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DANAPAROID SODIUM 750 ANTI-XA UNITS/0.6 ML SOLUTION FOR

Active substance(s): DANAPAROID SODIUM

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Danaparoid
Sodium
750 anti-Xa units/0.6 ml,
solution for injection
Information for the doctor

3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
• Prevention of deep vein
thrombosis and its possible
consequences in patients
undergoing general or
orthopaedic surgery.
• Treatment of thrombo-embolic
disorders in patients who
require urgent parenteral
anti-coagulation because
of the development or
history of heparin-induced
thrombocytopenia (HIT).
4.2 Posology and method of
administration
a) Non-HIT patients (DVT
prophylaxis)
In general Danaparoid Sodium
should be administered by
subcutaneous injection at a dose
of 750 anti-factor Xa units, twice
daily for 7 to 10 days or until the
risk of thromboembolism has
diminished.
In surgical patients it is
recommended to start this dosing
pre-operatively and to give the
last pre-operative dose 1-4 hours
before surgery.
Plasma anti-Xa activity is linearly
related to the dose of Danaparoid
Sodium given. If it is necessary
to monitor anticoagulant activity,
and for individual dose setting,
a functional anti-factor Xa test
using a chromogenic peptide
substrate should be used.
In this test Danaparoid Sodium
should be used as standard for
constructing the reference curve.
b) HIT patients
The diagnosis of HIT should as
a minimum be based on:
1) thrombocytopenia
(platelet count<100x109/L)
occurring during heparin
administration and
2) exclusion of all other causes
of thrombocytopenia
In general monitoring of plasma
anti-Xa activity is not necessary.
However, in patients suffering
from renal insufficiency and/or
patients weighing over 90kg,
monitoring (using an amidolytic
assay) is recommended.
Danaparoid Sodium should be
administered intravenously
as a bolus of 2500 antiXa units (for patients less
than 55kg 1250 units, if over
90kg, 3750 units) followed by
an intravenous infusion of
400units/h for 2 hours, then
300 units/h for 2 hours, then
a maintenance infusion of
200 units/h for 5 days. The
expected plasma anti-Xa levels
are 0.5-0.7 units/ml 5-10 minutes
after the bolus, not higher than
1.0 units/ml during the adjustment
phase of maintenance infusion
and 0.5-0.8 units/ml during the
maintenance infusion.
Dosage in the elderly:
Clearance of anti-factor
Xa activity has not been shown
to be markedly reduced in the
elderly and the usual dosage is
recommended.
Children:
There is insufficient experience
with the use of Danaparoid
Sodium in children to suggest
a dosage regimen for this group
of patients.
Dosage in patients with
moderately impaired renal and/or
liver function:
Danaparoid Sodium should be
used with caution in patients

Danaparoid
Sodium

750 anti-Xa units, solution
for injection
Danaparoid sodium
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Read all of this leaflet carefully
before you are given this medicine.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor or 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 Danaparoid Sodium is
and what it is used for
2. Before you are given
Danaparoid Sodium
3. How Danaparoid
Sodium is given
4. Possible side effects
5. How to store
Danaparoid Sodium
6. Further information
1. What Danaparoid Sodium is
and what it is used for
Danaparoid sodium, the active
ingredient in Danaparoid Sodium, is
a medicine that prevents blood from
clotting (anticoagulant), and belongs
to a group of medicines called
heparinoids.
Danaparoid Sodium prevents the
formation of blood clots in blood
vessels, and is used in patients who
have an increased risk of blood
clot formation, and in patients who
are allergic to another medicine
called heparin.
You should ask your doctor if you
are unsure why you have been given
Danaparoid Sodium.

