Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion – patient leaflet, side effects, dosage

1. What Ceftazidime Venus Pharma is and what it is used for

Ceftazidime Venus Pharma contains sodium

2. What you need to know before you use Ceftazidime Venus Pharma

3. How to use Ceftazidime Venus Pharma

Ceftazidime Venus Pharma 1 g contains 52 mg of sodium per dose. This is equivalent to 2.6 % of the recommended maximum daily dietary intake of sodium for an adult.

4. Possible side effects

Ceftazidime Venus Pharma 2 g contains 104 mg of sodium per dose. This is equivalent to 5.2 % of the recommended maximum daily dietary intake of sodium for an adult.

5. How to store Ceftazidime Venus Pharma

6. Contents of the pack and other information

1. 3. How to use Ceftazidime Venus Pharma
2. 1.

   What Ceftazidime Venus Pharma is and what it is used for

   Ceftazidime is usually given by a doctor or nurse. It can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle.

Ceftazidime is an antibiotic used in adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Ceftazidime is made up by the doctor, pharmacist or nurse using water for injections or a suitable infusion fluid.

The recommended dose

Ceftazidime Venus Pharma is used to treat severe bacterial infections of:

The correct dose of Ceftazidime for you will be decided by your doctor and depends on: the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys are working.

• the lungs or chest

• the lungs and bronchi in patients suffering from cystic fibrosis

  Newborn babies (0-2 months)

• the brain (meningitis)

  For every 1 kg the baby weighs, they’ll be given 25 to 60 mg Ceftazidime per day divided in two doses.

• the ear

  Babies (over 2 months) and children who weigh less than 40 kg

• the urinary tract

  For every 1 kg the baby or child weighs, they’ll be given 100 to 150 mg of Ceftazidime per day divided in three doses. Maximum 6 g per day.

• the skin and soft tissues

  Adults and adolescents who weigh 40 kg or more

• the abdomen and abdominal wall (peritonitis)

  1 to 2 g of Ceftazidime three times daily. Maximum of 9 g per day.

• the bones and joints.

  Patients over 65

Ceftazidime Venus Pharma can also be used:

The daily dose should not normally exceed 3 g per day, especially if you are over 80 years of age.

• to prevent infections during prostate surgery in men

  Patients with kidney problems

• to treat patients with low white blood cell counts (neutropenia) who have a fever due to a bacterial infection.

  You may be given a different dose to the usual dose. The doctor or nurse will decide how much Ceftazidime you will need, depending on the severity of the kidney disease. Your doctor will check you closely and you may have more regular kidney function tests.

  1. 2. What you need to know before you use Ceftazidime Venus Pharma

Do not use Ceftazidime :

If you are given more Ceftazidime Venus Pharma than you should

• if you are allergic to ceftazidime or any of the other ingredients of this medicine (listed in section 6).

  If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.

• if you have had a severe allergic reaction to any other antibiotic (penicillins, monobactams and carbapenems) as you may also be allergic to Ceftazidime.

  If you forget to use Ceftazidime Venus Pharma

→ Tell your doctor before you start on Ceftazidime if you think that this applies to you. You must not be given Ceftazidime .

However, if it is almost time for your next injection, skip the missed injection. Don’t take a double dose (two injections at the same time) to make up for a missed dose.

Warnings and Precautions

Don’t stop taking Ceftazidime Venus Pharma

You must look out for certain symptoms such as allergic reactions, nervous system disorders and gastrointestinal disorders such as diarrhoea while you are being given Ceftazidime . This will reduce the risk of possible problems. See (‘Conditions you need to look out for’) in section 4. If you have had an allergic reaction to other antibiotics you may also be allergic to Ceftazidime.

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The following information is intended for healthcare professionals only: Ceftazidime Venus Pharma 1 g powder for solution for injection/infusion Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion

ceftazidime

Keep vials in the outer carton to protect from light.

Special precautions for disposal and other handling.

All sizes of vials of Ceftazidime Venus Pharma are supplied under reduced pressure. As the product dissolves, carbon dioxide is released and a positive pressure develops. Small bubbles of carbon dioxide in the constituted solution may be ignored.

Instructions for constitution See Table 1 and Table 2 for addition volumes and solution concentrations, which may be useful when fractional doses are required.

Please refer to the Summary of Product Characteristics for further information

Table 1: Powder for Solution for Injection

Shelf Life

2 years.

After reconstitution:

Chemical and physical in-use stability has been demonstrated for 6 days at 2-8°C and 9 hours at 25°C in Water for Injections or compatible fluids listed below.

From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Note: •The resulting volume of the solution of ceftazidime in reconstitution medium is increased due to the displacement factor of the drug product resulting in the listed concentrations in mg/ml presented in the above table.

After dilution:

Table 2: Powder for Solution for Infusion

Chemical and physical in-use stability has been demonstrated for 6 days at 2-8°C and 9 hours at 25°C in Water for Injections or compatible fluids listed below.

From a microbiological point of view, the reconstituted and diluted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions

Special precautions for storage

This medical product does not require any special storage condition.

VENUS REMEDIES LIMITED

Party Name : UK

Embossing : No

Size : 450 x 450 mm (front / back)

Colours : BLACK

Brail : No

Other Process : No

Foil Colour : No

Paper Specification Code : Bible Paper

Foil Stamp : No

Fold :

Date : 24-09-2020, 13.05.2021

Reference : New Size as per text matter

2-D Barcode : Not Applicable

Grain :

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1. 4.

   Possible side effects

   • red blood cells destroyed too quickly

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• an increase in a certain type of white blood cells

Conditions you need to look out for

• severe decrease in the number of white blood cells.

