Ampicillin+sulbactam aptapharma

Package leaflet: Information for the patient

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
Ampicillinum + Sulbactamum
Please read this leaflet carefully before using this medicine because it contains information important for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Leaflet contents

1. What Ampicillin+Sulbactam AptaPharma is and what it is 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 pack and other information

1. What Ampicillin+Sulbactam AptaPharma is and what it is 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 antibiotics).
Sulbactam enhances the effect of ampicillin by inhibiting beta-lactamases, enzymes that inactivate penicillins.
Your doctor may prescribe 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 laryngitis (inflammation of the epiglottis);
• lower respiratory tract infections, including pneumonia;
• urinary tract infections, including kidney infections (pyelonephritis);
• intra-abdominal infections, including peritonitis (inflammation of the peritoneal lining), cholecystitis (inflammation of the gallbladder), endometritis (inflammation of the uterine mucosa), and infection of connective tissue adjacent to the uterus (pelvic connective tissue infection);
• bacterial sepsis; skin, soft tissue, bone, and joint infections;
• in the pre- or postoperative period to reduce the incidence of surgical site infections in patients undergoing abdominal or pelvic surgery.

2. Important information before using Ampicilin+Sulbactam AptaPharma

When not to use Ampicilin+Sulbactam AptaPharma

• if the patient is allergic to ampicillin, sulbactam, any penicillins, or other beta-lactams
• if the patient is allergic to lidocaine hydrochloride, which is administered in intramuscular injection
• if the patient has previously experienced liver damage after taking ampicillin

Children and adolescents
Ampicilin+Sulbactam AptaPharma must not be administered by intramuscular injection to children under 2 years of age.

Warnings and precautions
Before starting treatment with Ampicilin+Sulbactam AptaPharma, discuss with your doctor, pharmacist, or nurse if:

• the patient has previously experienced an allergic reaction to penicillins or other antibiotics (cephalosporins), or to other substances causing allergic reactions
• the patient has liver problems
• the patient suffers from mononucleosis or lymphocytic leukemia

As with any prolonged treatment, during therapy with Ampicilin+Sulbactam AptaPharma, the doctor may order periodic tests to monitor the function of internal organs such as kidneys, liver, and the blood-forming system, especially in children, newborns, and premature infants.

Immediately inform the doctor if abdominal pain, itching, dark urine, yellowing of the whites of the eyes or skin, nausea, or weakness occur. These may be symptoms of impaired liver function caused by treatment with ampicillin and sulbactam.

In patients with infectious mononucleosis (glandular fever), skin rashes are very commonly observed when using ampicillin with sulbactam; therefore, use of Ampicilin+Sulbactam AptaPharma should be avoided in these patients.

Immediately inform the doctor if the following occur during treatment with Ampicilin+Sulbactam AptaPharma:

• severe skin reactions (redness, rash). The doctor will decide whether treatment should be discontinued.
• allergic reactions. In such cases, administration of Ampicilin+Sulbactam AptaPharma must be stopped, and the doctor will initiate appropriate treatment. Severe hypersensitivity reactions require immediate medical intervention.
• persistent and severe diarrhea (mixed with blood and mucus). Contact the doctor immediately, as this may be a sign of a life-threatening condition. As with other antibiotics, prolonged treatment may lead to overgrowth of microorganisms resistant to Ampicilin+Sulbactam AptaPharma, including fungi. In such cases, appropriate treatment should be initiated as determined by the doctor based on the patient's health status. Do not take any anti-diarrheal medications without consulting a doctor.

Ampicilin+Sulbactam AptaPharma and other medicines
Tell your doctor, pharmacist, or nurse about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

Inform the doctor if the patient is taking any of the following medicines:

• medicines used in the treatment of gout (allopurinol, probenecid), which increase the frequency of rashes
• aminoglycoside antibiotics
• anticoagulants
• antibacterial agents (chloramphenicol, erythromycin, sulfonamides, and tetracyclines)
• methotrexate (a medicine used in cancer treatment or rheumatic diseases)

Effect on laboratory test results:
Ampicilin+Sulbactam AptaPharma may cause falsely positive results in urine glucose tests and certain tests measuring hormone levels in pregnant women.

Pregnancy, breastfeeding, and effect on fertility

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

Pregnancy
The doctor will carefully decide whether a pregnant patient should receive Ampicilin+Sulbactam AptaPharma, weighing the benefits against the risks, as there is no evidence that use of this medicine in pregnant women is safe.

