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GELASPAN SOLUTION FOR INFUSION

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343/NP34332/0714

SUMMARY OF PRODUCT CHARACTERISTICS

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B. Braun Melsungen AG · 34209 Melsungen, Germany

Gelaspan solution for infusion
1. NAME OF THE MEDICINAL PRODUCT
Gelaspan solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml solution contain:
Succinylated gelatine (= modified fluid gelatine)
40.0 g
(Molecular weight, weight average: 26 500 Dalton)
Sodium chloride
5.55 g
Sodium acetate trihydrate
3.27 g
Potassium chloride
0.30 g
Calcium chloride dihydrate
0.15 g
Magnesium chloride hexahydrate
0.20 g
Electrolyte concentrations
Sodium
151 mmol/l
Chloride
103 mmol/l
Potassium
4 mmol/l
Calcium
1 mmol/l
Magnesium
1 mmol/l
Acetate
24 mmol/l
Excipients:
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless or slightly yellowish solution
Theoretical osmolarity:
284 mosmol/l
pH:
7.4 ± 0.3
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Gelaspan is a colloidal plasma volume substitute in an isotonic, fully balanced electrolyte solution for:
• Prophylaxis and treatment of imminent or manifest relative or absolute hypovolaemia and shock
4.2 Posology and method of administration
Posology
Dosage and infusion rate are adjusted according to the amount of blood loss and to
individual needs for restoration and maintenance of a stable haemodynamic situation, respectively. The dose administered is initially 500 to 1000 ml on average, in
case of severe blood loss higher doses have to be applied.
Adults
In adults, 500 ml is administered at an appropriate rate depending on the haemodynamic status of the patient. In the case of more than 20 per cent blood loss usually blood or blood components should be given in addition to Gelaspan.
Paediatric population
The safety and efficacy of Gelaspan in children have not yet been completely established. Therefore, no recommendation on a posology can be made. Gelaspan should
only be administered to these patients if the expected benefits clearly outweigh
potential risks. In those cases the patient’s prevailing clinical condition should be
taken into account and the therapy should be monitored especially carefully. (See
also section 4.4.)
Maximum dose:
The maximum daily dose is determined by the degree of haemodilution. Care must
be taken to avoid a decrease of the haematocrit below critical values, see section
4.4.
If necessary, blood or packed red cells must be transfused additionally.
Attention must also be paid to the dilution of plasma proteins (e.g. albumin and
coagulation factors), which must be adequately substituted if necessary.
Infusion rate:
The infusion rate depends on the actual haemodynamic situation.
The first 20 – 30 ml of solution should be infused slowly in order to detect rare anaphylactoid reactions as early as possible. See also sections 4.4 and 4.8.
In shock situations, Gelaspan may be infused rapidly by pressure infusion, 500 ml
within 5 – 10 min.
Method of administration
Intravenous use
When given rapidly Gelaspan should be warmed to not more than 37°C if possible.
In case of pressure infusion, which might be necessary in vital emergencies, all air
must be removed from the container and the infusion set before the solution is
administered.
4.3 Contraindications
Gelaspan must not be used in the following situations:
• hypersensitivity to gelatine solutions or to any of the other ingredients of Gelaspan
• hypervolaemia
• hyperhydration
• hyperkalaemia

