TYGACIL 50 mg Infusion Solution

Зміст інструкції

1. Tygacil 50 mg powder for solution for infusion
   1. What is Tygacil and what is it used for
   2. What you need to know before using Tygacil
   3. How to use Tygacil
   4. Possible side effects
   5. How to store Tygacil
   6. Package contents and other information

Tygacil 50 mg powder for solution for infusion

tigecycline

Read this leaflet carefully before you start to use this medicine as it contains important
information for you or your child.

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

Contents of this leaflet

• 1. What Tygacil is and what it is used for
• 2. What you need to know before you use Tygacil
• 3. How to use Tygacil
• 4. Possible side effects
• 5. How to store Tygacil
• 6. Contents of the pack and other information

1. What is Tygacil and what is it used for

Tygacil is an antibiotic of the glycylcycline group that works by blocking the growth of bacteria that
cause infections.
Your doctor has prescribed Tygacil because you or a child of at least 8 years of age has one of the following types of
serious infection:

• Complicated skin (skin) and soft tissue (tissue under the skin) infection, excluding diabetic foot infections.
• Complicated abdominal infection.

Tygacil is used only when the doctor believes that other antibiotics are not appropriate.

2. What you need to know before using Tygacil

Do not use Tygacil

• If you are allergic to tigecycline, the active ingredient of Tygacil. If you are allergic to the tetracycline class of antibiotics (e.g. minocycline, doxycycline, etc.), you may also be allergic to tigecycline.

Warnings and precautions
Talk to your doctor or nurse before using Tygacil:

• if you have incomplete or slow wound healing.
• if you are suffering from diarrhoea before treatment with Tygacil. If you experience diarrhoea during or after treatment with Tygacil, tell your doctor immediately. Do not take medicines to stop diarrhoea without first consulting your doctor.
• if you have or have previously had any adverse effects due to antibiotics belonging to the tetracycline class (e.g. skin sensitivity due to sunlight, stains on developing teeth, inflammation of the pancreas and changes in some laboratory values performed to assess your blood's ability to clot).
• if you have or have previously had liver problems. Depending on the condition of your liver, your doctor may reduce the dose to avoid side effects.
• if you have an obstruction of the bile ducts (cholestasis).
• if you suffer from a blood clotting disorder or are taking anticoagulant drugs, as this medicine may interfere with blood clotting.

During treatment with Tygacil:

• Tell your doctor immediately if you develop symptoms of an allergic reaction.
• Tell your doctor immediately if you develop severe abdominal pain, nausea and vomiting; as these may be symptoms of acute pancreatitis (i.e. inflamed pancreas, which can lead to severe abdominal pain, nausea and vomiting).
• For certain serious infections, your doctor may decide to use Tygacil in combination with other antibiotics.
• Your doctor will carefully monitor you for the development of any other bacterial infection. In this case, they may prescribe you a different antibiotic, specific to the type of infection in progress.
• Although antibiotics like Tygacil fight some bacteria, other bacteria and fungi may continue to grow; this phenomenon is called overgrowth. Your doctor will carefully monitor you for any possible infection and, if necessary, will subject you to therapy.

Children
Tygacil should 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 induce permanent tooth defects
such as stains on developing teeth.

Other medicines and Tygacil
Always tell your doctor if you are taking or have recently taken any other medicine.
Tygacil may alter some tests that measure how well your blood clots. It is important that you
tell your doctor if you are taking medicines to prevent excessive blood clotting
(called anticoagulants). In this case, your doctor will keep you under close control.
Tygacil may interfere with the contraceptive pill (birth control pill). Talk to your
doctor about the need for additional contraceptive methods during treatment with
Tygacil.
Tygacil may increase the effect of medicines used to suppress the immune system (such as
tacrolimus or cyclosporine). It is important that you inform your doctor if you are taking these medicines in
order to be carefully monitored.

