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HUMULIN I KWIKPEN 100 IU/ML SUSPENSION FOR INJECTION

Active substance(s): HUMAN INSULIN

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Package leaflet: Information for the user

HUMULIN® I (Isophane) KwikPen™
100 IU/ml suspension for injection
(Insulin human)

Read all of this leaflet carefully before you start using 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, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Humulin I KwikPen is and what it is used for
2. What you need to know before you use Humulin I KwikPen
3. How to use Humulin I KwikPen
4. Possible side effects
5. How to store Humulin I KwikPen
6. Contents of the pack and other information

1. What Humulin I KwikPen is and what it is used for
Humulin I KwikPen is a pre-filled pen containing the active substance human
insulin, which is used to treat diabetes. You get diabetes if your pancreas does
not make enough insulin to control the level of glucose in your blood (blood
sugar). Humulin I is used to control glucose in the long term. Its action is
prolonged by the inclusion of protamine sulfate in the suspension.
Your doctor may tell you to use Humulin I KwikPen as well as a fast-acting
insulin. Each kind of insulin comes with its own patient information leaflet to
tell you about it. Do not change your insulin unless your doctor tells you to.
Be very careful if you do change insulin. Each type of insulin has a different
colour and symbol on the pack and the pen so that you can easily tell the difference.

2. What you need to know before you use Humulin I KwikPen
Do not use Humulin I KwikPen:
- If you think hypoglycaemia (low blood sugar) is starting. Further in this
leaflet it tells you how to deal with mild hypoglycaemia (see A in Section 4).
- If you are allergic to human insulin or any of the other ingredients of this
medicine (listed in section 6).









Pregnancy, breast-feeding and fertility

The amount of insulin you need usually falls during the first three months of
pregnancy and increases for the remaining six months. If you are breast-feeding,
you may need to alter your insulin intake or diet.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia
(low blood sugar). Please remember this in all situations where you might
put yourself and others at risk (e.g. driving a car or operating machinery).
You should contact your diabetes specialist nurse or doctor about the advisability
of driving if you have:
• frequent episodes of hypoglycaemia
• reduced or absent warning signs of hypoglycaemia.

3. How to use Humulin I KwikPen

Always check the pack and the label of the pre-filled pen for the name and
type of the insulin when you get it from your pharmacy. Make sure you get
the Humulin I KwikPen that your doctor has told you to use.
Always use this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure. To prevent the possible
transmission of disease, each pen must be used by you only, even if the needle
is changed.
Dosage





Other medicines and Humulin I KwikPen
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Your insulin needs may change if you are taking any of the following:
• steroids,
• thyroid hormone replacement therapy,
• oral hypoglycaemics (antidiabetic medication),
• acetylsalicylic acid (aspirin),

You should normally inject Humulin I as your basal insulin. Your doctor
has told you which insulin to use, how much, when and how often to inject.
These instructions are only for you. Follow them exactly and visit your
diabetes clinic regularly.
If you change your insulin type (for example from animal to human),
you may have to take more or less than before. This might just be for the
first injection or it may be a gradual change over several weeks or months.
Inject Humulin I under the skin. You should not administer it using a
different administration route. Under no circumstances should Humulin I
be given into a vein.

Preparing Humulin I KwikPen


Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Humulin I KwikPen.
• If your blood sugar levels are well controlled by your current insulin therapy,
you may not feel the warning symptoms when your blood sugar is falling too
low. Warning signs are listed later in this leaflet. You must think carefully
about when to have your meals, how often to exercise and how much to do.
You must also keep a close watch on your blood sugar levels by testing your
blood glucose often.
• A few people who have had hypoglycaemia (low blood sugar) after switching
from animal insulin to human insulin have reported that the early warning
symptoms were less obvious or different. If you often have hypoglycaemia
or have difficulty recognising the symptoms, please discuss this with your
doctor.
• If you answer YES to any of the following questions, tell your diabetes
specialist nurse, doctor or pharmacist.
- Have you recently become ill?
- Do you have trouble with your kidneys or liver?
- Are you exercising more than usual?
• The amount of insulin you need may also change if you drink alcohol.
• You should also tell your diabetes specialist nurse, doctor or pharmacist if
you are planning to go abroad. The time difference between countries may
mean that you have to have your injections and meals at different times to
when you are at home.
• Some patients with long-standing type 2 diabetes mellitus and heart disease or
previous stroke who were treated with pioglitazone and insulin experienced
the development of heart failure. Inform your doctor as soon as possible,
if you experience signs of heart failure such as unusual shortness of breath or
rapid increase in weight or localised swelling (oedema).