4.4 Special warnings and precautions for use
Gelaspan should be administered with caution to patients with a history of allergic
diseases, e.g. asthma.
Gelatine preparations for volume replacement may rarely cause allergic (anaphylactic/anaphylactoid) reactions of varying degrees of severity. In order to detect the
occurrence of an allergic reaction as early as possible, the first 20 – 30 ml should be
infused slowly and the patient should be under careful observation especially at the
beginning of the infusion. For symptoms of anaphylactoid reactions, see section 4.8.
In case of an allergic reaction, the infusion must be stopped immediately and appropriate treatment given.
Gelaspan should be administered only with caution to patients
• at risk due to circulatory overload e.g. patients with congestive heart failure, right
or left ventricular insufficiency, hypertension, pulmonary oedema or renal insufficiency with oligo- or anuria.
• with severely impaired renal function
• having oedema with water/salt retention
• with major blood coagulation disorders
Gelaspan must not be infused through the same infusion line together with blood or
blood products (packed cells, plasma and plasma fractions).
Checks of serum electrolyte concentrations and water balance are necessary, in particular in patients with hypernatraemia, hyperkalaemia or impairment of renal function.
The haemodynamic, haematological and coagulation system should be monitored.
During compensation of severe blood losses by infusions of large amounts of Gelaspan, haematocrit and electrolytes must be monitored. The haematocrit should not
decrease below 25 %. In elderly or critically ill patients it should not fall below 30%.
Likewise in those situations the dilution effect on coagulation factors should be
observed, especially in patients with existing disorders of haemostasis.
Because the product does not substitute lost plasma protein, it is advisable to check
the plasma protein concentrations, see also section 4.2, “Maximum dose”.
Paediatric population
There is no sufficient experience with the use of Gelaspan in children. Therefore
Gelaspan should only be administered to these patients if the expected benefits
clearly outweigh potential risks. (See also section 4.2)
Influence on laboratory tests
Laboratory blood tests (blood group or irregular antigens) are possible after Gelaspan infusions. Nevertheless it is recommended to draw blood samples before the
infusion of Gelaspan in order to avoid hampered interpretation of results.
Gelaspan may have an influence on the following clinical-chemical tests, leading to
falsely high values:
- erythrocyte sedimentation rate,
- specific gravity of urine,
- unspecific protein assays, e.g. the biuret method.
4.5 Interactions with other medicinal products and other forms of interaction
Caution should be exercised in patients concurrently taking or receiving medicinal
products that can cause potassium (e.g. potassium sparing diuretics, ACE inhibitors)
or sodium retention.
4.6 Fertility, pregnancy and lactation
Women of childbearing potential
No data available
Contraception in males and females
No data available
Pregnancy
There are no or limited amount of data from the use of Gelaspan in pregnant
women. Animal studies are insufficient with respect to reproductive toxicity (see
section 5.3).
Due to possible anaphylactoid reactions with consecutive foetal and neonatal distress due to maternal hypotension, the use of Gelaspan should be avoided during
pregnancy unless the clinical condition of the woman requires treatment with the
medicinal product.
Breastfeeding
There is insufficient information on the excretion of Gelaspan in human or animal
milk. A risk to the suckling child cannot be excluded. A decision must be made
whether to discontinue breast-feeding or to discontinue/abstain from Gelespan
therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data on the effect of Gelaspan on human or animal fertility.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
The only potentially serious adverse reactions are anaphylactoid reactions described
below. However, severe reactions are very rare.

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PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany

Gelaspan solution for infusion
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 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:

Pregnancy and breast-feeding

1. What Gelaspan is and what it is used for
2. Before you use Gelaspan
3. How to use Gelaspan
4. Possible side effects
5. How to store Gelaspan
6. Further information

Ask your doctor or pharmacist for advice before taking any medicine.
Your doctor will give you Gelaspan only if he thinks it is essential for you.

1. WHAT GELASPAN IS AND WHAT IT IS USED FOR

Driving and using machines
Gelaspan is normally given to immobile patients in a controlled setting (e.g.
emergency treatment, acute treatment in a hospital or a day therapy unit).
This will exclude driving and using machines.

3. HOW TO USE GELASPAN

Gelaspan is a so-called plasma volume substitute. This means that it
Gelaspan is given intravenously, i.e. by a drip.
replaces fluid lost from the circulation.
Gelaspan is used to replace blood and body fluid, which have been lost as Adults
a result of, for example, an operation, an accident or a burn.
How much you are given and for how long will depend on how much blood
or fluid you have lost and on your condition.

2. BEFORE YOU USE GELASPAN

Children:
There is only little experience of the use of Gelaspan in children. Your doc• if you are allergic (hypersensitive) to gelatine or any of the other ingre- tor will only administer this medicine to your child if he/she considers it
essential for your child’s recovery. In those cases the clinical condition of
dients of Gelaspan
your child will be taken into account and his/her therapy will be monitored
• if your blood volume is too high
especially carefully The doctor will carry out tests (on blood and blood
• if you have too much water in your body
pressure, for example) during treatment, and the dose of Gelaspan will be
• if you have an abnormally high blood potassium level.
adjusted according to the patients needs.
Special care will be taken with Gelaspan
In case of pressure infusion, all air must be removed from the container
if you suffer from:
and the infusion set before the solution is administered.
• heart problems
If you received more Gelaspan than you should
• high blood pressure
An overdose of Gelaspan may cause too high blood volume (hyper• water on your lungs
volaemia), circulatory overload and imbalances of your blood composition.
• severe kidney problems
Giving large amounts of liquids through an intravenous drip may worsen You may notice the following symptoms:
your condition.
• impairment of heart-and lung function
• headache, difficulties to breathe, congestion of blood in the jugular vein
Your doctor will also exercise caution
If an overdose occurred your doctor will give you any necessary treatment.
• if your blood clotting is severely impaired
• if you retain water and salt, which may be associated with tissue If you have any further questions on the use of this product, ask your doctor or pharmacist.
swelling.

