Biotum

Package leaflet: Information for the user

Biotum, 1 g, powder for solution for injection or infusion
Biotum, 2 g, powder for solution for injection or infusion
Ceftazidime
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform the doctor or nurse immediately. See section 4.

Table of contents

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

1. What Biotum is and what it is used for

Biotum is an antibiotic used in adults and children (including newborns). It acts bactericidally against bacteria causing infections. It belongs to a group of medicines called cephalosporins.
Biotum is used to treat serious bacterial infections:

• lower respiratory tract infections, including lungs
• lungs and bronchi in patients with cystic fibrosis
• central nervous system (meningitis)
• ear
• urinary tract
• skin and soft tissues
• abdominal cavity and peritoneum (peritonitis)
• bones and joints

Biotum may also be used:

• for prevention of infections during transurethral resection of the prostate in men
• in the treatment of patients with low white blood cell count (neutropenia) who have fever due to bacterial infection.

2. Important information before using Biotum

When not to use Biotum

• If the patient is allergic to ceftazidime or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had a severe allergic reaction to any other antibiotic (penicillins, monobactams, or carbapenems), as the patient may also be allergic to Biotum.

➢ If the patient suspects any of the above circumstances apply, they should
inform their doctor before starting treatment with Biotum.
Do not administer Biotum to the patient.
Warnings and precautions
Discuss this with the doctor or nurse before starting treatment with Biotum.
Care should be taken to monitor whether the patient experiences any specific symptoms during treatment with Biotum, such as allergic reactions, nervous system disorders, or gastrointestinal disorders including diarrhoea. This will reduce the risk of potential problems. See "Symptoms which require attention" in section 4. If the patient has ever had an allergic reaction to other antibiotics, they may also be allergic to Biotum.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with ceftazidime. If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, medical advice should be sought immediately.
Blood and urine tests
Biotum may alter the results of urine glucose tests and blood tests known as the Coombs test. If the patient is to undergo such tests:

• Inform the person collecting the sample that the patient has been taking Biotum.

Biotum and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The patient should not take Biotum without consulting their doctor if they are also taking:

• an antibiotic called chloramphenicol
• an antibiotic from a group called aminoglycosides, such as gentamicin or tobramycin
• diuretic tablets containing furosemide.

➢ If any of the above circumstances apply to the patient, inform their doctor.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
The treating doctor will assess whether the benefits of using Biotum during pregnancy or breastfeeding outweigh any potential risks to the child.
Driving and operating machinery
Biotum may cause side effects affecting the ability to drive, such as dizziness (see section 4). The patient should not drive or operate machinery unless they are certain these side effects have not occurred.
Biotum contains sodium
Each 1 g vial contains 60 mg of sodium. This corresponds to 3% of the maximum recommended daily dietary sodium intake for adults.
Each 2 g vial contains 120 mg of sodium. This corresponds to 6% of the maximum recommended daily dietary sodium intake for adults.
The medicine contains 60 mg of sodium (the main component of table salt) in each gram of powder. This corresponds to 3% of the maximum recommended daily dietary sodium intake for adults.
This should be taken into account in patients with impaired renal function and in patients who are monitoring their dietary sodium intake.
Preparation of the medicine for administration – see section: "Information intended exclusively for healthcare professionals" at the end of this leaflet. When calculating the total sodium content of the prepared diluted solution, the sodium originating from the diluent must also be considered. For accurate information on the sodium content in the solution used to dilute the medicine, refer to the patient leaflet of the diluent used.

3. How to use Biotum

This medicine should always be used exactly as directed by the doctor. If in doubt, consult your doctor.
Biotum is usually administered by a doctor or nurse.
Biotum 1 g may be given as an intravenous infusion (drip) or as an injection directly into a vein or as an intramuscular injection.
Biotum 2 g may be given as an intravenous infusion (drip) or as an injection directly into a vein.
Biotum is prepared by a doctor or nurse using water for injections or another suitable infusion fluid.