2. Before you are given
Danaparoid Sodium
You should not be given Danaparoid
Sodium if:
• you are allergic (hypersensitive)
to danaparoid sodium, or any
of the other ingredients of
Danaparoid Sodium.
• you are being treated for blood
clots, and are having a spinal or
epidural anaesthetic
• you are prone to bleeding
easily, unless you cannot be
given heparin
• you have an ulcer, unless
the ulcer is the reason for
your operation
• have had a stroke
• are bleeding and it
can’t be stopped
• you have severe kidney or severe
liver disease, unless you cannot
be given heparin
• have very high blood pressure
• have damage to the retina of the
eye due to diabetes
• have an infection of the inner
lining and valves of the heart
(acute bacterial endocarditis).
• previous treatment with heparins
(a group of medicines often
used to treat blood clots) caused
a large drop in the number
of a type of blood cell called
platelets, and if a blood test
showed that this may happen with
Danaparoid Sodium
Take special care with
Danaparoid Sodium
Medicines are not always suitable
for everyone.
➞➞Tell your doctor before you are
given Danaparoid Sodium if you
suffer from or have suffered in
the past from any of the following
conditions, as extra supervision
may be necessary:
• kidney or liver disease
• have an active stomach ulcer
• a history of asthma or allergy
as this medicine contains sodium
sulphite (see Important Information
about some of the Ingredients of
Danaparoid Sodium, below).
Taking other medicines
Some medicines can affect the

way Danaparoid Sodium works, or
Danaparoid Sodium itself can affect
how other medicines taken at the
same time work. These include:
• oral anticoagulants (medicines
used to stop blood clots)
• aspirin or anti-rheumatics
• steroids.
➞➞Tell your doctor or pharmacist if
you are taking or have recently
taken any other medicines,
including medicines obtained
without a prescription.
Pregnancy and Breast-feeding
If you are pregnant, or suspect
that you are pregnant or if you
are breast-feeding then tell your
doctor. Your doctor will decide
whether Danaparoid Sodium can be
given to you.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Danaparoid Sodium is not known
to have any effects on the ability to
drive, or use machinery.
Important information about
some of the ingredients of
Danaparoid Sodium
This medicine contains less
than 1 mmol sodium (23mg)
per dose - that is essentially
‘sodium free’.
• Danaparoid Sodium contains
sodium sulphite which may rarely
cause severe hypersensitivity
reactions and a difficulty in
breathing (bronchospasm).
Symptoms include: tightening of the
chest, swelling, itching or rash.
Please see section 6 for a full list of
ingredients.
3. How Danaparoid Sodium is given
Adults and elderly
The medicine is given as an
injection under the skin or as an
infusion (a slow injection) by your
doctor or nurse.
The normal dose is 750 units, twicea-day, for 7 to 10 days.
Higher doses may be necessary in
some patients.
Children
Danaparoid Sodium can be used in
children, but the doctor will decide
the dose as experience is limited.
00000000-00

PHARMA CODE N° xxxx

PHARMA CODE N° xxxx

2. QUALITATIVE AND
QUANTITATIVE COMPOSITION
Danaparoid Sodium contains
danaparoid sodium, which is
a non-heparin mixture of low
molecular weight sulphated
glycosaminoglycuronans
derived from animal mucosa,
comprising heparan sulphate,
dermatan sulphate and a minor
amount of chondroitin sulphates.
One ampoule (0.6mL) contains
750 amidolytic anti-factor
Xa units danaparoid sodium
and corresponding to 1250 antifactor Xa units per mL. The
anti-Xa unit is derived from the
international heparin standard
in an antithrombin containing
buffer system.
For excipients see section 6.1.

