Gelaspan infusion solution
1. What Is Gelaspan, And What Gelaspan Used For?
Gelaspan is a so-called volume substitute for plasma. This means that it replaces lost fluid in blood circulation.
Gelaspan used for:
- Replace blood and body fluid lost as a result of e.g. an operation, an accident or a burn. It can be used in combination with blood transfusion if needed.
- Prevent low blood pressure ( hypotension ), which may occur with spinal or epidural anesthesia or due to the risk of extensive blood loss in connection with surgery.
- In combination with other infusion fluids, increase the circulating blood volume using e.g. heart-lung machine.
2. What You Need To Know Before Using Gelaspan?
Do Not Use Gelaspan
- If you are allergic to gelatin or any of the other ingredients of this medicine (listed in section 6)
- If you are allergic to an allergen called galactose-α-1,3-galactose (alpha-gal) or to red meat (meat of mammals) and intestinal food
- If your circulating blood volume is too large
- If you have excess fluid in your body
- If you have a certain type of heart failure ( acute congestive heart failure )
- If you have too much potassium in your blood.
Warnings And Cautions
Talk to your doctor, pharmacist, or nurse before receiving Gelaspan. Tell your doctor
- If you have an allergic disease such as asthma . You may then be at greater risk of developing an allergic reaction .
Due to the risk of possible cross-reactions, Gelaspan iv should not be given to you in the following cases
- If you know you are allergic to red meat (meat of mammals) or intestinal foods
- If you have received a positive test result for antibodies ( IgE ) to allergen et alpha-gal
Your doctor should take special care if you suffer from the following:
- Heart disease
- High blood pressure
- Fluid in the lungs
- Severe kidney disease.
These conditions can worsen if you are given large amounts of fluid as a drip into a vein. The doctor prescribes the preparation with caution:
- If the concentration of sodium or chloride in your blood is greatly increased
- of water and salts accumulate in the body, which can cause swelling of the tissue, are
- If you have too much potassium in your blood or if you are taking or receiving medicines that cause the accumulation of potassium
- If the blood’s coagulation capacity is significantly reduced
- If you are older.
During treatment with Gelaspan, the composition of the blood is monitored. Your doctor may also give you other medicines, such as salts and fluids, if necessary.
Children: There is only limited experience with the use of Gelaspan in children. The doctor will give this medicine to children only if necessary.
Results for laboratory tests: Your doctor may take blood or urine samples before giving you Gelaspan iv. This is because some test results may be affected after you have received this medicine and may therefore be unreliable.
Other Medicines And Gelaspan
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Your doctor must know if you are taking or receiving medicines that may cause the following:
- Sodium accumulation eg spironolactone, triamterene, amiloride, ACE inhibitors such as:
- Captopril, or enalapril
- Corticosteroids such as:
- Cortisone or non-steroidal anti-inflammatory drugs such as:
- Diclofenac
- Cortisone or non-steroidal anti-inflammatory drugs such as:
- Concomitant use of this medicine may cause:
- Swelling of the arms, hands, legs, and feet ( edema)
Also, tell your doctor if you are taking medicines that cause potassium loss, e.g. drugs that increase water excretion.
Pregnancy And Breastfeeding
Pregnancy: Tell your doctor if you are pregnant. This medicine should be avoided during pregnancy due to possible allergic reactions. However, your doctor may give you this medicine in an emergency.
Breast-feeding: Tell your doctor if you are breastfeeding. There is limited information on the excretion of this medicine in breast milk. Your doctor will decide if you should stop breastfeeding or treat with this medicine after weighing the benefits of breastfeeding for your baby and the benefits of the treatment.
Fertility: There is no information on the effect of this medicine on the fertility of humans or animals. However, based on the properties of the constituents, fertility is unlikely to be affected.
Driving And Using Machines:
This medicine does not affect the ability to drive and use machines.
3. How To Use Gelaspan?
- Your doctor will only give you Gelaspan if treatment with preparations called crystalloids alone is not considered sufficient.
- Your doctor will carefully adjust the dose of Gelaspan to prevent fluid overload. This is especially true if you have lung, heart, or circulation problems. Dosage
- Gelaspan is given intravenously, ie by drip.
