Ampicilin+sulbactam Aptapharma

Leaflet attached to the packaging: patient information

Ampicillin+Sulbactam AptaPharma, 1 g + 0.5 g,

powder for solution for injection/infusion

Ampicillin+Sulbactam AptaPharma, 2 g + 1 g, powder for solution for injection/infusion

Ampicillin + Sulbactam

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor. See section 4.

Table of contents of the leaflet

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

1. What is Ampicillin+Sulbactam AptaPharma and what is it used for

Ampicillin+Sulbactam AptaPharma is a broad-spectrum antibiotic. It treats infections caused by bacteria sensitive to ampicillin and sulbactam.
Ampicillin belongs to a group of medicines called "penicillins" (a type of beta-lactam antibiotic).
Sulbactam enhances the effect of ampicillin by blocking beta-lactamases, enzymes that inactivate penicillins.
The doctor may give the patient Ampicillin+Sulbactam AptaPharma to treat the following bacterial infections:

• upper respiratory tract infections, including sinusitis (inflammation of the mucous membranes lining the sinuses), otitis media or pharyngitis (inflammation of the pharynx);
• lower respiratory tract infections, including pneumonia;
• urinary tract infections, including pyelonephritis (inflammation of the kidneys);
• intra-abdominal infections, including peritonitis (inflammation of the peritoneum) and cholecystitis (inflammation of the gallbladder), endometritis (inflammation of the endometrium) and pelvic inflammatory disease;
• bacteremia; skin, soft tissue, bone and joint infections
• pre- or post-operative to reduce the frequency of surgical wound infections if the patient is undergoing abdominal or pelvic surgery.

2. Important information before using Ampicillin+Sulbactam AptaPharma

When not to use Ampicillin+Sulbactam AptaPharma

intramuscularly

Children and adolescents
Ampicillin+Sulbactam AptaPharma should not be given to children under 2 years of age by intramuscular injection.

Warnings and precautions

Beforestarting treatment with Ampicillin+Sulbactam AptaPharma, discuss it with your doctor, pharmacist, or nurse if:

• the patient has had an allergic reaction to penicillins or other antibiotics (cephalosporins) or other substances that cause an allergic reaction
• the patient has liver problems;
• the patient has mononucleosis or lymphatic leukemia.

As with any prolonged treatment, during treatment with Ampicillin+Sulbactam AptaPharma, the doctor may order periodic tests of kidney, liver, and blood function, especially in children, newborns, and premature babies.
Inform the doctor immediately if abdominal pain, itching, dark urine, yellowing of the whites of the eyes or skin, nausea, or weakness occur. These may be signs of liver function disorders caused by ampicillin with sulbactam.
In patients with infectious mononucleosis, a skin rash is very often observed with the use of ampicillin with sulbactam, so this medicine should be avoided in these patients.

Inform the doctor immediately if the following occur during treatment with Ampicillin+Sulbactam

AptaPharma in the patient::

• severe skin reactions (redness, rash). The doctor will decide whether to discontinue treatment.
• allergic reactions. In such cases, the administration of Ampicillin+Sulbactam AptaPharma should be discontinued, and the doctor will start appropriate treatment. Severe hypersensitivity reactions will be treated immediately.
• persistent and severe diarrhea (mixed with blood and mucus). You should talk to your doctor immediately, as this may be a sign of a life-threatening condition. As with other antibiotics, during prolonged treatment, an "overgrowth" of microorganisms resistant to Ampicillin+Sulbactam AptaPharma may occur, including fungi. In such cases, appropriate treatment should be started, which will be determined by the doctor based on the patient's condition. Do not take any anti-diarrheal medications without consulting your doctor.

Ampicillin+Sulbactam AptaPharma and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor if you are taking any of the following medicines:

• medicines used to treat gout (allopurinol, probenecid) often increase the frequency of rashes
• aminoglycoside antibiotics
• anticoagulant medicines
• antibacterial medicines (chloramphenicol, erythromycin, sulfonamide, and tetracycline)
• methotrexate (a medicine used to treat cancer or rheumatic diseases)

Effect on laboratory test results:
Ampicillin+Sulbactam AptaPharma may cause false-positive results in urine sugar tests and some hormone level tests in pregnant women.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
The doctor will carefully decide whether a pregnant woman should receive Ampicillin+Sulbactam AptaPharma, considering the benefit-to-risk ratio, as there is no evidence that the use of this medicine in pregnant women is safe.
Breastfeeding
Ampicillin and sulbactam pass into breast milk in small amounts. In breastfeeding mothers, the use of the medicine may cause side effects in children, such as diarrhea. Ampicillin+Sulbactam AptaPharma should be used during breastfeeding only if the expected benefits outweigh the potential risk.
Fertility
Animal studies on reproductive effects have not shown evidence of a harmful effect of sulbactam and ampicillin on fertility.

