DALACIN C 150 MGML

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

CLINDAMYCIN PHOSPHATE

Disponible depuis:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Code ATC:

J01FF01

forme pharmaceutique:

SOLUTION FOR INJECTION

Composition:

CLINDAMYCIN PHOSPHATE 150 MG/ML

Mode d'administration:

I.V, I.M

Type d'ordonnance:

Required

Fabriqué par:

PFIZER INC, USA

Groupe thérapeutique:

CLINDAMYCIN

Domaine thérapeutique:

CLINDAMYCIN

indications thérapeutiques:

For the treatment of infections caused by susceptible anaerobic bacteria.

Date de l'autorisation:

2022-04-30

Notice patient

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
WARNING
_Clostridium difficile_ associated diarrhoea (CDAD) has been reported
with use of nearly all
antibacterial agents, including clindamycin phosphate and may range in
severity from mild
diarrhoea to fatal colitis. Treatment with antibacterial agents alters
the normal flora of the
colon, leading to overgrowth of _C. difficile_.
Because clindamycin phosphate therapy has been associated with severe
colitis which
may end fatally, it should be reserved for serious infections where
less toxic antimicrobial
agents are inappropriate, as described in the INDICATIONS section. It
should not be used
in patients with nonbacterial infections such as most upper
respiratory tract infections.
_C. difficile_ produces toxins A and B which contribute to the
development of CDAD. Hypertoxin
producing strains of _C. difficile_ cause increased morbidity and
mortality, as these infections
can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be
considered in all patients who present with diarrhoea following
antibiotic use. Careful
medical history is necessary since CDAD has been reported to occur
over two months after
the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed
against _C. difficile_
may need to be discontinued. Appropriate fluid and electrolyte
management, protein
supplementation, antibiotic treatment of _C. difficile_, and surgical
evaluation should be
instituted as clinically indicated.
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Dalacin C 150 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains clindamycin phosphate equivalent to 150
mg clindamycin.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
Clear, colourless, sterile solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dalacin C (clindamycin phosphate) is indicated for the treatment of
infections caused by
susceptible anaerobic bacteria.
Clindamycin does not penetrate the blood

Résumé des caractéristiques du produit

Dalacin C 150mg/ml LPD CC 280222
Page 1 of 11
2019-0057284, 2020-0061979, 2020-0061721
DALACIN
® C 150 MG/ML
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dalacin
®
C 150 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains clindamycin phosphate equivalent to 150
mg clindamycin.
Excipients with known effect:
Each ml of solution contains 9 mg of benzyl alcohol .
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
Clear, colourless, sterile solution for intramuscular or intravenous
use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dalacin® C (clindamycin phosphate) is indicated for the treatment of
infections caused by
susceptible anaerobic bacteria.
Clindamycin does not penetrate the blood/brain barrier in
therapeutically effective quantities
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Parenteral (IM or IV administration).
Dalacin
®
C
(clindamycin phosphate) MUST
be diluted
prior to IV administration and should be infused over at least 10-60
minutes.
_Adults_
: Serious infections: 600 mg - 1.2 g/day in two, three or four equal
doses.
More severe infections: 1.2-2.7 g/day in two, three or four equal
doses.
Single IM injections of greater than 600 mg are not recommended nor is
administration of
more than 1.2 g in a single one-hour infusion.
Dalacin C 150mg/ml LPD CC 280222
Page 2 of 11
2019-0057284, 2020-0061979, 2020-0061721
For more serious infections, these doses may have to be increased. In
life-threatening
situations, doses as high as 4.8 g daily have been given intravenously
to adults.
Alternatively, the drug may be administered in the form of a single
rapid infusion of the first
dose followed by continuous IV infusion.
_Paediatric population _
_Children (over 1 month of age)_
: Serious infections: 15-25 mg/kg/day in three or four equal
doses.
Clindamycin should be dosed based on total body weight regardless of
obesity.
More severe infections: 25-40 mg/kg/day in three or four equal doses.
In severe inf