The following serious side effects have occurred in a small number of people but their exact frequency is unknown:

Reporting of side effects

• Severe allergic reaction. Signs include raised and itchy rash, swelling, sometimes of the face or mouth causing difficulty in breathing.
• Skin rash, which may blister, and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge).

• A widespread rash with blisters and peeling skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).

  If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• Nervous system disorders: tremors, fits and, in some cases coma. These have occurred in people when the dose they are given is too high, particularly in people with kidney disease.

  1. 5. How to store Ceftazidime Venus Pharma

Keep this medicine out of the sight and reach of children.

• There have been rare reports of severe hypersensitivity reactions with severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung (a reaction called DRESS).

  Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of that month.

  This medical product does not require any special storage condition.

→ Contact a doctor or nurse immediately if you get any of these symptoms.

Keep vials in the outer carton to protect from light.

Common side effects

Reconstituted and diluted solution: The doctor, pharmacist or nurse will make up your medicine in Water for Injections or compatible fluids. Once made up, this

These may affect up to 1 in 10 people:

0 0 medicine should be used within 6 days if stored in refrigerator (at 2-8 C) or within 9 hours if stored at room temperature (below 25 C).

• Diarrhoea

• swelling and redness along a vein

  Do not throw away any medicines via wastewater or household waste. Your doctor or nurse will throw away any medicine that is no longer required. This will help protect the environment.

• red raised skin rash which may be itchiness

  1. 6. Contents of the pack and other information

• pain, burning, swelling or inflammation at the injection site.

  What Ceftazidime Venus Pharma contains

→ Tell your doctor if any of these are troubling you.

Ceftazidime Venus Pharma is available in the following strengths: 1 g and 2 g. The active substance 1 g and 2 g of ceftazidime (present as ceftazidime pentahydrate).

Common side effects that may show up in blood tests:

The only other ingredient is sodium carbonate (anhydrous sterile).

• an increase in a type of white blood cell (eosinophilia)

  See section 2 for further important information about sodium, one of the ingredients of Ceftazidime Venus Pharma.

• an increase in the number of cells that help the blood to clot

  What Ceftazidime Venus Pharma looks like and contents of the pack

• an increase in liver enzymes.

Uncommon side effects

Ceftazidime Venus Pharma 1 g powder for solution for injection/infusion is a sterile white to pale yellow powder packaged in 10 ml clear glass vials with a 20 mm grey butyl rubber plug and a 20 mm flip-off aluminium seal.

These may affect up to 1 in 100 people:

• inflammation of the gut which can cause pain, or diarrhoea which may contain blood

  Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion is a sterile white to pale yellow powder packaged in 20 ml clear glass vials with a 20 mm grey butyl rubber plug and a 20 mm flip-off aluminium seal.

• thrush (fungal infections in the mouth or vagina)

  Available in packs of 1, 5 or 10 vials.

• headache

  Not all pack sizes may be marketed.

• dizziness

  Your doctor, pharmacist or nurse will make the injection or infusion up with Water for Injections or a suitable infusion fluid.

• stomach ache

  Marketing Authorization Holder and Manufacturer

• feeling sick or being sick
• fever and chills.

→ Tell your doctor if you get any of these.

Venus Pharma GmbH,

Am Bahnhof, 1-3

D59368, Werne

Germany

Uncommon side effects that may show up in blood tests:

This leaflet was last revised in May 2021.

• a decrease in the number of white blood cells•
• a decrease in the number of blood platelets (cells that help the blood to clot)
• an increase in the level of urea, urea nitrogen or serum creatinine in the blood.

Very rare side effects

These may affect up to 1 in 10,000 people:

• inflammation or failure of the kidneys

Other side effects

Other side effects have occurred in a small number of people but their exact frequency is unknown:

• inflammation or failure of the kidneys
• pins and needles
• unpleasant taste in the mouth
• Yellowing of the whites of the eyes or skin.

Other side effects that may show up in blood tests:

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Note: The resulting volume of the solution of ceftazidime in reconstitution medium is increased due to the displacement factor of the drug product resulting in the listed concentrations in mg/ml presented in the above table.

For single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Solution is clear with the defined concentration, diluents and storage conditions used.

Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:

This leaflet was last revised in .

May 2021

• sodium chloride 9 mg/ml (0.9%) solution for injection

• /6 sodium lactate injection

  M

• % dextrose injection

  5

• 9% sodium chloride and 5% dextrose injection

  0.

• 0% dextrose Injection

  1

• eftazidime at concentrations detailed in Table 1 may be constituted for intramuscular use with 0.5% or 1% Lidocaine Hydrochloride Injection. C

1 g and 2 g powder for solution for injection/infusion:

Preparation of solutions for iv infusion from ceftazidime injection in standard vial presentation (mini-bag or burette-type set):

Prepare using a total of 50 ml (for 1 g and 2 g vials) and 75 ml (for 3 g vials) of compatible diluents (listed above), added in TWO stages as below.

1. 1. Introduce the syringe needle through the vial closure and inject 10 ml of diluent for the 1 g and 2 g vials.
2. 2. Withdraw the needle and shake the vial to give a clear solution.
3. 3. Do not insert a gas relief needle until the product has dissolved. Insert a gas relief needle through the vial closure to relieve the internal pressure.
4. 4. Transfer the reconstituted solution to final delivery vehicle (e.g. mini-bag o burette-type set) making up a total volume of at least 50 ml (75 ml for the 3 g vial), and administer by intravenous infusion over 15 to 30 min.

Note: To preserve product sterility, it is important that the gas relief needle is not inserted through the vial closure before the product has dissolved.

Any residual antibiotic solution should be discarded.