Ampicillin Sulbactam Delfarma

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Ampicillin Sulbactam Delfarma

2 g + 1 g, powder for solution for injection and infusion

Ampicillin + Sulbactam

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ampicillin Sulbactam Delfarma and what is it 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 packaging and other information

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

Ampicillin Sulbactam Delfarma is an antibiotic that works bactericidally on bacteria that cause infections. It contains two different medicines: ampicillin and sulbactam. Ampicillin belongs to a group of medicines called "penicillins", which may sometimes be inactivated. The second active ingredient (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;
• gonorrheal infections.

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

2. Important information before using Ampicillin Sulbactam Delfarma

Page 1 8

When not to use Ampicillin Sulbactam Delfarma

If the patient is allergic (hypersensitive) to ampicillin or sulbactam. If the patient has a history of hypersensitivity to penicillins.

Warnings and precautions

• If the patient has a history of allergic reactions to penicillins or other beta-lactam antibiotics, they should inform their doctor before starting treatment with the 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, they should discontinue the medicine and seek medical attention immediately.
• If the patient experiences diarrhea after taking an antibiotic, they should consult their doctor.
• If the patient experiences any of the following side effects: abdominal pain, itching, dark urine, yellowing of the skin or eyes, nausea (vomiting) or general malaise, they should inform their doctor immediately. These symptoms may indicate liver damage caused by the use of ampicillin with sulbactam.

The patient should also inform their doctor if:

• they have infectious mononucleosis (viral disease); patients with mononucleosis may experience a skin rash after taking ampicillin;
• they have kidney disease and/or need to control their sodium intake;
• they experience a new infection (e.g., thrush) while taking Ampicillin Sulbactam Delfarma; the doctor may then decide to discontinue treatment with the medicine.

During long-term therapy, periodic tests of the internal organs, kidneys, liver, and hematopoietic system are recommended. This is especially important in newborns (especially premature infants) and infants.

Ampicillin Sulbactam Delfarma and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should inform their doctor if they are taking:

• allopurinol (used to treat gout - a disease characterized by recurring joint inflammation): the frequency of skin rash increases;
• aminoglycoside antibiotics (e.g., streptomycin, tobramycin, gentamicin);
• anticoagulant medicines (medicines that prevent blood clotting), such as warfarin: the risk of bleeding may increase;
• probenecid (used to treat gout, with increased uric acid levels in the blood) administered simultaneously with amoxicillin may increase the concentration of the antibiotic in the blood;
• chloramphenicol, erythromycin, sulfonamides (antibiotics): concurrent administration of Ampicillin Sulbactam Delfarma with any of these medicines may reduce the effectiveness of the medicine;
• oral contraceptives containing estrogens: there is a risk that the effectiveness of the contraceptive may be reduced; to avoid unplanned pregnancy, a non-hormonal method of contraception should be used;
• methotrexate (a medicine used, for example, in rheumatoid arthritis, cancer): ampicillin may increase its toxicity;
• salicylic acid, indomethacin, phenylbutazone: may prolong the elimination of penicillins from the body.

Effect on laboratory test results
In patients treated with ampicillin, glucose tests in urine may be falsely positive, and therefore, if such a test is necessary, it is recommended to use enzymatic tests.

Pregnancy and breastfeeding

Page 2 8
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
The use of Ampicillin Sulbactam Delfarma should be avoided during pregnancy, unless the doctor considers it necessary.
During treatment with Ampicillin Sulbactam Delfarma, breastfeeding is not recommended.

Driving and using machines

The effect of the medicine on the ability to drive and use machines is unknown.

Ampicillin Sulbactam Delfarma contains sodium

The medicine contains 230.2 mg (10 mmol) of sodium (the main component of common salt) per vial.
This corresponds to 11.5% of the maximum recommended daily intake of sodium in the diet for adults.
The sodium content from the solvent should be taken into account when calculating the total sodium content in the prepared dilution of the product (see the "Instructions for preparing the medicine for use and method of administration" section).
This should be considered in patients with impaired renal function and in patients controlling their sodium intake.

