Clindamicin Noridem

Patient Information Leaflet: User Information

Clindamycin Noridem, 150 mg/mL, Solution for Injection/Infusion

Clindamycin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

Clindamycin Noridem contains the active substance clindamycin. Clindamycin is an antibiotic. It is used to treat infections in adults, adolescents, and children over 1 month of age.
Clindamycin Noridem is used to treat severe infections, especially when therapy with other antibiotics has not eliminated the infection, and provided that the bacteria causing the infection are sensitive to clindamycin.
Clindamycin Noridem is used to treat:

• bone and joint infections,
• chronic sinus infections,
• lower respiratory tract infections,
• intra-abdominal infections (peritonitis),
• female reproductive organ 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 gondiior Pneumocystis jiroveciiin adult patients with impaired immunity.

2. Important information before using Clindamycin Noridem

When not to use Clindamycin Noridem:

Warnings and precautions

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

• liver or kidney problems,
• muscle disorders, such as myasthenia (a pathological muscle weakness) or Parkinson's disease,
• currently occurring diarrhea or a history of gastrointestinal disease (e.g., colitis),
• any allergies, e.g., hypersensitivity to penicillin, as there are reports of individual cases where patients with known hypersensitivity to penicillin developed hypersensitivity to clindamycin,
• asthma, atopic dermatitis, or hay fever.

Consult your doctor if any of these warnings and required 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), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). If you experience any symptoms of hypersensitivity or severe skin reaction while using Clindamycin Noridem, inform your doctor immediately.
Severe skin reactions can occur after the first use. In such cases, your doctor will decide on the immediate discontinuation of Clindamycin Noridem and the implementation of standard emergency treatment methods.
Rapid intravenous infusions cause adverse reactions and should be avoided. Your doctor will dilute the medicine before intravenous administration and set the infusion time to at least 10-60 minutes.
In the case of long-term use of Clindamycin Noridem (more than 10 days), your doctor will regularly monitor your blood morphology and liver and kidney function test results.
Acute kidney function disorders may occur. Inform your doctor if you are currently taking any other medicines or have any kidney problems. If you experience decreased urine output, fluid retention manifested by 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 cause skin and mucous membrane infections with pathogens insensitive to clindamycin. It may also lead to the development of fungal infections.
During clindamycin treatment, severe colitis may occur. Therefore, inform your doctor immediately if you experience severe and persistent diarrhea during treatment or up to two months after its completion, especially if it is accompanied by abdominal pain or blood in the stool.

Children and adolescents

Do not give this medicine to children under 1 month of age, as its safety has not been confirmed.

Clindamycin Noridem and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or plan to take.
Particularly, inform your doctor about taking the following medicines:

• Warfarin or similar medicines used to thin the blood, increase the risk of bleeding. Your doctor may order regular blood tests to determine the blood's ability to clot.
• Erythromycin. Do not use Clindamycin Noridem at the same time as medicinal products containing erythromycin, as it cannot be excluded that their effectiveness may be mutually reduced.
• Lincomycin. Do not use Clindamycin Noridem after lincomycin therapy due to cross-resistance.
• Muscle relaxants. Clindamycin Noridem may increase the effectiveness of muscle relaxants, which can lead to unexpected, life-threatening events during surgical procedures.
• CYP3A4 inducers, such as rifampicin (an antibiotic used to treat tuberculosis), may reduce the effectiveness of Clindamycin Noridem.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Tell your doctor:

about pregnancy or suspected pregnancy. Your doctor will decide on the possibility of using Clindamycin Noridem based on a comparison of the benefits and risks associated with the use of clindamycin;

about breastfeeding. This medicine may pass into breast milk, so it should not be used during breastfeeding.

Driving and using machines

While using this medicine, you may experience dizziness, fatigue, or headaches. In such cases, do not drive vehicles or use tools or machines.

