MEFOXIN 1G/2 ML Powder and solvent for injectable solution

Зміст інструкції

1. Mefoxin 1 g / 2 ml Powder and solvent for injectable solution for intramuscular use, 1 g / 10 ml Powder and solvent for injectable solution for intravenous use, 2 g / 20 ml Powder and solvent for injectable solution for intravenous use
   1. What is Mefoxin and what is it used for
   2. What you need to know before using Mefoxin
   3. How to use Mefoxin
   4. Possible side effects
   5. How to store Mefoxin
   6. Package Contents and Other Information

Mefoxin 1 g / 2 ml Powder and solvent for injectable solution for intramuscular use, 1 g / 10 ml Powder and solvent for injectable solution for intravenous use, 2 g / 20 ml Powder and solvent for injectable solution for intravenous use

cefoxitin

Read this leaflet carefully before you use this medicine as 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.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Mefoxin and what is it used for

The active ingredient of Mefoxin is cefoxitin, which belongs to a group of medicines called beta-lactam antibiotics.
Cefoxitin works against serious infections caused by a particular type of bacteria called Gram-negative bacteria, considered difficult to treat, or by mixed-type bacteria with the presence of Gram-negative bacteria resistant to the most common antibiotics.
Mefoxin is particularly used in debilitated patients (cachectic) and/or with reduced natural defenses (immunocompromised).

2. What you need to know before using Mefoxin

Do not use Mefoxin

• if you are allergic to cefoxitin or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to cephalosporins;
• if you are allergic to lidocaine and are using the solution for intramuscular use (which contains lidocaine).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Mefoxin.
Before starting therapy with Mefoxin, the doctor must conduct a thorough investigation to establish whether
you have experienced allergic reactions (hypersensitivity) to beta-lactam antibiotics in the past. The possibility
of a severe, rapid-onset allergic reaction (anaphylactic shock) cannot be ruled out.
If you need to undergo long-term therapy with Mefoxin, your doctor will regularly check your
liver and kidney function, especially your kidney function if you are also taking medicines that can
cause kidney damage (nephrotoxic medicines).
As with other antibiotics, long-term use may promote the development of bacteria resistant to
this medicine (including fungi). In this case, consult your doctor to adopt appropriate
therapeutic measures.

Pay particular attention with Mefoxin:
If you have kidney problems. Your daily dose of Mefoxin must be reduced if you have reduced
kidney function with decreased urine output (both transient and persistent)
(see “How to use Mefoxin”). In fact, an excess of
medicine in your body can build up if you have impaired kidney function at normal doses.
If you are allergic to penicillin, as there is a possibility of cross-allergy development between two different antibiotics such as penicillins and cephalosporins (taking a beta-
lactam antibiotic like Mefoxin can develop an allergy to a different type of antibiotic, and
vice versa).
If you have previously experienced any form of allergy, especially to medicines, even if of
a different type than Mefoxin. If you have an allergic reaction after using Mefoxin,
immediately stop taking the medicine and consult your doctor.
If you have a history of gastrointestinal disease, particularly inflammation of the colon. Pseudomembranous colitis (inflammation of the colon associated with antibiotic use) has been observed
with practically all antibiotics and can range in severity from mild to
life-threatening. If you develop diarrhea during treatment with Mefoxin, consult
your doctor immediately, as diarrhea may be a symptom of pseudomembranous colitis.
Bacterial resistance
Third-generation cephalosporins, like other beta-lactams, can induce phenomena whereby
the microbe becomes resistant to certain antibiotics (microbial resistance). This occurrence is greater
towards Enterobacteriaceaeand Pseudomonasmicrobes, in patients with reduced immune defenses
(immunocompromised) and, probably, when combining multiple antibiotics of the same type (beta-lactams).
Meningitis
Mefoxin is not recommended for the treatment of meningitis. If you suspect meningitis, consult
your doctor for the use of an appropriate antibiotic.

Other medicines and Mefoxin
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Pay particular attention if you are taking the following medicines:

• other antibiotics, such as penicillins, cephalosporins or aminoglycoside antibiotics; Mefoxin may interact with these medicines, enhancing their toxic effect on the kidneys.
• probenecid (used for the treatment of gout);
• aspirin (acetylsalicylic acid), phenylbutazone (used against inflammation) or other anti-inflammatory drugs at high doses, as they increase the levels of Mefoxin in the blood.

