Piperital

Package leaflet: Information for the user

PIPERITAL 1 g/2 ml powder and solvent for injectable solution for intramuscular use, 2 g/4 ml powder and solvent for injectable solution for intramuscular use, 2 g powder for injectable solution, 4 g powder for infusion solution

Piperacillin sodium
Generic medicine
Please read all of this leaflet carefully before taking 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Piperital is and what it is used for

Piperital contains the active substance piperacillin sodium, which belongs to a class of medicines called beta-lactam antibiotics, broad-spectrum penicillins, and is capable of killing bacteria sensitive to piperacillin.
Piperital is used:

• for the treatment of short- and long-term (acute and chronic) infections caused by bacteria sensitive to piperacillin, particularly:
  • respiratory tract infections
  • kidney, urinary tract, and genital infections
  • widespread systemic infections (systemic infections and septicemia)
  • gynecological and abdominal infections
  • skin and soft tissue infections
• to prevent infections following surgical procedures (perioperative prophylaxis).

2. What you need to know before taking Piperital

Do not take Piperital

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to penicillins and cephalosporins
• if you are allergic to lidocaine or to other local anesthetics (amide-type). Lidocaine is contained in the solvent of Piperital powder and solvent for injectable solution for intramuscular use
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding")

Piperital must not be administered to children in the earliest infancy.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Piperital.
Before starting treatment with piperacillin, your doctor will ask whether you have had previous allergic
reactions to penicillins, cephalosporins, and other allergens, as severe and sudden allergic reactions (severe anaphylactic reactions) have been reported, mostly following administration of injectable penicillin.
The occurrence of such reactions is, however, more frequent in subjects with a history of hypersensitivity to
allergens causing asthma, hay fever, and itchy skin manifestations (urticaria).
If any allergic reaction occurs, your doctor will discontinue or instruct you to immediately stop
administration of the medicine and will provide appropriate therapy.
Prolonged use of penicillins, as with other antibiotics, may promote the development of non-susceptible microorganisms, including fungi, which will be appropriately treated by the doctor.
During prolonged treatments with high doses, your doctor will carry out periodic blood checks (hemogram) and liver and kidney function tests.
When piperacillin is administered in combination with medicines that thin the blood (heparins or oral anticoagulants or other medicines affecting the coagulation system), your doctor will perform more frequent monitoring.
Inform the anesthetist that you are taking piperacillin, as it may interact with medicines used to relax muscles during surgical procedures.
Do not use injectable sodium piperacillin solutions for local ophthalmic use.
Your doctor will use piperacillin with caution in patients with an infectious disease called mononucleosis.
Hemophagocytic lymphohistiocytosis
Cases of a disease in which the immune system produces an abnormally high number of white blood cells called histiocytes and lymphocytes, leading to inflammation (hemophagocytic lymphohistiocytosis), have been reported. This condition can be life-threatening if not diagnosed and treated early. If you develop several symptoms such as fever, swollen lymph nodes, feeling of weakness, mental confusion, shortness of breath, bruising, or skin rash, contact your doctor immediately.
Children
Piperital is contraindicated in the earliest infancy.
Other medicines and Piperital
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking any of the following medicines:

• other antibiotics (aminoglycosides, oxacillin, and flucloxacillin), as they may increase the effectiveness of Piperital
• penicillins and cephalosporins, as individuals allergic to these medicines may also be allergic to piperacillin
• medicines that thin the blood (heparins or oral anticoagulants or other medicines that may affect the coagulation system), as patients need to be monitored more frequently
• medicines that relax muscles during surgical procedures, as piperacillin may prolong their action
• methotrexate, a medicine used to treat cancer, arthritis, and psoriasis, as penicillins increase the time methotrexate remains in the body
• probenecid (a medicine used for gout), as it may increase the time required to eliminate piperacillin from the body

Piperacillin may interfere with certain laboratory tests (false positive Coombs test).
Piperacillin must not be mixed in the same solution with other antibiotics; it must be administered separately.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Piperital is contraindicated in pregnant and breastfeeding women.
Driving and using machines
Piperital does not impair the ability to drive or operate machinery.
Piperital contains sodium
This medicine contains approximately 1.9 mEq of sodium per gram of piperacillin. This should be taken into consideration in individuals with impaired renal function or those on a low-sodium diet.

3. How to take Piperital

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Piperacillin may be administered either into a muscle (intramuscular route) or into a vein (intravenous
route, either by direct injection or by infusion).
The recommended dose is:
intramuscular administration:

• adults: 2 g twice daily

intravenous administration:

• adults: 150–300 mg/kg/day (up to 24 g within 24 hours)

Use in children and adolescents
The recommended dose is:
intramuscular administration:

• children over 6 years of age: 1 g twice daily
• children under 6 years of age: 0.5 g twice daily

intravenous administration:

• children: 100–300 mg/kg/day.

