GERIOSTIM AQUA®
33.33 mg / 3 ml
What is in this leaflet
1. What GERIOSTIM AQUA® is used for
2. How GERIOSTIM AQUA® works
3. Before you use GERIOSTIM AQUA®
4. How to use GERIOSTIM AQUA®
5. While you are using it
6. Side Effects
7. Storage and Disposal of
GERIOSTIM AQUA®
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
What GERIOSTIM AQUA® is used for
In children, GERIOSTIM AQUA® is used to treat growth disturbances:
- If you do not have enough of your
own growth hormone.
- If you have Turner syndrome
(chromosomal error in girls that
can affect growth).
- If you have chronic renal (kidney)
insufficiency. As kidneys lose their ability to function normally, this can affect growth.
- If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you grow taller if you are still growing, and will also improve your body composition.
- If you were small or too light at birth or if you have not been able to catch up or maintain normal growth by four years of age or later.
In adults, GERIOSTIM AQUA® is used to treat persons with pronounced growth hormone deficiency. This can start during adult life, or it can continue from childhood. If you have been treated with GERIOSTIM AQUA® for growth hormone deficiency during childhood, your growth hormone status will be retested after completion of growth.
How GERIOSTIM AQUA® works
GERIOSTIM AQUA® is a recombinant human growth hormone (also called somatropin). It has the same structure
as natural human growth hormone, which is needed for bones and muscles to grow. It also helps your fat and muscle tissues to develop in the right amounts. It is a recombinant DNA-derived protein, meaning it is not made from human or animal tissue.
Before you use GERIOSTIM AQUA®
- When you must not use it
Do not take GERIOSTIM AQUA® if
- You are allergic (hypersensitive) to somatropin or any of the other
ingredients of GERIOSTIM AQUA® (listed under Product Description).
- You have an active tumour (cancer). Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with GERIOSTIM AQUA®.
- You are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute respiratory failure, accidental injury or similar conditions).
- Children who have already stopped growing (closed epiphyses).
Pregnancy and lactation
You should not use GERIOSTIM AQUA® if you are pregnant, or if you have childbearing potential but are not using contraception.
Ask your doctor for advice before using this medicine while breast- feeding.
- Before you start to use it
Talk to your doctor before taking GERIOSTIM AQUA®:
- If you are receiving
GERIOSTIM AQUA® and thyroid hormone replacement therapy concurrently, your doctor will
need to monitor your thyroid
function closely.
- If you are diabetic and are
receiving insulin therapy, GERIOSTIM AQUA® may reduce your insulin sensitivity, tell your doctor. Your dose of insulin may need to be adjusted after GERIOSTIM AQUA® is initiated.
- If you have severe or reoccurring headache, eye problems, vomiting and nausea, your doctor may examine your eyes to assess if you have increased pressure around your skull. Based on this examination, your doctor will determine whether or not to continue treatment with GERIOSTIM AQUA®.
- If you are receiving GERIOSTIM AQUA® therapy, you may be at risk of reduced cortisol levels (stress hormone) in your blood due to underactivity of your adrenal glands and may require steroids. If you were previously diagnosed with underactive adrenal gland, your doctor may need to adjust your steroid dose.
- If you are taking GERIOSTIM AQUA® and oral oestrogen therapy concurrently, your doctor may need to adjust the dose of GERIOSTIM AQUA®
- If you had cancer in childhood, there is an increased chance of getting tumours again after treatment with GERIOSTIM AQUA®.
- Experience in people above 80 years of age is limited. Elderly persons may be more sensitive to the action of GERIOSTIM AQUA® and therefore may be more prone to develop side effects.
- If you are suffering from any other critical illness, your doctor will decide on whether this medicine is suitable for you or not by weighing the possible benefit against the potential risk involved.
Consumer Medication Information Leaflet (RiMUP)
1
GERIOSTIM AQUA®
Children with Prader-Willi syndrome:
- Your doctor will give you diet
restrictions to follow to ensure effective weight control before and during treatment with GERIOSTIM AQUA®.
- Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your breathing is interrupted during sleep), or respiratory infection before you start treatment with GERIOSTIM AQUA®.
- During treatment, if you show signs of upper airway obstruction (including starting to snore or worsening of snoring), your doctor will refer you to an Ear, Nose and Throat (ENT) specialist for an assessment and your treatment with GERIOSTIM AQUA® may be interrupted.
