Tigecycline aptapharma

Package leaflet: Information for the user

Tigecycline AptaPharma, 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 the patient.

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

Contents of the leaflet

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

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

Tigecycline AptaPharma is an antibiotic belonging to the glycylcycline class, which works by inhibiting the growth of bacteria causing infections.
Your doctor has prescribed Tigecycline AptaPharma 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 (tissue located beneath the skin), excluding diabetic foot infections;
• complicated intra-abdominal infections.

Tigecycline AptaPharma is used only when your doctor considers other antibiotics inappropriate.

2. Important information before using Tigecycline AptaPharma

When not to use Tigecycline AptaPharma

• 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 AptaPharma, discuss with your doctor or nurse:

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

During treatment with Tigecycline AptaPharma

• 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).
• In some severe infections, the doctor may consider administering Tigecycline AptaPharma together with other antibiotics.
• The doctor will closely monitor whether the patient develops other bacterial infections. If another bacterial infection occurs, the doctor may prescribe a different antibiotic specific for that type of infection.
• Although antibiotics, including Tigecycline AptaPharma, eliminate 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 potential infections.

Children
Tigecycline AptaPharma 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 discolouration of developing teeth.

Tigecycline AptaPharma 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 AptaPharma 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 AptaPharma may reduce the effectiveness of oral contraceptives ("the pill"). The patient should discuss with the doctor whether an additional method of contraception is necessary during treatment with Tigecycline AptaPharma.
Tigecycline AptaPharma 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 AptaPharma may be harmful to the foetus. 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 this medicine.
It is not known whether tigecycline passes into human milk. Consult the doctor before starting breastfeeding.

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

3. How to use Tigecycline AptaPharma

Tigecycline AptaPharma 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 intravenously (directly into the bloodstream) over a period of 30 to 60 minutes.
Use in children and adolescents
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 is determined by the physician.
Use of a higher than recommended dose of Tigecycline AptaPharma
If the patient is concerned that they have received too high a dose of Tigecycline AptaPharma, they should immediately inform the doctor or nurse.
Missed dose of Tigecycline AptaPharma
If the patient is concerned that a dose of Tigecycline AptaPharma 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 AptaPharma, pseudomembranous colitis may occur. This condition 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 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 (vein irritation) after injection, which may cause pain, inflammation, swelling, and thrombus formation;
• abdominal pain, dyspepsia (stomach discomfort), anorexia (loss of appetite);
• increased liver enzyme activity, hyperbilirubinemia (excess bile pigment in the blood);
• pruritus (itching), rash;
• poor or slow wound healing;
• headache;
• increased amylase activity (an enzyme found in salivary glands and pancreas), increased blood urea nitrogen;
• pneumonia;
• low blood glucose levels;
• sepsis (severe systemic and blood infection) 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 blood protein levels.

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 bleeding tendency and development of bruises or haematomas).

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

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

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

• anaphylactic or anaphylactoid reactions (ranging from mild to severe, including sudden, generalized allergic reactions that 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 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, 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 AptaPharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Storage after solution preparation
Chemical and physical stability of the reconstituted and diluted medicine has been demonstrated for 1 hour at temperatures up to 25°C.
From a microbiological standpoint, the reconstituted and diluted medicine should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user, and storage should not exceed the period stated above.
Medicines must 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 AptaPharma contains

• The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
• The other ingredients are: arginine, hydrochloric acid concentrated (for pH adjustment)

What Tigecycline AptaPharma looks like and contents of the pack
Tigecycline AptaPharma is supplied as a powder for solution for infusion in a vial. The contents of the vial are in the form of an orange powder prior to reconstitution. The solution after reconstitution is orange in colour.
The pack contains 10 vials.
Marketing Authorisation Holder:
Apta Medica Internacional d.o.o.
Likozarjeva ulica 6
1000 Ljubljana
Slovenia
Tel.: 00386 51 615 015
E-mail: [email protected]
Manufacturer:
Laboratorios NORMON, S.A.
Ronda de Valdecarrizo,
6 - 28760 Tres Cantos – Madrid
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Information intended exclusively for healthcare professionals:

Instructions for use and handling of the medicinal product (see also section 3. How to use Tigecycline AptaPharma in this leaflet)
This medicinal product is for single use only.
Route of administration:
Tigecycline AptaPharma is administered intravenously (into the bloodstream) over a period of 30 to 60 minutes. The recommended infusion duration in children and adolescents is 60 minutes.

Preparation of the solution:
Reconstitute the powder with 5.3 ml of:

• 0.9% (9 mg/ml) sodium chloride injection solution,
• 5% (50 mg/ml) glucose injection solution, or
• lactated Ringer's injection solution,
  to obtain a tigecycline solution at a concentration of 10 mg/ml. Gently swirl the vial until the medicinal product is completely dissolved.

Immediately withdraw 5 ml of the prepared solution from the vial and add it to 100 ml of an intravenous infusion bag or another suitable container (e.g. glass bottle).
To prepare a 100 mg dose, prepare solutions from two vials and add both to 100 ml of an intravenous infusion bag or another suitable container (e.g. glass bottle).
Note: the vial contains a 6% overage of active substance; therefore, 5 ml of the prepared solution corresponds to 50 mg of active substance. The solution should be orange in color after reconstitution. Before using parenteral medicinal products, inspect visually for particulate matter and discoloration. Only solutions free from visible particulate matter should be used.

Storage after preparation:
Chemical and physical stability of the reconstituted and diluted medicinal product has been demonstrated for 1 hour at temperatures up to 25°C. From a microbiological standpoint, the reconstituted and diluted medicinal product should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration, which should not exceed the period stated above.

Tigecycline should be administered intravenously through a separate infusion line or via a Y-type connector.
If multiple active substances are administered sequentially through the same intravenous infusion line, flush the line with 0.9% (9 mg/ml) sodium chloride injection solution or 5% (50 mg/ml) glucose injection solution before and after the tigecycline infusion.
Only infusion solutions compatible with tigecycline and other medicinal products should be administered through the same infusion line.

Compatibility of the tigecycline solution administered via a Y-type connector, after dilution in 0.9% sodium chloride injection solution, has been demonstrated 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 AptaPharma must not be mixed with other medicinal products for which compatibility has not been established.

Disposal after use
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.