growth hormone,
octreotide, lanreotide,
beta2 stimulants (for example ritodrine, salbutamol or terbutaline),
beta-blockers,
thiazides or some antidepressants (monoamine oxidase inhibitors),
danazol,
some angiotensin converting (ACE) inhibitors (for example captopril,
enalapril) or angiotensin II receptor blockers

The KwikPen should be rotated in the palms of the hands 10 times and
inverted 10 times immediately before use to resuspend insulin until it appears
uniformly cloudy or milky. If not, repeat the above procedure until contents
are mixed. Cartridges in the pen contain a small glass bead to assist mixing.
Do not shake vigorously as this may cause frothing which may interfere with
the correct measurement of the dose. The cartridges in the pen should be
examined frequently and should not be used if clumps of material are present
or if solid white particles stick to the bottom or sides of the cartridge, giving
it a frosted appearance. Check each time you inject yourself.

Getting the KwikPen ready to use (Please see user manual)



First wash your hands.
Read the instructions on how to use your pre-filled insulin pen. Please follow
the instructions carefully. Here are some reminders.
- Use a clean needle. (Needles are not included).
- Prime your KwikPen before each use. This checks that insulin comes out
and clears the air bubbles from your KwikPen. There may still be some
small air bubbles left in the KwikPen - these are harmless, but if the air
bubble is too big, it may make the dose of your injection less accurate.

Injecting Humulin I


Before you make an injection, clean your skin as you have been instructed.
Inject under the skin, as you were taught. Do not inject directly into a vein.
After your injection, leave the needle in the skin for 5 seconds to make sure
you have taken the whole dose. Do not rub the area you have just injected.
Make sure you inject at least half an inch (1 cm) from where you last injected
and that you ‘rotate’ the places you inject, as you have been taught.

After injecting


As soon as you have done the injection, unscrew the needle from the
KwikPen using the outer needle cap. This will keep the insulin sterile and
prevent leaking. It will also stop air going back into the KwikPen and
the needle clogging up. Do not share your needles or your KwikPen.
Replace the cap on the KwikPen.

Further injections




Every time you use a KwikPen you must use a new needle. Before every
injection, clear any air bubbles. You can see how much insulin is left by
holding the KwikPen with the needle pointing down. The scale on the
cartridge shows about how many units you have left.
Do not mix any other insulin in your disposable pen. Once the KwikPen
is empty, do not use it again. Please get rid of it carefully - your diabetes
specialist nurse or pharmacist will tell you how to do this.

