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 side effects 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. Contents of the packaging 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

In case of doubts, consult a doctor or pharmacist.

Warnings and precautions

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

ampicillin may cause allergic reactions 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;

If the patient experiences diarrhea during or after treatment with ampicillin, they should tell their doctor. This may be a symptom of pseudomembranous colitis - a complication associated with the use of antibiotics. If diarrhea occurs, the use of the medicine should be discontinued, and in severe cases, appropriate treatment should be applied. Medicines that inhibit intestinal peristalsis or other constipating medicines should not be taken.
During long-term use of ampicillin, especially in chronically ill patients and patients with renal impairment, there may be an overgrowth of non-susceptible bacterial or fungal strains. If new bacterial or fungal infections occur during treatment with ampicillin, the antibiotic should be discontinued immediately and the doctor should be consulted.

Ampicillin TZF and other medicines

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

• probenecid, given simultaneously with Ampicillin TZF, increases its concentration in the blood and prolongs the duration of action;
• other bacteriostatic antibiotics;
• allopurinol, given simultaneously with Ampicillin TZF, increases the possibility of skin allergic reactions;
• oral contraceptives, as ampicillin weakens their effect.

In patients treated with ampicillin, glucose tests in urine may give false positive results, 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 they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
If the patient is pregnant or thinks they may be pregnant
Ampicillin TZF should be avoided during pregnancy, unless the doctor considers the use of the medicine to be 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 observed 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 the diet for 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 the diet for 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 the diet for adults.
Taking into account the dosing schedule presented in section 3, the maximum amount of sodium (the main component of common salt) that can be administered to the patient in a single dose is 140.4 mg (which corresponds to 7.02% of the maximum recommended daily sodium intake in the diet for adults), and in the maximum daily dose, 982.8 mg (which corresponds to 49.14% of the maximum recommended daily sodium intake in the diet for adults).

3. How to use Ampicillin TZF

Ampicillin TZF should always be used in accordance with the doctor's recommendations. In case of doubts, the doctor should be consulted.
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 with a body weight of 40 kg or more

• 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 with a body weight of more than 40 kg: 1-2 g every 6 hours.
• Gastrointestinal tract infections: 500 mg every 6 hours.
• Meningitis: 2 g every 4 hours.
• Septicemic or enterococcal endocarditis: 2 g every 4 hours.

The maximum dose for adults is 14 g per day.

Children with a body weight of less than 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 neonatal sepsis
Dosing depends on the age and weight of the neonate: usually 100-200 mg/kg per day in

• 2-4 divided doses.

Meningitis
Neonates

• 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 premature rupture of membranes: in combination with erythromycin;
administered 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 consecutive administrations of medicine.
Patients undergoing dialysis should be advised by the doctor to take a supplementary dose after the end of 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 preparing solutionsis given at the end of the leaflet, in the section "Information intended exclusively for healthcare professionals".

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 administered. However, if the patient suspects that they have been given too high a dose of the 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 of the medicine.

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 discontinued because the patient feels better. If the treatment cycle is discontinued too early, the infection may recur.
If the patient feels worse during treatment or does not feel well after the end of the recommended treatment cycle, they should consult their doctor.
In case of any further doubts related to the use of the medicine, the doctor should be consulted.

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, the patient should immediatelycontact their doctor or go directly to the hospital.
The following serious side effectsoccur rarely(less often than in 1 in 1000 people):

• sudden difficulty breathing, speaking, or 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 symptom of severe colitis;
• yellowing of the skin or whites of the eyes or dark urine and pale stools: these may be symptoms of liver function disorders.

Other side effects that may occur during treatment
The following side effects occur uncommonly(less often than in 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, urticaria, itching.

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

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

The following side effects may also occur:

• fatigue, insomnia, hyperactivity, 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 side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 in a place out of 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. 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 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 pack contains

White or almost white powder. After dissolution, a clear, opalescent solution is formed.
Packaging: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, the patient should contact the marketing authorization holder.

Date of last revision of the leaflet:

Information intended exclusively for healthcare professionals

Refer to 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 dissolution of the powder, a clear, opalescent solution is formed.
Before administering the medicine, the appearance of the solution should be checked. The solution can only be administered if it is clear and practically free from visible particles.
Any unused product or waste material should be disposed of in accordance with local regulations.
Method of preparation and administration of the solution
Intramuscular injections
The contents of the 500 mg vial should be dissolved in 2 ml of water for injections.
The contents of the 1 g vial should be dissolved in 4 ml of water for injections.
When administering intramuscularly, the usual limitations regarding the volume should be observed.
The solution should be administered by deep intramuscular injection. Doses exceeding 1 g are recommended to be injected into two different sites.
Intravenous injections
The contents of the 500 mg vial should be dissolved in 5 ml of water for injections.
The contents of the 1 g vial should be dissolved in 10 ml of water for injections.
The contents of the 2 g vial should be dissolved in 20 ml of water for injections.
Administer slowly, over approximately 3 to 10 minutes.
Intermittent infusion
500 mg of ampicillin powder should be dissolved in 50 ml of isotonic sodium chloride solution (0.9%). The solution is prepared in polyolefin containers.
1 g of ampicillin powder should be dissolved in 100 ml of isotonic sodium chloride solution (0.9%). The solution is prepared in polyolefin containers.
2 g of ampicillin powder should be dissolved 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
2 g of ampicillin powder should be dissolved in 15 ml of water for injections, and then 500 ml of 0.9% sodium chloride solution or 500 ml of glucose solution with a concentration of 50 mg/ml should be added.
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 time and 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.