SOLU-MEDRONE 2 GRAM

Active substance: METHYLPREDNISOLONE SODIUM SUCCINATE

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The following information is intended for healthcare professionals only:

methylprednisolone sodium succinate

RECTO

Solu-Medrone® 2 gram

8R2176
442

Posology and method of administration

For further information consult the SPC (Summary of Product
Characteristics).
Solu-Medrone may be administered intravenously or
intramuscularly, the preferred method for emergency use being
intravenous injection given over a suitable time interval. When
administering Solu-Medrone in high doses intravenously, it
should be given over a period of at least 30 minutes. Doses up to
250 mg should be given intravenously over a period of at least five
minutes. For intravenous infusion the initially prepared solution
may be diluted with 5% dextrose in water, isotonic saline solution,
or 5% dextrose in isotonic saline solution. To avoid compatibility
problems with other drugs, Solu-Medrone should be administered
separately, only in the solutions mentioned.
Undesirable effects may be minimised by using the lowest
effective dose for the minimum period (see Special warnings and
special precautions for use section of the SPC).
Parenteral drug products should wherever possible be visually
inspected for particulate matter and discoloration prior to
administration.
Adults: Dosage should be varied according to the severity of the
condition, initial dosage will vary from 10 to 500 mg. In the
treatment of graft rejection reactions following transplantation, a
dose of up to 1 g/day may be required. Although doses and
protocols have varied in studies using methylprednisolone sodium
succinate in the treatment of graft rejection reactions, the
published literature supports the use of doses of this level, with
500 mg to 1 g most commonly used for acute rejection. Treatment
at these doses should be limited to a 48-72 hour period until the
patient’s condition has stabilised, as prolonged high dose

corticosteroid therapy can cause serious corticosteroid induced
side effects (see Undesirable effects and Special warnings and
special precautions for use sections of the SPC).
Children: In the treatment of high dose indications, such as
haematological, rheumatic, renal and dermatological conditions, a
dosage of 30 mg/kg/day to a maximum of 1 g/day is
recommended. This dosage may be repeated for three pulses
either daily or on alternate days. In the treatment of graft rejection
reactions following transplantation, a dosage of 10 to
20 mg/kg/day for up to 3 days, to a maximum of 1 g/day, is
recommended. In the treatment of status asthmaticus, a dosage of
1 to 4 mg/kg/day for 1-3 days is recommended.
Solu-Medrone is NOT RECOMMENDED for use in spinal cord
injury in children.
Elderly patients: Solu-Medrone is primarily used in acute
short-term conditions. There is no information to suggest that a
change in dosage is warranted in the elderly. However, treatment of
elderly patients should be planned bearing in mind the more
serious consequences of the common side effects of corticosteroids
in old age and close clinical supervision is required (see Special
warnings and special precautions for use section of the SPC).
Detailed recommendations for adult dosage are as follows:
In anaphylactic reactions adrenaline or noradrenaline should
be administered first for an immediate haemodynamic effect,
followed by intravenous injection of Solu-Medrone
(methylprednisolone sodium succinate) with other accepted
procedures. There is evidence that corticosteroids through their
prolonged haemodynamic effect are of value in preventing
recurrent attacks of acute anaphylactic reactions.
Continued overleaf...

Package leaflet: Information for the patient

Solu-Medrone® 2 gram
methylprednisolone sodium succinate

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you
• Keep this leaflet. You may need to read it again
• If you have any further questions please 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 signs of illness are the
same as yours
• If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What Solu-Medrone is and what it is used for
2. What you need to know before you are given Solu-Medrone
3. How Solu-Medrone is given to you
4. Possible side effects
5. How to Store Solu-Medrone
6. Contents of the pack and other information