Usual dosage
The treating doctor will decide the appropriate dose of Biotum for the patient, taking into account the severity and type of infection, whether the patient is taking any other antibiotics, body weight, age, and kidney function.

Newborns and infants (aged 0–2 months)
For each kg of the infant's body weight, a daily dose of 25 mg to 60 mg of Biotum is given in two divided doses.

Infants (over 2 months of age) and children weighing less than 40 kg
For each kg of body weight, a daily dose of 100 mg to 150 mg of Biotum is given in three divided doses. Maximum 6 g per day.

Adults and adolescents weighing 40 kg or more
1 g to 2 g of Biotum three times daily. Maximum 9 g per day.

Patients aged over 65 years
The daily dose should usually not exceed 3 g per day, especially in patients over 80 years of age.

Patients with impaired kidney function
The patient may receive a different dose than the usual. The doctor or nurse will decide the appropriate dose of Biotum based on the severity of kidney disease. The doctor will closely monitor the patient and may order more frequent kidney function tests.

Accidental overdose of Biotum
If a larger than recommended dose of Biotum is accidentally administered, contact the treating doctor immediately or go to the nearest hospital.

Missed dose of Biotum
If an injection has been missed, it should be administered as soon as possible.
Do not administer a double dose (two injections at the same time) to make up for a missed dose. Instead, continue with the next dose at the usual time.

Stopping treatment with Biotum
Do not stop taking Biotum without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to be aware of
➢ The severe adverse reactions described below have occurred in a small number of people, but their exact frequency is unknown (frequency cannot be estimated from the available data).
If the patient experiences any of the following symptoms, contact a doctor immediately:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may cause difficulty breathing.
• Red spots on the trunk, rash resembling a target or circular lesions, often with central blisters, peeling of the skin, and ulcers in the mouth, throat, nose, genital organs or eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Red, peeling, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).
• Nervous system disorders: tremors, convulsions and sometimes coma. These disorders occurred in patients who received excessive doses, particularly in patients with kidney disease.

Common adverse reactions
May occur in not more than 1 in 10 patients:

• diarrhoea
• swelling and redness along the vein
• red, raised rash on the skin, which may be itchy
• pain, burning, swelling or inflammation at the injection site.

➢ If any of the above symptoms concern the patient, they should inform their doctor.
Common adverse reactions that may be revealed in blood test results:

• increased number of one type of white blood cells (eosinophilia)
• increased number of platelets, which are involved in blood clotting
• increased liver enzyme activity.

Uncommon adverse reactions
May occur in not more than 1 in 100 patients:

• inflammation of the intestine, which may cause pain or diarrhoea, possibly containing blood
• thrush – fungal infections of the mouth or vagina
• headache
• dizziness
• abdominal pain
• nausea or vomiting
• fever and chills.

➢ Inform the doctor if the patient experiences any of the above symptoms.
Uncommon adverse reactions that may be revealed in blood test results:

• decreased number of white blood cells
• decreased number of platelets (cells involved in blood clotting)
• increased concentration of urea, blood urea nitrogen or creatinine in blood serum.

Very rare adverse reactions
May occur in not more than 1 in 10,000 patients:

• inflammation or failure of the kidneys.

Other adverse reactions
Other adverse reactions which occurred in a small number of patients, but the exact frequency is unknown:

• tingling
• unpleasant taste in the mouth
• yellowing of the whites of the eyes and skin.

Other adverse reactions that may be revealed in blood test results:

• red blood cells break down too quickly
• increased number of one type of white blood cells in blood
• marked decrease in the number of white blood cells.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Biotum

The medicine should be stored at a temperature not exceeding 25°C. Protect from light.
The prepared solution can be stored for 24 hours in the refrigerator, i.e. at a temperature between 2°C and 8°C.
The medicine should be stored in a place inaccessible and not visible to children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Biotum contains

• The active substance is ceftazidime. Each vial contains 1 g or 2 g of ceftazidime in the form of buffered pentahydrate with sodium carbonate.
• Other ingredient: sodium carbonate.

