LIMERIK 2 G + 0,25 G/4 ML Proszek i rozpuszczalnik do roztworu do wstrzykiwań

Treść ulotki

1. LIMERIK
   1. WHAT LIMERIK IS AND WHAT IT IS USED FOR
   2. BEFORE USING LIMERIK
   3. HOW TO USE LIMERIK
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE LIMERIK
   6. OTHER INFORMATION

LIMERIK

2 g + 0.25 g/4 ml powder and solvent for injectable solution
4 g / 0.5 g powder for infusion solution
Piperacillin / tazobactam

Read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Never give it to other people, even if they have the same symptoms as you, because it could be dangerous,.
• If any undesirable effects occur, including those not listed in this leaflet

consult your doctor or pharmacist. See section 4

Contents of this leaflet:

• 1. What LIMERIK is and what it is used for
• 2. Before you use LIMERIK
• 3. How to use LIMERIK
• 4. Possible side effects
• 5. How to store LIMERIK
• 6. Further information

1. WHAT LIMERIK IS AND WHAT IT IS USED FOR

Piperacillin belongs to a group of medicines known as “broad-spectrum penicillin antibiotics” and is able to kill many types of bacteria. Tazobactam may prevent some resistant bacteria from surviving the effects of piperacillin. This means that, when piperacillin and tazobactam are administered together, they can kill more types of bacteria.
LIMERIK is used in adults and adolescents for the treatment of bacterial infections, such as those affecting the lower respiratory tract (lungs), the urinary tract (kidneys and bladder), the abdomen, the skin or the blood. LIMERIK can be used for the treatment of bacterial infections in patients with a low number of white blood cells (reduced resistance to infections).
LIMERIK is used in children aged between 2 and 12 years for the treatment of abdominal infections, such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs) and biliary (gallbladder) infections. LIMERIK can be used for the treatment of bacterial infections in patients with a low number of white blood cells (reduced resistance to infections).
In certain serious infections, the doctor may consider using LIMERIK in association with other antibiotics.

2. BEFORE USING LIMERIK

Do not use LIMERIK

• If you are allergic (hypersensitive) to piperacillin or tazobactam or to any of the excipients of LIMERIK.
• If you are allergic (hypersensitive) to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, because you may be allergic to LIMERIK.

Take special care with LIMERIK

• If you have allergies. If you have several allergies, inform your doctor or healthcare professional before receiving this medicine.
• If you suffer from diarrhoea before, or if you develop diarrhoea during or after treatment. In this case, you should inform your doctor or healthcare professional immediately. Do not take medicines against diarrhoea without first consulting your doctor.
• If you have low levels of potassium in your blood. Your doctor will need to check your kidney function before administering this medicine and may perform periodic blood tests during treatment.
• If you have problems with your kidneys or liver or if you are undergoing hemodialysis. Your doctor will need to check your kidney function before administering this medicine and may perform periodic blood tests during treatment.
• If you are taking certain medicines (called anticoagulants) to prevent excessive blood clotting (see also the section Use of LIMERIK with other medicinesin

In this case, you should inform your doctor or healthcare professional immediately.

• If you develop convulsions during treatment. In this case, you should inform your doctor or healthcare professional.
• If you think you have developed a new infection or if the infection has worsened. In this case, you should inform your doctor or healthcare professional.

Children under 2 years
The use of piperacillin / tazobactam is not recommended in children under 2 years due to
lack of safety and efficacy data.
Use with other medicines
Tell your doctor or healthcare professional if you are taking or have recently taken any other
medicines, including those available without a prescription. Some medicines may interact with
piperacillin and tazobactam.
These include:

• Medicine for gout (probenecid). It may increase the time it takes to eliminate piperacillin and tazobactam from the body.
• Medicines to make the blood more fluid or to treat blood clots (e.g. heparin, warfarin or aspirin).
• Medicines used to relax muscles during surgery. Tell your doctor if you are to undergo general anesthesia.
• Methotrexate (medicine used to treat cancer, arthritis or psoriasis). Piperacillin and tazobactam may increase the time it takes to eliminate methotrexate from the body.
• Medicines that can reduce the level of potassium in the blood (e.g. tablets that increase urine production or some medicines for cancer).
• Medicines containing the other antibiotics tobramycin or gentamicin. Tell your doctor if you have kidney problems.