If you use more Humulin I than you should
If you use more Humulin I than you should, your blood sugar may become low.
Check your blood sugar (see A in Section 4).
If you forget to use Humulin I KwikPen
If you use less Humulin I than you should, your blood sugar levels may increase.
Check your blood sugar. Do not inject a double dose to make up for a forgotten
dose.
If you stop using Humulin I KwikPen
If you use less Humulin I than you should, your blood sugar levels may become
too high. Do not change your insulin unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Human insulin may cause hypoglycaemia (low blood sugar). See more
information on hypoglycaemia below in the subsection “Common problems
of diabetes”.
Possible side effects
Systemic allergy is very rare (affects less than 1 person in 10,000).
The symptoms are as follows:
• fall in blood pressure
• rash over the whole body
• difficulty in breathing
• wheezing
• fast heart beat
• sweating
If you think you are having this sort of insulin allergy with Humulin I, tell your
doctor at once.
Local allergy is common (affects less than 1 person in 10). Some people get
redness, swelling or itching around the area of the insulin injection. This usually
clears up in anything from a few days to a few weeks. If this happens to you,
tell your doctor.
Lipodystrophy (thickening or pitting of the skin) is uncommon (affects less than
1 person in 100). If you notice your skin thickening or pitting at the injection
site, change your injection site and tell your doctor.
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported,
particularly at the start of insulin therapy or during a change in therapy to
improve control of your blood glucose.
Common problems of diabetes
A. Hypoglycaemia
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood.
This can be caused if you:
• take too much Humulin I or other insulin;
• miss or delay meals or change your diet;
• exercise or work too hard just before or after a meal;
• have an infection or illness (especially diarrhoea or vomiting);
• have a change in your need for insulin; or
• have trouble with your kidneys or liver which gets worse.
Alcohol and some medicines can affect your blood sugar levels.
The first symptoms of low blood sugar usually come on quickly and include the
following:
• tiredness
• rapid heartbeat
• nervousness or shakiness
• feeling sick
• headache
• cold sweat
Until you become confident in recognising your warning symptoms, avoid
situations such as driving a car, in which you or others would be put at risk by
hypoglycaemia.
Do not use Humulin I if you think hypoglycaemia (low blood sugar) is starting.
If your blood sugar is low, eat glucose tablets, sugar or drink a sugary drink.
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and
have some rest. This will often get you over mild hypoglycaemia or a minor
insulin overdose. If you get worse and your breathing is shallow and your skin
gets pale, tell your doctor at once. A glucagon injection can treat quite severe
hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not
respond to glucagon, you will have to go to hospital. Ask your doctor to tell you
about glucagon.
B. Hyperglycaemia and diabetic ketoacidosis
Hyperglycaemia (too much sugar in the blood) means that your body does not
have enough insulin. Hyperglycaemia can be brought about by:
• not taking your Humulin I or other insulin;
• taking less insulin than your doctor tells you to;
• eating a lot more than your diet allows; or
• fever, infection or emotional stress.
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on
slowly over many hours or days. The symptoms include the following:
• no appetite
• feeling sleepy
• flushed face
• fruity smell on the breath
• thirst
• feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help
immediately.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) are
not treated they can be very serious and cause headaches, nausea, vomiting,
dehydration, unconsciousness, coma or even death.
Three simple steps to avoid hypoglycaemia or hyperglycaemia are:
• Always keep spare syringes and a spare vial of Humulin I.
• Always carry something to show you are diabetic.
• Always carry sugar with you.
C. Illness
If you are ill, especially if you feel sick or are sick, the amount of insulin you
need may change. Even when you are not eating normally, you still need
insulin. Test your urine or blood, follow your ‘sick rules’, and tell your diabetes
specialist nurse or doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via 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, United Kingdom: Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Humulin I KwikPen
Keep this medicine out of the sight and reach of children.
Before the first use store your Humulin I KwikPen in a refrigerator (2°C – 8°C).
Do not freeze. Keep your ‘in use’ Humulin I KwikPen at room temperature
(below 30°C) for up to 28 days. Do not keep your ‘in use’ pen in the fridge.
Do not put it near heat or in the sun.
Do not use this medicine after the expiry date which is stated on the label and the
carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that clumps of material are present or solid
white particles stick to the bottom or sides of the cartridge, giving it a frosted
appearance. Check this each time you inject yourself.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help to protect the environment.

6. Contents of the pack and other information
What Humulin I KwikPen contains
- The active substance is human insulin. Human insulin is made in the
laboratory by a ‘recombinant DNA technology’ process. It has the same
structure as the natural hormone made by the pancreas. It is therefore
different from animal insulins. The human insulin in Humulin I is available
in a suspension together with protamine sulfate.
- The other ingredients are protamine sulfate, metacresol, phenol, glycerol,
dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium
hydroxide or hydrochloric acid may have been used during manufacture to
adjust the acidity.
What Humulin I KwikPen looks like and contents of the pack
Humulin I (Isophane) KwikPen 100 IU/ml suspension for injection is a white,
sterile suspension and contains 100 units of insulin in each millilitre (100 IU/ml).
Each Humulin I KwikPen contains 300 units (3 millilitres).
The Humulin I KwikPen comes in a pack of 5.
The Humulin I in your KwikPen is the same as the Humulin I, which comes
in separate Humulin I cartridges. The KwikPen simply has a built in cartridge.
When the KwikPen is empty you cannot use it again.
Marketing Authorisation Holder and Manufacturer
Humulin I KwikPen is made by: Lilly France S.A.S., Rue du Colonel Lilly,
67640 Fegersheim, France.
The marketing authorisation is held by: Eli Lilly and Company Limited,
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, U.K.
It is distributed in the Republic of Ireland by Eli Lilly and Company (Ireland)
Limited, Hyde House, 65 Adelaide Road, Dublin 2, Ireland.
This medicinal product is authorised in the Member States of the EEA
under the following names:
Huminsulin „Lilly“ Basal 100 I.E./ml – KwikPen (Austria)
Humuline-KwikPen NPH (Belgium, Luxembourg, The Netherlands)
Humulin N KwikPen (Estonia, Latvia, Lithuania, Poland, Romania)
Huminsulin Basal (NPH) 100 KwikPen (Germany)
Humulin NPH KwikPen (Denmark, Finland, Iceland, Norway, Slovenia, Sweden)
Humulin (NPH) KwikPen (Greece)
Humulina NPH KwikPen 100 (Spain)
Humulin I KwikPen (Ireland, UK)
Umuline NPH KwikPen (France)
This leaflet was last revised in May 2016
If you would like a large-print version of this leaflet, please phone
01256 315000 (UK) or 01 661 4377 (Ireland)