- During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity that might happen during rapid growth.
- During treatment, if you develop a lung infection, tell your doctor so that he can treat the infection.
Children with chronic renal (kidney) insufficiency:
- Your doctor should examine
your kidney function and verify your growth disturbance by following your growth for a year before starting GERIOSTIM AQUA® medical treatment for your kidney condition should be maintained throughout. GERIOSTIM AQUA® treatment should be stopped at kidney transplantation.
Children born small or too light at birth:
- Your doctor will check your
blood sugar and insulin levels before the start of treatment and every year during treatment.
- Takingothermedicines
Tell your doctor if you are taking
any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines when taken with GERIOSTIM AQUA® may cause GERIOSTIM AQUA® to be less effective and vice versa.
You should inform your doctor if you are taking
- medicines to treat diabetes,
- thyroid hormones,
- steroids to reduce inflammation (corticosteroids),
- sex hormones (for example, oestrogens),
- ciclosporin (a medicine that weakens the immune system after transplantation),
- medicines to control epilepsy (anticonvulsants).
How to use GERIOSTIM AQUA®
0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day. Higher doses can be used. When growth hormone deficiency continues into adolescence, GERIOSTIM AQUA® should be continued until completion of physical development.
Children with Turner syndrome: 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Children with chronic renal (kidney) insufficiency:
0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day). Higher doses may be necessary if the rate of growth is too low. Dosage adjustment may be necessary after 6 months of treatment.
Children with Prader-Willi syndrome:
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. The daily dosage should not exceed 2.7 mg. Treatment should not be used in children who have almost stopped growing after puberty.
Children born smaller or lighter than expected and with growth disturbance:
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day). It is important to continue treatment until final height is reached. Treatment should be discontinued after the first year if you are not responding or if you have reached your final height and stopped growing.
Adults with growth hormone deficiency:
- If you continue GERIOSTIM AQUA® after treatment during childhood you should start with 0.2-0.5 mg per day.
-
How much to use
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
Recommended dosage
The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you. Everyone is different. Your doctor will advise you about your individualized dose of GERIOSTIM AQUA® in milligrams(mg) from either your body weight in kilograms (kg) or your body surface area calculated from your height and weight in square metres (m2), as well as your treatment schedule. Do not change the dosage and treatment schedule without consulting your doctor.
Children with growth hormone deficiency:
Consumer Medication Information Leaflet (RiMUP)
2
GERIOSTIM AQUA®
- If your growth hormone deficiency starts during adult life you should start with 0.15-0.3 mg per day.
- This dosage should be gradually increased according to blood test results as well as clinical response and side effects.
Thedailymaintenancedoseseldom exceeds 1.0 mg per day. Women may require higher doses than men. Dosage should be monitored every 6 months.
Persons above 60 years should start with a dose of 0.1–0.2 mg per day which should be slowly increased according to individual requirements. The minimum effective dose should be used.
The maintenance dose seldom exceeds 0.5 mg per day. Follow the instructions given to you by your doctor.
- Whentouseit
Use as directed by your doctor or
pharmacist.
- Howlongtouseit
Continue taking GERIOSTIM AQUA® for as long as your doctor recommends.
- Ifyouforgettouseit
Consult your doctor or pharmacist
on what you should do if you forget to use it.
Inject the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not inject a double dose to make up for the missed dose.
- Ifyouusetoomuch(overdose)
If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or “not yourself”, and you might faint.
While you are using it
- Thingsyoumustdo
Take your medicine exactly as your doctor has told you.
Tell all the doctors, dentists and pharmacists treating you that you are taking GERIOSTIM AQUA®.
Tell your doctor immediately if you become pregnant while taking this medication.
If you are receiving GERIOSTIM AQUA® for growth hormone deficiency following a previous tumour (cancer), you should be examined regularly for recurrence of the tumour.
If you have diabetes, you should closely monitor your blood sugar level during treatment with GERIOSTIM AQUA® ,and discuss the results with your doctor to determine whether you need to change the dose of your medicines to treat diabetes.
Tell your doctor if you are taking growth hormone to stimulate growth and walk with a limp, or if you start to limp during your growth hormone treatment due to pain in your hip.
Refer to appendix 1 to find instructions for use.