Do not use Gelaspan

Children:
There is only little experience regarding the use of Gelaspan in children. So
the doctor will only administer this medicine to your child when he/she
thinks that it is absolutely necessary.
All plasma substitutes carry a slight risk of allergic reactions that are mostly mild or moderate but can in very few cases also become severe. Such
reactions are assumed to be more frequent in patients with known allergic
conditions such as asthma. For that reason you will be under close observation by a health professional, especially at the beginning of the infusion.
While receiving Gelaspan, your blood composition will be monitored.

4. POSSIBLE SIDE EFFECTS

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Like all medicines, Gelaspan can cause side effects, although not everybody
gets them.
In this section, side effects are ranked according to their frequency using
the following terms:
very common: affecting more than 1 treated patient of 10
common:
affecting 1 to 10 treated patients of 100
uncommon:
affecting 1 to 10 treated patients of 1,000
rare:
affecting 1 to 10 treated patients of 10,000
very rare:
affecting less than 1 treated patient of 10,000
Taking or using other medicines
cannot be estimated from the available data
Please tell your doctor or pharmacist if you are taking or using or have not known:
recently taken or used any other medicines, including medicines obtained The following side effects may become serious and require
without a prescription.
immediate medical treatment:
In particular your doctor should know if you are taking or receiving mediRare:
cines that make you retain sodium or potassium (e.g. spironolactone, tri• allergic skin reactions such as hives or nettle rash
amterene, amiloride; ACE-inhibitors like captopril or enalapril), such as
• other allergic (anaphylactoid) reactions, including e.g. difficulty breathcertain water tablets or cortisones.
ing, wheeze, nausea, vomiting, dizziness, sweating, chest or throat tightness, stomach ache, swelling of neck and face

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Uncommon
(≥ 1/1,000 to
< 1/100)
Immune system
disorders
Cardiac disorders
Vascular disorders
Respiratory, thoracic
and mediastinal
disorders
Skin and subcutaneous tissue disorders
General disorders
Mild transient
and administration
increase of body
site conditions
temperature

Rare
(≥ 1/10,000 to
< 1/1,000)
Anaphylactoid
reactions, all grades*

Very rare
(< 1/10,000)
Severe anaphylactoid reactions*
Tachycardia
Hypotension
Respiratory
difficulties

Allergic skin
reactions*
Fever, chills

*
Mild anaphylactoid reactions include:
Generalised oedema, urticaria, periorbital oedema, or angiooedema.
Moderate anaphylactoid reactions include:
Dyspnoea, stridor, wheeze, urticaria, nausea, vomiting, dizziness (presyncope),
diaphoresis, chest or throat tightness, or abdominal pain.
Severe anaphylactoid reactions include:
Cyanosis or SaO2 ≤ 92% at any stage, hypotension
(systolic blood pressure < 90 mmHg in adults), confusion, collapse, loss of consciousness or incontinence.
In the event of an anaphylactoid reaction, the infusion must be discontinued immediately and the usual acute treatment given.
Paediatric patients:
No special features
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product
is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse
reactions via the following:
United Kingdom
- Yellow card scheme:
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie;
e-mail: medsafety@hpra.ie
4.9 Overdose
Symptoms
Overdose of Gelaspan may cause hypervolaemia and circulatory overload with a significant fall in haematocrit and plasma proteins. This may be associated with consecutive impairment of heart and lung function (pulmonary oedema). Symptoms of
circulatory overload are e.g. headache, dyspnoea, and jugular vein congestion.
Treatment
In case of circulatory overload the infusion must be stopped and a rapid-acting
diuretic should be given. If an overdose occurs, the patient should be treated symptomatically and electrolytes should be monitored.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmaco-therapeutic group
Blood substitutes and plasma protein fractions
ATC code: B05A A06, gelatine agents.
Gelaspan is a 4 % w/v solution of succinylated gelatine (also known as modified
fluid gelatine) with an average molecular weight of 26 500 Dalton (weight average)
in a plasma–adapted, balanced isotonic electrolyte solution. The negative charges
introduced into the molecule by succinylation cause an expansion of the molecule.
The molecular volume is therefore higher than that of unsuccinylated gelatine of the
same molecular weight.
The measured initial volume effect of Gelaspan is about 100% of the infused volume with a sufficient volume effect over 4 – 5 hours.
Gelaspan does not interfere with the determination of blood groups and it is neutral regarding clotting mechanisms.
Therapeutic effect
Gelaspan substitutes intra- and extravascular volume deficits caused by losses of
blood, plasma and interstitial fluid. Thus the mean arterial pressure, the left-ventricular end-diastolic pressure, the cardiac stroke volume, the cardiac index, the oxygen supply, the microcirculation and the diuresis are increased without dehydrating
the extravascular space.
Mechanisms of action
The colloid-osmotic pressure of the solution determines its initial volume effect.
The duration of the effect depends on the clearance of the colloid mainly by renal
excretion. Since the volume effect of Gelaspan is equivalent to the administered
amount of solution, Gelaspan is a plasma substitute, not a plasma expander.

