mg / ml concentrate for solution for injection / infusion
granisetron
1. What Granisetron Hameln is and what it is used for
Granisetron Hameln contains a substance called granisetron. It belongs to a group of medicines called “5-HT 3 receptor antagonists” or “antiemetics” (medicines that prevent nausea and vomiting).
Granisetron Hameln is used to prevent and treat nausea and vomiting caused by other medical treatments, such as chemotherapy and radiation therapy for cancer and surgery.
Solution for injection/infusion is used for adults and children from 2 years of age.
Granisetron contained in Granisetron Hameln may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Granisetron Hameln
Do not use Granisetron Hameln
- if you are allergic (hypersensitive) to granisetron or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Granisetron Hameln.
Before using Granisetron Hameln, check with your doctor, nurse, or pharmacist if you:
– have problems with your bowel movements due to blockages in the intestines.
– have heart problems, are treated for cancer with a medicine that is known to be harmful to the heart, or have problems with the salt levels in the body, such as potassium, sodium, or calcium (electrolyte changes).
– take another medicine that is “5-HT 3 receptor antagonists”. This includes dolasetron, ondansetron which is used in the same way as Granisetron Hameln to treat and prevent nausea and vomiting.
Seratonin syndrome is a less common but possibly life-threatening reaction that may occur with the use of granisetron (see section 4). The reaction may occur if you take granisetron alone but are more likely to take granisetron with certain other medicines (especially fluoxetine , paroxetine , sertraline , fluvoxamine, citalopram , escitalopram, venlafaxine , duloxetine).
Other medicines and Granisetron Hameln
Tell your doctor, nurse, or pharmacist if you have recently taken or might take any other medicines. This is because Granisetron Hameln may affect the way some medicines work. Some other medicines may also affect the way Granisetron Hameln injection works.
In particular, tell your doctor, nurse, or pharmacist if you are taking any of the following medicines:
– medicines used to treat irregular heartbeats
– other medicines that are ‘5-HT 3 receptor antagonists’ such as dolasetron or ondansetron (see ‘Warnings and Precautions’ above)
phenobarbital, a medicine used to treat epilepsy
– SSRIs (selective serotonin reuptake inhibitors) are used to treat depression and/or anxiety. For example, fluoxetine , paroxetine , sertraline , fluvoxamine, citalopram , escitalopram.
– SNRI ( serotonin -noradrenaline uptake inhibitor) is used to treat depression and/or anxiety. For example venlafaxine , duloxetine.
Pregnancy, breastfeeding and fertility
If you are pregnant, planning to have a baby or breastfeeding, do not use this medicine unless your doctor tells you otherwise.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor, nurse, or pharmacist for advice before taking this medicine.
Driving and using machines
Granisetron Hameln is unlikely to affect your ability to drive or use tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Granisetron Hameln contains excipients
This medicine contains:
- 27.7 mg (or 1.2 mmol) sodium (the main ingredient in table salt / table salt) per 1 ml ampoule . This corresponds to 1.4% of the highest recommended daily intake of sodium for adults.
- 83.1 mg (or 3.6 mmol) of sodium (the main ingredient in table salt / table salt) per 3 ml ampoule . This corresponds to 4.2% of the highest recommended daily intake of sodium for adults.
How to use Granisetron Hameln
A doctor or nurse will give you an injection or an infusion one. Dosage one varies from one patient to another. It depends on your age, weight, and whether you are receiving the medicine to prevent or treat nausea and vomiting. Your doctor will calculate the dose you should receive.
Granisetron Hameln is given as an injection or infusion into the veins ( intravenously ).
Dosage
Usual doses are:
To prevent nausea or vomiting after radiation or chemotherapy
You will receive an injection or infusion before starting radiation therapy or chemotherapy. Injection one or infusion one into the veins will take between 30 seconds ( injection ) and 5 minutes ( infusion ) and dose one will usually be between 1 and 3 mg. The drug will be diluted before being injected.