Pregnancy and breastfeeding
Tygacil may cause fetal harm. If you are pregnant or breastfeeding, if
you suspect or are planning a pregnancy, ask your doctor for advice before taking Tygacil.
It is not known whether Tygacil is excreted in breast milk. Ask your doctor for advice before breastfeeding
your baby.

Driving and using machines
Tygacil may cause side effects such as dizziness. This may affect your ability to drive
vehicles or use machines.

Tygacil contains sodium
Tygacil contains less than 1 mmol (23 mg) of sodium per 5 mL of solution, i.e. essentially ‘sodium-free’.

3. How to use Tygacil

Tygacil will be administered to you by a doctor or nurse.
The recommended dose in adults is initially 100 mg, followed by a dose of 50 mg every 12 hours.
This dose is administered intravenously (into a vein) over a period of 30 to 60 minutes.
The recommended dose in children aged 8 to 12 years is 1.2 mg/kg administered every 12
hours intravenously up to a maximum dose of 50 mg every 12 hours.
The recommended dose in adolescents aged 12 to 18 years is 50 mg administered every
12 hours.
A treatment cycle usually lasts from 5 to 14 days. The doctor will decide the duration of
treatment.

If you use more Tygacil than you should
If you are concerned because you think you have received too much Tygacil, speak to your doctor
or nurse immediately.

If you forget a dose of Tygacil
If you are concerned because you think you have forgotten a dose, speak to your doctor or
nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Pseudomembranous colitis can occur with most antibiotics including Tygacil.
It consists of severe, persistent diarrhea or diarrhea with the presence of blood associated with abdominal pain or
fever, which may be a sign of a serious inflammation of the intestine, which can occur
during or after treatment.
Very common side effects (may affect more than 1 in 10 people) are:

• Nausea, vomiting, diarrhea.

Common side effects (may affect up to 1 in 10 people) are:

• Abscess (collection of pus), infections;
• Laboratory tests showing a decreased ability to coagulate;
• Dizziness;
• Irritation of the vein due to the injection including pain, inflammation, swelling and coagulation;
• Abdominal pain, dyspepsia (stomach pain and indigestion), anorexia (loss of appetite);
• Increased liver enzymes, hyperbilirubinemia (excess bile pigments in the blood);
• Itching, skin rash;
• Incomplete or slow wound healing;
• Headache;
• Increased amylase, an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN);
• Pneumonia;
• Low blood sugar levels;
• Sepsis (serious infection in the body and blood)/septic shock (serious medical condition that can lead to multiple organ damage and death as a result of sepsis);
• Injection site reactions (pain, redness, inflammation);
• Low levels of proteins in the blood;

Uncommon side effects (may affect up to 1 in 100 people) are:

• Acute pancreatitis (inflammation of the pancreas which can manifest with severe abdominal pain, nausea and vomiting);
• Jaundice (yellowing of the skin), liver inflammation;
• Low levels of platelets in the blood (which may lead to an increased tendency to bleed and bruising/hematoma).

Rare side effects (may affect up to 1 in 1,000 people) are:

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

Side effects with unknown frequency (frequency cannot be estimated based on available data)
are:

• Anaphylactic/anaphylactoid reaction (which can range from mild to severe, including a sudden and generalized allergic reaction that can lead to life-threatening shock [e.g. difficulty breathing, rapid drop in blood pressure, rapid pulse]);
• Liver failure;
• Skin reaction, which may manifest as severe blisters and cracking of the skin (Stevens-Johnson Syndrome).

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tygacil

Keep this medicine out of the sight and reach of children.
Tygacil must be stored at a temperature below 25  C. Do not use this medicine after the expiry date
indicated on the vial. The expiry date refers to the last day of that month.

Storage after preparation
Once the powder has been dissolved to form a solution and this diluted for use, it must
be administered immediately.
The solution of Tygacil after dissolution must be from yellow to orange in colour; if this is not
the case, the solution must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tygacil contains
The active ingredient is tigecycline. Each vial contains 50 mg of tigecycline.
The other excipients are lactose monohydrate, hydrochloric acid, and sodium hydroxide.

