Oxacillin norameda

Package leaflet: Information for the patient

Oxacilin Norameda, 1000 mg,
powder for solution for injection/infusion
Oxacillinum
Please read carefully all the information in this leaflet before using this medicine, as it
contains important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Oxacilin Norameda is and what it is used for

The active substance in Oxacilin Norameda is oxacillin, which belongs to a group of medicines called beta-lactams, specifically beta-lactamase-resistant penicillins.
Oxacillin acts against susceptible bacteria causing infections of the respiratory tract, skin, and bones. Oxacilin Norameda is also used in severe infections such as endocarditis (inflammation of the inner lining of the heart), meningitis, and bacteremia (sepsis). It may also be used for the prevention of postoperative infections.
Oxacillin may also be used for other types of infections, as directed by a physician.
The medicine is used in adults and children from birth for the treatment of the following infections:

• Endocarditis
• Meningitis
• Pneumonia
• Joint infections
• Osteomyelitis (bone and bone marrow infection)
• Skin and soft tissue infections
• Bacteremia associated with or suspected to be related to the above infections
• Prevention of postoperative infections in:
  • neurosurgery: craniotomy and implantation of internal cerebral spinal fluid (CSF) shunts
  • plastic and reconstructive surgery of varying complexity

Appropriate guidelines for the proper use of antibiotics should be taken into account.

2. Information before using Oxacilin Norameda

When not to use Oxacilin Norameda:

• if the patient is allergic to oxacillin, other beta-lactam antibiotics (penicillins and cephalosporins), or any of the other ingredients of this medicine (listed in section 6); The medication should be discontinued and the doctor informed immediately if the patient experiences an allergic reaction.

Warnings and precautions
Before starting treatment with Oxacilin Norameda, discuss it with your doctor.
Inform your doctor immediately if the patient develops symptoms of allergy during treatment.
Before using this medicine, inform your doctor if an allergic reaction occurred during previous treatment with antibiotics (even with another class of antibiotics), such as urticaria or other skin rash, itching, sudden swelling of the face and neck (angioedema) (see section 4).
While taking antibiotics, including Oxacilin Norameda, diarrhoea may occur even several weeks after completion of treatment. If diarrhoea worsens or does not resolve, or if blood or mucus appears in the stool, treatment with Oxacilin Norameda must be stopped immediately. Do not take medications that block or slow peristalsis, and contact your doctor (see section 4).
Oxacilin Norameda with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including methotrexate (a medicine used in the treatment of cancer or rheumatoid arthritis), probenecid (a medicine used in the treatment of gout), or another antibiotic, including over-the-counter medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Pregnancy
Oxacilin Norameda should not be used during pregnancy unless clearly indicated by a doctor.
Breastfeeding
Penicillins pass into human milk in small amounts, and the quantities ingested are considerably lower than therapeutic doses for newborns. Therefore, caution should be exercised when administering oxacillin to nursing mothers. If the newborn develops problems such as diarrhoea, skin rash, or candidiasis (infection caused by certain microscopic fungi), inform the doctor immediately, who will advise on the necessary steps, as these may be caused by the effect of this medicine on the infant's body.
Before using any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Oxacilin Norameda has no influence on the ability to drive vehicles or operate machinery.
Oxacilin Norameda contains sodium
Each vial of the medicine contains 64 mg of sodium (main component of table salt). This corresponds to 3.2% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Oxacilin Norameda?

Dosage
Oxacilin Norameda is a product intended for injections, administered by a qualified healthcare professional either deeply intramuscularly or intravenously. The physician will determine the appropriate dose for the patient.
Recommended doses:
Adults
Endocarditis (inflammation of the inner lining of the heart)
Infective endocarditis associated with native valve: 2 g intravenously every 4 hours or 3 g intravenously every 6 hours. Endocarditis associated with prosthetic valve: 2 g intravenously every 4 hours.
Total daily dose: 12 g/day.
Duration of treatment: 6 weeks for complicated right-sided endocarditis associated with native valve and left-sided endocarditis associated with native valve; 2 weeks for uncomplicated right-sided endocarditis associated with native valve; at least 6 weeks for endocarditis associated with prosthetic valve.
Meningitis
2 g intravenously every 4 hours.
Total daily dose: 12 g/day.
Duration of treatment: at least 2 weeks.
Pneumonia
2 g intravenously every 4–6 hours.
Total daily dose: 12 g/day.
Duration of treatment: at least 5 days for community-acquired pneumonia and 7 days for hospital-acquired pneumonia or ventilator-associated pneumonia; patients should be clinically stable and have normal vital signs before discontinuing therapy. Longer courses may be required in cases of severe pneumonia with necrosis; pneumonia complicated by meningitis, endocarditis, or other deep-seated infections; pneumonia caused by non-fermenting glucose Gram-negative bacteria; or complicated pneumonia caused by less common pathogens (e.g., Burkholderia pseudomallei, Mycobacterium tuberculosis, or endemic fungi).
Joint infection
2 g intravenously every 4–6 hours.
Total daily dose: 12 g/day.
Duration of treatment: 4–6 weeks.
Osteomyelitis (bone and bone marrow infection)
1.5 to 2 g intravenously every 4–6 hours.
Total daily dose: 12 g/day.
Duration of treatment: 4–6 weeks.
Skin or soft tissue infection
Surgical site infection (localized): 2 g intravenously every 6 hours.
Skin and soft tissue infections, necrotizing infections: 1 to 2 g intravenously every 4 hours.
Total daily dose: 12 g/day.
Duration of treatment: The duration of treatment for most bacterial skin or soft tissue infections should be 7–14 days. For necrotizing myositis, 2–3 weeks of therapy are recommended. For erysipelas and cellulitis, the recommended duration of antimicrobial therapy is 5 days, but treatment should be extended if infection does not improve within this period. In necrotizing infections, antimicrobial therapy should continue until further wound debridement is no longer necessary, the patient's clinical condition has improved, and the patient has been afebrile for 48 to 72 hours.
Bacteremia
2 g intravenously every 4–6 hours.
Total daily dose: 12 g/day.
Duration of treatment: 2–6 weeks.
Surgical prophylaxis
2 g intravenously within 60 minutes before the first incision, followed by 2 g intravenously every 4 hours or 1 g intravenously every 2 hours, if necessary.
Total daily dose: 12 g/day.
Duration of treatment: should not exceed 48 hours.

