Dalacin c

Package leaflet: Information for the user

DALACIN C, 150 mg/ml, solution for injection and infusion
Clindamycinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Dalacin C is and what it is used for

Dalacin C is an antibiotic. The active substance, clindamycin, acts primarily as a bacteriostatic agent and also has bactericidal activity depending on the concentration at the site of infection and the susceptibility of microorganisms.
Clindamycin has been shown to be effective in the treatment of the following bacterial infections caused by microorganisms sensitive to clindamycin:

• bone and joint infections,
• otitis media, pharyngitis, sinusitis,
• dental and oral cavity infections,
• lower respiratory tract infections,
• pelvic and intra-abdominal infections,
• female genital tract infections,
• skin and soft tissue infections,
• erysipelas,
• sepsis and endocarditis.

Intravenous administration of the product is indicated in severe disease.
In patients with endocarditis or sepsis, treatment should be initiated with intravenous clindamycin.

2. Important information before using Dalacin C

When not to use Dalacin C

• If the patient is allergic to clindamycin, lincomycin (patients allergic to one of these substances may also be allergic to the other — so-called cross-allergy — or to any of the other ingredients of this medicine (listed in section 6),
• In premature infants or newborns.

Warnings and precautions

• Special caution is required when administering Dalacin C to patients:
  • who are allergic to penicillin,
  • with impaired liver function,
  • with neuromuscular conduction disorders (myasthenia gravis, Parkinson's disease),
  • with a history of gastrointestinal disorders (e.g. previous colitis).
• During prolonged treatment (for more than 3 weeks), regular monitoring of blood morphology and liver and kidney function tests is necessary.
• Severe kidney function disorders may occur. Inform the physician about all concomitantly used medications and any existing kidney problems. If the patient experiences reduced urine output or fluid retention causing swelling of the legs, ankles or feet, shortness of breath or nausea, immediate medical attention is required.
• Prolonged or repeated use of clindamycin may lead to overgrowth of drug-resistant bacteria or yeasts.
• Dalacin C should not be used for the treatment of:
  • respiratory tract infections caused by viruses,
  • meningitis due to insufficient antibiotic concentration achievable in cerebrospinal fluid.
• If the patient develops severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS — a severe, life-threatening allergic reaction), Stevens-Johnson syndrome (a condition characterized by numerous skin blisters), or acute generalized exanthematous pustulosis (a disease characterized by numerous fluid-filled pustules on swollen and reddened skin), the patient should discontinue Dalacin C and seek immediate medical attention.
• The patient should consult a physician if diarrhea occurs during or within several weeks after treatment, especially if it is severe and persistent. This may be a sign of pseudomembranous colitis (in most cases caused by Clostridioides difficile). This antibiotic-associated complication may be life-threatening. Once pseudomembranous colitis is diagnosed, the physician should immediately discontinue Dalacin C and initiate appropriate treatment (oral metronidazole is administered; in severe cases — vancomycin). Do not use agents that inhibit intestinal peristalsis or have constipating effects.

Dalacin C and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

• Microorganisms resistant to lincomycin are also resistant to clindamycin (so-called cross-resistance).

• Due to its neuromuscular transmission-blocking properties, clindamycin may enhance the effects of muscle relaxants (e.g. ether, tubocurarine, pancuronium halides). This may lead to unexpected, life-threatening complications during surgical procedures.

• If the patient is concurrently using clindamycin with medications such as rifampicin (an antibiotic used to treat several types of bacterial infections), St. John's wort (used as a natural antidepressant and mood enhancer), phenytoin (an anticonvulsant),
  or carbamazepine (used in the treatment of epilepsy and neuropathic pain), monitoring of treatment progress by the attending physician is recommended.

• The effectiveness of oral contraceptives used concurrently with clindamycin has been questioned. Therefore, additional contraceptive methods should be used during treatment with this medicine.

• Warfarin or similar drugs affecting blood coagulation: the patient may have an increased tendency to bleed. The physician may decide to perform regular blood tests to monitor blood clotting.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Clindamycin crosses the human placenta. After multiple doses, antibiotic concentrations in amniotic fluid reach approximately 30% of maternal blood levels. Clinical studies in pregnant women show that systemic (oral or intravenous) administration of clindamycin during the second and third trimesters is not associated with an increased incidence of congenital malformations. Adequate clinical data in women during the first trimester of pregnancy are lacking.
Dalacin C contains benzyl alcohol (see section 2 "Dalacin C contains benzyl alcohol and sodium").
The physician may prescribe Dalacin C during pregnancy only if clearly necessary.
Clindamycin is excreted into human milk.
Serious adverse effects in breastfed infants cannot be excluded. Therefore, the physician will decide whether the patient may take clindamycin and breastfeed simultaneously.
Dalacin C contains benzyl alcohol (see section 2 "Dalacin C contains benzyl alcohol and sodium").

