Klimicin

Leaflet attached to the packaging: patient information

Klimicin, 300 mg/2 ml (150 mg/ml), solution for injection and 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Klimicin and what is it used for
• 2. Important information before taking Klimicin
• 3. How to take Klimicin
• 4. Possible side effects
• 5. How to store Klimicin
• 6. Contents of the pack and other information

1. What is Klimicin and what is it used for

Klimicin contains the active substance clindamycin, an antibiotic from the lincosamide group, used to treat infections. It works by inhibiting the growth and destroying bacteria that can cause infections.
Klimicin in the form of a solution for injection and infusion is used to treat the following severe infections caused by bacteria susceptible to clindamycin:
respiratory tract infections caused by Streptococcus pneumoniae and other streptococci, Staphylococcus aureus, and anaerobic bacteria;
skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobic bacteria;
bone and joint infections caused by Staphylococcus aureus;
septicaemia caused by Staphylococcus aureus;
intra-abdominal infections caused by anaerobic bacteria;
infections of the female genital organs caused by anaerobic bacteria.

2. Important information before taking Klimicin

When not to use Klimicin:

if you are allergic (hypersensitive) to clindamycin or any of the other ingredients of this medicine (listed in section 6);
if you have ever experienced symptoms such as rash, swelling of the face, neck or body, or difficulty breathing after taking clindamycin, this may indicate an allergy;
if you are allergic (hypersensitive) to the antibiotic lincomycin;
in newborns, especially premature babies (due to the presence of benzyl alcohol).

Warnings and precautions

Before starting treatment with Klimicin or during treatment, discuss with your doctor, nurse, or pharmacist if:
you have a history of allergic reactions, especially severe ones. If an allergic reaction or severe skin reaction occurs, tell your doctor immediately, as such reactions have been reported with clindamycin.
you are allergic to penicillin;
Klimicin is used for a long time and you have diarrhea or changes in the mucous membranes of the mouth and/or vagina, which may indicate superinfection with microorganisms resistant to this medicine;
you have a history of gastrointestinal disease (coeliac disease, diverticulitis, Crohn's disease, ulcerative colitis) or AIDS;
you have ever had diarrhea during or after treatment with antibiotics (you should tell your doctor); almost any antibiotic can cause pseudomembranous colitis and diarrhea caused by Clostridium difficile, ranging from mild diarrhea to life-threatening colitis; do not take medicines that slow down bowel movements;
you have meningitis, as clindamycin penetrates poorly into the cerebrospinal fluid;
you have severe kidney or liver disease; your doctor may adjust the dose and recommend blood tests to monitor kidney and liver function;
you have a disease that affects the transmission of nerve impulses to muscles (e.g., myasthenia gravis, Parkinson's disease).
Acute kidney injury may occur. You should inform your doctor about all concomitant medications and kidney problems. If you experience decreased urine output or fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea, contact your doctor immediately.
You should consult your doctor if any of the above warnings apply to you currently or have applied in the past.

Klimicin and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
You must inform your doctor about taking Klimicin:
before planned surgery,
before starting treatment with electroshocks,
in case of diseases that may cause seizures.

• before planned surgery,
• before starting treatment with electroshocks,
• in case of diseases that may cause seizures.

Additionally, if you are taking any of the following medicines, tell your doctor:
macrolide antibiotics (e.g., erythromycin) or chloramphenicol;
medicines that slow down bowel movements (peristalsis);
gentamicin (an antibacterial medicine);
primaquine (a medicine used to treat malaria);
trovafloxacin (an antibacterial medicine);
levofloxacin (an antibacterial medicine);
warfarin and similar medicines used to thin the blood. Concomitant use with clindamycin may increase the risk of bleeding. Your doctor may need to perform regular blood tests to monitor blood clotting.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Klimicin should only be used in pregnant women if absolutely necessary.
Breastfeeding
Clindamycin passes into breast milk, so you should not breastfeed while taking Klimicin.

Driving and using machines

Klimicin has no or negligible influence on the ability to drive and use machines.

