Cefazolin 2g Powder for solution for infusion/injection vials

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Cefazolin 2 g Powder for solution for injection/infusion but is referred to as Cefazolin throughout the rest of this leaflet.

1. What Cefazolin is and what it is used for
2. What you need to know before you are given Cefazolin
3. How Cefazolin is given
4. Possible side effects
5. How to store Cefazolin
6. Contents of the pack and other information

• if you are allergic to cefazolin.
• if you have ever had a severe allergic reaction to penicillin or a similar antibiotic.
• if you are allergic to lidocaine and you are to be given Cefazolin as an injection into a muscle

Talk to your doctor or pharmacist before you are given Cefazolin:

• if you have ever had a mild allergic reaction (such as skin rashes that may be itchy) to penicillin or similar antibiotics.
• if you have any allergies not mentioned in this leaflet.
• if you have ever had intestinal problems, especially colitis (inflammation of the bowel).
• if you have kidney problems.
• if you are on a low-sodium diet.

Signs of an allergic reaction to this medicine, including breathing problems and chest pain, have been reported with cefazolin. Stop immediately cefazolin and contact immediately your doctor or medical emergencies if you notice any of these signs.

Risk factors that lead to vitamin K deficiency or risk factors that affect other blood clotting mechanisms.

In rare cases, blood clotting disorders can occur during treatment with cefazolin. In addition, blood clotting changes are possible in patients with diseases that can cause or worsen bleeding, such as haemophilia, stomach or bowel ulcers. In these cases, your blood clotting will be monitored.

This medicine must not be injected in the area around the spinal cord (intrathecally) as there have been reports of central nervous system toxicity (including seizures).

Long-term treatment with Cefazolin may cause secondary infections. Your doctor will monitor you closely for their development and provide treatment if necessary.

Cefazolin should not be given to premature babies and infants in the first month of life.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This includes non-prescription medicines and herbal medicines, because Cefazolin can affect the way some medicines work. Also, some medicines can affect how Cefazolin works.

It is very important to talk to your doctor or nurse, especially if you are taking any of the following medicines:

• aminoglycosides or other antibiotics (used to treat infections)
• probenecid (used to treat gout)
• vitamin K
• anticoagulants (blood thinning medicines)
• furosemide (diuretics)

You should also tell your doctor or nurse if you have tests to measure levels of glucose or other blood tests.

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

Cefazolin has no influence on the ability to drive and use machines. However, side effects may occur which may affect the ability to drive and use machines (see also section 4, Possible side effects).

This medicine contains approximately 101.2 mg of sodium (table salt) in each vial. This is equivalent to 5.1% of the recommended maximum daily dietary intake of sodium for an adult.

This must be taken into consideration by patients on a controlled sodium diet.

Cefazolin is always administered by a healthcare professional. It will be given as an injection or infusion (into a vein) after being dissolved.

Your doctor will inform you about the necessary duration and frequency of administration of Cefazolin.

Adults with normal kidney function

• Infections caused by bacteria susceptible to this medicine:
  1-2 g daily, divided into 2-3 doses.
• Infections caused by bacteria less susceptible to this medicine:
  3-4 g daily, divided into 3-4 doses.

An increase of the daily dose up to 6 g in three or four equal doses is possible.

Premature babies and infants below the age of one month:

The safety in infants below the age of one month has not been determined.

Children over the age of one month:

• Infections caused by bacteria susceptible to this medicine:
  25 - 50 mg / kg body weight / day divided in 2-4 single doses, every 6, 8 or 12 hours.
• Infections caused by bacteria less susceptible to this medicine:
  Up to 100 mg /kg body weight/day divided in 3-4 single doses, every 6-8 hours.

This product is not recommended for children under 1 month of age.

No dosage adjustment is required for elderly patients with normal renal function.

Prevention of infections during surgical procedures: 1 g cefazolin 30 - 60 minutes before surgery. In case of long surgical procedures (2 hours or more), additional 0.5 g - 1 g cefazolin during the operation.

If you have problems with your kidneys, you may be given a lower dose or increase the time between each dose.

The treatment duration depends on the severity of the infection as well as on your recovery from your illness.

Since the medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too much.

Symptoms of overdose are headache, dizziness (vertigo), sensation of pricking or tingling on the skin (paraesthesia), restlessness (agitation), involuntary twitching of a muscle or a group of muscles (myoclonia) and cramps (convulsions). If these symptoms occur talk to your doctor immediately. In emergencies, your physician must take the necessary measures for the treatment of symptoms of overdose.

If you think you have missed a dose of Cefazolin, contact your doctor or nurse immediately.

A double dose must not be given to make up for a forgotten dose.

Low dosage, irregular administration or stopping the treatment too early can compromise the outcome of the therapy or lead to a relapse, that is more difficult to treat. Please follow the instructions of your doctor..

Common (may affect up to 1 in 10 people):

• skin rash,
• nausea and vomiting,
• diarrhoea,
• pain or skin hardening at the injection site.

Uncommon (may affect up to 1 in 100 people):

• yeast infection in the mouth,
• fever,
• seizures (fits),
• inflammation of the veins,
• skin redness and itching, joint pain, skin lesions, widespread rash and hives.

Rare (may affect up to 1 in 1,000 people):

• genital infection, vaginal thrush – sore and itchy vagina or vaginal discharge,
• prolonged use can lead to overgrowth of non-susceptible bacteria,
• increase or decrease in the number of blood cells,
• hypergylcaemia (high blood sugar),
• hypoglycaemia (low blood sugar),
• dizziness
• respiratory (breathing) disorders,
• kidney and urinary disorders,
• cough,
• runny nose,
• loss of appetite,
• liver impairment (detectable with blood analysis), jaundice,
• rapidly evolving severe rash (with blisters on the skin and skin peeling, and possible blisters in the mouth),
• severe fatigue and weakness,
• chest pain.

Very rare (may affect up to 1 in 10,000 people):

• blood clotting disorders,
• inflammation of the colon. Symptoms include diarrhoea (usually with blood and mucus), abdominal pain and fever,
• genital itching.

Not known (frequency cannot be estimated from the available data):

Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The active substance is cefazolin (as cefazolin sodium).

Each vial contains 2 g cefazolin (as cefazolin sodium).

Cefazolin is a white or almost white powder for solution for injection/infusion. It is available in glass vials in packs of 1 and 10 vials.

Not all pack sizes may be marketed.