- Adults:
- How much you get and for how long depends on how much blood or fluid you have lost and your condition.
- Your doctor will perform tests (eg on your blood and blood pressure ) during treatment, and dose one of Gelaspan will be tailored to your needs. You can also be given blood or packed red blood cells if necessary.
Use For Children:
There are only limited data from the use of this medicine in children. The doctor will only give this medicine to children if it is necessary for their recovery. In these cases, the child’s clinical condition is con,sidered and the treatment is monitored particularly closely.
If You Take More Gelaspan Than You Should:
- An overdose of Gelaspan can cause excessive blood volume in the body ( hypervolemia ) and fluid overload that can affect heart or lung function.
- You may experience headaches and difficulty breathing.
- In case of an overdose, the doctor will take the necessary measures.
If you have any further questions on using this product, ask your doctor or pharmacist.
4. Possible Gelaspan Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them. All plasma substitutes involve a small risk of allergic reactions, which are usually mild or moderate, but which, in very few cases, can also be serious.
Such reactions are thought to be more common in patients with known allergic conditions such as asthma. For this reason, healthcare professionals will observe you, especially at the beginning of infusion one.
The following side effects can be serious. If you get any of the following side effects, talk to your doctor straight away:
Rare (may affect up to 1 in 1,000 people):
- Allergic (anaphylactic / anaphylactoid) reactions, such as:
Infusion one should be stopped immediately, and you should be given the necessary care in case of an allergic reaction (see also section 2, “What you need to know before using Gelaspan,” especially for allergies involving the allergen et galactose-α-1,3-galactose (alpha-gal), red meat and offal).
Other side effects include:
Very common (may affect up to 1 in 10 people):
- Decreased number of red blood cells and protein in the blood.
Common (may affect up to 1 in 100 people):
- The blood does not clot as well as before, and you may notice that you are bleeding more than before.
Very rare (may affect up to 1 in 10,000 people):
- Palpitation
- Low blood pressure
- Fever
- Chills
Has been reported (occurs in an unknown number of users):
- Nausea
- Vomiting
- Abdominal pain
- Decreased oxygen content in the blood which can cause dizziness.
Additional side effects are in children.
There are no data on any differences in side effects in children.
Reporting of side effects
Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 Gelaspan?
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton after EXP. The expiration date is the last day of the specified month.
- Do not store above 25 ° C. Do not freeze.
- Do not use Gelaspan if you notice that:
- The solution is cloudy or discolored
- The packaging is leaking.
- Opened or partially used Gelaspan packaging must be discarded. Partially used bottles or bags should not be reconnected to the infusion set.
6. Contents Of The Packaging And Other Information:
Content Declaration
The active substances are:
- 1000 ml solution contains:
| Succinylated gelatin (= modified gelatin, liquid) | 40.0 g |
| Sodium chloride | 5.55 g |
| Sodium acetate trihydrate | 3.27 g |
| Potassium chloride | 0.30g |
| Calcium chloride dihydrate | 0.15 g |
| Magnesium chloride hexahydrate | 0.20 g |
| Electrolyte concentrations | |
| Sodium | 151 mmol / l |
| Chloride | 103 mmol / l |
| Potassium | 4 mmol / l |
| Calcium | 1 mmol / l |
| Magnesium | 1 mmol / l |
| Acetate | 24 mmol / l |
- Other ingredients are:
- Water for injections, sodium hydroxide (for pH adjustment), and hydrochloric acid, diluted (for pH adjustment).
What The Medicine Looks Like And Contents Of The Pack?
- Gelaspan solution for infusion is given as an intravenous drip (into a vein).
- Clear, colorless, or slightly yellowish sterile solution.
- Gelaspan infusion solution is available in:
- LDPE bottles (Ecoflac plus) containing 500 ml in packs of 10 × 500 ml
- Plastic bags (Ecobag) (non-PVC) sealed with rubber stopper and containing 500 ml in packs of 20 × 500 ml
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
Postal address
34209 Melsungen, Germany
For any information about this medicine, please get in touch with the local representative of the Marketing Authorization Holder:
B. Braun Medical AB
Box 110
182 12 Danderyd