TIGECICLINE HIKMA 50 mg POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you take Tigecycline Hikma

Do not use Tigecycline Hikma

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

Warnings and precautions

Consult your doctor or nurse before starting to use Tigecycline Hikma.

• If you have poor or slow wound healing.
• If you have diarrhea before taking tigecycline. If you develop diarrhea during or after treatment, inform your doctor immediately. Do not take any medicine for the treatment of diarrhea without consulting your doctor first.
• If you have or have had any side effects due to the use of antibiotics that belong to the tetracycline group (e.g. sensitivity of the skin to sunlight, staining of developing teeth, pancreatitis, and alteration of certain laboratory tests to measure if your blood clots properly).
• If you have or have had liver disorders. Depending on the state of your liver, your doctor may reduce the dose to avoid possible side effects.
• If you have bile duct obstruction (cholestasis).
• If you have a bleeding disorder or are being treated with anticoagulant medications, as this medicine may interfere with blood clotting.

During treatment with Tigecycline Hikma:

• 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. These may be symptoms of acute pancreatitis (inflammation of the pancreas that can cause severe abdominal pain, nausea, and vomiting).
• In certain severe infections, your doctor may consider the need to use tigecycline in combination with other antibiotics.
• Your doctor will closely monitor you for the appearance of any other bacterial infection. If you develop another bacterial infection, your doctor may prescribe a different antibiotic, specific to the type of infection.
• Although antibiotics like tigecycline attack certain types of bacteria, other bacteria and fungi may continue to grow. This process is called overgrowth. Your doctor will closely monitor you to detect any possible infection and treat you if necessary.

Children

Tigecycline should not be used in children under 8 years of age due to the lack of safety and efficacy data in this age group and because it may cause permanent dental defects, such as staining of developing teeth.

Other medicines and Tigecycline Hikma

Tell your doctor if you are using, have recently used, or might use any other medicines.

Tigecycline may prolong certain tests that measure if your blood clots properly. It is important that you inform your doctor if you are taking certain medications to avoid excessive blood clotting (called anticoagulants). If so, your doctor will closely monitor you.

Tigecycline may interfere with the contraceptive pill (birth control pill). Ask your doctor about the need to use an additional contraceptive method while receiving treatment with tigecycline.

Tigecycline may increase the effect of medications used to suppress the immune system (such as tacrolimus or cyclosporin). It is essential that you tell your doctor if you are taking these medications so that you can be closely monitored.

Pregnancy and breastfeeding

Tigecycline may cause harm to the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using tigecycline.

It is not known if tigecycline passes into breast milk. Consult your doctor before starting breastfeeding.

Driving and using machines

Tigecycline may cause side effects such as dizziness. This may reduce your ability to drive or use machines.

This medicine contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml of solution; this is essentially "sodium-free"

3. How to use Tigecycline Hikma

Tigecycline should be administered by a doctor or nurse.

The recommended dose of tigecycline in adults is an initial dose of 100 mg, followed by 50 mg every 12 hours. These doses are administered intravenously (directly into the bloodstream) over a period of 30 to 60 minutes.

The recommended dose in children aged 8 to <12 years is 1.2 mg kg administered intravenously every 12 hours, up to a maximum dose of 50 hours.< p>

The recommended dose for adolescents aged 12 to <18 years is 50 mg administered every 12 hours.< p>

The normal duration of treatment is 5 to 14 days. Your doctor will decide the appropriate duration of treatment for you.

If you receive more Tigecycline Hikma than you should

If you think you may have received more tigecycline than you should, inform your doctor or nurse immediately.

If you miss a dose of Tigecycline Hikma

If you are concerned about missing a dose, inform 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 may occur with most antibiotics, including tigecycline. Pseudomembranous colitis consists of severe, persistent, or bloody diarrhea associated with abdominal pain or fever, which can be a symptom 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):

• Abscesses (accumulation of pus), infections.
• Alterations in certain laboratory tests that indicate decreased ability to clot blood.
• Dizziness.
• Irritation of the vein where the medicine is injected, including pain, inflammation, swelling, and clot formation.
• Abdominal pain, dyspepsia (stomach pain and feeling of indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinemia (excess bilirubin in the blood).
• Pruritus (itching), skin rash.
• Poor or slow wound healing.
• Headache.
• Increased amylase, which is an enzyme present in the salivary glands and pancreas, increased blood urea nitrogen (BUN).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (severe infection that affects the whole body and blood)/septic shock (life-threatening medical condition resulting from sepsis and leading to multiple organ failure and death).
• Local reaction at the injection site (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 that causes severe abdominal pain, nausea, and vomiting).
• Jaundice (yellowing of the skin), liver inflammation.
• Low platelet count in the blood (which can lead to an increased tendency to bleed and bruise).