- Things you must not do
Do not stop taking the medicine unless advised by your doctor.
Do not take any new medicines without consulting your doctor.
Do not inject GERIOSTIM AQUA® ,to anyone else, even if they have the same symptoms or condition as you.
- Things to be careful of When you are mixing
GERIOSTIM AQUA® ,do not shake the solution. Mix it gently. Shaking the solution could make the growth hormone foam and damage the active substance.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Side Effects
Like all medicines, GERIOSTIM AQUA® can cause side effects, although not everybody gets them. Visit your doctor or pharmacist immediately if you experience any side effects after taking this medicine.
In children with growth hormone deficiency:
Very common side effects:
- temporaryreactionsattheinjection
site
In children with Turner syndrome: Very common side effects:
- jointpain
In children with chronic renal insufficiency:
Common side effects:
- temporaryreactionsattheinjection
site
- skinrash
In children with growth disturbance due to born small for gestational age:
Consumer Medication Information Leaflet (RiMUP)
If your doctor confirms that you have developed muscle pain or disproportionate pain near the injection site because of the preservative metacresol, you should use a GERIOSTIM AQUA® product without metacresol.
Tell your doctor if you develop stomach pain during the treatment with GERIOSTIM AQUA® It may be due to inflammation of the pancreas.
Injecting GERIOSTIM AQUA®:
3
GERIOSTIM AQUA®
Common side effects:
- temporary reactions at the injection
site
- skin rash
- red, raised, itchy skin rash (hives)
In children with Prader-Willi syndrome:
Common side effects:
- tingling or pricking sensation
- increased pressure inside the skull
- muscle pain
- jointpain
- water retention (which shows as
puffiness) at the legs
- skin rash
In adults with growth hormone deficiency:
Very common side effects:
- jointpain
- water retention (which shows as puffiness) at the legs
Commonsideeffects:
- numbness/tinglingofhand
- an abnormal sensation of tingling
or pricking
- muscle stiffness, muscle pain
These symptoms may be seen for the first months of treatment, but they disappear spontaneously or when the dosage is lowered.
You may report any side effects or adverse drug reactions directly to the National Centre for Adverse Drug Reaction Monitoring by visiting the website npra. gov.my [Consumers Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)]
Storage and Disposal of GERIOSTIM AQUA®
- Storage
Before reconstitution:
Store in a refrigerator (2°C – 8°C), or for a maximum of 1 month at or below 25°C. Keep the pre-filled pen in the outer carton in order to protect from light.
After reconstitution:
Store in a refrigerator (2C – 8C). Do not freeze. Keep the pre-filled pen in the outer carton in order to protect from light.
From a microbiological point of view, once reconstituted, the product may be stored for 4 weeks at 2C - 8C. Other in-use storage times and conditions are the responsibility of the user.
- Disposal
Any unused product or waste
material should be disposed of in accordance with local requirements. Empty GoQuick pre-filled pens should never be refilled and must be properly discarded.
Product Description
- Whatitlookslike
Two-chamber cartridge: Powder
and solvent for solution for injection. In the two-chamber cartridge there is a white powder in the front compartment and a clear solution in the rear compartment. The two-chamber cartridge is supplied for use in a disposable multidose pre-filled pen (GoQuick).
Powder and 1 ml solvent in a two-chamber glass cartridge (type I glass) separated by a rubber plunger (bromobutyl). The cartridge is sealed at one end with a rubber disc (bromobutyl) and an aluminium cap and at the other end by a rubber stopper (bromobutyl). The two-chamber cartridge is supplied in a sealed disposable multidose pre-filled pen, GoQuick.
- Ingredients
- Active ingredient:
Somatropin
- Inactive ingredients:
Front compartment (powder):
Glycine
Mannitol
Sodium dihydrogen phosphate, monohydrate
Disodium phosphate, dodecahydrate
Rear compartment (solvent):
Water for injections Metacresol Mannitol
GERIOSTIM AQUA®
Product Registration Holder
Wisma Averis, Tower 2 Avenue 5, Bangsar South
No. 8, Jalan Kerinchi
59200 Kuala Lumpur, Malaysia
Date of Revision
13/09/2021
Serial Number:
NPRA(R3/01)01092021/0142
Consumer Medication Information Leaflet (RiMUP)
4
GERIOSTIM AQUA® Somatropin
33.33 mg / 3 ml
For SQ injection
33.33 mg / 3 ml
What is in this leaflet
1. What GERIOSTIM AQUA® is used for
2. How GERIOSTIM AQUA® works
3. Before you use GERIOSTIM AQUA®
4. How to use GERIOSTIM AQUA®
5. While you are using it
6. Side Effects
7. Storage and Disposal of
GERIOSTIM AQUA®
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
What GERIOSTIM AQUA® is used for
In children, GERIOSTIM AQUA® is used to treat growth disturbances:
- If you do not have enough of your
own growth hormone.
