MONACEF

Pay special attention with Monacef
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with cefuroxime therapy.
Seek immediate medical advice if you notice any of the symptoms related to these severe skin reactions described in section 4.

Addition of volumes and concentrations that may be useful if fractional doses are required
Type of vial Route of administration Physical state Volume of water to add (ml) Approximate concentration of cefuroxime (mg/ml)**
750 mg powder for injection or infusion
750 mg intramuscular suspension 3 ml 216
intravenous bolus solution at least 6 ml 116
intravenous infusion solution at least 6 ml* 116
1500 mg powder for injection or infusion
1500 mg intramuscular suspension 6 ml 216
intravenous bolus solution at least 15 ml 94
intravenous infusion solution 15 ml* 94
2000 mg powder for infusion solution
2000 mg intravenous infusion solution 20 ml* 94
*Reconstituted solution to be added to 50 or 100 ml of compatible infusion fluid (see compatibility information below).
**The resulting volume of the cefuroxime solution in the reconstitution medium is increased due to the displacement factor of the active substance, resulting in the concentrations listed in mg/ml.

Compatibility
1.5 g of cefuroxime sodium reconstituted with 15 ml of water for injections can be added to an injectable solution of metronidazole (500 mg/100 ml).
1.5 g of cefuroxime sodium is compatible with azlocillin 1 g (in 15 ml) or 5 g (in 50 ml).
Cefuroxime sodium (5 mg/ml) can be used in a 5% w/v or 10% w/v xylitol injectable solution.
Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
Cefuroxime sodium is compatible with the following infusion fluids:
Sodium chloride 0.9% w/v for injections BP
Dextrose 5% for injections BP
Sodium chloride 0.18% w/v plus Dextrose 4% for injections BP
Dextrose 5% and Sodium chloride 0.9% w/v for injections BP
Dextrose 5% and Sodium chloride 0.45% w/v for injections
Dextrose 5% and Sodium chloride 0.225% w/v for injections
Dextrose 10% for injections
Lactated Ringer's solution for injections USP
Sodium lactate M/6 for injections
Compound sodium lactate for injections BP (Hartmann's solution).

The stability of cefuroxime sodium in 0.9% w/v sodium chloride solution for injections BP and in 5% dextrose solution for injections is not affected by the presence of sodium phosphate hydrocortisone.

Cefuroxime sodium has also been found to be compatible when mixed in intravenous infusion with:
Heparin (10 and 50 units/ml) in 0.9% w/v sodium chloride injectable solution; Potassium chloride (10 and 40 mEq/L) in 0.9% w/v sodium chloride injectable solution.

Package leaflet: Information for the user

MONACEF 1 g powder for injection solution Cefuroxime
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. See section 4.
Contents of this leaflet:

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

1. What MONACEF is and what it is used for

Monacef is an antibiotic used in adults and children. It works by killing the bacteria that cause infections and belongs to a group of medicines called cephalosporins.
MONACEF is used to treat infections of:
lungs or chest
urinary tract
skin and soft tissues
abdomen

MONACEF is also used:

• to prevent infections during surgery. Your doctor may identify the type of bacteria causing the infection and check whether the bacteria are sensitive to Monacef during treatment.

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

Do not take MONACEF:

• if you are allergic to any antibiotic of the cephalosporin class or to any of the other ingredients
  of Monacef (listed in section 6);
• if you have had a severe allergic reaction ( hypersensitivity ) to any other type of beta-lactam antibiotics
  (penicillins, monobactams, and carbapenems).

• if you have developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after treatment with cefuroxime or with any other antibiotic of the cephalosporin class.