These doses should be divided into multiple administrations depending on the site and severity of the infection.
Instructions for use

• for intramuscular administration: The vial included in the package, containing the local anesthetic lidocaine hydrochloride, must be used exclusively for intramuscular administration. The solution reconstituted with the solvent vial supplied in the package must be used immediately after preparation.
• intravenous administration: see the following section “The following information is intended exclusively for physicians or healthcare professionals”

Instructions for dissolution:
To achieve rapid dissolution of the product, inject the required solvent into the vial, shake vigorously for at least 15–20 seconds, and wait until a clear solution is obtained.
Patients with kidney problems
Your doctor will prescribe a reduced dose depending on the severity of the kidney impairment.
If you take more Piperital than you should
There are no known cases of overdose following piperacillin administration.
If you forget to take Piperital
Do not take a double dose to make up for the missed dose.
If you stop taking Piperital
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Side effects caused by piperacillin are rare and usually mild or moderate in severity, and generally common to all penicillins.
With this medicine, you may experience the following side effects:

• Severe allergic reactions (anaphylactic reactions) due to piperacillin and other serious allergic phenomena, as with other penicillins.

Hypersensitivity reactions
Itchy skin reactions (urticaria), fever, skin rashes are the most frequent manifestations; increase in a type of blood cells (eosinophilia), itching, skin inflammation with peeling (exfoliative dermatitis), severe skin reactions (erythema multiforme, Stevens-Johnson syndrome).
Gastrointestinal disorders
Nausea, vomiting, flatulence, diarrhoea.
Haematopoietic and lymphatic system disorders
Rarely and transiently, reduction in the number of certain blood cells (neutropenia, leucopenia, anaemia, granulocytopenia, thrombocytopenia) and disorders of blood coagulation.
Piperacillin may cause a positive Coombs test.
Renal and urinary disorders
Rarely, kidney damage (acute renal failure associated with interstitial nephritis).
Hepatobiliary disorders
Transient increases in plasma concentrations of certain parameters indicating liver function (transaminases, alkaline phosphatase, lactate dehydrogenase, gamma-glutamyl transferase, bilirubin), which return to normal after discontinuation of therapy.
Nervous system disorders
Dizziness, headache (cephalalgia), fatigue, hallucinations and muscle spasms (myoclonus).
General disorders and administration site conditions
Pain, redness (erythema) and hardening at the intramuscular injection site. Occasionally, inflammation of the veins (phlebitis and thrombophlebitis) after intravenous administration.
Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You may also report side effects directly via 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 Piperital

The solution reconstituted with the solvent vial supplied in the pack must be used
immediately after preparation.
Solutions prepared in a hospital environment are chemically and physically stable for 24 hours.
From a microbiological standpoint, stability is the direct responsibility of the operator; the solution may be
stored for a maximum of 24 hours under refrigeration (2-8°C).
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 Piperital contains
Piperital 1 g/2 ml powder and solvent for injectable solution for intramuscular use
Vial of powder:
Active substance: sodium piperacillin 1.04 g equivalent to 1 g of piperacillin
Solvent vial for exclusive intramuscular use:
Other components: lidocaine hydrochloride, water for injectable preparations

Piperital 2 g/4 ml powder and solvent for injectable solution for intramuscular use
Vial of powder:
Active substance: sodium piperacillin 2.08 g equivalent to 2 g of piperacillin
Solvent vial for exclusive intramuscular use:
Other components: lidocaine hydrochloride, water for injectable preparations

Piperital 2 g powder for injectable solution
Vial of powder:
Active substance: sodium piperacillin 2.08 g equivalent to 2 g of piperacillin

Piperital 4 g powder for injectable solution for infusion
Vial of powder:
Active substance: sodium piperacillin 4.16 g equivalent to 4 g of piperacillin

Description of the appearance of Piperital and pack contents
Powder and solvent for injectable solution for intramuscular use
1 vial of 1 g powder + 1 solvent vial of 2 ml
1 vial of 2 g powder + 1 solvent vial of 4 ml
The solvent vial is for intramuscular use only

Powder for injectable solution
10 vials of 2 g powder

Powder for infusion solution
1 vial of 4 g powder

Marketing Authorization Holder
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
Via Fossignano, 2 – 04011 Aprilia (LT)
e-mail: [email protected]

Manufacturer
Powder vials 1 g, 2 g, 4 g
ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI S.p.A. - Via Fossignano, 2 – 04011 Aprilia (LT)
S.A.L.F. S.p.A. Via Marconi, 2 - 24069 Cenate Sotto (Bergamo)

Responsible person for batch release
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. - Via Fossignano, 2 – 04011 Aprilia (LT)

The following information is intended exclusively for physicians or healthcare professionals

Piperital for intramuscular administration:
The vial supplied in the package, containing the local anesthetic lidocaine hydrochloride, must be used
exclusively for intramuscular administration.
The solution reconstituted with the solvent vial supplied in the package must be used
immediately after preparation.

Piperital for intravenous administration:
For direct intravenous administration, inject over a period of three to five minutes, using water
for injections (4 ml for the 1 g vial, 8 ml for the 2 g vial). For infusion, commonly used diluents may be employed, except those containing only sodium
bicarbonate. Piperacillin must not be mixed with 5-fluorouracil and aminoglycosides due to inactivation processes affecting the latter.
Do not use infusion solutions containing only sodium bicarbonate or solutions with a pH
higher than 8.5 or lower than 4.5.
Stability after reconstitution for intravenous use: 24 hours, both at room temperature and when refrigerated.

Reconstitution instructions:
To achieve rapid dissolution of the product, inject the required amount of solvent into the vial, shake vigorously for at least 15–20 seconds, and wait until a clear solution is obtained.