Erithromicinum Intravenosum Tzf

Leaflet attached to the packaging: patient information

Erythromycinum Intravenosum TZF, 300 mg, powder for solution for infusion

Erythromycinum

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 you need to.
• In case of any doubts, you should 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 as yours.
• If the patient experiences any side effects, including any 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 Erythromycinum Intravenosum TZF and what is it used for
• 2. Important information before using Erythromycinum Intravenosum TZF
• 3. How to use Erythromycinum Intravenosum TZF
• 4. Possible side effects
• 5. How to store Erythromycinum Intravenosum TZF
• 6. Contents of the packaging and other information

1. What is Erythromycinum Intravenosum TZF and what is it used for

Erythromycin belongs to the group of macrolide antibiotics. It has a bacteriostatic effect on many Gram-negative and Gram-positive bacteria.

Indications for use

Erythromycin in the form of intravenous infusions is used in severe infections caused by susceptible microorganisms, when it is necessary to quickly achieve a high concentration of the medicine in the blood or when oral administration is not possible.

• Infections of the upper respiratory tract - e.g. tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary bacterial infections in the course of influenza or colds.
• Infections of the lower respiratory tract - e.g. tracheitis, acute bronchitis or exacerbation of chronic bronchitis, pneumonia (lobar, bronchopneumonic, primary atypical pneumonia), bronchiectasis, Legionnaires' disease.
• Middle ear and outer ear infections.
• Gingivitis, Vincent's angina.
• Blepharitis.
• Skin and soft tissue infections: furuncles, multiple furuncles, cellulitis, erysipelas.
• Gastrointestinal tract infections - cholecystitis, staphylococcal enteritis and colitis.
• Prevention of postoperative infections, secondary infections in the course of burns, endocarditis in patients undergoing dental procedures.
• Endocarditis (inflammation of the lining of the heart chambers).
• Septicaemia (systemic infection).
• Other infections: osteomyelitis, urethritis, gonorrhoea, primary syphilis, venereal granuloma of the groin.

2. Important information before using Erythromycinum Intravenosum TZF

When not to use Erythromycinum Intravenosum TZF

• If the patient is allergic (hypersensitive) to erythromycin or other macrolide antibiotics.
• If the patient is taking any of the following medicines:
• lovastatin, simvastatin (medicines that lower blood cholesterol levels),
• astemizole or terfenadine (medicines commonly used to treat hay fever and allergies),
• cisapride (a medicine used to treat stomach disorders),
• pimozide (a medicine used to treat psychiatric disorders),
• ergotamine or dihydroergotamine (medicines used, among other things, to treat migraines), during erythromycin treatment, as the concomitant use of these medicines may sometimes cause serious heart rhythm disturbances. You should ask your doctor about alternative medicines that you can take instead of those listed above (see section 2 "Erythromycinum TZF and other medicines"),
• lomitapide (used to reduce elevated blood lipid levels, such as cholesterol and triglycerides). Taking this medicine with erythromycin may lead to increased liver enzyme activity (aminotransferase), which means that the liver is overloaded and liver function disorders may occur.
• If the patient has a low potassium or magnesium level in the blood (hypomagnesaemia or hypokalaemia).
• If the patient or a family member has a history of heart rhythm disorders (ventricular tachycardia or torsades de pointes rhythm disorder) or an abnormality in the electrocardiogram (a record of the heart's electrical activity) called "long QT interval syndrome".
• Erythromycin solutions should not be administered by rapid injection.

Warnings and precautions

You should inform your doctor if:

• the patient has a history of allergy to erythromycin or other macrolide antibiotics;
• the patient has been diagnosed with liver disease and/or is taking medicines that may be toxic to the liver;
• the patient suffers from myasthenia (a disease that causes muscle weakness and excessive fatigue);
• the patient is taking other medicines known to cause serious heart rhythm disturbances;
• the patient has heart problems;
• during or after treatment with the medicine, the patient experiences severe and persistent diarrhoea;
• during treatment of small children, vomiting or signs of irritation during feeding appear.

Erythromycinum Intravenosum TZF and other medicines

You should tell your doctor about all medicines you are currently taking, or have recently taken, and about medicines you plan to take, including those available without a prescription.

