Clindamycin noridem

Clindamycin Noridem, 150 mg/mL, solution for injection/infusion
clindamycin
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, nurse, or other healthcare professional.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist, nurse, or other healthcare professional. See section 4.

Table of contents

1. What Clindamycin Noridem is and what it is used for
2. Important information before using Clindamycin Noridem
3. How to use Clindamycin Noridem
4. Possible side effects
5. How to store Clindamycin Noridem
6. Contents of the pack and other information

1. What Clindamycin Noridem is and what it is used for

Clindamycin Noridem contains the active substance called clindamycin. Clindamycin is an antibiotic. It is used to treat infections in adults, adolescents, and children above 1 month of age.
Clindamycin Noridem is used to treat serious infections, particularly when therapy with other antibiotics has failed to eliminate the infection, and provided that the causative bacteria are susceptible to clindamycin.
Clindamycin Noridem is used to treat:

• bone and joint infections,
• chronic sinusitis,
• lower respiratory tract infections,
• intra-abdominal infections (peritonitis),
• female genital tract infections,
• skin and soft tissue infections,
• dental infections,
• bacteremia known or suspected to be associated with any of the above-mentioned infections, and
• infections caused by Toxoplasma gondii or Pneumocystis jirovecii in adult patients with compromised immunity.

2. Important information before using Clindamycin Noridem

When not to take Clindamycin Noridem:

• if the patient is allergic to clindamycin, lincomycin, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Clindamycin Noridem, discuss with your doctor,
pharmacist, or nurse if you have:

• impaired liver or kidney function,
• muscle disorders caused, for example, by myasthenia (pathological muscle weakness) or Parkinson’s disease,
• active diarrhoea or a history of diarrhoea during antibiotic treatment, or previous gastrointestinal diseases (e.g. colitis),
• any allergies, such as hypersensitivity to penicillin, as there have been reports of isolated cases in which patients with known hypersensitivity to penicillin developed hypersensitivity to clindamycin,
• asthma, atopic dermatitis, or hay fever.

You should consult your doctor if any of these warnings or precautions apply to you currently or have applied in the past.
Some patients treated with clindamycin have experienced severe hypersensitivity reactions, including severe skin reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). If any symptoms of hypersensitivity or severe skin reactions occur during treatment with Clindamycin Noridem, you should contact your doctor immediately.
Severe skin reactions may occur even after the first dose. In such cases, the doctor will decide to discontinue Clindamycin Noridem immediately and initiate standard emergency treatment measures.
Rapid intravenous infusions may cause adverse effects and should be avoided. The doctor will dilute the medicine before intravenous administration and set the infusion time to at least 10–60 minutes.
If Clindamycin Noridem is used for a prolonged period (more than 10 days), the doctor will regularly monitor blood count, liver, and kidney function test results.
Severe kidney function disorders may occur. Inform your doctor if you are currently taking any other medicines or have any kidney problems. If you experience reduced urine output, fluid retention causing swelling of the lower limbs, ankles or feet, shortness of breath, or nausea, contact your doctor immediately.
Prolonged and repeated use of Clindamycin Noridem may lead to skin and mucous membrane infections caused by pathogens resistant to clindamycin. It may also result in fungal infections.
Severe colitis may occur during treatment with clindamycin. Therefore, inform your doctor immediately if severe and persistent diarrhoea develops during or within two months after treatment, especially if mucus or blood is present in the stool.

Children and adolescents
This medicine should not be given to children under 1 month of age, as safety has not been established.

