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750 anti-Xa units, solution for injection
Danaparoid sodium
Information for the doctor
Name of the Medicinal Product
Orgaran, 750 anti-Xa units, solution
for injection
Qualitative and Quantitative
Orgaran 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 anti-factor
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.
3. Pharmaceutical form
Solution for injection.
4. Clinical Particulars
4.1 Therapeutic indications
•  revention of deep vein thrombosis
and its possible consequences in
patients undergoing general or
orthopaedic surgery.
•  reatment of thrombo-embolic
disorders in patients who require
urgent parenteral anti-coagulation
because of the development
or history of heparin-induced
thrombocytopenia (HIT).
Posology and method of
a) Non-HIT patients (DVT
In general Orgaran 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
Plasma anti-Xa activity is linearly
related to the dose of Orgaran
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 Orgaran
should be used as standard for
constructing the reference curve.

For Position Only

b) HIT patients
The diagnosis of HIT should as a
minimum be based on:
1) thrombocytopenia (platelet
count<100x109/L) occurring
during heparin administration
exclusion of all other causes of
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
Orgaran® 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.

Conversion to anticoagulants is
possible, however it is advisable only
to start such a therapy once there is
adequate antithrombotic control with
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:
stop the infusion and start
Orgaran® 750 anti-Xa units
subcutaneously twice a day,
then 24 hours later start
anticoagulants 48-72 hours
before Orgaran® 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 Orgaran® injection
(See “Interactions with other
medicaments and other forms of
interactions”)) or
stop the infusion, give no
further Orgaran® then start the
anticoagulants 12 hours later.
4.3 Contra-indications
•  s with heparins, in patients receiving
Orgaran for treatment rather than for
prophylaxis, locoregional anaesthesia
in elective surgical procedures is
• severe haemorrhagic diathesis,

e.g. haemophilia and idiopathic
thrombocytopenic purpura, unless the
patient also has HIT and no alternative
anti-thrombotic treatment is available
haemorrhagic stroke in the acute
•  ncontrollable active bleeding state
•  evere renal- and/or hepatic
insufficiency, unless the patient
also has HIT and no alternative antithrombotic treatment is available
•  evere uncontrolled hypertension
•  ctive gastroduodenal ulcer, unless it
is the reason for operation
•  iabetic retinopathy
•  cute bacterial endocarditis
•  positive in vitro aggregation test
for the heparin-induced antibody in
the presence of Orgaran in patients
with a history of thrombocytopenia
induced by heparin or heparin-like
hypersensitivity to sulphite.
hypersensitivity to the active
substance or to any of the excipients.
Special Warnings and Special
precautions for use
Orgaran should not be used if
an in vitro test for the heparininduced antibody in the presence of
Orgaran 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 crossreactivity of Orgaran with the heparininduced antibody before the start
of therapy is approximately 5%.The
incidence of clinical cross-reactivity
developing during Orgaran therapy is
approximately 3% and many of these
patients had a negative pre-treatment
serological cross-reactivity test.
Although the risk of antibody-induced
thrombocytopenia and thrombosis
during Orgaran 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 pre-treatment
cross-reactivity test with Orgaran
is positive but it is decided to use
Orgaran, then the number of platelets
should be checked daily until Orgaran
treatment is stopped. If antibodyinduced thrombocytopenia occurs, one
should stop the use of Orgaran and
consider alternative treatment.

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.

Orgaran should not be administered
to patients with severe hemorrhagic
diathesis, e.g. hemophilia and
idiopathic thrombocytopenic purpura,
unless the patient also has HIT and
no suitable alternative antithrombotic
treatment is available.

There is insufficient experience with
the use of Orgaran® in children to
suggest a dosage regimen for this
group of patients.

Orgaran 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.

RA 9400 UK P6 (ref 1.0)


750 anti-Xa units, solution for
Danaparoid sodium
Read all of this leaflet carefully
before you are given this
•  eep this leaflet. You may need
to read it again.
• f you have any further
questions, ask your doctor or
•  his 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
• f 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.  hat Orgaran is and what it
is used for
Before you are given Orgaran
How Orgaran is given
Possible side effects
How to store Orgaran
6. Further information
1.  hat Orgaran is and what it
is used for
Danaparoid sodium, the active
ingredient in Orgaran, is a
medicine that prevents blood
from clotting (anticoagulant),
and belongs to a group of
medicines called heparinoids.
Orgaran 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 Orgaran.

Orgaran 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.

Dosage in patients with moderately
impaired renal and/or liver function:
Orgaran® should be used with
caution in patients with moderately
impaired renal and/or liver function
with impaired haemostasis.