Breastfeeding
Ampicillin and sulbactam pass into human milk in small amounts. Use of this medicine in breastfeeding mothers may cause adverse effects in infants, such as diarrhea. Ampicilin+Sulbactam AptaPharma should be used during breastfeeding only if the expected benefits outweigh the potential risks.

Fertility
Animal studies on reproductive effects have not shown evidence of harmful effects of sulbactam and ampicillin on fertility.

Driving and operating machinery
Ampicilin+Sulbactam AptaPharma has negligible influence on the ability to drive or operate machinery. However, adverse reactions may occur that could prolong reaction time (such as dizziness, seizures, or drowsiness). In such cases, driving or operating machinery should be avoided.

Ampicilin+Sulbactam AptaPharma contains sodium

Ampicilin+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 dietary sodium intake for adults. Consult your doctor or pharmacist if administration of 4 or more vials per day for a prolonged period is necessary, especially in patients monitoring sodium intake in their diet.

Ampicilin+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 dietary sodium intake for adults. Consult your doctor or pharmacist if administration of 2 or more vials per day for a prolonged period is necessary, especially in patients monitoring sodium intake in their diet.

3. How to use Ampicilin+Sulbactam AptaPharma

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

Adults
The doctor will determine the dose depending on the severity of infection and the patient's condition. The recommended dose is 1.5 g (1 g ampicillin + 0.5 g sulbactam) up to 12 g (8 g ampicillin + 4 g sulbactam), which may be divided into equal doses every 8 or 6 hours. The total daily dose of sulbactam should not exceed 4 g.
Treatment is usually continued for 48 hours after the resolution of fever and other abnormal symptoms. Treatment typically lasts from 5 to 14 days, but additional doses of ampicillin may be administered in severe cases.

Surgical infection prophylaxis
During induction of anesthesia, administer 1.5–3 g (1 g ampicillin + 0.5 g sulbactam – 2 g ampicillin + 1 g sulbactam) of Ampicilin+Sulbactam AptaPharma. The dose may be repeated every 6–8 hours. Administration of the medicine usually ends within 24 hours after completion of most surgical procedures.

Use in children
Newborns, infants, and children
The dose of Ampicilin+Sulbactam AptaPharma 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). This dose is usually administered every 6 or 8 hours, except in newborns and premature infants during the first week of life (especially immature ones), where the recommended dose of Ampicilin+Sulbactam AptaPharma 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), divided into doses every 12 hours.

Patients with impaired renal function
Ampicilin+Sulbactam AptaPharma should be administered less frequently in such patients compared to those with normal renal function.

Administration of a higher than recommended dose of Ampicilin+Sulbactam AptaPharma
Administration of a dose higher than recommended by a doctor or healthcare professional, usually in a hospital setting, is unlikely. Since ampicillin and sulbactam are removed from circulation by hemodialysis, this procedure may assist in eliminating the drug from the body in cases of overdose in patients with impaired renal function.

Missed dose of Ampicilin+Sulbactam AptaPharma
Since the medicine will be administered under strict medical supervision, a missed dose is unlikely. However, if the patient suspects a dose has been missed, contact should be made with the doctor or pharmacist. The doctor or pharmacist will decide on further management of the patient's treatment.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause the following adverse reactions, although they do not occur in everyone.
Serious adverse reactions
Contact your doctor immediately if any of the following serious adverse reactions occur, as urgent medical care may be required:

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

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

• decrease in the number of red blood cells (anaemia) and platelets (thrombocytopenia), increase in the number of a certain type of white blood cells (eosinophilia). These reactions usually resolve after completion of treatment.
• inflammation of the vein
• diarrhoea
• transient increase in liver aminotransferase activity (AspAT, AlAT) and bilirubin due to impaired liver function
• pain at the injection site

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

• decrease in the number of white blood cells (usually resolves after completion of treatment)
• headache
• changes in blood cell count (reduced number of so-called neutrophil granulocytes)
• vomiting
• rash, itching
• fatigue
• malaise

Rare (may affect up to 1 in 1000 people):