Driving and operating machinery
There is no data available on the effects of Dalacin C on the ability to drive or operate machinery.

Dalacin C contains benzyl alcohol and sodium
Dalacin C in the form of injection/infusion solution contains 18 mg, 36 mg, and 54 mg of benzyl alcohol per 2 ml, 4 ml, and 6 ml of solution, respectively, equivalent to 9 mg/mL of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Administration to newborns and young children is associated with the risk of severe adverse effects, including respiratory disturbances (so-called "gasping syndrome"). Do not use benzyl alcohol-containing medicines in newborns (up to 4 weeks of age) or administer such medicines to young children (under 3 years of age) for longer than one week without medical advice. Patients with liver or kidney disease, or pregnant or breastfeeding women, should consult a physician before using this medicine, as large amounts of benzyl alcohol may accumulate in the body and cause adverse effects such as increased blood acidity (so-called metabolic acidosis).
The medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free."

3. How to use Dalacin C

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor, pharmacist, or nurse.
The dosage is determined by the doctor according to the severity of infection, the patient's condition, and the susceptibility
of the microorganism causing the infection.
Children over 1 month of age
The dose of clindamycin will be determined by the doctor based on the patient's total body weight,
regardless of overweight.
From 20 mg/kg body weight to 40 mg/kg body weight per day, divided into 3 or 4 equal doses.
Adults
In severe infections caused by more susceptible microorganisms, lower doses from 600 mg to 1200 mg
per day may be sufficient, administered in 2, 3, or 4 divided doses.
In severe abdominal infections and pelvic infections in women, as well as in other very severe or complicated infections,
the usual dose is from 1200 mg to 2700 mg of clindamycin per day, given in 2, 3, or 4 divided doses.
In severe, life-threatening infections, doses up to 4800 mg per day may be used.
Use in patients over 65 years of age
There is no need to modify the method or dosage of administration.
Use in patients with hepatic impairment
In patients with moderate to severe liver dysfunction, the half-life of clindamycin is prolonged.
Dose reduction is not necessary when Dalacin C is administered every 8 hours. However, in patients with advanced
hepatic failure, the doctor should monitor clindamycin plasma concentrations. Depending on the results,
dose reduction or extended dosing intervals may be required.
Use in patients with renal impairment
In patients with renal impairment, a slight prolongation of clindamycin half-life occurs, but this does not necessitate
dose reduction. Also, in patients with severe renal impairment, dose reduction is not necessary when Dalacin C
is administered every 8 hours. However, in patients with severe renal failure or anuria, the doctor should monitor
clindamycin plasma concentrations. Depending on test results, dose reduction or extension of dosing intervals
to 8 or even 12 hours may be necessary.
Use in patients undergoing hemodialysis
Clindamycin is not removed from the body during hemodialysis. Therefore, there is no need to administer
an additional dose before or after dialysis.
Method of administration
Dalacin C, solution for injection and infusion, is administered intramuscularly, directly from the ampoule,
or intravenously after dilution with an appropriate solvent.
Dalacin C, solution for injection and infusion, must not be administered intravenously as a rapid injection ( bolus )
or in undiluted form, but should be given by infusion lasting at least 10 to 60 minutes.
Instructions for preparation of solutions and incompatibilities are provided at the end of this leaflet in the section intended for
medical personnel.
Use of a higher than recommended dose of Dalacin C
If an overdose of Dalacin C is accidentally taken, seek immediate medical advice from a doctor or pharmacist.
The doctor will take appropriate measures, e.g. gastric lavage.
Overdose of Dalacin C may cause severe allergic reactions (serum sickness-like reactions, angioedema, anaphylactic reactions up to anaphylactic shock).
To date, no symptoms of overdose have been observed. There is no known antidote for overdose with Dalacin C.
Hemodialysis and peritoneal dialysis are ineffective.
Missed dose of Dalacin C
Do not take a double dose to make up for a missed dose.
If a dose is missed, take the medicine as soon as possible, unless it is almost time for the next dose.
Discontinuation of Dalacin C
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• severe, persistent or bloody diarrhoea (which may be associated with abdominal pain or fever). This is an adverse reaction that may occur during or after antibiotic treatment and may be a sign of a serious bowel inflammation (pseudomembranous colitis)*.
• 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)*.
• potentially life-threatening skin rashes:
  • blistering and peeling of large areas of skin, fever, cough, malaise and swelling of gums, tongue or lips*
  • widespread rash with blistering and peeling of large areas of skin, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome) * and a more severe form causing extensive peeling of the skin (toxic epidermal necrolysis) *
  • widespread red rash with small blisters containing pus (acute generalized exanthematous pustulosis, AGEP) *
  • fever, swollen lymph nodes or skin rash, which may be symptoms of a condition known as DRESS (drug reaction with eosinophilia and systemic symptoms), which can be severe and life-threatening. DRESS symptoms usually begin within a few weeks of exposure to clindamycin*
  • rare skin eruptions characterised by sudden appearance of red skin areas with small pustules (small blisters filled with white-yellow fluid) (acute generalised exanthematous pustulosis [AGEP])*
  • skin rash presenting with blisters and appearing as small spots (central dark spots surrounded by a lighter area, with a dark ring around the edge), known as erythema multiforme
• yellowing of the skin and whites of the eyes (jaundice)*
• significant reduction in blood cells, which may cause bruising or bleeding, or weakening of the immune system (agranulocytosis)*, mild decrease in white blood cells (leukopenia)*, reduced platelet count (thrombocytopenia)*
• fluid retention causing swelling of legs, ankles or feet, shortness of breath or nausea
• cardiac arrest