3. How to use Ampicillin Sulbactam Delfarma

The patient does not use this medicine on their own. The medicine will be administered to the patient by a qualified person, i.e., a doctor or nurse.
Ampicillin Sulbactam Delfarma can be administered by intramuscular or intravenous injection or by intravenous infusion.
Recommended dose

Adults

Usually, 1.5 g to 12 g is administered per day in divided doses every 6-8 hours.
The daily dose of Ampicillin Sulbactam Delfarma should not exceed 12 g (4 g of sulbactam).
Infections with a milder course can be treated by administering the medicine every 12 hours.
Dosage in the treatment of ventilator-associated pneumonia and bacteremia caused by Acinetobacter baumanii.
The recommended daily dose is 18 g (12 g + 6 g) in 6 divided doses.
Higher daily doses have been reported in the medical literature for this indication.
In the prevention of surgical infections, 1.5 g to 3 g of Ampicillin Sulbactam Delfarma should be administered during anesthesia, ensuring an adequate period to achieve therapeutic concentrations of the medicine in the blood and tissues during the procedure. The dose can be repeated every 6-8 hours; administration of the medicine is discontinued after 24 hours from the end of most surgical procedures, unless another therapeutic cycle with Ampicillin Sulbactam Delfarma is indicated.

Page 3 8
In the treatment of uncomplicated gonorrhea, Ampicillin Sulbactam Delfarma can be administered as a single dose of 1.5 g. To increase the concentration and prolong the action of ampicillin and sulbactam in the blood, 1.0 g of probenecid should be administered orally.

Children, infants, and newborns

The dose of Ampicillin Sulbactam Delfarma in the treatment of most infections in children, infants, and newborns is 150 mg/kg body weight per day (corresponding to a dose of 100 mg/kg body weight per day of ampicillin and 50 mg/kg body weight per day of sulbactam).
Children, infants, and newborns should be administered Ampicillin Sulbactam Delfarma every 6-8 hours, according to the usual dosing of ampicillin.
In newborns in the first week of life (especially premature infants), the recommended dose is 75 mg/kg body weight per day (corresponding to a dose of 50 mg/kg body weight per day of ampicillin and 25 mg/kg body weight per day of sulbactam) in divided doses every 12 hours.
In children with a weight below 40 kg, the recommended dose is 300 mg (200 mg of ampicillin + 100 mg of sulbactam)/kg body weight per day in divided doses every 6 hours.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Duration of treatment

The duration of treatment will be determined by the doctor, depending on the severity and type of infection. The patient should follow the doctor's recommendations.

Method of administration and preparation of solutions

Detailed information is provided at the end of the leaflet in the section intended for medical personnel - "Information intended exclusively for medical personnel".

Use of a higher dose of Ampicillin Sulbactam Delfarma than recommended

Administration of a dose higher than recommended is unlikely. If the patient believes they have been given a dose higher than recommended, they should contact their doctor, pharmacist, or nurse as soon as possible. Overdose of the medicine may lead to an increase in side effects, including central nervous system irritation and seizures. In case of doubts about the method of administration of the medicine, the patient should consult their doctor, pharmacist, or nurse.

Missing a dose of Ampicillin Sulbactam Delfarma

In case of missing a dose of the medicine at a fixed, specified time, the medicine should be administered as soon as possible, if the time to administer the next dose is long enough, or the regular administration of the medicine should be continued. A double dose should not be used to make up for a missed dose.

Discontinuation of Ampicillin Sulbactam Delfarma

It is important to use the medicine according to the recommended treatment cycle. The patient should not stop treatment because they feel better. If the treatment cycle is discontinued too early, the infection may recur.

4. Possible side effects

Like all medicines, this medicine can cause the following side effects, although not everybody gets them.

Severe side effects

Rare (occurring in 1 to 10 out of 10,000 patients):
Page 4 8

• widespread rash on the skin, with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals;
• severe diarrhea, persistent and bloody, with abdominal pain and fever; this may be a sign of severe colitis (pseudomembranous colitis), which can occur after antibiotic treatment.

Frequency not known (cannot be estimated from the available data):

• sudden wheezing, swelling of the 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 discoloration of the skin (urticaria).

