Ampicillin and sulbactam Ibi

Package leaflet: Information for the user

Ampicillin and Sulbactam IBI 500 mg + 250 mg / 1.6 ml

powder and solvent for injectable solution
Ampicillin/Sulbactam
Please read this leaflet carefully before starting treatment with this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed for personal use only and must not be given to other people,
as it may be harmful even if their symptoms are similar.
If you notice worsening of any adverse reaction, or if you notice any adverse reaction not listed
in this leaflet, consult your doctor or pharmacist.
In this leaflet:
1. What Ampicillin and Sulbactam IBI is and what it is used for
2. Before using Ampicillin and Sulbactam IBI
3. How to use Ampicillin and Sulbactam IBI
4. Possible side effects
5. How to store Ampicillin and Sulbactam IBI
6. Further information
1. What Ampicillin and Sulbactam IBI is and what it is used for
Ampicillin and Sulbactam IBI is a systemic antibacterial medicine containing a combination of two active substances: ampicillin and sulbactam.
Ampicillin is an antibiotic belonging to the penicillin group; sulbactam is a substance that enhances the activity of the medicine against bacteria resistant to ampicillin alone.
Ampicillin and Sulbactam IBI is used to treat infections caused by bacteria sensitive to Ampicillin and Sulbactam IBI and resistant to ampicillin alone, such as:

• infections of the upper and lower respiratory tract
• infections of the upper and lower urinary tract, including kidney infections
• intra-abdominal infections
• genital organ infections
• skin and mucous membrane infections
• preparation for surgical procedures (perioperative prophylaxis) to prevent severe infections in intra-abdominal surgery

2. Before using Ampicillin and Sulbactam IBI

Do not take Ampicillin and Sulbactam IBI:

• if you are allergic (hypersensitive) to penicillins or antibiotics in general, or to any of the components of Ampicillin and Sulbactam IBI
• if you have infectious mononucleosis, lymphatic leukemia, or infections caused by herpes viruses
• if you are pregnant and/or breastfeeding, when lidocaine for intramuscular injection is used Ampicillin and Sulbactam IBI must not be administered intramuscularly to neonates, infants, and children up to 2 years of age. Exercise particular caution with Ampicillin and Sulbactam IBI and consult your physician:
• if you have previously experienced skin rash or swelling of the face and neck after taking antibiotics
• if you have kidney problems
• if you are pregnant and/or breastfeeding (see "Pregnancy and breastfeeding")
• if you are on a high-fiber diet (non-absorbable carbohydrates): this may cause antibiotic-associated diarrhea
• if you are on a low-sodium diet: Ampicillin and Sulbactam IBI contains 57.5 mg of sodium per dose
• if you are taking other medicines listed under "Taking Ampicillin and Sulbactam IBI with other
  medicines"
• if your symptoms do not improve or worsen: as with many antibiotics, it may happen that some bacteria causing your infection have become resistant

Ampicillin and Sulbactam IBI may cause false positive results in certain urine tests, particularly for glucose (sugar). Therefore, if you are diabetic, inform your physician before changing your diet.
Caution: Ampicillin and Sulbactam IBI may cause allergic reactions (see "Possible Undesirable Effects") which may occur upon first administration, especially if you have or have had fungal skin infections.
Taking Ampicillin and Sulbactam IBI with other medicines
Inform your physician if you are currently using, or have recently used, any other medicines, including those without a prescription.
It is very important that you inform your physician if you are taking other medicines, particularly those containing probenecid, allopurinol, methotrexate, or hormonal contraceptives, other antibiotics or chemotherapeutic agents, or medicines used to prevent blood clots, such as warfarin.
Use of Ampicillin and Sulbactam IBI with food and drinks
Consult your physician before starting treatment with Ampicillin and Sulbactam IBI.
Pregnancy and breastfeeding
Ask your physician for advice before taking any medicine.
Consult your physician before starting treatment with Ampicillin and Sulbactam IBI if you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding.
Ampicillin and Sulbactam IBI with lidocaine for intramuscular injection must not be taken during pregnancy and breastfeeding (see "Do not take Ampicillin and Sulbactam IBI").
Driving and using machines
It is unlikely that Ampicillin and Sulbactam IBI will affect your ability to drive or use machines; however, some undesirable effects may occur during treatment (see "Possible Undesirable Effects").
Therefore, you should be aware of how you react to Ampicillin and Sulbactam IBI before driving vehicles or operating machinery.

3. How to use Ampicillina e Sulbactam IBI

Dosage
Always take Ampicillina e Sulbactam IBI exactly as directed by your doctor.
Your physician will determine the daily dosage and frequency of administration.
Maximum daily dosage: 8 g of ampicillin + 4 g of sulbactam.

Adults and adolescents (over 40 kg)
The recommended dose ranges from 3 g (ampicillin 2 g + sulbactam 1 g) to 12 g (ampicillin 8 g + sulbactam 4 g) administered daily in divided doses every 8 or 6 hours.
The dosage and administration schedule depend on the severity of the infection.

Children over 2 years of age
The recommended dose is 150 mg/kg/day (ampicillin 100 mg/kg/day + sulbactam 50 mg/kg/day).
The therapeutic dose should be administered in three or four equal doses.

Neonates, infants, and children up to 2 years of age
Do not administer Ampicillina e Sulbactam IBI intramuscularly (see "Do not take Ampicillina e Sulbactam IBI"). Ampicillina e Sulbactam IBI must be administered exclusively by intravenous route according to the methods described below.

Neonates from the second week of life onwards, infants, and children up to 2 years of age
The recommended dose is 150 mg/kg/day (ampicillin 100 mg/kg/day + sulbactam 50 mg/kg/day).
The therapeutic dose should be administered in three or four equal doses.

Neonates during the first week of life
The recommended dose is 75 mg/kg/day (ampicillin 50 mg/kg/day + sulbactam 25 mg/kg/day). The therapeutic dose should be administered in two equal doses.