Interactions with laboratory tests
Mefoxin may interfere with some laboratory tests, causing false positives in tests for the
determination of glucose levels in urine (glycosuria) with the Benedict, Fehling and Clinitest methods.
If you need to undergo this test, inform the laboratory personnel that you are undergoing therapy with Mefoxin
because in this case the test must be performed enzymatically.
High concentrations of cefoxitin in the urine can interfere with the values of 17-hydroxy-
corticosteroids (elements of some human hormones) with the Porter-Silber reaction (a chemical
reaction used in the evaluation of hormonal function), and produce slight increases in the reported levels.
Mefoxin may give positive (sometimes false) results of Coombs tests (a laboratory test used to detect the
presence of certain antibodies).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor, pharmacist or nurse for advice before using this
medicine.
During pregnancy and breastfeeding, use Mefoxin only when absolutely necessary and under the direct
control of your doctor.
Avoid breastfeeding during treatment with Mefoxin as cefoxitin passes into breast
milk.

Driving and using machines
Mefoxin does not impair the ability to drive vehicles or operate machinery.

Information on excipients
Mefoxin 1 g / 2 ml Powder and solvent for solution for intramuscular injection, contains less than
1 mmol of sodium (23 mg) per vial, i.e. essentially "sodium-free".

3. How to use Mefoxin

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Therapy can be started before having the results of sensitivity tests.
Mefoxin can be administered intravenously (intravenous administration) or intramuscularly
(intramuscular administration) (see reconstitution methods for each route of administration).
The dose and route of administration must be established at the doctor's discretion based on the severity
of your infection, the sensitivity of the agent that caused the infection, and your health conditions.

The recommended dosefor adults is 1 g or 2 g of Mefoxin every 8 hours.

Usual dose for adults

Use in patients with reduced kidney function(renal insufficiency)
If you suffer from renal insufficiency, an initial loading dose of 1-2 g may be administered. Subsequently
follow the instructions for the maintenance dose (see table below).

Maintenance dose in adults
with reduced kidney function

If you are undergoing blood dialysis (hemodialysis), the loading dose of 1-2 g should be administered
after each dialysis session (blood filtration using machinery) and maintenance doses
should be administered according to the instructions in the previous table.

Use in children
The recommended dosein children aged 3 months and over is 20-40 mg/kg every 6-8 hours.
In severe infections, the total daily dose may be increased up to 200 mg/kg, but it should not
exceed 12 g per day.
In children with reduced kidney function (renal insufficiency), the frequency of doses should be
reduced as indicated for adults.

Method of use
Intravenous administration(into the vein):
Intravenous administration must be performed only by healthcare personnel.
Reconstitute the powder with water for injectable preparation: 1 g is soluble in 2 ml. Although Mefoxin
is very soluble, for intravenous use it is preferable to add 10 ml of water for injectable preparation
to the 1 g vial and 20 ml of water for injectable preparation to the 2 g vial.
Shake to dissolve and draw the entire contents of the vial into the syringe. Mefoxin can be injected
slowly into a vein over 3-5 minutes. This medicine can also be administered by
infusion.
When Mefoxin is administered together with another antibiotic, it is important that they do not
be mixed in the same syringe or in the same infusion container, as with most beta-lactam antibiotics.

Intramuscular administration(into the muscle):
Reconstitute 1 g of Mefoxin with 2 ml of sterile water for injectable preparation or with 0.5% lidocaine hydrochloride solution.
Lidocaine hydrochloride should be used as a diluent only for intramuscular administration and should never be used for intravenous administration.

If you use more Mefoxin than you should
No toxic effects from overdose have been reported.
In case of accidental ingestion/administration of an excessive dose of Mefoxin, immediately inform
your doctor or nurse, or go to the nearest hospital.

