Ampicillin sulbactam delfarma

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Ampicillin Sulbactam Delfarma
1 g + 500 mg, powder for solution for injection and infusion
Ampicillinum + Sulbactamum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Ampicillin Sulbactam Delfarma is and what it is used for
2. Important information before using Ampicillin Sulbactam Delfarma
3. How to use Ampicillin Sulbactam Delfarma
4. Possible side effects
5. How to store Ampicillin Sulbactam Delfarma
6. Contents of the pack and other information

1. What Ampicillin Sulbactam Delfarma is and what it is used for

Ampicillin Sulbactam Delfarma is an antibiotic with bactericidal activity against bacteria causing infections. It contains two different active substances: ampicillin and sulbactam. Ampicillin belongs to a group of medicines called “penicillins”, whose activity may sometimes be inhibited (inactivated). The second active component (sulbactam) counteracts this inactivation.
Ampicillin Sulbactam Delfarma is indicated for the treatment of the following infections caused by microorganisms sensitive to ampicillin with sulbactam:

• upper respiratory tract infections, including sinusitis, otitis media, and tonsillitis;
• lower respiratory tract infections, including bacterial pneumonia and bronchitis;
• urinary tract infections and pyelonephritis;
• skin and soft tissue infections;
• gonococcal infections.

Ampicillin Sulbactam Delfarma may also be administered in the perioperative period to reduce the incidence of postoperative wound infections in patients undergoing abdominal or pelvic surgery, where peritonitis may occur.
Ampicillin Sulbactam Delfarma is recommended for the treatment of ventilator-associated pneumonia and bacteremia (presence of bacteria in the blood) caused by Acinetobacter baumannii.
Ampicillin Sulbactam Delfarma may be used prophylactically after childbirth or caesarean section to reduce the risk of postoperative sepsis.

2. Important information before using Ampicillin Sulbactam Delfarma

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When not to use Ampicillin Sulbactam Delfarma

If the patient is allergic (hypersensitive) to ampicillin or sulbactam.
If the patient has previously experienced hypersensitivity to penicillins.

Warnings and precautions

• If the patient has previously had an allergic reaction to penicillins or other beta-lactam antibiotics, this must be reported to the doctor before starting treatment with this medicine.
• If the patient experiences an allergic reaction, characterized by sudden onset of wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, administration of the medicine must be stopped immediately and medical advice sought without delay.
• If diarrhoea occurs after using the antibiotic, the patient should consult a doctor.
• If any of the following adverse effects occur: abdominal pain, itching, darkening of the urine, yellowing of the skin or eyes, nausea (feeling sick) or general malaise, the patient should inform the doctor immediately. These symptoms may indicate liver damage caused by ampicillin with sulbactam.

The doctor should also be informed if:

• the patient has infectious mononucleosis (a viral disease); skin rash may occur in patients with mononucleosis after taking ampicillin;
• the patient has kidney disease and/or needs to monitor sodium intake;
• a new infection (e.g. fungal infection) occurs during treatment with Ampicillin Sulbactam Delfarma; the doctor may then decide to discontinue treatment.

During long-term therapy, periodic monitoring of kidney, liver, and haematopoietic system function is recommended. This is particularly important in newborns (especially premature infants) and infants.

Ampicillin Sulbactam Delfarma and other medicines

Tell the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.

In particular, inform the doctor if the patient is taking:

• allopurinol (used in the treatment of gout – a disease characterized by recurrent joint inflammation): the frequency of skin rash may increase;
• aminoglycoside antibiotics (e.g. streptomycin, tobramycin, gentamicin);
• anticoagulants (medicines preventing blood clots), such as warfarin: tendency to bleeding may increase;
• probenecid (used in the treatment of gout, in cases of elevated uric acid levels in blood) administered concomitantly with amoxicillin may increase antibiotic concentration in blood serum;
• chloramphenicol, erythromycin, sulfonamides (antibiotics): concomitant administration of Ampicillin Sulbactam Delfarma with any of these drugs may reduce its effectiveness;
• oral contraceptives containing estrogens: there is a risk that the contraceptive efficacy may decrease; to avoid unintended pregnancy, an additional non-hormonal method of contraception should be used;
• methotrexate (a medicine used e.g. in rheumatoid arthritis, in neoplastic diseases): ampicillin may increase its toxicity;
• salicylic acid, indometacin, phenylbutazone: may prolong the elimination of penicillins from the body.

Effect on laboratory test results

In patients treated with ampicillin, urine glucose tests may yield false positive results; therefore, if such testing is necessary, enzymatic tests are recommended.

Pregnancy and breastfeeding

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If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Use of Ampicillin Sulbactam Delfarma during pregnancy should be avoided unless the doctor considers its use necessary.

Breastfeeding is not recommended during treatment with Ampicillin Sulbactam Delfarma.

Driving and operating machinery

The effect of the medicine on the ability to drive and operate machinery is unknown.