1. What Solu-Medrone is and what it is
used for

Solu-Medrone contains Methylprednisolone Sodium Succinate.
Methylprednisolone belongs to a group of medicines called
corticosteroids (steroids). Corticosteroids are produced naturally in
your body and are important for many body functions.
Boosting your body with extra corticosteroid such as Solu-Medrone
can help following surgery (e.g. organ transplants), immediately
following severe spinal injuries or other stressful conditions.
These include inflammatory or allergic conditions affecting the:
• brain caused by a tumour or meningitis
• bowel and gut e.g. ‘Crohn’s disease’ and ‘ulcerative colitis’
• lungs caused by asthma, severe allergy or hypersensitivity,
tuberculosis or breathing in (aspirating) vomit or stomach contents.
• skin e.g. Stevens-Johnson Syndrome.
Solu-Medrone may be prescribed to treat conditions other than
those listed above.
Ask your doctor if you are unsure why you have been given this
medicine.

2. What you need to know before you are
given Solu-Medrone
Do not use Solu-Medrone if:

• You think you have ever suffered an allergic reaction, or any
other type of reaction after being given Solu-Medrone, or any
other medicine containing a corticosteroid, or any of the
ingredients in this medicine (Section 6 of this leaflet contains a
list of ingredients). An allergic reaction may cause a skin rash or
reddening, swollen face or lips or shortness of breath.
• You have any fungal infection (such as thrush) which is not
being treated.
• You are suffering from, or receiving treatment for malaria.
• You have recently had, or are about to have any vaccination.
• You are suffering from a head injury or stroke.
See your doctor immediately if any of the above applies to
you.

Warnings and precautions:

You must tell your doctor before you take this medicine if you have
any of the following conditions.
Your doctor may have to monitor your treatment more closely, alter
your dose or give you another medicine.
• Chickenpox, measles, shingles or a herpes eye infection. If
you think you have been in contact with someone with
chickenpox, measles or shingles and you have not already had
these illnesses, or if you are unsure if you have had them.
• Worm infestation (e.g. threadworm).
• Severe depression or manic depression (bipolar disorder).
This includes having had depression before while taking steroid
medicines like Solu-Medrone, or having a family history of these
illnesses.
• Diabetes (or if there is a family history of diabetes).
• Epilepsy, fits or seizures.
• Glaucoma (increased pressure in the eye) or if there is a family
history of glaucoma.
• Heart problems, including a recent heart attack, heart failure or
infections.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Joint infection - which is active and so requires treatment.
• Kaposi’s sarcoma (a type of skin cancer).
• Kidney or liver disease.
• Muscle problems (pain or weakness) have happened while
taking steroid medicines in the past.
• Myasthenia gravis (a condition causing tired and weak muscles).
• Osteoporosis (brittle bones).
• Skin abscess.
• Stomach ulcer, diverticulitis (inflammation of the bowel wall)
or other serious stomach or intestinal problems.
• Thrombophlebitis - vein problems due to thrombosis (clots in
the veins) resulting in phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered tuberculosis in the past.
• Unusual stress.
• Cushing’s disease (condition caused by an excess of cortisol
hormone in your body).
• Acute pancreatitis (inflammation of the pancreas).
You must tell your doctor before you take this medicine if you have
any of the conditions listed above.

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Other medicines and Solu-Medrone

Always tell your doctor or pharmacist if you are taking any
medicines (including any you have bought without a prescription)
as taking Solu-Medrone with other medicines could be harmful.
You should tell your doctor if you are taking any of the following
medicines which can affect the way Solu-Medrone or the other
medicine works:
• Acetazolamide - used to treat glaucoma and epilepsy.
• Aminoglutethimide or Cyclophosphamide - used for
treating cancer.
• Anticoagulants - used to ‘thin’ the blood such as
acenocoumarol, phenindione and warfarin.
• Anticholinesterases - used to treat myasthenia gravis (a
muscle condition) such as distigmine and neostigmine.

