bhpardo/ema_en · Datasets at Hugging Face

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4.8 Undesirable effects
8.4
Choose one day of the month that will be easy to remember:
NAME OF THE MEDICINAL PRODUCT
Your doctor will consider warnings and precautions associated with autologous blood predonation, especially volume replacement.
©EMEA 2006
Once the needle has been inserted completely, release your grasp of the skin.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
4.1 Therapeutic indications
PHARMACOLOGICAL PROPERTIES
There is no accumulation: the levels remain the same, whether they are determined 24 hours after the first injection or 24 hours after the last injection.
After reconstitution, each ml solution for injection contains approximately 300 IU octocog alfa. * The potency (International Units) is determined using the chromogenic assay against an in-house standard that is referenced to the WHO standard.
Do not use vials exhibiting foreign particles or discoloration.
CLINICAL PARTICULARS
Local skin reactions can be a sign that the drug is working as intended.
Amgen Europe B. V.
Do not store above 25°C.
Reproduction is authorised provided the source is acknowledged. unable to grow.
Other adverse reactions reported at a lower frequency are as follows:
BAXTER AG Industriestrasse 67 A-1220 Vienna Austria
In this study, the time to 20% of total AUC and the AUC (0-2h) representing the early glucose lowering activity were respectively of 114 minutes and 427mg. kg-1 for insulin glulisine, 121 minutes and 354mg. kg-1 for lispro, 150 minutes and 197mg. kg-1 for regular human insulin (see figure 2).
In clinical pharmacology trial WP18551, after a single dose intravenous administration of 6 mg (15 minutes infusion), mean AUC0-24 increased by 14% and 86%, respectively, in subjects with mild (mean estimated CLcr=68.1 mL/ min) and moderate (mean estimated CLcr=41.2 mL/ min) renal impairment compared to healthy volunteers (mean estimated CLcr=120 mL/ min).
Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction with other medicinal products by protein binding displacement are expected.
For subcutaneous use Read the package leaflet before use.
Intramuscular use
36 A.
These strengths are supplied in blister packs containing 14, 28, 56, 2x56, 3x56 or 180 film-coated tablets.
12.
For intravenous or subcutaneous use Read the package leaflet before use.
The dosage should therefore be reduced in these patients (see section 4.2).
MANUFACTURING AUTHORISATION HOLDERRESPONSIBLE FOR BATCH RELEASE
Poorly controlled hypertension.
At the end of this period, the product should not be put back in the refrigerator, but should be used or discarded.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
By inhibiting the protease enzyme APTIVUS helps control HIV infection.
Resuspending is easier when the insulin has reached room temperature.
B.
MARKETING AUTHORISATION NUMBERS
Lot {number}
Sodium starch glycollate (Type A) hypromellose microcrystalline cellulose lactose monohydrate magnesium stearate.
11.
The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy.
60-100
(≥ 1/ 10)
- The active substance is desloratadine 2.5 mg
Psychiatric disorders
8.
Metabolism and nutrition disorders
Clinical studies have demonstrated that darbepoetin alfa had similar effectiveness when administered as a single injection either once every three weeks, once every two weeks, or weekly without any increase in total dose requirements.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
2.
Median peak maraviroc plasma concentrations is attained at 2 hours (range 0.5-4 hours) following single oral doses of 300 mg commercial tablet administered to healthy volunteers.
METHOD AND ROUTE(S) OF ADMINISTRATION
4.7 Effects on ability to drive and use machines
Hypertensive crisis with encephalopathy-like symptoms can occur.
NAME OF THE MEDICINAL PRODUCT
6.
The following injections may be self-administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention.
Actraphane 50 NovoLet is designed to be used with NovoFine needles.
- If you have heart failure.
MPA is metabolised principally by glucuronyl transferase to form the phenolic glucuronide of MPA (MPAG), which is not pharmacologically active.
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Nasal use
Nervous system disorders
No data are available on the efficacy of entecavir in HBeAg-negative patients co-infected with HIV.
Why has Aldara been approved?
SOLVENT PRE-FILLED SYRINGE LABEL
You should not be given Aclasta
Tumour growth potential
Ask your doctor or pharmacist for advice before taking ABILIFY.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
13.
Abseamed 10 000 IU/ 1 ml solution for injection in a pre-filled syringe
EXPIRY DATE
Each pack also contains one transfer needle and one filter needle.
Astellas Pharma Europe B. V.
METHOD AND ROUTE OF ADMINISTRATION
Driving and using machines You can drive and use machines as it’s very unlikely that Bondenza will affect your ability to drive and use machines.
2.

