and other medicinal products should be administered through the same infusion line.
Compatible intravenous solutions include: sodium chloride 9 mg/mL (0.9%) injection solution, dextrose 50 mg/mL (5%) injection solution, and lactated Ringer's injection solution.
When administered via a Y-type connector, the tigecycline solution diluted in 0.9% sodium chloride injection solution has been shown to be compatible with the following medicinal products or solvents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, haloperidol, lactated Ringer's solution, lidocaine hydrochloride, metoclopramide, morphine, noradrenaline, piperacillin with tazobactam (formulation containing EDTA), potassium chloride, propofol, ranitidine hydrochloride, theophylline, and tobramycin.
Tigecycline Norameda must not be mixed with other medicinal products for which compatibility data are not available.
Tigecycline, once reconstituted and diluted in an infusion bag or another appropriate infusion container (e.g. a glass bottle), must be used immediately.
This product is for single use only; any unused portions of the solution must be discarded.