Cefuroxim Pfizer 250 mg, poeder voor suspensie voor injectie of oplossing voor injectie

You must not be given Cefuroxime Pfizer:

• if you are allergic (hypersensitive) to any cephalosporin antibiotics or any of the other ingredients of Cefuroxime Pfizer.

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

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

• Tell your doctor before you start on Cefuroxime Pfizer if you think that this applies to you. You must not be given Cefuroxime Pfizer.

Take special care with Cefuroxime Pfizer

You must look out for certain symptoms such as allergic reactions and gastrointestinal disorders such as diarrhoea while you are being given Cefuroxime Pfizer. 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 Pfizer.

If you need a blood or urine test

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

 Tell the person taking the sample that you have been given Cefuroxime Pfizer.

Other medicines and Cefuroxime Pfizer

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 Pfizer 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 Pfizer.

Contraceptive pills

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

Pregnancy and breast-feeding and fertility

Tell your doctor before you are given Cefuroxime Pfizer:

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

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

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

Driving and using machines

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

Cefuroxime Pfizer contains sodium

Cefuroxime Pfizer contains sodium. You need to take this into account if you are on a controlled sodium diet.

Cefuroxime Pfizer strength	Amount per vial
250 mg	14 mg
750 mg	41 mg
1.5 g	81 mg

Cefuroxime Pfizer 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 Pfizer 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 Pfizer 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 Pfizer per day divided in three or four doses.

Adults and adolescents

750 mg to 1.5 g of Cefuroxime Pfizer 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.

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

Conditions you need to look out for

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

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

• 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) erythema multiformae.
• 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 Pfizer 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 Pfizer 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 Coomb’s test.

Other side effects

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

• high temperature (fever)
• 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).

 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 clot – thrombocytopenia)

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

• 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.

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 vial and carton after EXP. The expiry date refers to the last day of that month.

Unopened vials: The unopened medicinal product does not require any special storage conditions.

[250 mg]:

Intravenous injection:

After reconstitution: Chemical and physical in-use stability has been demonstrated for up to 12 hours when stored at 2-8 ºC for solutions prepared by reconstitution with compatible diluents.

From a microbiological point of view, the product should be used immediately.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not, under any circumstances, exceed the demonstrated chemical and physical stability period and conditions.

[750 mg & 1.5 g]:

Intravenous injection:

After reconstitution: Chemical and physical in-use stability has been demonstrated for up to 12 hours when stored at 2-8 ºC for solutions prepared by reconstitution with compatible diluents.

Intravenous infusion:

After initial reconstitution: The product should be diluted immediately.

After further dilution of the reconstituted solution: Chemical and physical in-use stability has been demonstrated for up to 12 hours when stored at 2-8 ºC for solutions prepared by diluting the initially reconstituted solution with compatible diluents.

After further dilution of the reconstituted solution (with 10% invert sugar or 10% Dextrose): Chemical and physical in-use stability has been demonstrated for up to 6 hours when stored at 2-8 ºC for solutions prepared by diluting the initially reconstituted solution with 10 % invert sugar and 10% Dextrose (see section 6.6).

From a microbiological point of view, the product should be used immediately.

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not, under any circumstances, exceed the demonstrated chemical and physical stability period and conditions.

Do not use this medicine if you notice visible signs of deterioration such as particulate matter and discoloration.

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

What Cefuroxime Pfizer contains

The active substance is cefuroxime (present as cefuroxime sodium).

Each vial of Cefuroxime Pfizer 250 mg contains 250 mg cefuroxime (as 263 mg cefuroxime sodium).

Each vial of Cefuroxime Pfizer 750 mg contains 750 mg cefuroxime (as 789 mg of cefuroxime sodium).

Each vial of Cefuroxime Pfizer 1.5 g contains 1.5 g cefuroxime (as 1.578 g of cefuroxime sodium).

There are no other ingredients. However, see section 2 for “Cefuroxime Pfizer contains sodium”.

What Cefuroxime Pfizer looks like and contents of the pack

[Cefuroxime Pfizer 250 mg]: Powder for suspension for injection or solution for injection

[Cefuroxime Pfizer 750 mg & 1.5 g]: Powder for suspension for injection or solution for injection/infusion

A white to slightly yellow powder.

