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CEFTAZIDIME COPHARMA 1 G POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFTAZIDIME PENTAHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ceftazidime Copharma 1 g Powder for Solution for Injection
Ceftazidime (as pentahydrate)
Read all this leaflet carefully before you have been given Ceftazidime Copharma injection
 Keep this leaflet. You may need to read it again
 If you have any further questions, please ask your doctor or pharmacist
 If any of the side effects become serious or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
 This medicine has been prescribed for you personally and should not be passed on to others.
It may harm them even if their symptoms are the same as yours
In this leaflet:
1. What Ceftazidime Copharma for injection is and what it is used for
2. Before you are given Ceftazidime Copharma for injection
3. How Ceftazidime Copharma for injection is given
4. Possible side-effects
5. Storing Ceftazidime Copharma for injection
6. Further information
1. What Ceftazidime Copharma for injection is and what it is used for
Ceftazidime Copharma belongs to a group of antibiotics called cephalosporins. Antibiotics are used to
kill the bacteria or “germs” that cause infections.
Ceftazidime Copharma is used to treat specific types of infections which are sensitive to the drug
which include:
 Pneumonia acquired at hospitals (nosocomial pneumonia)
 Lung infections in patients with cystic fibrosis
 Infections of the tissues covering the brain
2. Before you are given Ceftazidime Copharma for injection:
You should not be given Ceftazidime Copharma for injection if:
 You are allergic to Cephalosporins including Ceftazidime Copharma or any of the ingredients in
this injection (e.g. sodium carbonate)
 You have had a previous, immediate and/or severe allergic reaction to penicillin or any betalactam antibiotic (if you are unsure what a beta-lactam antibiotic is, please ask your doctor or
pharmacist)
Take special care with Ceftazidime Copharma for injection if:
 You are taking a diuretic (water tablet) such as furosemide
 You are taking any other antibiotics e.g. chloramphenicol or aminoglycoside antibiotics
 You are on a low sodium diet
 You have any diseases of the stomach and/or intestine (gastrointestinal diseases e.g. colitis)
 If you experience bloody diarrhoea, you must stop treatment and contact your doctor
immediately
 You have kidney problems. You may still receive Ceftazidime Copharma but you may need a
lower dose.
If you are unsure, ask your doctor or the other health care personnel for advice. If you are having a
blood test for any reason, tell the person who is taking your blood sample that you are having

Ceftazidime Copharma, as it may affect your results. If your urine is being tested for sugar,
Ceftazidime Copharma may cause a false positive result.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Medicines which may interact with Ceftazidime Copharma include:
 chloramphenicol
 macrolides
 tetracyclines
 drugs known to cause diseases or damage to the kidney as a side effect (e.g. cisplatin),
aminoglycoside antibiotics such as gentamicin or amikacin, diuretics (e.g. furosemide or
cyclosporine)
Pregnancy and Breastfeeding
Please inform your doctor if you are pregnant, planning on becoming pregnant or breastfeeding before
taking this medicine. This medicine should not be used during pregnancy or breastfeeding unless
advised by your doctor.
Driving and using machines
Ceftazidime Copharma can cause dizziness and convulsions. If affected you should not drive or operate
machinery.
Important information about some of the ingredients of Ceftazidime Copharma
This medicinal product contains 52.5 mg (2.28 mmol) of sodium per dose.
To be taken into consideration by patients on a controlled sodium diet.
3. How Ceftazidime Copharma for injection is given
The dose depends on the severity and type of infection you have, as well as on your age, weight and
function of your kidney. Tell your doctor if you have any kidney problems.
Adults
The usual adult dose is 1 g three times a day or 2 g twice a day. For severe infections, or for patients
who have a special risk of infections due to a low white blood cell count, the usual dose is 2 g three
times a day.
Adults with moderate to severe kidney problems
For patients with moderate to severe kidney problems the dose of Ceftazidime Copharma will be
reduced.
For patients with renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration
the dose is 1 g daily in divided doses.
For patients who have haemodialysis courses, the appropriate dose should be repeated after each
haemodialysis period. This is because some of the Ceftazidime Copharma may be removed from the
body during this type of dialysis and so needs to be topped up.
Elderly
For elderly patients the total daily dose should normally not be more than 3 g, especially in those over
80 years of age.
Children aged over 2 months
For children aged over 2 months the usual dose is 30 mg to

