Streptomicinum Tzf

Package Leaflet: Information for the Patient

Streptomycinum TZF, 1 g, Powder for Solution for Injection

Streptomycinum

Table of Contents of the Leaflet

• 1. What is Streptomycinum TZF and what is it used for
• 2. Important information before using Streptomycinum TZF
• 3. How to use Streptomycinum TZF
• 4. Possible side effects
• 5. How to store Streptomycinum TZF
• 6. Contents of the pack and other information

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

Streptomycinum TZF contains the active substance streptomycin, which is a natural aminoglycoside antibiotic. It acts on tuberculosis bacteria and some other Gram-positive and Gram-negative bacteria.
Streptomycin is used to treat moderate to severe infections caused by susceptible microorganisms.
Tuberculosis infectionscaused by Mycobacterium tuberculosis; it is used in combination with other anti-tuberculosis medications.

Non-tuberculous infections

• Plague
• Tularemia
• Brucellosis
• Ingrown toenail
• Soft ulcer
• Respiratory tract infections, endocarditis; used in combination with other medications

It is essential to carefully read the contents of the leaflet before using the medication, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of doubts, the patient should consult a doctor or nurse.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

antibiotics (most often with β-lactams)

• Pneumonia; used in combination with other antibiotics
• Urinary tract infections
• Endocarditis; used in combination with penicillin
• Septicemia caused by Gram-negative rods; used in combination with other antibiotics.

2. Important information before using Streptomycinum TZF

When not to use Streptomycinum TZF:

• if the patient is allergic to streptomycin or other aminoglycoside antibiotics;
• if the patient has hearing or balance disorders;
• if the patient has myasthenia gravis (a disease that causes muscle weakness and excessive fatigue).

Warnings and precautions

• During streptomycin treatment, hearing and balance disorders may occur. If the patient has hearing or balance disorders before or during treatment, they should inform their doctor before starting streptomycin treatment.
• If the patient has been prescribed streptomycin for long-term treatment, the doctor will order hearing tests (caloric test, audiometric test) before starting treatment and periodically during treatment. If symptoms of hearing damage occur, such as headache, nausea, vomiting, balance disorders, and/or negative hearing test results, the medication should be discontinued and the patient should contact their doctor as soon as possible. In such cases, prompt medical intervention can prevent permanent hearing damage.
• In patients with kidney function disorders, the toxic effects of streptomycin are enhanced; if the patient has kidney disease, they should inform their doctor before taking streptomycin.
• During streptomycin treatment, an overgrowth of non-susceptible microorganisms, such as yeast, may occur. If symptoms of new fungal or bacterial infections occur during streptomycin treatment, the medication should be discontinued and the patient should contact their doctor.
• If the patient is being treated for a venereal disease (e.g., ingrown toenail, soft ulcer), the doctor may suspect a concurrent syphilis infection and usually orders appropriate tests before starting treatment, during treatment, and after its completion.
• In patients with myasthenia gravis, streptomycin may exacerbate the symptoms of the disease.
• If the patient experiences hearing or balance disorders or other severe side effects (see section 4. Possible side effects) during streptomycin treatment, the medication should be discontinued and the patient should contact their doctor.

Children

In young children, streptomycin should be used with caution, not exceeding the recommended doses. The patient should be closely monitored for signs of neurological or respiratory disorders.

Streptomycinum TZF and other medications

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

• muscle relaxants and general anesthetics;
• diuretics (e.g., ethacrynic acid, furosemide, mannitol);
• antibiotics such as neomycin, kanamycin, gentamicin, cefaloridine, paromomycin, viomycin, polymyxin B, colistin, tobramycin;
• cyclosporine (a medication used to weaken the immune system).

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 medication.
The use of this medication in pregnant women is only justified when its use is absolutely necessary, and the use of a safer alternative medication is not possible or is contraindicated.
If a woman is receiving streptomycin, she should stop breastfeeding during treatment.

Driving and using machines

There is no data on the effect of the medication on the ability to drive vehicles and operate machinery.

3. How to use Streptomycinum TZF

Streptomycinum TZF should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor.
Streptomycinum TZF is administered by a doctor or nurse, injected into the gluteal or thigh muscle.
The exact dose of the medication and its frequency of administration will be determined by the doctor, depending on the severity of the infection, the type of microorganism causing the infection, the patient's age, and weight.

Tuberculosis

Streptomycin is used in the first phase of tuberculosis treatment, always in combination with other anti-tuberculosis medications (e.g., isoniazid, pyrazinamide, rifampicin), usually for the first 2 months of treatment. Streptomycin is also used as one of the anti-tuberculosis medications in intermittent therapy.

The total dose of streptomycin during one treatment course should not exceed 120 g.