2. efore you are given Orgaran
You should not be given
Orgaran if:
•  ou are allergic
(hypersensitive) to danaparoid
sodium, or any of the other
ingredients of Orgaran.
•  ou are being treated for
blood clots, and are having a
spinal or epidural anaesthetic
•  ou are prone to bleeding
easily, unless you cannot be
given heparin
•  ou have an ulcer, unless the
ulcer is the reason for your
•  ave had a stroke
•  re bleeding and it can’t be
•  ou have severe kidney or
severe liver disease, unless
you cannot be given heparin
•  ave very high blood pressure
•  ave damage to the retina of
the eye due to diabetes
•  ave an infection of the inner
lining and valves of the heart
(acute bacterial endocarditis).
•  revious 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
Take special care with Orgaran
Medicines are not always
suitable for everyone.
→ Tell your doctor before you
are given Orgaran if you
suffer from or have suffered
in the past from any of the
following conditions, as
extra supervision may be
• kidney or liver disease

•  ave an active stomach ulcer
•  history of asthma or allergy
as this medicine contains
sodium sulphite (see
Important Information about
some of the Ingredients of
Orgaran, below).

Orgaran 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, Orgaran is not
recommended during the procedure,
unless no other antithrombotic
treatment is available.
Orgaran® contains sodium sulphite.

In asthma patients hypersensitive
to sulphite the latter can result in
bronchospasm and/or anaphylactic
Orgaran® should not be given by the

intramuscular route.
The safety and efficacy of Orgaran®

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 Orgaran®.
However, as for heparin, treatment
with glycosaminoglycuronan may
result in osteoporosis if the dosage is
It should be noted that the anti-Xa

units of Orgaran® 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 Orgaran
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
In decision-making on the interval

between the last administration
of Orgaran 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 Orgaran 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.

Interactions with other Medicaments
and other forms of Interaction
In clinical studies no clinically
significant interactions with other
medications have been found.
Orgaran® may be used together
with oral anticoagulants, drugs
which interfere with platelet
function (such as aspirin and nonsteroidal anti-inflammatory drugs)
or potentially ulcerogenic drugs
(such as corticosteroids), but caution
remains necessary this is particularly
important in 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
Orgaran® administration.
There is no data available on the
effect of Orgaran® on thyroid function
Interaction studies have only been
performed in adults.

Taking other medicines
Some medicines can affect the
way Orgaran works, or Orgaran
itself can affect how other
medicines taken at the same
time work. These include:
•  ral anticoagulants (medicines
used to stop blood clots)
•  spirin or anti-rheumatics
•  teroids.
→ Tell your doctor or pharmacist
if you are taking or have
recently taken any other
medicines, including
medicines obtained without a
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 Orgaran can be given
to you.
Ask your doctor or pharmacist
for advice before taking any
Driving and using machines
Orgaran is not known to have
any effects on the ability to
drive, or use machinery.
Important information about
some of the ingredients of
This medicine contains less
than 1 mmol sodium (23mg)
per dose - that is essentially
‘sodium free’.
•  rgaran 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.
How Orgaran 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,
twice-a-day, for 7 to 10 days.

For Position Only

RA 9400 UK S10 (ref 1.0)

Caution should be exercised when
prescribing to pregnant women. If
alternative antithrombotic treatment
is unacceptable for medical reasons
(e.g. HIT patients) Orgaran can be
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) Orgaran can be
used during lactation.
Effects on Ability to Drive and Use
Orgaran® is not known to have any
effect on the ability to drive and use
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.
Antibody induced
thrombocytopenia, as can be
caused by (low molecular weight)
heparin, was observed in rare cases
during the use of Orgaran®, but
only in patients who were already
sensitised to either heparin or low
molecular weight heparin (see
section 4.4).
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 Orgaran. 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

For Position Only

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, Orgaran® should be
stopped and transfusion of
fresh frozen plasma or, if
uncontrollable, plasmapheresis
should be considered. Although
protamine partially neutralises the
anticoagulant activity of Orgaran®
the relevance for the reversal of the
bleeding is not clear and therefore
cannot be recommended. The
effects of Orgaran on anti-Xa activity
cannot be antagonized with any
known agent at this time.