Premature neonates
The recommended dose during the first four weeks up to the sixth week is 75 mg/kg/day (corresponding to ampicillin 50 mg/kg/day + sulbactam 25 mg/kg/day). The therapeutic dose should be administered in two equal doses.

Renal impairment
In patients with severe renal impairment, the dose of Ampicillina e Sulbactam IBI must be determined and monitored by the physician and administered with reduced frequency.

Patients on dialysis
Ampicillin and sulbactam are removed from the blood by dialysis. Therefore, Ampicillina e Sulbactam IBI should be administered immediately after dialysis and then at intervals of 48 hours until the next dialysis session.

Perioperative prophylaxis of serious infections in intra-abdominal surgery
For prophylaxis of surgical infections, 1.5 g (ampicillin 1 g + sulbactam 500 mg) to 3 g (ampicillin 2 g + sulbactam 1 g) of Ampicillina e Sulbactam IBI should be administered at the time of induction of anesthesia, and the dose should be repeated every 6–8 hours. Administration of Ampicillina e Sulbactam IBI is generally discontinued 24 hours after surgery, unless therapeutic use is indicated.

Method and route of administration
Ampicillina e Sulbactam IBI can be administered either intramuscularly or intravenously. Intravenous administration of Ampicillina e Sulbactam IBI must be performed exclusively by a physician.

Intravenous use
Intravenous injection: The sterile powder contained in the vial must be reconstituted with the solvent vial (water for injections) supplied in the package and administered as a bolus over at least 3 minutes after complete dissolution.

Intravenous infusion: The sterile powder in the vial may be reconstituted with the solvent vial (water for injections) supplied in the package and then further diluted with 50/100 ml of one of the compatible solutions, or it may be reconstituted directly with 50/100 ml of one of the compatible solutions (not with water for injections) and administered over 15–30 minutes.

Ampicillina e Sulbactam IBI is compatible with the following diluent solutions:

• Sodium chloride solution 9 mg/ml (0.9%)
• Sodium lactate solution
• Ringer's lactate solution
• Glucose infusion solution 50 mg/ml (5%)
• Sucrose infusion solution 100 mg/ml (10%)

After reconstitution, the solution must be used immediately and any unused portion must be discarded.

Intramuscular use
The sterile powder contained in the vial must be reconstituted with the solvent vial (water for injections) supplied in the package or with approximately 2 ml of a 0.5% lidocaine hydrochloride solution (for contraindications, see "Pregnancy and breastfeeding"). The solution should be administered by deep intramuscular injection. After reconstitution, the solution must be used immediately and any unused portion must be discarded.

The reconstituted solution should be inspected visually for the presence of particles and discoloration before administration. The reconstituted solution is clear and colorless.

Duration of treatment
Treatment duration: 5–14 days.
Treatment should be continued for at least 48 hours after the disappearance of fever and other symptoms.

If you take more Ampicillina e Sulbactam IBI than prescribed
Inform your doctor immediately. High doses of the medicine may cause convulsive or spastic crises.

If you forget to take Ampicillina e Sulbactam IBI
Do not take a double dose if you have forgotten to take the previous dose.

If you stop treatment with Ampicillina e Sulbactam IBI
It is important to continue taking Ampicillina e Sulbactam IBI unless otherwise instructed by your doctor.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Ampicillina e Sulbactam IBI may cause adverse reactions, although not everyone experiences them. Adverse reactions may be increased by alcohol consumption.

Very common adverse reactions (occur in more than 1 out of 10 patients):
Pain at the injection site associated with intramuscular administration.

Common adverse reactions (occur in more than 1 out of 100, but less than 1 out of 10 patients):
Pain at the injection site associated with intravenous administration, inflammation of the vein after intravenous administration (phlebitis), nausea, vomiting, mouth pain, black tongue, abdominal pain, flatulence (presence of gas in the abdomen), and diarrhoea.

Uncommon adverse reactions (occur in more than 1 out of 1,000, but less than 1 out of 100 patients):
Skin rash, pruritus, dermatitis and other non-specific skin eruptions, weakness, somnolence, dizziness and headache, cramps.

Rare adverse reactions (occur in more than 1 out of 10,000, but less than 1 out of 1,000 patients):
Inflammation of the kidneys (interstitial nephritis), crystal formation in the urine.

Very rare adverse reactions (occur in less than 1 out of 10,000 patients, including isolated reports):
Alterations in red blood cells (anaemia), changes in white blood cell count, reduction in platelets with altered coagulation mechanism, increased creatine phosphokinase (CPK), liver-related problems (hepatic dysfunction), changes in liver function tests (elevated transaminases, blood urea nitrogen, and creatinine), jaundice.

Warning: Discontinue Ampicillina e Sulbactam IBI and seek immediate medical attention or go to the nearest emergency room if you experience one or more of the following symptoms due to hypersensitivity to the medicine or allergic reactions (anaphylactic reactions): skin eruptions, pruritus, fever, joint pain, facial oedema, sweating, hypersalivation, laryngeal oedema with narrowing of the airways, laboured breathing, rapid heartbeat, abnormally low blood pressure (hypotension), numbness and weakness.

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

5. How to store Ampicillin and Sulbactam IBI

• Ampicillin and Sulbactam IBI does not require any special storage precautions
• Keep the medicine out of the reach and sight of children
• Do not use Ampicillin and Sulbactam IBI after the expiry date stated on the pack. The expiry date refers to the product stored correctly in its original intact packaging

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 Ampicillina e Sulbactam IBI contains
Each vial of powder contains:
Active substances
Ampicillin sodium 531.5 mg equivalent to Ampicillin 500 mg
Sodium sulbactam 273.5 mg equivalent to Sulbactam 250 mg
Each solvent vial contains:
1.6 ml of water for injections.

What Ampicillina e Sulbactam IBI looks like and contents of the pack
Ampicillina e Sulbactam IBI is supplied in a cardboard carton containing 1 vial of powder and 1 solvent vial.

