Tigecicline Aptapharma

Package Leaflet: Information for the User

Tigecycline AptaPharma, 50 mg, Powder for Solution for Infusion

Tigecycline

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

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

Table of Contents of the Leaflet

• 1. What is Tigecycline AptaPharma and What is it Used For
• 2. Important Information Before Using 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 is Tigecycline AptaPharma and What is it Used For

Tigecycline AptaPharma is an antibiotic belonging to the group of glycylcyclines, which works by inhibiting the growth of bacteria that cause infections.
Your doctor has prescribed Tigecycline AptaPharma to an adult patient or a child aged 8 years or older for the treatment of one of the following types of severe infections:

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

Tigecycline AptaPharma is used only when your doctor considers other antibiotics to be unsuitable.

2. Important Information Before Using Tigecycline AptaPharma

When Not to Use Tigecycline AptaPharma

• If the patient is allergic to tigecycline or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to antibiotics from the tetracycline group (e.g., minocycline, doxycycline, etc.), they may also be allergic to tigecycline.

Warnings and Precautions

Before Starting Treatment with Tigecycline AptaPharma, Discuss the Following with Your Doctor or Nurse:

• If the patient has poorly or slowly healing wounds.
• If the patient had diarrhea before starting treatment with Tigecycline AptaPharma. If diarrhea occurs during or after treatment, tell your doctor immediately. Do not use any anti-diarrheal medications without consulting your doctor first.
• If the patient has ever experienced side effects after using tetracycline antibiotics (e.g., increased sensitivity of the skin to sunlight, tooth discoloration during development, pancreatitis, and changes in some laboratory test results used to evaluate blood clotting).
• If the patient has had liver function disorders. Depending on the liver condition, your doctor may reduce the dose to avoid side effects.
• If the patient has bile duct obstruction (bile stasis).
• If the patient has blood clotting disorders or is taking anticoagulant medications, as this medicine may affect blood clotting.

During Treatment with Tigecycline AptaPharma

• Tell your doctor immediately if you experience symptoms of an allergic reaction.
• Tell your doctor immediately if you experience severe abdominal pain, nausea, and vomiting. These may be symptoms of acute pancreatitis (inflammation of the pancreas, which can cause severe abdominal pain, nausea, and vomiting).
• In some severe infections, your doctor may consider administering Tigecycline AptaPharma with other antibiotics.
• Your doctor will closely monitor you for the development of other bacterial infections. If another bacterial infection occurs, your doctor may prescribe a different antibiotic specific to that type of infection.
• Although antibiotics, including Tigecycline AptaPharma, combat some types of bacteria, other types of bacteria and fungi may continue to multiply. This phenomenon is called superinfection. Your doctor will closely observe your condition to diagnose and treat any potential infections.

Children

Tigecycline AptaPharma should not be used in children under 8 years of age due to the lack of data on safety and efficacy in this age group, and because it may cause permanent tooth discoloration.

Tigecycline AptaPharma and Other Medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tigecycline AptaPharma may increase the values of certain parameters used to evaluate blood clotting. It is essential to inform your doctor if you are taking anticoagulant medications. In this case, your doctor will closely monitor your health.
Tigecycline AptaPharma may affect the action of birth control pills ("the pill"). You should discuss with your doctor whether you need to use an additional method of contraception while taking Tigecycline AptaPharma.
Tigecycline AptaPharma may enhance the action of immunosuppressive drugs (such as tacrolimus or cyclosporine). It is crucial to inform your doctor if you are taking these medicines so that they can closely monitor you.

Pregnancy and Breastfeeding

Tigecycline AptaPharma may be harmful to the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
It is not known whether tigecycline passes into human milk. Before breastfeeding, consult your doctor.

Driving and Operating Machines

Tigecycline AptaPharma may cause side effects such as dizziness.
These symptoms may impair your ability to drive or operate machines.

3. How to Use Tigecycline AptaPharma

Tigecycline AptaPharma is administered by your doctor or nurse.
The recommended initial dose for adults is 100 mg, followed by 50 mg every 12 hours. The medicine is administered 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 your doctor.

Using a Higher Dose of Tigecycline AptaPharma than Recommended

If you are concerned that you have received too high a dose of Tigecycline AptaPharma, tell your doctor or nurse immediately.