Clindamycin Noridem contains sodium

Each mL of this medicine contains 7.72 mg of sodium (the main component of common 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 in the form of an undiluted solution or by intravenous infusion (drip) in the form of a diluted solution. The medicine is usually administered by a doctor or nurse.
Your doctor will choose the appropriate dose of clindamycin for you.
Dosage for adults and adolescents over 12 years old
in the treatment of mild infections:
from 1200 to 1800 mg of clindamycin per day,
in the treatment of severe infections:
from 1800 to 2700 mg of clindamycin per day,
in two equal doses.
Usually, the maximum daily dose for adults and adolescents over 12 years old is 2700 mg of Clindamycin Noridem in two equal doses. In life-threatening infections, doses up to 4800 mg per day can be used.
Liver and kidney problems
In patients with liver or kidney disease, the metabolism of clindamycin is slowed down.
In most cases, however, there is no need to adjust the dose. It is recommended to monitor the clindamycin level in the blood.
Clindamycin is not dialyzable (removed from the blood through artificial filtration, performed in patients with impaired kidney function). Therefore, there is no need to use additional doses before or after dialysis.

Use in children

Depending on the severity and location of the infection, children over 4 weeks and under 12 years old are given 15-40 mg of clindamycin per kilogram of body weight in three or four equal doses. The dosage of clindamycin should be based on the total body weight, also in cases of obesity.
The duration of treatment depends on the disease and its course.

Overdose of Clindamycin Noridem

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

Missed dose of Clindamycin Noridem

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

Discontinuation of Clindamycin Noridem

Do not stop using Clindamycin Noridem without your doctor's advice.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or healthcare worker.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor immediatelyif you experience:

• symptoms of a severe allergic reaction, such as sudden onset of wheezing, difficulty breathing, dizziness, swelling of the eyelids, face, lips, throat, or tongue, rash, or itching (especially if it affects the whole body);
• severe, persistent, bloody diarrhea (which may be accompanied by abdominal pain or fever). This may occur during the use of some antibiotics and may be a sign of severe colitis;
• symptoms of a severe and potentially life-threatening skin reaction, such as blisters and peeling of the skin on a large surface 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, shortness of breath, or nausea;
• drop in blood pressure (drowsiness, dizziness, fainting) in case of too rapid injection, and, in rare cases, cardiac arrest;
• increased frequency of infections, manifested by fever, severe chills, sore throat, or oral mucosa ulcers (infections may result from a decrease in the number of white blood cells).

Other possible side effects:
Very common: may occur more frequently than in 1 in 10 patients

• diarrhea, abdominal pain, nausea, vomiting;

Common: may occur in up to 1 in 10 patients
vascular disorders, such as phlebitis;
skin disorders, such as drug rash (manifested by a rash with small nodules on a large surface area) or urticaria;
changes in liver function test results;
Uncommon: may occur in up to 1 in 100 patients
nervous system disorders, such as neuromuscular blockade (blockage of nerve impulses to muscles) and taste disorders (dysgeusia);
general disorders and administration site conditions, such as pain or abscess at the injection site;
Rare: may occur in up to 1 in 1000 patients
itching;
vaginal inflammation;
Very rare: may occur in up to 1 in 10,000 patients
joint inflammation (polyarthritis);
Frequency not known: cannot be estimated from the available data
vaginal infection;
drowsiness;
dizziness;
headache;
jaundice;
irritation at the injection site.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or healthcare worker.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring, Drug Registration Office, Medical Device Registration Office, and Biocide Product Registration Office,
Al. Jerozolimskie 181C
PL-02 222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clindamycin Noridem

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule label after: "EXP". The expiry date refers to the last day of the specified month.
Store below 25°C.
Shelf life after dilution
The chemical and physical stability of the product has been demonstrated for 24 hours at 25°C and at 2-8°C in a sodium chloride 9 mg/mL (0.9%) solution and glucose 50 mg/mL (5%) solution, at clindamycin concentrations of 6 or 18 mg/mL in a polypropylene infusion bag.
From a microbiological point of view, the product should be used immediately, unless the dilution process precludes the risk of microbial contamination. If the ready-to-use solution is not used immediately, the user is responsible for the storage conditions and time.

6. Contents of the pack and other information

What Clindamycin Noridem contains

The active substance is clindamycin.
Each mL of the solution for injection/infusion contains 150 mg of clindamycin (in the form of phosphate).
Each 2 mL ampoule contains 300 mg of clindamycin (in the form of phosphate).
Each 4 mL ampoule contains 600 mg of clindamycin (in the form of phosphate).
Each 6 mL ampoule contains 900 mg of clindamycin (in the form of 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, colorless or almost colorless 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 authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

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
Date of last revision of the leaflet: }>.
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Information intended for healthcare professionals only:

Incompatibilities

There is a physical incompatibility between clindamycin and the following active substances:
ampicillin, aminophylline, barbiturates, calcium gluconate, ceftriaxone sodium, ciprofloxacin, phenytoin sodium, and ranitidine hydrochloride. Clindamycin phosphate solutions have a low pH, and incompatibility with alkaline products and medicinal products unstable at low pH can be expected with a high degree of probability.