The solution also restores the extravascular compartment, does not disturb the electrolyte balance of the extracellular space. Gelaspan is isotonic, it therefore does not
cause fluid shifts into the intracellular space as caused by hypotonic solutions.
Gelaspan contributes in the restoration of electrolyte balance and the correction of
acidosis. Gelaspan is lactate free and can be used in patients with liver diseases. As
a precursor of bicarbonate the solution contains acetate which is metabolisable in
all organs and muscles.
5.2 Pharmacokinetic properties
Distribution
After infusion, Gelaspan is rapidly distributed in the intravascular compartment.
There is no evidence that Gelaspan is stored in the reticulo-endothelial system or
elsewhere in the organism.
Metabolism/elimination
Most of the infused Gelaspan is excreted via the kidneys. Only a minor amount is
excreted in faeces and not more than about 1 % is metabolised. The smaller molecules are excreted directly by glomerular filtration while the larger molecules first
are degraded proteolytically and then excreted via kidneys. The proteolytic metabolism is so adaptable that even under the condition of renal insufficiency no accumulation of Gelaspan is observed.
Pharmacokinetics in special clinical situations
The plasma half-life of Gelaspan may be prolonged in patients on haemodialysis
(GFR < 0.5 ml/min). Gelaspan minimizes the risks of dilutional acidosis and rebound
alkalosis as observed with lactate containing solutions infused to patients with liver
diseases. Gelaspan contains acetate and is lactate free. It therefore can also be indicated in hypovolaemic patients with liver disease.
5.3 Preclinical safety data
Non-clinical data for the individual components of Gelaspan reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity.
There is no or limited non-clinical data available for reproductive toxicity.
The maximum dose of the product is limited by its volume and dilution effects, not
by any intrinsic toxicological properties.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium hydroxide (for pH adjustment),
Hydrochloric acid, diluted (for pH-adjustment),
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed
with other medicinal products.
6.3 Shelf life
• Unopened
Polyethylene containers “Ecoflac plus”: 2 years
Plastic bags “Ecobag” (non-PVC): 2 years
• After first opening the container
The infusion should commence immediately after connecting the container to the
giving set.
• After admixture of an additive
Not applicable (see section 6.2)
6.4 Special precautions for storage
Do not store above 25 °C. Do not freeze.
6.5 Nature and contents of container
Gelaspan is supplied in:
• Bottles of low-density polyethylene “Ecoflac plus”, contents: 500 ml
available in packs of 10 × 500 ml
• Plastic bags “Ecobag” (non-PVC), sealed with halogenbutyl rubber stoppers contents: 500 ml
available in packs of 20 × 500 ml
Not all pack sizes may be marketed
6.6 Special precautions for disposal and other handling
No special requirements for disposal
The product is supplied in containers for single use only. Unused contents of an
opened container must be discarded.
Only to be used if solution is clear and free of precipitate and the container undamaged.
Use immediately after connecting container to the giving set.
7. MARKETING AUTHORISATION HOLDER
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Postal address
34209 Melsungen
8. MARKETING AUTHORISATION NUMBER(S)
PA 736/34/1 (Ireland)
PL 03551/0120 (United Kingdom)
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
9th September 2011 (Ireland)
14th June 2011 (UK)
10. DATE OF REVISION OF THE TEXT
June 2014

