CEFTAZIDIME MIP 2 g POWDER FOR INJECTION AND INFUSION SOLUTION

2. What you need to know before you use Ceftazidime MIP

Ceftazidime MIP should not be administered to you:

• if you are allergic (hypersensitive) to ceftazidime or any of the other components of this medicine (listed in section 6).
• if you have ever had a severe allergic reaction to any other antibiotic (penicillins, monobactams, and carbapenems) as you may also be allergic to Ceftazidime MIP.

?Tell your doctor before starting treatment with Ceftazidime MIP if you think this applies to you. You should not be given Ceftazidime MIP.

Warnings and precautions

While you are being administered Ceftazidime MIP, you should be aware of certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disorders, such as diarrhea. This will reduce the risk of potential problems (see 'Symptoms to be aware of' in section 4). If you have ever had an allergic reaction to other antibiotics, you may also be allergic to Ceftazidime MIP.

If you need a blood or urine test

Ceftazidime MIP may affect the results of urine glucose tests and a blood test known as the Coombs test. If you are having tests:

?Tell the person taking the samplethat you have been given Ceftazidime MIP.

Other medicines and Ceftazidime MIP

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

You should not be given Ceftazidime MIP without talking to your doctor if you are also taking:

• a type of antibiotic called chloramphenicol
• a type of antibiotics called aminoglycosides, e.g., gentamicin, tobramycin.
• a "water pill" (a diuretic called furosemide)

?Tell your doctorif this applies to you.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Your doctor will assess the benefits of treating you with Ceftazidime MIP against the risks to the baby.

Driving and using machines

Ceftazidime MIP may cause side effects such as dizziness that affect your ability to drive or use machines.

Do not drive or use machines unless you are sure that you are not affected.

Ceftazidime MIP contains sodium

This medicine contains approximately 104 mg of sodium (the main component of table/cooking salt) per vial, which is 5.2% of the maximum recommended daily sodium intake for an adult.

You should take this into account if you are on a low-sodium diet.

3. How to use Ceftazidime MIP

Ceftazidime MIP is usually administered by a doctor or nurse.It can be administered as a drip(intravenous infusion) or directly as an injectioninto a vein or muscle.

Ceftazidime MIP is reconstituted by your doctor, pharmacist, or nurse using water for injections or a suitable infusion fluid.

Recommended dose

The correct dose of Ceftazidime MIP for you will be decided by your doctor and depends on: the severity and type of infection, whether you are being treated with other antibiotics, your weight and age, and your kidney function.

Newborn babies (0-2 months)

For every 1 kg of the baby's weight, 25 to 60 mg of ceftazidime will be administered per day, divided into two doses.

Babies (over 2 months) and childrenweighing less than 40 kg

For every 1 kg of the baby's or child's weight, 100 to 150 mg of ceftazidime will be administered per day, divided into three doses. Maximum 6 g per day.

Adults and adolescentsweighing 40 kg or more

1 to 2 grams of ceftazidime three times a day. Maximum 9 g per day.

Patient over 65 years

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

Patient with kidney problems

You may be given a different dose than usual. Your doctor will decide how much Ceftazidime MIP you need, depending on the severity of your kidney disease. Your doctor will closely monitor you and perform kidney tests more frequently.

If you are given more Ceftazidime MIP than you should

If you accidentally receive more than the prescribed dose, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you miss a dose of Ceftazidime MIP

If you miss an injection, you should receive it as soon as possible. However, if it is almost time for the next injection, skip the missed injection. Do not use a double dose (two injections at the same time) to make up for the missed dose.

If you stop using Ceftazidime MIP

Do not stop receiving Ceftazidime MIP unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Symptoms to be aware of

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

• Severe allergic reaction. The signs include a bumpy, itchy rash, swelling, sometimes on the face or mouth, causing difficulty breathing.
• Skin rash, which can form blisters, and appears as small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge).
• Widespread skin rash with blisters and skin peeling. (These can be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Nervous system disorders: tremors, seizures, and, in some cases, coma. These have occurred in patients given very high doses, especially in patients with kidney disease.
• Rare cases of severe hypersensitivity reactions have been reported, accompanied by severe rash, which could be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (a type of white blood cell), effects on the liver, kidneys, or lungs (a reaction called DRESS).

?Contact your doctor or nurse immediately if you experience any of these symptoms.

Common side effects

May affect up to 1 in 10patients:

• diarrhea
• swelling and redness around a vein
• red, bumpy skin rash, which can be itchy
• pain, burning, swelling, or inflammation at the injection site.

?Tell your doctorif any of these side effects worry you.

