Package leaflet: Information for the user

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

Keep this leaflet, as 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 any not listed in this leaflet, inform your doctor or nurse. See section 4.

Leaflet contents

What Tigecycline TZF is and what it is used for
What you need to know before using Tigecycline TZF
How to use Tigecycline TZF
Possible side effects
How to store Tigecycline TZF
Contents of the pack and other information

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

Tigecycline TZF is an antibiotic belonging to the glycylcycline class, which works by
inhibiting the growth of bacteria causing infections.
Tigecycline TZF has been prescribed by a doctor for an adult patient or a child aged 8 years or older 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 TZF is used only when the doctor considers that other antibiotics are not suitable.

2. Important information before using Tigecycline TZF

When not to use Tigecycline TZF:

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 (e.g. minocycline, doxycycline, etc.) may also be allergic to tigecycline.

Warnings and precautions
Before starting treatment with Tigecycline TZF, discuss with your doctor or nurse if:

the patient has poorly or slowly healing wounds.
the patient had diarrhoea before starting treatment with Tigecycline TZF. If diarrhoea occurs during or after treatment, inform your doctor immediately. Do not take any anti-diarrhoeal medicines without first consulting your doctor.
the patient currently has or has ever had adverse reactions to tetracycline antibiotics (e.g. photosensitivity, tooth discolouration during tooth development,

pancreatitis, and changes in certain laboratory test results used to assess
blood coagulation).

the patient has or has ever had liver function disorders. Depending on the condition of the liver, the doctor may reduce the dose to avoid adverse reactions.
the patient has biliary obstruction (cholestasis).
the patient has blood coagulation disorders or is being treated with anticoagulant medicines, because this medicine may interfere with blood clotting.

During treatment with Tigecycline TZF:

Contact your doctor immediately if symptoms of allergic reactions occur.
Contact your doctor immediately if severe abdominal pain, nausea, or vomiting occur. These may be symptoms of acute pancreatitis (an inflammatory condition of the pancreas that may cause severe abdominal pain, nausea, and vomiting).
For certain severe infections, the doctor may consider administering Tigecycline TZF together with other antibiotics.
The doctor will closely monitor whether another bacterial infection develops. If another bacterial infection occurs, the doctor may prescribe a different antibiotic appropriate for that type of infection.
Although antibiotics such as Tigecycline TZF fight specific types of bacteria, other bacteria and fungi may still multiply. This is known as "superinfection." The doctor will closely monitor the patient's condition to detect and treat any possible infections if necessary.

Children and adolescents
Tigecycline TZF 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 occurring during tooth development.
Tigecycline TZF 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 TZF 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 that prevent excessive blood clotting (anticoagulants). In such cases, the doctor will closely monitor the patient's health status.
Tigecycline TZF may reduce the effectiveness of oral contraceptives ("the pill"). The patient should discuss with the doctor whether an additional method of contraception is needed during treatment with Tigecycline TZF.
Tigecycline TZF 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 about taking these medicines so that the patient's condition can be closely monitored.
Pregnancy and breastfeeding
Tigecycline TZF may be harmful to the unborn child. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
It is not known whether Tigecycline TZF passes into breast milk. Consult your doctor before starting breastfeeding.
Driving and operating machinery
Tigecycline TZF may cause adverse effects such as dizziness, which may impair the ability to drive or operate machinery.

3. How to use Tigecycline TZF

Tigecycline TZF is administered by a doctor or nurse.
The recommended initial dose for 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.
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.
The treatment course usually lasts from 5 to 14 days, and the duration is determined by the physician.
Use of a higher than recommended dose of Tigecycline TZF
If the patient is concerned that they have received too high a dose of Tigecycline TZF, they should immediately inform the doctor or nurse.
Missed dose of Tigecycline TZF
If the patient is concerned that a dose of Tigecycline TZF has been missed, they should immediately inform the doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
During treatment with most antibiotics, including Tigecycline TZF, 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 side effects (may affect more than 1 in 10 people):

nausea, vomiting, diarrhoea.

Common side effects (may affect less than 1 in 10 people):

abscess (collection of pus), infections,
laboratory test results indicating reduced blood clotting,
dizziness,
phlebitis (vein irritation) after injection, including pain, inflammation, swelling and blood clots,
abdominal pain, dyspepsia (stomach discomfort), anorexia (loss of appetite),
increased liver enzyme activity, hyperbilirubinemia (elevated levels of bile pigments in the blood),
itching, rash,
poorly or slowly healing wounds,
headache,
increased amylase activity (an enzyme found in the salivary glands and pancreas),
increased blood urea nitrogen levels,
pneumonia,
low blood sugar levels,
sepsis (serious infection of the body and blood) or septic shock (a severe condition resulting from seps游戏副本

5. How to store Tigecycline TZF

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicinal product.
Do not use this medicine after the expiry date stated on the carton and vial label following:
(EXP). The expiry date refers to the last day of the stated month.
Storage after reconstitution
The reconstituted solution has been shown to be chemically and physically stable for 1 hour at 25°C.
From a microbiological standpoint, the medicine should be used immediately after preparation.
If administration is delayed, the user is responsible for the storage conditions and duration.
After reconstitution, the solution of Tigecycline TZF should be clear and orange in colour; otherwise, it should be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What the medicine Tigecycline TZF contains

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

What Tigecycline TZF looks like and contents of the pack
Tigecycline TZF is available as an orange-colored lyophilized powder for solution for intravenous infusion in a vial. Vials are supplied to hospitals in packaging containing 10 units.
The powder must be reconstituted in the vial with a small volume of solvent. Gently swirl the vial until the drug is completely dissolved. Then immediately withdraw the prepared solution from the vial and transfer it into a 100 ml intravenous infusion bag or another infusion container available in the hospital.

Marketing Authorisation Holder
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw, Poland

Manufacturer

Laboratorios NORMON S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid, Spain
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw, Poland

For further information about this medicine, please contact the local representative of the marketing authorisation holder:
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw, Poland
Tel. +48 22 811-18-14

Information intended exclusively for healthcare professionals:
Instructions for preparation of the medicine for use (see also section 3 "How to use Tigecycline TZF")
To obtain a tigecycline solution at a concentration of 10 mg/ml, the lyophilized 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 lactated Ringer's injection solution. Gently swirl the vial until the active substance is completely dissolved. Immediately withdraw 5 ml of the prepared solution from the vial and add it to a 100 ml intravenous infusion bag or another suitable container (e.g. a glass bottle).
To prepare a 100 mg dose, solutions should be prepared in two vials and both added to a 100 ml intravenous infusion bag or another suitable container (e.g. a glass bottle).
Note: Each vial contains 6% excess of the active substance; therefore, 5 ml of the reconstituted solution corresponds to 50 mg of the active substance. The solution should be orange in colour after reconstitution; if not, it must be discarded. Before administration of parenteral products, visually inspect the solution for particulate matter and discoloration.
Tigecycline should be administered intravenously through a separate infusion line or via a Y-type connector.
If other active substances are administered sequentially through the same intravenous infusion line, the line must be flushed before initiating and after completing 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 concomitant medications should be administered through the same infusion line.
Compatible intravenous infusion solutions: 0.9% (9 mg/ml) sodium chloride injection solution, 5% (50 mg/ml) glucose injection solution, and lactated Ringer's injection solution.
Tigecycline TZF must not be mixed with other medicinal products for which compatibility data are not available.
The tigecycline solution should be used immediately after reconstitution and dilution in an intravenous infusion bag or another infusion fluid container (e.g. a glass bottle).
For single use only – any unused solution must be discarded.