Missing a Dose of Tigecycline AptaPharma

If you are concerned that a dose of Tigecycline AptaPharma has been missed, tell your doctor or nurse immediately.

4. Possible Side Effects

Like all medicines, Tigecycline AptaPharma can cause side effects, although not everybody gets them.
During treatment with most antibiotics, including Tigecycline AptaPharma, pseudomembranous colitis may occur. This is characterized by severe, persistent, or bloody diarrhea, abdominal pain, or fever, which may be a sign of severe intestinal inflammation that can occur during or after treatment.
Very Common Side Effects(may affect more than 1 in 10 people):

• nausea, vomiting, diarrhea.

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

• abscess (collection of pus), infections;
• laboratory test results indicating decreased blood clotting;
• dizziness;
• vein irritation after injection, which can cause pain, inflammation, swelling, and thrombophlebitis;
• abdominal pain, indigestion (stomach pain), loss of appetite;
• increased liver enzyme activity, hyperbilirubinemia (excessive bilirubin in the blood);
• itching (pruritus), rash;
• poor or slow wound healing;
• headache;
• increased amylase activity (an enzyme found in salivary and pancreatic glands), increased blood urea nitrogen levels;
• pneumonia;
• low blood sugar levels;
• sepsis (severe infection of the body and blood) or septic shock (a severe condition resulting from sepsis, which can lead to organ dysfunction and death);
• injection site reaction (pain, redness, inflammation);
• low protein levels in the blood.

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

• acute pancreatitis (inflammation of the pancreas, which can cause severe abdominal pain, nausea, and vomiting);
• jaundice (yellowing of the skin), hepatitis;
• low platelet count (which can lead to increased bleeding tendency and bruising).

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

• low fibrinogen levels in the blood (a protein involved in blood clotting). Side Effects of Unknown Frequency(frequency cannot be estimated from available data):
• anaphylactic or pseudoanaphylactic reactions (ranging from mild to severe, including sudden, generalized allergic reaction, which can lead to life-threatening shock [e.g., difficulty breathing, low blood pressure, rapid heartbeat]);
• liver failure;
• skin rash that can lead to widespread blistering and peeling of the skin (Stevens-Johnson syndrome).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Tigecycline AptaPharma

Store the medicine out of 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 month.
There are no special storage instructions for this medicine.

Storage After Preparation of the Solution

The chemical and physical stability of the reconstituted and diluted medicine has been demonstrated for 1 hour at a temperature up to 25°C.
From a microbiological point of view, the reconstituted and diluted medicine should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not exceed the times specified above.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack 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 (to adjust pH)

What Tigecycline AptaPharma Looks Like and Contents of the Pack

Tigecycline AptaPharma is supplied as a powder for solution for infusion in a vial, which, before dilution, is a orange powder. The solution after reconstitution is orange in color.
The pack contains 10 vials.

Marketing Authorization 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 Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:

:

Date of Last Revision of the Leaflet:
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Information Intended for Healthcare Professionals Only:

Instructions for Use and Handling of the Medicine (See Also Section 3. How to Use Tigecycline AptaPharma in This Leaflet)

This medicine is for single use only
Method of administration:
Tigecycline AptaPharma is administered intravenously (directly into the bloodstream) over a period of 30 to 60 minutes. The recommended infusion time for children and adolescents is 60 minutes.
Preparation of the solution:
The powder should be reconstituted in 5.3 ml of:

• 0.9% (9 mg/ml) sodium chloride injection solution,
• 5% (50 mg/ml) glucose injection solution, or
• Ringer's solution with lactate for injection, to obtain a tigecycline solution with a concentration of 10 mg/ml The vial should be gently swirled in a circular motion until the product is completely dissolved.

Then, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to 100 ml of an intravenous infusion bag or other suitable container (e.g., a glass bottle).
To prepare a 100 mg dose, solutions from two vials should be prepared and added to 100 ml of an intravenous infusion bag or other suitable container (e.g., a glass bottle).
Note: The vial contains a 6% overfill of the active substance, so 5 ml of the reconstituted solution is equivalent to 50 mg of the active substance. The solution after reconstitution should be orange in color; Before using products for intravenous administration, check for visible particles and changes in the color of the solution. Only solutions without visible particles should be used.
Handling after use
Any unused medicine or waste material should be disposed of in accordance with local regulations.