- If you have Turner syndrome
(chromosomal error in girls that
can affect growth).
- If you have chronic renal (kidney)
insufficiency. As kidneys lose their ability to function normally, this can affect growth.
- If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you grow taller if you are still growing, and will also improve your body composition.
- If you were small or too light at birth or if you have not been able to catch up or maintain normal growth by four years of age or later.
In adults, GERIOSTIM AQUA® is used to treat persons with pronounced growth hormone deficiency. This can start during adult life, or it can continue from childhood. If you have been treated with GERIOSTIM AQUA® for growth hormone deficiency during childhood, your growth hormone status will be retested after completion of growth.
How GERIOSTIM AQUA® works
GERIOSTIM AQUA® is a recombinant human growth hormone (also called somatropin). It has the same structure
as natural human growth hormone, which is needed for bones and muscles to grow. It also helps your fat and muscle tissues to develop in the right amounts. It is a recombinant DNA-derived protein, meaning it is not made from human or animal tissue.
Before you use GERIOSTIM AQUA®
- When you must not use it
Do not take GERIOSTIM AQUA® if
- You are allergic (hypersensitive) to somatropin or any of the other
ingredients of GERIOSTIM AQUA® (listed under Product Description).
- You have an active tumour (cancer). Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with GERIOSTIM AQUA®.
- You are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute respiratory failure, accidental injury or similar conditions).
- Children who have already stopped growing (closed epiphyses).
Pregnancy and lactation
You should not use GERIOSTIM AQUA® if you are pregnant, or if you have childbearing potential but are not using contraception.
Ask your doctor for advice before using this medicine while breast- feeding.
- Before you start to use it
Talk to your doctor before taking GERIOSTIM AQUA®:
- If you are receiving
GERIOSTIM AQUA® and thyroid hormone replacement therapy concurrently, your doctor will
need to monitor your thyroid
function closely.
- If you are diabetic and are
receiving insulin therapy, GERIOSTIM AQUA® may reduce your insulin sensitivity, tell your doctor. Your dose of insulin may need to be adjusted after GERIOSTIM AQUA® is initiated.
- If you have severe or reoccurring headache, eye problems, vomiting and nausea, your doctor may examine your eyes to assess if you have increased pressure around your skull. Based on this examination, your doctor will determine whether or not to continue treatment with GERIOSTIM AQUA®.
- If you are receiving GERIOSTIM AQUA® therapy, you may be at risk of reduced cortisol levels (stress hormone) in your blood due to underactivity of your adrenal glands and may require steroids. If you were previously diagnosed with underactive adrenal gland, your doctor may need to adjust your steroid dose.
- If you are taking GERIOSTIM AQUA® and oral oestrogen therapy concurrently, your doctor may need to adjust the dose of GERIOSTIM AQUA®
- If you had cancer in childhood, there is an increased chance of getting tumours again after treatment with GERIOSTIM AQUA®.
- Experience in people above 80 years of age is limited. Elderly persons may be more sensitive to the action of GERIOSTIM AQUA® and therefore may be more prone to develop side effects.
- If you are suffering from any other critical illness, your doctor will decide on whether this medicine is suitable for you or not by weighing the possible benefit against the potential risk involved.
Consumer Medication Information Leaflet (RiMUP)
1
GERIOSTIM AQUA®
Children with Prader-Willi syndrome:
- Your doctor will give you diet
restrictions to follow to ensure effective weight control before and during treatment with GERIOSTIM AQUA®.
- Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your breathing is interrupted during sleep), or respiratory infection before you start treatment with GERIOSTIM AQUA®.
- During treatment, if you show signs of upper airway obstruction (including starting to snore or worsening of snoring), your doctor will refer you to an Ear, Nose and Throat (ENT) specialist for an assessment and your treatment with GERIOSTIM AQUA® may be interrupted.
