1 mg / ml injection solution
hydroxocobalamin
1. What Hydroxocobalamin Alternova is and what it is used for
Hydroxocobalamin Alternova is a B 12 vitamin preparation. The active substance of the preparation is hydroxocobalamin.
Hydroxocobalamin Alternova is given for pernicious anemia (a special type of anemia that occurs with vitamin B 12 deficiency ) and for other types of vitamin B 12 deficiency when tablets are not considered sufficient.
Hydroxocobalamin Alternova can also be used to investigate whether B 12 can be absorbed from the intestine (flush dose in Schilling test).
Hydroxocobalamin contained in Hydroxocobalamin Alternova may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you use Hydroxocobalamin Alternova
Do not use Hydroxocobalamin Alternova
- if you are allergic to hydroxocobalamin or any of the other ingredients of this medicine (listed in section 6).
Other medicines and Hydroxocobalamin Alternova
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
This is especially important if you are taking:
- birth control pills . The pill can reduce the amount of B 12 – vitamin in the blood.
- medicines for infection (the most common antibiotics , pyrimethamine, chloramphenicol, aminoglycosides , paraaminosalicylic acid)
- if you eat / drink large amounts of vitamin C / ascorbic acid, then it may reduce the absorption of vitamin B 12
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Hydroxocobalamin Alternova can be used during pregnancy and lactation.
Hydroxocobalamin Alternova is excreted in human milk but the risk of adverse effects on the infant appears to be unlikely with therapeutic doses.
Driving and using machines
Hydroxocobalamin Alternova does not affect your ability to drive or use machines.
Hydroxocobalamin Alternova contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free.
How to use Hydroxocobalamin Alternova
Always use this medicine exactly as your doctor or nurse has told you. If you are not sure, talk to your doctor or nurse.
Hydroxocobalamin Alternova is injected into a muscle or under the skin. The medicine is given by a nurse or doctor.
Your doctor will determine the appropriate dosage and duration of treatment for your illness.
If you use more Hydroxocobalamin Alternova than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Contact your doctor or nurse if you think you have been given too much Hydroxocobalamin Alternova.
Overdoses usually do not cause any symptoms.
If you forget to use Hydroxocobalamin Alternova
Contact a doctor or nurse if you think a dose has been missed.
If you stop using Hydroxocobalamin Alternova
Contact your doctor if you want to stop treatment.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if the following serious side effects occur:
Has been reported (occurs in an unknown number of users:
- Sudden hypersensitivity / allergic reactions including skin reactions (eg rash, itching ), in rare cases anaphylactic reaction ( allergic reaction ) – life threatening
Has been reported (occurs in an unknown number of users:
- Blood disease (reactive thrombocytosis ) may occur during the first weeks of use in pernicious anemia .
- Palpitations due to potassium deficiency ( hypokalaemia ).
- Nausea, vomiting, diarrhea.
- Acne rash and blisters.
- Headache.
- Tremors.
- Emotional disorders such as tingling
- Discoloration of the urine
Fever, chills, feeling hot, redness, dizziness, malaise, pain.
Injection site reactions such as pain, redness, itching, hardening, and swelling
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 Hydroxocobalamin Alternova
No special storage instructions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
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 hydroxocobalamin
- The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
Hydroxocobalamin Alternova, 1 mg / ml solution for injection is a red, clear solution.
Carton containing:
1 brown glass ampoule with 1 ml.
3 brown glass ampoules are with 1 ml.
5 brown glass ampoules are with 1 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Alternova A / S
Lodshusvej 11
4230 Skælskør
Denmark
Manufacturer
Biologists Italia Laboratories SRL
Via Filippo Serpero 2 20060 Masate (Milano)
Italy