Manufacturer and Marketing Authorization Holder:
Istituto Biochimico Italiano G. Lorenzini S.p.A. - Via di Fossignano 2 - Aprilia (LT) – Italy
Tel: +39 (0) 6 92 150 1
Fax: +39 (0) 6 92 150 500
e-mail: [email protected]

This medicinal product is authorized for sale in the following European Economic Area Member States
under the following names:
Italy: Ampicillina e Sulbactam IBI 500 mg + 250 mg / 1.6 ml powder and solvent for injectable solution

Date of the latest approval of this package leaflet by the Italian Medicines Agency (Agenzia Italiana del Farmaco)
July 2012

Package leaflet: Information for the user

Ampicillin and Sulbactam IBI 1 g + 500 mg / 3.2 ml

powder and solvent for injectable solution for intramuscular use
Ampicillin/Sulbactam
Read the leaflet carefully before starting treatment with this medicine
Keep this leaflet. You may need to read it again
If you have any questions, consult your doctor or pharmacist
This medicine has been prescribed for your personal use only and must not be given to other people,
as it may be harmful even if their symptoms are similar
If you notice worsening of any adverse reaction, or if you notice any adverse reaction not
listed in this leaflet, consult your doctor or pharmacist
In this leaflet:
1. What Ampicillin and Sulbactam IBI is and what it is used for
2. Before using Ampicillin and Sulbactam IBI
3. How to use Ampicillin and Sulbactam IBI
4. Possible side effects
5. How to store Ampicillin and Sulbactam IBI
6. Further information
1. What Ampicillin and Sulbactam IBI is and what it is used for
Ampicillin and Sulbactam IBI is a systemic antibacterial medicine containing the combination of
two active substances: ampicillin and sulbactam.
Ampicillin is an antibiotic belonging to the penicillin group; sulbactam is a substance that
enhances the activity of the medicine against bacteria resistant to ampicillin alone.
Ampicillin and Sulbactam IBI is used to treat infections caused by bacteria sensitive to
Ampicillin and Sulbactam IBI and resistant to ampicillin alone, such as:

• infections of the upper and lower respiratory tract
• infections of the upper and lower urinary tract, including kidney infections
• intra-abdominal infections
• genital organ infections
• skin and mucous membrane infections
• preoperative preparation (perioperative prophylaxis) to prevent serious infections during intra-abdominal surgery

2. Before using Ampicillina e Sulbactam IBI

Do not take Ampicillina e Sulbactam IBI:

• if you are allergic (hypersensitive) to penicillins or antibiotics in general, or to any of the components of Ampicillina e Sulbactam IBI
• if you have infectious mononucleosis, lymphatic leukemia, or infections caused by herpes viruses
• if you are pregnant and/or breastfeeding when lidocaine is used for intramuscular injection

Ampicillina e Sulbactam IBI must not be administered by intramuscular injection in newborns, infants, and children up to 2 years of age.

Take special care with Ampicillina e Sulbactam IBI and consult your doctor:

• if you have previously experienced skin rash or swelling of the face and neck after taking antibiotics
• if you have kidney problems
• if you are on a high-fiber diet (non-absorbable carbohydrates): this may cause antibiotic-associated diarrhea
• if you are on a low-sodium diet: Ampicillina e Sulbactam IBI contains 115 mg of sodium per dose
• if you are taking other medicines listed under "Taking Ampicillina e Sulbactam IBI with other medicines"
• if your symptoms do not improve or worsen: as with many antibiotics, it may happen that some bacteria causing your infection have become resistant

Ampicillina e Sulbactam IBI may give false positive results in certain urine tests, particularly for glucose (sugar). Therefore, if you are diabetic, inform your doctor before making any changes to your diet.

Warning: Ampicillina e Sulbactam IBI may cause allergic reactions (see "Possible Side Effects") which may occur upon first administration, especially if you have or have had fungal skin infections.

Taking Ampicillina e Sulbactam IBI with other medicines

Inform your doctor if you are currently using, or have recently used, any other medicines, including those without a prescription.

It is very important that you inform your doctor if you are taking other medicines, particularly those containing probenecid, allopurinol, methotrexate, or hormonal contraceptives, other antibiotics or chemotherapeutic agents, or medicines used to prevent blood clots, such as warfarin.

Use of Ampicillina e Sulbactam IBI with food and drinks

Consult your doctor before starting treatment with Ampicillina e Sulbactam IBI.

Pregnancy and breastfeeding

Ask your doctor for advice before taking any medicine.

Ampicillina e Sulbactam IBI with lidocaine must not be taken during pregnancy and breastfeeding (see "Do not take Ampicillina e Sulbactam IBI").

Consult your doctor before starting treatment with Ampicillina e Sulbactam IBI if you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding.

Driving and using machines

It is unlikely that Ampicillina e Sulbactam IBI affects your ability to drive or operate machinery. However, some side effects may occur during treatment (see "Possible Side Effects"). Therefore, you should be aware of how you react to Ampicillina e Sulbactam IBI before driving or operating machinery.

3. How to use Ampicillina e Sulbactam IBI

Dosage
Always take Ampicillina e Sulbactam IBI exactly as prescribed by your doctor.
Your doctor will determine the daily dosage and frequency of administration.
Maximum daily dosage: 8 g ampicillin + 4 g sulbactam.

Adult and adolescent patients (over 40 kg)
The recommended dose ranges from 3 g (ampicillin 2 g + sulbactam 1 g) to 12 g (ampicillin 8 g + sulbactam 4 g) administered daily in divided doses every 8 or 6 hours.
The dosage and administration schedule depend on the severity of the infection.

Children over 2 years of age
The recommended dose is 150 mg/kg/day (ampicillin 100 mg/kg/day + sulbactam 50 mg/kg/day).
The therapeutic dose should be administered in three or four equal doses.

Renal impairment
In patients with severe renal impairment, the dose of Ampicillina e Sulbactam IBI must be determined and monitored by the physician and administered less frequently.