• Antibiotics (such as erythromycin, clarithromycin or troleandomycin).
• Antidiabetics – medicines used to treat high blood sugar.
• Antihypertensives – medicines used to lower blood pressure.
• Aprepitant and Fosaprepitant – used to prevent nausea and
vomiting.
• Aspirin and non-steroidal anti-inflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat mild to moderate pain.
• Barbiturates, carbamazepine, phenytoin and primidone used to treat epilepsy.
• Carbenoxolone and cimetidine - used for heartburn and acid
indigestion.
• Ciclosporin - used to treat conditions such as severe
rheumatoid arthritis, severe psoriasis or following an organ or
bone marrow transplant.
• Digoxin - used for heart failure and/or an irregular heart beat.
• Diltiazem or mibefradil – used for heart problems or high
blood pressure.
• Ethinylestradiol and norethisterone – an oral contraceptive.
• Indinavir and Ritonavir - used to treat HIV infections.
• Isoniazid - used to treat bacterial infections.
• Ketoconazole or itraconazole - used to treat fungal infections.
• Mifepristone – used for the medical termination of a pregnancy.
• Pancuronium or vercuronium - or other medicines called
neuromuscular blocking agents which are used in some surgical
procedures.
• Potassium depleting agents – such as diuretics (sometimes
called water tablets), amphotericin B, xanthenes or beta2
agonists (e.g. medicines used to treat asthma).
• Rifampicin and rifabutin - antibiotics used to treat
tuberculosis (TB).
• Tacrolimus – used following an organ transplant to prevent
rejection of the organ.
• Vaccines - tell your doctor or nurse if you have recently had, or
are about to have any vaccination. You should not have ‘live’
vaccines while using this medicine. Other vaccines may be less
effective.

If you are taking long term medication(s)

If you are being treated for diabetes, high blood pressure or water
retention (oedema) tell your doctor as he/she may need to adjust the
dose of the medicines used to treat these conditions.
Before you have any operation tell your doctor, dentist or
anesthetist that you are taking Solu-Medrone.
If you require a test to be carried out by your doctor or in
hospital it is important that you tell the doctor or nurse that you are
taking Solu-Medrone. This medicine can affect the results of some tests.

Pregnancy and breast-feeding

You must tell your doctor if you are pregnant, think you might be
pregnant or are trying to become pregnant as this medicine could
slow the baby’s growth.
Cataracts have been observed in infants born to mothers undergoing
long-term treatment with corticosteroids during pregnancy.
Tell your doctor if you are breast-feeding as small amounts of
corticosteroid medicines may get into breast milk.

Driving and using machines

Undesirable effects, such as dizziness, vertigo, visual disturbances
and fatigue are possible after treatment with corticosteroids. If you
are affected do not drive or operate machinery.

3. How Solu-Medrone is given to you
Steroid Cards

Remember to always carry a Steroid Treatment Card.
Make sure your doctor or pharmacist has filled out the
details of your medicine, including the dose and how long
you will require steroid treatment.
You should show your steroid card to anyone who gives you
treatment (such as a doctor, nurse or dentist) while you are taking
this medicine, and for 3 months after your last injection.
If you are admitted to hospital for any reason always tell your doctor
or nurse that you are taking Solu-Medrone. You can also wear a
medic-alert bracelet or pendant to let medical staff know that you are
taking a steroid if you have an accident or become unconscious.

Dosage information:

Your doctor will decide on the site of the injection, how much of the
medicine and how many injections you will receive depending on
the condition being treated and its severity. Your doctor will inject
you with the lowest dose for the shortest possible time to get
effective relief of your symptoms.

Adults

Solu-Medrone will be given as an injection by your doctor or nurse,
either into a vein (intravenous) or into a muscle (intramuscular).
Usually the first dose is given into a vein, especially in an
emergency.
It will be given slowly over at least 5 minutes. For larger doses this
may take 30 minutes or more. Large doses should normally be used
for only two to three days.
The medicine is first dissolved in Sterile Water for Injections. If the
medicine is to be given by infusion (using a pump or drip) it is then
mixed with another suitable fluid. No other medicines should be
mixed with it.

