Ampicillin sulbactam delfarma

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Ampicillin Sulbactam Delfarma
2 g + 1 g, powder for solution for injection and infusion
Ampicillinum + Sulbactamum
Please read this leaflet carefully before using the 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 another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 known as “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 combined 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 peritoneal contamination 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

Page 1 of 8
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, it is essential to inform 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 taking an 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 treatment with ampicillin and 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;
• the patient develops a new infection (e.g. fungal infection) while receiving Ampicillin Sulbactam Delfarma; the doctor may then decide to discontinue treatment.

During prolonged 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 used 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);
• anticoagulant medicines (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) – when administered concomitantly with amoxicillin, may increase antibiotic serum concentration;
• chloramphenicol, erythromycin, sulfonamides (antibiotics): concomitant administration of Ampicillin Sulbactam Delfarma with any of these medicines may reduce its effectiveness;
• oral contraceptives containing estrogens: there is a risk that contraceptive effectiveness may decrease; to avoid unintended pregnancy, an additional non-hormonal contraceptive method should be used;
• methotrexate (a medicine used e.g. in rheumatoid arthritis, in neoplastic diseases): ampicillin may increase its toxicity;
• salicylic acid, indomethacin, phenylbutazone: may prolong 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

Page 2 of 8

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

Use of Ampicillin Sulbactam Delfarma during pregnancy should be avoided unless the doctor considers it 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 230.2 mg (10 mmol) of sodium (the main component of table salt) per vial.
This corresponds to 11.5% of the maximum recommended daily sodium intake in the adult diet.
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 preparation of the medicine for use and method of administration").

This should be taken into consideration 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 self-administer this medicine. The medicine will be given to the patient by a qualified healthcare professional, i.e. a doctor or nurse.
Ampicillin Sulbactam Delfarma can 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 (containing 4 g of sulbactam) should not exceed 12 g.
Milder infections may be treated by administering the medicine every 12 hours.

Dosage for the treatment of ventilator-associated pneumonia and bacteremia caused by Acinetobacter baumannii
The recommended daily dose is 18 g (12 g + 6 g) administered in 6 divided doses.
Higher daily doses have been described in the medical literature for this indication.
For surgical 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 serum and tissues during the procedure. The dose may be repeated every 6–8 hours; administration of the drug should be discontinued within 24 hours after completion of most surgical procedures, unless further cycles of therapy with Ampicillin Sulbactam Delfarma are indicated.
Page 3 of 8
For the treatment of uncomplicated gonorrhea, Ampicillin Sulbactam Delfarma may be administered as a single 1.5 g dose. To increase serum concentration and prolong the action of ampicillin and sulbactam, 1.0 g of probenecid should be administered orally.
Children, infants, and newborns
The dose of Ampicillin Sulbactam Delfarma for the treatment of most infections in children, infants, and newborns 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 newborns every 6–8 hours, in accordance with standard ampicillin dosing recommendations.
In newborns during the first week of life (especially in preterm 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), given 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, administered 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 their physician.
Duration of treatment
The duration of treatment will be determined by the physician according to the severity and type of infection. The physician's instructions must be followed.
Method of administration and preparation of solutions
Detailed information is provided at the end of this leaflet in the section intended for healthcare professionals – "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 overdose has occurred, they should contact their physician, pharmacist, or nurse as quickly as possible. Overdose may lead to an increase in adverse effects, 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, regular dosing should be continued. A double dose should not be administered to make up for the missed dose.
Discontinuation of Ampicillin Sulbactam Delfarma
It is important to use the drug according to the recommended treatment regimen. Treatment should not be discontinued simply because the patient feels better. Premature discontinuation of therapy may result in recurrence of infection.

4. Possible adverse effects

Like all medicines, this medicine can cause the following adverse effects, although they do not occur in everyone.
Serious adverse effects
Rare (occur in 1 to 10 out of 10,000 patients):
Page 4 of 8

• widespread skin rash, with possible blisters and peeling of the skin, 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 a serious intestinal inflammation (called pseudomembranous colitis), which may occur following antibiotic use.

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

• sudden wheezing, swelling of lips, face or body, 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, you must immediately stop taking this medicine and
seek immediate medical advice from your doctor or go to the nearest hospital emergency department.
Other adverse effects that should be reported to your doctor if they occur
Very common (occur in more than 1 in 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
• convulsions, dizziness
• colitis (inflammation of the colon)
• tubulointerstitial nephritis
• toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis (serious skin reactions with skin peeling or detachment)

Frequency unknown (cannot be estimated from available data):

• candidiasis (yeast infection), reduced susceptibility of pathogenic bacteria to the antibiotic used
• changes in the number of different types of blood cells: pancytopenia (reduction in all normal blood cell components: red blood cells, white blood cells and platelets), prolonged blood clotting time, marked decrease in granulocytes, leukopenia, neutropenia, anaemia, including haemolytic anaemia (reduction in red blood cells, including due to red blood cell breakdown), eosinophilia, thrombocytopenic purpura
• loss of appetite
• symptoms of nervous system damage (including mood changes, agitation, insomnia, depression, psychosis, convulsions, visual disturbances, tinnitus)
• allergic vasculitis
• shortness of breath

Page 5 of 8

• 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 disturbances, jaundice, increased liver enzyme activity
• joint pain
• mucosal inflammation
• rash, itching, skin reactions, urticaria
• impaired platelet aggregation

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects 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 wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will 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 2 g of ampicillin and 1 g 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.
Packaging: one vial in a cardboard box.

Marketing Authorisation Holder 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: 42506/14-10-2008
Page 6 of 8
Parallel Import Authorisation Number: 57/24

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 pain at the injection site, 0.5% sterile solution of lidocaine hydrochloride anhydrous may be used for reconstitution.

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 of the infusion solution should be achieved by adding an appropriate diluent (do not use water for injections). 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 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 Ampicillin Sulbactam Delfarma, is incompatible with aminoglycosides and should not be mixed in the same container.

The concentrated solution for intramuscular injection should be used within 1 hour after preparation.

Solutions intended for intravenous injection and infusion remain stable depending on the diluent used and the storage temperature.

Page 7 of 8

Page 8 of 8