Patients on dialysis
Ampicillin and sulbactam are removed from the blood by dialysis. Therefore, Ampicillina e Sulbactam IBI should be administered immediately after dialysis and then repeated every 48 hours until the next dialysis session.

Perioperative prophylaxis of serious infections in intra-abdominal surgery
For surgical infection prophylaxis, 1.5 g (ampicillin 1 g + sulbactam 500 mg) to 3 g (ampicillin 2 g + sulbactam 1 g) of Ampicillina e Sulbactam IBI should be administered at the time of induction of anesthesia, and the dose should be repeated every 6–8 hours. Administration of Ampicillina e Sulbactam IBI is generally discontinued 24 hours after surgery, unless therapeutic use is indicated.

Method and route of administration
Ampicillina e Sulbactam IBI with lidocaine must be administered exclusively by intramuscular route.

Intramuscular use
Intramuscular use
The sterile powder in the vial must be reconstituted with the solvent vial (chloridrato di lidocaina 0,5%) supplied in the package (for contraindications, see “Pregnancy and breastfeeding”) or with approximately 3 ml of water for injections. The solution must be administered by deep intramuscular injection.
After reconstitution, the solution must be used immediately and any unused portion must be discarded.
The reconstituted solution must be inspected visually for the presence of particles and discoloration prior to administration. The reconstituted solution is clear and colourless.

Duration of treatment
Treatment duration: 5–14 days.
Treatment should be continued for at least 48 hours after fever and other symptoms have resolved.

If you take more Ampicillina e Sulbactam IBI than prescribed
Inform your doctor immediately. High doses of the medicine may cause convulsive or spastic crises.

If you forget to take Ampicillina e Sulbactam IBI
Do not take a double dose if you have missed a dose.

If you stop treatment with Ampicillina e Sulbactam IBI
It is important to continue taking Ampicillina e Sulbactam IBI unless otherwise instructed by your doctor.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ampicillin and Sulbactam IBI may cause side effects, although not everybody experiences them. Side effects may be increased by alcohol consumption.

Very common side effects (occur in more than 1 in 10 patients):
Pain at the injection site associated with intramuscular administration.

Common side effects (occur in more than 1 in 100 but less than 1 in 10 patients):
Nausea, vomiting, mouth pain, black tongue, abdominal pain, flatulence (gas in the abdomen), and diarrhoea.

Uncommon side effects (occur in more than 1 in 1,000 but less than 1 in 100 patients):
Skin rash, itching, dermatitis and other non-specific skin eruptions, weakness, drowsiness, dizziness, headache, cramps.

Rare side effects (occur in more than 1 in 10,000 but less than 1 in 1,000 patients):
Inflammation of the kidneys (interstitial nephritis), formation of crystals in the urine.

Very rare side effects (occur in less than 1 in 10,000 patients, including isolated reports):
Changes in red blood cells (anaemia), changes in white blood cell count, reduction in platelets with altered blood clotting mechanism, increased creatine phosphokinase (CPK), liver problems (hepatic dysfunction), changes in liver function tests (increased transaminases, blood urea nitrogen and creatinine), jaundice.

Warning: Discontinue Ampicillin and Sulbactam IBI and seek immediate medical advice from a doctor or the nearest emergency department if you experience one or more of the following symptoms due to hypersensitivity or allergic reactions (anaphylactic reactions): skin eruptions, itching, fever, joint pain, facial oedema, sweating, hypersalivation, laryngeal oedema with narrowing of the airways, laboured breathing, rapid heartbeat, abnormally low blood pressure (hypotension), numbness and weakness.

If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

5. How to store Ampicillin and Sulbactam IBI

• Ampicillin and Sulbactam IBI does not require any special storage precautions
• Keep the medicine out of the reach and sight of children
• Do not use Ampicillin and Sulbactam IBI after the expiry date stated on the packaging. The expiry date refers to the product properly stored in its original, intact packaging
  Medicines must 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 Ampicillina e Sulbactam IBI contains
Each vial of powder contains:
Active substances
Sodium ampicillin 1063 mg equivalent to ampicillin 1000 mg
Sodium sulbactam 547 mg equivalent to sulbactam 500 mg
Each solvent vial contains:
3.2 ml of 0.5% lidocaine hydrochloride and water for injections.

What Ampicillina e Sulbactam IBI looks like and contents of the pack
Ampicillina e Sulbactam IBI is supplied in a cardboard carton containing 1 vial of powder and 1 solvent vial.

Manufacturer and Marketing Authorization Holder:
Istituto Biochimico Italiano G. Lorenzini S.p.A. - Via Fossignano 2 - Aprilia (LT) – Italy
Tel: +39 (0) 6 92 150 1
Fax: +39 (0) 6 92 150 500
e-mail: [email protected]

This medicinal product is authorized for sale in the following European Economic Area Member States
under the following names:
Italy: Ampicillina e Sulbactam IBI 1 g + 500 mg / 3.2 ml powder and solvent for solution for intramuscular injection

Date of the latest approval of this package leaflet by the Italian Medicines Agency
July 2012

Package leaflet: information for the user

Ampicillin and Sulbactam IBI 1 g + 500 mg powder for injectable solution

Ampicillin/Sulbactam
Read the package leaflet carefully before starting treatment with this medicine.
Keep this package leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for your personal use only and must not be given to other people,
as it may be harmful even if their symptoms are similar.
If you notice a worsening of any adverse reaction, or if you notice any adverse reaction not listed
in this leaflet, consult your doctor or pharmacist.
In this leaflet:
1. What Ampicillin and Sulbactam IBI is and what it is used for
2. Before using Ampicillin and Sulbactam IBI
3. How to use Ampicillin and Sulbactam IBI
4. Possible side effects
5. How to store Ampicillin and Sulbactam IBI
6. Further information
1. What Ampicillin and Sulbactam IBI is and what it is used for
Ampicillin and Sulbactam IBI is a systemic antibacterial medicine containing a combination of
two active substances: ampicillin and sulbactam.
Ampicillin is an antibiotic belonging to the penicillin group; sulbactam is a substance that
enhances the activity of the medicine against bacteria resistant to ampicillin alone.
Ampicillin and Sulbactam IBI is used to treat infections caused by bacteria sensitive to
Ampicillin and Sulbactam IBI and resistant to ampicillin alone, such as:

• infections of the upper and lower respiratory tract
• infections of the upper and lower urinary tract, including kidney infections
• intra-abdominal infections
• genital organ infections
• skin and mucous membrane infections
• preoperative preparation (perioperative prophylaxis) to prevent serious infections in intra-abdominal surgery

2. Before using Ampicillin and Sulbactam IBI

Do not take Ampicillin and Sulbactam IBI:

• if you are allergic (hypersensitive) to penicillins or antibiotics in general, or to any component of Ampicillin and Sulbactam IBI
• if you have infectious mononucleosis, lymphatic leukemia, or infections caused by herpes viruses
• if you are pregnant and/or breastfeeding when lidocaine is used for intramuscular injection
  Ampicillin and Sulbactam IBI must not be administered intramuscularly to neonates, infants, and children up to 2 years of age.
  Take special care with Ampicillin and Sulbactam IBI and consult your doctor:
• if you have previously experienced skin rash or swelling of the face and neck after taking antibiotics
• if you have kidney problems
• if you are pregnant and/or breastfeeding (see "Pregnancy and breastfeeding")
• if you are on a high-fiber diet (non-absorbable carbohydrates): this may cause antibiotic-associated diarrhea
• if you are on a low-sodium diet: Ampicillin and Sulbactam IBI contains 115 mg of sodium per dose
• if you are taking other medicines listed under "Taking Ampicillin and Sulbactam IBI with other medicines"
• if your symptoms do not improve or worsen: as with many antibiotics, it may happen that some bacteria causing your infection have become resistant

Ampicillin and Sulbactam IBI may cause false positive results in certain urine tests, particularly for glucose. Therefore, if you are diabetic, inform your doctor before making any dietary changes.
Warning: Ampicillin and Sulbactam IBI may cause allergic reactions (see "Possible Side Effects") which may occur upon first administration, especially if you have or have had fungal skin infections.
Taking Ampicillin and Sulbactam IBI with other medicines
Inform your doctor if you are currently using, or have recently used, any other medicines, including over-the-counter medicines.
It is very important that you inform your doctor if you are taking other medicines, particularly those containing probenecid, allopurinol, methotrexate, or hormonal contraceptives, other antibiotics or chemotherapeutic agents, or medicines used to prevent blood clots, such as warfarin.
Use of Ampicillin and Sulbactam IBI with food and beverages
Consult your doctor before starting treatment with Ampicillin and Sulbactam IBI.
Pregnancy and breastfeeding
Ask your doctor for advice before taking any medicine.
Consult your doctor before starting treatment with Ampicillin and Sulbactam IBI if you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding.
Ampicillin and Sulbactam IBI with lidocaine for intramuscular injection must not be used during pregnancy and breastfeeding (see "Do not take Ampicillin and Sulbactam IBI").
Driving and using machines
It is unlikely that Ampicillin and Sulbactam IBI affects your ability to drive or operate machinery, but some side effects may occur during treatment (see "Possible Side Effects").
Therefore, you should be aware of how you react to Ampicillin and Sulbactam IBI before driving or operating machinery.

3. How to use Ampicillina e Sulbactam IBI

Dosage
Always take Ampicillina e Sulbactam IBI exactly as directed by your doctor.
Your doctor will determine the daily dosage and frequency of administration.
Maximum daily dosage: 8 g of ampicillin + 4 g of sulbactam.

Adults and adolescents (over 40 kg)
The recommended dose ranges from 3 g (ampicillin 2 g + sulbactam 1 g) to 12 g (ampicillin 8 g + sulbactam 4 g) administered daily in divided doses every 8 or 6 hours.
The dosage and administration schedule depend on the severity of the infection.

Children older than 2 years
The recommended dose is 150 mg/kg/day (ampicillin 100 mg/kg/day + sulbactam 50 mg/kg/day).
The therapeutic dose should be administered in three or four equal doses.

Neonates, infants, and children up to 2 years of age
Do not administer Ampicillina e Sulbactam IBI intramuscularly (see “Do not take Ampicillina e Sulbactam IBI”). Ampicillina e Sulbactam IBI must be administered exclusively by intravenous route according to the following instructions.

Neonates from the second week of life onwards, infants, and children up to 2 years of age
The recommended dose is 150 mg/kg/day (ampicillin 100 mg/kg/day + sulbactam 50 mg/kg/day).
The therapeutic dose should be administered in three or four equal doses.

Neonates during the first week of life
The recommended dose is 75 mg/kg/day (ampicillin 50 mg/kg/day + sulbactam 25 mg/kg/day). The therapeutic dose should be administered in two equal doses.

Premature neonates
The recommended dose during the first four weeks and up to the sixth week is 75 mg/kg/day (corresponding to ampicillin 50 mg/kg/day + sulbactam 25 mg/kg/day). The therapeutic dose should be administered in two equal doses.

Renal impairment
In patients with severe renal impairment, the dose of Ampicillina e Sulbactam IBI must be determined and monitored by the physician and should be administered less frequently.

Patients on dialysis
Ampicillin and sulbactam are removed from the blood by dialysis. Therefore, Ampicillina e Sulbactam IBI should be administered immediately after dialysis and then repeated at 48-hour intervals until the next dialysis session.

Perioperative prophylaxis of serious infections in intra-abdominal surgery
For prophylaxis of surgical infections, 1.5 g (ampicillin 1 g + sulbactam 500 mg) to 3 g (ampicillin 2 g + sulbactam 1 g) of Ampicillina e Sulbactam IBI should be administered at the time of induction of anesthesia, and the dose should be repeated every 6–8 hours. Administration of Ampicillina e Sulbactam IBI is generally discontinued 24 hours after surgery, unless therapeutic use is indicated.