If you forget to use Mefoxin
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Mefoxin is generally well tolerated. Side effects have rarely required discontinuation of
treatment and have been mostly transient and mild.
The most common side effects are local reactions at the injection site.
The following side effects may occur with the use of Mefoxin:

• thrombophlebitis (inflammation of superficial veins with possible redness and local swelling) (following administration into the vein);
• pain, hardening and tenderness at the injection site (following administration into the muscle); allergic reactions such as redness (rash), scaling skin irritation (exfoliative dermatitis), urticaria, itching, fever and other allergic reactions, including anaphylaxis (severe allergic reaction with rapid onset);
• low blood pressure (hypotension);
• symptoms of pseudomembranous colitis (such as diarrhea) that may occur during or after antibiotic therapy (see “Warnings and precautions”);
• nausea and vomiting;
• blood changes: increased number of white blood cells (eosinophilia), decreased number of white blood cells (leukopenia, including granulocytopenia and neutropenia), decreased number of red blood cells (anemia, including hemolytic anemia), decreased number of platelets (thrombocytopenia) and disorders of blood cell production (bone marrow depression);
• positive direct Coombs test (laboratory test used to detect the presence of certain antibodies), especially in patients with excess nitrogenous substances in the blood (hyperazotemic);
• transient increases in liver enzyme levels (SGOT, SGPT, serum LDH, serum alkaline phosphatase) and yellowish discoloration of the skin, mucous membranes and whites of the eyes due to liver disorders (jaundice);
• increases in serum creatinine levels and/or azotemia (increases that signal abnormalities in kidney function).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor,
pharmacist or nurse. You can also report side effects directly through the national reporting system at 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 Mefoxin

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 pack after “Scad.”. The expiry
date refers to the last day of that month.
Store the medicine at a temperature not exceeding 30° C.
After reconstitution, Mefoxin is stable for 24 hours at room temperature, for 48 hours in
refrigeration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Mefoxin contains
Mefoxin 1 g / 2 ml Powder and solvent for injectable solution for intramuscular use

• The active ingredient is cefoxitin sodium salt. Each vial of sterile powder contains 1.05 g of cefoxitin sodium salt (corresponding to 1.0 g of cefoxitin free acid).
• The components of the vial are: lidocaine hydrochloride, sodium chloride, water for injections.

Mefoxin 1 g / 10 ml Powder and solvent for injectable solution for intravenous use

• The active ingredient is cefoxitin sodium salt. Each vial of sterile powder contains 1.05 g of cefoxitin sodium salt (corresponding to 1.0 g of cefoxitin free acid).
• The vial contains water for injections.

Mefoxin 2 g / 20 ml Powder and solvent for injectable solution for intravenous use

• The active ingredient is cefoxitin sodium salt. Each vial of sterile powder contains 2.10 g of cefoxitin sodium salt (corresponding to 2.0 g of cefoxitin free acid).
• The vial contains water for injections.

Description of the appearance of Mefoxin and package contents
Mefoxin 1 g / 2 ml Powder and solvent for injectable solution for intramuscular use
Pack of one vial of sterile powder + one vial of 2 ml solvent

Mefoxin 1 g / 10 ml Powder and solvent for injectable solution for intravenous use
Pack of one vial of sterile powder + one vial of 10 ml solvent

Mefoxin 2 g / 20 ml Powder and solvent for injectable solution for intravenous use
Pack of one vial of sterile powder + one vial of 20 ml solvent

Marketing Authorisation Holder
I.B.N. SAVIO S.r.l. – Via del Mare, 36 – Pomezia (RM)

Manufacturer
Vial
Vianex S.A., Plant D,
Ag. Stephanos 25018 – Patrasso – Greece
Biopharma S.r.l.
Via delle Gerbere, 22/30
00134 Roma

Solvent vials
Vianex S.A., Plant A,
12 Km Athens, Lamia National Road
14451 Metamorphossi Attiki, Athens - Greece
Injectalia S.r.l.
Via Castagnetta, 7
00040 Pomezia (RM)
LABORATORIO FARMACEUTICO CT S.R.L.
Via Dante Alighieri 71

• 18038 – Sanremo Italy “Only for 1 g/10 ml pack”

Packaging and release
Vianex S.A., Plant D,
Ag. Stephanos 250 18 – Patrasso - Greece
Biopharma S.r.l.
Via delle Gerbere, 22/30
00134 Roma