➢ If any of these symptoms occur, the patient should discontinue the medicine and immediately inform their doctor or go to the emergency room of the nearest hospital.
Other side effects that the patient should inform their doctor about if they occur
Very common (occurring in more than 1 in 10 patients):

• diarrhea

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

• nausea, abdominal pain

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

• thrombocytopenia (low platelet count, which can affect blood clotting)
• headache, drowsiness
• fatigue
• vomiting, glossitis
• hyperbilirubinemia (increased bilirubin levels)

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

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

Frequency not known (cannot be estimated from the available data):

• candidiasis (fungal infection), decreased susceptibility of pathogenic bacteria to the antibiotic used
• changes in blood cell count: pancytopenia (deficiency of all normal blood cell elements), prolonged bleeding time, significant decrease in granulocyte count, decrease in white blood cell count, decrease in neutrophil count, anemia, including hemolytic anemia (decrease in red blood cell count), eosinophilia, thrombocytopenic purpura
• anorexia
• symptoms of nervous system damage (including mood changes, excitement, insomnia, depression, psychosis, seizures, vision disturbances, tinnitus)
• allergic vasculitis
• dyspnea

Page 5 8

• hematemesis, gastrointestinal bleeding, oral mucositis, dry mouth, abdominal pain, taste disturbances, bloating, black hairy tongue
• cholestasis, liver function disorders, jaundice, increased liver enzyme activity
• arthralgia
• stomatitis
• rash, pruritus, skin reactions, urticaria
• platelet aggregation disorder

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ampicillin Sulbactam Delfarma

The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ampicillin Sulbactam Delfarma contains

The active substances of the medicine are ampicillin (in the form of ampicillin sodium) and sulbactam (in the form of sulbactam sodium). 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 what the packaging contains

White or almost white powder.
Packaging:one vial in a cardboard box.

Responsible entity in Greece, the 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Greek marketing authorization number: 42506/14-10-2008
Page 6 8

Parallel import authorization number: 57/24

Date of leaflet approval: 12.02.2024 -------------------------------------------------------------------------------------------------------------

Information intended exclusively for medical personnel

Instructions for preparing the medicine for use and method of administration

Any unused product or waste materials should be disposed of in accordance with local regulations.

Incompatibilities

Ampicillin Sulbactam Delfarma and aminoglycosides should be prepared and administered separately due to the in vitro inactivation of aminoglycosides by all aminopenicillins.

Preparation of solutions

Intramuscular injection
Ampicillin Sulbactam Delfarma should be dissolved in 3.2 ml of sterile water for injections or another compatible solution (e.g., isotonic sodium chloride solution, 5% aqueous glucose solution). To avoid pain during injection, 0.5% sterile lidocaine hydrochloride solution can be used to prepare the solution.
Intravenous injection
Ampicillin Sulbactam Delfarma should be dissolved in at least 3.2 ml of sterile water for injections or another compatible solution (e.g., isotonic sodium chloride solution, 5% aqueous glucose solution) and administered slowly (over at least 3 minutes).
Intravenous infusion
Ampicillin Sulbactam Delfarma should be dissolved in at least 3.2 ml of sterile water for injections or another compatible solution (e.g., isotonic sodium chloride solution, 5% aqueous glucose solution). The final volume of the infusion solution should be achieved by adding an appropriate solvent (do not use water for injections). Administer intravenously as an infusion over 15-30 minutes.
To ensure complete dissolution of the medicine, wait a few minutes until the active ingredients are completely dissolved and the foam has disappeared.
Sulbactam sodium is compatible with most intravenous solvents, but ampicillin sodium, and therefore Ampicillin Sulbactam Delfarma, is less stable in solutions containing glucose or other carbohydrates, and should not be mixed with blood products or protein hydrolysates.
Ampicillin, and therefore Ampicillin Sulbactam Delfarma, is incompatible with aminoglycosides and should not be mixed in the same container.
The concentrated solution for intramuscular injectionsshould be used within 1 hour of preparation.
Solutions for intravenous injections and infusionsare stable depending on the diluent used and the storage temperature.

Page 7 8

Page 8 8