Talk to your doctor before starting treatment with Monacef if you think this applies to you, because in
this case Monacef must not be administered to you.
Warnings and precautions Talk to your doctor, pharmacist, or nurse before taking Monacef.
Be alert for certain symptoms such as allergic reactions, skin rashes, gastrointestinal disturbances such as
diarrhoea, or fungal infections while being treated with Monacef. This will reduce the risk of possible problems. See
( Conditions requiring caution ) in section 4. If you have ever had an allergic reaction to other
antibiotics such as penicillin, you may also be allergic to Monacef.
Exercise particular caution with Monacef
Severe skin reactions have been reported in association with cefuroxime treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS).
Seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
If you need blood or urine tests
Monacef may interfere with the results of urine or blood tests for glucose (sugar) and with the blood test known as the Coombs test. If you are undergoing these tests:
Inform the person collecting the sample that you are being treated with Monacef.
Other medicines and Monacef
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the activity of Monacef or increase the likelihood of side effects.
These include:

• aminoglycoside antibiotics
• diuretic medicines such as furosemide
• probenecid
• oral anticoagulants Inform your doctor if this applies to you. You may need additional monitoring to assess kidney function while being treated with Monacef.

Oral contraceptives
Monacef may reduce the effectiveness of the oral contraceptive pill. If you are taking the oral contraceptive while being treated with Monacef, you should also use a barrier method of contraception (such as a condom). Consult your doctor for advice.
Pregnancy, breastfeeding, and fertility
Inform your doctor before being given Monacef:

• if you are pregnant, think you may be pregnant, or are planning to become pregnant
• if you are breastfeeding
  Your doctor will assess the benefit of treatment with Monacef against the potential risk to your baby.

Driving and using machines
Do not drive or operate machinery if you do not feel well.
Monacef contains sodium
You should take into account the following if you are on a sodium-controlled diet.
This medicine contains 56 mg of sodium (a main component of table salt) per vial. This corresponds to 2.8% of the maximum recommended daily dietary intake of sodium for an adult.

3. How MONACEF is administered

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Monacef is generally administered by a doctor or nurse. It can be given as an intravenous infusion or as an injection directly into a vein or into a muscle.
Recommended dose:
The appropriate dose of Monacef will be decided by your doctor and depends on the severity and type of infection; whether you are being treated with other antibiotics; your body weight and age; and the condition of your kidneys.
Use in newborns (from 0 to 3 weeks)
For each kg of the child's body weight, 30 to 100 mg of Monacef per day will be administered, divided into two or three doses.
Use in infants (over 3 weeks) and children
For each kg of the infant's or child's body weight, 30 to 100 mg of Monacef per day will be administered, divided into three or four doses.
Adults and adolescents
750 mg to 1.5 g of Monacef two, three or four times a day. Maximum dose: 6 g per day.
Patients with renal problems
If you have kidney problems, your doctor may adjust the dose.
Talk to your doctor if this applies to you.

4. Possible side effects

Like all medicines, MONACEF can cause side effects, although not everyone experiences them.

Conditions requiring attention
A small number of people being treated with Monacef may develop an allergic reaction or a potentially severe skin reaction. Symptoms of these reactions include:

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty breathing.
• Skin rash with blisters resembling small targets (a dark spot in the center surrounded by a lighter area with a black ring around the edge).
• Widespread rash with blisters and peeling of the skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain in the context of allergic reactions, which may be a symptom of heart attack triggered by an allergy (Kounis syndrome).

Other symptoms you should be aware of while being treated with Monacef:

• Fungal infections. Rarely, medicines such as Monacef can cause overgrowth of fungi ( Candida ) in the body, leading to fungal infections (such as thrush). This side effect is more likely if you take Monacef for a prolonged period.
• Severe diarrhoea ( pseudomembranous colitis ). Medicines like Monacef can cause inflammation of the colon (large intestine), leading to severe diarrhoea, usually with blood and mucus, stomach pain, and fever.

→Contact your doctor or nurse immediately if you experience any of these symptoms.

Common side effects
These may affect up to 1 in 10 patients:

• Pain at the injection site, swelling and redness along the vein.
  →Inform your doctor if any of these conditions concern you.