Ampicillin Sulbactam Delfarma contains sodium

The medicine contains 115.1 mg (5 mmol) of sodium (main component of table salt) per vial.
This corresponds to 5.8% of the maximum recommended daily dietary sodium intake for adults.
The sodium content originating from the solvent should be taken into account when calculating the total sodium content in the prepared dilution of the product (see section “Instructions for preparing the medicine for use and method of administration”).

This should be considered in patients with impaired kidney function and in patients monitoring sodium intake in their diet.

3. How to use Ampicillin Sulbactam Delfarma

The patient does not administer this medicine independently. The medicine will be given by a suitably trained person,
i.e. a doctor or nurse.
Ampicillin Sulbactam Delfarma may be administered by intramuscular or intravenous injection or by intravenous infusion.
Recommended dose
Adults
The usual dose is 1.5 g to 12 g per day given in divided doses every 6–8 hours.
The daily dose of Ampicillin Sulbactam Delfarma (4 g of sulbactam) must not exceed 12 g.
Milder infections may be treated by administering the drug every 12 hours.

Dosage in the treatment of respiratory tract pneumonia and bacteremia caused by Acinetobacter baumannii
The recommended daily dose is 18 g (12 g + 6 g) administered in 6 divided doses.
Medical literature describes the use of even higher daily doses for this indication.
For surgical infection prophylaxis, 1.5 g to 3 g of Ampicillin Sulbactam Delfarma should be administered during anesthesia to ensure adequate time to achieve therapeutic drug concentrations in blood serum and tissues during the procedure. The dose may be repeated every 6–8 hours; administration of the drug should be discontinued 24 hours after completion of most surgical procedures, unless further cycles of Ampicillin Sulbactam Delfarma therapy are indicated.
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For treatment of uncomplicated gonorrhea, Ampicillin Sulbactam Delfarma may be administered as a single 1.5 g dose. To increase and prolong plasma concentrations of ampicillin and sulbactam, 1.0 g of probenecid should be administered orally.
Children, infants, and neonates
The dose of Ampicillin Sulbactam Delfarma for treatment of most infections in children, infants, and neonates is 150 mg/kg body weight per day (corresponding to 100 mg/kg body weight per day of ampicillin and 50 mg/kg body weight per day of sulbactam).
Ampicillin Sulbactam Delfarma should be administered to children, infants, and neonates every 6–8 hours, in accordance with standard ampicillin dosing regimens.
In neonates during the first week of life (especially premature infants), the recommended dose is 75 mg/kg body weight per day (corresponding to 50 mg/kg body weight per day of ampicillin and 25 mg/kg body weight per day of sulbactam), administered in divided doses every 12 hours.
In children with body weight < 40 kg, the recommended dose is 300 mg (200 mg ampicillin + 100 mg sulbactam)/kg body weight per day, given in divided doses every 6 hours.
If during treatment the patient feels that the effect of the drug is too strong or too weak, they should consult a physician.
Duration of treatment
The duration of treatment will be determined by the physician according to the severity and type of infection. The patient should follow the physician's instructions.
Method of administration and preparation of solutions
Detailed information is provided at the end of this leaflet in the section intended for medical personnel – "Information intended exclusively for healthcare professionals".
Administration of a higher than recommended dose of Ampicillin Sulbactam Delfarma
Administration of a dose higher than recommended is unlikely. If the patient suspects that an excessive dose has been administered, they should contact their physician, pharmacist, or nurse as soon as possible. Overdose may intensify adverse reactions, including central nervous system irritation and seizures. In case of doubt regarding the method of administration, consult a physician, pharmacist, or nurse.
Missed dose of Ampicillin Sulbactam Delfarma
If a dose scheduled at a fixed time is missed, the drug should be administered as soon as possible, provided that sufficient time remains before the next scheduled dose; otherwise, continue with the regular dosing schedule. Do not administer a double dose to compensate for a missed dose.
Discontinuation of Ampicillin Sulbactam Delfarma
It is important to use the drug exactly as prescribed for the full duration of treatment. Do not discontinue treatment simply because the patient feels better. Premature discontinuation of treatment may result in recurrence of infection.

4. Possible adverse reactions

Like any medicine, this medicine can cause the following adverse reactions, although they do not occur in everyone.
Serious adverse reactions
Rare (occur in 1 to 10 out of 10,000 patients):
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• widespread skin rash, with blisters and skin peeling within the rash, particularly around the mouth, nose, eyes, and genital organs;
• severe diarrhoea, persisting for a prolonged period or containing blood, accompanied by abdominal pain and fever; this may be a sign of severe intestinal inflammation (called pseudomembranous colitis), which may occur after antibiotic use.

Frequency unknown (frequency cannot be estimated from available data):

• sudden wheezing, swelling of the lips, face or body, skin rash, fainting or difficulty swallowing, anaphylactic shock, angioedema (severe allergic reaction);
• swelling of the face, lips, tongue and (or) throat with difficulty swallowing or breathing (angioedema), skin rash (erythema), blisters, redness or bruising of the skin (urticaria).

