Document: leaflet MAH GENERIC_PL 04416-0491 change

• leaflet MAH GENERIC_PL 04416-0491
• leaflet MAH GENERIC_PL 04569-1597
• leaflet MAH GENERIC_PL 25174-0006
• leaflet MAH GENERIC_PL 29831-0030

---

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefotaxime 0.5 g Powder for Solution for Injection Cefotaxime 1 g Powder for Solution for Injection Cefotaxime 2 g Powder for Solution for Injection

Cefotaxime

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.

•    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Cefotaxime is and what it is used for

2.    What you need to know before you use Cefotaxime

3.    How to use Cefotaxime

4.    Possible side effects

5.    How to store Cefotaxime

6.    Contents of the pack and other Information

Other medicines and Cefotaxime

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines you have obtained without a prescription. This is important because some medicines should not be taken with Cefotaxime.

Do NOT take Cefotaxime together with these medicines:

•    Certain antibiotics - tetracyclines (such as doxycycline or minocycline), erythromycin, chloramphenicol. They may not work properly if used with Cefotaxime.

The use of the following medicines is not recommended:

•    Any other antibiotics. They may not work properly if used with Cefotaxime.

•    Probenecid (for gout). This can increase the time it takes for cefotaxime to leave your body.

•    Medicines that may affect the way your kidneys work, like aminoglycoside antibiotics or diuretics (water tablets such as furosemide).

Pregnancy, breast-feeding and fertility

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

Cefotaxime can pass to a baby in the womb or through breast milk. If you are pregnant or breast-feeding, your doctor will decide whether Cefotaxime is right for you.

Driving and using machines

There are no reports that this medicine may affect your ability to drive or use machines.

However, certain side effects could occur (see section 4), which may influence your ability to drive or use machines. If you feel dizzy, do not drive or use any machines.

Cefotaxime contains sodium

Cefotaxime contains 2.09 mmol (equivalent to 48 mg) of sodium per gram. This should be taken into consideration by patients on a sodium controlled diet.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Cefotaxime is normally given by a doctor or nurse.

It is given:

•    by slow injection (for 3-5 minutes) or through a drip (for 20-60 minutes) into one of your veins (intravenous) or

•    by deep injection into a large muscle of the buttock (intramuscular).

The dose of Cefotaxime is determined by your doctor depending on your age, your weight and the severity of the infection and on how well your liver and kidneys are working. Your doctor will explain this to you.

The recommended dose is:

Adults and children over 12 years who weigh more than 50 kg:

•    2-6 g daily. The daily dose should be divided.

•    In severe infections the dose may go up to 12 g daily.

Continued on the next page >>

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

Cefotaxime 0.5 g powder for solution for injection Cefotaxime 1 g powder for solution for injection Cefotaxime 2 g powder for solution for injection

Cefotaxime

This is an extract from the Summary of Product Characteristics to assist in the administration of Cefotaxime. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the SPC.

For slow intravenous injection/infusion and intramuscular injection.

INCOMPATIBILITIES WITH DILUENTS AND OTHER MEDICINAL PRODUCTS

•    Cefotaxime should not be added with other antibiotics, in the same syringe or solution for infusion. This concerns especially aminoglycosides.

•    Cefotaxime should not be mixed with solutions containing sodium bicarbonate.

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL

Aseptic techniques should be used to reconstitute the solution. The reconstituted solution should be administered immediately.

Cefotaxime is compatible with several commonly used intravenous infusion fluids:

•    Water for Injection

•    0.9 % Sodium Chloride solution

•    5 % Glucose solution

•    5 % Glucose/0.9 % Sodium Chloride solution

•    Ringer-lactate solution

•    5 % Metronidazole solution

•    Dextran 40 in 0.9 % Sodium Chloride solution

•    Dextran 40 in 5 % Glucose solution

The compatibility of cefotaxime in other infusion fluids should be checked before use.

Following reconstitution the solution should be clear and pale yellowish to brown-yellowish. Do not use if any particulate matter is visible. Withdraw only one dose.

Any unused solution should be discarded.

00000000

SZ00000LT000    Continued on the next page >>

Infants and children (1 month to 12 years of age) who weigh less than 50 kg:

•    50-150 mg for each kg of body weight per day in two to four divided doses.

•    In severe infections the dose may go up to 200 mg for each kg of body weight per day in divided doses.

Infants (younger than four weeks old):

•    50 mg per kg body weight daily in two to four divided doses.

•    In severe infections the dose may go up to 150-200 mg for each kg of body weight per day.

The elderly:

The usual dosage for adults does not need to be adjusted if the kidney function and liver function are good.

Special dosage information:

•    Gonorrhoea: a single injection of 0.5 -1 g is required.

•    Uncomplicated bladder or kidney infections: the dose is 1 g twice daily

•    Brain infections: in adults the dose is 6-12 g daily, in children 150-200 mg for each kg of body weight per day and in newborns 50 mg for each kg of body weight per day.

•    Abdominal infections: Cefotaxime may be used in combination with other antibiotics.

In special cases Cefotaxime may be injected directly into a large muscle. In this case Cefotaxime powder for solution for injection may be dissolved in a medicine called lidocaine which is intended to make the injection less painful.

If you use more Cefotaxime than you should

As you will be given Cefotaxime by a doctor or nurse, you are unlikely to be given the wrong dose. However, if you experience bad side effects or think you have been given too much, tell your doctor immediately.