Method and route of administration
Ampicillina e Sulbactam IBI can be administered either intramuscularly or intravenously. Intravenous administration of Ampicillina e Sulbactam IBI must be performed exclusively by a physician.

Intravenous use
Intravenous injection: The sterile powder in the vial should be reconstituted with approximately 3 ml of water for injections and administered as a bolus over at least 3 minutes after complete dissolution.
Intravenous infusion: The sterile powder in the vial may be reconstituted with 50/100 ml of one of the compatible solutions (not with water for injections) and administered over 15–30 minutes.
Ampicillina e Sulbactam IBI is compatible with the following diluent solutions:

• Sodium chloride 9 mg/ml (0.9%) solution
• Sodium lactate solution
• Ringer's lactate solution
• Glucose 50 mg/ml (5%) infusion solution
• Sucrose 100 mg/ml (10%) infusion solution

After reconstitution, the solution must be used immediately and any unused portion must be discarded.

Intramuscular use
The sterile powder in the vial should be reconstituted with approximately 3 ml of water for injections or 0.5% lidocaine hydrochloride solution (for contraindications, see Pregnancy and lactation). The solution should be administered by deep intramuscular injection. After reconstitution, the solution must be used immediately and any unused portion must be discarded.

The reconstituted solution should be visually inspected for the presence of particles and discoloration prior to administration. The reconstituted solution is clear and colorless.

Duration of treatment
Treatment duration: 5–14 days.
Treatment should continue for at least 48 hours after the disappearance of fever and other symptoms.

If you take more Ampicillina e Sulbactam IBI than you should
Inform your doctor immediately. High doses of the medicine may cause convulsive or spastic crises.

If you forget to take Ampicillina e Sulbactam IBI
Do not take a double dose if you have missed a previous dose.

If you stop treatment with Ampicillina e Sulbactam IBI
It is important to continue taking Ampicillina e Sulbactam IBI unless otherwise instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ampicillina e Sulbactam IBI may cause side effects, although not everybody gets them. The side effects may be increased by alcohol consumption.

Very common side effects (occur in more than 1 in 10 patients):
Pain at the injection site associated with intramuscular administration.

Common side effects (occur in more than 1 in 100 patients but less than 1 in 10):
Pain at the injection site associated with intravenous administration, inflammation of the vein after intravenous administration (phlebitis), nausea, vomiting, mouth pain, black tongue, abdominal pain, flatulence (gas in the abdomen), and diarrhoea.

Uncommon side effects (occur in more than 1 in 1,000 patients but less than 1 in 100):
Skin rash, itching, dermatitis and other non-specific skin eruptions, weakness, drowsiness, dizziness and headache, cramps.

Rare side effects (occur in more than 1 in 10,000 patients but less than 1 in 1,000):
Inflammation of the kidneys (interstitial nephritis), formation of crystals in the urine.

Very rare side effects (occur in less than 1 in 10,000 patients, including isolated reports):
Alterations in red blood cells (anaemia), changes in white blood cell count, reduction in platelets with altered coagulation mechanism, increased creatine phosphokinase (CPK), liver problems (hepatic dysfunction), changes in liver function tests (elevated transaminases, blood urea nitrogen and creatinine), jaundice.

Warning: Stop using Ampicillina e Sulbactam IBI and contact a doctor or go immediately to the nearest emergency department if you experience one or more of the following symptoms due to hypersensitivity or allergic reactions (anaphylactic reactions): skin eruptions, itching, fever, joint pain, facial oedema, sweating, hypersalivation, laryngeal oedema with narrowing of the airways, laboured breathing, rapid heartbeat, abnormally low blood pressure (hypotension), numbness and weakness.

If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

5. How to store Ampicillina e Sulbactam IBI

• Ampicillina e Sulbactam IBI does not require any special storage precautions
• Keep the medicine out of the reach and sight of children
• Do not use Ampicillina e Sulbactam IBI after the expiry date stated on the packaging. The expiry date refers to the product properly stored in its intact original packaging

Medicines must 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 Ampicillina e Sulbactam IBI contains
Each vial of powder contains:
Active substances
Sodium ampicillin 1063 mg equivalent to ampicillin 1000 mg
Sodium sulbactam 547 mg equivalent to sulbactam 500 mg

What Ampicillina e Sulbactam IBI looks like and contents of the pack
Ampicillina e Sulbactam IBI is supplied in a cardboard carton containing 1 vial of powder (20 ml or 50 ml) or 10 vials of powder (20 ml or 50 ml).

Manufacturer and Marketing Authorization Holder:
Istituto Biochimico Italiano G. Lorenzini S.p.A. - Via Fossignano 2 - Aprilia (LT) – Italy
Tel: +39 (0) 6 92 150 1
Fax: +39 (0) 6 92 150 500
e-mail: [email protected]

This medicinal product is authorized for sale in the following European Economic Area Member States
under the following names:
Czech Republic: Ampicillin and Sulbactam IBI 1 g + 500 mg prášek pro přípravu injekčního roztoku
Germany: Ampicillin und Sulbactam IBI 1 g + 500 mg Pulver zur Herstellung einer Injektionslösung
Italy: Ampicillina e Sulbactam IBI 1 g + 500 mg polvere per soluzione iniettabile

Date of the latest approval of this package leaflet by the Italian Medicines Agency (Agenzia Italiana del Farmaco)
July 2012