HIT and no suitable alternative
antithrombotic treatment is
available.
Danaparoid Sodium should not
be used in patients with severe
renal and hepatic insufficiency
unless the patient also has HIT
and no alternative antithrombotic
treatment is available.
Danaparoid Sodium should be
used with caution in patients
with moderately impaired
renal, and/or liver function with
impaired haemostasis, ulcerative
lesions of the gastro-intestinal
tract or other diseases which
may lead to an increased danger
of haemorrhage into a vital
organ or site.
Danaparoid Sodium should not
be administered to patients
with active gastric or duodenal
ulceration, unless it is the reason
for operation.
• Since severe bleeding may occur
post-operatively in HIT patients
undergoing a cardiopulmonary
bypass procedure, Danaparoid
Sodium is not recommended
during the procedure, unless no
other antithrombotic treatment is
available.
• Danaparoid Sodium contains
sodium sulphite. In asthma
patients hypersensitive to
sulphite the latter can result
in bronchospasm and/or
anaphylactic shock.
• Danaparoid Sodium
should not be given by the
intramuscular route.
• The safety and efficacy of
Danaparoid Sodium in patients
with non-haemorrhagic stroke
remains to be confirmed.
• No incidences of osteoporosis
have been reported in
patients treated with the
recommended dose of
Danaparoid Sodium. However,
as for heparin, treatment with
glycosaminoglycuronan may
result in osteoporosis if the
dosage is inappropriate.
• It should be noted that the antiXa units of Danaparoid Sodium
have a different relationship
to clinical efficacy than those
of heparin and low molecular
weight heparins.
• As with heparins, in patients
undergoing peridural or
spinal anaesthesia or spinal
puncture, the prophylactic use
of Danaparoid Sodium may
theoretically be associated with
epidural or spinal haematoma
resulting in prolonged or
permanent paralysis. The risk
is increased by the prolonged
use of a peridural or spinal
catheter for analgesia, by
the concomitant use of drugs
affecting haemostasis such as
nonsteroidal anti-inflammatory
drugs (NSAIDs), and by traumatic
or repeated puncture.
• In decision-making on the
interval between the last
administration of Danaparoid
Sodium at prophylactic doses
and the placement or removal of
a peridural or spinal catheter, the
product characteristics and the
patient profile should be taken
into account. Subsequent dose
should not take place before at
least four hours have elapsed.
Re-administration should be
delayed until the surgical
procedure is completed.
• Should a physician decide to
administer Danaparoid Sodium
in the context of peridural or
spinal anaesthesia, extreme
vigilance and frequent monitoring
must be exercised to detect
any signs and symptoms of
neurologic impairment, such
as back pain, sensory and
motor deficits (numbness and
weakness in lower limbs) and
bowel or bladder dysfunction.
Nurses should be trained to
detect such signs and symptoms.
Patients should be instructed
to inform immediately a nurse
or a clinician if they experience
any of these.
• If signs or symptoms of epidural
or spinal haematoma are
suspected, urgent diagnosis
and treatment including spinal
cord decompression should be
initiated.
4.5 Interactions with other
Medicaments and other
forms of Interaction
In clinical studies no clinically
significant interactions with
other medications have been
found. Danaparoid Sodium
may be used together with
oral anticoagulants, drugs
which interfere with platelet
function (such as aspirin and
non-steroidal anti-inflammatory
drugs) or potentially ulcerogenic
drugs (such as corticosteroids),
but caution remains necessary
this is particularly important in

