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SAYANAJECT 104 MG SUSPENSION FOR INJECTION

Active substance(s): MEDROXYPROGESTERONE ACETATE

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Package leaflet: Information for the user
SAYANAJECT 104 mg suspension for injection
Medroxyprogesterone acetate
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 SAYANAJECT is and what it is used for
2. What you need to know before you use SAYANAJECT
3. How to use SAYANAJECT
4. Possible side effects
5. How to store SAYANAJECT
6. Contents of the pack and other information
1.

What SAYANAJECT is and what it is used for

SAYANAJECT is a contraceptive.
The active ingredient in SAYANAJECT, medroxyprogesterone acetate (MPA), is similar to (but not
the same as) the natural hormone progesterone that is produced in the ovaries during the second half
of your menstrual cycle. This medicine acts by preventing an egg from fully developing and being
released from the ovaries during your menstrual cycle. If an egg is not released it cannot become
fertilised by sperm and result in pregnancy.
It can be used:
 For long-term contraception where you and the person who provides your contraception (e.g.
your doctor, nurse or healthcare provider) have decided that this method is the most suitable for
you. It is important to be aware that as a long-acting contraceptive its effects last at least 12
weeks. If you wish to use this medicine for more than 2 years, your health
professional/doctor/nurse may wish to re-evaluate the risks and benefits of using this medicine to
make sure that it is still the best option for you.
 By teenagers, but only after other methods of contraception have been discussed with the person
who provides your contraception and are considered unsuitable or unacceptable.
2.

What you need to know before you use SAYANAJECT

Do not use SAYANAJECT:
 If you are allergic to medroxyprogesterone acetate (MPA) or any of the other ingredients of
SAYANAJECT (listed in section 6)
 If you think you may be pregnant
 If you have had or think you have cancer of the breast or sex organs
 If you have unexplained vaginal bleeding
 If you have liver disease
 If you have been diagnosed with thinning, softening or weakening of your bones
 If you have a blood clot in a vein in your leg (a ‘deep vein thrombosis’) or a blood clot that has
travelled to your lung or another part of your body (an ‘embolus’)
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If you have problems with your circulation (e.g. pains in your legs or chest when you walk), or
with your blood clotting too easily ('thrombosis' or 'embolism')
If you have or have had a disease affecting the blood vessels of the brain

