Document: leaflet MAH GENERIC_PL 04515-0393 change

• leaflet MAH GENERIC_PL 04515-0393
• leaflet MAH GENERIC_PL 04515-0394

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h

Hospira

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Cefuroxime 250 mg Powder for Solution for Injection

Cefuroxime 750 mg Powder for Solution for Injection

Cefuroxime 1.5 g

Powder for Solution for Injection/Infusion

Cefuroxime

The name of your medicine is Cefuroxime Powder for Solution for Injection 250 mg, 750 mg & Cefuroxime Powder for Solution for Injection/Infusion 1.5 g which will be referred to as cefuroxime throughout the rest of this document.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or nurse.

•    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What cefuroxime is and what it is used for

2.    What you need to know before you are given cefuroxime

3.    How cefuroxime is given

4.    Possible side effects

5.    How to store cefuroxime

6.    Contents of the pack and further information

1. WHAT CEFUROXIME IS AND WHAT IT IS USED FOR

Cefuroxime is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Cefuroxime is used to treat infections of:

•    the lungs or chest

•    the urinary tract

•    the skin and soft tissue

•    the abdomen Cefuroxime is also used:

•    to prevent infections during surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFUROXIME

You must not be given cefuroxime:

•    if you are allergic (hypersensitive) to any cephalosporin antibiotics

or any of the other ingredients of cefuroxime

•    if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems)

Tell your doctor before you start on cefuroxime; if you think that this applies to you, you must not be given cefuroxime.

Take special care with cefuroxime

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

If you need a blood or urine test

Cefuroxime can affect the results of urine or blood tests for sugar and a blood test known as Coombs’ test. If you are having tests:

Tell the person taking the sample that you have been given cefuroxime.

Other medicines and cefuroxime

Tell your doctor if you are taking any other medicines, if you've started taking any recently or you start taking new ones. This includes medicines you can obtain without a prescription.

Some medicines may affect how cefuroxime works, or make it more likely that you'll have side effects. These include:

•    aminoglycoside-type antibiotics

•    water tablets (diuretics), such as furosemide

•    Probenecid

•    oral anticoagulants

Tell your doctor if this applies to you. You may need extra check-ups to monitor your renal function while you are taking cefuroxime.

Contraceptive pills

Cefuroxime may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with cefuroxime you also need to use a barrier method of contraception (such as condoms). Ask your doctor for advice.

Pregnancy, breast-feeding and fertility

Tell your doctor before you are given cefuroxime:

•    if you are pregnant, think you might be pregnant or are planning to become pregnant

•    if you are breast-feeding

Your doctor will consider the benefit of treating you with cefuroxime against the risk to your baby.

Driving and using machines

Don't drive or use machines if you do not feel well.

Important information about some of the ingredients of cefuroxime:

You need to take this into account if you are on a controlled sodium diet. Cefuroxime 250 mg Powder for Solution for Injection:

This medicinal product contains 0.59 mmol (13.56 mg) of sodium per vial Cefuroxime 750 mg Powder for Solution for Injection:

This medicinal product contains 1.77 mmol (40.69 mg) of sodium per vial Cefuroxime 1.5 g Powder for Solution for Injection / Infusion:

This medicinal product contains 3.54 mmol (81.38 mg) of sodium per vial

3. HOW CEFUROXIME IS GIVEN

Cefuroxime 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.

The usual dose

The correct dose of cefuroxime 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.

Newborn babies (0 - 3 weeks)

For every 1 kg the baby weighs, they'll be given 30 to 100 mg

cefuroxime per day divided in two or three doses.

Babies (over 3 weeks) and children

For every 1 kg the baby or child weighs, they'll be given 30 to 100 mg

of cefuroxime per day divided in three or four doses.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended for medical or healthcare professionals only.

Instructions for use and handling:

For single use only: Any unused product or waste material should be disposed of in accordance with local requirements, immediately after use.

Intramuscular use

Add 1 ml water for injection to Cefuroxime 250 mg or at least 3 ml for Cefuroxime 750 mg Powder for Injection.

Shake gently to produce an opaque suspension.

Intravenous use

Dissolve in water for Injection using at least 2 ml for Cefuroxime 250 mg,

6 ml for Cefuroxime 750 mg or 15 ml for Cefuroxime 1.5 g to produce a clear solution. For short intravenous infusion (e.g. up to 30 minutes), Cefuroxime 1.5 g may be dissolved in 15 ml water for injection, add the reconstituted solution of Cefuroxime sodium to 50 or 100 ml of any of the compatible infusion solution mentioned below.

Reconstituted solution may be diluted with:

5% glucose injection

0.9% sodium chloride injection

0.18% sodium chloride + 4% glucose

Hartman's solution

The contents and concentrations of cefuroxime as a suspension/solution are shown in the table below:

Cefuroxime per vial (mg)	Route of administration	Volume of solvent to be added (mL)	Final volume of suspension/ solution (mL)	Concentration of suspension/ solution (mg/ml)
250	IM	1	1.2	208
	IV Bolus	2	2.2	114
750	IM	3	3.5	214
	IV Bolus	6	6.7	112
1500	IV Bolus	15	16.2	93
	IV Infusion	15 + 50	66.5	23
	IV Infusion	15 + 100	116.4	13

These solutions may be given directly into the vein or introduced into the tubing of the giving set of a compatible parenteral infusion.

