Tygacil

Package Leaflet: Information for the User

Tygacil 50 mg powder for solution for infusion

tigecycline
Please read this leaflet carefully before you or the child are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you or the child experience any side effects, including 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 using 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 Tygacil is and what it is used for

Tygacil is an antibiotic belonging to the glycylcycline group that works by inhibiting the growth of bacteria causing infections.
Your doctor has prescribed Tygacil because you or a child aged at least 8 years have one of the following types of serious infection:

• Complicated skin (skin) and soft tissue (tissues beneath the skin) infections, excluding diabetic foot infections.
• Complicated intra-abdominal infection.

Tygacil is used only when your doctor considers that other antibiotics are not suitable.

2. What you need to know before using Tygacil

Do not use Tygacil

• If you are allergic to tigecycline, the active substance in Tygacil. If you are allergic to the class of antibiotics known as tetracyclines (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 delayed or slow wound healing.
• if you already have diarrhoea before starting treatment with Tygacil. If you develop diarrhoea during or after treatment with Tygacil, inform your doctor immediately. Do not take medicines for diarrhoea without first consulting your doctor.
• if you currently have or have previously had any adverse reactions to tetracycline antibiotics (e.g. skin sensitivity to sunlight, tooth discoloration in developing teeth, inflammation of the pancreas, or changes in certain laboratory test results assessing your blood’s clotting ability).
• if you have or have previously had liver problems. Depending on your liver condition, your doctor may reduce the dose to avoid adverse effects.
• if you have bile duct obstruction (cholestasis).
• if you have a blood clotting disorder or are taking anticoagulant medicines, as this medicine may interfere with blood clotting.

During treatment with Tygacil:

• Inform your doctor immediately if you develop symptoms of an allergic reaction.
• Inform your doctor immediately if you develop severe abdominal pain, nausea, and vomiting, as these may be symptoms of acute pancreatitis (i.e. inflammation of the pancreas, which can cause 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 closely monitor you for the development of any additional bacterial infections. If necessary, your doctor may prescribe a different antibiotic specific to the type of infection present.
• Although antibiotics like Tygacil fight certain bacteria, other bacteria and fungi may continue to grow; this is known as overgrowth. Your doctor will closely monitor you for any possible infections and, if needed, will initiate appropriate treatment.

Children
Tygacil must not be used in children under 8 years of age due to lack of safety and efficacy data in this age group and because it may cause permanent tooth defects such as discoloration of developing teeth.
Other medicines and Tygacil
Always tell your doctor if you are taking or have recently taken any other medicines.
Tygacil may alter certain tests measuring how well your blood clots. It is important that you inform your doctor if you are taking medicines to prevent excessive blood clotting (called anticoagulants). In such cases, your doctor will monitor you closely.
Tygacil may interfere with the oral contraceptive pill (birth control pill). Talk to your doctor about the need for an additional contraceptive method 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 so that you can be closely monitored.
Pregnancy and breastfeeding
Tygacil may cause fetal harm. If you are pregnant or breastfeeding, suspect you are pregnant, or are planning to become pregnant, consult your doctor before taking Tygacil.
It is not known whether Tygacil is excreted in human breast milk. Consult your doctor before breastfeeding.
Driving and using machines
Tygacil may cause side effects such as dizziness. This may affect your ability to drive or operate machinery.
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 50 mg every 12 hours.
This dose is given 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 course usually lasts from 5 to 14 days. Your doctor will decide on the duration of
treatment.
If you use more Tygacil than you should
If you are concerned that you may have received too much Tygacil, speak to your doctor or nurse immediately.
If you forget a dose of Tygacil
If you are concerned that you may have missed a dose, speak to your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Pseudomembranous colitis may occur with most antibiotics, including Tygacil. It consists of severe, persistent diarrhoea or diarrhoea with blood, associated with abdominal pain or fever, which may be signs of a serious inflammation of the intestine. This may occur during or after treatment.

Very common side effects (may affect more than 1 in 10 people) are:

• Nausea, vomiting, diarrhoea.

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

• Abscess (collection of pus), infections;
• Laboratory tests showing reduced blood clotting ability;
• Dizziness;
• Vein irritation due to injection, including pain, inflammation, swelling and clotting;
• Abdominal pain, dyspepsia (stomach pain and indigestion), anorexia (loss of appetite);
• Increased liver enzymes, hyperbilirubinaemia (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 (a serious medical condition that may lead to multiple organ failure and death as a result of sepsis);
• Reactions at the injection site (pain, redness, inflammation);
• Low levels of protein in the blood;