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using SAYANAJECT.
Before your doctor prescribes SAYANAJECT, you may need to have a physical examination.
It is important to tell your doctor if you have, or have had in the past, any of the following conditions.
Your doctor will then discuss with you whether SAYANAJECT is suitable for you.
Tell your doctor if you have:
 Irregular, light, or heavy menstrual periods
 Family history of breast cancer
 An unusual breast x-ray, fibrocystic breast disease, breast nodules or lumps, or bleeding from
your nipples
 A blood clot in the lung (pulmonary embolism)
 A blood clot in your eye affecting your vision (retinal thrombosis)
 Had a stroke
 Severe pain or swelling in the calf (indicating a possible clot in the leg, which may be called
phlebitis)
 Migraine headaches
 Past history of depression
 Diabetes or a family history of diabetes
 A history of heart disease or cholesterol problems including any family history
 High blood pressure
 Kidney disease
 Asthma
 Epilepsy
Possible effect on your periods
Most women using SAYANAJECT will experience a change in their bleeding patterns. It is likely
that fewer women will experience irregular bleeding, and after 12 months of use 60% will experience
little or no bleeding at all.
Possible effect on your bones
SAYANAJECT works by lowering levels of estrogen and other hormones. However, low estrogen
levels can cause bones to become thinner (by reducing bone mineral density). Women who use
SAYANAJECT tend to have lower bone mineral density than women of the same age who have never
used it. The effects of SAYANAJECT are greatest in the first 2-3 years of use. Following this, bone
mineral density tends to stabilise and there appears to be some recovery when SAYANAJECT is
stopped. It is not yet possible to say whether SAYANAJECT increases the risk of osteoporosis (weak
bones) and fractures in later life.
The following are risk factors in the development of osteoporosis in later life. You should discuss
with your doctor before starting treatment if you have any of the following as an alternative
contraceptive may be more suitable to your needs;
· Chronic alcohol and/or tobacco use
· Chronic use of drugs that can reduce bone mass, e.g. epilepsy medication or steroids
· Low body mass index or eating disorder, e.g. anorexia nervosa or bulimia
· Previous low trauma fracture that was not caused by a fall
· Strong family history of osteoporosis
Teenagers (up to 18 years) Normally, the bones of teenagers are rapidly growing and increasing in
strength. The stronger the bones are when adulthood is reached, the greater the protection against
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osteoporosis in later life. Since SAYANAJECT may cause teenage bones to become thinner at a time
when they should be growing, its effect may be particularly important in this age group. Bones start
to recover when SAYANAJECT is stopped, but it is not yet known whether the bone mineral density
reaches the same levels as it would have if SAYANAJECT had never been used.
You should therefore discuss whether another form of contraception might be more suitable for
you with the person who provides your contraception before starting SAYANAJECT.
If you use SAYANAJECT, it may help your bones if you take regular weight-bearing exercise and
have a healthy diet, including an adequate intake of calcium (e.g. in dairy products) and vitamin D
(e.g. in oily fish).
Possible risk of cancer
Studies of women who have used a range of medicine-based contraception found that women who
used injectable progestogen like SAYANAJECT for contraception had no increased overall risk of
developing cancer of the ovary, womb, cervix, or liver.
Breast cancer is rare under 40 years of age, but the risk increases as a woman becomes older.
There seems to be a slightly increased risk of breast cancer in women who take injectable
contraceptives compared to women of the same age who do not use hormonal contraceptives.
This small extra risk of developing breast cancer has to be weighed against the known benefits of
medicines like SAYANAJECT. It is not certain whether the injection causes the increased risk of
breast cancer. It may be that women receiving the injection are examined more often, so that breast
cancer is noticed earlier. The breast cancer seems less likely to have spread when found in women
who receive medicines like SAYANAJECT than in women who do not.
The risk of finding breast cancer is not affected by how long a woman is on the injection, but by the
age at which she stops. This is because the risk of breast cancer strongly increases as a woman
becomes older. Ten years after stopping hormonal contraceptive injections, the risk of finding breast
cancer is the same as for women who have never used hormonal contraceptives.
In 10,000 women who receive injections like SAYANAJECT for up to 5 years, but stop taking it by
the time they are aged 20, it is estimated that less than 1 additional case of breast cancer would be
found up to 10 years afterwards, compared with the number found in 10,000 women who had never
had the injection.
For 10,000 women who are on injections like SAYANAJECT for 5 years and stop it by the age of 30,
there would be 2 or 3 extra cases of breast cancer found up to 10 years afterwards (in addition to the
44 cases of breast cancer found in 10,000 women in this age group who had never had the injection).
For 10,000 women who take SAYANAJECT for 5 years and stop it by the age of 40, there would be
about 10 extra cases found up to 10 years afterwards (in addition to 160 cases of breast cancer found
in 10,000 women in this age group who had never had the injection).
Other risks:
If you develop
 A sudden partial or complete loss of vision, double vision, blood clotting disorders such as
pulmonary embolus (blood clot in the lung) or a stroke, you should not receive further injections
of SAYANAJECT
 Migraine, you should consult your doctor before receiving further injections of SAYANAJECT .
 Jaundice (yellowing of the skin or eyes) you should consult your doctor before receiving further
injections of SAYANAJECT.