- During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity that might happen during rapid growth.
- During treatment, if you develop a lung infection, tell your doctor so that he can treat the infection.
Children with chronic renal (kidney) insufficiency:
- Your doctor should examine
your kidney function and verify your growth disturbance by following your growth for a year before starting GERIOSTIM AQUA® medical treatment for your kidney condition should be maintained throughout. GERIOSTIM AQUA® treatment should be stopped at kidney transplantation.
Children born small or too light at birth:
- Your doctor will check your
blood sugar and insulin levels before the start of treatment and every year during treatment.
- Takingothermedicines
Tell your doctor if you are taking
any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines when taken with GERIOSTIM AQUA® may cause GERIOSTIM AQUA® to be less effective and vice versa.
You should inform your doctor if you are taking
- medicines to treat diabetes,
- thyroid hormones,
- steroids to reduce inflammation (corticosteroids),
- sex hormones (for example, oestrogens),
- ciclosporin (a medicine that weakens the immune system after transplantation),
- medicines to control epilepsy (anticonvulsants).
How to use GERIOSTIM AQUA®
0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day. Higher doses can be used. When growth hormone deficiency continues into adolescence, GERIOSTIM AQUA® should be continued until completion of physical development.
Children with Turner syndrome: 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Children with chronic renal (kidney) insufficiency:
0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day). Higher doses may be necessary if the rate of growth is too low. Dosage adjustment may be necessary after 6 months of treatment.
Children with Prader-Willi syndrome:
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. The daily dosage should not exceed 2.7 mg. Treatment should not be used in children who have almost stopped growing after puberty.
Children born smaller or lighter than expected and with growth disturbance:
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day). It is important to continue treatment until final height is reached. Treatment should be discontinued after the first year if you are not responding or if you have reached your final height and stopped growing.
Adults with growth hormone deficiency:
- If you continue GERIOSTIM AQUA® after treatment during childhood you should start with 0.2-0.5 mg per day.
-
How much to use
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
Recommended dosage
The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you. Everyone is different. Your doctor will advise you about your individualized dose of GERIOSTIM AQUA® in milligrams(mg) from either your body weight in kilograms (kg) or your body surface area calculated from your height and weight in square metres (m2), as well as your treatment schedule. Do not change the dosage and treatment schedule without consulting your doctor.
Children with growth hormone deficiency:
Consumer Medication Information Leaflet (RiMUP)
2
GERIOSTIM AQUA®
- If your growth hormone deficiency starts during adult life you should start with 0.15-0.3 mg per day.
- This dosage should be gradually increased according to blood test results as well as clinical response and side effects.
Thedailymaintenancedoseseldom exceeds 1.0 mg per day. Women may require higher doses than men. Dosage should be monitored every 6 months.
Persons above 60 years should start with a dose of 0.1–0.2 mg per day which should be slowly increased according to individual requirements. The minimum effective dose should be used.
The maintenance dose seldom exceeds 0.5 mg per day. Follow the instructions given to you by your doctor.
- Whentouseit
Use as directed by your doctor or
pharmacist.
- Howlongtouseit
Continue taking GERIOSTIM AQUA® for as long as your doctor recommends.
- Ifyouforgettouseit
Consult your doctor or pharmacist
on what you should do if you forget to use it.
Inject the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not inject a double dose to make up for the missed dose.
- Ifyouusetoomuch(overdose)
If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or “not yourself”, and you might faint.
While you are using it
- Thingsyoumustdo
Take your medicine exactly as your doctor has told you.
Tell all the doctors, dentists and pharmacists treating you that you are taking GERIOSTIM AQUA®.
Tell your doctor immediately if you become pregnant while taking this medication.
If you are receiving GERIOSTIM AQUA® for growth hormone deficiency following a previous tumour (cancer), you should be examined regularly for recurrence of the tumour.
If you have diabetes, you should closely monitor your blood sugar level during treatment with GERIOSTIM AQUA® ,and discuss the results with your doctor to determine whether you need to change the dose of your medicines to treat diabetes.
Tell your doctor if you are taking growth hormone to stimulate growth and walk with a limp, or if you start to limp during your growth hormone treatment due to pain in your hip.
Refer to appendix 1 to find instructions for use.
- Things you must not do
Do not stop taking the medicine unless advised by your doctor.