Driving and using machines

Ampicillin+Sulbactam AptaPharma has a minor influence on the ability to drive and use machines, but side effects may occur that can prolong the reaction time (such as dizziness, seizures, or drowsiness). In such cases, do not drive vehicles or operate machines.

Ampicillin+Sulbactam AptaPharma contains sodium

Ampicillin+Sulbactam AptaPharma, 1 g + 0.5 g:
This medicine contains 5 mmol (115 mg) of sodium (the main component of table salt) per vial. This corresponds to 5.75% of the maximum recommended daily sodium intake in the diet for adults. Consult your doctor or pharmacist if it is necessary to use 4 or more vials per day for a longer period, especially in patients controlling their sodium intake.
Ampicillin+Sulbactam AptaPharma, 2 g + 1 g:
This medicine contains 10 mmol (230 mg) of sodium (the main component of table salt) per vial. This corresponds to 11.5% of the maximum recommended daily sodium intake in the diet for adults. Consult your doctor or pharmacist if it is necessary to use 2 or more vials per day for a longer period, especially in patients controlling their sodium intake.

3. How to use Ampicillin+Sulbactam AptaPharma

The medicine will always be prepared and administered to the patient by a doctor or healthcare professional.
The medicine can be administered intramuscularly as a deep intramuscular injection or intravenously in a bolus lasting at least 3 minutes or using larger dilutions (50-100 mL) in intravenous infusion lasting 15-30 minutes.

Adults

The doctor will determine the dose based on the severity of the infection and the patient's condition. The recommended dose is 1.5 g (1 g ampicillin + 0.5 g sulbactam) to 12 g (8 g ampicillin + 4 g sulbactam), which can be divided into equal doses every 8 or 6 hours. The total dose of sulbactam should not exceed 4 g per day.
Treatment is usually continued for 48 hours after the fever and other abnormal symptoms have subsided. Treatment usually lasts from 5 to 14 days, but in severe cases, additional doses of ampicillin may be given
Surgical infection prophylaxis
During the induction of anesthesia, 1.5-3 g (1 g ampicillin + 0.5 g sulbactam - 2 g ampicillin + 1 g sulbactam) of Ampicillin+Sulbactam AptaPharma should be administered. The dose can be repeated every 6-8 hours.
Administration of the medicine usually ends 24 hours after the end of most surgical procedures.

Use in children Newborns, infants, and children

The dose of Ampicillin+Sulbactam AptaPharma for 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 ampicillin per day and 50 mg/kg body weight sulbactam per day). The dose is usually given every 6 or 8 hours, except for newborns and premature babies in the first week of life (especially premature babies), where the recommended dose of Ampicillin+Sulbactam AptaPharma is 75 mg/kg body weight per day (corresponding to a dose of 50 mg/kg body weight ampicillin per day and 25 mg/kg body weight sulbactam per day) in divided doses every 12 hours.

Patients with impaired renal function

Ampicillin+Sulbactam AptaPharma should be administered less frequently in such patients than in patients with normal renal function.

Use of a higher dose of Ampicillin+Sulbactam AptaPharma than recommended

Administration of a dose higher than recommended by the doctor or healthcare professional, usually in a hospital, is unlikely. Due to the fact that ampicillin and sulbactam are removed from the circulation by hemodialysis, this procedure may facilitate the elimination of the medicine from the body in case of overdose in patients with impaired renal function.

Missing a dose of Ampicillin+Sulbactam AptaPharma

Since the medicine will be administered under strict medical supervision, missing a dose is unlikely. However, if the patient suspects that a dose has been missed, they should contact their doctor or pharmacist. The doctor or pharmacist will decide on further treatment.

4. Possible side effects

Like all medicines, this medicine can cause the following side effects, although they may not occur in everyone.

Severe side effects

Contact a doctor immediately if any of the following severe side effects occur, as urgent medical attention may be necessary:

• sudden onset of allergic reactions (anaphylactoid) and anaphylactic shock (circulatory collapse)
• severe diarrhea due to colitis (bacterial pseudomembranous colitis)
• severe skin diseases with blisters, peeling, and necrotic changes (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• kidney inflammation The frequency of the above side effects is unknown (cannot be determined from available data).

Common(may occur in up to 1 in 10 people):

• decrease in red blood cell count (anemia) and platelet count (thrombocytopenia), increase in the number of a certain type of white blood cell (eosinophilia). These reactions usually resolve after treatment is discontinued.
• phlebitis
• diarrhea
• transient increase in liver enzyme activity (AspAT, AlAT) and bilirubin due to abnormal liver function
• pain at the injection site

Uncommon(may occur in up to 1 in 100 people):

• decrease in white blood cell count (usually resolves after treatment is discontinued)
• headache
• change in blood cell count (decrease in the number of granulocytes)
• vomiting
• rash, itching
• fatigue
• malaise

Rare(may occur in up to 1 in 1,000 people):

• nausea
• glossitis
• abdominal pain

Frequency not known(frequency cannot be determined from available data):