• nausea
• inflammation of the tongue
• abdominal pain

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

• anaemia caused by increased destruction of red blood cells (haemolytic anaemia)
• change in blood morphology (decrease in the number of so-called granulocytes)
• large, bleeding red spots due to reduced number of platelets
• anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock, hypersensitivity, Kounis syndrome
• seizures, dizziness, somnolence
• breathing difficulties
• inflammation of the small and large intestine (so-called enterocolitis), bloody stools
• inflammation of the mouth
• discolouration of the tongue
• extensive skin reactions (reddish, swollen, purulent 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 difficulties in swallowing and breathing (angioedema), with skin rash (erythema), blisters, redness of the skin or bruising

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Ampicilin+Sulbactam AptaPharma

Keep the medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date (EXP) stated on the vial or
the cardboard box. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater. 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 Ampicilin+Sulbactam AptaPharma contains
The active substances in this medicinal product are ampicillin and sulbactam.
Ampicilin+Sulbactam AptaPharma, 1g + 0.5g powder for solution for injection/infusion:
Each vial contains 1 g of ampicillin (as sodium ampicillin) and 0.5 g of sulbactam (as sodium sulbactam).
Ampicilin+Sulbactam AptaPharma, 2g + 1g powder for solution for injection/infusion:
Each vial contains 2 g of ampicillin (as sodium ampicillin) and 1 g of sulbactam (as sodium sulbactam).
The medicinal product does not contain any other ingredients.

What Ampicilin+Sulbactam AptaPharma looks like and contents of the pack
Ampicilin+Sulbactam AptaPharma is a white or almost white crystalline powder for solution for injection/infusion.
Ampicilin+Sulbactam AptaPharma, 1 g + 0.5 g, powder for solution for injection/infusion is contained in a 20 mL clear, colourless glass vial (type I), closed with a bromobutyl rubber stopper and a blue aluminium flip-off cap.
Ampicilin+Sulbactam AptaPharma, 2 g + 1 g, powder for solution for injection/infusion is contained in a 20 mL clear, colourless glass vial (type I), closed with a bromobutyl rubber stopper and an orange aluminium flip-off cap.
The carton pack contains 10 vials.

Marketing Authorisation 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 authorised in the European Economic Area member states under the following names:

Information intended exclusively for professional medical personnel:

Intravenous or intramuscular administration:
Intravenous injection 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 Ampicilin+Sulbactam AptaPharma:
The following volumes of diluent may be used for reconstitution:

* There is a sufficient overage to allow for withdrawal and administration of the specified volumes.
For intravenous injection, the vial contents should be reconstituted (and further diluted in the case of intravenous infusion) using:

• Water for injections
• Sodium chloride 9 mg/mL (0.9%)
• Sodium lactate
• Glucose solution 50 mg/mL (5%)
• Glucose 50 mg/mL (5%) with sodium chloride 4.5 mg/mL (0.45%)
• Invert sugar aqueous solution 100 mg/mL (10%)
• Ringer's solution with lactate

To ensure complete dissolution after reconstitution, allow the foam to disperse and verify visually. The dose may be administered as an intravenous bolus over at least 3 minutes or by using larger dilutions (50–100 mL) as an intravenous infusion lasting 15–30 minutes.
For intramuscular administration, deep intramuscular injection is recommended. To minimize pain, the powder may be dissolved using 0.5% sterile lidocaine hydrochloride solution (3.2 mL of 0.5% sterile lidocaine hydrochloride injection solution for the 1 g + 0.5 g ampicillin + sulbactam strength, and 6.4 mL for the 2 g + 1 g ampicillin + sulbactam strength).
Intramuscular administration of Ampicilin+Sulbactam AptaPharma is contraindicated in children under 2 years of age.
Ampicilin+Sulbactam AptaPharma and aminoglycosides must be prepared and administered separately due to in vitro inactivation of aminoglycosides by all aminopenicillins.
Sodium ampicillin is less stable in solutions containing glucose and other carbohydrates and must not be mixed with blood products or protein hydrolysates.
Stability after reconstitution/dilution:
The concentrated solution for intramuscular injection (dissolved in 0.5% lidocaine and stored at 25°C) should be used within 1 hour after reconstitution.
Chemical and physical stability during use with various intravenous diluents is as follows:

From a microbiological standpoint, unless the method of opening, reconstitution, or dilution eliminates the risk of microbiological contamination, the product should be used immediately.
If the product is not used immediately, the user is responsible for the storage time and conditions during use.