Do not take any new medicines without consulting your doctor.
Do not inject GERIOSTIM AQUA® ,to anyone else, even if they have the same symptoms or condition as you.
- Things to be careful of When you are mixing
GERIOSTIM AQUA® ,do not shake the solution. Mix it gently. Shaking the solution could make the growth hormone foam and damage the active substance.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Side Effects
Like all medicines, GERIOSTIM AQUA® can cause side effects, although not everybody gets them. Visit your doctor or pharmacist immediately if you experience any side effects after taking this medicine.
In children with growth hormone deficiency:
Very common side effects:
- temporaryreactionsattheinjection
site
In children with Turner syndrome: Very common side effects:
- jointpain
In children with chronic renal insufficiency:
Common side effects:
- temporaryreactionsattheinjection
site
- skinrash
In children with growth disturbance due to born small for gestational age:
Consumer Medication Information Leaflet (RiMUP)
If your doctor confirms that you have developed muscle pain or disproportionate pain near the injection site because of the preservative metacresol, you should use a GERIOSTIM AQUA® product without metacresol.
Tell your doctor if you develop stomach pain during the treatment with GERIOSTIM AQUA® It may be due to inflammation of the pancreas.
Injecting GERIOSTIM AQUA®:
3
GERIOSTIM AQUA®
Common side effects:
- temporary reactions at the injection
site
- skin rash
- red, raised, itchy skin rash (hives)
In children with Prader-Willi syndrome:
Common side effects:
- tingling or pricking sensation
- increased pressure inside the skull
- muscle pain
- jointpain
- water retention (which shows as
puffiness) at the legs
- skin rash
In adults with growth hormone deficiency:
Very common side effects:
- jointpain
- water retention (which shows as puffiness) at the legs
Commonsideeffects:
- numbness/tinglingofhand
- an abnormal sensation of tingling
or pricking
- muscle stiffness, muscle pain
These symptoms may be seen for the first months of treatment, but they disappear spontaneously or when the dosage is lowered.
You may report any side effects or adverse drug reactions directly to the National Centre for Adverse Drug Reaction Monitoring by visiting the website npra. gov.my [Consumers Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)]
Storage and Disposal of GERIOSTIM AQUA®
- Storage
Before reconstitution:
Store in a refrigerator (2°C – 8°C), or for a maximum of 1 month at or below 25°C. Keep the pre-filled pen in the outer carton in order to protect from light.
After reconstitution:
Store in a refrigerator (2C – 8C). Do not freeze. Keep the pre-filled pen in the outer carton in order to protect from light.
From a microbiological point of view, once reconstituted, the product may be stored for 4 weeks at 2C - 8C. Other in-use storage times and conditions are the responsibility of the user.
- Disposal
Any unused product or waste
material should be disposed of in accordance with local requirements. Empty GoQuick pre-filled pens should never be refilled and must be properly discarded.
Product Description
- Whatitlookslike
Two-chamber cartridge: Powder
and solvent for solution for injection. In the two-chamber cartridge there is a white powder in the front compartment and a clear solution in the rear compartment. The two-chamber cartridge is supplied for use in a disposable multidose pre-filled pen (GoQuick).
Powder and 1 ml solvent in a two-chamber glass cartridge (type I glass) separated by a rubber plunger (bromobutyl). The cartridge is sealed at one end with a rubber disc (bromobutyl) and an aluminium cap and at the other end by a rubber stopper (bromobutyl). The two-chamber cartridge is supplied in a sealed disposable multidose pre-filled pen, GoQuick.
- Ingredients
- Active ingredient:
Somatropin
- Inactive ingredients:
Front compartment (powder):
Glycine
Mannitol
Sodium dihydrogen phosphate, monohydrate
Disodium phosphate, dodecahydrate
Rear compartment (solvent):
Water for injections Metacresol Mannitol
GERIOSTIM AQUA®
Product Registration Holder
Wisma Averis, Tower 2 Avenue 5, Bangsar South
No. 8, Jalan Kerinchi
59200 Kuala Lumpur, Malaysia
Date of Revision
13/09/2021
Serial Number:
NPRA(R3/01)01092021/0142
Consumer Medication Information Leaflet (RiMUP)
4
GERIOSTIM AQUA® Somatropin
33.33 mg / 3 ml
For SQ injection