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Protection against sexually transmitted diseases
SAYANAJECT does not protect against HIV infection (AIDS) and other sexually transmitted
diseases.
Other medicines and SAYANAJECT
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. There are some medicines that may
interact with SAYANAJECT. These include medicines that thin your blood (anticoagulants).
Medicines can sometimes interfere with each other. If you receive treatment from any other doctor,
nurse or qualified healthcare professional make sure they are aware that you are using
SAYANAJECT as a contraceptive.
Pregnancy and breast-feeding
Do not take SAYANAJECT if you are pregnant. If you think you may have become pregnant while
using SAYANAJECT, tell your doctor immediately.
If you are breast-feeding, the injection should be given no sooner than 6 weeks after childbirth, when
the baby is more developed. SAYANAJECT can be passed to the nursing infant in the breast milk,
however no harmful effects have been found in children.
Always ask your doctor, nurse, or healthcare professional for advice before taking any medicine.
Driving and using machines
No effects on the ability to drive or use machines have been seen with SAYANAJECT.
SAYANAJECT contains methyl parahydroxybenzoate (E218) & propyl parahydroxybenzoate
(E216) and sodium
Methyl parahydroxybenzoate (E218) & propyl parahydroxybenzoate (E216):
These may cause allergic reactions (possibly delayed).
Sodium:
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially
‘sodium-free’.
3.

How to use SAYANAJECT

Administration of SAYANAJECT is initiated by a healthcare professional (HCP). If considered
appropriate by the HCP, you may be able to self-inject your injections following suitable instruction
and training on injection technique and schedule of administration.
Method and route of administration
SAYANAJECT is injected under the skin into the front upper thigh or abdomen. The first injection
should be performed under the supervision of your doctor, nurse, or healthcare provider. If your
doctor considers it appropriate you may choose to give yourself the injections. You will be shown
how to give yourself the injection under supervision before you do this on your own at home. The
detailed instructions on the injection procedure are provided at the end of this leaflet and should be
followed very carefully. You should continue to receive SAYANAJECT for as long as instructed by
your doctor or until you want to have a baby or switch to a different method of contraception.
First injection
A dose of 104 mg of SAYANAJECT is given subcutaneously (into the fatty layer just under the skin),
into the front upper thigh or abdomen every 3 months (12 to 13 weeks). SAYANAJECT will only be
effective if you receive your injection at the proper time. To ensure that you are not pregnant at the
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time of the first injection, it is essential that your first injection be given ONLY during the first 5 days
of your normal menstrual cycle.
After childbirth: If you use SAYANAJECT after having a baby and you are not breast-feeding, the
first injection MUST be given within 5 days.
There is evidence that women prescribed SAYANAJECT immediately after childbirth or termination
of pregnancy can experience prolonged and heavy bleeding. Because of this, SAYANAJECT should
be used with caution at this time.
Further injections
Further doses of SAYANAJECT will then be given every 12 to 13 weeks, (but no later than 14 weeks
past your last injection), regardless of when and how much menstrual bleeding you have.
It is important that you have your next injections at the right time.
Planning your injections
 If you are giving yourself injections, ensure you have a way of reminding yourself (for example
a calendar, diary or phone alert) so you know when to give yourself the next injection.
Preparing for an injection
1. Choose an injection site (abdomen or front upper thigh) that you find easy to see and reach
with both hands and find a sitting position which is comfortable for you. Try to use a different
injection site for each injection so you are not injecting into the same place too often.
2. Make sure the medicine is at room temperature. Carefully tear open the foil pouch at the tear
notch and take out the injector.
3. Hold the injector firmly and shake it vigorously for at least 30 seconds to mix the medicine.
Giving yourself injections:
Carefully follow the step by step instructions at the end of this leaflet on how to give yourself the
injection.
Important points to note:
When giving yourself the injection, you must squeeze the injector with slow even pressure over 5-7
seconds to push out the medicine. If you try to squeeze too quickly you may feel resistance and be
unable to inject the medicine. If this happens adjust your grip if necessary and squeeze more gently to
fully push out the medicine.
It is normal for a very small amount of medicine to be left around the edges of the blister (reservoir).
If you have had a problem during the injection or if you feel for any reason you might not have given
yourself the full dose, do NOT give yourself an additional injection. It is important you get advice
from your doctor, nurse or healthcare provider because a partial dose may not prevent pregnancy.
If, at any time, you don’t want to continue injecting yourself for any reason, speak to your doctor,
nurse or healthcare provider before your next injection is due, so they can arrange to give it to you at
the right time.
It is recommended that you continue to see your doctor or healthcare provider periodically as
recommended by your HCP at least once a year as a minimum so they can check SAYANAJECT is
still the best option for you and for you to have routine contraceptive health checks.