Clindamycin Noridem and other medicines
Tell your doctor, pharmacist, or nurse about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform your doctor if you are taking any of the following medicines:

• Warfarin or similar anticoagulant medicines: these may increase the risk of bleeding. Your doctor may order regular blood tests to monitor blood clotting ability.
• Erythromycin: Do not use Clindamycin Noridem simultaneously with medicinal products containing erythromycin, as mutual reduction in effectiveness cannot be excluded.
• Lincomycin: Do not use Clindamycin Noridem after treatment with lincomycin due to cross-resistance.
• Medicines that reduce muscle tone: Clindamycin Noridem may enhance the effect of muscle relaxants, potentially leading to unexpected, life-threatening events during surgical procedures.
• CYP3A4 inducers, such as rifampicin (an antibiotic used in the treatment of tuberculosis), which may reduce the effectiveness of Clindamycin Noridem.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Inform your doctor:
about pregnancy or suspected pregnancy. The doctor will decide whether Clindamycin Noridem can be used based on a benefit-risk assessment of clindamycin treatment;
about breastfeeding. This medicine may pass into human milk; therefore, it should not be used during breastfeeding.

Driving and operating machinery
This medicine may cause dizziness, fatigue, or headache. In such cases, you must not drive or operate tools or machinery.

Clindamycin Noridem contains sodium
Each mL of this medicine contains 7.72 mg of sodium (the main component of table salt). This corresponds to 0.39% of the recommended maximum daily sodium intake for an adult.

3. How to use Clindamycin Noridem

Clindamycin Noridem is administered by intramuscular injection as an undiluted solution or by intravenous infusion (drip infusion) as a diluted solution. The medicine is usually given by a doctor or nurse.
The doctor will determine the appropriate dose of clindamycin for each individual patient.

Dosage in adults and adolescents over 12 years of age:

• For treatment of mild infections: 1200 to 1800 mg of clindamycin per day,
• For treatment of severe infections: 1800 to 2700 mg of clindamycin per day,
  divided into two equal doses.
  Usually, the maximum daily dose in adults and adolescents over 12 years of age is 2700 mg of Clindamycin Noridem given in two equal doses. In life-threatening infections, doses up to 4800 mg per day may be used.

Liver and kidney function disorders
In patients with liver or kidney disease, metabolism of clindamycin is slowed. However, in most cases dose adjustment is not necessary. Monitoring of clindamycin blood levels is recommended.
Clindamycin is not removed by hemodialysis (the process of filtering and removing metabolic waste products from the blood artificially, performed in patients with impaired kidney function). Therefore, there is no need to administer additional doses before or after hemodialysis.

Use in children
Depending on the severity and site of infection, children older than 4 weeks and younger than 12 years should receive 15–40 mg of clindamycin per kg of body weight, divided into three or four equal doses. Clindamycin dosing should be based on total body weight, including in cases of obesity.
The duration of treatment depends on the disease and its course.

If you take more Clindamycin Noridem than you should
This medicine will always be administered under strictly controlled conditions. If you feel that the dose of Clindamycin Noridem being administered is too high, inform your doctor or nurse immediately.

If a dose of Clindamycin Noridem is missed
Clindamycin Noridem is administered by a doctor or nurse. However, if you think a dose has been missed, inform your doctor or nurse.

Stopping Clindamycin Noridem
Do not stop using Clindamycin Noridem without your doctor's instruction.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, nurse, or healthcare professional.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform a doctor if the patient experiences:

• symptoms of a severe allergic reaction, such as sudden wheezing, difficulty breathing, dizziness, swelling of the eyelids, face, lips, throat or tongue, rash or itching (especially if affecting the whole body);
• severe, persistent, bloody diarrhoea (which may be accompanied by abdominal pain or fever). This may occur during treatment with certain antibiotics and may indicate a serious intestinal inflammation;
• symptoms of a severe and potentially life-threatening skin reaction, such as blistering and peeling of the skin over a large area, fever, cough, malaise, and swelling of the gums, tongue or lips;
• yellowing of the skin and whites of the eyes (jaundice);
• fluid retention causing swelling of the lower limbs, feet or ankles, breathlessness or nausea;
• drop in blood pressure (drowsiness, dizziness, fainting) if the injection is administered too rapidly, and, in rare cases, cardiac arrest;
• increased frequency of infections manifested by fever, severe chills, sore throat or oral mucosal ulceration (infections may result from a reduced number of white blood cells).