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

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

Frequency not known (frequency cannot be estimated from the available data):

• Anaphylactic/anaphylactoid reactions (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, decreased blood pressure, rapid heartbeat]).
• Liver failure.
• Skin rash, which can lead to severe skin peeling (Stevens-Johnson syndrome).

Reporting of side effects

If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tigecycline Hikma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial and carton after "EXP". The expiry date is the last day of the month shown.

Store below 25°C.

Storage after reconstitution

Chemical and physical stability has been demonstrated for 48 hours at 2-8°C after reconstitution with sodium chloride 0.9% or dextrose 5%.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the dilution has been made in controlled and validated aseptic conditions.

The solution of this medicine should have a yellow to orange color after dissolution; if not, it should be discarded immediately.

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 further information

Composition of Tigecycline Hikma

The active substance is tigecycline. Each vial contains 50 mg of tigecycline.

The other ingredients are: arginine, hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

Appearance and packaging

This medicine is supplied as a powder or compact powder for solution for infusion in vials containing orange to reddish-orange powder before dissolution. These vials are marketed in hospitals in packs of 10 vials or 1 vial. 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 shaken until the medicine is dissolved. Then, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or other suitable hospital infusion container (e.g., glass bottle).

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, Nº 8, 8A e 8B

Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer

Hikma Italia S.p.A.

Viale Certosa 10, 27100 – Pavia (PV)

Italy

Or

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36

San Agustín de Guadalix, 28750, Madrid,

Spain

Or

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park, Paola,PLA 3000,

Malta

Or

Galenicum Health, S.L.U

Sant Gabriel 50,Esplugues de Llobregat 08950 BarcelonaSpain

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

Date of last revision of this leaflet:August 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/

The following information is intended for healthcare professionals only:

Instructions for use and handling (see also section 3 of the leaflet "How to use Tigecycline Hikma"):

The powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9%) injection solution or dextrose 50 mg/ml (5%) injection solution to achieve a concentration of 10 mg/ml of tigecycline. The vial should be gently shaken until the active substance is dissolved. Then, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or other suitable hospital infusion container (e.g., glass bottle).

To obtain a dose of 100 mg, two vials should be reconstituted in a 100 ml intravenous infusion bag or other suitable hospital infusion container (e.g., glass bottle).

Note: The vial contains a 6% excess dose. Thus, 5 ml of reconstituted solution is equivalent to 50 mg of active substance. The reconstituted solution should be yellow to orange in color; if not, the solution should be discarded. Parenteral products should be visually inspected for particulate matter and discoloration prior to administration.

Tigecycline should be administered intravenously through a dedicated line or through a Y-line. If the same intravenous line is used for sequential infusion of other active substances, the line should be flushed before and after infusion of tigecycline with sodium chloride 9 mg/ml (0.9%) injection solution or dextrose 50 mg/ml (5%) injection solution. The infusion should be made with a solution compatible with tigecycline and any other medicine administered through this common line.

Compatible intravenous solutions include: sodium chloride 9 mg/ml (0.9%) injection solution and dextrose 50 mg/ml (5%) injection solution. It has been shown that the product is not compatible with Ringer's lactate solution.

When administration is through a Y-line, the compatibility of tigecycline, diluted in sodium chloride injection solution 0.9%, has been verified with the following drugs or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, lidocaine HCl, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.

Tigecycline should not be mixed with other medicines for which compatibility data are not available.

Once reconstituted and diluted in the bag or other suitable infusion container (e.g., glass bottle), tigecycline should be used immediately.

This medicine should only be used for the administration of a single dose; any unused solution should be discarded.