Ampicillin Tzf

Leaflet attached to the packaging: patient information

Ampicillin TZF, 500 mg, powder for solution for injection

Ampicillin TZF, 1 g, powder for solution for injection

Ampicillin TZF, 2 g, powder for solution for injection

Ampicillin

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 pharmacist.
• 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ampicillin TZF and what is it used for
• 2. Important information before using Ampicillin TZF
• 3. How to use Ampicillin TZF
• 4. Possible side effects
• 5. How to store Ampicillin TZF
• 6. Package contents and other information

1. What is Ampicillin TZF and what is it used for

Ampicillin TZF contains the active substance ampicillin, which is a semi-synthetic penicillin.
Ampicillin has a bactericidal effect on many species of Gram-negative and Gram-positive bacteria.
Ampicillin TZF is indicated for the treatment of the following infections caused by bacteria sensitive to ampicillin:

• acute and chronic urinary tract infections;
• respiratory tract infections;
• gastrointestinal tract infections;
• meningitis;
• endocarditis;
• use in perioperative prophylaxis.

2. Important information before using Ampicillin TZF

When not to use Ampicillin TZF

• if the patient is allergic to ampicillin or other beta-lactam antibiotics (penicillins, cephalosporins);
• if the patient has infectious mononucleosis or lymphatic leukemia - there is an increased risk of rash.

In case of doubts, consult a doctor or pharmacist.

Warnings and precautions

Before taking the medicine, the patient should inform their doctor:

• if the patient has had an allergic reaction to any antibiotic in the past;
• if the patient has had any other allergic reaction in the past. Allergic reactions to ampicillin may occur more frequently in people with a tendency to allergic reactions to many different substances. These reactions can have various symptoms and severity - from skin changes to anaphylactic shock (severe allergic reaction) inclusive;

ampicillin may cause false-positive results in glucose tests in urine, therefore, if such a test is necessary, it is recommended to use enzymatic tests.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to have a child, she should consult a doctor before using this medicine.
If the patient is pregnant or thinks she may be pregnant
Ampicillin TZF should be avoided during pregnancy unless the doctor considers the use of the medicine absolutely necessary.
If the patient is breastfeeding
Ampicillin TZF can be used during breastfeeding with caution. Apart from the risk of allergy in infants related to small amounts of the medicine passing into breast milk, no other adverse effects have been reported in breastfed infants.

Driving and using machines

Ampicillin TZF does not affect the ability to drive vehicles or operate machinery. However, if side effects occur that reduce concentration (e.g., drowsiness, see section 4. Possible side effects), it is not recommended to drive vehicles or operate machinery.

Ampicillin TZF contains sodium

This should be taken into account in patients controlling their sodium intake.
Ampicillin TZF, 500 mg, contains 35.1 mg of sodium (the main component of common salt) per vial.
This corresponds to 1.76% of the maximum recommended daily sodium intake in adults.
Ampicillin TZF, 1 g, contains 70.2 mg of sodium (the main component of common salt) per vial.
This corresponds to 3.51% of the maximum recommended daily sodium intake in adults.
Ampicillin TZF, 2 g, contains 140.4 mg of sodium (the main component of common salt) per vial.
This corresponds to 7.02% of the maximum recommended daily sodium intake in adults.
Taking into account the dosing regimen presented in section 3, the maximum amount of sodium (the main component of common salt) that can be administered to a patient in a single dose is 140.4 mg (which corresponds to 7.02% of the maximum recommended daily sodium intake in adults), and in the maximum daily dose - 982.8 mg (which corresponds to 49.14% of the maximum recommended daily sodium intake in adults).

3. How to use Ampicillin TZF

Ampicillin TZF should always be used in accordance with the doctor's recommendations. In case of doubts, consult a doctor.
Ampicillin TZF is administered by a doctor or nurse. The dose depends on the severity of the infection, the microorganism causing the infection, the patient's age, and weight.

Adults and children over 40 kg

• Urinary tract infections: 500 mg every 6 hours.
• Gonococcal urethritis: 2 doses of 500 mg administered at 12-hour intervals.
• Community-acquired pneumonia in adults: 1-2 g every 6 hours.
• Community-acquired pneumonia in children over 40 kg: 1-2 g every 6 hours.
• Gastrointestinal tract infections: 500 mg every 6 hours.
• Meningitis: 2 g every 4 hours.
• Septic endocarditis and enterococcal bacteremia: 2 g every 4 hours.

The maximum dose for adults is 14 g per day.

Children under 40 kg

Most bacterial infections: usually 12.5 mg/kg every 6 hours.
Community-acquired pneumonia: 25-50 mg/kg every 6 hours
Early-onset infections in newborns
Dosing depends on the age and weight of the newborn: usually 100-200 mg/kg per day in

• 2-4 divided doses.

Meningitis
Newborns

• 0-7 days of life - 150-300 mg/kg per day in 3 divided doses.
• 8-28 days of life - 300-400 mg/kg per day in 3-4 divided doses. Infants and children
• 300-400 mg/kg per day in 4-6 divided doses.

The maximum daily dose in children is 12 g.
Prophylactic use of ampicillin
In perioperative prophylaxis of S. agalactiaeinfections (as an alternative to penicillin) - the first dose of 2 g ivand then 1 g every 4 hours until delivery.
In preterm premature rupture of membranes: in combination with erythromycin;
used in a dose of 2 g ivevery 4 hours for the first 48 hours, then switched to amoxicillin.

Patients with renal impairment

In patients with severe renal impairment (creatinine clearance <10 ml min), the doctor will consider reducing dose or increasing interval between administrations.
Patients undergoing dialysis should be advised by the doctor to take a supplementary dose after dialysis.