Other possible adverse reactions:
Very common: may occur in more than 1 in 10 patients

• diarrhoea, abdominal pain, nausea, vomiting;

Common: may occur in no more than 1 in 10 patients
vascular disorders such as phlebitis;
skin disorders such as drug eruption (characterised by a rash with small papules occurring over a large area) or urticaria;
changes in liver function test results;
Uncommon: may occur in no more than 1 in 100 patients
nervous system disorders such as neuromuscular blockade (blocking of nerve impulse transmission to muscles) and taste disturbances (dysgeusia);
general disorders and administration site conditions such as pain or abscess at the injection site;
Rare: may occur in no more than 1 in 1000 patients
itching;
vaginal mucosal inflammation;
Very rare: may occur in no more than 1 in 10,000 patients
joint inflammation (polyarthritis);
Not known: frequency cannot be estimated from the available data
vaginal infection;
drowsiness;
dizziness;
headache;
jaundice;
irritation at the injection site.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, nurse or other healthcare professional.
Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
PL-02 222 Warsaw,
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Clindamycin Noridem

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial label after "EXP". The expiry date refers to the last day of the specified month.
Store below 25°C.

Storage after dilution
Chemical and physical stability of the product has been demonstrated for 24 hours at 25°C and at 2-8°C in 9 mg/mL (0.9%) sodium chloride solution and 50 mg/mL (5%) glucose solution, with clindamycin concentrations of 6 or 18 mg/mL in polypropylene infusion bags.
From a microbiological standpoint, the product should be used immediately, unless the dilution process has excluded the risk of microbiological contamination. If the prepared solution is not used immediately, the user is responsible for the storage duration and conditions.

Do not dispose of medicines 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 pack and other information

What Clindamycin Noridem contains
The active substance is clindamycin.
Each mL of injection/infusion solution contains 150 mg clindamycin (as phosphate).
Each 2 mL ampoule contains 300 mg clindamycin (as phosphate).
Each 4 mL ampoule contains 600 mg clindamycin (as phosphate).
Each 6 mL ampoule contains 900 mg clindamycin (as phosphate).
Other ingredients are: disodium edetate, sodium hydroxide 5N (for pH adjustment), hydrochloric acid 5N (for pH adjustment), and water for injections.

What Clindamycin Noridem looks like and contents of the pack
Clindamycin Noridem is a clear, colourless or almost colourless solution for injection/infusion, free from visible particles, supplied in glass ampoules containing 2 mL, 4 mL or 6 mL of solution. Clindamycin Noridem is available in packs containing 1, 5, 10 or 25 ampoules. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Noridem Enterprises Limited, Evagorou & Makariou,
Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus

Manufacturer
DEMO S.A. PHARMACEUTICAL INDUSTRY,
21st km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece,
T: +30 210 8161802, F: +30 2108161587.

This medicinal product is authorised in the following names in the European Economic Area countries:
Germany Clindamycin Noridem 150 mg/ml Injektions-/Infusionslösung
Greece Clindamycin/DEMO
Sweden Clindamycin Noridem 150 mg/ml Injektions-/infusionsvätska, lösning
Norway Clindamycin Noridem
Finland Clindamycin Noridem 150 mg/ml Injektio-/infuusioneste, liuos
Czech Republic Clindamycin Noridem
Slovakia Clindamycin Noridem 150 mg/ml Injekčný/infúzny roztok
Hungary Klindamicin Noridem 150 mg/ml, Oldatos injekció/infúzió
Romania Clindamicină Noridem 150 mg/ml Soluţie injectabilă/perfuzabilă
Poland Clindamycin Noridem
Ireland Clindamycin 150 mg/ml Solution for injection/infusion
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Information intended exclusively for medical professionals:

Pharmaceutical incompatibilities
Physical incompatibility occurs between clindamycin and the following active substances:
ampicillin, aminophylline, barbiturates, calcium gluconate, sodium ceftriaxone,
ciprofloxacin, phenytoin, idarubicin hydrochloride, magnesium sulfate, sodium phenytoin, and ranitidine hydrochloride.
Solutions of clindamycin salts have low pH and incompatibility is highly likely with alkaline preparations and medicinal products unstable at low pH.

