12 mg solution <\/p>\n\n\n\n
for injection
businesses<\/p>\n\n\n\n
Spinraza contains the active substance\u00a0businesses<\/em>\u00a0which belong to a group of medicines called\u00a0antisense oligonucleotides.\u00a0Spinraza is used to treat a genetic disease called\u00a0spinal\u00a0muscular atrophy<\/em>\u00a0(SMA).<\/p>\n\n\n\n Spinal\u00a0muscular atrophy<\/strong>\u00a0is caused by a lack of a\u00a0protein\u00a0called\u00a0survival<\/em>\u00a0motor neuron, (SMN) in the body.\u00a0This results in loss of nerve cells in the spine, leading to muscle weakness in the shoulders, hips, thighs, and upper back.\u00a0It can also weaken the muscles used for breathing and swallowing.<\/p>\n\n\n\n Spinraza works by making it easier for the body to produce more of the SMN protein that people with SMA lack. This reduces the loss of nerve cells and can improve muscle strength. If you are not sure, talk to your doctor or nurse before giving you or your child Spinraza.<\/a><\/p>\n\n\n\n There is a risk of\u00a0side effects\u00a0occurring after Spinraza is given by lumbar puncture (see section 3).\u00a0These can include headaches, vomiting, and back pain.\u00a0There may also be difficulties in giving drugs through this method in very young patients and those with scoliosis (twisted and curved spine).<\/p>\n\n\n\n Other drugs that are part of the same drug group as Spinraza have been shown to affect the blood cells that cause the blood to clot. Before you or your child are given Spinraza, your doctor may order blood tests to check whether your or your child’s blood is clotting properly. This may not be needed every time you or your child is given Spinraza.<\/p>\n\n\n\n Other drugs in the same drug group as Spinraza have been shown to affect the kidneys. Before you or your child is given Spinraza, your doctor may order urine samples to check whether your or your child’s kidneys are working normally. This may not be needed every time you or your child is given Spinraza.<\/p>\n\n\n\n There have been a small number of reports of patients developing\u00a0hydrocephalus\u00a0(an accumulation of too much fluid around the brain) after receiving Spinraza.\u00a0Some of these patients needed to have a so-called ventriculoperitoneal\u00a0shunt\u00a0implanted to treat\u00a0hydrocephalus.\u00a0If you notice any symptoms of increased head circumference, decreased consciousness, persistent nausea, vomiting or headache, or other symptoms that worry you, tell your or your child’s doctor to get the necessary treatment.\u00a0The benefits and risks of continuing treatment with Spinraza concurrently with an inoperable ventriculoperitoneal\u00a0shunt\u00a0are currently unknown.<\/p>\n\n\n\n Talk to your doctor before giving you or your child Spinraza.<\/a><\/p>\n\n\n\n Tell the doctor if you or your child are taking, have recently taken, or might be taking other medicines.<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being given this medicine.\u00a0The use of Spinraza should be avoided during pregnancy and breastfeeding.<\/p>\n\n\n\n Spinraza has no or negligible effect on the ability to drive and use machines.<\/a><\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg) of\u00a0sodium\u00a0per 5 ml\u00a0vial, i.e. it is almost “sodium-free” and can be used by patients who have been prescribed a low-salt diet.<\/p>\n\n\n\n This medicine contains less than 1 mmol of\u00a0potassium\u00a0(39 mg) per 5 ml\u00a0vial, i.e. it is almost “potassium-free”. The normal dose of Spinraza is 12 mg.<\/p>\n\n\n\n How Spinraza is given:<\/p>\n\n\n\n Spinraza is given as an\u00a0injection\u00a0into the lower back.\u00a0This\u00a0injection, called a lumbar puncture, is performed by inserting a cannula into the space around the spinal cord.\u00a0This is done by a doctor who is experienced in performing lumbar punctures.\u00a0You or your child may also be given medicine to make you relax or sleep during the procedure.<\/p>\n\n\n\n How long Spinraza is used<\/strong><\/p>\n\n\n\n Your doctor will tell you how long you or your child will need to receive Spinraza. Do not stop treatment with Spinraza unless your doctor advises you to do so.<\/p>\n\n\n\n If you or your child miss an injection<\/strong><\/p>\n\n\n\n If you or your child have missed a dose of Spinraza, talk to your doctor to make sure Spinraza can be given as soon as possible.<\/p>\n\n\n\n If you have any questions about how Spinraza is given, ask your doctor.<\/a><\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Side effects related to lumbar puncture may occur when Spinraza is given or shortly thereafter. Most of these side effects have been reported within 72 hours of the procedure.<\/p>\n\n\n\n Very common (may affect more than 1 in 10 people)<\/p>\n\n\n\n Other\u00a0side effects\u00a0are<\/strong><\/p>\n\n\n\n Frequency not known (cannot be estimated from available data)<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Use before the expiry date which is stated on the vial and carton after “EXP”. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0C to 8 \u00b0C). Do not freeze.<\/p>\n\n\n\n Store the vial in the outer carton. Light sensitive.<\/p>\n\n\n\n If a refrigerator is not available, Spinraza should be stored in its original carton, protected from light, at or below 30\u00b0C for a maximum of 14 days.<\/p>\n\n\n\n Unopened vials of Spinraza can be removed from and returned to the refrigerator as needed. If the vial is removed from the original carton, the total time outside the refrigerator must not exceed 30 hours, at a temperature not exceeding 25 \u00b0C.<\/a><\/p>\n\n\n\n Spinraza is a clear, colorless\u00a0solution for injection.<\/p>\n\n\n\n Each carton of Spinraza contains one\u00a0vial.<\/p>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat you need to know before you or your child is given Spinraza<\/h2>\n\n\n\n
Spinraza must not be given:<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Other medicines and Spinraza<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Spinraza contains a small amount of sodium and potassium<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow Spinraza is given<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Spinraza<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n