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

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

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

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

Side effects not known (frequency cannot be estimated from the available data) are:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system referred to in Annex 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 should be stored below 25 °C. Do not use this medicine after the expiry date stated 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 diluted for use, it should be administered immediately.
The Tygacil solution after reconstitution should be yellow to orange in colour; if not, the solution must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tygacil contains
The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
The other ingredients 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 dilution, appears as an orange powder or tablet. These vials are supplied to hospitals in packs of ten vials. The powder must be mixed in the vial with a small amount of solution. The vial should then be gently shaken until the drug dissolves completely. The solution should then be immediately withdrawn from the vial and added to a 100 mL intravenous infusion bag or another suitable container for hospital infusion.
Marketing Authorization Holder Manufacturer
Pfizer Europe MA EEIG Wyeth Lederle S.r.l.
Boulevard de la Plaine 17 Via Franco Gorgone Z.I.
1050 Brussels 95100 Catania (CT)
Belgium Italy
For any information about Tygacil, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas
Pfizer NV/SA Lietuvoje
Tél/Tel: +32 (0)2 554 62 11 Tel: + 370 5 251 4000
България Magyarország
Пфайзер Люксембург САРЛ, Клон Pfizer Kft.
България Tel: +36 1 488 37 00
Teл:: +359 2 970 4333
Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel: +420-283-004-111 Tel: +356 21344610
Danmark Nederland
Pfizer ApS Pfizer BV
Tlf: +45 44 20 11 00 Tel: +31 (0)800 63 34 636
Deutschland Norge
PFIZER PHARMAGmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00
Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel.: +372 666 7500 Tel: +43 (0)1 521 15-0
Ελλάδα Polska
Pfizer Ελλάς Α.Ε. Pfizer Polska Sp. z o.o.,
Τηλ: +30 210 6785800 Tel.: +48 22 335 61 00
España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel:+34 91 490 99 00 Tel: (+351) 21 423 5500
France România
Pfizer Pfizer Romania S.R.L
Tél +33 (0) 1 58 07 34 40 Tel: +40 (0) 21 207 28 00
Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: +385 1 3908 777 Pfizer, podružnica za svetovanje s
področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400
Ireland Slovenská republika
Pfizer Healthcare Ireland Pfizer Luxembourg SARL,
Tel: +1800 633 363 (toll free) organizačná zložka
Tel: +44 (0) 1304 616161 Tel: +421 2 3355 5500
Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Simi: +354 540 8000 Puh/Tel: +358 (0)9 430 040
Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00
Κύπρος United Kingdom (Northern Ireland)
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Pfizer Limited,
Τηλ: +357 22817690 Tel: +44 (0) 1304 616161
Latvijā
Pfizer Luxembourg SARL filiāle Latvijā
Tel.: + 371 670 35 775
This leaflet was last approved in 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:

Instructions for use and handling (see also in this package leaflet 3. How to use Tygacil)

The powder must be reconstituted with 5.3 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion, or with 50 mg/mL (5%) dextrose solution for infusion, or with Ringer's Lactate solution for infusion, to obtain a concentration of 10 mg/mL of tigecycline. The vial should be gently shaken until the active substance is completely dissolved. Subsequently, 5 mL of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 mL intravenous infusion bag or to another suitable infusion container (e.g., a glass bottle).

For a 100 mg dose, reconstitute using two vials in a 100 mL intravenous infusion bag or in another suitable infusion container (e.g., a glass bottle).

(Note: the vial contains a 6% overage. Therefore, 5 mL of the reconstituted solution are equivalent to 50 mg of active substance.) The reconstituted solution should be yellow to orange in color; if not, the solution must be discarded. Parenteral products should be inspected visually before administration for the presence of particulate matter or discoloration (e.g., green or black).

Tigecycline must be administered intravenously through a dedicated line or via a Y-site connector. If the same intravenous line is used for sequential infusions of different active substances, the line must be flushed before and after administration of tigecycline with either sodium chloride 9 mg/mL (0.9%) solution for infusion or 50 mg/mL (5%) dextrose solution for infusion. The injection through this common line must be performed using an infusion solution compatible with both tigecycline and the other drug, if any.

Compatible intravenous solutions include: sodium chloride 9 mg/mL (0.9%) solution for infusion, 50 mg/mL (5%) dextrose solution for infusion, and Ringer's Lactate solution for infusion.

When administered via a Y-site connector, compatibility of tigecycline diluted in 0.9% sodium chloride solution for infusion has been demonstrated with the following drugs or diluents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, haloperidol, Ringer's Lactate, lidocaine hydrochloride, metoclopramide, morphine, noradrenaline, piperacillin/tazobactam (EDTA-containing formulation), potassium chloride, propofol, ranitidine hydrochloride, theophylline, and tobramycin.

Tygacil must not be mixed with medicinal products for which compatibility data are not available.

Once reconstituted and diluted in an infusion bag or another suitable infusion container (e.g., a glass bottle), tigecycline must be used immediately.

For single use only; any unused solution must be discarded.