[250 mg]: 10 ml type I moulded glass vial stoppered with a grey bromobutyl rubber stopper and sealed with an aluminium seal with a dark blue coloured polypropylene disc. [750 mg]: 15 ml type I moulded glass vial stoppered with a grey bromobutyl rubber stopper and sealed with an aluminium seal with a dark blue coloured polypropylene disc. [1.5 g]: 20 ml type I moulded glass vial stoppered with a grey bromobutyl rubber stopper and sealed with an aluminium seal with a dark blue coloured polypropylene disc.

Pack sizes: 1, 5, 10, 25 and 100 vials.

Not all pack sizes may be marketed.

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder: Pfizer bv

Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland

Manufacturer:

Pfizer Service Company BVBA

Hoge Wei 10, B-1930, Zaventem

België

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

Name of	Name of the medicinal product
country
AT	Cefuroxim Pfizer 250 mg Pulver zur Herstellung einer Injektionssuspension
	oder Injektionslösung
	Cefuroxim Pfizer 750 mg/1,5 g Pulver zur Herstellung einer
	Injektionssuspension oder Injektions-/Infusionslösung
BE	Cefuroxime Pfizer 250 mg poudre pour suspension ou solution injectable;
	poeder voor suspensie of oplossing voor injectie; Pulver zur Herstellung
	einer Injektionssuspension oder Injektionslösung
	Cefuroxime Pfizer 750 mg/1.5 g poudre pour suspension injectable ou pour
	solution injectable ou pour perfusion; poeder voor suspensie voor injectie of
	oplossing voor injectie/infusie; Pulver zur Herstellung einer
	Injektionssuspension oder Injektions-/Infusionslösung
CY	Cefuroxime Pfizer
DE	Cefuroxim Pfizer 250 mg Pulver zur Herstellung einer Injektionssuspension
	oder Injektionslösung
	Cefuroxim Pfizer 750 mg/1,5 g Pulver zur Herstellung einer
	Injektionssuspension oder Injektions-/Infusionslösung
DK	Cefuroxim Pfizer
EL	Cefuroxime Pfizer
IE	Cefuroxime 250 mg powder for suspension for injection or solution for
	injection
	Cefuroxime 750 mg/1.5 g powder for suspension for injection or solution
	for injection/infusion
LU	Cefuroxime Pfizer 250 mg, poudre pour suspension ou solution injectable
	Cefuroxime Pfizer 750 mg & 1.5 g, poudre pour suspension injectable ou
	pour solution injectable ou pour perfusion
NL	Cefuroxim Pfizer 250 mg, poeder voor suspensie voor injectie of oplossing
	voor injectie
	Cefuroxim Pfizer 750 mg/1500 mg, poeder voor suspensie voor injectie of
	oplossing voor injectie/infusie
NO	Cefuroxim Pfizer
PL	Cefuroxime Pfizer

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

	1.3.1 SPC, Labelling and Package Leaflet
PT	Cefuroxima Pfizer
SK	Cefuroxim Pfizer 750 mg/1.5 g prášok na injekčný suspenziu alebo roztok
	na injekčný / infúzny roztok
UK	Cefuroxime 250 mg powder for suspension for injection or solution for
	injection
	Cefuroxime 750 mg/1.5 g powder for suspension for injection or solution
	for injection/infusion

In het register ingeschreven onder:

Cefuroxim Pfizer 250 mg: RVG 109155

Cefuroxim Pfizer 750 mg: RVG 109156

Cefuroxim Pfizer 1500 mg: RVG 109157

Deze bijsluiter is voor het laatst goedgekeurd in juni 2013.

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

-----------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

This leaflet contains practical information on the preparation and/or handling of medicinal product. Read this leaflet carefully before administering this medicine to the patient.

Please note: This leaflet does not contain all the necessary information for this medicine. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the Summary of Product Characteristics (SmPC).

For single use only.

The dilution is to be made under aseptic conditions.

Shake the vials gently to reconstitute fully.

Instructions for reconstitution

See table for addition volumes and solution/suspension concentrations, which may be useful when fractional doses are required. Water for Injections is recommended as the diluent for reconstitution of cefuroxime powder.

Addition volumes and solution/suspension concentrations, which may be useful when fractional doses are required.