Elderly

Treatment will normally be the same as for younger adults. However
your doctor may want to see you more regularly to check how you
are getting on with this medicine.

Children

Corticosteroids can affect growth in children so your doctor will
prescribe the lowest dose that will be effective for your child. This
medicine is not recommended for use in treating spinal cord injuries
in children.
Do not drink grapefruit juice while being treated with Solu-Medrone.

If you are given more Solu-Medrone than you should
If you think you have been given too many injections of
Solu-Medrone please speak to your doctor immediately.

Stopping/reducing the dose of your Solu-Medrone

Your doctor will decide when it is time to stop your treatment.
You will need to come off this treatment slowly if you:
• have had repeated doses of corticisteroids for more than
3 weeks;
Continued overleaf...

VERSO

In sensitivity reactions Solu-Medrone is capable of providing
relief within one half to two hours. In patients with status
asthmaticus, Solu-Medrone may be given at a dose of 40 mg
intravenously, repeated as dictated by patient response. In some
asthmatic patients it may be advantageous to administer by slow
intravenous drip over a period of hours.
In graft rejection reactions following transplantation doses of
up to 1 g per day have been used to suppress rejection crises,
with doses of 500 mg to 1 g most commonly used for acute
rejection. Treatment should be continued only until the patient’s
condition has stabilised; usually not beyond 48-72 hours.
In cerebral oedema corticosteroids are used to reduce or
prevent the cerebral oedema associated with brain tumours
(primary or metastatic).
In patients with oedema due to tumour, tapering the dose of
corticosteroid appears to be important in order to avoid a rebound
increase in intracranial pressure. If brain swelling does occur as
the dose is reduced (intracranial bleeding having been ruled out),
restart larger and more frequent doses parenterally. Patients with
certain malignancies may need to remain on oral corticosteroid
therapy for months or even life. Similar or higher doses may be
helpful to control oedema during radiation therapy.
The following are suggested dosage schedules for oedemas due to
brain tumour.
Schedule A (1) Dose (mg)
Pre-operative: 20
During Surgery: 20 to 40
Post-operative: 20
16
12
8
4
4
4

Route
IM
IV
IM
IM
IM
IM
IM
IM
IM

Schedule B (2) Dose (mg)

Route

Pre-operative: 40
Post-operative: 40
20
12
8
4
4

IM
IM
Oral
Oral
Oral
Oral
Oral

Interval
in hours
3-6
hourly
3
3
3
3
3
6
12
Interval
in hours
6
6
6
6
8
12

Duration

45 minute pause, and then a continuous infusion of 5.4 mg/kg per
hour for 23 hours.
There should be a separate intravenous site for the infusion pump.
The treatment should begin within eight hours of injury.
In other indications, initial dosage will vary from 10 to 500 mg
depending on the clinical problem being treated. Larger doses
may be required for short-term management of severe, acute
conditions. The inital dose, up to 250 mg, should be given
intravenously over a period of at least 5 minutes, doses exceeding
250 mg should be given intravenously over a period of at least
30 minutes. Subsequent doses may be given intravenously or
intramuscularly at intervals dictated by the patient’s response and
clinical condition. Corticosteroid therapy is an adjunct to, and not
replacement for, conventional therapy.
Shelf-life
The shelf-life is printed on labels and cartons. Do not use
Solu-Medrone after this date. After reconstitution with Sterile
Water for Injections, use immediately, discard any remainder.
Storage of the product
Store below 25°C. Refer to Posology and method of
administration section above. No diluents other than those referred
to are recommended. Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to
administration.
Ref: SM 6_6

24 hours
24 hours
24 hours
24 hours
24 hours
24 hours
24 hours
Days
Duration
2-3
3-5
1
1
1
1
1