USER MANUAL

Supplies needed to give your injection:



Humulin I KwikPen™ 100 IU/ml
Humulin M3 KwikPen 100 IU/ml
®



Humulin KwikPen 100 IU/ml containing your insulin
Humulin KwikPen 100 IU/ml compatible Needle (BD [Becton, Dickinson and Company]
Pen Needles recommended)
Alcohol swab

Preparing your Pen



PLEASE READ THIS USER MANUAL BEFORE USE



Read the User Manual before you start taking Humulin and each time you get another
Humulin KwikPen 100 IU/ml. There may be new information. This information does not take the
place of talking to your healthcare professional about your medical condition or your treatment.



Humulin KwikPen 100 IU/ml (“Pen”) is a disposable pre-filled pen containing 300 units (3 ml)
of insulin. You can give yourself multiple doses using one Pen. The Pen dials 1 unit at a time.
You can give from 1 to 60 units in a single injection. If your dose is more than 60 units,
you will need to give yourself more than one injection. The plunger only moves a little
with each injection, and you may not notice that it moves. The plunger will only reach the end
of the cartridge when you have used all 300 units in the Pen.



Do not share your Pen with other people, even if the needle has been changed.
Do not reuse or share needles with other people. You may give an infection to them
or get an infection from them.
This Pen is not recommended for use by the blind or visually impaired without the help of
someone trained to use the Pen.
KwikPen Parts

Cap Clip

Cartridge Holder

Label

Follow the instructions for sanitary injection technique recommended by your healthcare
professional.
Check the Pen to make sure you are taking the right type of insulin. This is especially
important if you use more than one type of insulin.
Do not use your Pen past the expiration date printed on the Label or for more than 28 days
after you first start using the Pen.
Always use a new Needle for each injection to help prevent infections and blocked Needles.

Step 1:



Pull the Pen Cap straight off.

- Do not remove the Pen Label.

Wipe the Rubber Seal with an alcohol
swab.

Step 6:




Pull
off the Outer Needle Shield. Do not
throw it away.

Pull off the Inner Needle Shield and throw
it away.

Keep

Throw Away

Priming your Pen
Prime before each injection.



Priming your Pen means removing the air from the Needle and Cartridge that may
collect during normal use and ensures that the Pen is working correctly.
If you do not prime before each injection, you may get too much or too little insulin.

Step 7:


To prime your Pen, turn the Dose Knob
to select 2 units.

Step 2:


Gently roll the Pen 10 times.

AND


Invert the Pen 10 times.

Step 8:


Mixing is important to make sure you get
the right dose. The insulin should look evenly
mixed.

Hold your Pen with the Needle pointing up.
Tap the Cartridge Holder gently to collect air
bubbles at the top.

Dose Indicator

Step 9:
Pen Cap

Rubber Seal

Plunger

Pen Body

Dose
Window

Pen Needle Parts
Paper Tab



Check the appearance of the insulin.
– HUMULIN I and HUMULIN M3 should
look white and cloudy after mixing.
Do not use if it looks clear or contains
any lumps or particles.

Needle

How to recognise your Humulin KwikPen 100 IU/ml:

Pen Body colour:

Step 3:


(Needles Not Included)

Outer Needle Inner Needle
Shield
Shield

Dose
Knob

You should see insulin at the tip of the
Needle.
– If you do not see insulin, repeat the
priming steps, but not more than 4 times.

Step 4:

Humulin
I

Humulin
M3

Beige

Beige



Select a new Needle.



Pull off the Paper Tab from the Outer
Needle Shield.

– If you still do not see insulin, change the
Needle and repeat the priming steps.
Small air bubbles are normal and will not
affect your dose.

Dose Knob:

Step 5:

Labels:

White with Light
Green Colour Bar

White with Brown
Colour Bar

Push the capped Needle straight onto the
Pen and twist the Needle on until it is tight.

Continue holding your Pen with Needle
pointing up. Push the Dose Knob in until it
stops, and “0” is seen in the Dose Window.
Hold the Dose Knob in and count to 5
slowly.

Selecting your dose




You can give from 1 to 60 units in a single injection.

If your dose is more than 60 units, you will need to give more than one injection.