Effect on laboratory tests
Tell your doctor or laboratory personnel that you are taking LIMERIK if you need to provide a
blood or urine sample.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, inform your
doctor or healthcare professional before receiving this medicine. The doctor will decide if LIMERIK
is suitable for you.
Piperacillin and tazobactam can pass to the baby in the womb or through breast milk.
If you are breastfeeding, your doctor will decide if LIMERIK is suitable for you.
Driving and using machines
It is not expected that the use of LIMERIK will alter the ability to drive vehicles and operate machinery.
Important information about some excipients of LIMERIK
LIMERIK 2 g / 0.25 g contains 5.58 mmol (128 mg) of sodium.
LIMERIK 4 g / 0.5 g contains 11.16 mmol (256 mg) of sodium.
This should be taken into consideration if you are following a diet with controlled sodium intake.

3. HOW TO USE LIMERIK

Limerik 2 g+0.25 g can be administered both intramuscularly and by slow intravenous injection (duration at least 3-5 minutes) or by infusion (duration 20-30 min.).
The solvent vial with lidocaine, included in the Limerik 2 g+0.25 g package, should only be used
for intramuscular administration.
Limerik 4 g+0.5 mg can only be administered by slow intravenous injection or by infusion.
The dose of medicine administered depends on the reason for treatment, age and any
existing kidney problems.
Adults and adolescents over 12 years of age
The usual dose is 2 g / 0.25 g of piperacillin / tazobactam every 12 hours intramuscularly;
for intravenous administration, the dosage varies from a minimum of 2 g / 0.25 g of piperacillin / tazobactam up
to a maximum of 4 g / 0.5 g of piperacillin / tazobactam administered every 6, 8 or 12 hours.
Children from 2 to 12 years
The usual dose for children with abdominal infections is 100 mg / 12.5 mg / kg of body weight of
piperacillin / tazobactam, every 8 hours, administered intravenously (directly into the bloodstream).
The usual dose for children with a low white blood cell count is 80 mg / 10 mg / kg of body weight of
piperacillin / tazobactam, every 6 hours, administered intravenously (directly into the
bloodstream).
The doctor will calculate the dose based on the child's weight; in any case, the daily dose will not
exceed 4 g / 0.5 g of LIMERIK.
LIMERIK will be administered until the complete disappearance of signs of infection (5-14 days).
Patients with kidney problems
It may be necessary for the doctor to reduce the dose of LIMERIK or the frequency of
administration.
The doctor may also perform blood tests to ensure that the prescribed dose for
treatment is correct, especially if you have to take this medicine for a prolonged
period.
If you receive more LIMERIKthan you should
If adverse effects occur, such as convulsions, or if you think you have been given an
excessive dose of medicine, inform your doctor immediately.
If you miss a dose of LIMERIK
If you think you have not been given a dose of LIMERIK, inform your
doctor or healthcare professional immediately.
If you have any doubts about the use of this product, consult your doctor or healthcare professional.

INSTRUCTIONS FOR RECONSTITUTION AND DILUTION

• A. Intramuscular administrationLimerik 2g+0.25 g must be reconstituted with the solvent vial included in the package, containing 4 ml of lidocaine solution at 0.5%. The solvent vial with lidocaine, included in the package, must be used only forintramuscular administration.Do not exceed the dose of 2g+0.25g of piperacillin/tazobactam per injection site.

Follow the following procedure for correct reconstitution

• 1) Shake the vial containing the powder to be reconstituted so as to detach the powder from the bottom of the vial.
• 2) Remove the plastic cap with a reversible opening from the vial to expose the central portion of the rubber stopper and keep it (Fig.1). Always avoid touching the central portion of the rubber stopper with your hand.

Fig.1

• 3) With a syringe, draw the solvent containing lidocaine and introduce it into the vial containing the powder
• 4) Place the plastic cap on the rubber stopper to avoid touching the central portion of the stopper with your fingers. Shake vigorously until the powder is completely dissolved. With constant shaking, reconstitution should occur within 10 minutes (Fig.2)

Fig. 2

• 5) Allow the resulting solution to stand until the foam disappears and a clear solution is obtained. Make sure there are no residual undissolved particles.
• 6) Remove the plastic cap and draw the solution with a 5 ml syringe for intramuscular administration.