Klimicin contains benzyl alcohol

The medicine contains 18 mg of benzyl alcohol in each ampoule.
If the medicine is used as recommended, the benzyl alcohol content in the maximum daily dose used in adults with very severe infections (2700 mg) is up to 162 mg, in the maximum daily dose used in adults with life-threatening infections (4800 mg) is up to 288 mg, and in the maximum daily dose used in children (40 mg/kg body weight) is 2.4 mg/kg body weight.
Benzyl alcohol may cause allergic reactions.
Do not give to small children (under 3 years) for more than a week without consulting a doctor or pharmacist.
Pregnant or breastfeeding women should consult a doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Klimicin contains sodium

This medicine contains 15.1 mg of sodium (the main component of common salt) in each ampoule. This corresponds to 0.75% of the maximum recommended daily intake of sodium in the diet for adults.
If the medicine is used as recommended, the maximum daily dose used in adults with very severe infections (2700 mg) contains up to 135.9 mg of sodium, and the maximum daily dose used in adults with life-threatening infections (4800 mg) contains up to 242 mg of sodium. This corresponds to 6.8% and 12.1% of the maximum recommended daily intake of sodium in the diet for adults, respectively. The maximum daily dose used in children contains 2 mg/kg body weight of sodium.
This should be taken into account if you have kidney problems or control your sodium intake.
The medicine may be diluted - see below "Information intended exclusively for healthcare professionals". The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared solution. For accurate information on the sodium content in the solution used for dilution, refer to the patient leaflet of the diluent used.

3. How to take Klimicin

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor, nurse, or pharmacist.
The medicine will be administered by your doctor or nurse - in exceptional cases, qualified personnel may train a relative or caregiver on how to administer the medicine.

Dosage for adults

The recommended daily dose for severe infections is 600 mg to 1200 mg administered in 2, 3, or 4 divided doses.
In very severe infections, the recommended daily dose is 1200 mg to 2700 mg in 2, 3, or 4 divided doses.
In life-threatening infections, your doctor may increase the maximum daily dose of the medicine administered intravenously to 4800 mg.
Do not administer more than 600 mg intramuscularly and 1200 mg intravenously (in infusion) in a single dose.
No dose adjustment is necessary for the elderly.

Dosage for children (from 1 month to 16 years)

The recommended daily dose is 20 to 40 mg/kg body weight in 3 or 4 divided doses.
The maximum daily dose is 40 mg/kg body weight.

Dosage for patients with renal impairment

In patients with severe renal impairment, half of the usual recommended dose is used.
In patients undergoing haemodialysis, peritoneal dialysis, or haemofiltration, no dose adjustment is necessary.

Dosage for patients with hepatic impairment

Your doctor will adjust the dose based on measurements of the medicine's concentration in the serum.
Method of administration
The medicine is administered intramuscularly or in slow intravenous infusion. The infusion should last at least 10 to 60 minutes.
Duration of treatment
In infections caused by beta-haemolytic streptococci, the antibiotic should be administered for at least 10 days to minimize the risk of late complications, such as rheumatic fever or glomerulonephritis.

Using more than the recommended dose of Klimicin

It is unlikely that medical staff will administer a higher dose than recommended.
Very rarely, severe allergic reactions are observed. If they occur, discontinue the administration of Klimicin and use measures commonly used in such cases (e.g., administration of antihistamines, corticosteroids, sympathomimetic agents, or assisted breathing).
Clindamycin cannot be removed from the body by haemodialysis or peritoneal dialysis.

Missing a dose of Klimicin

Klimicin should be used as directed by your doctor. If you are unsure whether you have received a dose of the medicine, inform your doctor or nurse.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Klimicin

It is very important to use the medicine for as long as your doctor has prescribed. Do not stop treatment early, even if you feel better. Stopping treatment too early may cause the infection to recur, and may even lead to complications such as kidney damage or rheumatic fever.
If you have any further questions about using this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, Klimicin can cause side effects, although not everybody gets them.
The most common side effects of clindamycin are hypersensitivity reactions and gastrointestinal reactions.

If you experience any of the following reactions, stop treatment with clindamycin immediately and seek medical help:

and seek medical help:

• swelling of the face, lips, mouth, throat, or other areas, causing difficulty in swallowing or breathing;
• chills;
• dizziness, loss of consciousness;
• formation of blisters and peeling of the skin and mucous membranes. These are very severe side effects. Their occurrence may indicate a severe allergic reaction to Klimicin or another severe side effect associated with taking the medicine. Hospitalization may be necessary. All these very severe side effects are rare. You should inform your doctor immediately if you experience:
• fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea.