– If you need help deciding how to divide up your dose, ask your healthcare professional.
– You should use a new Needle for each injection and repeat the priming step.

Step 13:

Step 10:




Turn the Dose Knob to select the number
of units you need to inject. The Dose
Indicator should line up with your dose.
– The Pen dials 1 unit at a time.



– The Dose Knob clicks as you turn it.
 O NOT dial your dose by counting
– D
the clicks because you may dial the
wrong dose.
dose can be corrected by turning
– The

the Dose Knob in either direction until
the correct dose lines up with the
Dose Indicator.








Always
check the number in the Dose

Window to make sure you have dialed
the correct dose.

The Pen will not let you dial more than the number of units left in the Pen.

If you need to inject more than the number of units left in the Pen, you may either:

the amount left in your Pen and then use a new Pen to give the rest of your dose, or
– inject

– get a new Pen and inject the full dose.
It is normal to see a small amount of insulin left in the Pen that you cannot inject.

Giving your injection


Inject your insulin as your healthcare professional has shown you.



Do not try to change your dose while injecting.



Change (rotate) your injection site for each injection.

The used Pen may be discarded in your household trash after you have removed the Needle.

Check the number in the Dose Window



Ask your healthcare professional about options to dispose of the sharps container properly.

– If you still do not think you received the
full amount you dialed for your injection,
do not start over or repeat that
injection. Monitor your blood glucose
as instructed by your healthcare
professional.
– If you normally need to give 2 injections
for your full dose, be sure to give your
second injection.

(Example: 25 units shown
in the Dose Window)

 he plunger only moves a little with each
T
injection, and you may not notice that it moves.
If you see blood after you take the Needle out
of your skin, press the injection site lightly with
a piece of gauze or an alcohol swab. Do not
rub the area.
After your injection
Step 14:


Carefully replace the Outer Needle Shield.

Step 11:




 your skin with an alcohol swab, and
Wipe
let your skin dry before you inject your dose.

Step12:


Insert the Needle into your skin.



Push the Dose Knob all the way in.



Continue to hold the Dose Knob
in and slowly count to 5 before
removing the Needle.

Do not try to inject your insulin by turning the
Dose Knob. You will NOT receive your insulin
by turning the Dose Knob.




Do not recycle the filled sharps container.

The directions regarding needle handling are not intended to replace local, healthcare
professional or institutional policies.

Storing your Pen
Unused Pens


Store unused Pens in the refrigerator at 2°C to 8°C.



Unused Pens may be used until the expiration date printed on the Label, if the Pen has been
kept in the refrigerator.



Do not freeze Humulin. Do not use if it has been frozen.

In-use Pen



Store the Pen you are currently using at room temperature (up to 30°C) and away from heat
and light.
Throw away the Pen you are using after 28 days, even if it still has insulin left in it.

General information about the safe and effective use of your Pen


Keep your Pen and Needles out of the sight and reach of children.



Always carry an extra Pen in case yours is lost or damaged.



Do not use your Pen if any part looks broken or damaged.

Troubleshooting



If you cannot remove the Pen Cap, gently twist the cap back and forth, and then pull the cap
straight off.
If the Dose Knob is hard to push:

– Pushing the Dose Knob more slowly will make it easier to inject.

– Your Needle may be blocked. Put on a new Needle and prime the Pen.

– You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a
new Pen.
If you have any questions or problems with your Humulin KwikPen, call your healthcare
professional for help or contact your local Lilly affiliate.

Choose your injection site.
Humulin is injected under the skin
(subcutaneously) of your stomach area,
buttocks, upper legs or upper arms.

Put used Needles in a sharps container or a hard plastic container with a secure lid.
Do not throw needles directly into your household trash.



– If you do not see “0” in the Dose
window, do not redial. Insert the needle
into your skin and finish your injection.

(Example: 12 units shown
in the Dose Window)



– A drop of insulin at the Needle tip is
normal. It will not affect your dose.
– If you see “0” in the Dose window, you
have received the full amount
you dialed.

– The even numbers are printed on the
dial.
– The odd numbers, after the number
1, are shown as full lines.

Pull the Needle out of your skin.

Disposing of Pens and Needles

Step 15:


Unscrew the capped Needle and dispose
of it as described below (see Disposing
of Pens and Needles section).



Do not store the Pen with the Needle
attached to prevent leaking, blocking
the Needle, and air from entering the Pen.

Step 16:


Replace the Pen Cap by lining up the
Cap Clip with the Dose Indicator and
pushing straight on.

Document Revision Date: May 2016

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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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