Tigecycline pharmline

Package leaflet: Information for the user

Tigecycline PHARMLINE, 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. You may need to read it again.
• If you have any further questions, please ask 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.

Contents of the leaflet

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

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

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

2. Important information before using Tigecycline PHARMLINE
When not to use Tigecycline PHARMLINE

• If the patient is allergic to tigecycline or to any of the other ingredients of this medicine (listed in section 6). Patients who have been diagnosed with allergy to tetracycline antibiotics (e.g. minocycline, doxycycline, etc.) may also be allergic to tigecycline.

Warnings and precautions
Before starting treatment with Tigecycline PHARMLINE, discuss with your doctor or
nurse

• If the patient's wounds are healing poorly or slowly.
• If the patient has had diarrhoea before starting treatment with Tigecycline PHARMLINE. If diarrhoea occurs during or after treatment, inform the doctor immediately. Do not take anti-diarrhoeal medicines without first consulting the doctor.
• If the patient has ever experienced any adverse reactions related to the use of tetracycline antibiotics (e.g. photosensitivity, tooth discoloration during tooth development, pancreatitis, or changes in certain laboratory test results used to assess blood).
• If the patient currently has or has previously had liver disease. Depending on the liver condition, the doctor may reduce the dose to avoid possible adverse effects.
• If the patient has biliary obstruction (cholestasis).
• If the patient has blood clotting disorders or is being treated with anticoagulant medicines, because this medicine may interfere with blood clotting.

During treatment with Tigecycline PHARMLINE:

• Contact the doctor immediately if symptoms of allergic reactions occur.
• Contact the doctor immediately if the patient develops severe abdominal pain, nausea and vomiting. These may be symptoms of acute pancreatitis (inflammation of the pancreas which may lead to severe abdominal pain, nausea and vomiting).
• For certain serious infections, the doctor may consider administering Tigecycline PHARMLINE together with other antibiotics.
• The doctor will closely monitor the patient for the development of other bacterial infections. If another bacterial infection occurs, the doctor may prescribe another antibiotic specific for that type of infection.
• Although antibiotics, including Tigecycline PHARMLINE, fight certain types of bacteria, other types of bacteria and fungi may continue to grow. This phenomenon is known as superinfection. The doctor will carefully observe the patient for possible infections and treat them if necessary.

Children
Tigecycline PHARMLINE 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 during tooth development.

Tigecycline PHARMLINE 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 PHARMLINE may increase values of certain parameters measured to assess blood coagulation. It is important that the patient informs the doctor if taking medicines to prevent excessive blood clotting (anticoagulants). In such cases, the doctor will closely monitor the patient's health status.
Tigecycline PHARMLINE may interfere with the action of oral contraceptives ("the pill"). The patient should discuss with the doctor the need for using an additional method of contraception during treatment with Tigecycline PHARMLINE.
Tigecycline PHARMLINE may enhance the effect 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 PHARMLINE 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 her doctor or pharmacist before using Tigecycline PHARMLINE.
It is not known whether Tigecycline PHARMLINE passes into human milk. Consult the doctor before breastfeeding.

Driving and using machines
Tigecycline PHARMLINE may cause side effects such as dizziness. These may impair the ability to drive or operate machinery.

3. How to use Tigecycline PHARMLINE

Tigecycline PHARMLINE is administered by a doctor or nurse.
The recommended initial dose for adults is 100 mg, followed by 50 mg every 12 hours.
This dose 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.
Treatment usually lasts from 5 to 14 days. The doctor will decide how long the patient should be treated.
Use of a higher than recommended dose of Tigecycline PHARMLINE
If the patient is concerned that they have received too high a dose of Tigecycline PHARMLINE, they should immediately inform the doctor or nurse.
Missed dose of Tigecycline PHARMLINE
If the patient is concerned that a dose of Tigecycline PHARMLINE has been missed, they should immediately inform the doctor or nurse.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
When using most antibiotics, including Tigecycline PHARMLINE, pseudomembranous colitis may occur.
This condition is characterized by severe, persistent or bloody diarrhoea, 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
• Vein irritation after injection, including pain, inflammation, swelling and blood clots
• 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 salivary glands and pancreas, increased blood urea nitrogen
• Pneumonia
• Low blood sugar levels
• Sepsis (severe infection affecting the body and bloodstream)/septic shock (a severe condition resulting from sepsis, potentially leading 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, possibly causing severe abdominal pain, nausea and vomiting)
• Jaundice (yellowing of the skin), hepatitis (liver inflammation)
• Low platelet count (which may lead to increased bleeding tendency and bruising/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 available data):