Use in children and adolescents
Endocarditis
Children aged 1 year or older: 200 mg/kg/day intravenously in divided doses every 4 to 6 hours.
Maximum dose: 12 g/day.
The maximum dose, calculated based on body weight, should not exceed 12 g per day.
Duration of treatment: at least 4 to 6 weeks.
Meningitis
Newborns aged 0 to 7 days: 25 mg/kg intravenously every 8 to 12 hours.
Newborns aged 8 to 28 days: 50 mg/kg intravenously every 6 to 8 hours.
Infants, children, and adolescents: 50 mg/kg intravenously every 6 hours.
The maximum dose, calculated based on body weight, should not exceed 12 g per day.
Duration of treatment: at least 2 weeks.
In very low birth weight newborns (<2000 g), lower doses and longer intervals between doses may be recommended.
Pneumonia
Infants and children over 3 months of age: 150–200 mg/kg/day intravenously or intramuscularly in divided doses every 6 to 8 hours.
The maximum dose, calculated based on body weight, should not exceed 12 g per day.
Duration of treatment: 5–14 days.
Osteomyelitis (bone and bone marrow infection)
Infants and children over 3 months of age: 150–200 mg/kg/day intravenously in divided doses every 4 to 6 hours.
Duration of treatment: 3–4 weeks. A longer duration may be required in cases of infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or Salmonella, pelvic or spinal infections, severe and/or complicated infections, or in patients with slow response to treatment.
Joint infection
Infants and children over 3 months of age: 150–200 mg/kg/day intravenously in divided doses every 4 to 6 hours.
The maximum dose, calculated based on body weight, should not exceed 12 g per day.
Duration of treatment: The total duration of treatment, intravenous plus oral, should average 2–3 weeks. A longer duration may be required (up to 4–6 weeks) in cases of MRSA infection or infection associated with Panton-Valentine leukocidin (PVL), in newborns and young infants, in cases of slow or poor response to treatment, or in complications or involvement of pelvis or spine.
Skin or soft tissue infection
Infants and children over 1 month of age: 100–150 mg/kg/day intravenously in divided doses every 6 hours. In necrotizing infection: 200 mg/kg/day intravenously in divided doses every 6 hours.
Duration of treatment: The duration of treatment for most bacterial skin or soft tissue infections (SSTI) should be 7–14 days. For necrotizing myositis, 2–3 weeks of therapy are recommended. For erysipelas and cellulitis, the recommended duration of antimicrobial therapy is 5 days, but treatment should be extended if infection does not improve within this period. In necrotizing infections, antimicrobial therapy should continue until further wound debridement is no longer necessary, the patient's clinical condition has improved, and the patient has been afebrile for 48 to 72 hours.
Bacteremia

Maximum dose: 12 g/day.
Duration of treatment: 2-6 weeks

Prophylaxis of postoperative infections
50 mg/kg intravenously over 60 minutes before the first incision, followed by 50 mg/kg intravenously
every 4 hours, if necessary.
The maximum dose, calculated based on body weight, should not exceed 12 g per day.
Duration of treatment: should not exceed 48 hours.

Elderly patients
When administering intravenously, especially in elderly patients, caution should be exercised due to the risk of thrombophlebitis.

Use of the drug in patients with renal function impairment
In patients with severe renal function impairment, dose adjustment is necessary.
The physician should consider creatinine clearance and monitoring of drug concentration is recommended.
Treatment should be continued for at least 48 hours after the disappearance of objective and subjective signs of infection.