If the patient is taking any of these medicines, concomitant use of erythromycin is contraindicated:

• lovastatin, simvastatin, lomitapide, astemizole, terfenadine, cisapride, pimozide, ergotamine or dihydroergotamine

It is also important to note if the patient is taking medicines such as:

• mizolastine (used in allergic reactions)
• theophylline (used in the treatment of asthma)
• digoxin, quinidine, disopyramide, verapamil (used in the treatment of heart disorders)
• cyclosporine, tacrolimus (immunosuppressive medicines used after organ transplants)
• cisapride, cimetidine (used in the treatment of stomach disorders)
• rifampicin, rifapentine, rifabutin (antibiotics used in the treatment of tuberculosis)
• fluconazole, ketoconazole, itraconazole (antifungal medicines)
• alfentanil, alprazolam, triazolam, midazolam (medicines used in anxiety or insomnia, often administered before surgery)
• methylprednisolone (an anti-inflammatory medicine)
• omeprazole (a medicine that reduces stomach acid production)
• cilostazol (a medicine used in circulatory disorders)
• sildenafil (a medicine used in erectile dysfunction in men)
• vinblastine (a medicine used in cancer chemotherapy)
• colchicine (a medicine used in the treatment of gout)
• bromocriptine (a medicine used in Parkinson's disease)
• zolpidem (a medicine used in insomnia)
• medicines used in epilepsy (e.g. carbamazepine, phenytoin, valproic acid)
• anticoagulant medicines, e.g. warfarin, acenocoumarol and rivaroxaban (used to thin the blood)
• antibacterial medicines (antibiotics from the penicillin group, cyclosporine, clindamycin, lincomycin, chloramphenicol, streptomycin, tetracycline, colistin)
• corticosteroids, administered orally, by injection or inhalation (used to weaken the body's immune system - this is useful in the treatment of many diseases),
• hydroxychloroquine or chloroquine (used in the treatment of diseases such as rheumatoid arthritis or in the treatment or prevention of malaria). Taking these medicines with erythromycin may increase the risk of abnormal heart rhythm and other serious heart-related side effects.
• St. John's Wort (used, among other things, in gastrointestinal and liver disorders, depression and insomnia).

Oral contraceptives
Erythromycin reduces their effectiveness and increases the risk of liver damage. If the patient is taking oral contraceptives, she should inform her doctor before starting erythromycin treatment. The doctor will pay special attention to any liver-related problems that may occur during treatment and may recommend the use of additional, non-hormonal contraceptive methods.
Diagnostic tests
If the patient is to undergo a urine test, they should inform their doctor or nurse that they are taking Erythromycinum Intravenosum TZF. Erythromycin may affect the results of urine tests.

Children and adolescents

In infants treated with erythromycin, cases of hypertrophic pyloric stenosis have been reported. If a child treated with erythromycin experiences vomiting or signs of irritation during feeding, they should tell their doctor.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The active substance of Erythromycinum Intravenosum TZF may pass through the placenta in pregnant women and is excreted in breast milk. Information from studies on the risk of congenital defects is inconsistent, but in some studies, heart defects have been found after the use of Erythromycinum Intravenosum TZF in early pregnancy.
Erythromycin can be given to pregnant or breastfeeding women only if, in the doctor's opinion, it is absolutely necessary.

Driving and using machines

The medicine may cause dizziness, confusion and disorientation, which may affect the ability to drive and use machines.

3. How to use Erythromycinum Intravenosum TZF

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor.

Adults

Mild and moderate infections (when oral administration is not possible) - 25 mg/kg body weight per day.
Severe infections - 50 mg/kg body weight per day (up to 4 g per day).

Children

Usually, 12.5 mg/kg body weight is administered 4 times a day. In severe infections, the doctor may double the dose.
Newborns up to 1 month of age
10 to 15 mg/kg body weight 3 times a day.

Treatment duration

The treatment duration is determined by the doctor, depending on the severity and type of infection.
After the patient's clinical condition improves, the doctor may recommend continuing erythromycin treatment in oral form.

Method of administration

The medicine is intended for intravenous infusion.

Using a higher dose of Erythromycinum Intravenosum TZF than recommended

The medicine is administered by medical personnel, so it is unlikely that the patient will receive a higher dose than recommended. You should contact your doctor or nurse as soon as possible if you think you have been given a higher dose than recommended. Symptoms may include gastrointestinal disturbances (nausea, vomiting, diarrhoea) and hearing disturbances.
If you are unsure about the method of administration, you should consult your doctor or nurse.