Treatment for nausea or vomiting after radiotherapy or chemotherapy
Injection one or infusion one will take between 30 seconds ( injection ) and 5 minutes ( infusion ) and dose one will usually be between 1 and 3 mg. The drug will be diluted before being injected or infused into your veins. After receiving the first dose, you may be given more injections or infusions to stop the nausea. There will be at least 10 minutes between each injection. The highest dose of Granisetron you receive is 9 mg per day.
Combination with steroids is
The effect of injection or infusion can be enhanced by the use of medicines called corticosteroids . Steroid one can either be given with a dose between 8 and 20 mg dexamethasone before the radiation or chemotherapy treatment starts or as 250 mg methylprednisolone which will be given both before and after your radiation or chemotherapy treatment.
Use in children to prevent or treat nausea or vomiting after radiotherapy or chemotherapy
Children will receive Granisetron Hameln by injection into your vein as described above. Dose one depends on the weight of the child. The solution for injection will be diluted and given before starting radiation therapy or chemotherapy. Injection one will take 5 minutes. Children will receive a maximum of 2 doses per day at least 10 minutes apart.
Treatment of nausea or vomiting after surgery
Injection one into the veins will take between 30 seconds and 5 minutes and dose one is usually 1 mg. The highest dose of Granisetron Hameln that will be given is 3 mg per day.
Use in children to prevent or treat nausea or vomiting after surgery
Children should not be given this injection to treat nausea or vomiting after surgery .
If you take more Granisetron Hameln than you should
Because an injection or infusion is given to you by a doctor or nurse, it is unlikely that you will receive an overdose. Talk to your doctor or nurse if you are worried. The symptoms of overdose are a mild headache. You will be treated depending on your symptoms.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
Information intended for healthcare professionals is provided at the end of this leaflet.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following problems, see a doctor immediately:
– allergic reactions ( anaphylaxis ). Signs of this may be swelling of the throat, face, lips, and mouth, difficulty breathing, and swallowing.
Other side effects that may occur when you take this medicine are:
Very common: affects more than 1 user in 10
– headache
– constipation. Your doctor will examine you.
Common: affects 1 to 10 users in 100
– sleep problems (insomnia)
– diarrhea.
– changes in how your liver works, shown by blood tests.
Uncommon: affects 1 to 10 users in 1,000
– Skin rash or an allergic skin reaction or hives ( urticaria ). Signs of this may be red, raised itchy rashes.
– Abnormal involuntary movements such as tremors, muscle stiffness, and muscle contractions.
Altered heartbeat (rhythm) and changes seen on ECG (electrical recording of the heart).
– Serotonin syndrome. Symptoms may include diarrhea, nausea, vomiting, fever, high blood pressure, excessive sweating, and rapid heartbeat, agitation, confusion, hallucinations, chills, muscle tremors, twitching or stiffness, loss of coordination, and restlessness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Granisetron Hameln
Keep this medicine out of the sight and reach of children.
No special temperature instructions.
Store ampoule one in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the label and carton. The expiration date is the last day of the specified month.
Do not use this medicine if you notice that the solution is cloudy or has visible particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is granisetron hydrochloride.
Each 1 ml ampoule contains 1 mg of granisetron as hydrochloride in 1 ml of sterile solution.
Each 3 ml ampoule contains 3 mg of granisetron as hydrochloride in 3 ml of sterile solution.
The other ingredients are sodium chloride, citric acid monohydrate, sodium hydroxide, and water for injections.
What the medicine looks like and contents of the pack
Granisetron Hameln concentrate for solution for injection or infusion is a clear, colorless solution.
Pack sizes:
Granisetron Hameln is available in packs of 5 or 10 glass ampoules. One ampoule contains 1 ml or 3 ml of solution.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany
Manufacturer:
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
This medicinal product is authorized under the European Economic Area under the names
| Germany | Granisetron hameln 1 mg / ml |
| Denmark | Granisetron Hameln 1 mg / ml |
| Finland | Granisetron Hameln 1 mg / ml |
| Netherlands | Granisetron hameln 1 mg / ml |
| Portugal | Granite granules Hameln 1 mg / ml |
| Sweden | Granisetron Hameln 1 mg / ml |
| UK | Granisetron Hameln 1 mg / ml |