Dosage
Adults and adolescents above 12 years of age

• For the treatment of severe infections: 1800 to 2700 mg clindamycin per day in two to four equally divided doses, typically in combination with an antibiotic effective against aerobic Gram-negative bacteria.
• Or for the treatment of milder infections: 1200 to 1800 mg clindamycin per day in three or four equally divided doses.

The usual maximum daily dose for adults and adolescents above 12 years of age is 2700 mg clindamycin in two to four equally divided doses. Doses up to 4800 mg per day have been used in life-threatening infections.

Children and adolescents
Children (aged 1 month to 12 years):

• Serious infections: 15–25 mg/kg/day in three or four equally divided doses.
• Very severe infections: 25–40 mg/kg/day in three or four equally divided doses. In very severe infections, children should receive at least 300 mg/day regardless of body weight.

Clindamycin dosage should be based on total body weight, including in cases of obesity.
The maximum daily dose must not exceed the adult dose.

Elderly patients:
The elimination half-life, volume of distribution, clearance, and extent of absorption after administration of clindamycin phosphate do not change with age. Analysis of clinical trial data has not revealed age-related increase in toxicity. Therefore, dosage adjustment in elderly patients is not required, provided that liver and kidney function are normal (age-appropriate norms).

Patients with hepatic impairment
In patients with moderate to severe liver disease, the elimination half-life of clindamycin is prolonged. Dose reduction is generally not necessary if clindamycin is administered every 8 hours. However, serum concentrations of clindamycin should be monitored in patients with severe hepatic impairment. Depending on results, dose reduction or extended dosing intervals may be necessary.

Patients with renal impairment
In renal disease, the elimination half-life of clindamycin is prolonged, but dose reduction is not necessary if renal impairment is mild to moderate. However, serum concentrations of clindamycin should be monitored in patients with severe renal impairment or anuria. Depending on results, dose reduction or extension of dosing intervals by 8 to 12 hours may be necessary.

Dosing in haemodialysed patients
Clindamycin is not removed from the body during haemodialysis. Therefore, there is no need for additional doses before or after haemodialysis.

Duration of treatment
In confirmed or suspected infections caused by β-haemolytic streptococci, treatment with clindamycin should continue for at least 10 days to prevent rheumatic fever and glomerulonephritis.

Method of administration
Clindamycin Noridem is administered by intramuscular (i.m.) injection or intravenous (i.v.) infusion.
Clindamycin Noridem must be diluted before intravenous administration, and the infusion should last at least 10–60 minutes. The concentration should not exceed 18 mg clindamycin per mL of solution.
Do not dilute Clindamycin Noridem prior to intramuscular administration.
For dilution instructions, see section "Instructions for use".

It is not recommended to administer more than 600 mg by intramuscular injection (i.m.) or more than 1.2 g in a single one-hour infusion.
This medicinal product may also be administered as a single, rapid initial infusion dose followed by continuous intravenous (i.v.) infusion.

Disposal
Any unused medicinal product or waste material must be disposed of in accordance with local requirements.

Overdose
No symptoms of overdose have been observed to date. Haemodialysis and peritoneal dialysis are not effective methods of removing the substance from the body. There is no known specific antidote. Clindamycin Noridem is administered by i.m. or i.v. routes, therefore gastric lavage is not applicable.

Instructions for use
Clindamycin Noridem must be diluted before intravenous administration (do not exceed 18 mg clindamycin per mL), and the infusion should last at least 10–60 minutes (do not exceed 30 mg/min).
Intravenous bolus injection must not be used.

The Clindamycin Noridem medication may be diluted with sodium chloride solution 9 mg/mL (0.9%) or glucose 50 mg/mL (5%).
After dilution:
Storage conditions of the diluted medicinal product, see section 5 above in the package leaflet.
Intramuscular administration is indicated when intravenous infusion is impossible for any reason.
For single use only.
The medicinal product should be inspected visually before administration, including after dilution.
Only clear solutions free from visible particles should be used.