If you forget to use Cefotaxime

If you think you have not been given a dose of Cefotaxime, tell your doctor immediately.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

You must contact your doctor immediately if you notice

any ofthe following:

Uncommon: may affect up to 1 in 100 people

•    increased tendency to bleed or bruise more easily caused by a fall in the number of blood platelets (thrombocytopenia), fever, sore throat or mouth ulcers due to infections caused by a low level of white blood cells (leucopenia) or high level of a specific type of white blood cells (eosinophilia).

Not known: frequency cannot be estimated from the

available data

•    Inflammation of the bowels, called colitis (or antibiotic-associated colitis), causing severe long-lasting watery or bloody diarrhoea with stomach cramps and fever

•    Serious blood problems, including changes in the numbers of some white blood cells (which may cause frequent infections, fever, severe chills, sore throat, or mouth ulcers)

•    Damage to red blood cells (causing tiredness, being short of breath or looking pale)

•    Severe allergic reactions with symptoms such as swelling of the lips, tongue, face and neck, sudden difficulty in breathing, speaking and swallowing;

•    Headache, dizziness, convulsions (fits) (these may be symptoms of a brain disorder called encephalopathy)

•    Changes in heart beat (rhythm or rate), after a very quick injection into a vein

•    Yellow skin and eyes, loss ofappetite, light-coloured urine caused by inflammation of the liver.

•    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).

•    Increased or reduced urine output, or traces of blood in your urine, sometimes with swollen limbs and / or flank pain caused by kidney problems

•    For intramuscular injection: combination with lidocaine can cause systemic reactions

Other possible side effects:

Very common: may affect more than 1in10 people

•    Intramuscular injection may be painful

Uncommon: may affect up to 1 in 100 people

•    People being treated for infections with bacteria called spirochetes often show symptoms like fever and shivering which are described as ‘Herxheimer reaction' and indicate the effectiveness of the therapy.

•    Changes in the results of blood tests that check how the liver and kidneys are working

•    Fever

•    Allergic reactions such as skin rash (nettle rash), itchy skin

•    Painful swelling and inflammation where the injection is given into a vein

•    Soft stools or diarrhoea

Not known: frequency cannot be estimated from the available data

•    Feeling sick (nausea) and being sick (vomiting)

•    Pain in your stomach (abdomen)

Your doctor may want to perform tests during your treatment to measure any changes.

Reporting of side effects

If you get any side effects, talk to your doctor 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 (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

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

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

Powder:

Do not store above 25°C. Keep container in the outer carton in order to protect from light.

For storage conditions of the reconstituted/diluted medicinal product, see the area of the package leaflet headed ‘The following information is intended for medical or healthcare professionals only'.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Cefotaxime contains

•    Active substance:

The active substance is cefotaxime (as sodium salt). Cefotaxime contains [0.5 g /1 g / 2 g] cefotaxime.

•    Other ingredients:

The medicinal product contains no other ingredients than the active substances.

What Cefotaxime looks like and contents of the pack

Cefotaxime is a powder for solution for injection or infusion packaged in glass bottles. The bottles are packed in carton boxes. Each box contains Cefotaxime glass bottles.

Content

1 vial per carton, 1 vial per carton in pack of 5 cartons, 1 vial per carton in pack of 10 cartons, 1 carton of 10 vials, 1 carton of 25 vials, 1 carton of 50 vials, 1 carton of 100 vials

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Ltd, Frimley Business Park, Frimley, Camberley Surrey, GU16 7SR,UK.

This leaflet was last revised in 05/2014.

SZ00000LT000

Method of administration:

In order to prevent any risk of infection, the preparation of the infusion should be done in close aseptic conditions. Do not delay the infusion after the preparation of the solution. Cefotaxime and aminoglycosides should not be mixed in the same syringe or perfusion fluid.

•    Intravenous infusion

For short intravenous infusion Cefotaxime 1 g/2 g should be dissolved in 40-50 ml Water for Injections or in another compatible fluid (e.g. glucose 10%). After preparation the solution should be given as a 20 minute intravenous infusion.

For long lasting intravenous infusion Cefotaxime 2 g should be dissolved in 100 ml of a suitable fluid e.g. 0.9% sodium chloride or isotonic glucose solution or other compatible fluids for infusions. After preparation the solution should be given as a 50-60 minute intravenous infusion.

•    Intravenous injection

Cefotaxime 0.5 g/1 g/2 g should be dissolved in 2 ml/4 ml/ 10 ml Water for Injections and should be injected over a period of 3-5 minutes. During post-marketing surveillance, potentially life-threatening arrhythmia has been reported in a very few patients who received rapid intravenous administration of cefotaxime through a central venous catheter.

• Intramuscular injection

Cefotaxime 0.5 g/1 g should be dissolved in 2 ml/4 ml Water for Injections. The solution should be administered by deep intramuscular injection. In order to prevent pain from injection Cefotaxime 0.5 g/1 g may be dissolved in 2 ml/4 ml 1 % Lidocaine Hydrochloride (only for adults). Solutions with lidocaine must not be administered intravenously. If the total daily dose is more than 2 g, the intravenous administration should be chosen. In the case of severe infections, intramuscular injection is not recommended. The product information of the chosen lidocain-containing medicinal product must be regarded.

The following table shows the volume ofdilution for each vial size