Common side effects that may appear in blood tests:

• an increase in a type of white blood cell (eosinophilia)
• an increase in the number of cells that help blood clot
• an increase in liver enzymes.

Uncommon side effects

May affect up to 1 in 100patients:

• inflammation of the intestine that can cause pain or diarrhea that may contain blood
• fungal infections in the mouth or vagina
• headache
• dizziness
• stomach pain
• nausea or vomiting
• fever and chills.

?Tell your doctorif you experience any of these.

Uncommon side effects that may appear in blood tests:

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

Rare side effects

May affect up to 1 in 10,000patients:

• inflammation or failure of the kidneys

Other side effects

Other side effects that have occurred in a small number of patients, but whose exact frequency is unknown:

• tingling
• bad taste in the mouth
• yellowing of the skin or the whites of the eyes.

Other side effects that may appear in blood tests:

• rapid destruction of red blood cells
• increase in a certain type of white blood cell
• significant decrease in the number of white blood cells.

Reporting of side effects

If you experience 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 through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftazidime MIP

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

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

Do not store above 30°C. Store the vial in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftazidime MIP

• The active substance is ceftazidime. Each vial contains 2 g of ceftazidime (as pentahydrate).
• The other ingredients are anhydrous sodium carbonate.

Appearance of the product and pack contents

White or yellowish powder.

Ceftazidime MIP 2 g is available in 50 ml glass vials with a rubber stopper and a flip-off cap.

Pack sizes: Packs of 1, 5, or 10 glass vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

MIP Pharma GmbH

Kirkeler Str. 41

66440 Blieskastel, Germany

Tel.: 0049 (0) 6842 9609 0

Fax: 0049 (0) 6842 9609 355

Date of last revision of this leaflet:August 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

As the product dissolves, carbon dioxide is released and positive pressure develops. Small carbon dioxide bubbles in the reconstituted solution should be ignored.

Reconstitution instructions

See the table for volumes of addition and solution concentrations that may be useful when fractionated doses are needed.

The solutions vary in color from pale yellow to amber, depending on concentration, diluent, and storage conditions. Within the recommended limits, the potency of the product is not affected by these color variations.

Compatibility with intravenous solutions

The following solvents are suitable for preparing the solution:

• Water for injections
• Glucose 50 mg/ml (5%) injection solution
• Sodium chloride 9 mg/ml (0.9%) injection solution

Ceftazidime can be reconstituted for intramuscular use with 1% lidocaine hydrochloride injection solution.

Reconstitution instructions:

Preparation of solutions for bolus injection

1. Insert the needle of the syringe through the vial stopper and inject the recommended volume of diluent. Remove the needle with the syringe.
2. Shake until dissolved: carbon dioxide is released and a clear solution is obtained in 1 or 2 minutes.
3. Invert the vial. With the syringe plunger fully compressed, insert the needle through the vial stopper and withdraw the total volume of the solution (the pressure created in the vial helps to withdraw the volume). Make sure the needle remains in the solution, not in the air chamber. The withdrawn solution may contain small carbon dioxide bubbles that can be ignored.

These solutions can be administered directly into a vein or introduced into parenteral administration systems if the patient is receiving parenteral fluids. Ceftazidime is compatible with the most common parenteral fluids.

Preparation of solutions for intravenous infusion:

Prepare using a total of 50 ml of compatible diluent, added in TWO stages as described below:

1. Insert the needle of the syringe through the vial stopper and inject 10 ml of diluent.
2. Remove the needle and shake the vial until a clear solution is obtained.
3. Do not insert a needle to release gas until the product has dissolved. Insert a needle to release gas through the vial stopper to release the internal pressure.
4. Transfer the reconstituted solution to the final distribution vehicle (e.g., mini-bag or burette-type set) to a total volume of 50 ml, and administer by intravenous infusion over 15 to 30 minutes.

Note: To preserve the sterility of the product, it is essential not to insert the needle to release gas through the vial stopper until the product has dissolved.

Important incompatibilities

Ceftazidime is less stable in sodium bicarbonate solutions than in other intravenous fluids. It is not recommended as a diluent.

Ceftazidime and aminoglycosides should not be mixed in the injection solution due to the risk of precipitation.

Precipitation may occur when vancomycin is added to ceftazidime in solution. It is recommended to flush intravenous cannulas and catheters with physiological saline solution between administrations of ceftazidime and vancomycin to avoid precipitation.

Storage after reconstitution

Validity period of the prepared solution

The chemical and physical stability of the prepared solution has been demonstrated for 6 hours at 25 °C and for 12 hours at 2-8 °C. After reconstitution with lidocaine, the product should be used immediately (within 2 hours). From a microbiological point of view, the prepared solution should be used immediately.