Other possible adverse reactions may include:

Common (may occur in up to 1 in 10 people)

• blood clots (phlebitis)
• diarrhoea
• increased white blood cell count in blood (eosinophilia)
• abnormal liver function test results
• rash characterised by flat, red areas on the skin covered with small bumps

Uncommon (may occur in up to 1 in 100 people)

• low blood pressure
• vomiting
• abdominal pain
• nausea
• taste disturbances
• urticaria (hives)
• pain, abscess at the injection site

Rare (may occur in up to 1 in 1,000 people)

• itching

Frequency not known (frequency cannot be estimated from available data)

• oesophagitis*, open sores or changes in the oesophageal mucosa*
• vaginal infection*
• cutaneous vasculitis (inflammation of blood vessels in the skin)*
• chickenpox-like rash (vesicular rash)*
• skin reaction characterised by symmetrical, clearly defined redness of skin folds, particularly in the buttocks, groin and armpits*
• irritation at the injection site*

* Adverse reactions observed after marketing of the medicinal product.
Adverse reactions observed only during use of the injectable form of the medicine.
Adverse reactions observed only during use of the oral form of the medicine.
Rare cases of adverse reactions observed after too rapid intravenous administration of the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dalacin C

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system 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 Dalacin C contains

• The active substance is clindamycin. 1 ml of solution contains 150 mg clindamycin as clindamycin phosphate.
• Other ingredients: benzyl alcohol (E 1519) (see section 2 "Dalacin C contains benzyl alcohol and sodium"), disodium edetate, sodium hydroxide (see section 2 "Dalacin C contains benzyl alcohol and sodium"), water for injections.

What Dalacin C looks like and contents of the pack
A vial made of type I glass containing: 2 ml, 4 ml or 6 ml of solution, in a cardboard box.
Marketing Authorisation Holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Manufacturer
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium
For further information about this medicinal product, contact the
local representative of the Marketing Authorisation Holder:
Pfizer Polska Sp. z o.o.; tel. 22 335 61 00
Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://urpl.gov.pl

Information intended exclusively for healthcare professionals

Administration method
Dalacin C is administered intramuscularly—directly from the vial—or intravenously—after dilution with an appropriate solvent.
The following are the commonly used intravenous infusion durations:

It is not recommended to administer intramuscular single injections exceeding 600 mg, or intravenous infusions exceeding 1200 mg over one hour.
The concentration of clindamycin in the infusion solution should not exceed 12 mg/ml, and the infusion rate

• should not be greater than 30 mg per minute.

The neck of the ampoule is scored at the constricted area. The colored dot on the neck of the ampoule facilitates proper positioning for opening. The ampoule should be held in the hand with the colored dot facing towards the user. The ampoule opens easily after gentle pressure applied with the thumb to the neck of the ampoule.
Pharmaceutical incompatibilities
The following drugs exhibit physical incompatibility with clindamycin phosphate: ampicillin, sodium phenytoin, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate. Compatibility and stability duration of mixtures in solutions vary depending on concentrations and other conditions.
Studies indicate that at room temperature, for 24 hours, clindamycin phosphate used in injection and infusion solutions at usual therapeutic concentrations containing sodium chloride, glucose, calcium or potassium, and in solutions containing vitamin B complex, shows no physical or biological incompatibilities.
The following antibiotics show no incompatibility with clindamycin phosphate: cephalothin, kanamycin, gentamicin, penicillin, and carbenicillin.
Dalacin C solution may be diluted in the following intravenous infusion solutions:

• 5% glucose solution,
• 0.9% sodium chloride solution,
• Ringer's lactate infusion solution (Hartmann's solution).