Aim to discontinue therapy after a total of 10 days.
For treatment of acute spinal cord injury, administer
intravenously 30 mg methylprednisolone per kilogram of body
weight in a bolus dose over a 15 minute period, followed by a

• have been given high doses of Solu-Medrone, over 32 mg daily,
even if it was only for 3 weeks or less;
• have already had a course of corticosteroid tablets or injections in
the last year;
• already had problems with your adrenal glands (adrenocortical
insufficiency) before you started this treatment.
You will need to come off this medicine slowly to avoid
withdrawal symptoms. These symptoms may include itchy skin,
fever, muscle and joint pains, runny nose, sticky eyes, sweating and
weight loss.
If your symptoms seem to return or get worse as your dose of this
medicine is reduced tell your doctor immediately.
Mental problems while taking Solu-Medrone
Mental health problems can happen while taking steroids like
Solu-Medrone (see also section 4, Possible Side Effects).
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the
medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the
medicine is stopped. However if the problems do happen they
might need treatment.
Talk to a doctor if you (or someone using this medicine) shows any
signs of mental problems. This is particularly important if you are
depressed, or might be thinking about suicide. In a few cases mental
problems have happened when doses are being lowered or stopped.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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4. Possible side effects

Like all medicines this medicine can cause side effects, although not
everybody gets them. Your doctor will have given you this medicine
for a condition which if not treated properly could become serious.
In certain medical conditions medicines like Solu-Medrone
(steroids) should not be stopped abruptly. If you suffer from
any of the following symptoms seek IMMEDIATE medical
attention. Your doctor will then decide whether you should
continue taking your medicine:
• Allergic reactions, such as skin rash, swelling of the face or
wheezing and difficulty breathing. This type of side effect is rare,
but can be serious.
• Pancreatitis, stomach pain spreading to your back, possibly
accompanied by vomiting, shock and loss of consciousness.
• Burst or bleeding ulcers, symptoms of which are stomach
pain (especially if it seems to spread to your back), bleeding from
the back passage, black or bloodstained stools and/or vomiting
blood.
• Infections. This medicine can hide or change the signs and
symptoms of some infections, or reduce your resistance to the
infection, so that they are hard to diagnose at an early stage.
Symptoms might include a raised temperature and feeling unwell.
Symptoms of a flare up of a previous TB infection could be
coughing blood or pain in the chest. Symptoms of a previous
malaria infection could involve chills and fever. Solu-Medrone
may also make you more likely to develop a severe infection.
• Pulmonary embolus (blood clots in the lung), symptoms
include sudden sharp chest pain, breathlessness and coughing
up blood.
• Raised pressure within the skull of children (pseudotumour
cerebri) symptoms of which are headaches with vomiting, lack of
energy and drowsiness. This side effect usually occurs after
treatment is stopped.
• Thrombophlebitis (blood clots or thrombosis in a leg vein),
symptoms of which include painful swollen, red and tender veins.
If you experience any of the following side effects, or
notice any other unusual effects not mentioned in this
leaflet, tell your doctor straight away.
The side effects may occur with certain frequencies, which are
defined as follows:
• common: affects 1 to 10 users in 100
• not known: frequency cannot be estimated from the available data.
Blood, heart and circulation
common
• High blood pressure, symptoms of which are headaches, or
generally feeling unwell.
not known
• Problems with the pumping of your heart (heart failure)
symptoms of which are swollen ankles, difficulty in breathing and
palpitations (awareness of heart beat) or irregular beating of the
heart, irregular or very fast or slow pulse.
• Low blood pressure, symptoms may include dizziness, fainting,
lightheadedness, blurred vision, a rapid, or irregular heartbeat
(palpitations), general weakness.
• Increased numbers of white blood cells (leucocytosis).
Body water and salts
common
• Swelling and high blood pressure, caused by increased levels of
water and salt content.
not known
• Cramps and spasms, due to the loss of potassium from your
body. In rare cases this can lead to congestive heart failure (when
the heart cannot pump properly).
Digestive system
common
• Ulcers
not known
• Nausea (feeling sick) or vomiting (being sick).
• Diarrhoea.
• Thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Bloated stomach.
• Abdominal pain.
• Hiccups.
Ears
not known
• A feeling of dizziness or spinning (vertigo).
Eyes
common
• Cataracts (indicated by failing eyesight).
not known
• Glaucoma (raised pressure within the eye, causing pain in the
eyes and headaches).
• Swollen optic nerve (papilloedema, indicated by sight disturbance).
• Thinning of the clear part at the front of the eye (cornea) or of the
white part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).