PHARMA CODE N° xxxx

PHARMA CODE N° xxxx

1. NAME OF THE
MEDICINAL PRODUCT
Danaparoid Sodium
750 anti-Xa units/0.6 ml,
solution for injection

with moderately impaired
renal and/or liver function with
impaired haemostasis.
Conversion to anticoagulants is
possible, however it is advisable
only to start such a therapy once
there is adequate antithrombotic
control with Danaparoid Sodium.
Oral anticoagulants can be given
with the infusion (maximum rate
300units/h) which can then be
stopped when the international
normalised ratio is ≥1.5. If the
bleeding risk is high then either:
(a) stop the infusion and
start Danaparoid Sodium
750 anti-Xa units/0.6 ml
subcutaneously twice a day,
then 24 hours later start
anticoagulants 48-72 hours
before Danaparoid Sodium
is withdrawn to give
time for the prothrombin
time, Thrombotest and
international normalised
ratio to reach therapeutic
levels (measurement of
these parameters is not
reliable within 5 hours of
Danaparoid Sodium injection
(See “Interactions with other
medicaments and other forms
of interactions”)) or
(b) stop the infusion, give no
further Danaparoid Sodium
then start the anticoagulants
12 hours later.
4.3 Contra-indications
• As with heparins, in patients
receiving Danaparoid Sodium
for treatment rather than for
prophylaxis, locoregional
anaesthesia in elective surgical
procedures is contra-indicated.
• severe haemorrhagic diathesis,
e.g. haemophilia and idiopathic
thrombocytopenic purpura,
unless the patient also has
HIT and no alternative antithrombotic treatment is available
• haemorrhagic stroke in the
acute phase
• uncontrollable active
bleeding state
• severe renal- and/or hepatic
insufficiency, unless the patient
also has HIT and no alternative
anti-thrombotic treatment
is available
• severe uncontrolled hypertension
• active gastroduodenal
ulcer, unless it is the reason
for operation
• diabetic retinopathy
• acute bacterial endocarditis
• a positive in vitro aggregation
test for the heparin-induced
antibody in the presence
of Danaparoid Sodium in
patients with a history of
thrombocytopenia induced
by heparin or heparin-like
anticoagulants
• hypersensitivity to sulphite.
• hypersensitivity to the active
substance or to any of the
excipients.
4.4 Special Warnings and Special
precautions for use
Danaparoid Sodium should not
be used if an in vitro test for
the heparin-induced antibody
in the presence of Danaparoid
Sodium is positive in patients
with thrombocytopenia
induced by heparin or
heparin-like anticoagulants,
unless no suitable alternative
antithrombotic treatment is
available.
The incidence of serological
cross-reactivity of Danaparoid
Sodium with the heparininduced antibody before the
start of therapy is approximately
5%. The incidence of clinical
cross-reactivity developing
during Danaparoid Sodium
therapy is approximately
3% and many of these patients
had a negative pre-treatment
serological cross-reactivity test.
Although the risk of antibodyinduced thrombocytopenia and
thrombosis during Danaparoid
Sodium therapy (i.e. clinical
cross-reactivity) is very small,
it is advisable to check the
number of platelets daily during
the first week of treatment, on
alternate days during the second
and third weeks, and weekly
to monthly thereafter. If a pretreatment cross-reactivity
test with Danaparoid Sodium
is positive but it is decided
to use Danaparoid Sodium,
then the number of platelets
should be checked daily until
Danaparoid Sodium treatment
is stopped. If antibody-induced
thrombocytopenia occurs,
one should stop the use of
Danaparoid Sodium and consider
alternative treatment.
Danaparoid Sodium should not
be administered to patients with
severe hemorrhagic diathesis,
e.g. hemophilia and idiopathic
thrombocytopenic purpura,
unless the patient also has

patients undergoing peridural
or spinal anaesthesia or spinal
puncture (see section 4.4.).
Monitoring of anticoagulant
activity of oral anticoagulants
by prothrombin time and
thrombotest is unreliable within
5 hours after Danaparoid Sodium
administration.
There is no data available on the
effect of Danaparoid Sodium on
thyroid function tests
Interaction studies have only
been performed in adults.
4.6 Pregnancy and Lactation
Pregnancy
Danaparoid Sodium has been
used in over 60 pregnancies
(starting during the first
trimester in almost 50% of
the pregnancies, the second
trimester in approximately
20% of the pregnancies and
the third trimester in 25% of the
pregnancies. For a small number
of patients the starting trimester
is unknown). Overall, the use
of Danaparoid Sodium was
successful.
Animal studies have not
demonstrated any teratogenic
effect or placental transfer.
In the few cases in which
human umbilical cord blood was
tested for the presence of antiXa activity, no activity was found.
Although Danaparoid Sodium
has been used with success in
a small number of pregnancies,
the available information
is still considered to be
insufficient to assess whether
deleterious effects may occur
in pregnancy during the use of
Danaparoid Sodium.
Caution should be exercised
when prescribing to pregnant
women. If alternative
antithrombotic treatment is
unacceptable for medical
reasons (e.g. HIT patients)
Danaparoid Sodium can be used.
Lactation
In five cases in which breast
milk samples were tested for
anti-Xa activity, all showed
no or negligible amounts
of anti-Xa activity (which
would be hydrolyzed in the
infant’s stomach and rendered
harmless).
Although the data are limited,
if alternative antithrombotic
treatment is unacceptable
for medical reasons (e.g. HIT
patients) Danaparoid Sodium can
be used during lactation.
4.7 Effects on Ability to Drive and
Use Machines
Danaparoid Sodium is not known
to have any effect on the ability
to drive and use machines.
4.8 Undesirable Effects
Enhanced bleeding or
haematoma may occur at the
operation site.
Bruising and/or pain may occur
at injection sites.
Within each frequency grouping,
undesirable effects are
presented in order of decreasing
seriousness.