Non-tuberculous infections Adults

Usually 1 to 2 g per day in divided doses, depending on the susceptibility of the microorganism and the severity of the infection, for 3 to 7 days.
Tularemia
1 to 2 g per day in divided doses for 7 to 14 days; if the disease is afebrile - 5 to 7 days.
Plague
2 g per day in 2 divided doses for at least 10 days.
Endocarditis

• Caused by streptococci.Streptomycin is administered for 2 weeks in combination with penicillin. During the first week of therapy, 1 g of streptomycin is administered twice a day, and during the second week - 500 mg twice a day. In patients over 60 years of age, the medication should be administered in a dose of 500 mg twice a day for 2 weeks.
• Caused by enterococci.Streptomycin in combination with penicillin is administered for 6 weeks. During the first 2 weeks of treatment, 1 g is administered twice a day, and during the next 4 weeks - 500 mg twice a day.

Children
Usually 20 to 40 mg/kg body weight/day (max. 1 g/day) in divided doses, every 6 or 12 hours.
Patients over 50 years of age
Patient over 50 years of age usually receive a lower dose of the medication, and during treatment, the doctor usually recommends determining the serum creatinine and urea levels and performing a hearing test.

Duration of treatment

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 administration

Streptomycin can only be administered intramuscularly.
Detailed information on the administration of the medication and the preparation of solutions is provided at the end of the leaflet, in the section "Information intended exclusively for healthcare professionals".

Use of a higher than recommended dose of Streptomycinum TZF

Since Streptomycinum 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 received too high a dose of the medication, they should immediately inform their doctor or go to the emergency department of the nearest hospital.

Missing a dose of Streptomycinum TZF

A double dose should not be taken to make up for a missed dose of the medication.

Discontinuation of Streptomycinum TZF

It is essential to use the medication according to 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 completing the recommended treatment cycle, they should contact their doctor.

• In case of any further doubts about the use of the medication, the patient should consult their doctor.

4. Possible side effects

Like all medications, Streptomycinum TZF can cause side effects, although not everybody gets them.

Severe side effects

Occurring very rarely(less than 1 in 10,000 patients):
tinnitus, ear pain, hearing disorders;
localized swelling, usually in the face or throat, which can be life-threatening, severe allergic reaction, which may cause sudden difficulty breathing, speaking, and swallowing, severe dizziness or fainting;
Occurring with unknown frequency(cannot be estimated from the available data):
severe, itching, exfoliative skin rashes, especially with blistering and pain in the eyes, mouth, or genital organs;
In case of any of the above severe side effects, the patient should immediately contact their doctor or go to the hospital.

Other side effects that may occur during treatment

These side effects occur with unknown frequency:
decreased or increased number of certain types of white blood cells, decreased platelet count (thrombocytopenia), abnormal breakdown of red blood cells (hemolytic anemia) manifested by increased tendency to bleeding, bruising, or infections;
feeling of tingling, numbness of the face or limbs, numbness of the limbs, optic neuritis;
nausea, vomiting, balance disorders;
skin rashes, urticaria, itching;
muscle weakness;
kidney function disorders, increased serum creatinine and urea levels - usually affects patients with pre-existing kidney disease who receive high doses of the medication;
pain and irritation at the injection site.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 {current address, phone number, and fax of the Department}
e-mail: adr@urpl.gov.pl .
Reporting side effects can help gather more information on the safety of the medication.

5. How to store Streptomycinum TZF

The medication should be stored out of sight and reach of children.
Store in a temperature not exceeding 25°C. Protect from light.
Do not use this medication after the expiry date stated on the packaging after ‘EXP’.
The expiry date refers to the last day of the month.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Streptomycinum TZF contains

The active substance of the medication is streptomycin in the form of streptomycin sulfate.
One vial contains 1 g of streptomycin.
The medication does not contain any other ingredients.

What Streptomycinum TZF looks like and what the pack contains

White or almost white powder.
Packaging:1 vial in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Phone number: 22 811-18-14
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder.

Date of last revision of the leaflet:

Information intended exclusively for healthcare professionals

Method of administration Streptomycin can only be administered intramuscularly.

Adults and older children
Usually administered in the upper, outer quadrant of the buttock or in the large muscle groups of the thigh.
In justified cases, streptomycin can be administered in the deltoid muscle, with special caution due to the risk of nerve damage in this area.
Infants and young children
Usually administered in the large muscle groups of the thigh. Administration of streptomycin in the buttock is not recommended due to the risk of damage to the sciatic nerve.

Instructions for preparing the solution for injection

The contents of the vial should be dissolved in at least 2 ml of water for injection or 0.9% sodium chloride solution. Solutions with a concentration above 500 mg/ml should not be used.
In accordance with the principles of good practice, the solution should be administered immediately after preparation.
Streptomycin solutions are stable for 24 hours at a temperature between 2°C and 8°C (in the refrigerator).
Streptomycin solutions prepared in controlled and validated aseptic conditions are stable for 5 days at a temperature between 2°C and 8°C or at 25°C.

Incompatibilities

Streptomycin should not be mixed in a syringe with medications with an acidic or alkaline pH.