• anemia caused by increased destruction of red blood cells (hemolytic anemia)
• change in blood cell morphology (decrease in granulocyte count)
• bleeding red spot of large size due to decreased platelet count
• anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock, hypersensitivity, Kounis syndrome
• seizures, dizziness, drowsiness
• breathing difficulties
• inflammation of the small and large intestine (enteritis), bloody stools
• stomatitis
• discoloration of the tongue
• widespread skin reactions (red, swollen, pus-filled blisters)
• exfoliative dermatitis
• liver function disorders, jaundice, cholestasis, hepatitis with cholestasis
• reaction at the injection site
• swelling of the face, lips, tongue, and/or throat with difficulty swallowing and breathing (angioedema), with skin rash (erythema), blisters, redness of the skin, or bruising

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ampicillin+Sulbactam AptaPharma

Store the medicine out of sight and reach of children.
The medicine does not require any special storage conditions.
Do not use this medicine after the expiration date (after the EXP date) stated on the vial or carton. The expiration date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 AptaPharma contains

The active substance of the medicine is ampicillin and sulbactam.
Ampicillin+Sulbactam AptaPharma, 1g + 0.5g powder for solution for injection/infusion:
Each vial contains 1 g ampicillin (as ampicillin sodium) and 0.5 g sulbactam (as sulbactam sodium).
Ampicillin+Sulbactam AptaPharma, 2g + 1g powder for solution for injection/infusion:
Each vial contains 2 g ampicillin (as ampicillin sodium) and 1 g sulbactam (as sulbactam sodium).
The medicine does not contain any other ingredients.

What Ampicillin+Sulbactam AptaPharma looks like and contents of the pack

Ampicillin+Sulbactam AptaPharma is a white or almost white crystalline powder for solution for injection/infusion.
Ampicillin+Sulbactam AptaPharma, 1 g + 0.5 g, powder for solution for injection/infusion is placed in a vial made of clear, colorless glass (type I) with a capacity of 20 mL, closed with a bromobutyl rubber stopper and a blue aluminum flip-off seal.
Ampicillin+Sulbactam AptaPharma, 2 g + 1 g, powder for solution for injection/infusion is placed in a vial made of clear, colorless glass (type I) with a capacity of 20 mL, closed with a bromobutyl rubber stopper and an orange aluminum flip-off seal.
The carton contains 10 vials.

Marketing authorization holder

Apta Medica Internacional d.o.o.
Likozarjeva Ulica 6
1000 Ljubljana
Slovenia
Tel.: 00386 51 615 015
e-mail: [email protected]

Manufacturer

MITIM S.r.l.
Via Cacciamali, 34-38
25125 Brescia
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:April 2025
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Information intended for healthcare professionals only:

Administration by injection or infusion:

Intravenous or intramuscular injection after reconstitution or intravenous infusion after further dilution.
For single use only.
Use only clear or opalescent and particle-free solutions after reconstitution/dilution.

Instructions for reconstitution and dilution of Ampicillin+Sulbactam AptaPharma:

The following volumes of diluent can be used for reconstitution:
* There is a sufficient excess to allow the withdrawal and administration of the stated volumes.
For intravenous injection, the contents of the injection vial should be reconstituted (and further diluted in the case of infusion) using:

• sterile water for injections
• sodium chloride 9 mg/mL (0.9%)
• sodium lactate
• glucose solution 50 mg/mL (5%)
• glucose solution 50 mg/mL (5%) in NaCl 4.5 mg/mL (0.45%)
• aqueous solution of invert sugar 100 mg/mL (10%)
• Ringer's solution with lactate

To ensure complete dissolution after reconstitution, wait until the foam has dispersed and evaluate visually. The dose can be administered in a bolus lasting at least 3 minutes or using larger dilutions (50-100 mL) in intravenous infusion lasting 15-30 minutes.
For intramuscular administration, it is recommended to use a deep intramuscular injection. To avoid pain, 0.5% sterile lidocaine hydrochloride solution can be used to dissolve the powder (3.2 mL of 0.5% sterile lidocaine hydrochloride solution for injection for 1 g + 0.5 g ampicillin + sulbactam and 6.4 mL for 2 g + 1 g ampicillin + sulbactam).
Administration of Ampicillin+Sulbactam AptaPharma is contraindicated in children under 2 years of age.
Ampicillin+Sulbactam AptaPharma and aminoglycosides should be prepared and administered separately due to the in vitro inactivation of aminoglycosides by all aminopenicillins.
Ampicillin sodium is less stable in solutions containing glucose and other carbohydrates and should not be mixed with blood derivatives or protein hydrolysates.
Shelf-life after reconstitution/dilution:

From a microbiological point of view, provided that the method of opening, reconstitution, or dilution does not preclude the risk of microbial contamination, the product should be used immediately.
If the product is not used immediately, the user is responsible for the storage conditions during use.