All above terms in this section
and synonym terms (with same
or less severity) coded with
the MedDRA dictionary are
considered as ‘listed’.
All hemorrhages are listed
adverse events for Danaparoid
Sodium. This also means that
symptoms or signs which
are clearly directly related to
a hemorrhage (e.g. anaemia,
decreased Hb, rbc, hematocrit,
faintness, tiredness, tamponade)
are listed adverse events.
Liver abnormalities such as
changes in transaminase
and alkaline phosphatase
have been observed, but no
clinical significance has been
demonstrated.
Very rarely, cases of epidural
and spinal haematomas were
reported in association with
prophylactic use of heparins
in the context of peridural or
spinal anaesthesia and of spinal
puncture. These haematomas
have caused various degrees
of neurological impairment,
including prolonged or
permanent paralysis (see Section
4.4 ‘Special warnings and
precautions for use’).
4.9 Overdose
In the event of serious bleeding
other than caused by a surgical
error, Danaparoid Sodium should
be stopped and transfusion
of fresh frozen plasma or, if
uncontrollable, plasmapheresis
should be considered. Although
protamine partially neutralises
the anticoagulant activity
of Danaparoid Sodium the
relevance for the reversal
of the bleeding is not clear
and therefore cannot be
recommended. The effects
of Danaparoid Sodium on
anti-Xa activity cannot be
antagonized with any known
agent at this time.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Danaparoid sodium has been
shown both in animal models
and in human studies to be
an effective antithrombotic
substance. At therapeutic
doses danaparoid sodium has
no or only a minor effect on
haemostatic plug formation,
platelet function and platelet
aggregability with no significant
effect on bleeding time at
the recommended doses.
Occasionally, after high
intravenous or subcutaneous
doses, a prolonged bleeding time
has been observed.
The anticoagulant activity of
danaparoid sodium in clotting
assays such as prothrombin time,
activated partial thromboplastin
time, kaolin cephalin clotting time
and prothrombin time is small,
and characterised by a very
flat dose-response curve up to
relatively high doses.

Common
Uncommon
(≥1/100 to
(≥1/1,000 to
1/10 of patients) 1/100 of patients)
Blood and the thrombocytopenia*,
lymphatic
heparin-induced
system
thrombocytopenia
disorders
Immune
hypersensitivity,
system
drug
disorders
hypersensitivity
Skin and
rash
purpura,
subcutaneous
rash maculotissue
papular, rash
disorders
erythematous,
pruritus, urticaria

Rare
(≥1/10,000 to
<1/1,000 of patients)
auto-immune
thrombocytopenia

rash
generalised, rash
maculovesicular,
injection or
infusion site rash,
rash macular
Injection (inj.) site:
General
Injection site
- hemorrhage
disorders and
reaction
- discomfort
administration
- hypersensitivity
site conditions
- irritation
- coldness
- pruritus
inj. or infusion site:
- erythema
- pain
- swelling
- warmth
infusion site:
- bruising
- reaction
Injury,
post
post procedural incision site
poisoning and procedural
hematoma,
hemorrhage,
procedural
hemorrhage
operative
anastomotic
complications
hemorrhage
hemorrhage
Note: terms are coded with MedDRA dictionary version 8.1
Antibody induced
thrombocytopenia, as can
be caused by (low molecular
weight) heparin, was observed
in rare cases during the use of
Danaparoid Sodium, but only
in patients who were already
sensitised to either heparin or
low molecular weight heparin
(see section 4.4).

