DICYNONE INJECTION 250 mg2 ml

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

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Ladda ner Bipacksedel (PIL)
29-10-2014
Ladda ner Produktens egenskaper (SPC)
29-10-2014

Aktiva substanser:

ETAMSYLATE

Tillgänglig från:

PHARMA TO MARKET PTE. LTD.

ATC-kod:

B02BX01

Dos:

250 mg/2 ml

Läkemedelsform:

INJECTION

Sammansättning:

ETAMSYLATE 250 mg/2 ml

Administreringssätt:

INTRAVENOUS, INTRAMUSCULAR

Receptbelagda typ:

Prescription Only

Tillverkad av:

SANOFI WINTHROP INDUSTRIE

Bemyndigande status:

ACTIVE

Tillstånd datum:

1988-04-21

Bipacksedel

                                DICYNONE
®
 
 250 MG/ 2 ML
 
SOLUTION FOR INJECTION 
 
COMPOSITION 
_Active substance:_ Etamsylate  
_Excipients_: sodium metabisulfite, sodium hydrogen
carbonate, water for injections 
 
PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT 
Solution for injection in an ampoule (2 ml). 
Each ampoule contains 250 mg of etamsylate. 
 
INDICATIONS 
In general medicine: 
• blood loss through fragile capillaries 
• menorrhagia (heavy periods) with no detectable
organic cause 
• in general or specialized surgery  (ENT,
ophthalmology,gynaecology): reduction of blood loss during 
operations, particularly diffuse
haemorrhage, patients treated with anticoagulants. 
 
DOSAGE AND ADMINISTRATION  
Usual dosages: 
-Adults: 
• emergency, 2 to 3 ampoules 3 times daily 
• pre-operative period, 1 hour before surgery: 2 ampoules 
• peri-operative period :according to requirement 
• post-operative period: 1 ampoule, twice daily 
-In newborn and children: half the adult dose 
IV or IM ROUTE. The Injectable solution may also be used by the
oral route (diluted in a half-glass water) 
or locally (dabbing). 
 
CONTRAINDICATIONS  
– Acute porphyria 
– Bronchial asthma, confirmed hypersensitivity to sulphites 
– Hypersensitivity to
any of the ingredients of the medicinal product 
 
SPECIAL WARNINGS AND PRECAUTIONS 
Due to the risk of a fall in blood pressure
during parenteral administration,
caution is required in patients 
presenting unstable blood pressure or
hypotension (see “Undesirable effects”). 
DICYNONE 250 solution for injection
contains sodium metabisulfite as antioxidant, which may cause 
allergic reactions, nausea and diarrhea in susceptible patients.
The allergic reactions may go as far as 
anaphylactic shock and cause life-threatening
asthma attacks. The prevalence in the population is not 
known but is p
                                
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Produktens egenskaper

                                DICYNONE
® 250 MG/ 2 ML
SOLUTION FOR INJECTION
COMPOSITION
_Active substance:_ Etamsylate
_Excipients_: sodium metabisulfite, sodium hydrogen carbonate, water
for injections
PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT
Solution for injection in an ampoule (2 ml).
Each ampoule contains 250 mg of etamsylate.
INDICATIONS
In general medicine:
• blood loss through fragile capillaries
• menorrhagia (heavy periods) with no detectable organic cause
• in general or specialized surgery (ENT,
ophthalmology,gynaecology): reduction of blood loss during
operations, particularly diffuse haemorrhage, patients treated with
anticoagulants.
DOSAGE AND ADMINISTRATION
Usual dosages:
-Adults:
• emergency, 2 to 3 ampoules 3 times daily
• pre-operative period, 1 hour before surgery: 2 ampoules
• peri-operative period :according to requirement
• post-operative period: 1 ampoule, twice daily
-In newborn and children: half the adult dose
IV or IM ROUTE. The Injectable solution may also be used by the oral
route (diluted in a half-glass water)
or locally (dabbing).
CONTRAINDICATIONS
– Acute porphyria
– Bronchial asthma, confirmed hypersensitivity to sulphites
– Hypersensitivity to any of the ingredients of the medicinal
product
SPECIAL WARNINGS AND PRECAUTIONS
Due to the risk of a fall in blood pressure during parenteral
administration, caution is required in patients
presenting unstable blood pressure or hypotension (see “Undesirable
effects”).
DICYNONE 250 solution for injection contains sodium metabisulfite as
antioxidant, which may cause
allergic reactions, nausea and diarrhea in susceptible patients. The
allergic reactions may go as far as
anaphylactic shock and cause life-threatening asthma attacks. The
prevalence in the population is not
known but is probably low. However, hypersensitivity to sulphites is
observed more frequently in patient
with asthma than in those without asthma (see «Contraindications»).
If a hypersensitivity reaction occurs,
the administration of Dicynone 250 solution f
                                
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