Q7MBB2 TN/DRUGS/763

Adults and adolescents

750 mg to 1.5 g of cefuroxime per day divided into two, three or four doses. Maximum dose: 6 g per day.

Patients with kidney problems

If you have a kidney problem, your doctor may change your dose. Talk to your doctor if this applies to you.

4. POSSIBLE SIDE EFFECTS

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

Conditions you need to look out for

A small number of people taking cefuroxime get an allergic reaction or potentially serious skin reaction. Symptoms of these reactions include:

•    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)

•    fungal infections on rare occasions, medicines like cefuroxime can cause an overgrowth of yeast (Candida) in the body which can lead to fungal infections (such as thrush). This side effect is more likely if you take cefuroxime sodium for a long time

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

Common side effects

These may affect up to 1 in 10 people:

•    injection site pain, swelling and redness along a vein Tell your doctor if any of these are troubling you.

Common side effects that may show up in blood tests:

•    increases in substances (enzymes) produced by the liver

•    changes in your white blood cell count (neutropenia or eosinophilia)

•    low levels of red blood cells (anaemia)

Uncommon side effects

These may affect up to 1 in 100 people:

•    skin rash, itchy, bumpy rash (hives)

•    diarrhoea, nausea, stomach pain

Tell your doctor if you get any of these.

Uncommon side effects that may show up in blood tests:

•    low levels of white blood cells (leucopenia)

•    increase in bilirubin (a substance produced by the liver)

•    positive Coombs' test

Other side effects

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

•    fungal infections

•    high temperature (fever)

•    allergic reactions

•    inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, stomach pain

•    inflammation in the kidney and blood vessels

•    red blood cells destroyed too quickly (haemolytic anaemia)

•    skin rash, which may be blister, and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge) erythema multiformae

Tell your doctor if you get any of these.

Side effects that may show up in blood tests:

•    decrease in number of blood platelets (cells that help blood to clot -thrombocytopenia)

•    increase in levels of urea nitrogen and serum creatinine in the blood.

If you get any side effects

Tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE CEFUROXIME

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

Do not use cefuroxime after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Keep vial(s) in the outer carton.

After the solution is made, it may be stored at 2-8°C for up to 24 hours.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any medicine that is no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cefuroxime contains:

The active substance is Cefuroxime Sodium. There are no other ingredients.

Each vial of 250 mg, 750 mg & 1.5 g contains 263 mg, 789 mg & 1.578 g of cefuroxime sodium equivalent to 250 mg, 750 mg & 1.5 g of cefuroxime, respectively.

What Cefuroxime looks like and contents of the pack

Cefuroxime is a white to faint yellow, amorphous sterile powder packaged in 20 ml / 100 ml clear glass vial and sealed with grey bromo butyl rubber stopper and coloured flip off seal.

Cefuroxime 250mg and 750mg Powder for Solution for Injection:

Packs of 1,5, 10 or 25 vials in a carton.

Cefuroxime 1.5g Powder for Solution for Injection/Infusion:

Packs of 1 vial in a carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom:

Cefuroxime 250 mg Powder for solution for injection Cefuroxime 750 mg Powder for solution for injection Cefuroxime 1.5 g Powder for solution for injection/infusion Last date of revision {}

Storing Cefuroxime Injection:

This medicinal product does not require any special storage conditions.

Keep vial(s) in outer carton.

Reconstituted solution: Chemical and physical stability has been demonstrated for 24 hours at 2-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally be no longer than 24 hours at 2-8°C unless reconstitution has taken place in controlled and validated aseptic conditions.

Incompatibilities

Solutions containing Cefuroxime should not be mixed with or added to solutions containing other agents other than those mentioned above.

The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects the colour of solutions and therefore this solution is not recommended for the dilution of Cefuroxime powder for injection. However, if required, for patients receiving sodium bicarbonate injection by infusion, the Cefuroxime powder for injection may be introduced into the tube of the giving set.

Cefuroxime powder for injection should not be mixed in the same syringe with aminoglycoside antibiotics.

Usually Cefuroxime is effective when administered alone, but when appropriate it may be used in combination with metronidazole or an aminoglycoside apart from each other.

Q74&&2

TN/DRUGS/763

Component Specification
Item number:	Q74882
Request number:	AS2702
Country:	United Kingdom
OI template:	OCI001
Amalia version:	7
Mulgrave version:	N/A
Dimensions:	118 x 712 mm
Container(s):	Vial
Supplier:	Hospira India
Stock:	N/A
Folded dimensions:	30 x 118 mm
Printed both sides:	Yes
Perforated:	No
2D barcode:	Datamatrix
2D barcode content:	948026233
Supplier Code:	948026233
Colours
Black:	■
	h
	Hospira

Requester

I have checked this artwork against the registered text including spelling, layout, size, colours, registration numbers and scientific equations, the name and address and trademarks. Also for any possible changes to related items.

This artwork is in conformance with the Marketing Authorisation and can now proceed to the printing stage.

Previous Item Number: N/A

Signed:

Date:

Version 1 Technician: Date:	NC 20/Mar/13	Version 2 Technician: Date:	MW 16/Apr/13
Version 3 Technician: Date:	EM 13/Nov/14	Version 4 Technician: Date:	xx dd/mmm/yy
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