Higher doses may be necessary
in some patients.
Orgaran can be used in children,
but the doctor will decide the
dose as experience is limited.
If you are given more Orgaran
than you should
Orgaran will be given to you
by a doctor or nurse so you are
unlikely to be given too much
medicine. However, if too much
Orgaran is given you may bleed
too much. This may be shown
• nosebleeds, bleeding gums;

• blackened stools (may indicate

blood loss from stomach or
• blood in the urine;

• unusually severe periods in
→ If you have any of these
symptoms or you think you
have been given too much
Orgaran, tell your doctor
If you have any further
questions about being given
Orgaran, ask your doctor or
4. ossible side effects
Like all medicines, Orgaran 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.
•  ack pain
•  ingling, numbness or
weakness in the legs
•  owel or bladder problems.
Common side effects
(affect up to 1 in 10 people)
•  large drop in the number
of cells that clot the blood
(thrombocytopenia) in
patients already
hypersensitive to heparin
• ncreased bleeding after the


(≥1/100 to 1/10 of
Blood and
the lymphatic


(≥1/1,000 to
(≥1/10,000 to <1/1,000 of
1/100 of patients) patients)






Skin and

rash maculopapular, rash
pruritus, urticaria

rash generalised,
rash maculovesicular,
injection or infusion site
rash, rash macular

disorders and
site conditions

Injection site

Injection (inj.) site:
- hemorrhage
- discomfort
- hypersensitivity
- irritation
- coldness
- pruritus
inj. or infusion site:
- erythema
- pain
- swelling
- warmth
infusion site:
- bruising
- reaction

post procedural
poisoning and hemorrhage

post procedural

incision site

Note: terms are coded with MedDRA dictionary version 8.1
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.

25 hours and 7 hours respectively,
after both subcutaneous and
intravenous administration are
independent of the dose. Steadystate 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.
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

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 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.

6.1  of Excipients

Orgaran® shows low cross-reactivity
(<10%) with the heparin induced
antibody. This can be explained by
the absence of heparin in Orgaran®
and its low degree of sulphation (see
section 4.4).

Nature and Contents of Container

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.

Sodium sulphite
Sodium chloride
Hydrochloric acid

Ph. Eur.
Ph. Eur.
Ph. Eur.
Ph. Eur.

6.2 Incompatibilities
When administered as an
intravenous bolus or infusion,
Orgaran® should be given separately
and not mixed with other drugs.
However, Orgaran® is compatible
with, and therefore can be added
to, infusions of saline, dextrose or
6.3 Shelf Life
3 years.
Special Precautions for Storage
Do not store above 30°C. Do not
freeze. Keep the ampoules in the
outer carton to protect from light.
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.
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
Date of First Authorisation/Renewal
of Authorisation
14 April 1993/09 October 1998
Date of revision of the text
February 2014

The half-lives of elimination of
anti-Xa and thrombin generation
inhibiting activities of approximately

•  kin rash
Uncommon side effects
(affect up to 1 in 100 people)
•  ruises and/or pain around
the injection site
•  llergic reaction to Orgaran.
This may cause sudden
wheeziness, difficulty in
breathing, swelling of eyelids,
face or lips, rash or itching
(especially affecting the whole
Rare side effects
(affect up to 1 in 1000 people)
• ncreased bleeding or swelling
containing blood at the
operation site (haematoma);
Very rare side effects
(affect up to 1 in 10000 people)
When Orgaran 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. ow to store Orgaran
Keep out of the reach and sight
of children.
Do not store above 30 °C.
Do not freeze.
Keep the ampoules in the outer
carton to protect from light.
Do not use Orgaran 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 Orgaran contains
Each 1ml glass ampoule
contains 750 anti-factor Xa
units (0.6ml) of the active
ingredient danaparoid sodium,
corresponding to 1250 antifactor Xa units per ml.
The other ingredients are:
Sodium sulphite, Sodium
chloride, Hydrochloric acid,
What Orgaran looks like and
contents of the pack
Orgaran comes in glass
ampoules. It is a solution for
injection. Each ampoule of

Orgaran contains 0.6ml of
medicine, and is available in
packs of 10 or 20 ampoules.
More about Orgaran
Orgaran contains a natural
substance, derived from pig
intestine, which prevents the
formation of blood clots in
blood vessels (thrombosis).
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
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 Orgaran to
prevent the formation of blood
Marketing Authorisation Holder
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
N.V. Organon,
Kloosterstraat 6,
Postbus 20, 5340 BH Oss,
The Netherlands
This leaflet was last updated in
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: Orgaran
Reference Number:
PL 39699/0057
This is a service provided by the
Royal National Institute for Blind

For Position Only

Pregnancy and Lactation
Orgaran 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 Orgaran was
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 anti-Xa activity, no
activity was found.
Although Orgaran® 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

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Further information

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