Method of administration
Oxacillin should be administered deep intramuscularly, by intravenous injection, or by intravenous infusion, after dissolving in a compatible solvent.

Duration of treatment
For this antibiotic to be effective, it must be used regularly at the prescribed doses and for as long as directed by the physician.
The disappearance of fever or any other symptom does not mean complete recovery.
Any feeling of fatigue is not caused by antibiotic therapy but by the infection itself.
Reducing the dose or interrupting treatment will not affect this feeling and may delay recovery.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will
experience them.
If the patient experiences any of the following adverse reactions,
seek immediate medical advice from a doctor or healthcare professional – urgent
medical assistance may be required:

• anaphylactic shock – difficulty breathing, drop in blood pressure, rapid heartbeat (very rare), severe watery diarrhoea with abdominal pain and possible presence of blood and mucus (very rare) (see section 2. Warnings and precautions),
• allergic reaction (frequency not known), such as skin rash, itching or hives, breathing difficulties, swelling of the face and neck,
• fever, unusual bleeding, seizures (frequency not known).

If the patient experiences any of the following adverse reactions,
contact a doctor as soon as possible:

Adverse reactions occurring rarely (less than 1 in 1000 people)

• increased activity of certain liver enzymes (aminotransferases, alkaline phosphatase), hepatitis with jaundice

Adverse reactions with unknown frequency

• insufficient number of red blood cells (anaemia) or certain white blood cells (leukopenia) or blood cells involved in blood clotting
  (platelets) (thrombocytopenia) resolving after discontinuation of treatment
• increased number of certain white blood cells in blood (eosinophilia)
• nausea, vomiting, diarrhoea
• kidney disease (acute interstitial nephropathy)
• rapid fatigue
• neurological disorders such as disturbances of consciousness, confusion, abnormal movements, involuntary muscle contractions, reported after administration of high doses of oxacillin-based antibiotics, especially in patients with impaired kidney function.
• fungal superinfection (vaginal candidiasis)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
Tel.: 22 49-21-301,
Fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Oxacilin Norameda

Keep this medicine out of sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the cardboard box,
bottle, following EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Oxacilin Norameda contains

• The active substance is oxacillin: each vial contains 1000 mg of oxacillin (as sodium oxacillin monohydrate)
• The other ingredient is disodium phosphate

What Oxacilin Norameda looks like and contents of the pack
Oxacilin Norameda is a white or almost white powder in a vial made of colourless glass (type
III), closed with a grey rubber stopper and secured with an aluminium flip-off cap.
Pack: a cardboard box containing 1, 10, 25 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
UAB Norameda
Meistrų g. 8A,
02189 Vilnius,
Lithuania

Contact
Norameda Polska Sp. z o.o.
ul. Kilińskiego 20, 05-500 Piaseczno, Poland
Tel.: +48 504 278 778
e-mail: [email protected]

Manufacturer
Mitim S.r.l.
Via Giovanni Battista Cacciamali 34-38
Brescia
BS, 25125
Italy

This medicinal product is authorised in the following countries of the European Economic Area under the following names:
Czech Republic Oxacilin AVMC
Slovakia Oxacilin AVMC
Poland Oxacilin Norameda
Estonia Oxacillin Auxilia
Italy Oxciva

Information intended exclusively for medical professionals:

Reconstitution and dilution
Intramuscular injection
To prepare a solution for intramuscular injection, add to the vial
5.7 mL of Water for Injections or 0.9% sodium chloride solution.
Shake the vial until the solution is clear. The solution should be administered deep intramuscularly
immediately after preparation or within 8 hours if stored at 2–8°C.

Intravenous injection
For intravenous administration, add 10 mL of Water for Injections or 10 mL of 0.9% sodium chloride solution. Shake the vial until the solution is clear.
The solution should be administered slowly intravenously over 10 minutes. The prepared solution should be used immediately or within 8 hours if stored at 2–8°C.
The reconstituted solution may be further diluted with one of the following infusion solutions:

• Sodium chloride 0.9% solution
• 5% glucose solution in Water for Injections
• 5% glucose in sodium chloride 0.9% solution
• 10% D-fructose solution in Water for Injections
• 10% D-fructose in sodium chloride 0.9% solution
• Ringer's solution with lactate for infusion
• Sodium chloride and potassium chloride solution with lactate for injection
• 10% invert sugar solution in Water for Injections
• 10% invert sugar in sodium chloride 0.9% solution
• 10% invert sugar + 0.3% potassium chloride in Water for Injections

Chemical and physical stability (after reconstitution for injection or after reconstitution and further dilution for infusion as described above) has been demonstrated for 6 hours at room temperature when using the following infusion diluents: sodium chloride 0.9% solution, 5% glucose solution in Water for Injections, and 5% glucose in sodium chloride 0.9% solution. Other diluents have confirmed stability for 8 hours when stored at 2–8°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user.