DICYNENE 250MG/2ML SOLUTION FOR INJECTION 250/2 Micromol Solution for Injection

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

ETAMSILATE

থেকে পাওয়া:

OM PHARMA SA

INN (আন্তর্জাতিক নাম):

ETAMSILATE

ডোজ:

250/2 Micromol

ফার্মাসিউটিকাল ফর্ম:

Solution for Injection

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may not be renewed (A)

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

0000-00-00

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE 
USER
This leaflet should be read by the parents of a baby 
receiving Dicynene Injection
Dicynene 250 mg/2 ml
Solution for injection 
Etamsylate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 
USING THIS MEDICINE.
- 
Keep this leaflet. You may need to read it again.
- 
If you have any further questions, ask your  
doctor or your pharmacist.
- 
This medicine has been prescribed for you. Do 
not pass it on to others. It may harm them, even 
if their symptoms are the same as yours.
- 
If any of the side effects gets serious, or if you 
notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1
. 
What Dicynene is and what it is used for
2. 
Before you use Dicynene
3. 
How to use Dicynene
4. 
Possible side effects
5. 
How to store Dicynene
6. 
Further information
1.  WHAT DICYNENE

IS AND WHAT IT IS 

USED FOR
Dicynene Injection is available as a clear solution for 
injection in a 2ml ampoule containing 250 mg etam-
sylate, (125 mg per ml) which is the active ingredient.
Dicynene is a non-hormonal drug known as a hae-
mostatic agent. It reduces the loss of fluid and blood 
from small blood vessels known as capillaries, and 
is particularly useful in low birth weight newborn.
It is used for the prevention and treatment of bleed-
ing into the brain (periventricular haemorrhage) in 
newborns weighing less than 1.5kg.
2.  BEFORE YOU USE DICYNENE
THIS PRODUCT IS INTENDED FOR NEONATAL USE ONLY.
DO NOT USE DICYNENE:
- 
if the patient is allergic to etamsylate or any of 
the other ingredients of this medicine (listed in  
section 6).
- 
if the patient has porphyria (an illness character-
ized by a defect in the synthesis of haemoglobin).
-  
if the patient has asthma or is allergic to sulphites
If one of the above applies to your baby, the doctor 
will know what to do.
WARNINGS AND PRECAUTIONS
Dicynene injection should be used with caution 
- 
in case of live

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dicynene 250mg/2 ml Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient is etamsylate 125mg/ml of injection solution.
(250mg per 2 ml ampoule).
Excipients: Each 2ml ampoule also contains 0.8mg of sodium metabisulphite (E223)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection (injection).
A clear, colourless, aqueous solution for injection (pH 6.2 to 6.8).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dicynene injection is indicated in neonates.
Dicynene injection is used clinically for the prophylaxis and treatment of periventricular haemorrhage (bleeding into
the brain immediately adjacent to cerebralventricles) in low birth weight infants (< 1.5 Kg).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Neonates only :
The normal dosage is 12.5mg/kg body weight given by intravenous or intramuscular route within an hour of birth and
every six hours for the first 4 days of life.
Clinical studies have not been performed in patients presenting hepatic or renal impairment. Consequently, caution is
required when administering Dicynene injection to these patients.
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to etamsylate or to any of the excipients.
Acute porphyria
Bronchial asthma, confirmed hypersensitivity to sulphites.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Dicynene injection is intended for neonatal use only.
If the infant develops a fever then treatment should be discontinued.
Due to the risk of a fall in blood pressure during parenteral administration, caution is required in patients presenting
unstable pressure or hypotension (see section 4.8 “undesirable effects”).
Dicynene injection solution contains sodium metabisulphi