If you are given more Danaparoid
Sodium than you should
Danaparoid Sodium will be given
to you by a doctor or nurse so you
are unlikely to be given too much
medicine. However, if too much
Danaparoid Sodium is given you
may bleed too much. This may
be shown by:
• nosebleeds, bleeding gums;
• blackened stools (may indicate blood
loss from stomach or intestines);
• blood in the urine;
• unusually severe
periods in women.
➞➞If you have any of these symptoms
or you think you have been given
too much Danaparoid Sodium, tell
your doctor immediately.
If you have any further questions
about being given Danaparoid
Sodium, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Danaparoid
Sodium can cause side effects,
although not everybody gets them.
➞➞Tell your doctor immediately
if you experience any of the
following symptoms after being
given this medicine together with
a spinal or epidural anaesthetic.
Although they are very rare, these
symptoms can be serious.
• back pain
• tingling, numbness or weakness
in the legs
• bowel or bladder problems.
Common side effects
(affect up to 1 in 10 people)
• a large drop in the number
of cells that clot the blood
(thrombocytopenia) in patients
already hypersensitive to heparin
• increased bleeding after
the operation
• skin rash
Uncommon side effects
(affect up to 1 in 100 people)
• bruises and/or pain around the
injection site
• allergic reaction to
Danaparoid Sodium.
This may cause sudden wheeziness,
difficulty in breathing, swelling of

and thrombus formation. The
anti-Xa activity is mediated
by antithrombin-III and is not
inactivated by endogenous
heparin-neutralising factors. The
small antithrombin activity is
mediated by heparin co-factor II
and antithrombin-III. The heparan
sulphate fraction with low affinity
for antithrombin-III, lacking
significant effects on coagulation
factors Xa and IIa in vitro, has
been shown in animal studies to
contribute substantially to the
antithrombotic activity by an as yet
unexplained mechanism.
Danaparoid Sodium shows low
cross-reactivity (<10%) with the
heparin induced antibody. This
can be explained by the absence
of heparin in Danaparoid Sodium
and its low degree of sulphation
(see section 4.4).
5.2 Pharmacokinetic Properties
Pharmacokinetic studies have
primarily been based on the
kinetics of relevant anticoagulant
activities of danaparoid
sodium, because no specific
chemical assay methods are
available. In animal models the
time courses of the thrombin
generation inhibitory activity
and antithrombotic activities
of danaparoid sodium were
strongly related.
The absolute bioavailability
of danaparoid sodium after
subcutaneous administration
approaches 100%. In humans
the time to reach peak plasma
anti-Xa activity levels is
approximately 4-5 hours.
The half-lives of elimination
of anti-Xa and thrombin
generation inhibiting activities
of approximately 25 hours and
7 hours respectively, after both
subcutaneous and intravenous
administration are independent
of the dose. Steady-state levels
of plasma anti-Xa activity are
usually reached within 4-5 days
of dosing. Measured by thrombin
generation inhibiting activity
steady-state levels are reached
earlier, i.e. within 1-2 days.
Danaparoid sodium is mainly
eliminated by renal excretion
and animal experiments indicate
that the liver is not involved in
its metabolism. In patients with
severely impaired renal function
the half-life of elimination of
plasma anti-factor Xa activity
may be prolonged.
5.3 Preclinical Safety Data
The results of pre-clinical studies
do not add to the information
included in the other sections
of the SmPC.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Sodium sulphite Ph. Eur.
Sodium chloride Ph. Eur.
Hydrochloric acid Ph. Eur.
Water
Ph. Eur.
6.2 Incompatibilities
When administered as an
intravenous bolus or infusion,
Danaparoid Sodium should be
given separately and not mixed
with other drugs. However,
Danaparoid Sodium is compatible
with, and therefore can be added
to, infusions of saline, dextrose
or dextrose-saline.
6.3 Shelf Life
3 years.
6.4 Special Precautions for Storage
Do not store above 30°C. Do not
freeze. Keep the ampoules in the
outer carton to protect from light.
6.5 Nature and Contents of Container
1-ml glass ampoules containing
750 anti-factor Xa units (0.6ml)
danaparoid sodium per ampoule
(1250 anti-factor Xa units/ml) in
packs of 10 or 20 ampoules.
6.6 Instructions for Use/Handling
See section 4.2
Administrative Data
7. MARKETING
AUTHORISATION HOLDER
Aspen Pharma Trading Limited,
3016 Lake Drive, Citywest
Business Campus, Dublin
24, Ireland
8. MARKETING
AUTHORISATION NUMBER
PL 39699/0057
9. DATE OF FIRST
AUTHORISATION/RENEWAL OF
AUTHORISATION
14 April 1993/09 October 1998