After reconstitution, the solution must be administered immediately
Unused solutions must be discarded.

• B. Intravenous administrationTo be performed only by healthcare professionals

Intravenous use
Reconstitute each vial with the volume of solvent indicated in the following table, using
one of the compatible solvents for reconstitution. Shake with a rotary motion until dissolved.
If shaken with constant rotary motion, reconstitution generally occurs within 5-10 minutes
(for details on handling, see below).

*Compatible solvents for reconstitution:

• 0.9% sodium chloride injectable solution (9 mg/ml)
• sterile water for injection
• 5% glucose

) The maximum recommended volume of sterile water for injection per dose is 50
ml.
The reconstituted solution must be drawn from the vial with a syringe. Once reconstituted
according to the instructions, the contents of the vial drawn with the syringe will provide the amount of
piperacillin and tazobactam indicated on the label.
Reconstituted solutions can be further diluted to the desired volume (e.g. from 50 ml to
150 ml) with one of the following compatible solvents:

• 0.9% sodium chloride injectable solution (9 mg/ml)
• 5% glucose
• 6% dextran in 0.9% sodium chloride
• Ringer lactate injectable solution
• Hartmann's solution
• Ringer acetate
• Ringer acetate/malate

Incompatibilities
When LIMERIK is used concurrently with another antibiotic (e.g. aminoglycosides), the
substances must be administered separately. Mixing beta-lactam antibiotics
with aminoglycosides in vitrocan cause substantial inactivation of the aminoglycoside.
However, the compatibility of amikacin and gentamicin with LIMERIK in vitrohas been determined in
certain diluents at specific concentrations (see paragraph Co-administration of LIMERIK
with aminoglycosides).
LIMERIK should not be mixed with other substances in a syringe or infusion bottle,
as compatibility has not been established.
Due to chemical instability, LIMERIK should not be used with solutions containing only
sodium bicarbonate.
LIMERIK is compatible with Ringer lactate solution and for co-administration via a
Y-connector.

Co-administration of LIMERIK with aminoglycosides
Due to the in vitroinactivation of the aminoglycoside by beta-lactam antibiotics, it is
recommended to administer LIMERIK and the aminoglycoside separately. When concomitant therapy with aminoglycosides is indicated, LIMERIK and the aminoglycoside should be reconstituted and
diluted separately.
In circumstances where co-administration is recommended, LIMERIK is compatible for simultaneous co-
administration by infusion with a Y-connector only with the following
aminoglycosides, under the following conditions:

* The dose of aminoglycoside must be based on the patient's weight, the state of the infection
(severe or potentially life-threatening) and renal function (creatinine clearance).
The compatibility of LIMERIK with other aminoglycosides has not been established. Only the concentration and
diluents for amikacin and gentamicin with the LIMERIK dose reported in the table above
have been established as compatible for co-administration by infusion via a Y-connector.
Simultaneous co-administration via a Y-connector with modalities other than those
above may result in inactivation of the aminoglycoside by LIMERIK.

4. POSSIBLE SIDE EFFECTS

Like all medicines, LIMERIK can cause side effects, although not everybody gets them.
If any of these side effects gets serious, or if you notice any side effects not listed here, please tell your
doctor or pharmacist. The serious side effects of LIMERIK are:

• severe skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis) which initially appear as reddish spots or as circular blisters often with central blisters on the trunk. Further symptoms include the presence of ulcers in the mouth, throat, nose, extremities, genitals and conjunctivitis (red and swollen eyes). The rash may increase with widespread blisters or skin peeling which can potentially be life-threatening
• swelling of the face, lips, tongue or other parts of the body
• shortness of breath, wheezing or difficulty breathing
• severe rash, itching or hives on the skin
• yellowing of the eyes or skin
• damage to blood cells (signs include: unexpected breathlessness, urine that is red or brown, bleeding from the nose and bruising)
• severe or persistent diarrhea accompanied by fever or weakness
• unexpected bleeding, especially for those taking anticoagulants such as warfarin