100 mg per kg of body weight daily divided into 2 or 3 separate doses. Severely ill children may receive
up to 150 mg per kg of body weight daily (to a maximum of 6 g daily), divided into 3 separate doses.
Newborn and children aged under 2 months
For new-borns and children less than 2 months old, the usual dose is 25 mg to 60 mg per kg of body
weight daily divided into 2 or doses.
If you are given too much, or too little, Ceftazidime Copharma
Your medication will usually be given to you by the health professional – if you think you may have
missed a dose or have received too much or too little of the medicine please tell your doctor or nurse
immediately. Signs of overdose include pain and swelling of injection site, dizziness, pins and needles,
headaches, and fits, inflammation of the brain and loss of consciousness.
As with all antibiotics it is important that you are given Ceftazidime Copharma regularly and the full
course is completed.
If you have any further questions on the use of this product, ask your doctor or the other health
personnel.
4. Possible side effects
Like all medicines, Ceftazidime Copharma can cause side effects, although not everybody gets them.
As with some other antibiotics, some people find they have an allergy to Ceftazidime Copharma.
If any of the following serious side effects happens tell your doctor or nurse immediately:
- allergic reactions, such as sudden wheezing and tightness of the chest, swelling of the eyelids, face,
throat or lip, severe skin rashes that can blister and may involve the eyes, mouth and throat and
genital, fainting.
- diarrhoea that is serious lasts a long time or has blood in it, with stomach pain or fever. This can be a
sign of serious bowel inflammation that can happen during or after taking antibiotics.
Common side effects: affects 1 to 10 users in 100
 Blood: blood abnormalities causing changes in blood test results of the numbers of some blood
cells including an increase in red blood cells and platelets, which may cause blood clots.
 Skin: itching, flushing, eruption on the skin (maculopapulous rash or exanthema)
 General: local skin reactions, inflammation of a blood vessel, inflammation at the site of
injection after intravenous administration.
Uncommon side effects: affects 1 to 10 users in 1,000
 Blood: blood abnormalities causing bleeding tendency, easy bruising, increased risk of
infections. Changes in blood test results of the number of some blood cells
 Nervous system: “pins and needles”, bad taste in the mouth, headache, dizziness, numbness,
tingling, burning sensations, cramps, confusion, sleepiness, convulsions
 Gastrointestinal: nausea, vomiting, diarrhoea and pain in the gut
 General: fever
Rare side effects: affects 1 to 10 users in 10,000
 Skin: severe skin reactions with blistering of the skin, mouth or eyes (e.g. Stevens Johnson’s
syndrome) or with peeling of the skin (e.g. Lyell’s syndrome)
 Blood: anaemia with symptoms such as fatigue, pale skin colouration and shortness of
breath, big fall in the number of circulating white blood cells (agranulocytosis) leading to
an increase in the risk of infection
 Liver: changes in the result of the blood tests that check the liver function
 Genitals: itching or pain in the vagina (symptoms of fungal or bacterial vaginal infections)
 Gastrointestinal: fungal infection in the mouth, a particular infection of the large gut
following treatment with antibiotics causing severe and persistent diarrhoea

(pseudomembranous colitis)
 Kidney: impaired kidney function, changes in the results of the blood tests that check the
kidney function
Very rare side effects: affects less than 1 user in 10,000
 Liver: yellowing of the skin and eyes (jaundice)
 Immune system: severe allergic reaction causing sudden swelling of the throat, wheezing,
shortness of breath and sudden drop in blood pressure
 Nervous system: trembling, uncontrolled stiffness of the muscle, fits, unconsciousness and a
general inflammation of the brain can also happen, but usually only in people with poor
kidneys.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.
5. Storing Ceftazidime Copharma for Injection:
Keep out of the reach and sight of children
Store below 25°C
Keep the vial in the outer carton in order to protect from light
Discard any unused solution
This product should not be used after the expiry date printed on the carton and ampoule label after
EXP. The doctor or nurse will check that the product has not passed this date. Any product that has
passed this date must be returned to a pharmacist or doctor for safe disposal.
6. Further Information
What Ceftazidime Copharma for injection contains
Each vial contains the active ingredient, Ceftazidime Copharma pentahydrate, equivalent to 1 g of
Ceftazidime Copharma, as a powder for solution for injection. It also contains the inactive ingredient,
sodium carbonate. This medicinal product contains 52.5 mg (2.28 mmol) of sodium per dose. To be
taken into consideration by patients on a controlled sodium diet.
What Ceftazidime Copharma for injection looks like and contents of the pack
Ceftazidime Copharma is available powder for solution for injection. The powder is white or off-white.
The vials are placed in cartons. Pack sizes: Boxes of one, five or ten vials.
Marketing Authorisation Holder
COPHARMA ApS
Jægersborg Allé 164
DK-2820 Gentofte
Denmark
Manufacturer
Cardinal Health, Bampton Road,
Romford,
United Kingdom.
RM3 8UG