General disorders
common
• Poor wound healing.
not known
• Feeling tired or unwell.
• Skin reactions at the site of injection.
Hormones and metabolic system
common
• Slowing of normal growth in infants, children and adolescents
which may be permanent.
• Round or moon-shaped face (Cushingoid facies).
not known
• Irregular or no periods in women.
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of some hormones
which in turn can cause low blood pressure and dizziness. This
effect may persist for months.
• The amount of certain chemicals (enzymes) called alanine
transaminase, aspartate transaminase and alkaline phosphatase
that help the body digest drugs and other substances in your
body may be raised after treatment with a corticosteroid. The
change is usually small and the enzyme levels return to normal
after your medicine has cleared naturally from your system. You
will not notice any symptoms if this happens, but it will show up
if you have a blood test.
Immune system
common
• Increased susceptibility to infections.
not known
• Suppression of reactions to skin tests, such as that for
tuberculosis.
Muscles and bones
common
• Brittle bones (that break easily).
• Muscle weakness.
not known
• Muscle wasting.
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood, this causes
pain in the hip.
• Torn muscle tendons causing pain and/or swelling.
• Muscle cramps or spasms.
Nerves and mood issues
common
Steroids including methylprednisolone can cause serious mental
health problems.
These are common in both adults and children. They can affect
about 5 in every 100 people taking medicines like
methylprednisolone.
• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking
or being confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having
strange and frightening thoughts, changing how you act or having
feelings of being alone.
Skin
common
• Acne.
• Bruising.
• Thinning of skin (skin atrophy).
not known
• Stretch marks (skin striae).
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised patches which are
an unusual colour.
• Excessive growth of bodily and facial hair.
• Rash, itching, hives.
• Increased sweating.
If you experience any of the side effects listed above tell
your doctor straight away.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

5. How to store Solu-Medrone

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
label and carton after EXP. The expiry date refers to the last day of
that month.
This medicine must be stored below 25°C.
Once the medicine has been mixed with Sterile Water for Injections
the solution should be used straight away. Any unused liquid should
be disposed of safely.
Your doctor will check that the solution contains no particles and is
not discoloured before using it.

6. Contents of the pack and other
information
What Solu-Medrone contains

This medicine contains 2.652 g of Methylprednisolone Sodium
Succinate (equivalent to 2 g Methylprednisolone) as the active
ingredient.
Solu-Medrone also contains the inactive ingredients sodium
biphosphate and sodium phosphate.

What Solu-Medrone looks like and contents of the
pack

Solu-Medrone is a powder which comes in a clear glass vial fitted
with a rubber stopper. Each pack also contains a vial of Sterile Water
for Injections.

Marketing Authorisation Holder

Pharmacia Ltd., Ramsgate Road, Sandwich, Kent CT13 9NJ, UK.

Manufacturer

Pharmacia NV/SA, Rijksweg 12, B-2870, Puurs, Belgium.

Company contact address

For further information on your medicine contact Medical
Information at the following address:
Pfizer Limited, Walton Oaks,
Dorking Road, Tadworth, Surrey, KT20 7NS.
Tel: 01304 616161.
This leaflet was last revised in: Oct 2012.
Ref: SM 6_6
8R2176

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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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