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If you have any questions or worries ask your doctor, nurse, or healthcare professional for advice,
particularly if there have been any problems during or immediately after the injection.
If you miss an injection of SAYANAJECT
If you miss your injection or wait longer than 14 weeks between injections, there is a greater risk that
you could become pregnant. Tell your doctor, pharmacist, or healthcare professional to find out when
you should have your next injection of SAYANAJECT and which type of contraception should be
used in the meantime.
Switching from other Methods of Contraception
When you switch from other contraceptive methods, your doctor will make sure you are not at risk of
becoming pregnant by giving you your first injection at the appropriate time. If you switch from oral
contraceptives, you should have your first injection of SAYANAJECT within 7 days after taking your
last pill.
What if you decide you want to get pregnant
Your usual level of fertility will return when the effect of the last injection has worn off. The time
this takes varies in different women, and does not depend on how long you have been using
SAYANAJECT. In most women the effect will have worn off 5 to 6 months after the last injection.
Over 80 % of women will get pregnant within a year of stopping SAYANAJECT. It is possible to get
pregnant in the first month after missing an injection.
4.

Possible side effects
Like all medicines, SAYANAJECT can cause side effects, although not everybody gets them. 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.
If you are injecting SAYANAJECT yourself and not seeing your doctor as regularly, it is important
you are aware of possible side effects , how to recognise them and when to get urgent medical help .
Please familiarise yourself with this section of the leaflet and re-read it regularly.
If you are worried about any unusual symptoms or changes in your health, talk to your doctor, nurse
or healthcare provider.
If you experience any of the following serious side effects, seek medical help immediately:
 A serious allergic reaction (it is not known how frequently this occurs)
Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the
eyelids, face, lips or throat, skin rash, hives. Allergic reactions may happen soon after
injection or can take time to develop in some people. If any of these symptoms appear at any
time, even if you have used SAYANAJECT before, seek medical help immediately.
 A blood clot in the lungs (it is not known how frequently this occurs)
Symptoms include
o an unusual sudden cough (which may bring up blood)
o severe pain in the chest which may increase with deep breathing
o sudden unexplained breathlessness or rapid breathing
o severe light headedness or dizziness
o rapid or irregular heartbeat
o severe pain in your abdomen
 A blood clot in the leg (it is not known how frequently this occurs)
Symptoms include severe pain or swelling in either of your legs or feet that may be
accompanied by tenderness, warmth or discoloured skin
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 A blood clot in the eye (it is not known how frequently this occurs)
Symptoms include loss of vision, pain and swelling of the eye especially if sudden
 A stroke (it is not known how frequently this occurs)
Symptoms include
o weakness or numbness of the face, arm or leg, especially on one side of the body
o sudden confusion, trouble speaking or understanding
o sudden trouble seeing in one or both eyes
o sudden trouble walking, dizziness, loss of balance or coordination
o sudden, severe or prolonged headache with no known cause
o loss of consciousness or fainting with or without seizure.
Other side effects include:
Common: (may affect up to 1 in 10 people)
 Weight increase
 Abdominal pain (cramps)
 Nausea
 Acne
 Amenorrhea (very light or no period)
 Heavy, frequent and/or unexpected bleeding
 Irregular periods
 Period pains
 Breast pain / tenderness
 Depression
 Weakness or tiredness
 Headache
 Injection site reactions (including pain, tenderness, lump, persistent skin indentation/dimpling).
You may feel some soreness or see redness around the injection site immediately after an
injection. Mild reactions like this are common. If you get a reaction that worries you in any way,
is particularly painful, or does not get better after a short time please talk to your doctor.











