Clindamycin 150 mg/ml Solution for injection/infusion

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

CLINDAMYCIN PHOSPHATE

Fáanlegur frá:

Noridem Enterprises Limited

ATC númer:

J01FF01

INN (Alþjóðlegt nafn):

CLINDAMYCIN PHOSPHATE

Lyfjaform:

Solution for injection/infusion

Lækningarsvæði:

clindamycin

Leyfisstaða:

Not marketed

Leyfisdagur:

2023-05-12

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLINDAMYCIN_ _150 MG/ML SOLUTION FOR INJECTION/INFUSION
Clindamycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist, nurse
or healthcare personnel.
-
If you get any side effects, talk to your doctor, pharmacist, nurse or
healthcare personnel. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Clindamycin
_ _
is and what it is used for
2.
What you need to know before you are given Clindamycin
3.
How Clindamycin is given
4.
Possible side effects
5.
How to store Clindamycin
6.
Contents of the pack and other information
1.
WHAT CLINDAMYCIN_ _IS AND WHAT IT IS USED FOR
Clindamycin
_ _
contains the active substance Clindamycin. Clindamycin is an
antibiotic. It is used to treat infections in adults, adolescents and
children aged over 1 month.
Clindamycin
_ _
is used for the treatment of severe infections especially when other
antibiotics have been
unable to clear the infection and when the infection is caused by
bacteria that are sensitive to
clindamycin.
Clindamycin
_ _
is used for the treatment of:
-
bone and joint infections
-
chronic infections of paranasal sinuses
-
infections of the lower respiratory tract
-
abdominal infections (peritonitis)
-
infections of the female reproductive organs
-
skin and soft tissue infections
-
dental infection
-
treatment of bacteraemia that occurs in association with, or is
suspected to be associated with
any of the infections listed above
and
-
infections caused by
_Toxoplasma gondii_
and
_Pneumocystis jirovecii_
in adult patients with low
immune defenses
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CLINDAMYCIN
_ _
YOU MUST NOT BE GIVEN CLINDAMYCIN_ _IN THE FOLLOWING CASES:
-
if you are allergic to clindamycin or lincomycin or any of the other
ingredients of this medicine
_ _
(listed in s

Vara einkenni

Health Products Regulatory Authority
12 May 2023
CRN00CN6S
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clindamycin 150 mg/ml Solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 150 mg clindamycin (as phosphate).
Each ampoule of 2 ml contains 300 mg clindamycin (as phosphate).
Each ampoule of 4 ml contains 600 mg clindamycin (as phosphate).
Each ampoule of 6 ml contains 900 mg clindamycin (as phosphate).
Excipient with known effect
Each ml of solution contains up to 7.72 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion [injection/infusion]
Clear and colourless to almost colourless solution.
pH: 5.50 – 7.00
Osmolality: 760-900 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clindamycin is indicated for the treatment of the following severe
infections caused by clindamycin susceptible
microorganisms in adults, adolescents and children ≥1 months (see
sections 4.2 and 5.1):

Bone and joint infections

Chronic sinusitis

Infections of the lower respiratory tract

Intra-abdominal infections

Pelvic and female genital infections.

Skin and soft tissue infections

Dental Infection

Treatment of bacteraemia that occurs in association with, or is
suspected to be associated with any of the
infections listed above
and

Treatment of opportunistic infections from _Toxoplasma gondii_ and
_Pneumocystis jirovecii_ in adult
immunocompromised patients.
In case of aerobic infections clindamycin constitutes an alternative
treatment in case other antibacterial agents are inactive or
contraindicated (e.g. in case of allergy to penicillins). In case of
anaerobic infections a treatment with clindamycin as first choice
Health Products Regulatory Authority
12 May 2023
CRN00CN6S
Page 2 of 12
agent can be envisaged. In case of polymicrobial infection,
consideration should be given to use in combination with an agent
with adequate activity against