Dosage

Adults and adolescents over 12 years old

• in the treatment of severe infections: 1800-2700 mg of clindamycin per day in two to four equal doses, typically in combination with an antibiotic with good efficacy against aerobic Gram-negative bacteria.
• or in the treatment of mild infections: 1200-1800 mg of clindamycin per day in three or four equal doses.

Usually, the maximum daily dose for adults and adolescents over 12 years old is 2700 mg of clindamycin in two to four equal doses. In life-threatening infections, doses up to 4800 mg per day have been used.
Children and adolescents
Children (from 1 month to 12 years old):
Severe infections: 15-25 mg/kg/day in three or four equal doses.
Very severe infections: 25-40 mg/kg/day in three or four equal doses. In very severe infections, it is recommended to administer at least 300 mg/day to children, regardless of body weight.
The dosage of clindamycin should be based on the total body weight, also in cases of obesity.
The maximum daily dose should not exceed the dose for adults.
Elderly patients:
The half-life, volume of distribution, clearance, and degree of absorption of clindamycin phosphate do not change with age. Analysis of clinical trial data did not reveal any age-related increase in toxicity. Therefore, dose adjustment is not required in elderly patients, provided that liver and kidney function is normal (according to age norms).
Patients with impaired liver function
In patients with moderate to severe liver disease, the half-life of clindamycin in the elimination phase is prolonged. Dose reduction is usually not necessary if clindamycin is administered every 8 hours. However, clindamycin levels should be monitored in patients with severe liver impairment. Depending on the results, dose reduction or prolongation of the dosing interval may be necessary.
Patients with impaired kidney function
In kidney disease, the half-life of clindamycin in the elimination phase is prolonged. However, there is no need to reduce the dose if the kidney impairment is mild to moderate.
Clindamycin levels should be monitored in patients with severe kidney impairment and anuria. Depending on the results, dose reduction or prolongation of the dosing interval by 8, or even 12 hours, may be necessary.
Dosage in hemodialysis patients
Clindamycin is not removed from the body during hemodialysis. Therefore, there is no need to use additional doses before or after hemodialysis.
Duration of treatment
In the case of confirmed or suspected infection with ß-hemolytic streptococci, clindamycin treatment should be continued for at least 10 days to prevent rheumatic fever and glomerulonephritis.

Administration

Clindamycin Noridem is administered by intramuscular injection or intravenous infusion.
The medicine should be diluted before intravenous administration, and the infusion should last at least 10-60 minutes. The concentration should not exceed 18 mg of clindamycin per mL of solution.
Clindamycin Noridem should not be diluted before intramuscular administration.
Instructions for dilution of the medicinal product before administration, see section Instructions for use.
It is not recommended to administer a dose greater than 600 mg by intramuscular injection (i.m.) or a dose greater than 1.2 g in a single, one-hour infusion.
This medicinal product can also be administered as a single, rapid infusion of the first dose, followed by continuous intravenous infusion (i.v.).

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Overdose

No symptoms of overdose have been observed to date. Hemodialysis and peritoneal dialysis are not effective in removing the substance from the body. There is no known specific antidote. Clindamycin Noridem is administered intramuscularly or intravenously, so gastric lavage is not applicable.

Instructions for use

The medicine should be diluted before intravenous administration (not exceeding 18 mg of clindamycin per mL), and the infusion should last at least 10-60 minutes (not exceeding 30 mg/min).
It is not recommended to administer the medicine as an intravenous bolus.

Clindamycin Noridem can be diluted with a sodium chloride 9 mg/mL (0.9%) solution or a glucose 50 mg/mL (5%) solution.
After dilution:
Storage conditions for the medicinal product after dilution, see section 5 above.
Intramuscular administration is indicated when intravenous infusion is not possible for any reason.
For single use only.
Visually inspect the medicinal product before use, also after dilution.
Only clear solutions free from visible particles should be used.