4.8 Undesirable effects

8.4

Choose one day of the month that will be easy to remember:

NAME OF THE MEDICINAL PRODUCT

Your doctor will consider warnings and precautions associated with autologous blood predonation, especially volume replacement.

©EMEA 2006

Once the needle has been inserted completely, release your grasp of the skin.

Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.

4.1 Therapeutic indications

PHARMACOLOGICAL PROPERTIES

There is no accumulation: the levels remain the same, whether they are determined 24 hours after the first injection or 24 hours after the last injection.

After reconstitution, each ml solution for injection contains approximately 300 IU octocog alfa. * The potency (International Units) is determined using the chromogenic assay against an in-house standard that is referenced to the WHO standard.

Do not use vials exhibiting foreign particles or discoloration.

CLINICAL PARTICULARS

Local skin reactions can be a sign that the drug is working as intended.

Amgen Europe B. V.

Do not store above 25°C.

Reproduction is authorised provided the source is acknowledged. unable to grow.

Other adverse reactions reported at a lower frequency are as follows:

BAXTER AG Industriestrasse 67 A-1220 Vienna Austria

In this study, the time to 20% of total AUC and the AUC (0-2h) representing the early glucose lowering activity were respectively of 114 minutes and 427mg. kg-1 for insulin glulisine, 121 minutes and 354mg. kg-1 for lispro, 150 minutes and 197mg. kg-1 for regular human insulin (see figure 2).

In clinical pharmacology trial WP18551, after a single dose intravenous administration of 6 mg (15 minutes infusion), mean AUC0-24 increased by 14% and 86%, respectively, in subjects with mild (mean estimated CLcr=68.1 mL/ min) and moderate (mean estimated CLcr=41.2 mL/ min) renal impairment compared to healthy volunteers (mean estimated CLcr=120 mL/ min).

Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction with other medicinal products by protein binding displacement are expected.

For subcutaneous use Read the package leaflet before use.

Intramuscular use

36 A.

These strengths are supplied in blister packs containing 14, 28, 56, 2x56, 3x56 or 180 film-coated tablets.

12.

For intravenous or subcutaneous use Read the package leaflet before use.

The dosage should therefore be reduced in these patients (see section 4.2).

MANUFACTURING AUTHORISATION HOLDERRESPONSIBLE FOR BATCH RELEASE

Poorly controlled hypertension.

At the end of this period, the product should not be put back in the refrigerator, but should be used or discarded.

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

By inhibiting the protease enzyme APTIVUS helps control HIV infection.

Resuspending is easier when the insulin has reached room temperature.

B.

MARKETING AUTHORISATION NUMBERS

Lot {number}

Sodium starch glycollate (Type A) hypromellose microcrystalline cellulose lactose monohydrate magnesium stearate.

11.

The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy.

60-100

(≥ 1/ 10)

- The active substance is desloratadine 2.5 mg

Psychiatric disorders

8.

Metabolism and nutrition disorders

Clinical studies have demonstrated that darbepoetin alfa had similar effectiveness when administered as a single injection either once every three weeks, once every two weeks, or weekly without any increase in total dose requirements.

The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).

2.

Median peak maraviroc plasma concentrations is attained at 2 hours (range 0.5-4 hours) following single oral doses of 300 mg commercial tablet administered to healthy volunteers.

METHOD AND ROUTE(S) OF ADMINISTRATION

4.7 Effects on ability to drive and use machines

Hypertensive crisis with encephalopathy-like symptoms can occur.

NAME OF THE MEDICINAL PRODUCT

6.

The following injections may be self-administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention.

Actraphane 50 NovoLet is designed to be used with NovoFine needles.

- If you have heart failure.

MPA is metabolised principally by glucuronyl transferase to form the phenolic glucuronide of MPA (MPAG), which is not pharmacologically active.

Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).

Nasal use

Nervous system disorders

No data are available on the efficacy of entecavir in HBeAg-negative patients co-infected with HIV.

Why has Aldara been approved?

SOLVENT PRE-FILLED SYRINGE LABEL

You should not be given Aclasta

Tumour growth potential

Ask your doctor or pharmacist for advice before taking ABILIFY.

DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION

13.

Abseamed 10 000 IU/ 1 ml solution for injection in a pre-filled syringe

EXPIRY DATE

Each pack also contains one transfer needle and one filter needle.

Astellas Pharma Europe B. V.

METHOD AND ROUTE OF ADMINISTRATION

Driving and using machines You can drive and use machines as it’s very unlikely that Bondenza will affect your ability to drive and use machines.

2.