Description of the appearance of Tygacil and contents of the pack
Tygacil is supplied as a powder for solution for infusion in a vial and before being diluted
it appears as an orange powder or cake. These vials are distributed to hospitals in a
pack of ten vials. The powder must be mixed in the vial with a small
quantity of solution. The vial must be shaken gently until the drug is dissolved.
Subsequently, the solution must be immediately withdrawn from the vial and added to a
100 mL intravenous infusion bag or another suitable container for infusion in
hospital.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Wyeth Lederle S.r.l.
Via Franco Gorgone Z.I.
95100 Catania (CT)
Italy
For any information on Tygacil, please contact the local representative of the Marketing Authorisation
Holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas
Lietuvoje
Tel: + 370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон
България
Teл:: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel: +36 1 488 37 00

Česká republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Danmark
Pfizer ApS
Tlf: +45 44 20 1 1 00

Nederland
Pfizer BV
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMAGmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel.: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς Α.Ε.
Τηλ: +30 210 6785800

Polska
Pfizer Polska Sp. z o.o.,
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel:+34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 5500

France
Pfizer
Tél +33 (0) 1 58 07 34 40

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s
področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0) 1304 616161

Slovenská republika
Pfizer Luxembourg SARL,
organizačná zložka
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
Simi: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22817690

United Kingdom (Northern Ireland)
Pfizer Limited,
Tel: +44 (0) 1304 616161

Latvijā
Pfizer Luxembourg SARL filiāle Latvijā
Tel.: + 371 670 35 775

This leaflet was last approved on MM/YYYY.
More detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu .

The following information is intended exclusively for healthcare professionals:
use Tygacil)
The powder must be reconstituted with 5.3 mL of sodium chloride 9 mg/mL (0.9%) for
infusion, or a 50 mg/mL (5%) dextrose solution for infusion or a Ringer Lactate infusion solution, to obtain a concentration of 10 mg/mL of tigecycline. The vial
must be shaken slowly until the active ingredient is dissolved. Subsequently, 5 mL
of the reconstituted solution must be immediately withdrawn from the vial and added to a
100 mL intravenous infusion bag or another suitable container for infusion (e.g. a
glass bottle).
For a 100 mg dose, reconstitute using two vials in a 100 mL intravenous infusion bag or another suitable container for infusion (e.g. a
glass bottle).
(Note: the vial contains a 6% excess. Therefore, 5 mL of the reconstituted solution are
equivalent to 50 mg of active ingredient). The reconstituted solution should be yellow
to orange in color; if not, the solution should be discarded. Before administration, parenteral products must be visually inspected for particulate matter and
color change (e.g. green or black).

Tigecycline must be administered intravenously through a dedicated line or through a
Y-connector. If the same intravenous line is used for sequential infusions of different active
ingredients, the line must be flushed before and after the infusion of tigecycline, or with a sodium chloride 9 mg/mL (0.9%) for
infusion or a 50 mg/mL (5%) dextrose solution for infusion.
The injection through this common line must be performed with an infusion solution
compatible with tigecycline and with any other drug.
Compatible intravenous solutions include: sodium chloride 9 mg/mL (0.9%) for
infusion, 50 mg/mL (5%) dextrose solution for infusion, and Ringer Lactate solution for
infusion.
When administered via a Y-connector, the compatibility of tigecycline diluted in a 0.9% sodium chloride solution for infusion, has been demonstrated for the following drugs or diluents: amikacin,
dobutamine, dopamine hydrochloride, gentamicin, haloperidol, Ringer Lactate, lidocaine hydrochloride,
metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine hydrochloride, theophylline, and tobramycin.
Tygacil must not be mixed with other medicinal products for which compatibility data are not
available.
Once reconstituted and diluted in the bag or other suitable container for infusion (e.g. a
glass bottle), tigecycline must be used immediately.
For single use only, any unused solution must be discarded.