Medical help may also be necessary if you experience severe, rare side effects, such as:

• severe, prolonged diarrhea;
• muscle paralysis.

The following side effects may occur after taking Klimicin.
Common (less than 1 in 10 people): thrombophlebitis, loose stools, oesophagitis and oral mucositis, pseudomembranous colitis, abnormal liver function tests, maculopapular rash, intravenous thrombophlebitis (after intravenous administration).
Uncommon (less than 1 in 100 people): transient changes in blood cell counts, e.g., decreased granulocyte count (granulocytopenia), taste disturbances, effects on neuromuscular transmission, diarrhea, nausea, erythema multiforme, pruritus, urticaria, pain after intravenous or intramuscular administration, abscess at the injection site after intravenous administration, hypotension, and in rare cases, cardiac arrhythmias, cardiac arrest, and respiratory arrest.
Rare (less than 1 in 1,000 people): oedema (Quincke's oedema, joint swelling).
Very rare (less than 1 in 10,000 people): anaphylactic shock, severe, acute hypersensitivity reactions.
Frequency not known (frequency cannot be estimated from the available data): vaginal infection, Clostridium difficile-associated colitis, changes in the number of certain blood cells, i.e., complete or almost complete lack of granulocytes (agranulocytosis), decreased white blood cell count (leukopenia), decreased neutrophil count (neutropenia), decreased platelet count (thrombocytopenia), increased eosinophil count (eosinophilia), anaphylactic shock (reported after marketing), anaphylactic or pseudo-anaphylactic reactions, hypersensitivity reactions, dizziness, somnolence, headache, rash with eosinophilia and systemic symptoms (most commonly involving the liver, kidneys, lungs, heart), vomiting, abdominal pain, jaundice, severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis [Lyell's syndrome], acute generalized exanthematous pustulosis, exfoliative dermatitis, erythema multiforme), angioedema, injection site irritation.
Prolonged treatment may lead to superinfections with resistant microorganisms, most commonly fungi.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 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 Klimicin

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Klimicin contains

The active substance is clindamycin.
1 ml of the solution for injection and infusion contains 150 mg of clindamycin in the form of clindamycin phosphate.
2 ml of the solution for injection and infusion (1 ampoule) contains 300 mg of clindamycin (in the form of clindamycin phosphate).
The other ingredients are: benzyl alcohol, sodium hydroxide (for pH adjustment), water for injections.

What Klimicin looks like and contents of the pack

Ampoules made of colourless glass, in a cardboard box, containing 2 ml of the solution. The pack contains 5 or 10 ampoules.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. +48 22 209 70 00
Date of last revision of the leaflet:08/2021
(logo of the marketing authorization holder)

Information intended exclusively for healthcare professionals

The medicine should be administered intramuscularly or in slow intravenous infusion.
Intravenous administration of the medicine is indicated only for the treatment of severe bacterial infections. In patients with sepsis, it is recommended to start treatment with clindamycin intravenously.
Undiluted clindamycin should not be administered by rapid intravenous injection (bolus).
Too rapid intravenous administration of clindamycin may cause ventricular arrhythmias and cardiac arrest.
Before intravenous administration, the solution should be diluted and administered in an infusion lasting at least 10 to 60 minutes. The concentration of clindamycin in the solution for intravenous administration should be less than 18 mg/ml, and the rate of administration of the solution should not exceed 30 mg/min.
Prepared solutions can be stored at room temperature for 24 hours.
Diluents used to prepare the clindamycin solution:
0.9% sodium chloride solution
5% glucose solution
5% glucose solution in 0.9% sodium chloride solution
5% glucose solution in Ringer's solution
5% glucose solution in 0.35% sodium chloride solution plus 40 mEq/l potassium chloride solution
2.5% glucose solution in lactated Ringer's solution
A solution of Klimicin with a concentration of 0.6 mg/ml, obtained by dilution in the above-mentioned solutions, stored in infusion bags, is stable for 24 hours at a temperature of 25°C.
The clindamycin solution has a low pH, so incompatibilities with medicines having an alkaline reaction or low stability at low pH can be expected.

Incompatibilities with the following medicines have been observed: ampicillin, sodium phenytoin, difenylohydantoin, barbiturates, aminophylline, calcium gluconate, magnesium sulphate, sodium ceftriaxone, ranitidine hydrochloride.