Missing a dose of Erythromycinum Intravenosum TZF

The medicine is administered by medical personnel, so it is unlikely that the patient will miss a dose at a fixed, specified time. However, if you think you have missed a dose at the right time, you should inform your doctor or nurse.
You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Diagnostic tests
Increased liver enzyme activity.
Blood and lymphatic system disorders
Eosinophilia, agranulocytosis.
Vascular disorders
Hypotension.
Renal and urinary disorders
Interstitial nephritis, renal dysfunction.
General disorders and administration site conditions
Chest pain, fever, malaise, redness at the injection site, skin irritation.
Administering the infusion slowly and using a sufficiently diluted solution minimizes pain and vein injury.
Psychiatric disorders
Delirium.
Cardiac disorders
Abnormal heart rhythm (including palpitations, faster heart rate, life-threatening arrhythmias called torsades de pointes or abnormal heart rhythm in the ECG) or cardiac arrest.
The frequency of these side effects is unknown (cannot be estimated from the available data).
Skin and subcutaneous tissue disorders
Skin rash, angioedema, urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
If the patient experiences a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular psoriasis), they should contact their doctor immediately. The frequency of these side effects is unknown (cannot be estimated from the available data).
Ear and labyrinth disorders
Deafness, tinnitus, especially after administration of high doses of the medicine above 4 g per day.
There have been reports of transient hearing loss, especially in patients with renal failure or after high doses.
Immune system disorders
Allergic reactions from urticaria and mild skin rashes to anaphylactic reactions.
Nervous system disorders
There have been reports of transient central nervous system disorders, including confusion, seizures, dizziness, but a causal relationship with erythromycin has not been established.
Hepatobiliary disorders
Cholestatic or hepatocellular hepatitis, liver failure, liver dysfunction, liver enlargement, jaundice.
Gastrointestinal disorders
The most common side effects after oral administration of erythromycin are gastrointestinal disorders, which depend on the dose used:
hypertrophic pyloric stenosis in infants, anorexia, pancreatitis, abdominal pain, nausea, vomiting, diarrhoea (especially after high doses of the medicine), pseudomembranous colitis (may occur during or after erythromycin treatment).
Infections and infestations
Superinfections with erythromycin-resistant bacteria or fungi during prolonged or repeated erythromycin treatment.

Reporting side effects

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

5. How to store Erythromycinum Intravenosum TZF

The medicine should be stored out of the sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Do not use 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. You should 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 does Erythromycinum Intravenosum TZF contain

The active substance of the medicine is erythromycin.
One vial contains 300 mg of erythromycin in the form of laktobionate.

What Erythromycinum Intravenosum TZF looks like and what the pack contains

White or slightly yellowish powder.
Packaging: one vial in a cardboard box.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Phone number: 22 811-18-14
Manufacturer
Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Phone number: 22 811-18-14
Manufacturer
FISIOPHARMA S.R.L
Nucleo Industriale, Palomonte (SA)
84020 Italy
To obtain more detailed information about this medicine, you should contact the marketing authorisation holder.

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Method of administration

Erythromycinum Intravenosum TZF should be administered by continuous or intermittent infusion, lasting 20 to 60 minutes, every 6 or 8 hours.
The optimal concentration of erythromycin solutions is 1 mg/ml (0.1%). If necessary, the concentration of erythromycin solutions can be increased to 5 mg/ml (0.5%). Solutions of erythromycin at a concentration of 5 mg/ml should be administered over at least 60 minutes. Faster administration of the medicine increases the risk of arrhythmias or a drop in blood pressure.
To minimize vein irritation, it is recommended to use at least 100 ml of diluent when preparing erythromycin solutions for intermittent infusions.
Solutions of erythromycin at a concentration above 5 mg/ml should not be administered, as they cause pain that spreads along the vein.
Solutions of erythromycin should not be administered by rapid injection (bolus).

Preparation of solutions

Basic solution

The contents of the vial should be dissolved in 6 ml of water for injection.

Infusion solution

The resulting basic solution should be topped up with 0.9% sodium chloride solution or 5% glucose solution to achieve the desired concentration, and then administered intravenously by continuous or intermittent infusion.
Infusion solutions are recommended to be prepared in at least 100 ml of diluent.
In accordance with good manufacturing practice, solutions should be administered immediately after preparation.
Prepared infusion solutions in 0.9% sodium chloride solution or 5% glucose solution remain stable for 24 hours at a temperature between 2°C and 8°C (in the refrigerator).

Incompatibilities

The laktobionate erythromycin solution should not be mixed with other antibiotics, aminophylline, and barbiturates.
Solutions of laktobionate erythromycin below pH 5.5 rapidly lose their activity.