• Anaphylactic/anaphylactoid reactions (ranging from mild to severe, including sudden, generalized allergic reaction potentially leading to life-threatening shock [e.g. breathing difficulties, drop in blood pressure, rapid pulse])
• 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 or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tigecycline PHARMLINE

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the vial after EXP. The expiry date refers to the last day of the stated month.
Storage after preparation
After reconstitution of the powder and dilution to a solution ready for use, the medicine should be administered to the patient immediately.
After reconstitution, the Tigecycline PHARMLINE 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 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 the medicine Tigecycline PHARMLINE contains

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

What the medicine Tigecycline PHARMLINE looks like and contents of the pack
Tigecycline PHARMLINE is supplied as a powder for solution for infusion in a vial and, before dilution, appears as an orange powder.
Tigecycline PHARMLINE may be packaged as follows:

• one vial packed in a cardboard box with the package leaflet, or
• ten vials (two PVC/PET/PE foil blisters containing 5 vials each) packed in a cardboard box with the package leaflet.

Not all pack sizes may be marketed.
The powder should be mixed in the vial with a small amount of solution. The vial should be gently rotated until the medicine is completely dissolved. The solution should then be immediately withdrawn from the vial and added to an intravenous infusion bag of 100 mL or another suitable hospital infusion container.

Marketing Authorisation Holder
Pharmline Company Sp. z o.o.
ul. Juliana Ursyna Niemcewicza 17/11
02-306 Warszawa
Poland
tel: +48 780 008 085
e-mail: [email protected]

Manufacturer
S.C. Rompharm Company S.R.L.
Eroilor 1A
075100 Otopeni, Ilfov
Romania

This medicine is authorised for marketing in the European Economic Area countries under the following names:
Bulgaria: Тигециклин Ромфарм 50 mg прах за инфузионен разтвор
Hungary: Tigeciklin Rompharm 50 mg por oldatos infúzióhoz
Romania: Tigeciclină Rompharm 50 mg pulbere pentru soluție perfuzabilă
Poland: Tigecycline PHARMLINE

Information intended exclusively for medical professionals:

Instructions for preparation of the medicinal product for use (see also section 3. How to use the medicinal product
Tigecycline Pharmline)
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 lactated Ringer's injection solution. The vial should be gently swirled until the active substance is completely dissolved. Then, 5 mL of the reconstituted solution should be promptly withdrawn from the vial and added to 100 mL of an intravenous infusion bag or another suitable infusion container (e.g. a glass bottle).
To prepare a 100 mg dose, solutions from two vials should be reconstituted and added to
100 mL of an intravenous infusion bag or another suitable infusion 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 active substance. After reconstitution, the solution should be yellow to orange in color; if not, the solution should be discarded. Prior to administration of parenteral products, inspect visually for particulate matter and discoloration (e.g. green or black coloration).
Only clear solutions that are practically free from particulate matter should be used.
Tigecycline should be administered intravenously via a separate infusion line or through a Y-connector.
If multiple active substances are administered sequentially through the same intravenous infusion line, the line should be flushed with 0.9% (9 mg/mL) sodium chloride injection solution or 5% (50 mg/mL) glucose injection solution before initiating and after completion of the tigecycline infusion.
The injection should be performed using an infusion solution compatible with tigecycline and with other medicinal products administered through the same line.
Pharmaceutically compatible intravenous infusion solutions include: 0.9% (9 mg/mL) sodium chloride injection solution, 5% (50 mg/mL) glucose injection solution, and lactated Ringer's injection solution.
Compatibility of tigecycline solution administered via a Y-connector, after dilution in 9 mg/mL (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 (the formulation containing EDTA), potassium chloride, propofol, ranitidine hydrochloride, theophylline, and tobramycin.
Tigecycline Pharmline should not be mixed with other medicinal products for which compatibility data are not available.
The tigecycline solution should be used immediately after preparation and dilution in an intravenous infusion bag or another appropriate container for infusion fluid (e.g. a glass bottle).
The reconstituted solution has a pH of 4.5–5.5.
For single use only; any unused solution should be discarded.