If you notice any of the above effects, consult your doctor immediately. For the
frequency of these reactions, refer to the following information.
Possible side effects are listed according to the following categories:

• common: affects 1 to 10 users out of 100
• uncommon: affects 1 to 10 users out of 1,000
• rare: affects 1 to 10 users out of 10,000
• very rare: affects less than 1 user out of 10,000

Common side effects:

• diarrhea, vomiting, nausea
• skin rashes

Uncommon side effects:

• thrush
• reduction (abnormal) in the number of white blood cells (leukopenia, neutropenia) and platelets (thrombocytopenia)
• allergic reaction
• headache, insomnia
• low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area)
• jaundice (yellowing of the skin or whites of the eyes), inflammation of the mucous membranes of the mouth, constipation, indigestion, stomach disorders
• increase in certain enzymes in the blood (increased alanine aminotransferase, increased aspartate aminotransferase)
• itching, hives
• increase in muscle metabolism product in the blood (increased creatinine in the blood)
• fever, reaction at the injection site
• yeast infection (candida overinfection)

Rare side effects:

• reduction (abnormal) in the number of red blood cells or blood pigment / hemoglobin, reduction (abnormal) of red blood cells due to premature degradation (hemolytic anemia), appearance of bruises with small spots (purpura), nosebleeds (epistaxis) and prolonged bleeding time, increase (abnormal) in a specific type of white blood cells (eosinophilia)
• severe allergic reaction (anaphylactic/anaphylactoid reaction, including shock)
• flushed skin with hot flushes
• a certain form of colon infection (pseudomembranous colitis), abdominal pain
• inflammation of the liver (hepatitis), increase in the degradation product of blood pigment (bilirubin), increase in certain blood enzymes (increased alkaline phosphatase in the blood, increased gamma-glutamyltransferase)
• skin reactions with redness and formation of lesions on the skin (exanthema, erythema multiforme), skin reactions with blister formation (bullous dermatitis)
• joint and muscle pain
• poor kidney function and kidney problems
• chills / rigidity

Very rare side effects:

• severe reduction of granular white blood cells (agranulocytosis), severe reduction of red blood cells, white blood cells and platelets (pancytopenia)
• prolongation of blood coagulation time (prolongation of partial thromboplastin time, prolongation of prothrombin time), abnormal laboratory test (positive direct Coombs test), increase in platelets (thrombocytemia)
• reduction of potassium in the blood (hypokalaemia), reduction of sugar in the blood (glucose), reduction of albumin protein in the blood, reduction of total proteins in the blood
• detachment of the upper layer of the skin all over the body (toxic epidermal necrolysis), severe allergic reaction spreading all over the body with rash on the skin and mucous membranes and various skin eruptions (Stevens-Johnson syndrome)
• increased azotemia

Therapy with piperacillin has been associated with a higher incidence of fever and rash in patients
with cystic fibrosis.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE LIMERIK

Keep LIMERIK out of sight and reach of children.
Do not use LIMERIK after the expiry date which is reported on the label and the vial after
“Exp.”. The expiry date refers to the last day of the month.
Intact vials: do not store at a temperature above 25ºC.
Single use only. Discard any unused solution.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What LIMERIK contains

• The active ingredients are piperacillin and tazobactam. Each vial contains 2 g of piperacillin (as sodium salt) and 0.25 g of tazobactam (as sodium salt). The solvent vial contains: lidocaine hydrochloride, water for injections. Each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of tazobactam (as sodium salt).

Description of the appearance of LIMERIK and contents of the pack
LIMERIK 2 g / 0.25 g is a white to off-white powder, supplied in a vial.
The packs contain 1 vial of powder + 1 solvent vial.
LIMERIK 4 g / 0.5 g is a white to off-white powder, supplied in a vial.
The packs contain 1 vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
LABORATORIO FARMACEUTICO C.T. S.r.l. - Strada Solaro, 75/77 - Sanremo (IM)

Manufacturer
LABORATORIO FARMACEUTICO C.T. S.r.l. – Via Dante Alighieri, 71 - Sanremo (IM)