Package leaflet: information for the user

Ampicillin and Sulbactam IBI 2 g + 1 g powder for injectable solution

Ampicillin/Sulbactam
Read this leaflet carefully before starting treatment with 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 for your personal use only and must not be given to other people,
as it may be harmful even if their symptoms are similar.
If you notice worsening of any adverse reaction or if you notice a side effect not listed in this leaflet,
contact your doctor or pharmacist.
This leaflet contains:
1. What Ampicillin and Sulbactam IBI is and what it is used for
2. Before using Ampicillin and Sulbactam IBI
3. How to use Ampicillin and Sulbactam IBI
4. Possible side effects
5. How to store Ampicillin and Sulbactam IBI
6. Further information
1. What Ampicillin and Sulbactam IBI is and what it is used for
Ampicillin and Sulbactam IBI is a systemic antibacterial medicine containing the combination of two active substances: ampicillin and sulbactam.
Ampicillin is an antibiotic belonging to the penicillin group; sulbactam is a substance that enhances the activity of the medicine against bacteria resistant to ampicillin alone.
Ampicillin and Sulbactam IBI is used to treat infections caused by bacteria sensitive to Ampicillin and Sulbactam IBI and resistant to ampicillin alone, such as:

• infections of the upper and lower respiratory tract
• infections of the upper and lower urinary tract, including kidney infections
• intra-abdominal infections
• genital organ infections
• skin and mucous membrane infections
• preoperative preparation (perioperative prophylaxis) to prevent serious infections during intra-abdominal surgery

2. Before using Ampicillin and Sulbactam IBI

Do not take Ampicillin and Sulbactam IBI:

• if you are allergic (hypersensitive) to penicillins or antibiotics in general, or to any of the components of Ampicillin and Sulbactam IBI
• if you have infectious mononucleosis, lymphocytic leukemia, or infections caused by herpes viruses
• if you are pregnant and/or breastfeeding when lidocaine is used for intramuscular injection. Ampicillin and Sulbactam IBI must not be administered intramuscularly to neonates, infants, and children up to 2 years of age.

Take special care with Ampicillin and Sulbactam IBI and consult your doctor:

• if you have previously experienced skin rash or swelling of the face and neck after taking antibiotics
• if you have kidney problems
• if you are pregnant and/or breastfeeding (see "Pregnancy and breastfeeding")
• if you are on a high-fiber diet (non-absorbable carbohydrates): this may cause diarrhea associated with antibiotic use
• if you are on a low-sodium diet: Ampicillin and Sulbactam IBI contains 230 mg of sodium per dose
• if you are taking other medicines listed under "Taking Ampicillin and Sulbactam IBI with other medicines"
• if your symptoms do not improve or worsen: as with many antibiotics, it may happen that some bacteria causing your infection have become resistant

Ampicillin and Sulbactam IBI may cause false positive results in certain urine tests, particularly for glucose (sugar). Therefore, if you are diabetic, inform your doctor before making any changes to your diet.
Warning: Ampicillin and Sulbactam IBI may cause allergic reactions (see "Possible Side Effects") which may occur even with the first dose, especially if you have or have previously had fungal skin infections.

Taking Ampicillin and Sulbactam IBI with other medicines
Inform your doctor if you are currently using, or have recently used, any other medicines, including those not requiring a prescription.
It is very important that you inform your doctor if you are taking other medicines, particularly those containing probenecid, allopurinol, methotrexate, or hormonal contraceptives, other antibiotics or chemotherapeutic agents, or medicines used to prevent blood clots, such as warfarin.

Use of Ampicillin and Sulbactam IBI with food and beverages
Consult your doctor before starting treatment with Ampicillin and Sulbactam IBI.

Pregnancy and breastfeeding
Ask your doctor for advice before taking any medicine.
Consult your doctor before starting treatment with Ampicillin and Sulbactam IBI if you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding.
Ampicillin and Sulbactam IBI with lidocaine for intramuscular injection must not be used during pregnancy and breastfeeding (see "Do not take Ampicillin and Sulbactam IBI").

Driving and using machines
It is unlikely that Ampicillin and Sulbactam IBI will affect your ability to drive or operate machinery. However, some side effects may occur during treatment (see "Possible Side Effects").
Therefore, you should be aware of how you react to Ampicillin and Sulbactam IBI before driving or operating machinery.

3. How to use Ampicillina e Sulbactam IBI

Dosage
Always take Ampicillina e Sulbactam IBI exactly as prescribed by your doctor.
Your physician will determine the daily dosage and frequency of administration.
Maximum daily dosage: 8 g of ampicillin + 4 g of sulbactam.

Adults and adolescents (over 40 kg)
The recommended dose ranges from 3 g (ampicillin 2 g + sulbactam 1 g) to 12 g (ampicillin 8 g + sulbactam 4 g) administered daily in divided doses every 8 or 6 hours.
The dosage and administration schedule depend on the severity of the infection.

Children over 2 years of age
The recommended dose is 150 mg/kg/day (ampicillin 100 mg/kg/day + sulbactam 50 mg/kg/day).
The therapeutic dose should be administered in three or four equal doses.

Neonates, infants, and children up to 2 years of age
Do not administer Ampicillina e Sulbactam IBI by intramuscular route (see "Do not take Ampicillina e Sulbactam IBI"). Ampicillina e Sulbactam IBI must be administered exclusively by intravenous route according to the methods described below.

Neonates from the second week of life onwards, infants, and children up to 2 years of age
The recommended dose is 150 mg/kg/day (ampicillin 100 mg/kg/day + sulbactam 50 mg/kg/day).
The therapeutic dose should be administered in three or four equal doses.

Neonates during the first week of life
The recommended dose is 75 mg/kg/day (ampicillin 50 mg/kg/day + sulbactam 25 mg/kg/day). The therapeutic dose should be administered in two equal doses.

Premature neonates
The recommended dose during the first four weeks up to the sixth week is 75 mg/kg/day (corresponding to ampicillin 50 mg/kg/day + sulbactam 25 mg/kg/day). The therapeutic dose should be administered in two equal doses.

Renal impairment
In patients with severe renal impairment, the dose of Ampicillina e Sulbactam IBI must be determined and monitored by the physician and should be administered less frequently.