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B. Braun Melsungen AG
34209 Melsungen, Germany

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If an allergic reaction, especially an anaphylactoid reaction occurs your 6. FURTHER INFORMATION
infusion will be stopped immediately and you will be given any necessary
What Gelaspan contains
treatment.
Active substances:
Very rare:
1000 ml of the solution contain:
• quickening of heartbeat
Succinylated (modified fluid) gelatine
40.0 g
• severe allergic (anaphylactoid) reactions such as drop of blood pressure,
Sodium chloride
5.55 g
confusion, involuntary excretion of urine, blue coloration of the skin and
Sodium acetate trihydrate
3.27 g
mucous membranes (so-called cyanosis) and extremely rare cases of loss
Potassium chloride
0.30 g
of consciousness and collapse.
Calcium chloride dihydrate
0.15 g
Such reactions are assumed to be more frequent in patients with known Magnesium chloride hexahydrate
0.20 g
allergic conditions such as asthma.
Electrolyte concentrations
Unfortunately, there is no test which can show in advance who is likely to
Sodium
151 mmol/l
experience such reactions, nor can their course be predicted.
Chloride
103 mmol/l
Potassium
4 mmol/l
Other side effects include:
Calcium
1 mmol/l
Uncommon:
Magnesium
1 mmol/l
• mild short lasting increase of body temperature
Acetate
24 mmol/l
Very rare:
The other ingredients are:
• fever, chills
Water for injections, hydrochloric acid, diluted (for pH-adjustment) and
If any of the side effects gets serious, or if you notice any side effects not
sodium hydroxide (for pH adjustment).
listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie;
e-mail: medsafety@hpra.ie

What Gelaspan looks like and contents of the pack
Gelaspan is a solution for infusion administered through an intravenous
drip (a drip into a vein).
It is a clear colourless or slightly yellowish sterile solution.
Gelaspan is supplied in:
• Bottles of low-density polyethylene “Ecoflac plus”, contents: 500 ml
available in packs of 10 × 500 ml
• Plastic bags “Ecobag” (non-PVC), sealed with rubber stoppers, contents:
500 ml
available in packs of 20 × 500 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder

B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
5. HOW TO STORE GELASPAN
Postal address
Keep out of the reach and sight of children.
Do not use Gelaspan after the expiry date which is stated on the label and 34209 Melsungen
the outer carton. The expiry date refers to the last day of that month.
Manufacturer
Do not store above 25 °C. Do not freeze.
B. Braun Melsungen AG
Carl-Braun-Straße 1
Do not use Gelaspan if you notice:
34212 Melsungen, Germany
• cloudiness or discolouration of the solution
Postal address
• leaking of the container.
Previously opened or partly used Gelaspan should be thrown away. Partial- 34209 Melsungen
Phone: +49-5661-71-0
ly used bottles or bags should not be reconnected.
Fay: +49-5661-4567

This leaflet was last approved in June 2014.

The following information is intended for health-care profes- Influence on laboratory tests
Laboratory blood tests (blood group or irregular antigens) are possible after
sionals only:
Gelaspan infusions. Nevertheless it is recommended to draw blood samples
before the infusion of Gelaspan in order to avoid hampered interpretation
of results.
Gelaspan may have an influence on the following clinical-chemical tests,
leading to falsely high values:
- erythrocyte sedimentation rate,
- specific gravity of urine,
- unspecific protein assays, e.g. the Biuret method.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be
mixed with other medicinal products.

B|BRAUN

Schwarz
210x700 mm
343/NP34332/0714
Lätus: 7385
Großbritannien/Irland
Font size 8 SPC; 9 PIL

B. Braun Melsungen AG
34209 Melsungen
Germany

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Precautions for use
Gelaspan must not be infused through the same infusion line together with
blood or blood products (packed cells, plasma and plasma fractions).
During compensation of severe blood losses by infusions of large amounts
of Gelaspan, haematocrit and electrolytes must be monitored. The haematocrit should not decrease below 25 %. In elderly or critically ill patients it
should not fall below 30%.
Likewise in those situations the dilution effect on coagulation factors
should be observed, especially in patients with existing disorders of
haemostasis.
Because the product does not substitute lost plasma protein, it is advisable
to check the plasma protein concentrations.

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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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