➢ If any of these symptoms occur, the medicine must be discontinued immediately and
a doctor must be contacted immediately or the nearest hospital emergency department visited.
Other adverse reactions that should be reported to a doctor if they occur
Very common (occur in more than 1 out of 10 patients):

• diarrhoea

Common (occur in 1 to 10 out of 100 patients):

• nausea, abdominal pain

Uncommon (occur in 1 to 10 out of 1,000 patients):

• thrombocytopenia (low platelet count, affecting blood clotting)
• headache, drowsiness
• feeling of fatigue
• vomiting, glossitis (inflammation of the tongue)
• hyperbilirubinemia (increased bilirubin levels)

Rare (occur in 1 to 10 out of 10,000 patients):

• pseudomembranous colitis
• seizures, dizziness
• colitis
• tubulointerstitial nephritis
• toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis (severe skin reactions with skin peeling or detachment)

Frequency unknown (cannot be estimated from available data):

• candidiasis (yeast infection), reduced sensitivity of pathogenic bacteria to the antibiotic used
• changes in the number of various types of blood cells: pancytopenia (deficiency of all normal blood cells: red blood cells, white blood cells, and platelets), prolonged blood clotting time, marked reduction in granulocytes, reduced number of leukocytes, reduced number of neutrophil granulocytes, anaemia, including haemolytic anaemia (reduced number of red blood cells, including due to red blood cell breakdown), eosinophilia, thrombocytopenic purpura
• loss of appetite
• symptoms of nervous system damage (e.g. mood changes, agitation, insomnia, depression, psychosis, seizures, visual disturbances, tinnitus)
• allergic vasculitis
• shortness of breath

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• vomiting blood, bleeding from the small intestine and (or) colon, inflammation of the oral mucosa, dry mouth, epigastric pain, taste disturbances, bloating, black hairy tongue
• bile stasis (cholestasis), liver function disorders, jaundice, increased liver enzyme activity
• joint pain
• mucositis (inflammation of mucous membranes)
• rash, itching, skin reactions, urticaria
• impaired platelet aggregation

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ampicillin Sulbactam Delfarma

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ampicillin Sulbactam Delfarma contains
The active substances are ampicillin (in the form of sodium ampicillin) and sulbactam (in the form of sodium sulbactam). One vial contains 1 g of ampicillin and 500 mg of sulbactam.
The medicine does not contain any other ingredients.

What Ampicillin Sulbactam Delfarma looks like and contents of the pack
White or almost white powder.
Pack: one vial in a cardboard box.

Responsible entity in Greece, country of export:
Pfizer Hellas A.E., A. Mesogeion 243, 154 51 Neo Psichiko, Greece
Manufacturer:
Haupt Pharma Latina S.r.l., Strada Statale 156 Km 47,600, 04100 Borgo San Michele, Latina, Italy
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Greece, country of export: 42504/14-10-2008
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Parallel import authorisation number: 56/24

Information intended exclusively for healthcare professionals

Instructions for preparation of the medicinal product for use and method of administration
Any unused product or waste material must be disposed of in accordance with local regulations.

Pharmaceutical incompatibilities
Ampicillin Sulbactam Delfarma and aminoglycosides must be prepared and administered separately due to in vitro inactivation of aminoglycosides by all aminopenicillins.

Preparation of solutions

Intramuscular injection
Dissolve Ampicillin Sulbactam Delfarma in 3.2 mL of sterile water for injections or another compatible diluent (e.g. isotonic sodium chloride solution, 5% aqueous glucose solution). To reduce injection pain, 0.5% sterile solution of lidocaine hydrochloride anhydrous may be used as solvent.

Intravenous injection
Dissolve Ampicillin Sulbactam Delfarma in at least 3.2 mL of sterile water for injections or another compatible diluent (e.g. isotonic sodium chloride solution, 5% aqueous glucose solution) and administer slowly (over at least 3 minutes).

Intravenous infusion
Dissolve Ampicillin Sulbactam Delfarma in at least 3.2 mL of sterile water for injections or another compatible diluent (e.g. isotonic sodium chloride solution, 5% aqueous glucose solution). The final volume for infusion should be achieved by adding an appropriate diluent (do not use water for injections for final dilution). Administer intravenously by infusion over 15–30 minutes.
To ensure complete dissolution of the active substances and dissipation of foam, wait several minutes after reconstitution.

Sodium sulbactam is compatible with most intravenous diluents; however, sodium ampicillin, and thus the medicinal product Ampicillin Sulbactam Delfarma, is less stable in solutions containing glucose or other carbohydrates. Therefore, it should not be mixed with blood products or protein hydrolysates.

Ampicillin, and thus the medicinal product Ampicillin Sulbactam Delfarma, is incompatible with aminoglycosides and must not be mixed in the same container.

The concentrated solution for intramuscular injection must be used within 1 hour after preparation.
Solutions intended for intravenous injection and infusion retain stability depending on the diluent used and storage temperature.

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