Addition volumes and solution/suspension concentrations, which may be useful
when fractional doses are required
Vial size		Amount	of	Approximate	Resulting
		water to	be	cefuroxime	Product
		added (ml)		concentration
				(mg/mL)**
250 mg powder for suspension for injection or solution for injection
250 mg	Intramuscular	1 mL		208	Suspension
	Intravenous	at least 2 mL		114	Solution
750 mg powder for suspension for injection or solution for injection/infusion
750 mg	Intramuscular	3 mL		208	Suspension
	intravenous bolus	at least 6 mL		114	Solution
	intravenous infusion	6 mL*		114	Solution
1.5 g powder for suspension for injection or solution for injection/infusion
1.5 g	Intramuscular	6 mL		208	Suspension
	intravenous bolus	at least 15 mL	93	Solution
	intravenous infusion	15 mL*		93	Solution

*: Reconstituted solution to be added to 50 ml or 100 ml of compatible infusion fluid (see information on compatibility, below)

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

**: Resulting volume of the solution/suspension of cefuroxime in reconstitution medium is increased due to the displacement factor of the drug substance resulting in listed concentrations in mg/ml.

As for all parenteral medicinal products, inspect the reconstituted solution or suspension visually for particulate matter and discoloration prior to administration.

[Intramuscular injection]: After addition of the specified amount of diluent for intramuscular injection, a suspension is formed.

[Intravenous bolus injection or intravenous infusion]: The solution should only be used if the solution is clear and practically free from particles.

Solutions and suspensions range in colour from clear to yellow coloured depending on concentration, diluent and storage conditions used.

[750 mg & 1.5 g]

Cefuroxime Pfizer 750 mg & 1.5 g should be reconstituted following the instructions for reconstitution of intravenous injection with water for injection (see table above).

Further dilution should take place in 50 - 100 ml of one of the following compatible infusion fluids prior to intravenous infusion administration:

Cefuroxime Pfizer 750 mg & 1.5 g is compatible for up to 12 hours at 2-8oC in following diluents:

• Sterile water for Injection
• Sodium chloride intravenous infusion (0.9% w/v)
• Potassium chloride (10 and 40 meq) in 0.9% sodium chloride intravenous infusion
• Ringer’s injection
• Lactated Ringer’s injection
• Sodium lactate intravenous infusion (M/6).

Cefuroxime Pfizer 750 mg & 1.5 g is compatible for up to 6 hours at 2-8oC in following diluents:

• 10% invert sugar in intravenous infusion
• 10% Dextrose.

[250 mg]: Cefuroxime Pfizer should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or by deep intramuscular injection.

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

[750 mg & 1.5 g]: Cefuroxime Pfizer should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection.

[250 mg]:

Unopened vials: 2 years.

Intravenous injection:

After reconstitution: Chemical and physical in-use stability has been demonstrated for up to 12 hours when stored at 2-8 ºC for solutions prepared by reconstitution with compatible diluents (see section 6.6 of the SmPC).

From a microbiological point of view, the product should be used immediately.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not, under any circumstances, exceed the demonstrated chemical and physical stability period and conditions.

[750 mg & 1.5 g]:

Unopened vials: 2 years.

Intravenous injection:

After reconstitution: Chemical and physical in-use stability has been demonstrated for up to 12 hours when stored at 2-8 ºC for solutions prepared by reconstitution with compatible diluents (see section 6.6 of the SmPC).

Intravenous infusion:

After initial reconstitution: The product should be diluted immediately.

After further dilution of the reconstituted solution: Chemical and physical in-use stability has been demonstrated for up to 12 hours when stored at 2-8 ºC for solutions prepared by diluting the initially reconstituted solution with compatible diluents (see section 6.6 of the SmPC).

After further dilution of the reconstituted solution (with 10% invert sugar or 10% Dextrose): Chemical and physical in-use stability has been demonstrated for up to 6 hours when stored at 2-8 ºC for solutions prepared by diluting the initially reconstituted solution with 10 % invert sugar and 10% Dextrose (see section 6.6 of the SmPC).

From a microbiological point of view, the product should be used immediately.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not, under any circumstances, exceed the demonstrated chemical and physical stability period and conditions.

This medicinal product must not be mixed with other medicinal products except those mentioned in the section containing reconstitution instructions.

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion

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

MARKETING AUTHORISATION APPLICATION Cefuroxime Pfizer 250 mg powder for suspension for injection or solution for injection;

Cefuroxime 750 mg & 1.5 g powder for suspension for injection or solution for injection/infusion