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 using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Leaflet contents

1. What Biotum is and what it is used for
2. What you need to know 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:

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

Biotum may also be used:

• to prevent infections during transurethral resection of the prostate in men
• to treat 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 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), because the patient may also be allergic to Biotum.

➢ If the patient suspects that any of the above situations apply, they should
inform their doctor before starting treatment with Biotum.
Do not administer Biotum to the patient.
Warnings and precautions
Before starting treatment with Biotum, discuss this with a doctor or nurse.
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.
Serious skin reactions have been reported during treatment with ceftazidime, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). If the patient develops any symptoms related to these serious skin reactions described in section 4, medical advice should be sought immediately.
Blood and urine tests
Biotum may alter the results of tests for sugar (glucose) in urine and blood tests known as the Coombs test. If the patient is due to have such tests:

• The person collecting the sample should be informed 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, i.e. gentamicin, tobramycin
• diuretic tablets containing furosemide.

➢ If any of the above situations apply to the patient, they must 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 taking 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 intake of sodium for adults.
Each 2 g vial contains 120 mg of sodium. This corresponds to 6% of the maximum recommended daily dietary intake of sodium for adults.
The medicine contains 60 mg of sodium (a main component of table salt) in each gram of powder. This corresponds to 3% of the maximum recommended daily dietary intake of sodium for adults.
This should be taken into account in patients with impaired renal function and in patients controlling sodium intake in their diet.
Preparation of the medicine for administration – see section: "Information intended exclusively for healthcare professionals" at the end of the leaflet. When calculating the total sodium content in the prepared diluted solution, sodium from the diluent must also be considered. For accurate information on the sodium content of 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 (IV infusion) or as an injection directly into a vein or as an intramuscular injection.
Biotum 2 g may be given as an intravenous infusion (IV infusion) 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 1 kg of the infant's body weight, 25 mg to 60 mg of Biotum per day is administered in two divided doses.

Infants (over 2 months of age) and children with body weight less than 40 kg
For each kg of the infant's or child's body weight, 100 mg to 150 mg of Biotum per day is administered in three divided doses. Maximum dose: 6 g per day.

Adults and adolescents with body weight of 40 kg or more
1 g to 2 g of Biotum three times daily. Maximum dose: 9 g per day.

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

Patients with kidney disease
The patient may receive a dose different from 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 a dose of Biotum is 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 the missed dose. Instead, administer 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 any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to be aware of
➢ The serious adverse reactions described below 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, target-like spots or round lesions, often with central blisters, peeling of the skin, and ulcers in the mouth, throat, nose, genital organs, and 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, seizures, 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 the blood clotting process
• increased activity of liver enzymes.

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

• inflammation of the intestine, which may cause abdominal 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 has experienced 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 that 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 the blood
• marked decrease in the number of white blood cells.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Biotum

Store the medicine 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
from 2°C to 8°C.
Keep the medicine out of sight and reach of 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 in use. This will 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 sodium carbonate buffered pentahydrate.
• The other ingredient is: sodium carbonate.

What Biotum looks like and contents of the pack
White or light yellow powder contained 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
POLPHARMA Pharmaceuticals S.A.
Pelplińska Street 19, 83-200 Starogard Gdanski
tel. +48 22 364 61 01

Manufacturer
POLPHARMA Pharmaceuticals S.A.
Pelplińska Street 19, 83-200 Starogard Gdanski
POLPHARMA Pharmaceuticals S.A.
Production Branch in Duchnice
Ożarowska Street 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
Ceftazidime
The pressure in vials of Biotum of each size is lower than atmospheric pressure. During
dissolution of the powder, pressure increases due to the release of carbon dioxide. Small
carbon dioxide bubbles present 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 solvent should be added in two steps.
The solution's 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 the solution's color
do not adversely affect the product's efficacy.
For the preparation of intravenous infusion solutions containing ceftazidime concentrations between 1 mg/ml
and 40 mg/ml, the following solvents may be used:

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

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 G on the Gauge [G] scale). Insert the needle perpendicularly (90°) 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 the powder dissolves completely: 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 will facilitate this process). Keep the needle tip submerged in the solution to avoid drawing air. 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 system)
Prepare using a total volume of 50 ml (for 1 g and 2 g vials) of a compatible solvent, added in TWO steps as described below:

1. Pierce the stopper with a needle and inject 10 ml of solvent 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 to the final container (mini-bag or burette), 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 medication, do not insert the venting needle through the vial stopper before the drug is completely dissolved.