Irritability
Anxiety
Difficulty sleeping
Decreased sexual feeling
Vaginal irritation or itching
Mood changes
Dizziness
Back pain
Pain in limbs
Abnormal cervical smear

Uncommon: (may affect up to 1 in 100 people)
 Drug allergy
 Hirsutism (abnormal hairiness)
 Feeling bloated
 Fluid retention
 Vaginal discharge
 Vaginal dryness
 Pain during sexual intercourse
 Ovarian cyst
 Pelvic pain
 Premenstrual syndrome
 Change in breast size
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Milky discharge from breasts in women who are not breastfeeding
Change in appetite
Muscle cramps
Joint pain
Sleepiness
Migraine
Vertigo ( a spinning sensation)
Hot flushes
High blood pressure
Rapid heart rate
Varicose veins
Rash
Itching
Hives
Hair loss
Skin irritation
Bruising
Facial discoloration
Inflammation in the veins (felt as tenderness or redness in the affected area)
Nervousness
Loss of bone mineral density (a test used to diagnose osteoporosis or weak bones)
Weakness
Decreased glucose tolerance (excess sugar level in the blood)
Emotional disturbance
Inability to achieve a sexual climax

Rare: (may affect up to 1 in 1,000 people)
 Breast cancer
 Fever
 Weight decrease
 Deformation of skin at the injection site
 Abnormal liver function test results (blood tests to measure liver injury)
Not known: frequency cannot be estimated from the available data
 Osteoporosis (weak bones) including osteoporotic fractures
 Seizures
 Abnormal liver function such as yellowing of the skin or eyes (jaundice)
 Skin stretch marks
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 the Yellow Card Scheme
at: 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 SAYANAJECT





Keep out of sight and reach of children.
Do not refrigerate or freeze.
Do not use SAYANAJECT after the expiry dates stated on the injector, foil pouch and carton
after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you
notice any leakage or discolouration of the suspension.

Carefully and properly dispose of SAYANAJECTafter use. The injector should NEVER be reused.
Do not throw used injectors into household waste. The used injector should not be recapped after use
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and should be disposed of safely in a special container, in accordance with local authority
requirements for the disposal of sharps. Do not throw away any medicines via household waste. Ask
your pharmacist how to throw away medicines you no longer use. These measures will help protect
the environment. Ask your pharmacist for guidance on disposal of medicines.
6.

Contents of the pack and other information

What SAYANAJECT contains
The active substance is medroxyprogesterone acetate (MPA).
The pre-filled injector contains 104mg medroxyprogesterone acetate (MPA) in 0.65 ml.
The other ingredients are macrogol, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), sodium chloride, polysorbate 80, monobasic sodium phosphate
monohydrate, disodium phosphate dodecahydrate, methionine, povidone, sodium hydroxide and/or
hydrochloric acid for pH adjustment and water for injection.
What SAYANAJECT looks like and contents of the pack
SAYANAJECT is a white to off-white suspension for subcutaneous injection (an injection given
under the skin). It is supplied in a single-dose container in the form of a pre-filled injector.
SAYANAJECT is available with a pack size of one single-dose container.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
B-2870 Puurs
Belgium
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:
United Kingdom
Pfizer Limited
Ramsgate Road
Sandwich, CT13 9NJ –
United Kingdom
Tel: + 44 (0) 1304 616161
This medicinal product is authorised in the Member States of the EEA under the following
names:
Denmark, Finland, Italy, Sweden
France
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Romania
Spain
United Kingdom

Sayanaject 104 mg suspensie injectabilă
Sayanaject 104 mg suspensión inyectable
Sayanaject 104 mg suspension for injection

This leaflet was last revised 12/2015
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SAYANAJECT 104 mg suspension for injection

Single-dose container
Medroxyprogesterone acetate
SAYANAJECT can be given by a healthcare provider or the patient.