The ultimate step in blood
coagulation, the fibrinogen-fibrin
conversion, is critically dependent
on prothrombin generation to
which Factor Xa and thrombin
contribute substantially. The
anticoagulant profile of danaparoid
sodium is characterised by a high
ratio of anti-factor Xa/antithrombin
activities, resulting in an effective
inhibition of thrombin generation

10. DATE OF REVISION OF THE TEXT
01/2016

eyelids, face or lips, rash or itching
(especially affecting the whole body)

Blood clots which form in veins may
restrict the blood flow causing tissue
to die. Small parts of the clot can
break off and may block the blood
circulation in the lungs. A blood clot
in the lungs may be very serious.
Patients who are bedridden have
an increased risk of clot formation
in the veins of the legs, especially if
they have undergone an operation.
These patients receive Danaparoid
Sodium to prevent the formation of
blood clots.

Rare side effects
(affect up to 1 in 1000 people)
• increased bleeding or swelling
containing blood at the operation
site (haematoma);
Very rare side effects
(affect up to 1 in 10000 people)
When Danaparoid Sodium is used at
the same time as a spinal or epidural
anaesthetic, bruising of the spine
may occur.
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet, tell
your doctor or pharmacist.
5. How to store Danaparoid Sodium
Keep out of the reach and sight
of children.
Do not store above 30 ºC.
Do not freeze.
Keep the ampoules in the outer
carton to protect from light.
Do not use Danaparoid Sodium after
the expiry date which is stamped on
the pack. The expiry date refers to
the last day of that month.
6. Further information
What Danaparoid Sodium contains
Each 1ml glass ampoule contains
750 anti-factor Xa units (0.6ml) of the
active ingredient danaparoid sodium,
corresponding to 1250 anti-factor
Xa units per ml.
The other ingredients are:
Sodium sulphite, Sodium chloride,
Hydrochloric acid, Water
What Danaparoid Sodium looks like
and contents of the pack
Danaparoid Sodium comes in
glass ampoules. It is a solution
for injection. Each ampoule of
Danaparoid Sodium contains 0.6ml of
medicine, and is available in packs
of 10 or 20 ampoules.

Marketing Authorisation Holder
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland
Manufacturer
FAMAR Health Care Services
Madrid, S.A.U
Avda. Leganés, 62,
Alarcón 28923
Madrid,
Spain
This leaflet was last updated
in 01/2016
To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name: Danaparoid Sodium
Reference Number:
PL 39699/0057
This is a service provided by
the Royal National Institute for
Blind People
______

More about Danaparoid Sodium
Danaparoid Sodium contains
a natural substance, derived from
pig intestine, which prevents the
formation of blood clots in blood
vessels (thrombosis).

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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