Common side effects that may be detected by blood tests:

• Increased levels of substances ( enzymes ) produced by the liver
• Changes in 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 patients:
Skin rash, itching, irregular rash ( urticaria )
Diarrhoea, nausea, stomach pain
→Inform your doctor if you experience any of these conditions.

Uncommon side effects that may be detected by blood tests:
Low levels of white blood cells ( leucopenia )
Increased bilirubin levels (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 of the kidneys and blood vessels
Too rapid destruction of red blood cells ( haemolytic anaemia )
Skin rash with blister-like formations resembling small targets (a dark spot in the center surrounded by a lighter area with a black ring around the edge) – erythema multiforme.

→Inform your doctor if you experience any of these conditions.

Side effects that may be detected by blood tests:

• Decreased number of platelets (cells that help blood clotting – thrombocytopenia )
• Increased blood levels of urea nitrogen and creatinine

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MONACEF

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. The suspension must be used immediately after reconstitution with the indicated volume of solvent.
Once reconstituted for injection, the medicinal product may be stored for 5 hours if kept below 25°C, or for 48 hours if kept at 4°C.
The reconstituted product may show an intensification of colour during storage.
From a microbiological point of view, the product should be used immediately. Otherwise, the conditions of storage after reconstitution are the responsibility of the user and normally should not exceed 24 hours between 2 and 8°C, unless reconstitution takes place under controlled and validated aseptic conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What MONACEF contains
MONACEF 1 g powder for injectable solution:
One vial contains: cefuroxime sodium 1.052 g equivalent to cefuroxime 1.000 g
Description of the appearance of MONACEF and package contents
MONACEF 1 g powder for injectable solution
Monacef is a powder for injectable solution, supplied in a glass vial closed with a butyl rubber stopper and an aluminium cap.
White to off-white powder.
Each package may contain either 1 vial or 100 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Esseti Farmaceutici S.r.l. - Via R. De Cesare, 7, 80132 Napoli
Manufacturer:
Esseti Farmaceutici S.r.l - Via Campobello, 15 – 00071 Pomezia (RM)
This leaflet was last approved on
The following information is intended exclusively for physicians or healthcare professionals:
Addition of volumes and concentrations of the solution which may be useful when fractional doses are required.

* The resulting volume of the cefuroxime solution in the reconstitution medium is increased due to the
displacement factor of the active substance, resulting in the concentrations listed in mg/ml.
Once reconstituted with water, the suspension appears yellow in color without signs of precipitation.

Compatibility
1.5 g of cefuroxime sodium reconstituted with 15 ml of water for injections can be added to
an injectable solution of metronidazole (500 mg/100 ml).
1.5 g of cefuroxime sodium is compatible with azlocillin 1 g (in 15 ml) or 5 g (in 50 ml).
Cefuroxime sodium (5 mg/ml) can be used in an injectable solution of 5% w/v or 10% w/v xylitol.
Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
Cefuroxime sodium is compatible with the following infusion fluids:
Sodium chloride 0.9% w/v for injections BP
Dextrose 5% for injections BP
Sodium chloride 0.18% w/v plus Dextrose 4% for injections BP
Dextrose 5% and Sodium chloride 0.9% w/v for injections BP
Dextrose 5% and Sodium chloride 0.45% w/v for injections BP
Dextrose 5% and Sodium chloride 0.225% w/v for injections BP
Dextrose 10% for injections BP
Ringer's lactate solution for injections USP
Sodium lactate M/6 for injections
Compound sodium lactate for injections BP (Hartmann's solution).

The stability of cefuroxime sodium in sodium chloride 0.9% w/v for injections BP and in dextrose 5% for injections BP is not affected by the presence of sodium hydrocortisone phosphate. Cefuroxime sodium has also been found to be compatible when mixed in intravenous infusion with:
Heparin (10 and 50 units/ml) in 0.9% w/v sodium chloride injectable solution; Potassium chloride (10 and 40 mEq/L) in 0.9% w/v sodium chloride injectable solution.