This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark
Finland
Norway
Sweden

Ceftazidime
Ceftazidime
Ceftazidime
oppløsning
Ceftazidime

"Copharma"
Copharma 1 g Injektiokuiva-aine, liuosta varten
Copharma 1 g pulver til injeksjonsvæske,
Copharma, 1 g pulver til injektionsvätska, lösning

Product Licence Nos.:
PL 40386/0019

TECHNICAL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Ceftazidime Copharma 1 g Powder for Solution for Injection
PHARMACEUTICAL FORM
Powder for solution for injection
Incompatibilities
Ceftazidime Copharma and aminoglycosides must not be mixed in the same infusion solution due to
the risk of precipitation.
Cannulae and catheters for intravenous application must be rinsed with isotonic salt water between
the administration of Ceftazidime Copharma and vancomycin to avoid precipitation.
This medicinal product must not be mixed with other medicinal products except those mentioned in
section ‘Special precautions for use and handling’.
Shelf life
Vial before breaking open:
1 year
Vial after breaking open:
The product should be used immediately
After reconstitution:
The product should be used immediately
From the microbiological point of view, the product must be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Chemical and physical in-use stability has been demonstrated for 12 hours at 2ºC - 8oC when prepared
in Sterile Water for Injection or 1% Lidocaine Hydrochloride Injection.
Special precautions for use and handling
Disposal
For single use only. Discard any unused solution.

Any unused product or waste material should be disposed of in accordance with local requirements.
The dilution is to be made under aseptic conditions. The solution is to be inspected visually for
particulate matter and discolouration prior to administration. The solution should only be used if the
solution is clear and free from particles.
Instructions for reconstitution:
Ceftazidime Copharma should be reconstituted with Sterile Water for Injection or 1% Lidocaine
Hydrochloride Injection (intramuscular use only)(see the following table).

Preparation of solutions of Ceftazidime Copharma
Amount of diluent to be
added (ml)

Approximate ceftazidime
concentration (mg/ml)

Intramuscular
1g

3.0 *

260

1g

3.0 **

260

Intravenous-Injection
1g

10.0 *

90

* Sterile Water for Injection
** 1% Lidocaine Hydrochloride Injection (intramuscular use only)

All vials as supplied are under reduced pressure.
When Ceftazidime Copharma is dissolved, carbon dioxide is released and a positive pressure develops.
For ease of use, follow the recommended techniques of reconstitution described below.
Preparation for direct administration for 1 g
The following reconstitution guidelines should be followed:
1. Insert the syringe needle through the original vial closure and inject the recommended volume of
diluent. The vacuum may assist entry of the diluent.
2. Remove the syringe needle.
3. Shake the original vial to dissolve the content. Carbon dioxide is released and a clear solution will
be obtained in about 1 to 2 minutes.
4. Invert the original vial. With the syringe plunger fully depressed, insert the needle through the vial
closure and withdraw the total volume of solution into the syringe (the pressure in the vial may aid
withdrawal). Ensure that the needle remains within the solution and does not enter the head space.
5. The withdrawn solution may contain small bubbles of carbon dioxide; they may be disregarded.
For intravenous injection, the solution must be administered directly into the vein.
Please refer to section 6.3 for in use stability of the reconstituted product.
Extemporaneous solutions for paediatric single doses are to be reconstituted with the most adequate
strength in order to reduce as far as possible volumes to be discarded. Multiple use of the single dose
containers is not appropriate. The reconstituted product should be used immediately (see section 6.3).

Solutions range from light yellow to amber depending on concentration, diluent and storage conditions
used. Within the stated recommendations, product potency is not adversely affected by such colour
variations.
Before administration, the reconstituted and diluted solutions should be inspected visually for
particulate matter and discolouration. Only clear and colourless solution free from particles should be
used.
Marketing Authorisation Holder
COPHARMA ApS
Jægersborg Allé 164
DK-2820 Gentofte
Denmark
Manufacturer
Cardinal Health UK 434 Ltd.
Bampton Road, Harold Hill
Romford, Essex
RM3 8UG
United Kingdom
Product Licence Nos.:
PL 40386/0019
This leaflet was approved in August 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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