Duration of use

The duration of treatment depends on the severity and type of infection.
The doctor will determine the appropriate duration of treatment, which should be followed.
Method of solution preparationis given at the end of the leaflet, in the section "Information intended for healthcare professionals only”.

Using a higher dose of Ampicillin TZF than recommended

Since Ampicillin TZF will be administered by a doctor or nurse, it is unlikely that an incorrect dose will be given. However, if the patient suspects that they have been given too much medicine, they should immediately tell their doctor or go to the emergency department of the nearest hospital.

Missing a dose of Ampicillin TZF

A double dose should not be used to make up for a missed dose.

Stopping the use of Ampicillin TZF

It is important to use the medicine in accordance with the recommended treatment cycle. The treatment should not be stopped because the patient feels better. If the treatment cycle is stopped too early, the infection may recur.
If the patient feels worse during treatment or does not feel well after completing the recommended treatment cycle, they should consult their doctor.
In case of any further doubts related to the use of the medicine, consult a doctor.

4. Possible side effects

Like all medicines, Ampicillin TZF can cause side effects, although not everybody gets them.
In case of any of the following serious side effects, consult a doctor or go to the hospital immediately.
The following serious side effectsoccur rarely(less than 1 in 1000 people):

• sudden difficulty breathing, speaking, and swallowing;
• painful swelling of the lips, tongue, face, or throat;
• severe dizziness or fainting;
• severe or itchy skin rashes, especially with blistering and eye, mouth, or genital pain;
• severe, prolonged, or bloody diarrhea: this may be a sign of severe colitis;
• yellowing of the skin or whites of the eyes or dark urine and pale stools: these may be signs of liver problems.

Other side effects that may occur during treatment
The following side effects occur uncommonly(less than 1 in 100 people):

• changes in the number of white and red blood cells (decrease in the number of red or white blood cells and platelets), abnormal breakdown of red blood cells (hemolytic anemia);
• skin rashes, hives, itching.

The following side effects occur rarely(less than 1 in 1000 people):

• mild, transient increase in liver enzyme activity;
• interstitial nephritis.

The following side effects may also occur:

• feeling tired, insomnia, restlessness, seizures. Seizures may occur in patients with renal impairment and/or taking high doses of the medicine;
• diarrhea, nausea, vomiting (these symptoms most often occur in patients receiving ampicillin);
• redness of the skin, pain at the injection site.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ampicillin TZF

Store in a temperature below 25°C. Protect from light.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ampicillin TZF contains

The active substance of the medicine is ampicillin (in the form of ampicillin sodium)
Ampicillin TZF, 500 mg
Each vial contains 500 mg of ampicillin (Ampicillinum) in the form of ampicillin sodium.
Ampicillin TZF, 1 g
Each vial contains 1 g of ampicillin (Ampicillinum) in the form of ampicillin sodium.
Ampicillin TZF, 2 g
Each vial contains 2 g of ampicillin (Ampicillinum) in the form of ampicillin sodium.
The medicine does not contain any other ingredients.

What Ampicillin TZF looks like and what the package contains

White or almost white powder. After dissolution, a clear, opalescent solution is formed.
Package:1 vial in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information about this medicine, please contact the marketing authorization holder.

Date of the last update of the leaflet:

Information intended for healthcare professionals only

Read the detailed information about this medicine, which is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (www.urpl.gov.pl).
After dissolving the powder, a clear, opalescent solution is formed.
Before administering the medicine, check the appearance of the solution. The solution can only be administered if it is clear and practically free from visible particles.
Any unused product or waste should be disposed of in accordance with local regulations.
Method of preparation and administration of the solution
Intramuscular injections
Dissolve the contents of the 500 mg vial in 2 ml of water for injections.
Dissolve the contents of the 1 g vial in 4 ml of water for injections.
When administering intramuscularly, follow the usual restrictions on volume.
The solution should be administered by deep intramuscular injection. Doses exceeding 1 g are recommended to be injected into two different sites.
Intravenous injections
Dissolve the contents of the 500 mg vial in 5 ml of water for injections.
Dissolve the contents of the 1 g vial in 10 ml of water for injections.
Dissolve the contents of the 2 g vial in 20 ml of water for injections.
Administer slowly, over about 3 to 10 minutes.
Intermittent infusion
Dissolve 500 mg of ampicillin powder in 50 ml of isotonic sodium chloride solution (0.9%). The solution is prepared in polyolefin containers.
Dissolve 1 g of ampicillin powder in 100 ml of isotonic sodium chloride solution (0.9%). The solution is prepared in polyolefin containers.
Dissolve 2 g of ampicillin powder in 100 ml of isotonic sodium chloride solution (0.9%) or water for injections. The solution is prepared in a polyolefin container.
Ampicillin TZF solution can be administered as an intravenous infusion at a rate of 100 mg/min.
Continuous infusion
Dissolve 2 g of ampicillin powder in 15 ml of water for injections, then add 500 ml of 0.9% sodium chloride solution or 500 ml of glucose solution at a concentration of 50 mg/ml.
Solutions prepared using 0.9% sodium chloride solution can be prepared in polyolefin or polyvinyl chloride containers.
Solutions using glucose solution should be prepared in polyolefin containers.
The concentration of the prepared solution should not exceed 30 mg/ml.
Warning!Ampicillin injection solutions should be prepared immediately before administration.
From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions before use.
Ampicillin solutions should not be mixed with other medicines due to the possibility of inactivation.
Incompatibilities
Ampicillin should not be administered with blood products or other fluids containing proteins (e.g., protein hydrolysates), or with lipid emulsions for intravenous administration.
Ampicillin solutions should not be mixed with other medicines in the same syringe or infusion bottle due to the possibility of inactivation.