What Biotum looks like and contents of the pack
White or light yellow powder placed in a glass vial, closed with a rubber stopper
and sealed with an aluminium cap or an aluminium cap with a plastic flip-off seal,
packed in a cardboard box.
The pack contains 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Duchnica
ul. Ożarowska 28/30, 05-850 Ożarów Mazowiecki

Information intended exclusively for healthcare professionals

Biotum, 1 g, powder for solution for injection or infusion
Biotum, 2 g, powder for solution for injection or infusion
Ceftazidimum
The pressure in Biotum vials of each size is lower than atmospheric pressure. During dissolution of the powder, pressure increases due to release of carbon dioxide. Small bubbles of carbon dioxide in the prepared solution may be disregarded.
Instructions for preparation of the medicinal product for administration
Refer to the table of added volumes and resulting concentrations, which may be useful when partial doses are required.

* Note. The addition should be performed in two steps.
The solution color, ranging from light yellow to amber, depends on the concentration, type of solvent,
and storage conditions. Provided the recommended conditions are met, variations in solution color
do not adversely affect the product's efficacy.
To prepare intravenous infusion solutions containing ceftazidime concentrations between 1 mg/ml
and 40 mg/ml, the following solutions may be used:

• 9 mg/ml (0.9%) sodium chloride injection solution
• M/6 sodium lactate injection solution
• compound sodium lactate injection solution (Hartmann's solution)
• 5% glucose injection solution
• 0.225% sodium chloride with 5% glucose injection solution
• 0.45% sodium chloride with 5% glucose injection solution
• 0.9% sodium chloride with 5% glucose injection solution
• 0.18% sodium chloride with 4% glucose injection solution
• 10% glucose injection solution
• 10% dextran 40 in 0.9% sodium chloride injection solution
• 10% dextran 40 in 5% glucose injection solution
• 6% dextran 70 in 0.9% sodium chloride injection solution
• 6% dextran 70 in 5% glucose injection solution.

Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with peritoneal dialysis fluid (lactated).
Ceftazidime for intramuscular injection may be dissolved in a solution containing 0.5% or
1% lidocaine hydrochloride for injection.

Preparation of solution for rapid injection

1. Pierce the stopper with a needle and inject the recommended volume of solvent into the vial. To pierce the stopper, use a needle with a diameter no larger than 0.8 mm (21 Gauge [G]). Insert the needle at a 90° angle into the centrally marked area, as shown in the diagram below:

The negative pressure inside the vial may facilitate solvent entry. Withdraw the needle with the syringe.

2. Shake until dissolution is complete: carbon dioxide is released, and a clear solution is obtained within 1 to 2 minutes.
3. Invert the vial. While keeping the syringe plunger fully depressed, pierce the vial stopper with the needle and withdraw the entire solution volume into the syringe (increased pressure inside the vial facilitates this process). Keep the needle tip submerged in the solution to avoid air aspiration. Small bubbles of carbon dioxide may be present in the solution drawn into the syringe.

These solutions may be administered directly into the vein or into an intravenous infusion set if the patient
is receiving intravenous fluids. Ceftazidime is compatible with commonly used intravenous fluids.

Preparation of intravenous infusion solution with ceftazidime in a standard vial (mini-bag or burette set)
Prepare using a total of 50 ml (for 1 g and 2 g vials) of a compatible diluent, added in TWO steps as described below:

1. Pierce the stopper with a needle and inject 10 ml of diluent into the 1 g and 2 g vials.
2. Remove the needle and shake the vial until a clear solution is obtained.
3. Do not insert the venting needle before the drug is completely dissolved. Insert the venting needle through the stopper to reduce internal pressure in the vial.
4. Transfer the solution into the final container (mini-bag or burette set), ensuring a total volume of at least 50 ml, and administer by intravenous infusion over 15 to 30 minutes.

Note: To ensure sterility of the medicinal product, the venting needle must not be inserted through
the vial stopper before the drug is completely dissolved.