INSTRUCTIONS FOR USE
Preparing and giving an injection with SAYANAJECT.
Introduction
SAYANAJECT is a disposable injector that contains a single dose of medicine sealed in a
reservoir. These instructions show step-by-step how to prepare and give the injection.

Step 1: Getting ready
You will need
– A SAYANAJECT injector (in its sealed foil pouch).
– A suitable container for the used injector.
– A clean cotton pad or clean paper tissue.






Wash and dry your hands thoroughly before starting.
Check that the pouch does not appear to be damaged.
Check that the expiry date has not passed.
Ensure the pouch is at room temperature.

Step 2: Selecting an injection area


Choose a suitable area for the injection, either the
abdomen or the front upper thigh. Avoid bony areas and
the navel (belly button).



The area of skin must be free from scars and skin
conditions such as eczema or psoriasis.



Change the site with each injection



Clean the area of skin as your healthcare provider has told
you.

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Step 3: Preparing the injector


Carefully tear open the foil pouch at the tear notch.



Take out the injector. Do not remove the needle shield
from the injector yet.



Check the injector. There should be a gap between the
needle shield and the port.



Discard the injector and use a new one if:


There is no gap.



The injector is damaged.



The needle shield has come off or is missing.

Step 4: Mixing the medicine


Hold the injector firmly by the port.



Shake the injector vigorously for at least 30 seconds to mix
the medicine.



The medicine should appear white and uniform. If it is
not, discard the injector and use a new one.



If you see liquid leaking out or any other problem, discard
the injector and use a new one.



If there is a delay before injecting, you must repeat the
mixing step.

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Step 5: Activating the injector


Hold the injector firmly by the port, making sure the
needle shield is pointing upwards. Take care not to
squeeze the reservoir.



Hold the needle shield with the other hand.



Push the needle shield firmly towards the port until it will
go no further. The injector is now activated.



Pull the needle shield off, and discard it.

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Step 6: Injecting the dose


Gently pinch a large area of skin. Keep the skin pinched
all through this step.



Hold the injector by the port with the needle pointing
straight downwards.



Insert the needle into the skin so that the port just touches
the skin.



Squeeze the reservoir slowly to inject the medicine. You
should take about 5-7 seconds to do this.



Gently pull the needle out of the skin. Let go of the skin.



Check whether any medicine has leaked out of the injector
or has appeared on the skin.



Do not replace the needle shield.



Use a clean cotton pad to press lightly on the injection area
for a few seconds. Do not rub the area.

Important advice


After the injection a small amount of medicine will be left
around the inside edge of the reservoir. This is normal.



However, if any medicine has leaked out of the injector or
appeared on the skin, then a problem may have occurred.



If you believe for any reason that the full dose has not
been given, speak to your healthcare provider about
alternative methods of contraception until the next
scheduled injection.



Do not inject an additional dose.
After injection care:



If you get any symptoms of allergic reaction (see leaflet
Section 4 above) seek medical help immediately.



Monitor the appearance of the injection site until the next
injection. If you notice any skin indentation or dimpling at
the injection site, tell your healthcare provider.

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Step 7: Disposing of the injector


Immediately dispose of the used injector into a suitable
container in accordance with your local authority
requirements or as you have been told by your healthcare
provider.



The injector is for a single injection only and must not be
re-used.

Step 8: Record the date of your injection and should you
wish to continue, calculate the date of your next scheduled
injection of SAYANAJECT
Retain this leaflet for your records.

Date_____________________
Date of Next Injection
(add 3 months)
______________________

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Expand view ⇕

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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