Patients undergoing dialysis
Ampicillin and sulbactam are removed from the blood by dialysis. Therefore, Ampicillina e Sulbactam IBI should be administered immediately after dialysis and then repeated at intervals of 48 hours until the next dialysis session.

Perioperative prophylaxis of serious infections in intra-abdominal surgery
For surgical infection prophylaxis, 1.5 g (ampicillin 1 g + sulbactam 500 mg) to 3 g (ampicillin 2 g + sulbactam 1 g) of Ampicillina e Sulbactam IBI should be administered at the time of anesthesia induction, and the dose should be repeated every 6–8 hours. Administration of Ampicillina e Sulbactam IBI is generally discontinued 24 hours after surgery, unless therapeutic use is indicated.

Method and route of administration
Ampicillina e Sulbactam IBI can be administered either by intramuscular or intravenous route. The intravenous administration of Ampicillina e Sulbactam IBI must be performed exclusively by a physician.

Intravenous use
Intravenous injection: The sterile powder contained in the vial should be reconstituted with 6–7 ml of water for injections and administered as a bolus over at least 3 minutes, after complete dissolution.

Intravenous infusion: The sterile powder contained in the vial should be reconstituted with 100 ml of one of the compatible solutions (not with water for injections) and administered over 15 to 30 minutes.
Ampicillina e Sulbactam IBI is compatible with the following diluent solutions:

• Sodium chloride 9 mg/ml (0.9%) solution
• Sodium lactate solution
• Lactated Ringer's solution
• Glucose 50 mg/ml (5%) infusion solution
• Sucrose 100 mg/ml (10%) infusion solution

After reconstitution, the solution must be used immediately and any unused portion must be discarded.

Intramuscular use
The sterile powder in the vial must be reconstituted with 6–7 ml of water for injections or 0.5% lidocaine hydrochloride solution (for contraindications, see "Pregnancy and lactation"). The solution should be administered by deep intramuscular injection. After reconstitution, the solution must be used immediately and any unused portion must be discarded.

The reconstituted solution should be visually inspected for the presence of particles and discoloration prior to administration. The reconstituted solution is clear and colorless.

Duration of treatment
Treatment duration: 5–14 days.
Treatment should be continued for at least 48 hours after the disappearance of fever and other symptoms.

If you take more Ampicillina e Sulbactam IBI than prescribed
Inform your doctor immediately. High doses of this medicine may cause convulsive or spastic crises.

If you forget to take Ampicillina e Sulbactam IBI
Do not take a double dose if you have missed a dose.

If you stop treatment with Ampicillina e Sulbactam IBI
It is important to continue taking Ampicillina e Sulbactam IBI unless otherwise instructed by your doctor.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ampicillina e Sulbactam IBI can cause side effects, although not everyone experiences them. Side effects may be increased by alcohol consumption.

Very common side effects (occur in more than 1 in 10 patients):
Pain at the injection site associated with intramuscular administration.

Common side effects (occur in more than 1 in 100 patients but less than 1 in 10):
Pain at the injection site associated with intravenous administration, inflammation of the vein after intravenous administration (phlebitis), nausea, vomiting, mouth pain, black tongue, abdominal pain, flatulence (gas in the abdomen), and diarrhoea.

Uncommon side effects (occur in more than 1 in 1,000 patients but less than 1 in 100):
Skin rash, pruritus, dermatitis and other non-specific skin eruptions, weakness, drowsiness, dizziness, headache, cramps.

Rare side effects (occur in more than 1 in 10,000 patients but less than 1 in 1,000):
Inflammation of the kidneys (interstitial nephritis), crystal formation in the urine.

Very rare side effects (occur in less than 1 in 10,000 patients, including isolated reports):
Alterations in red blood cells (anaemia), changes in white blood cell count, reduction in platelets with coagulation disorders, increased creatine phosphokinase (CPK), liver problems (hepatic dysfunction), changes in liver function tests (increased transaminases, blood urea nitrogen and creatinine), jaundice.

Warning: Discontinue Ampicillina e Sulbactam IBI and seek immediate medical attention from a doctor or the nearest emergency department if you experience one or more of the following symptoms due to hypersensitivity to the medicine or allergic reactions (anaphylactic reactions): skin eruptions, pruritus, fever, joint pain, facial oedema, sweating, hypersalivation, laryngeal oedema with narrowing of the airways, laboured breathing, rapid heartbeat, abnormally low blood pressure (hypotension), numbness and weakness.

If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

5. How to store Ampicillin and Sulbactam IBI

• Ampicillin and Sulbactam IBI does not require any special storage precautions
• Keep the medicine out of the reach and sight of children
• Do not use Ampicillin and Sulbactam IBI after the expiry date stated on the pack. The expiry date refers to the product properly stored in its original intact packaging

Medicines must 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 Ampicillina e Sulbactam IBI contains
Each vial of powder contains:
Active substances
Sodium ampicillin 2132 mg equivalent to ampicillin 2000 mg
Sodium sulbactam 1099 mg equivalent to sulbactam 1000 mg

What Ampicillina e Sulbactam IBI looks like and contents of the pack
Ampicillina e Sulbactam IBI is supplied in a cardboard carton containing 1 vial of powder (20 ml or 100 ml) or 10 vials of powder (20 ml or 100 ml).

Manufacturer and Marketing Authorization Holder:
Istituto Biochimico Italiano G. Lorenzini S.p.A. - Via di Fossignano 2 - Aprilia (LT) – Italy
Tel: +39 (0) 6 92 150 1
Fax: +39 (0) 6 92 150 500
e-mail: [email protected]

This medicinal product is authorized for sale in the following European Economic Area Member States under the following names:
Germany: Ampicillin und Sulbactam IBI 2 g + 1 g powder for solution for injection
Italy: Ampicillina e Sulbactam IBI 2 g + 1 g powder for injectable solution

Date of the latest approval of this package leaflet by the Italian Medicines Agency (Agenzia Italiana del Farmaco)
July 2012